domenicrosati/clinical_trial_texts · Datasets at Hugging Face

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full study rank 61917 study protocol section identification module n c t id NCT04830228 org study id info org study id C1903 organization org full name Biotronik AG org class INDUSTRY brief title BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions official title BIOTRONIK Dynetic-35 for the Treatment of Peripheral Iliac Lesions, Using the Cobalt Chromium Balloon-expandable Dynetic-35 Stent in Association With Passeo-35 Xeo Peripheral Dilation Catheter acronym BIONETIC-I status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 10, 2021 start date type Actual primary completion date struct primary completion date September 2023 primary completion date type Anticipated completion date struct completion date September 2027 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 19, 2022 last update post date struct last update post date July 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Biotronik AG lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions detailed description Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries conditions module condition list condition Peripheral Artery Disease keyword list keyword Iliac arteries design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 159 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name Ballon expandable stent and PTA intervention description Endovascular treatment for the peripheral artery disease of the Iliac artery outcomes module primary outcome list primary outcome primary outcome measure MAE at 12 months post-index procedure. primary outcome description The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure. primary outcome time frame 12 Months eligibility module eligibility criteria Inclusion Criteria: Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements De novo, restenotic, occluded or in-stent lesion(s) representing atherosclerotic lesion(s) in the iliac arteries Reference lumen (vessel) diameter between 5mm and 10 mm The target lesion can be successfully crossed with a guide wire The target lesion length is ≤ 100 mm Subjects has more than 70% stenosis in target lesion Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb or limbs Exclusion Criteria: Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study. Subject is with a current medical condition with a life expectancy of less than one year. Pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, has intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring EVAR (Endovascular Aneurysm Repair) treatment The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet. Refuses blood transfusion Chronic renal insufficiency (eGFR < 30 mL/min within 72 hours prior to index procedure) Subject has IFU listed contraindication(s) healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population The study will enroll subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo, restenotic and in-stent atherosclerotic lesions in iliac arteries sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Damon Judges central contact role Contact central contact phone 0754295286 central contact phone ext +41 central contact e mail damon.judges@biotronik.com overall official list overall official overall official name Marianne Brodmann, Prof. Dr. overall official affiliation Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine overall official role Principal Investigator location list location location facility LKH Univ.-Klinikum Graz, Ambulanz für Angiologie location status Recruiting location city Graz location country Austria location contact list location contact location contact name Marianne Brodmann, Prof Dr location contact role Contact location facility Zol Genk location status Recruiting location city Genk location zip 3600 location country Belgium location contact list location contact location contact name Wouter Lansink, Dr location contact role Contact location facility UZ Gent location status Recruiting location city Gent location zip 9000 location country Belgium location contact list location contact location contact name Nathlie Moreels, Dr location contact role Contact location facility Regionaal Ziekenhuis Heilig Hart Tienen location status Recruiting location city Tienen location country Belgium location contact list location contact location contact name Koen Keirse, MD location contact role Principal Investigator location facility Az Jan Potaels Vilvoorde location status Recruiting location city Vilvoorde location zip 1800 location country Belgium location contact list location contact location contact name Jorn Robijn, Dr location contact role Contact location facility Hôpital Privé du grand Narbonne location status Recruiting location city Narbonne location zip 11100 location country France location contact list location contact location contact name Bertrand Saint-Lebes, Dr location contact role Contact location facility Hôpital Ambroise Paré location status Recruiting location city Paris location country France location contact list location contact location contact name Raphaël Coscas, Prof. Dr location contact role Principal Investigator location facility Klinikum Bayreuth location status Recruiting location city Bayreuth location zip 95445 location country Germany location contact list location contact location contact name Thomas Hüttner, Dr. location contact role Contact location facility Diakonissenkrankenhaus location status Recruiting location city Flensburg location zip 24939 location country Germany location contact list location contact location contact name Stefan Müller-Hülsbeck, Prof. Dr. location contact role Contact location facility St. Franziskushospital Münster location status Recruiting location city Münster location zip 48145 location country Germany location contact list location contact location contact name Martin Austermann, Prof. Dr. location contact role Contact location facility Universitätsklinikum Tübingen location status Recruiting location city Tübingen location zip 72076 location country Germany location contact list location contact location contact name Gerd Grözinger, Prof. Dr. location contact role Contact location facility Semmelweis University Hospital location status Not yet recruiting location city Budapest location country Hungary location contact list location contact location contact name Balázs Nemes, Dr location contact role Principal Investigator location facility Pauls Stradins Clinical University Hospital location status Recruiting location city Riga location country Latvia location contact list location contact location contact name kārlis kupčs, Prof. location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000058729 condition mesh term Peripheral Arterial Disease condition ancestor list condition ancestor condition ancestor id D000050197 condition ancestor term Atherosclerosis condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000016491 condition ancestor term Peripheral Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M28366 condition browse leaf name Peripheral Arterial Disease condition browse leaf as found Peripheral Artery Disease condition browse leaf relevance high condition browse leaf id M6444 condition browse leaf name Dilatation, Pathologic condition browse leaf relevance low condition browse leaf id M18046 condition browse leaf name Peripheral Vascular Diseases condition browse leaf relevance low condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M5249 intervention browse leaf name Chromium intervention browse leaf relevance low intervention browse leaf id M5417 intervention browse leaf name Cobalt intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals	NCT04830228	[ 101, 1554, 2025, 3997, 5391, 1580, 16770, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 13144, 20581, 1604, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 140, 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full study rank 61396 study protocol section identification module n c t id NCT04837014 org study id info org study id F11-70846 organization org full name McGill University Health Centre/Research Institute of the McGill University Health Centre org class OTHER brief title Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery official title Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial acronym eNARCOS status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 4, 2022 start date type Actual primary completion date struct primary completion date April 2023 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 6, 2022 last update post date struct last update post date September 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Andrew Zakhari responsible party investigator title Principal Investigator responsible party investigator affiliation McGill University Health Centre/Research Institute of the McGill University Health Centre lead sponsor lead sponsor name McGill University Health Centre/Research Institute of the McGill University Health Centre lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Laparoscopic gynecologic surgeries are generally very well tolerated procedures, and patients are able to go home on the same day, with a prescription for pain control. There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery, and patients are going home with anything from zero to 5 or even 20 tabs of narcotics. Aside from negative side effect of opioids (like nausea/vomiting, dizziness, constipation, and possibly addiction), unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community, worsening an ongoing nationwide opioid crisis. Although most patients report low pain level following these kinds of procedure, there are no current standard prescriptions after gynecologic laparoscopy. In an effort to standardize discharge prescriptions following gynecologic laparoscopy, this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery. There will be 2 standardized set of discharge prescriptions to which patient will be randomized; both containing multimodal medications for pain control. Pain control, and patients satisfaction will be measured in the first post-operative week. detailed description Narcotic prescribing patterns vary greatly among gynecologists performing minimally invasive gynecologic surgery (MIGS). There is no clear consensus or established guideline regarding the choice of narcotic or total amount to be prescribed, if any, for MIGS. These represent a generally well-tolerated group of procedures that are less painful than conventional open surgery. Unnecessary opioid prescriptions and excess unused narcotics have been identified as major contributors to narcotic abuse in the community, and efforts geared towards minimizing unnecessary narcotic prescriptions may help curb the growing opioid crisis. This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients. Given the general tolerability and low pain associated with MIGS, the investigators hypothesize that elimination of narcotics from post-operative pain control, in conjunction with regular use of non-narcotic analgesics, will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription. Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria. Patients will be randomly allocated to either intervention or control groups in a one to one fashion. Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol. Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability. Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone, with regular non-opioid analgesic use. All patient will be contacted on day one and seven after surgery to evaluate pain scores, mobility, adequacy of analgesia, adherence to treatment, side-effects, and total opioid consumption. conditions module condition list condition Pain, Postoperative Opioid Use keyword list keyword Gynecology Minimally invasive surgery Laparoscopy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description In this randomized controlled trial, consented patient will be randomly allocated to either intervention or control groups in a 1:1 fashion. Allocation will be determined by a computerized randomization generator with block randomization in groups of four. Allocations will be placed in sequentially numbered, sealed, opaque envelopes to be opened only upon completion of surgery of consenting patients. design primary purpose Prevention design masking info design masking Double design masking description Although the patient and operative team will not be blinded to the allocation, the research team member completing the post-operative questionnaires as well as the statistician responsible for data analysis will remain blinded to the allocation. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Acetaminophen and naproxen only arm arm group type Experimental arm group description Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. arm group intervention list arm group intervention name Other: prescription for regular acetaminophen and naproxen arm group label Acetaminophen, naproxen and dilaudid arm arm group type Active Comparator arm group description Patient allocated to the control group will be discharged home with a prescription for regular acetaminophen, naproxen, and 5 tabs of hydromorphone 1 mg, with instruction to prioritize non opioid analgesic as first line. arm group intervention list arm group intervention name Other: prescription for regular acetaminophen , naproxen and dilaudid intervention list intervention intervention type Other intervention name prescription for regular acetaminophen and naproxen intervention description Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then prn for one week's duration. No narcotic will be prescribed at discharge post-operatively. intervention arm group label list intervention arm group label Acetaminophen and naproxen only arm intervention type Other intervention name prescription for regular acetaminophen , naproxen and dilaudid intervention description prescription for regular acetaminophen , naproxen and dilaudid intervention arm group label list intervention arm group label Acetaminophen, naproxen and dilaudid arm outcomes module primary outcome list primary outcome primary outcome measure Pain score on post-operative day one primary outcome description The primary outcome of this study is patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day two, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control). primary outcome time frame Post-operative day one secondary outcome list secondary outcome secondary outcome measure Patient mobility and satisfaction of analgesia secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be asked a standardised set of questions binary question (Yes / No) to evaluate patient mobility and satisfaction of analgesia. secondary outcome time frame Post-operative day one and seven secondary outcome measure Total narcotic consumption in the first post-operative week secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be asked total amount of narcotic consumed since discharge from the hospital, including need for rescue prescription secondary outcome time frame Post-operative day seven secondary outcome measure Opioid related side effect secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be inquired about specific opioid side effect. secondary outcome time frame First post-operative week (Day 7) secondary outcome measure Unplanned return to emergency room / clinic secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be inquired about any unplanned visit to emergency room / clinic since discharged from the hospital. secondary outcome time frame First post-operative week (Day 7) secondary outcome measure Overall satisfaction with pain control secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be asked about overall satisfaction with pain control via standardised questionnaire. secondary outcome time frame First post-operative week (Day 7) secondary outcome measure Pain score on post-operative day one secondary outcome description Patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day one, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control). secondary outcome time frame Post-operative day 7 eligibility module eligibility criteria Inclusion Criteria: Women undergoing elective outpatient gynecologic laparoscopy Able to provide informed consent Planned for same day discharge Exclusion Criteria: Chronic pain conditions including, but not limited to: chronic pelvic pain, fibromyalgia, connective tissue disorders, migraines on medication, severe osteoarthritis, sciatica, degenerative disk disease Regular use of analgesia or narcotics. Defined as use of pain medication on most days of the week, most weeks of the month History of substance abuse (opioid addiction, IV drug use, etc.) Known depression or anxiety conditions with or without medication Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater Current or recent use of pain modulators such as pregabalin or gabapentin (one month pre-operatively). Allergy or contraindication to acetaminophen or NSAIDs or hydromorphone/narcotics Intraoperative complications : Conversion to laparotomy or mini-laparotomy > 4 cm Intra-operative gastrointestinal or urologic injury Intra-operative hemorrhage or need for blood transfusion Need for admission healthy volunteers Accepts Healthy Volunteers gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Andrew Zakhari, M.D. central contact role Contact central contact phone 5142288889 central contact e mail andrew.zakhari@mcgill.ca central contact name Jade Desilets, M.D. central contact role Contact central contact phone 5143583147 central contact e mail jade.desilets@mail.mcgill.ca overall official list overall official overall official name Andrew Zakhari, M.D. overall official affiliation McGill University Health Centre/Research Institute of the McGill University Health Centre overall official role Principal Investigator location list location location facility McGill University Health Center location status Recruiting location city Montreal location state Quebec location zip H4A 3J1 location country Canada location contact list location contact location contact name Andrew Zakhari, M.D. location contact role Contact location contact phone (514) 228-8889 location contact e mail andrew.zakhari@mcgill.ca location contact name Andrew Zakhari, M.D. location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Pain, Postoperative condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000000082 intervention mesh term Acetaminophen intervention mesh id D000009288 intervention mesh term Naproxen intervention mesh id D000004091 intervention mesh term Hydromorphone intervention ancestor list intervention ancestor intervention ancestor id D000018712 intervention ancestor term Analgesics, Non-Narcotic intervention ancestor id D000000700 intervention ancestor term Analgesics intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000058633 intervention ancestor term Antipyretics intervention ancestor id D000000894 intervention ancestor term Anti-Inflammatory Agents, Non-Steroidal intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000006074 intervention ancestor term Gout Suppressants intervention ancestor id D000016861 intervention ancestor term Cyclooxygenase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000701 intervention ancestor term Analgesics, Opioid intervention ancestor id D000009294 intervention ancestor term Narcotics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention browse leaf list intervention browse leaf intervention browse leaf id M2341 intervention browse leaf name Acetaminophen intervention browse leaf as found Of each intervention browse leaf relevance high intervention browse leaf id M11391 intervention browse leaf name Naproxen intervention browse leaf as found Mode intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M6427 intervention browse leaf name Hydromorphone intervention browse leaf as found Spatial intervention browse leaf relevance high intervention browse leaf id M11397 intervention browse leaf name Narcotics intervention browse leaf relevance low intervention browse leaf id M19939 intervention browse leaf name Analgesics, Non-Narcotic intervention browse leaf relevance low intervention browse leaf id M28329 intervention browse leaf name Antipyretics intervention browse leaf relevance low intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M3370 intervention browse leaf name Anti-Inflammatory Agents, Non-Steroidal intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M18361 intervention browse leaf name Cyclooxygenase Inhibitors intervention browse leaf relevance low intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Antipy intervention browse branch name Antipyretics intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants	NCT04837014	[ 101, 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24262, 1110, 1141, 1104, 1103, 1558, 19492, 1106, 9468, 19878, 14426, 6704, 1107, 1103, 1661, 117, 4146, 3381, 1126, 7173, 9708, 11769, 2660, 2386, 5532, 119, 1966, 1211, 4420, 2592, 1822, 2489, 1634, 1378, 1292, 7553, 1104, 7791, 117, 1175, 1132, 1185, 1954, 2530, 24259, 1116, 1170, 176, 10941, 2528, 13791, 1596, 4443, 14452, 11428, 5005, 119, 1130, 1126, 3098, 1106, 2530, 3708, 12398, 24259, 1116, 1378, 176, 10941, 2528, 13791, 1596, 4443, 14452, 11428, 5005, 117, 1142, 2025, 8469, 1106, 1525, 1126, 17307, 6716, 1179, 1111, 2489, 1654, 1107, 1103, 2112, 118, 13035, 1669, 1378, 4443, 14452, 21442, 176, 10941, 2528, 13791, 1596, 6059, 119, 1247, 1209, 1129, 123, 18013, 1383, 1104, 12398, 24259, 1116, 1106, 1134, 5351, 1209, 1129, 7091, 2200, 132, 1241, 4051, 4321, 3702, 6919, 23897, 1111, 2489, 1654, 119, 13304, 1654, 117, 1105, 4420, 10241, 1209, 1129, 7140, 1107, 1103, 1148, 2112, 118, 13035, 1989, 119, 6448, 6136, 11896, 19878, 14426, 3073, 1116, 27362, 6692, 7907, 5958, 1621, 176, 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1129, 15207, 1313, 1114, 170, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 1105, 22956, 2180, 25926, 1111, 3615, 2005, 117, 1105, 1173, 1112, 1834, 1111, 1141, 1989, 112, 188, 9355, 119, 7195, 9080, 1107, 1654, 1372, 1209, 1129, 12398, 1114, 170, 2530, 24259, 1104, 1421, 27629, 4832, 1104, 122, 17713, 177, 19694, 26271, 9293, 117, 1114, 2366, 1664, 118, 11769, 2660, 2386, 24443, 7562, 1596, 1329, 119, 1398, 5351, 1209, 1129, 12017, 1113, 1285, 1141, 1105, 1978, 1170, 6059, 1106, 17459, 2489, 7432, 117, 16178, 117, 8050, 1162, 13284, 3457, 1104, 24443, 7562, 1465, 117, 8050, 21634, 1106, 3252, 117, 1334, 118, 3154, 117, 1105, 1703, 11769, 2660, 2386, 8160, 119, 2975, 13196, 3879, 2190, 3879, 13304, 117, 3799, 19807, 5838, 9126, 2660, 2386, 11696, 2501, 12565, 2190, 2501, 12565, 144, 10941, 12241, 14393, 7435, 1193, 19849, 6059, 2001, 17482, 2155, 20739, 1902, 13196, 2025, 2076, 11300, 21987, 1348, 4065, 2190, 4065, 1753, 138, 8661, 9538, 2165, 1902, 23992, 1902, 18205, 19441, 2200, 1902, 9108, 2235, 23994, 4838, 1233, 1249, 19638, 1880, 1902, 9108, 2235, 6136, 1130, 1142, 7091, 2200, 4013, 3443, 117, 9635, 1174, 5351, 1209, 1129, 19729, 11117, 1106, 1719, 9108, 1137, 1654, 2114, 1107, 170, 122, 131, 122, 4633, 119, 1398, 13335, 1891, 1209, 1129, 3552, 1118, 170, 2775, 2200, 7091, 2734, 14622, 1114, 3510, 7091, 2734, 1107, 2114, 1104, 1300, 119, 1398, 13335, 6006, 1209, 1129, 1973, 1107, 14516, 21967, 1193, 8324, 117, 10410, 117, 11769, 23911, 11427, 1116, 1106, 1129, 1533, 1178, 1852, 6026, 1104, 6059, 1104, 9635, 1158, 4420, 119, 1902, 2425, 3007, 18461, 1902, 7739, 1158, 23992, 1902, 7739, 1158, 8543, 1902, 7739, 1158, 6136, 1966, 1103, 5351, 1105, 13035, 1264, 1209, 1136, 1129, 24255, 1106, 1103, 18205, 117, 1103, 1844, 1264, 1420, 7332, 1103, 2112, 118, 13035, 2304, 24730, 1116, 1112, 1218, 1112, 1103, 188, 19756, 5562, 1811, 2784, 1111, 2233, 3622, 1209, 3118, 24255, 1106, 1103, 18205, 119, 1902, 1150, 19970, 2190, 1902, 1150, 19970, 1130, 5710, 3121, 25524, 1766, 3929, 19191, 1116, 1249, 8830, 21484, 10803, 23992, 10803, 5099, 2908, 10803, 2076, 8329, 6617, 16963, 1181, 1739, 22496, 13196, 1981, 1372, 2190, 1981, 1372, 1981, 1372, 3107, 12860, 20284, 4559, 27801, 1179, 1105, 22956, 2180, 25926, 1178, 1981, 1981, 1372, 2076, 17635, 1981, 1372, 6136, 7195, 9080, 11117, 1106, 1103, 9108, 1981, 1209, 1129, 15207, 1313, 1114, 170, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 1105, 22956, 2180, 25926, 1111, 3615, 2005, 117, 1105, 1173, 1112, 1834, 1111, 1141, 1989, 112, 188, 9355, 119, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 2189, 131, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 1105, 22956, 2180, 25926, 1981, 1372, 3107, 12860, 20284, 4559, 27801, 1179, 117, 22956, 2180, 25926, 1105, 4267, 15554, 3309, 1181, 1981, 1981, 1372, 2076, 17244, 3291, 8223, 4626, 2772, 1981, 1372, 6136, 7195, 9080, 11117, 1106, 1103, 1654, 1372, 1209, 1129, 15207, 1313, 1114, 170, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 117, 22956, 2180, 25926, 117, 1105, 126, 27629, 4832, 1104, 177, 19694, 26271, 9293, 122, 17713, 117, 1114, 8235, 1106, 2988, 17030, 3171, 1664, 11769, 2660, 2386, 24443, 7562, 1596, 1112, 1148, 1413, 119, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 2189, 131, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 117, 22956, 2180, 25926, 1105, 4267, 15554, 3309, 1181, 9108, 2190, 9108, 9108, 2076, 2189, 9108, 1271, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 1105, 22956, 2180, 25926, 9108, 6136, 7195, 9080, 11117, 1106, 1103, 9108, 1981, 1209, 1129, 15207, 1313, 1114, 170, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 1105, 22956, 2180, 25926, 1111, 3615, 2005, 117, 1105, 1173, 185, 4558, 1111, 1141, 1989, 112, 188, 9355, 119, 1302, 9468, 19878, 14426, 1209, 1129, 17421, 1120, 12398, 2112, 118, 13035, 1193, 119, 9108, 1981, 1372, 3107, 2190, 9108, 1981, 1372, 3107, 12860, 20284, 4559, 27801, 1179, 1105, 22956, 2180, 25926, 1178, 1981, 9108, 2076, 2189, 9108, 1271, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 117, 22956, 2180, 25926, 1105, 4267, 15554, 3309, 1181, 9108, 6136, 24259, 1111, 2366, 20839, 20284, 4559, 27801, 1179, 117, 22956, 2180, 25926, 1105, 4267, 15554, 3309, 1181, 9108, 1981, 1372, 3107, 2190, 9108, 1981, 1372, 3107, 12860, 20284, 4559, 27801, 1179, 117, 22956, 2180, 25926, 1105, 4267, 15554, 3309, 1181, 1981, 13950, 13196, 2425, 9386, 2190, 2425, 9386, 2425, 9386, 4929, 13304, 2794, 1113, 2112, 118, 13035, 1285, 1141, 2425, 9386, 6136, 1109, 2425, 9386, 1104, 1142, 2025, 1110, 5351, 2103, 2489, 1606, 1126, 1429, 118, 1553, 151, 15447, 17211, 21632, 1158, 20334, 113, 151, 8900, 114, 1113, 2112, 118, 13035, 1285, 1160, 117, 1113, 170, 3418, 1121, 121, 1106, 1275, 1107, 1134, 2299, 7432, 5057, 2299, 2489, 113, 4146, 2489, 1654, 114, 119, 2425, 9386, 1159, 4207, 3799, 118, 13035, 1285, 1141, 3718, 9386, 2190, 3718, 9386, 3718, 9386, 4929, 7195, 9080, 16178, 1105, 10241, 1104, 24443, 7562, 1465, 3718, 9386, 6136, 7195, 24767, 1209, 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full study rank 61655 study protocol section identification module n c t id NCT04833647 org study id info org study id 0239-14-RMB organization org full name Rambam Health Care Campus org class OTHER brief title Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood official title Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date April 1, 2016 start date type Actual primary completion date struct primary completion date August 1, 2020 primary completion date type Actual completion date struct completion date February 1, 2021 completion date type Actual study first submit date April 3, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ori Hochwald , MD responsible party investigator title Director, NICU responsible party investigator affiliation Rambam Health Care Campus lead sponsor lead sponsor name Rambam Health Care Campus lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Prospective study comparing hemodynamic and respiratory changes and exercise capacity during Cardio-Pulmonary-Exercise-Testing (CPET) in 4 groups of infants; Three different groups of premature infants and term controls detailed description The study population included 4 groups of infants; preterm infants born < 300 weeks' gestation with BPD (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants born < 300 weeks' gestation without BPD, late preterm infants (born at 340-366 weeks' gestation) and term controls. Pulmonary function testing and spirometry were measured Participants performed CPET on an electronically braked cycle ergometer. During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study. conditions module condition list condition The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description Participants performed CPET on an electronically braked cycle ergometer . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study. A CPET technician and a senior pediatrician were present and monitored the participants' condition during the study. design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 83 enrollment type Actual arms interventions module arm group list arm group arm group label Term arm group type Other arm group description 7-10 years old born at 37-42 weeks gestation arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) arm group label Late preterms arm group type Other arm group description 7-10 years old born at 34.0-36.6 weeks gestation arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) arm group label Preterms with BPD arm group type Other arm group description 7-10 years old born before 30 weeks gestation with the diagnosis of BPD: the need for oxygen at 36 weeks gestation and/or flow or 3LPM or more, and/or the need for CPAP or invasive ventilation arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) arm group label pretermas without BPD arm group type Other arm group description 7-10 years old born before 30 weeks gestation without the diagnosis of BPD (without the need for oxygen at 36 weeks gestation and/or flow or 3LPM or more, and/or the need for CPAP or invasive ventilation) arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) intervention list intervention intervention type Diagnostic Test intervention name Cardio-Pulmonary-Exercise-Testing (CPET) intervention description Cardio-Pulmonary-Exercise-Testing (CPET) . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study intervention arm group label list intervention arm group label Late preterms Preterms with BPD Term pretermas without BPD outcomes module primary outcome list primary outcome primary outcome measure The peak oxygen consumption (VO2max) primary outcome description The peak oxygen consumption (VO2max) primary outcome time frame During the 1 day test eligibility module eligibility criteria Inclusion Criteria: 7-10 years of age The ability to ride stationary bicycles as assessed by the parents. Exclusion Criteria: Immobility An acute febrile or upper respiratory illness in the last 2 weeks The use systemic or inhaled steroids or antiepileptic drugs in the previous month Inhaled bronchodilator use in the previous 24 hours A chronic lung illness (with the exception of BPD and asthma) Congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale). healthy volunteers Accepts Healthy Volunteers gender All minimum age 7 Years maximum age 10 Years std age list std age Child i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000047928 condition mesh term Premature Birth condition ancestor list condition ancestor condition ancestor id D000007752 condition ancestor term Obstetric Labor, Premature condition ancestor id D000007744 condition ancestor term Obstetric Labor Complications condition ancestor id D000011248 condition ancestor term Pregnancy Complications condition browse leaf list condition browse leaf condition browse leaf id M25022 condition browse leaf name Premature Birth condition browse leaf as found Prematurity condition browse leaf relevance high condition browse leaf id M9924 condition browse leaf name Obstetric Labor, Premature condition browse leaf relevance low condition browse leaf id M9916 condition browse leaf name Obstetric Labor Complications condition browse leaf relevance low condition browse leaf id M13279 condition browse leaf name Pregnancy Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions	NCT04833647	[ 101, 1554, 2025, 3997, 5391, 27677, 1571, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 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full study rank 61601 study protocol section identification module n c t id NCT04834349 org study id info org study id 2020-0354 secondary id info list secondary id info secondary id NCI-2021-00123 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) secondary id 2020-0354 secondary id type Other Identifier secondary id domain M D Anderson Cancer Center organization org full name M.D. Anderson Cancer Center org class OTHER brief title Re-irradiation With NBTXR3 in Combination With Pembrolizumab for the Treatment of Inoperable Locoregional Recurrent Head and Neck Squamous Cell Cancer official title A Phase II Study of Reirradiation With NBTXR3 in Patients With Inoperable Locoregional Recurrent Head and Neck Squamous Cell Carcinoma status module status verified date May 2022 overall status Active, not recruiting start date struct start date March 9, 2021 start date type Actual primary completion date struct primary completion date May 18, 2025 primary completion date type Anticipated completion date struct completion date May 18, 2025 completion date type Anticipated study first submit date March 5, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 23, 2022 last update post date struct last update post date May 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name M.D. Anderson Cancer Center lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary This phase II trial studies the effect of re-irradiation with NBTXR3 in combination with pembrolizumab in treating patients with head and neck squamous cell cancer that cannot be removed by surgery (inoperable) and has come back (recurrent). NBTXR3 is a drug that is designed to improve the effectiveness (how well something works) of radiation therapy. The drug is injected into a tumor and activated (turned on) by radiation. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Radiation therapy, such as intensity modulated radiation therapy or intensity modulated proton therapy, uses high energy to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3 activated by radiation together with pembrolizumab may help to control head and neck squamous cell cancer. detailed description PRIMARY OBJECTIVES: I. To estimate progression free survival (PFS) and early clinical benefit in patients treated with hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by stereotactic body radiation therapy (SBRT) reirradiation, with concurrent pembrolizumab. II. To assess the safety profile and estimate early clinical benefit of NBXTR3 activated by dose reduction intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) reirradiation with concurrent pembrolizumab, in subjects with locoregional recurrent head and neck squamous cell carcinoma (HNSCC) not eligible for SBRT. SECONDARY OBJECTIVES: I. To evaluate tumor response after NBTXR3 activated by SBRT reirradiation with concurrent pembrolizumab. II. To evaluate tumor response after NBTXR3 activated by dose reduction IMRT/IMPT reirradiation with concurrent pembrolizumab. III. To evaluate the safety profile of NBTXR3 activated by SBRT reirradiation with concurrent pembrolizumab. IV. To evaluate time-to-event outcomes of NBTXR3 activated by SBRT reirradiation with concurrent pembrolizumab. V. To evaluate time-to-event outcomes of NBTXR3 activated by dose reduction IMRT/IMPT reirradiation with concurrent pembrolizumab. EXPLORATORY OBJECTIVES: I. To evaluate lymphedema/fibrosis & dysphagia-related toxicities and functional outcomes of treatment with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. II. To assess functional and patient reported outcomes (PRO) of treatment with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. III. To associate radiomic measurements with outcomes of treatment with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. IV. To evaluate biomarkers of response in subjects treated with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients receive NBTXR3 intratumorally (IT) on day 1. Patients then undergo SBRT every other day (QOD) on days 15-29. Beginning the first day of radiation therapy, patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. COHORT II: Patients receive NBTXR3 IT on day 1. Patients then undergo IMRT/IMPT every day (QD) on days 15-50. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 5 years. conditions module condition list condition Recurrent Head and Neck Squamous Cell Carcinoma Unresectable Head and Neck Squamous Cell Carcinoma design module study type Interventional phase list phase Phase 2 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) arm group type Experimental arm group description Patients receive NBTXR3 IT on day 1. Patients then undergo SBRT QOD on days 15-29. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Other: Hafnium Oxide-containing Nanoparticles NBTXR3 Biological: Pembrolizumab Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy arm group label Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) arm group type Experimental arm group description Patients receive NBTXR3 IT on day 1. Patients then undergo IMRT/IMPT QD on days 15-50. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Other: Hafnium Oxide-containing Nanoparticles NBTXR3 Procedure: Intensity-Modulated Proton Therapy Radiation: Intensity-Modulated Radiation Therapy Biological: Pembrolizumab Other: Quality-of-Life Assessment Other: Questionnaire Administration intervention list intervention intervention type Other intervention name Hafnium Oxide-containing Nanoparticles NBTXR3 intervention description Given IT intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name NBTXR3 intervention type Procedure intervention name Intensity-Modulated Proton Therapy intervention description Undergo IMPT intervention arm group label list intervention arm group label Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name IMPT intervention type Radiation intervention name Intensity-Modulated Radiation Therapy intervention description Undergo IMRT intervention arm group label list intervention arm group label Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy intervention type Biological intervention name Pembrolizumab intervention description Given IV intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name Keytruda Lambrolizumab MK-3475 SCH 900475 intervention type Other intervention name Quality-of-Life Assessment intervention description Ancillary studies intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name Quality of Life Assessment intervention type Other intervention name Questionnaire Administration intervention description Ancillary studies intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention type Radiation intervention name Stereotactic Body Radiation Therapy intervention description Undergo SBRT intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) intervention other name list intervention other name SABR SBRT Stereotactic Ablative Body Radiation Therapy outcomes module primary outcome list primary outcome primary outcome measure Progression free survival (PFS) primary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. primary outcome time frame From NBTXR3 injection to local or regional recurrence, local or regional progression, distant (outside the head and neck region) progression, or death from any cause, whichever occurs first, assessed up to 5 years primary outcome measure Early clinical benefit activated by SBRT reirradiation primary outcome description Defined as radiographic evidence of complete response (CR), partial response (PR) or stable disease (SD) primary outcome time frame At 6-months post radiation therapy (RT) primary outcome measure Incidence of acute adverse events activated by dose reduction IMRT or IMPT reirradiation primary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 adverse event (AE), excluding dermatitis and mucositis as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. primary outcome time frame Up to 90 days post RT primary outcome measure Incidence of late adverse events activated by dose reduction IMRT or IMPT reirradiation primary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 AE, excluding dermatitis and mucositis as per NCI CTCAE v 5.0. primary outcome time frame From 90 days post RT to end of study (up to 5 years) From 90 days post RT to end of study (up to 5 years) primary outcome measure Incidence of late adverse events activated by SBRT reirradiation primary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 AE, excluding dermatitis and mucositis as per NCI CTCAE v 5.0. primary outcome time frame From 90 days post RT to end of study (up to 5 years) secondary outcome list secondary outcome secondary outcome measure Objective response rate secondary outcome description Defined as complete or partial response per RECIST v1.1 in the target lesion(s), which are those injected with NBTXR3 and irradiated. All other malignant lesions that have not received NBTXR3 injection will be evaluated as per RECIST v1.1, i.e. as measurable or non-measurable lesions (according to their characteristics) and included for the determination of best objective response. secondary outcome time frame Up to 5 years post treatment secondary outcome measure Overall response secondary outcome description Evaluated as per RECIST v1.1 secondary outcome time frame Up to 5 years post treatment secondary outcome measure Incidence of acute adverse events activated by SBRT reirradiation secondary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 AE, excluding dermatitis and mucositis as per NCI CTCAE v 5.0. secondary outcome time frame Up to 90 days post RT secondary outcome measure Local PFS secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to the radiographic and/or histological confirmation of local (within 2 cm of the high-dose reirradiation treatment volume [PTV]) disease recurrence, local progression, or death from any cause, assessed up to 5 years secondary outcome measure Regional PFS secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to the radiographic and/or histological confirmation of regional disease recurrence, regional progression, or death from any cause, whichever occurs first, assessed up to 5 years secondary outcome measure Distant PFS secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to the radiographic and/or histological confirmation of a new lesion outside the head and neck region, or death from any cause, whichever occurs first, assessed up to 5 years secondary outcome measure Overall survival secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to death from any cause or EoS, whichever occurs first, assessed up to 5 years other outcome list other outcome other outcome measure Evaluation of the clinical-grading of lymphedema/fibrosis other outcome description Evaluation of the clinical-grading of lymphedema/fibrosis according to the Head and Neck-Lymphedema Fibrosis (HN-LEF) Lymphedema/Fibrosis Grading: Clinician-grading of lymphedema/fibrosis will be conducted according to the published Head and Neck-Lymphedema Fibrosis (HN-LEF) per physical examination of the patient. Clinical grading is a brief assessment that can be completed in < 5 minutes. other outcome time frame Up to 5 years post treatment other outcome measure Evaluation of the clinical-grading of lymphedema/fibrosis other outcome description Evaluation of the clinical-grading of lymphedema/fibrosis according Cervical range of motion (CROM) per physical examination of patient. Cervical range of motion (CROM): A goniometer will measure CROM (degrees) to assess active cervical spine ROM. Five core CROM measures will be collected, including cervical extension, sagittal plane at rest, lateral flexion (left/right), coronal plane at rest, and lateral rotation (left/right). The primary CROM measure of interest is cervical extension. Cervical extension measures are highly reliable (ICC=.90). Average extension measures in healthy adults aged 60 to 69 range from 57 degrees in males (SD: 10.5) to 65 degrees in females (SD: 13.3). Cervical extension measures decrease by approximately 5 degrees for each decade of life[41]. other outcome time frame Up to 5 years post treatment other outcome measure Evaluation of the clinical-grading of lymphedema/fibrosis other outcome description Evaluation of the clinical-grading of lymphedema/fibrosis according to the Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H&N). Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H&N)25 is a 64-item instrument designed to assess lymphedema symptoms in head and neck cancer patients. Survey items were selected to address six domains (head and neck-specific functioning, systemic symptoms, psychosocial issues, altered sensation symptoms, neck-shoulder musculoskeletal/skin symptoms, and miscellaneous symptoms) identified by an expert panel. Preliminary testing of LSIDS-H&N demonstrated both feasibility and readability. other outcome time frame Up to 5 years post treatment other outcome measure Patient reports outcomes other outcome description Questionnaires measuring the patients' views of their health status other outcome time frame Up to 5 years post treatment other outcome measure Biomarkers of response other outcome description Multiplex IHC (mIHC) analysis of tumor microenvironment (i.e. CD8, PD-L1, PD1, CD3, CD68, FoxP3, etc.) in biopsies Flow cytometry analysis (cell counts) of the immune cell biomarkers in blood. other outcome time frame Up to 5 years post treatment eligibility module eligibility criteria Inclusion Criteria: Patients with biopsy proven locoregional recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC Previous documented receipt of at least 30 Gy and up to 70 Gy of radiation for HNSCC with overlapping fields based on actual dose, prescription percentage 30 Gy for conventional fractionation 15 Gy for hypofractionation 10 Gy for single fraction Time interval from prior radiotherapy to NBTXR3 injection (day 1) of at least 6 months Not eligible (unresectable) or poor candidate or patient refusal of surgery for HNSCC recurrence Amenable to undergo the image guided intratumoral/intranodal injection of NBTXR3 by Interventional Radiologist or ear, nose, and throat (ENT) surgeon, as per investigator or treating physician The target lesion(s) in the head and neck should be measurable as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 on cross sectional imaging and repeated measurements at the same anatomical location should be achievable Up to 3 target lesions may be injected with NBTXR3 and radiated, including the primary tumor and involved lymph node(s) SBRT cohort: =< 60 cm^3 per site, total volume =< 120 cm^3 IMRT/IMPT cohort: =< 120 cm^3 per site, total volume =< 200 cm^3 Nodal target lesions must be >= 15mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI) Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Hemoglobin >= 9.0 g/dL Absolute neutrophil count (ANC) >= 1,000/mm^3 Platelet count >= 100,000/mm^3 Leukocytes >= 1500/mm^3 Creatinine =< 1.5 x upper limit of normal (ULN) Calculated (Calc.) creatinine clearance > 30 mL/min Total bilirubin =< 1.5 mg/dL Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) Serum albumin > 3.5 g/L Negative urine or serum pregnancy test =< 7 days prior to NBTXR3 injection in all women of child-bearing potential (WOCBP). WOCBP must agree to follow instructions for method(s) of contraception for the duration the entire study period and 6 months after the last dose of pembrolizumab treatment. Local laws and regulations may require use of alternative and/or additional contraception methods. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but should still undergo pregnancy testing Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study Exclusion Criteria: Locoregional relapse with skin ulceration Head and neck carcinoma with radiographic evidence of metastasis at screening Surgery to the head and neck Excluding diagnostic biopsy History of severe immune-related adverse events observed with previous immunotherapy (anti-PD-1/L1) or known sensitivity (grade >= 3) to any excipients Has received any approved or investigational anti-neoplastic agent within 4 weeks prior to NBTXR3 injection Except anti-PD-1 therapy, which will not require a washout window Note: a reduced washout window may be considered for therapies with short half-lives (i.e., kinase inhibitors) after discussion with Nanobiotix and investigator Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement [=< 10 mg prednisone] therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has not recovered from adverse events (AEs) due to previous anti-neoplastic or immune-oncology therapy and/or interventions (including radiation) to =< grade 1 Participants with alopecia and =< grade 2 neuropathy may be eligible Any live-virus vaccine therapy used for prevention of infectious diseases administered within 4 weeks prior to NBTXR3 injection Except killed-virus Influenza vaccine Exception of other vaccines (e.g. pneumonia) is at the discretion of the treating physician after conducting a personalized risk assessment on a case by case basis Prior allogenic stem cell transplantation or organ allograft Known contraindication to iodine-based or gadolinium-based IV contrast Active malignancy, in addition to head and neck carcinoma, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year since diagnosis or low risk prostate cancer Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection Female patients who are pregnant or breastfeeding Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months, for females, and 220 days for males after the last dose of pembrolizumab Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Jack Phan, MD overall official affiliation M.D. Anderson Cancer Center overall official role Principal Investigator location list location location facility M D Anderson Cancer Center location city Houston location state Texas location zip 77030 location country United States references module see also link list see also link see also link label M D Anderson Cancer Center see also link u r l http://www.mdanderson.org derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002294 condition mesh term Carcinoma, Squamous Cell condition mesh id D000077195 condition mesh term Squamous Cell Carcinoma of Head and Neck condition mesh id D000012008 condition mesh term Recurrence condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000018307 condition ancestor term Neoplasms, Squamous Cell condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf as found Recurrent condition browse leaf relevance high condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4702 condition browse leaf name Carcinoma, Squamous Cell condition browse leaf as found Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M1689 condition browse leaf name Squamous Cell Carcinoma of Head and Neck condition browse leaf as found Head and Neck Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id M19604 condition browse leaf name Neoplasms, Squamous Cell condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms intervention browse module intervention mesh list intervention mesh intervention mesh id C000582435 intervention mesh term Pembrolizumab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, 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full study rank 61537 study protocol section identification module n c t id NCT04835181 org study id info org study id HBPCIC-2020-05 organization org full name Hubei Hospital of Traditional Chinese Medicine org class OTHER brief title Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency official title Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency: A Study Protocol for a Randomized Controlled Trial status module status verified date February 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date December 1, 2021 primary completion date type Anticipated completion date struct completion date January 31, 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hubei Hospital of Traditional Chinese Medicine lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Obesity is a chronic metabolic disease that seriously harms human health, while abdominal obesity is more closely related to diseases such as type 2 diabetes, cardiovascular disease, and tumors, and has a higher risk. In recent years, traditional Chinese medicine therapy has become the choice of more and more obese patients, and acupuncture therapy is also known as a green therapy for weight loss due to its safety and no side effects. Through the analysis of the TCM physique types of obese people, it is found that Yang-deficiency constitution is one of the TCM constitution types closely related to simple obesity. This topic is based on the constitution theory of traditional Chinese medicine, and on the basis of the earlier research that has clarified the weight loss and lipid-lowering effects of electroacupuncture, it further aims at the type of yang deficiency in obese people, and clarifies the regulation and improvement of umbilical moxibustion on the constitution of obese patients with yang deficiency. In this project, patients with abdominal obesity with yang-deficiency constitution were divided into electro-acupuncture + umbilical moxibustion group and electro-acupuncture group to observe and analyze the advantages and effects of electro-acupuncture combined with umbilical moxibustion on the improvement of obesity symptoms and physical fitness of patients. The ELISA method was used to determine the metabolic indexes related to yang-deficiency constitution, to further clarify the material basis of electroacupuncture combined with umbilical moxibustion to improve the yang-deficiency constitution of patients with abdominal obesity, and to provide scientific and reasonable theoretical guidance for clinical treatment. conditions module condition list condition Obesity, Abdominal design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 68 enrollment type Anticipated arms interventions module arm group list arm group arm group label Electroacupuncture combined with umbilical moxibustion arm group type Experimental arm group intervention list arm group intervention name Behavioral: Electroacupuncture combined with umbilical moxibustion arm group label Electroacupuncture arm group type Active Comparator arm group intervention list arm group intervention name Behavioral: Electroacupuncture intervention list intervention intervention type Behavioral intervention name Electroacupuncture combined with umbilical moxibustion intervention description ①Umbilical moxibustion intervention: point selection: Shenque point Operation: Place the aconite cake on the Shenque point, place the Aizhu in the middle of the aconite cake, ignite the Aizhu and apply moxibustion to make the local warm sensation without burning pain, until the skin is flushed. ②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot. Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points. Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance. intervention arm group label list intervention arm group label Electroacupuncture combined with umbilical moxibustion intervention type Behavioral intervention name Electroacupuncture intervention description ②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot. Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points. Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance. intervention arm group label list intervention arm group label Electroacupuncture outcomes module primary outcome list primary outcome primary outcome measure Change from baseline Waist circumference(WC) at week 12 primary outcome description The horizontal girth through the center of the umbilicus primary outcome time frame Baseline and Week 12 secondary outcome list secondary outcome secondary outcome measure Weight(WG) secondary outcome description Weight(WG) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure BMI(weight/(height) secondary outcome description BMI (weight/(height) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure hip circumference(HC) secondary outcome description hip circumference(HC) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure Waist-to-hip ratio(waist circumference/hip circumference) secondary outcome description waist-to-hip ratio(waist circumference/hip circumference) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure The impact of weight on quality of life (IWQOL)-Lite scale secondary outcome description The impact of weight on quality of life (IWQOL)- Lite scale will be measured to assess the improvement in the quality of life of participants. The minimum value is 31，the maximum value is 155. The lower the total score, the lighter the clinical symptoms of the patient. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure The 10-item Kessler Psychological Distress (K10) Scale secondary outcome description The 10-item Kessler Psychological Distress (K10) Scale will be measured to assess participant's mental state. The minimum value is 10，the maximum value is 50. The lower the total score, the lighter the clinical symptoms of the patient. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure TCM Physique Classification and Judgment Table secondary outcome description Refer to the physical characteristics in the "Traditional Chinese Medicine Physique Classification and Judgment Table" to determine the changes in the yang deficiency constitution of the participants. The symptom score is quantified in 5 levels: always, 5 points; often, 4 points; sometimes, 3 points; very Less, 2 points, no, 1 point. Then calculate the constitutional symptom conversion score, and the change value of the constitutional symptom conversion score compared with the baseline.The minimum value is 0，the maximum value is 100. The lower the total score, the lighter the clinical symptoms of the patient. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure Serum cortisol (FC) secondary outcome description Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. secondary outcome time frame Week 0, Week 8 secondary outcome measure Serum corticosterone (CORT) secondary outcome description Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. secondary outcome time frame Week 0, Week 8 secondary outcome measure Serum adrenocorticotropic hormone (ACTH) secondary outcome description Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. secondary outcome time frame Week 0, Week 8 eligibility module eligibility criteria Inclusion Criteria: 1. People who meet the following diagnostic criteria and are diagnosed with abdominal obesity due to yang deficiency: Diagnostic criteria for abdominal obesity: Refer to the criteria in the "Guidelines for the Comprehensive Medical Management of Obese People" jointly issued by the American Academy of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) in May 2016: male waist circumference ≥85cm, female Waist circumference ≥80cm can be diagnosed as abdominal obesity. Yang Deficiency Quality Criteria: Meet the diagnostic criteria of Yang Deficiency in the "Classification and Judgment Table of Traditional Chinese Medicine Constitution". Common manifestations are chills, cold limbs, swollen face, pale complexion, pale tongue, white slippery fur, and weak pulse. 2. Age: 18 to 55 years old; 3. Sign the informed consent and voluntarily accept the intervention method of this project. Exclusion Criteria: Severe lung, heart, liver, kidney and other diseases; Combined endocrine diseases (polycystic ovary syndrome, hypothyroidism, Cushing syndrome, etc.); Have a history of surgery to lose weight; have a history of adhesions after previous surgery; Have taken drugs that are known to affect weight or appetite in the past 3 months, such as weight loss drugs, corticosteroids, etc.; have used hormone drugs, lipid-lowering drugs, and hypoglycemic drugs in the past 3 months; Women during pregnancy, lactation and menopause; Participated in clinical research on weight loss in the past 3 months; Those who meet any of the above will be excluded from the study. healthy volunteers No gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module central contact list central contact central contact name Kou Xu, MM central contact role Contact central contact phone +8613667248326 central contact e mail 1932707307@stmail.hbtcm.edu.cn overall official list overall official overall official name Zhong-Yu Zhou, MD overall official affiliation Hubei Hospital of Traditional Chinese Medicine overall official role Principal Investigator references module reference list reference reference p m i d 30364290 reference type background reference citation Park BY, Lee MJ, Kim M, Kim SH, Park H. 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Review. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009765 condition mesh term Obesity condition mesh id D000056128 condition mesh term Obesity, Abdominal condition mesh id D000016711 condition mesh term Yang Deficiency condition ancestor list condition ancestor condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf as found Obesity condition browse leaf relevance high condition browse leaf id M27580 condition browse leaf name Obesity, Abdominal condition browse leaf as found Obesity, Abdominal condition browse leaf relevance high condition browse leaf id M18226 condition browse leaf name Yang Deficiency condition browse leaf as found Yang Deficiency condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All 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16963, 1181, 2425, 6026, 2236, 188, 23055, 2425, 6026, 2236, 1382, 122, 117, 17881, 1475, 2425, 6026, 2236, 2076, 8329, 6617, 16963, 1181, 6026, 2236, 188, 23055, 6026, 2236, 1356, 1955, 117, 17881, 1477, 6026, 2236, 2076, 8329, 6617, 16963, 1181, 2025, 1148, 12295, 2236, 1345, 1955, 117, 17881, 1475, 2025, 1148, 12295, 186, 172, 2236, 1364, 126, 117, 17881, 1475, 2025, 1148, 2112, 2236, 188, 23055, 2025, 1148, 2112, 2236, 1364, 129, 117, 17881, 1475, 2025, 1148, 2112, 2236, 2076, 2173, 4746, 1314, 11984, 12295, 2236, 1364, 126, 117, 17881, 1475, 1314, 11984, 2112, 2236, 188, 23055, 1314, 11984, 2112, 2236, 1364, 129, 117, 17881, 1475, 1314, 11984, 2112, 2236, 2076, 2173, 4746, 10767, 24146, 13196, 2784, 1710, 2784, 1710, 2076, 156, 5674, 27035, 1197, 1730, 10767, 1730, 10767, 1271, 20164, 16791, 3355, 1104, 12144, 1922, 5734, 1730, 10767, 1705, 152, 24162, 9637, 20051, 13196, 20051, 1144, 173, 182, 172, 1302, 1110, 175, 173, 170, 12521, 3850, 1302, 1110, 175, 173, 170, 12521, 4442, 1302, 6136, 13196, 4094, 14940, 152, 27655, 1110, 170, 13306, 25158, 3653, 1115, 5536, 7031, 1116, 1769, 2332, 117, 1229, 24716, 184, 27655, 1110, 1167, 4099, 2272, 1106, 8131, 1216, 1112, 2076, 123, 17972, 117, 3621, 25575, 3653, 117, 1105, 24309, 117, 1105, 1144, 170, 2299, 3187, 119, 1130, 2793, 1201, 117, 2361, 1922, 5182, 7606, 1144, 1561, 1103, 3026, 1104, 1167, 1105, 1167, 184, 12866, 1162, 4420, 117, 1105, 170, 18637, 3488, 22355, 7606, 1110, 1145, 1227, 1112, 170, 2448, 7606, 1111, 2841, 2445, 1496, 1106, 1157, 3429, 1105, 1185, 1334, 3154, 119, 4737, 1103, 3622, 1104, 1103, 157, 27847, 185, 7889, 24808, 3322, 1104, 184, 12866, 1162, 1234, 117, 1122, 1110, 1276, 1115, 8772, 118, 21344, 7119, 1110, 1141, 1104, 1103, 157, 27847, 7119, 3322, 4099, 2272, 1106, 3014, 184, 27655, 119, 1188, 8366, 1110, 1359, 1113, 1103, 7119, 2749, 1104, 2361, 1922, 5182, 117, 1105, 1113, 1103, 3142, 1104, 1103, 2206, 1844, 1115, 1144, 22484, 1103, 2841, 2445, 1105, 4764, 2386, 118, 15405, 3154, 1104, 24266, 7409, 4455, 3488, 22355, 117, 1122, 1748, 8469, 1120, 1103, 2076, 1104, 11078, 2118, 21344, 1107, 184, 12866, 1162, 1234, 117, 1105, 172, 5815, 9387, 1103, 8585, 1105, 8331, 1104, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 1113, 1103, 7119, 1104, 184, 12866, 1162, 4420, 1114, 11078, 2118, 21344, 119, 1130, 1142, 1933, 117, 4420, 1114, 24716, 184, 27655, 1114, 11078, 2118, 118, 21344, 7119, 1127, 3233, 1154, 24266, 118, 170, 18637, 3488, 22355, 116, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 1372, 1105, 24266, 118, 170, 18637, 3488, 22355, 1372, 1106, 12326, 1105, 19774, 1103, 13300, 1105, 3154, 1104, 24266, 118, 170, 18637, 3488, 22355, 3490, 1114, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 1113, 1103, 8331, 1104, 184, 27655, 8006, 1105, 2952, 12691, 1104, 4420, 119, 1109, 142, 2162, 6258, 1592, 3442, 1108, 1215, 1106, 4959, 1103, 25158, 7448, 1279, 2272, 1106, 11078, 2118, 118, 21344, 7119, 117, 1106, 1748, 172, 5815, 6120, 1103, 2578, 3142, 1104, 24266, 7409, 4455, 3488, 22355, 3490, 1114, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 1106, 4607, 1103, 11078, 2118, 118, 21344, 7119, 1104, 4420, 1114, 24716, 184, 27655, 117, 1105, 1106, 2194, 3812, 1105, 9483, 10093, 8815, 1111, 7300, 3252, 119, 2975, 13196, 3879, 2190, 3879, 152, 27655, 117, 22358, 18882, 7050, 1902, 13196, 2025, 2076, 11300, 21987, 1348, 4065, 2190, 4065, 1753, 138, 8661, 9538, 2165, 1902, 23992, 1902, 18205, 19441, 2200, 1902, 9108, 2235, 23994, 4838, 1233, 1249, 19638, 1880, 1902, 2425, 3007, 19165, 1902, 7739, 1158, 23992, 1902, 7739, 1158, 7330, 113, 3353, 20943, 114, 10803, 23992, 10803, 5099, 5599, 10803, 2076, 8329, 6617, 16963, 1181, 1739, 22496, 13196, 1981, 1372, 2190, 1981, 1372, 1981, 1372, 3107, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 3490, 1114, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 1981, 1372, 2076, 17635, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 4108, 2328, 17564, 1348, 131, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 3490, 1114, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 1981, 1372, 3107, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 1981, 1372, 2076, 17244, 3291, 8223, 4626, 2772, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 4108, 2328, 17564, 1348, 131, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 9108, 2190, 9108, 9108, 2076, 4108, 2328, 17564, 1348, 9108, 1271, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 3490, 1114, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 9108, 6136, 100, 182, 10649, 13292, 8954, 1988, 9108, 131, 1553, 4557, 131, 26197, 3530, 1553, 5158, 131, 5033, 1103, 170, 7235, 3150, 10851, 1113, 1103, 26197, 3530, 1553, 117, 1282, 1103, 19294, 1584, 6583, 1107, 1103, 2243, 1104, 1103, 170, 7235, 3150, 10851, 117, 178, 22152, 1566, 1103, 19294, 1584, 6583, 1105, 6058, 182, 10649, 13292, 8954, 1988, 1106, 1294, 1103, 1469, 3258, 8710, 1443, 4968, 2489, 117, 1235, 1103, 2241, 1110, 13338, 119, 100, 118, 170, 18637, 3488, 22355, 9108, 131, 138, 18637, 21506, 4557, 131, 157, 5895, 6583, 117, 163, 11700, 1179, 2646, 117, 163, 15564, 5491, 117, 12556, 1776, 3313, 117, 10136, 10436, 1403, 117, 159, 20309, 117, 4434, 2787, 117, 20164, 14452, 15447, 1179, 117, 22358, 18882, 7050, 148, 12512, 119, 5158, 131, 28117, 18351, 1700, 117, 9285, 2241, 4267, 10606, 11916, 1988, 119, 1258, 9285, 170, 18637, 3488, 22355, 1120, 1103, 170, 18637, 21506, 1116, 117, 6058, 1103, 5531, 1104, 3596, 5208, 1158, 117, 1231, 7136, 21816, 1158, 117, 1231, 7174, 3970, 117, 1105, 1231, 7174, 3970, 186, 1182, 119, 157, 5895, 6583, 1105, 10136, 10436, 1403, 1827, 117, 3569, 117, 1127, 26126, 3387, 1106, 1103, 24266, 4704, 1104, 1103, 24266, 7409, 4455, 3488, 22355, 6337, 1113, 1103, 13864, 17180, 1104, 1103, 20557, 157, 5895, 6583, 1105, 10136, 10436, 1403, 1827, 119, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 11934, 131, 3476, 4003, 117, 1954, 7657, 122, 118, 126, 1306, 1592, 117, 24266, 7409, 4455, 3488, 22355, 7657, 1110, 2548, 1106, 5351, 15745, 119, 9108, 1981, 1372, 3107, 2190, 9108, 1981, 1372, 3107, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 3490, 1114, 15276, 15197, 4571, 182, 10649, 13292, 8954, 1988, 9108, 2076, 4108, 2328, 17564, 1348, 9108, 1271, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 9108, 6136, 100, 118, 170, 18637, 3488, 22355, 9108, 131, 138, 18637, 21506, 4557, 131, 157, 5895, 6583, 117, 163, 11700, 1179, 2646, 117, 163, 15564, 5491, 117, 12556, 1776, 3313, 117, 10136, 10436, 1403, 117, 159, 20309, 117, 4434, 2787, 117, 20164, 14452, 15447, 1179, 117, 22358, 18882, 7050, 148, 12512, 119, 5158, 131, 28117, 18351, 1700, 117, 9285, 2241, 4267, 10606, 11916, 1988, 119, 1258, 9285, 170, 18637, 3488, 22355, 1120, 1103, 170, 18637, 21506, 1116, 117, 6058, 1103, 5531, 1104, 3596, 5208, 1158, 117, 1231, 7136, 21816, 1158, 117, 1231, 7174, 3970, 117, 1105, 1231, 7174, 3970, 186, 1182, 119, 157, 5895, 6583, 1105, 10136, 10436, 1403, 1827, 117, 3569, 117, 1127, 26126, 3387, 1106, 1103, 24266, 4704, 1104, 1103, 24266, 7409, 4455, 3488, 22355, 6337, 1113, 1103, 13864, 17180, 1104, 1103, 20557, 157, 5895, 6583, 1105, 10136, 10436, 1403, 1827, 119, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 11934, 131, 3476, 4003, 117, 1954, 7657, 122, 118, 126, 1306, 1592, 117, 24266, 7409, 4455, 3488, 22355, 7657, 1110, 2548, 1106, 5351, 15745, 119, 9108, 1981, 1372, 3107, 2190, 9108, 1981, 1372, 3107, 2896, 10294, 8005, 7409, 4455, 3488, 22355, 13950, 13196, 2425, 9386, 2190, 2425, 9386, 2425, 9386, 4929, 9091, 1121, 2259, 2568, 160, 15837, 1204, 172, 3161, 19172, 16792, 113, 16857, 114, 1120, 1989, 1367, 2425, 9386, 6136, 1109, 10012, 176, 25074, 1324, 1194, 1103, 2057, 1104, 1103, 15276, 15197, 14191, 2425, 9386, 1159, 4207, 14562, 2042, 1105, 6237, 1367, 3718, 9386, 2190, 3718, 9386, 3718, 9386, 4929, 25589, 113, 160, 2349, 114, 3718, 9386, 6136, 25589, 113, 160, 2349, 114, 1209, 1129, 7140, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 125, 117, 6237, 129, 117, 6237, 1367, 3718, 9386, 4929, 139, 14038, 113, 2841, 120, 113, 3976, 114, 3718, 9386, 6136, 139, 14038, 113, 2841, 120, 113, 3976, 114, 1209, 1129, 7140, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 125, 117, 6237, 129, 117, 6237, 1367, 3718, 9386, 4929, 5110, 172, 3161, 19172, 16792, 113, 18315, 114, 3718, 9386, 6136, 5110, 172, 3161, 19172, 16792, 113, 18315, 114, 1209, 1129, 7140, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 125, 117, 6237, 129, 117, 6237, 1367, 3718, 9386, 4929, 160, 15837, 1204, 118, 1106, 118, 5110, 6022, 113, 5111, 172, 3161, 19172, 16792, 120, 5110, 172, 3161, 19172, 16792, 114, 3718, 9386, 6136, 5111, 118, 1106, 118, 5110, 6022, 113, 5111, 172, 3161, 19172, 16792, 120, 5110, 172, 3161, 19172, 16792, 114, 1209, 1129, 7140, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 125, 117, 6237, 129, 117, 6237, 1367, 3718, 9386, 4929, 1109, 3772, 1104, 2841, 1113, 3068, 1104, 1297, 113, 146, 2924, 4880, 13901, 114, 118, 5255, 1566, 3418, 3718, 9386, 6136, 1109, 3772, 1104, 2841, 1113, 3068, 1104, 1297, 113, 146, 2924, 4880, 13901, 114, 118, 5255, 1566, 3418, 1209, 1129, 7140, 1106, 15187, 1103, 8331, 1107, 1103, 3068, 1104, 1297, 1104, 6635, 119, 1109, 5867, 2860, 1110, 1955, 1099, 1103, 4177, 2860, 1110, 14691, 119, 1109, 2211, 1103, 1703, 2794, 117, 1103, 9310, 1103, 7300, 8006, 1104, 1103, 5351, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 125, 117, 6237, 129, 117, 6237, 1367, 3718, 9386, 4929, 1109, 1275, 118, 8926, 26835, 27061, 24797, 12120, 2050, 7370, 113, 148, 10424, 114, 20334, 3718, 9386, 6136, 1109, 1275, 118, 8926, 26835, 27061, 24797, 12120, 2050, 7370, 113, 148, 10424, 114, 20334, 1209, 1129, 7140, 1106, 15187, 14031, 112, 188, 4910, 1352, 119, 1109, 5867, 2860, 1110, 1275, 1099, 1103, 4177, 2860, 1110, 1851, 119, 1109, 2211, 1103, 1703, 2794, 117, 1103, 9310, 1103, 7300, 8006, 1104, 1103, 5351, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 125, 117, 6237, 129, 117, 6237, 1367, 3718, 9386, 4929, 157, 27847, 7642, 6834, 5484, 19295, 1105, 23915, 1181, 14294, 11389, 3718, 9386, 6136, 11336, 6732, 1106, 1103, 2952, 5924, 1107, 1103, 107, 12144, 1922, 5734, 7642, 6834, 5484, 19295, 1105, 23915, 1181, 14294, 11389, 107, 1106, 4959, 1103, 2607, 1107, 1103, 11078, 2118, 21344, 7119, 1104, 1103, 6635, 119, 1109, 188, 17162, 6451, 4165, 2794, 1110, 186, 27280, 6202, 1107, 126, 3001, 131, 1579, 117, 126, 1827, 132, 1510, 117, 125, 1827, 132, 2121, 117, 124, 1827, 132, 1304, 13568, 117, 123, 1827, 117, 1185, 117, 122, 1553, 119, 1599, 20446, 1103, 7950, 188, 17162, 6451, 4165, 7497, 2794, 117, 1105, 1103, 1849, 2860, 1104, 1103, 7950, 188, 17162, 6451, 4165, 7497, 2794, 3402, 1114, 1103, 2259, 2568, 119, 1109, 5867, 2860, 1110, 121, 1099, 1103, 4177, 2860, 1110, 1620, 119, 1109, 2211, 1103, 1703, 2794, 117, 1103, 9310, 1103, 7300, 8006, 1104, 1103, 5351, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 125, 117, 6237, 129, 117, 6237, 1367, 3718, 9386, 4929, 19536, 1818, 1884, 3740, 1548, 4063, 113, 3604, 114, 3718, 9386, 6136, 19536, 1818, 1884, 3740, 1548, 4063, 113, 3604, 114, 1209, 1129, 7140, 1106, 6043, 1107, 11636, 2607, 1107, 6635, 112, 8772, 21344, 7119, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 129, 3718, 9386, 4929, 19536, 1818, 1884, 3740, 10658, 4648, 4798, 113, 18732, 10460, 114, 3718, 9386, 6136, 19536, 1818, 1884, 3740, 10658, 4648, 4798, 113, 18732, 10460, 114, 1209, 1129, 7140, 1106, 6043, 1107, 11636, 2607, 1107, 6635, 112, 8772, 21344, 7119, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 129, 3718, 9386, 4929, 19536, 1818, 8050, 5123, 13335, 12148, 10658, 8005, 20437, 21055, 113, 21111, 3048, 114, 3718, 9386, 6136, 19536, 1818, 8050, 5123, 13335, 12148, 10658, 8005, 20437, 21055, 113, 21111, 3048, 114, 1209, 1129, 7140, 1106, 6043, 1107, 11636, 2607, 1107, 6635, 112, 8772, 21344, 7119, 119, 3718, 9386, 1159, 4207, 6237, 121, 117, 6237, 129, 11768, 13196, 11768, 9173, 3561, 17855, 140, 10587, 3464, 131, 122, 119, 2563, 1150, 2283, 1103, 1378, 20346, 9173, 1105, 1132, 11534, 1114, 24716, 184, 27655, 1496, 1106, 11078, 2118, 21344, 131, 12120, 8517, 14226, 2941, 9173, 1111, 24716, 184, 27655, 131, 11336, 6732, 1106, 1103, 9173, 1107, 1103, 107, 7500, 10443, 1111, 1103, 25187, 3875, 3973, 1104, 152, 12866, 1162, 2563, 107, 10824, 3010, 1118, 1103, 1237, 2127, 1104, 15961, 5135, 13335, 16987, 17246, 113, 10419, 10954, 114, 1105, 1103, 1237, 1531, 1104, 5135, 13335, 16987, 6360, 113, 9690, 2036, 114, 1107, 1318, 1446, 131, 2581, 5111, 172, 3161, 19172, 16792, 864, 1604, 1571, 1665, 1306, 117, 2130, 160, 15837, 1204, 172, 3161, 19172, 16792, 864, 18910, 1665, 1306, 1169, 1129, 11534, 1112, 24716, 184, 27655, 119, 8772, 3177, 23622, 14801, 140, 10587, 3464, 131, 16053, 1103, 20346, 9173, 1104, 8772, 3177, 23622, 1107, 1103, 107, 19295, 1105, 23915, 1181, 14294, 11389, 1104, 12144, 1922, 5734, 5317, 107, 119, 6869, 23487, 6006, 1132, 11824, 1116, 117, 2504, 10765, 117, 13930, 1339, 117, 4554, 2703, 1988, 117, 4554, 3661, 117, 1653, 27562, 9015, 117, 1105, 4780, 8561, 119, 123, 119, 4936, 131, 1407, 1106, 3731, 1201, 1385, 132, 124, 119, 20979, 1103, 6189, 9635, 1105, 19446, 4392, 1103, 9108, 3442, 1104, 1142, 1933, 119, 16409, 1665, 17855, 140, 10587, 3464, 131, 22087, 25243, 13093, 117, 1762, 117, 11911, 117, 16042, 1105, 1168, 8131, 132, 16544, 1322, 13335, 8643, 8131, 113, 185, 23415, 3457, 5668, 184, 24022, 9318, 117, 177, 1183, 11439, 7889, 16219, 1863, 117, 140, 17760, 9318, 117, 3576, 119, 114, 132, 4373, 170, 1607, 1104, 6059, 1106, 3857, 2841, 132, 1138, 170, 1607, 1104, 8050, 23746, 1116, 1170, 2166, 6059, 132, 4373, 1678, 5557, 1115, 1132, 1227, 1106, 6975, 2841, 1137, 21518, 1107, 1103, 1763, 124, 1808, 117, 1216, 1112, 2841, 2445, 5557, 117, 1884, 3740, 10658, 4648, 18093, 117, 3576, 119, 132, 1138, 1215, 21055, 5557, 117, 4764, 2386, 118, 15405, 5557, 117, 1105, 177, 1183, 5674, 18901, 2093, 7257, 5557, 1107, 1103, 1763, 124, 1808, 132, 2453, 1219, 10203, 117, 2495, 5822, 1891, 1105, 1441, 4184, 25134, 1162, 132, 4539, 27989, 16963, 1181, 1107, 7300, 1844, 1113, 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full study rank 61706 study protocol section identification module n c t id NCT04832984 org study id info org study id PRIME organization org full name Monash University org class OTHER brief title Prevention and Treatment of Diabetes in Adults official title Addressing Disparity in Diabetes Prevention Through Digital Health Supported PRe-diabetes Intervention, Management and Evaluation (PRIME) Program Based in Malaysian Community Pharmacies status module status verified date June 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 23, 2022 start date type Actual primary completion date struct primary completion date June 30, 2024 primary completion date type Anticipated completion date struct completion date June 30, 2024 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 13, 2022 last update post date struct last update post date June 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Shaun Lee Wen Huey responsible party investigator title Associate Professor responsible party investigator affiliation Monash University Malaysia lead sponsor lead sponsor name Monash University lead sponsor class OTHER collaborator list collaborator collaborator name Caring Pharmacy collaborator class UNKNOWN collaborator name Bionime Corporation collaborator class INDUSTRY collaborator name Tigas Pharma collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Currently, an estimated 3.9 million Malaysians continue to live with diabetes with many more who live with prediabetes. Diabetes was the one of the leading causes of death in the Malaysia and the leading cause for kidney failure, lower-limb amputations, and adult-onset blindness. Heart disease and stroke are two to four times more likely for individuals with diabetes. The use of mHealth or mobile health application can reduce blood sugar among individuals with prediabetes but also prevent a later occurrence of diabetes. In this study, the investigators aim to develop and evaluate the effectiveness of a digital health supported pre-diabetes management program based in an urban community pharmacy setting detailed description Pre-diabetes is an intermediate state of hyperglycaemia with glycaemic parameters above normal but below the type 2 diabetes mellitus (T2DM) threshold. It was estimated that >25% of individuals who are pre-diabetic convert to T2DM within 3-5 years and 70% of individuals with pre-diabetes will develop into full-fledge T2DM within their lifetimes. According to the 2017 estimate, the disease burden of pre-diabetes at Western Pacific region was 7.6% (126.7 millions). The situation is more alarming in Malaysia where a national pre-diabetes prevalence of 22.1% was noted. Currently available support and self-care services offered in Public Hospitals such as the Diabetes Mellitus Treatment Adherence Clinics (DMTAC) are managed based on the in-person appointment basis. Most of the clinics are available only in specific locations. The need to travel long distance as well as long waiting hours has deterred the success of the programs. This is particularly true for the urban poor who are less likely to take time off from work than those from the higher income group. It is also noteworthy to state that the management program when available, generally target the diagnosed T2DM patients. Studies have shown that individuals with pre-diabetes can substantially reduce their risk of progression to T2DM via participation in evidence-based lifestyle change programs. Previous reports have recorded 54-58% reduction in risk for development to T2DM over 1-3 years with the protective benefit persisting up to 10 years following completion of the program. However, there are several considerations when implementing effective lifestyle intervention program among the pre-diabetes populations in Malaysia. The intervention program should easily be accessible and not confined to public primary and secondary healthcare centres which are already suffering from an overcapacity. Furthermore, consultation should be provided by properly trained healthcare professionals while the ease of communication between the patients and the "lifestyle coach" should be made available. The advancement of information technology coupled with the increasing availability and acceptance of internet and mobile devices provide useful opportunities for application of wireless and mobile technology in order to enhance self-management of chronic conditions. The incorporation of digital technologies can improve patient adherence and facilitate real-time monitoring of vital biological measurements (i.e. via wearable). Additionally, the "mobile health" (mHealth) services are easily scalable, thus providing opportunities to a greater public accessibility and narrow the disparity in access to disease management. In this study, the investigators propose to pilot a digital health supported pre-diabetes management program based in an urban community pharmacy setting conditions module condition list condition PreDiabetes keyword list keyword digital health mobile health lifestyle program design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Double design masking description Cluster randomisation with blinding of statisticians design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 300 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm arm group type Experimental arm group description Participants receiving the phone app together with a fitness tracker. All participants will receive the educational curriculum through the app over a period of 24 weeks. The mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve goals. The participants can use the app to log their food intake, weight, steps, exercise, in addition to participating in the peer support via the chat function. Participants will also receive regular care and follow up in community pharmacies for support. arm group intervention list arm group intervention name Behavioral: Mobile health arm group label Usual care arm arm group type Active Comparator arm group description The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period. Participants will be given physical tracking sheets to record their food intake, weight, steps and exercises. arm group intervention list arm group intervention name Behavioral: Usual care intervention list intervention intervention type Behavioral intervention name Mobile health intervention description Participants will be issued a fitness tracker, Bluetooth enabled glucometer, and a custom developed app which they can communicate digitally to the study investigators either as a group or individually. In the beginning of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (biweekly bite-sized content over 24 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis. intervention arm group label list intervention arm group label Intervention arm intervention type Behavioral intervention name Usual care intervention description Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app. All participants will be given physical tracking sheets to log in their food intake, blood glucose levels and food diary but will not have access to a personal coaching. Participants are free to seek any assistance for their medical care during the study period. intervention arm group label list intervention arm group label Usual care arm outcomes module primary outcome list primary outcome primary outcome measure Change in body weight primary outcome description Weight Loss by % of change and total weight change (kg) primary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome list secondary outcome secondary outcome measure Incidence of diabetes secondary outcome description Number of participants who develop diabetes after 12 months secondary outcome time frame 12 months secondary outcome measure Change in hemoglobin A1c secondary outcome description Haemoglobin A1c measured during follow-up appointments secondary outcome time frame Baseline, 3 months, 6 months, 12 months secondary outcome measure Change in health related quality of life secondary outcome description EuroQol (EQ-5D-5L) to assess quality of life, with higher scores indicating better quality of life. Hospital Anxiety Depression Scale, Perceived Stress Scale and Brief Illness Perception Questionnaire to access mood and mental health. secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in dietary practice secondary outcome description 3-day diet recall to assess changes in food intake secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in physical activity secondary outcome description Physical Activity Questionnaire (short form) (IPAQ) to obtain internationally comparable data on health-related physical activity secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in cardiovascular risks secondary outcome description Blood pressure and lipid profile will be collected to assess cardiovascular risks. secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in anthropometry measures secondary outcome description Body fat composition in % change, and change in waist-to-hip ratio. secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months eligibility module eligibility criteria Inclusion Criteria: Aged 18 years and above BMI 23 and above HbA1c 5.7 - 6.4% or FPG 5.6mmol/L - 6.9mmol/L Exclusion Criteria: Unable to give informed consent Pregnant or lactating Established diabetes Terminal illness Does not own a mobile phone Plans to relocate to an area or travel plans that do not permit full participation in the study healthy volunteers No gender All minimum age 18 Years maximum age 99 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chun Wie Chong, PhD central contact role Contact central contact phone 0355146688 central contact e mail chong.chun.wie@monash.edu central contact name Shaun Lee, PhD central contact role Contact central contact phone 0355145890 central contact e mail shaun.lee@monash.edu overall official list overall official overall official name Shaun Lee overall official affiliation Monash University Malaysia overall official role Principal Investigator overall official name Chun Wie Chong overall official affiliation Monash University Malaysia overall official role Principal Investigator location list location location facility Shaun Lee location status Recruiting location city Subang Jaya location state Selangor location zip 47500 location country Malaysia location contact list location contact location contact name Shaun Lee location contact role Contact location contact e mail shaun.lee@monash.edu i p d sharing statement module i p d sharing Undecided i p d sharing description We plan to share any related individual participant data within reasonable request which can be obtained from the principal investigators derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011236 condition mesh term Prediabetic State condition ancestor list condition ancestor condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M13269 condition browse leaf name Prediabetic State condition browse leaf as found Prediabetes condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M19447 condition browse leaf name Glucose Intolerance condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf 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full study rank 61486 study protocol section identification module n c t id NCT04835844 org study id info org study id IRB 20-461 organization org full name The Cleveland Clinic org class OTHER brief title RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation official title RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation: MAP-AF Study acronym MAP-AF status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 24, 2020 start date type Actual primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date July 1, 2024 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 22, 2022 last update post date struct last update post date March 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name The Cleveland Clinic lead sponsor class OTHER collaborator list collaborator collaborator name Boston Scientific Corporation collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes. detailed description Pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (AF). Identifying gaps in prior ablation lines is essential to achieve successful outcomes. High density mapping systems have been proposed to allow the identification of such gaps with speed and accuracy. The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes. conditions module condition list condition Paroxysmal Atrial Fibrillation design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 70 enrollment type Anticipated arms interventions module arm group list arm group arm group label Mapping with CARTO arm group description CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter arm group intervention list arm group intervention name Device: CARTO arm group label Mapping with RHYTHMIA arm group description RHYTHMIA (Boston Scientific) in conjunction with the 64-electrodes ORION mini-basket catheter. arm group intervention list arm group intervention name Device: RHYTHMIA intervention list intervention intervention type Device intervention name CARTO intervention description Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter intervention arm group label list intervention arm group label Mapping with CARTO intervention type Device intervention name RHYTHMIA intervention description Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter. intervention arm group label list intervention arm group label Mapping with RHYTHMIA outcomes module primary outcome list primary outcome primary outcome measure System is able to accurately identify gaps primary outcome description Incidence of accurate identification of gaps in prior ablation lines by the system primary outcome time frame At the time of procedure secondary outcome list secondary outcome secondary outcome measure Treatment success secondary outcome description Freedom from AF recurrence secondary outcome time frame Up to 12 months eligibility module eligibility criteria Inclusion Criteria: Adult patients (18-90 years of age) undergoing redo ablation procedures for paroxysmal AF regardless of the systems or energy sources used during the pre-study ablation procedure(s). Paroxysmal AF: defined as AF terminating within 7 days of onset either spontaneously or with electrical or medical cardioversion. Exclusion Criteria: Persistent AF Prior cardiac surgery Patients with only AFL or AT as the documented recurrent arrhythmia after the pre-study AF ablation(s). healthy volunteers No gender All minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult study population Electrophysiology clinic patients who are considered candidates for redo paroxysmal AF ablation. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Ayman Hussein, MD central contact role Contact central contact phone 216-444-6171 central contact e mail husseia@ccf.org overall official list overall official overall official name Ayman Hussein, MD overall official affiliation The Cleveland Clinic overall official role Principal Investigator location list location location facility Cleveland Clinic location status Recruiting location city Cleveland location state Ohio location zip 44195 location country United States location contact list location contact location contact name Ayman Hussein, MD location contact role Contact location contact phone 216-444-6171 location contact e mail husseia@ccf.org location contact name Ayman Hussein, MD location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001281 condition mesh term Atrial Fibrillation condition ancestor list condition ancestor condition ancestor id D000001145 condition ancestor term Arrhythmias, Cardiac condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M3738 condition browse leaf name Atrial Fibrillation condition browse leaf as found Atrial Fibrillation condition 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full study rank 61853 study protocol section identification module n c t id NCT04831073 org study id info org study id 100968 organization org full name Helsinki University Central Hospital org class OTHER brief title European Registry of Type A Aortic Dissection official title European Registry of Type A Aortic Dissection acronym ERTAAD status module status verified date May 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date July 1, 2021 start date type Anticipated primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 27, 2021 last update post date struct last update post date June 1, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Fausto Biancari responsible party investigator title Professor responsible party investigator affiliation Helsinki University Central Hospital lead sponsor lead sponsor name Helsinki University Central Hospital lead sponsor class OTHER collaborator list collaborator collaborator name University Hospitals, Leicester collaborator class OTHER collaborator name University Hospital Southampton NHS Foundation Trust collaborator class OTHER collaborator name Azienda Ospedaliera Universitaria Integrata Verona collaborator class OTHER collaborator name Centre Hospitalier Universitaire de Besancon collaborator class OTHER collaborator name Assistance Publique - Hôpitaux de Paris collaborator class OTHER collaborator name Ziekenhuis Oost-Limburg collaborator class OTHER collaborator name University Hospital Muenster collaborator class OTHER collaborator name University of Hamburg-Eppendorf collaborator class OTHER collaborator name Institute for Clinical and Experimental Medicine collaborator class OTHER_GOV collaborator name Northern General Hospital, Herries Road, Sheffield collaborator class UNKNOWN collaborator name Liverpool Heart and Chest Hospital NHS Foundation Trust collaborator class OTHER collaborator name University Hospital, Udine, Italy collaborator class OTHER collaborator name Heart Center Leipzig - University Hospital collaborator class OTHER collaborator name Cliniques universitaires Saint-Luc- Université Catholique de Louvain collaborator class OTHER collaborator name AZ Sint-Jan AV collaborator class OTHER collaborator name University Hospital, Antwerp collaborator class OTHER collaborator name Universitaire Ziekenhuizen KU Leuven collaborator class OTHER collaborator name University of Turin, Italy collaborator class OTHER collaborator name University of Barcelona collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD. detailed description Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit. conditions module condition list condition Type A Aortic Dissection keyword list keyword Aortic dissection design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 4000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Acute type A aortic dissection arm group description Patients who underwent surgery for acute type A aortic dissection arm group intervention list arm group intervention name Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch intervention list intervention intervention type Procedure intervention name Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch intervention description Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch intervention arm group label list intervention arm group label Acute type A aortic dissection outcomes module primary outcome list primary outcome primary outcome measure Mortality rate primary outcome description All-cause mortality primary outcome time frame During the index hospital stay until last follow-up control primary outcome measure Cumulative incidence of reoperation on the aorta primary outcome description Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication primary outcome time frame During the index hospital stay until last follow-up control secondary outcome list secondary outcome secondary outcome measure Incidence of stroke secondary outcome description change in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke duration of a focal or global neurological deficit ≥ 24 h; OR <24 h if available neuroimaging documents a new brain hemorrhage or infarct; OR the neurological deficit results in death. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of acute kidney injury secondary outcome description It will be defined according to postoperative change in serum creatinine levels and its severity will be stratified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of surgical site infection secondary outcome description Proven infection involving deep sternal wound tissues and/or mediastinum. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of reoperation for bleeding secondary outcome description Chest reopening for excessive bleeding. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence and amount of blood transfusion secondary outcome description Transfusions of red blood cells secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Length of stay in the intensive care unit secondary outcome description Duration of stay in the intensive care unit secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of global brain ischemia secondary outcome description Diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of paraplegia/paraparesis secondary outcome description Bilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months eligibility module eligibility criteria Inclusion Criteria: Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta; Patients aged > 18 years: Symptoms started within 7 days from surgery; Primary surgical repair of acute type A aortic dissection; Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection. Exclusion Criteria: Patients aged < 18 years; Onset of symptoms > 7 days from surgery; Prior procedure for type A aortic dissection; Retrograde type A aortic dissection (with primary tear located in the descending aorta); Concomitant endocarditis; Type A aortic dissection secondary to blunt or penetrating chest trauma. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients who underwent surgical repair for acute type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Fausto Biancari, Professor central contact role Contact central contact phone +358407333973 central contact e mail fausto.biancari@hus.fi central contact name Tatu Juvonen, Professor central contact role Contact central contact phone +358504080562 central contact e mail tatu.juvonen@hus.fi overall official list overall official overall official name Fausto Biancari overall official affiliation Helsinki University Hospital, Helsinki, Finland overall official role Principal Investigator location list location location facility AZ St-Jan location city Brugge location country Belgium location contact list location contact location contact name Marc Schepens location contact role Contact location facility Saint-Luc's Hospital location city Brussels location country Belgium location contact list location contact location contact name Stefano Mastrobuoni location contact role Contact location contact name Laurent De Kerchove location contact role Sub-Investigator location facility University Hospital Antwerp location city Edegem location country Belgium location contact list location contact location contact name Steve Laga location contact role Contact location facility Ziekenhuis Oost-Limburg location city Genk location country Belgium location contact list location contact location contact name Matteo Pettinari location contact role Contact location facility University Hospitals Leuven location city Leuven location country Belgium location contact list location contact location contact name Bart Meuris location contact role Contact location facility Institute of Clinical and Experimental Medicine location city Prague location country Czechia location contact list location contact location contact name Marek Pol location contact role Contact location contact name Peter Ivak location contact role Sub-Investigator location contact name Filip Schlosse location contact role Sub-Investigator location facility Helsinki University Hospital location city Helsinki location country Finland location facility Henri Mondor University Hospital location city Créteil location state Paris location country France location contact list location contact location contact name Antonio Fiore location contact role Contact location contact name Thierry Folliguet, Prof location contact role Sub-Investigator location facility University Hospital Jean Minjoz location city Besançon location country France location facility University Heart & Vascular Centre Hamburg location city Hamburg location country Germany location contact list location contact location contact name Till Demal location contact role Contact location contact name Lenard Conradi location contact role Sub-Investigator location contact name Christian Detter location contact role Sub-Investigator location facility Leipzig Heart Center location city Leipzig location country Germany location contact list location contact location contact name Michael Borger location contact role Contact location contact name Christian Etz location contact role Sub-Investigator location contact name Thilo Noack location contact role Sub-Investigator location facility Münster University Hospital location city Münster location country Germany location contact list location contact location contact name Angelo M Dell'Aquila location contact role Contact location facility University of Torino location city Torino location country Italy location contact list location contact location contact name Mauro Rinaldi, Professor location contact role Contact location contact name Luisa Ferrante location contact role Sub-Investigator location facility University of Udine location city Udine location country Italy location facility University of Verona Medical School location city Verona location country Italy location contact list location contact location contact name Francesco Onorati location contact role Contact location contact name Alessandra Francica location contact role Sub-Investigator location contact name Cecilia Rossetti location contact role Sub-Investigator location facility Hospital Clínic de Barcelona location city Barcelona location country Spain location contact list location contact location contact name Eduard Quintana location contact role Contact location contact name Manuel Castellá location contact role Sub-Investigator location facility University Hospitals of Leicester location city Leicester location country United Kingdom location facility Liverpool Heart and Chest Hospital location city Liverpool location country United Kingdom location contact list location contact location contact name Mark Field location contact role Contact location contact name Amer Harky location contact role Sub-Investigator location contact name Manoj Kuduvalli location contact role Sub-Investigator location facility Northern General Hospital location city Sheffield location country United Kingdom location contact list location contact location contact name Stefano Forlani location contact role Contact location contact name Govind Chetty location contact role Sub-Investigator location facility Southampton University Hospital location city Southampton location country United Kingdom location contact list location contact location contact name Geoffrey Tsang location contact role Contact location contact name Suvitesh Luthra location contact role Sub-Investigator references module reference list reference reference p m i d 34112230 reference type derived reference citation Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5. Erratum in: J Cardiothorac Surg. 2021 Aug 9;16(1):225. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000784 condition mesh term Aneurysm, Dissecting condition ancestor list condition ancestor condition ancestor id D000000783 condition ancestor term Aneurysm condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M3266 condition browse leaf name Aneurysm, Dissecting condition browse leaf as found Aortic Dissection condition browse leaf relevance high condition browse leaf id M3265 condition browse leaf name Aneurysm condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low 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3355, 1116, 117, 11248, 20715, 1705, 152, 24162, 9637, 20715, 1271, 1239, 3355, 11881, 18435, 2974, 4623, 20715, 1705, 152, 24162, 9637, 20715, 1271, 138, 15039, 7807, 152, 20080, 14604, 9888, 1161, 12118, 25105, 5168, 3464, 1130, 1566, 14867, 1777, 22051, 20715, 1705, 152, 24162, 9637, 20715, 1271, 2961, 3355, 2852, 12118, 25105, 5168, 5817, 1260, 4108, 9995, 7235, 20715, 1705, 152, 24162, 9637, 20715, 1271, 20778, 21385, 21492, 118, 145, 28206, 18965, 10172, 1260, 2123, 20715, 1705, 152, 24162, 9637, 20715, 1271, 163, 24324, 1424, 23618, 1116, 152, 15540, 118, 21551, 3410, 20715, 1705, 152, 24162, 9637, 20715, 1271, 1239, 3355, 19569, 5026, 2083, 20715, 1705, 152, 24162, 9637, 20715, 1271, 1239, 1104, 8339, 118, 142, 20564, 13645, 11931, 20715, 1705, 152, 24162, 9637, 20715, 1271, 2024, 1111, 15961, 1105, 17635, 5734, 20715, 1705, 152, 24162, 9637, 168, 27157, 2559, 20715, 1271, 2579, 1615, 3355, 117, 26497, 1905, 1914, 117, 8139, 20715, 1705, 7414, 2428, 2249, 17056, 2249, 20715, 1271, 5555, 4641, 1105, 20394, 2556, 3355, 18435, 2974, 4623, 20715, 1705, 152, 24162, 9637, 20715, 1271, 1239, 3355, 117, 158, 10399, 117, 2413, 20715, 1705, 152, 24162, 9637, 20715, 1271, 4641, 1945, 11212, 118, 1239, 3355, 20715, 1705, 152, 24162, 9637, 20715, 1271, 140, 21472, 11962, 8362, 25105, 5168, 22758, 2216, 118, 13174, 118, 25955, 8572, 14084, 5484, 1260, 10111, 2497, 1394, 20715, 1705, 152, 24162, 9637, 20715, 1271, 138, 5301, 14009, 1204, 118, 4945, 138, 2559, 20715, 1705, 152, 24162, 9637, 20715, 1271, 1239, 3355, 117, 14492, 20715, 1705, 152, 24162, 9637, 20715, 1271, 12118, 25105, 5168, 5817, 163, 24324, 1424, 23618, 10947, 148, 2591, 3180, 19581, 1179, 20715, 1705, 152, 24162, 9637, 20715, 1271, 1239, 1104, 14283, 117, 2413, 20715, 1705, 152, 24162, 9637, 20715, 1271, 1239, 1104, 7120, 20715, 1705, 152, 24162, 9637, 20051, 13196, 20051, 1144, 173, 182, 172, 1302, 1110, 175, 173, 170, 12521, 3850, 1302, 1110, 175, 173, 170, 12521, 4442, 1302, 6136, 13196, 4094, 14940, 138, 23987, 8036, 2076, 138, 170, 12148, 1596, 4267, 11553, 5796, 113, 157, 11189, 2137, 114, 1110, 170, 1297, 118, 8400, 3879, 119, 17910, 1110, 1932, 1982, 1112, 170, 22212, 7791, 1105, 1110, 2628, 1114, 2418, 2112, 19807, 5838, 1346, 14471, 1105, 182, 1766, 14598, 1785, 119, 21300, 1103, 5351, 112, 188, 2975, 1105, 3252, 10700, 1134, 1132, 2628, 1114, 1292, 16798, 1958, 1110, 6818, 1111, 1126, 5806, 2635, 1104, 12104, 157, 11189, 2137, 119, 6448, 6136, 7714, 6425, 1121, 2022, 1735, 6425, 1104, 17688, 6059, 1138, 8303, 1106, 2561, 170, 4321, 8298, 1874, 8310, 1348, 25097, 113, 23580, 9159, 14569, 114, 117, 1134, 1209, 4035, 10747, 4776, 4420, 1150, 9315, 6059, 1111, 12104, 157, 11189, 2137, 1121, 1356, 1478, 1106, 1345, 17881, 1475, 119, 1109, 17718, 1209, 14133, 5351, 112, 188, 3254, 1766, 14598, 4233, 117, 3879, 1120, 5991, 4412, 117, 13467, 10700, 1105, 1679, 2660, 3365, 5838, 14115, 1107, 4420, 1114, 1105, 1443, 1346, 1105, 1523, 16798, 1958, 119, 1109, 2425, 7300, 9386, 1209, 1129, 1107, 118, 2704, 14471, 117, 1523, 14471, 1105, 1231, 19807, 6006, 1113, 1103, 170, 12148, 1161, 119, 7934, 13950, 1209, 1129, 6625, 117, 12104, 16042, 3773, 117, 13467, 1751, 8974, 117, 1231, 19807, 1891, 1111, 9793, 117, 14715, 17149, 1104, 1892, 2982, 1105, 2251, 1104, 2215, 1107, 1103, 12885, 1920, 2587, 119, 2975, 13196, 3879, 2190, 3879, 6902, 138, 138, 12148, 1596, 12120, 11553, 5796, 2501, 12565, 2190, 2501, 12565, 138, 12148, 1596, 4267, 11553, 5796, 1902, 13196, 2025, 2076, 152, 4832, 1200, 11583, 1348, 5351, 25097, 1302, 1902, 23992, 1902, 8310, 1348, 2235, 2190, 1902, 8310, 1348, 2235, 3291, 13252, 1204, 1902, 1159, 7281, 2190, 1902, 1159, 7281, 11336, 8005, 16776, 10803, 23992, 10803, 5099, 21955, 10803, 2076, 8329, 6617, 16963, 1181, 1739, 22496, 13196, 1981, 1372, 2190, 1981, 1372, 1981, 1372, 3107, 138, 23987, 2076, 138, 170, 12148, 1596, 4267, 11553, 5796, 1981, 1372, 6136, 7195, 24767, 1150, 9315, 6059, 1111, 12104, 2076, 138, 170, 12148, 1596, 4267, 11553, 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1891, 1113, 1103, 170, 12148, 1161, 2425, 9386, 6136, 6291, 13467, 1105, 1322, 8625, 1116, 11702, 7791, 1113, 1251, 6441, 1104, 1103, 170, 12148, 1161, 1111, 170, 12148, 1596, 4267, 11553, 5796, 1137, 1157, 2272, 3254, 15534, 2425, 9386, 1159, 4207, 1507, 1103, 7448, 2704, 2215, 1235, 1314, 2812, 118, 1146, 1654, 3718, 9386, 2190, 3718, 9386, 3718, 9386, 4929, 3561, 26859, 2093, 1104, 6625, 3718, 9386, 6136, 1849, 1107, 1103, 1634, 1104, 8418, 117, 23123, 9717, 27412, 1465, 117, 23123, 9717, 18828, 1548, 117, 18152, 1757, 117, 1137, 19144, 2445, 12759, 1141, 1334, 1104, 1103, 1404, 117, 173, 6834, 20695, 6370, 1137, 170, 20695, 6370, 117, 23123, 16265, 15748, 117, 1821, 3984, 21556, 175, 15650, 1775, 117, 1137, 1168, 24928, 11955, 7810, 5300, 1137, 8006, 8080, 1114, 6625, 9355, 1104, 170, 17811, 1137, 4265, 24928, 11955, 7810, 16312, 864, 1572, 177, 132, 23066, 133, 1572, 177, 1191, 1907, 24928, 11955, 8628, 3375, 4961, 170, 1207, 3575, 23123, 1766, 1197, 19911, 1137, 1107, 14794, 5822, 132, 23066, 1103, 24928, 11955, 7810, 16312, 2686, 1107, 1473, 119, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 3718, 9386, 4929, 3561, 26859, 2093, 1104, 12104, 16042, 3773, 3718, 9386, 6136, 1135, 1209, 1129, 3393, 2452, 1106, 2112, 19807, 5838, 1849, 1107, 23651, 172, 11811, 6105, 2042, 3001, 1105, 1157, 20997, 1209, 1129, 188, 4487, 3121, 8971, 2452, 1106, 1103, 9847, 4695, 20012, 131, 146, 8223, 20620, 5357, 3929, 19191, 1116, 113, 148, 17243, 2349, 2346, 114, 9173, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 3718, 9386, 4929, 3561, 26859, 2093, 1104, 13467, 1751, 8974, 3718, 9386, 6136, 5096, 7912, 8974, 5336, 1996, 12172, 1348, 5785, 14749, 1105, 120, 1137, 2394, 2050, 1394, 1818, 119, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 3718, 9386, 4929, 3561, 26859, 2093, 1104, 1231, 19807, 1891, 1111, 9793, 3718, 9386, 6136, 20394, 2556, 1231, 15622, 3381, 1111, 12177, 9793, 119, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 3718, 9386, 4929, 3561, 26859, 2093, 1105, 2971, 1104, 1892, 14715, 17149, 3718, 9386, 6136, 13809, 17149, 1116, 1104, 1894, 1892, 3652, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 3718, 9386, 4929, 16758, 1104, 2215, 1107, 1103, 12885, 1920, 2587, 3718, 9386, 6136, 12786, 6108, 1104, 2215, 1107, 1103, 12885, 1920, 2587, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 3718, 9386, 4929, 3561, 26859, 2093, 1104, 4265, 3575, 1110, 4386, 8191, 3718, 9386, 6136, 12120, 3101, 5613, 177, 1183, 26466, 1596, 3290, 1112, 11534, 1120, 3575, 14377, 1105, 24266, 7008, 20695, 13791, 18385, 119, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 3718, 9386, 4929, 3561, 26859, 2093, 1104, 18311, 7136, 9037, 120, 18311, 17482, 16317, 3718, 9386, 6136, 139, 8009, 16719, 11477, 1105, 120, 1137, 4321, 3702, 6919, 1785, 19144, 19019, 2071, 1103, 1634, 1104, 1103, 1110, 4386, 7257, 19245, 8241, 1988, 119, 3718, 9386, 1159, 4207, 1622, 2236, 1104, 7791, 1235, 1103, 2236, 1104, 2704, 12398, 117, 14758, 1146, 1106, 124, 1808, 11768, 13196, 11768, 9173, 3561, 17855, 140, 10587, 3464, 131, 6902, 138, 170, 12148, 1596, 4267, 11553, 5796, 1137, 1107, 4487, 14535, 1233, 23123, 10024, 1918, 5336, 1103, 170, 12148, 1596, 7261, 120, 26457, 170, 12148, 1161, 132, 7195, 24767, 4079, 135, 1407, 1201, 131, 156, 17162, 6451, 17112, 1408, 1439, 128, 1552, 1121, 6059, 132, 6933, 13467, 6949, 1104, 12104, 2076, 138, 170, 12148, 1596, 4267, 11553, 5796, 132, 6291, 1168, 1558, 17688, 13467, 7791, 14255, 8178, 5168, 2227, 1114, 6059, 1111, 2076, 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full study rank 61733 study protocol section identification module n c t id NCT04832633 org study id info org study id 18MMHIS052e organization org full name Mackay Memorial Hospital org class OTHER brief title The Best Parameters for Imaging Agent Injection and Scanning Methods in Computed Tomography Angiography official title The Best Parameters for Imaging Agent Injection and Scanning Methods in Computed Tomography Angiography status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 1, 2018 start date type Actual primary completion date struct primary completion date February 28, 2020 primary completion date type Actual completion date struct completion date February 28, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Mackay Memorial Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Background: The contrast time-enhancement profiles of pulmonary artery (PA) and the aorta differ by using computed tomography (CT) angiography. Our purpose is to identify the optimal CT protocol for assessment of both vessels in one-time CT scan. Methods: The investigators prospectively enrolled 101 cases of CT angiography with suspicion of pulmonary embolism or aortic dissection in our center from 2018 to 2020. Forty cases receiving traditional two-time CT scans were collected retrospectively from 2015 to 2018. The investigators designed four groups: test bolus (TB) I, II and bolus-tracking (BT) I, II. The enhancement of the both vessels and the radiation dose of these four groups were collected. Traditional group was separated into traditional PA scan and traditional aorta scan. Data analyzed among the BT groups and the traditional groups were performed. detailed description Patients All cases with suspicion of PE or AD referred for CTA in our hospital between March 2018 and February 2020 had been reviewed. Those cases with known allergic history, poor renal function (creatinine level>1.5 mg/dl), pregnant women or age less than twenty years old were excluded from the study. The investigators finally enrolled and analyzed 101 cases of CTA. The collected data included age, sex, blood pressure, body mass index (BMI), Hounsfield unit (HU) at bifurcation of PA, HU at the descending aorta with the same level of PA bifurcation, time to peak enhancement, and radiation dose. This study had been approved by the institutional review board in our hospital. All patients signed informed consent. In addition, forty cases with suspicion of PE or AD performing traditional two-time CT scans were reviewed retrospectively. For controlling the dose of contrast media, the two-time CT scans in our hospital were performed with single 80ml contrast media injection at 3ml/sec, followed by 20ml normal saline injection at 3ml/sec. The CT PA angiography was performed when the density of the PA achieved baseline PA density plus 150 HU during tracking scans, followed immediately by the CT aortogram. The investigators compared the experimental groups and traditional groups. Experimental designs of contrast media injection After the contrast injection, the contrast media goes to the right heart via peripheral veins and then the contrast is pumped out to the PA. The interval from contrast injection to the peak enhancement of PA is defined as P seconds. After pulmonary circulation, the contrast media travels through the pulmonary veins, the left atrium, and the left ventricle and contracts into the aorta. The interval from contrast injection to the peak enhancement of aorta is defined as A seconds. Afterward, the contrast media starts a new cycle of systemic circulation. Based on the published data, for the pulmonary artery, adequate attenuation is known to be greater than 180 HU, and for the aorta, sufficient attenuation is known to be greater than 200 HU. However, the requirement of vascular enhancement for diagnosing PE is high because the size of the PA is significantly tapering and the thrombus in the distal PA branches will be vague if the enhancement of the PA is not vivid. Therefore, insufficient enhancement of the PA restricts the ability to diagnose PE. The investigators design a biphasic contrast media injection protocol, including a low rate(2ml/s) first phase injection and high rate(3ml/s) second phase injection, followed by high rate(3ml/s) normal saline injection. The first phase injection is kept for (A - P) seconds and the second phase injection is kept until the rest contrast media is completely injected. Theoretically, when the start time of the scan is at the A seconds, the first phase contrast media is about to significantly enhance the aorta, though the peak time and peak enhancement will not be optimal because the time intervals are calculated on the basis of high rate (3ml/s) injection. On the other hand, the second phase contrast media will maximally enhance the PA at the same time because the second phase contrast media has been injected for P seconds [A-(A-P)=P]. The pre-diagnostic axial CT images were set at the level of the PA bifurcation using 10ml test bolus contrast media injection at the 3ml/s rate. Radiology technologists in our team placed circular region of interest (ROI) within the areas of PA bifurcation and the descending aorta at the same level. The CT densities were collected and demonstrated the time-enhancement data. The peak enhancement time for the PA was chosen as P seconds and that for the aorta as A seconds. The investigators designed four groups, including two groups using the test bolus (TB) method and two groups using the bolus-tracking (BT) method. The two TB groups were different at the total amount of contrast media with 80ml and 70ml respectively. The P and A seconds were calculated from the pre-diagnostic images and the start time of scan was fixed at A seconds. Based on the results of initial 22 cases in the two TB groups, the mean interval between P and A seconds was approximately 9.5 seconds. Therefore, we roughly assumed the A-P interval in most cases was about 10 seconds and designed the two BT groups with a fixed 10-second first phase contrast media injection time. The start time of scan was based on the tracking method when the descending aorta at the PA bifurcation achieved the baseline density plus 150 HU. The tracking scan started after contrast injection was initiated for 15 seconds. The two BT groups were also different at the total amount of contrast media with 80ml and 70ml respectively, including the 10ml for the pre-diagnostic images in order to have the same condition before the diagnostic CT images. Details of the four experimental groups: TB I: The investigators use the TB method with biphasic injection, followed by the saline flush. Initially, the investigators inject the 10 ml of test contrast media with a velocity of 3ml/s and apply the ROI at the bifurcation of PA and descending aorta at the same level. The dynamic curve demonstrates the time to peak enhancement of P second and A second. The first phase of contrast media injection uses a velocity of 2ml/s and the volume of contrast is measured as 2ml/s multiply (A-P) second. The second phase of contrast media injection uses a velocity of 3ml/s and the volume of contrast media is 70ml minus the amount of first phase injection. The total volume of the contrast media is 80ml, including the 10ml for pre-diagnostic test bolus images. The investigators performed the saline flush following the administration of the contrast media with 20 ml normal saline. The start time of the diagnostic scan is at the A second. TB II: This group is similar to the TB I. However, the investigators use the lesser contrast media in the second phase of injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus the amount of first phase injection. The total volume of the contrast media is 70 ml, also including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The start time of the diagnostic scan is at the A second as well. BT I: Initially, 10ml of test contrast media was administrated but no calculation was performed for these pre-diagnostic test bolus images in this group. Unlike the TB method, the investigators use 10 seconds as the fixed interval of (A-P) in this group. The first phase of contrast media injection uses a velocity of 2ml/s and thus the volume of contrast is 20ml. The second phase of contrast media injection is administered with a velocity of 3ml/s and the volume of the contrast media is 70ml minus 20ml. The total volume of the contrast media is 80 ml. The following saline flush uses 20 ml of normal saline. The tracking scan started after contrast injection was initiated for 15 seconds. The ROI is placed in the descending aorta at the same level of PA bifurcation and the diagnostic CT scan is triggered when the density in the ROI achieves the baseline density plus 150HU. BT II: This group is similar to the BT I. The first phase of injection is the same as the BT I group. The investigators use lesser contrast media in the second phase of contrast injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus 20ml. The total volume of the contrast media is 70 ml, including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The protocol for triggering diagnostic CT scan is the same as that in BT I. CT scan technique and contrast medium administration CT was performed using a 320-MDCT (Canon Aquilion PRIME CT scanner, Toshiba Medical Systems, Otawara, Japan). Prior to the initiation of the diagnostic CT scan, a series of low-radiation sequential axial pre-diagnostic CT images were acquired at a fixed level of the PA bifurcation while the test bolus of contrast media was being injected at 3ml/s with 10ml amount. This pre-diagnostic CT scan was applied for all patients. The scan parameters were as the following: 5 mm section thickness, 100kVp, automatic exposure control of current (mA), and 0.5 second rotation time. Following the completion of the pre-diagnostic CT scan, the patient was given a breath-hold instruction for the standard diagnostic CT using either TB or BT method. Scanning was performed in the cranial-caudal direction. All cases were administrated contrast medium with 300 mg iodine (I)/ml Omnipaque using a dual-power injector (MEDRAD Stellant CT injector). All cases were administrated 10ml of contrast medium for establishment of pre-diagnostic CT images. The total volume of contrast media was fixed at 70 or 80 ml in accordance with the designed injection protocols. For all cases, a right upper limb antecubital venous access was achieved using an 18 or 20 Gauge venous catheter. The biphasic contrast injection protocol was conducted with two connected phases of contrast medium injection immediately followed by saline flush. The investigators performed the saline flush at the rate of 3ml/s following the administration of the contrast medium with different amounts (20 or 30 ml) to achieve 100ml fluid injection in total. Estimation of radiation dose The dose length product (DLP) of all cases was recorded. Effective radiation dose was estimated by multiplying the DLP by a conversion factor. The effective radiation dose correlates with different parts of the body which varies the radiation sensitivity of the tissue. Our study applied conversion factor of 0.014 mSV/(mGy x cm) based on the region of chest and abdomen. Statistical analysis: A one-way analysis of variance (ANOVA) test was used for comparing the data of different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. All statistical analysis was performed using software (SPSS version 25.0, IBM Corp.). conditions module condition list condition Enhancement of Aorta and Pulmonary Artery Radiation Exposure keyword list keyword computed tomography angiography aortic dissection pulmonary embolism contrast media design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Diagnostic design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 101 enrollment type Actual arms interventions module arm group list arm group arm group label test bolus(TB) I arm group type Experimental arm group description We use the TB method with biphasic injection, followed by the saline flush. Initially, we inject the 10 ml of test contrast media with a velocity of 3ml/s and apply the ROI at the bifurcation of PA and descending aorta at the same level. The dynamic curve demonstrates the time to peak enhancement of P second and A second. The first phase of contrast media injection uses a velocity of 2ml/s and the volume of contrast is measured as 2ml/s multiply (A-P) second. The second phase of contrast media injection uses a velocity of 3ml/s and the volume of contrast media is 70ml minus the amount of first phase injection. The total volume of the contrast media is 80ml, including the 10ml for pre-diagnostic test bolus images. We performed the saline flush following the administration of the contrast media with 20 ml normal saline. The start time of the diagnostic scan is at the A second. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods arm group label test bolus(TB) II arm group type Experimental arm group description This group is similar to the TB I. However, we use the lesser contrast media in the second phase of injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus the amount of first phase injection. The total volume of the contrast media is 70 ml, also including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The start time of the diagnostic scan is at the A second as well. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods arm group label bolus-tracking(BT) I arm group type Experimental arm group description Initially, 10ml of test contrast media was administrated but no calculation was performed for these pre-diagnostic test bolus images in this group. Unlike the TB method, we use 10 seconds as the fixed interval of (A-P) in this group. The first phase of contrast media injection uses a velocity of 2ml/s and thus the volume of contrast is 20ml. The second phase of contrast media injection is administered with a velocity of 3ml/s and the volume of the contrast media is 70ml minus 20ml. The total volume of the contrast media is 80 ml. The following saline flush uses 20 ml of normal saline. The tracking scan started after contrast injection was initiated for 15 seconds. The ROI is placed in the descending aorta at the same level of PA bifurcation and the diagnostic CT scan is triggered when the density in the ROI achieves the baseline density plus 150HU. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods arm group label bolus-tracking(BT) II arm group type Experimental arm group description This group is similar to the BT I. The first phase of injection is the same as the BT I group. We use lesser contrast media in the second phase of contrast injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus 20ml. The total volume of the contrast media is 70 ml, including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The protocol for triggering diagnostic CT scan is the same as that in BT I. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods intervention list intervention intervention type Diagnostic Test intervention name Different contrast media injection methods intervention description Different contrast media injection methods intervention arm group label list intervention arm group label bolus-tracking(BT) I bolus-tracking(BT) II test bolus(TB) I test bolus(TB) II outcomes module primary outcome list primary outcome primary outcome measure Enhancement of the aorta primary outcome description The enhancement of the aorta at the level of pulmonary artery bifurcation will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows better enhancement of the aorta. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average enhancement of the aorta among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. primary outcome time frame Through study completion, an average of 1 year primary outcome measure Enhancement of the pulmonary artery primary outcome description The enhancement of the pulmonary artery at the level of pulmonary artery bifurcation will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows better enhancement of the pulmonary artery. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average enhancement of the pulmonary artery among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. primary outcome time frame Through study completion, an average of 1 year secondary outcome list secondary outcome secondary outcome measure Radiation dose secondary outcome description The overall radiation dose for the complete CT angiography will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows less radiation exposure. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average radiation dose among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. secondary outcome time frame Through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria: All cases with suspicion of pulmonary embolism or aortic dissection referred for CT angiography in our hospital Exclusion Criteria: Those cases with known allergic history, poor renal function (creatinine level>1.5 mg/dl), pregnant women or age less than twenty years old were excluded from the study. healthy volunteers No gender All minimum age 20 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Chun Chao Huang, MD overall official affiliation Mackay Memorial Hospital overall official role Principal Investigator location list location location facility Mackay Memorial Hospital location city Taipei location zip 10449 location country Taiwan references module reference list reference reference p m i d 34717585 reference type derived reference citation Hsieh CC, Zeng AB, Chen CH, Jhou ZY, Wang CH, Yang YL, Hsieh FC, Lin JK, Yeh JY, Huang CC. A practical biphasic contrast media injection protocol strongly enhances the aorta and pulmonary artery simultaneously using a single CT angiography scan. BMC Med Imaging. 2021 Oct 30;21(1):160. doi: 10.1186/s12880-021-00691-4. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M13661 condition browse leaf name Pulmonary Embolism condition browse leaf relevance low condition browse leaf id M6936 condition browse leaf name Embolism condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions	NCT04832633	[ 101, 1554, 2025, 3997, 5391, 1559, 23493, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 17101, 1545, 23493, 8916, 2025, 25021, 23992, 8916, 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full study rank 61879 study protocol section identification module n c t id NCT04830735 org study id info org study id 0S-20-5 secondary id info list secondary id info secondary id NCI-2020-04367 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) secondary id 0S-20-5 secondary id type Other Identifier secondary id domain USC / Norris Comprehensive Cancer Center secondary id P30CA014089 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/P30CA014089 organization org full name University of Southern California org class OTHER brief title Dasatinib for the Treatment of Moderate and Severe COVID-19 official title A Phase II Randomized Double-Blind Trial of Dasatinib Modulation of Hyperinflammation in Moderate and Severe Patients With COVID-19 status module status verified date August 2022 overall status Withdrawn why stopped PI decided not to pursue study expanded access info has expanded access No start date struct start date August 5, 2022 start date type Actual primary completion date struct primary completion date December 15, 2023 primary completion date type Anticipated completion date struct completion date December 15, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 5, 2022 last update post date struct last update post date August 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Southern California lead sponsor class OTHER collaborator list collaborator collaborator name National Cancer Institute (NCI) collaborator class NIH oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary This phase II trial investigates how well dasatinib works in treating patients with moderate and severe COVID-19. Dasatinib is a drug used to treat chronic leukemia which may help reduce the strong inflammation caused by COVID-19 that can damage the lungs or other organs. detailed description PRIMARY OBJECTIVES: I. To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying. II. To determine 1 month survival. SECONDARY OBJECTIVES: I. To estimate the safety and tolerability of dasatinib anhydrous (dasatinib) in the setting of COVID-19 infection. II. To determine change in C-reactive protein (CRP) levels after starting therapy. III. To document activity of dasatinib in lessening cytokine release syndrome (CRS) and sequential organ failure assessment (SOFA) score. EXPLORATORY OBJECTIVES: I. Interleukin-6 /cytokine assay weekly on treatment protocol. II. Ferritin levels at study entry and every (q) 2 days on treatment protocol. III. D-dimer levels at study entry and q 2 days on treatment protocol. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dasatinib anhydrous orally (PO) once daily (QD) for 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days. conditions module condition list condition Symptomatic COVID-19 Infection Laboratory-Confirmed design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Arm I (dasatinib anhydrous) arm group type Experimental arm group description Patients receive dasatinib anhydrous PO QD for 14 days in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Drug: Dasatinib Anhydrous arm group label Arm II (placebo administration) arm group type Placebo Comparator arm group description Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Drug: Placebo Administration intervention list intervention intervention type Drug intervention name Dasatinib Anhydrous intervention description Given PO intervention arm group label list intervention arm group label Arm I (dasatinib anhydrous) intervention type Drug intervention name Placebo Administration intervention description Given PO intervention arm group label list intervention arm group label Arm II (placebo administration) outcomes module primary outcome list primary outcome primary outcome measure Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying primary outcome description Outcome reported as the number of patients requiring mechanical ventilation, requiring tocilizumab or dying. primary outcome time frame Up to 28 days secondary outcome list secondary outcome secondary outcome measure Absolute lymphocyte count secondary outcome description Assessment via standard blood chemistry and metabolic panel secondary outcome time frame Baseline, during treatment (day 1-14) up to 1 month secondary outcome measure CRP (C-reactive protein) level secondary outcome description Assessment via standard blood chemistry and metabolic panel secondary outcome time frame Baseline, during treatment (day 1-14) up to 1 month secondary outcome measure Change of the SOFA (Sequential Organ Failure Assessment) secondary outcome description The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine secondary outcome time frame Baseline, during treatment (day 1-14) up to 1 month secondary outcome measure Number of participants with treatment-related side effects secondary outcome description Outcome reported as the number of adverse events and serious adverse events that occurred. secondary outcome time frame During treatment and up to 30 days after the last treatment dose secondary outcome measure Radiological response secondary outcome description Will be evaluated by chest x-ray or pulmonary computed tomography (CT) secondary outcome time frame Baseline (optional), after seven days and if clinically indicated(up to 1 month) secondary outcome measure Duration of hospitalization secondary outcome description Outcome reported as the duration of hospitalization of patients secondary outcome time frame From baseline up to patient's discharge (up to 1 month) secondary outcome measure Remission of respiratory symptoms secondary outcome description Time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation. secondary outcome time frame Up to 1 month secondary outcome measure Remission of respiratory symptoms secondary outcome description Time to definitive extubation calculated from intubation (any time occurred) to extubation in days. secondary outcome time frame Up to 1 month secondary outcome measure Remission of respiratory symptoms secondary outcome description Time to independence from oxygen therapy in days. secondary outcome time frame Up to 1 month eligibility module eligibility criteria Inclusion Criteria: Patients must have laboratory test proven COVID19 and symptomatic disease requiring hospitalization: virological diagnosis of Sars-CoV2 infection (polymerase chain reaction [PCR]) within 14 days Able to sign informed consent for participation in the study Subject is hospitalized with one or more of the following: Moderate disease: peripheral capillary oxygen saturation (SpO2) >= 93% on room air with one of the following risk factors for developing severe disease: age >= 60 years, history of hypertension, diabetes mellitus, cardiac disease, chronic lung disease, obesity (calculated body mass index [BMI] >= 30 kg/m^2), and cardiovascular disease, clinical and/or radiological evidence of chest involvement, CRP > 2X upper limit of normal, doubling of CRP in 24 hours where chest findings and CRP elevation not explained by other underlying disease. After the first interim analysis, we may allow enrollment of severe disease COVID infected patients if safety and efficacy analysis appears favorable: Severe disease: Respiratory rate >= 30 breaths/ minute (min) SpO2 < 93% while breathing room air Partial pressure of oxygen measurement (PaO2)/fraction of inspired oxygen (FiO2) =< 300 mmHg Absolute neutrophil count (ANC) > 1000 (baseline blood counts) Platelets > 50,000 / mmc (baseline blood counts) Alanine aminotransferase/aspartate aminotransferase (ALT/AST) < 5 times the upper limit of the normality Total bilirubin < 3 x institutional upper limit of normal (IULN) Creatinine < 2.5 times the upper limit of the normality Azithromycin allowed but if on both drugs patient should be on constant cardiovascular (CV) monitoring Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessment/procedures being conducted Subject is willing and able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Pleural effusion > grade 2 evident on chest x-ray (CXR) or chest computed tomography (CT) Intubation/mechanical ventilation Known hypersensitivity to dasatinib Patient being treated with immunomodulators or anti-rejection drugs Known active infections or other clinical condition that contraindicate dasatinib and cannot be treated or solved according to the judgement of the clinician ALT/AST > 5 times the upper limit of the normality Total bilirubin > 3 x IULN Neutrophils < 1000 / mmc unless; platelets < 50,000 / mmc healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Ann Mohrbacher, MD overall official affiliation University of Southern California overall official role Principal Investigator location list location location facility USC / Norris Comprehensive Cancer Center location city Los Angeles location state California location zip 90033 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000007757 condition mesh term Laboratory Infection condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000009784 condition ancestor term Occupational Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M9929 condition browse leaf name Laboratory Infection condition browse leaf as found Infection Laboratory- condition browse leaf relevance high condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M11871 condition browse leaf name Occupational Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC24 condition browse branch name Occupational Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000069439 intervention mesh term Dasatinib intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors 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full study rank 61892 study protocol section identification module n c t id NCT04830553 org study id info org study id SONIFY organization org full name University Medicine Greifswald org class OTHER brief title Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial official title Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date March 26, 2021 start date type Actual primary completion date struct primary completion date April 1, 2022 primary completion date type Actual completion date struct completion date October 1, 2022 completion date type Actual study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 27, 2022 last update post date struct last update post date October 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Medicine Greifswald lead sponsor class OTHER collaborator list collaborator collaborator name Humboldt-Universität zu Berlin collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of immediate sound feedback for physical distance and touch between individuals as a potential means to complement existing methods in couple therapy. The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial. detailed description According to early 20th century psychoanalysis, the "unsaid" becomes apparent in the relationship between patient and therapist, as well as in metaphors and symbols revealed through unintended utterances, imaginative techniques, and dreams. To convey emotions and thoughts, this method relies on the use of spoken language. Likewise, spoken language remains central to the practice of psychotherapy in subsequent decades, as clinicians and researchers sought to translate and transform major claims of psychoanalysis into newer paradigms, the most prominent of them being cognitive-behavioral, client-centered and family-systems psychotherapy. Inspired by somatic psychology and neuroscience evidence, more recent approaches focus on body and movement to target the "unsaid" beyond spoken language. Funded by the German Federal Ministry of Education and Research, the "Sentire" project attempts to provide immediate sound feedback for physical distance and touch between individuals (www.sentire.me). The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of "Sentire" as a potential means to complement existing methods in couple therapy. The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial. conditions module condition list condition Depression design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label Music-based couple therapy. arm group type Experimental arm group description Each couple will receive five treatment sessions, including established methods from client-centered and family-systems psychotherapy as well as "Sentire," a technological approach providing immediate sound feedback for physical distance and touch. Duration of the treatment phase: five weeks. arm group intervention list arm group intervention name Behavioral: Music-based couple therapy. arm group label Waiting list. arm group type No Intervention arm group description Each couple will go through an initial waiting period before the treatment phase. Duration of the waiting period: five weeks. intervention list intervention intervention type Behavioral intervention name Music-based couple therapy. intervention description Each couple will receive five treatment sessions, including established methods from client-centered and family-systems psychotherapy as well as "Sentire," a technological approach providing immediate sound feedback for physical distance and touch. Duration of the treatment phase: five weeks. intervention arm group label list intervention arm group label Music-based couple therapy. outcomes module primary outcome list primary outcome primary outcome measure Change in Couples Satisfaction Index, CSI-32. primary outcome description This self-report questionnaire was conceived to quantify various aspects of a person's satisfaction in a couple relationship on a Likert scale ranging from 0 (very low satisfaction) to 6 (very high satisfaction). primary outcome time frame Change on the CSI-32, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up. secondary outcome list secondary outcome secondary outcome measure Change in Beck's Depression Inventory, BDI-II. secondary outcome description This self-report measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability. secondary outcome time frame Change on the BDI-II, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up. secondary outcome measure Change in ICD-10 Symptom Rating, ISR. secondary outcome description This self-report measure based on the ICD-10 criteria of mental disorders serves as a screening instrument for psychological syndromes. secondary outcome time frame Change on the ISR, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up. other outcome list other outcome other outcome measure Childhood Trauma Questionnaire, CTQ. other outcome description This self-report measure serves as a covariate to determine the relationship between childhood trauma and present issues in a couple relationship. other outcome time frame Beginning of the treatment phase. (Note: This outcome measure is only assessed once prior to the treatment phase.) other outcome measure Positive and Negative Affect Schedule, PANAS. other outcome description This self-report measure serves as an indicator of change in emotional arousal within each couple therapy session. other outcome time frame Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting). other outcome measure Standortbestimmung. other outcome description This self-report measure serves as an indicator of subjective benefit from the treatment experienced within each couple therapy session. other outcome time frame Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting). other outcome measure Working Alliance Inventory. other outcome description This self-report measure serves as an indicator of therapeutic relationship quality. other outcome time frame 12-month follow-up. (Note: This outcome measure is only assessed once at the 12-month follow-up.) eligibility module eligibility criteria Inclusion Criteria: In couple relationship for at least six months; Living in shared household or close daily contact. Exclusion Criteria: Currently acute episode of any mental disorder. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Benjamin Stahl, PhD overall official affiliation University Medicine of Greifswald overall official role Principal Investigator location list location location facility Humboldt-Universität zu Berlin location city Berlin location zip 10117 location country Germany references module see also link list see also link see also link label Study website. see also link u r l https://www.musikundmedien.hu-berlin.de/de/musikwissenschaft/systematik/projekte/sentire-soziale-interaktion-durch-klang-feedback/dr-benjamin-stahl i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 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full study rank 61461 study protocol section identification module n c t id NCT04836169 org study id info org study id InCaveoDanielandDaniel2021 organization org full name InCaveo org class INDUSTRY brief title Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy official title Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy to Lower Pain Catastrophizing Scores acronym P1RESPECT status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date October 2021 start date type Anticipated primary completion date struct primary completion date April 2022 primary completion date type Anticipated completion date struct completion date May 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name InCaveo lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes is u s export No description module brief summary The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo's EOA system with integrated mobile CBT but without tapering to improve The Pain Catastrophizing Scale (PCS) scores, and secondarily scores on the VNS pain scale, the Tampa Scale of Kinesiophobia (TSK), and patient satisfaction scores in the subacute period (defined as 2 weeks to 3 months post TKR). Statistically significant positive results on the Pain Catastrophizing Scale (PCS) will trigger phase 2. Phase 1 will also inform the detailed conditions and patient management algorithms for Phase II. detailed description The InCaveo End Opioid Addiction (EOA) System is an integrated pain management therapeutic and opioid tapering system providing alternate treatment options via self-service Cognitive Behavior Therapy (CBT) built into a mobile software app, patient medication usage, and tracking of patient PROs. It is designed to be used alongside Usual Standard of Care using Pill Bottles or to simplify, Usual Care with Pill Bottles (UCPB) treatment practices. The InCaveo EOA System is designed to improve a set of patient outcome measures, primarily Pain Catastrophizing Scale (PCS) and secondarily the Visual Numeric Pain (VNS), Kinesiophobia (TSK) and satisfaction scores while facilitating the ability of patients to taper off their pain medication faster than through the use of USPB in the management of post-operative pain. In order to reduce confounding variables, the study will focus on pain management following a single surgical procedure: Total Knee Replacement (TKR) surgery. conditions module condition list condition Pain, Postoperative Analgesics, Opioid keyword list keyword pain design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized parallel-group design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label InCaveo EOA System arm group type Experimental arm group description InCaveo EOA System (including integrated CBT but without tapering) group arm group intervention list arm group intervention name Device: InCaveo's EOA system with integrated mobile CBT arm group label Control Group-usual care with pill bottles arm group type No Intervention arm group description UCPB group-usual care with pill bottles intervention list intervention intervention type Device intervention name InCaveo's EOA system with integrated mobile CBT intervention description integrated pain management therapeutic and tapering system including a software apt that manages and tracks patient-reported outcomes, including pain levels, medication use, quality of life intervention arm group label list intervention arm group label InCaveo EOA System outcomes module primary outcome list primary outcome primary outcome measure Pain Catastrophizing Scale (PCS) primary outcome description A measure of the extent of catastrophizing primary outcome time frame 60 days eligibility module eligibility criteria Inclusion Criteria: Patient has a Pain Catastrophizing Score >16 55 years of age and older. English speaking. Has a smartphone (iPhone). Able to swallow oral medications. No continuous daily opioid as defined as more than 15 days in the 30 days before surgery. Undergoing TKR surgery. Patients who are willing and able to comply with scheduled visits and study procedures. Exclusion Criteria: Diagnosed with Opioid Use Disorder (OUD). Actively using illicit drugs. Allergy to opioids Older than 85 years healthy volunteers No gender All minimum age 55 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Cynthia Harris, BS central contact role Contact central contact phone 8326776747 central contact e mail cindy@clinregconsult.com central contact name Michael A Daniel, MBA central contact role Contact central contact phone 4154070223 central contact e mail madaniel@clinregconsult.com overall official list overall official overall official name Hoyman Hong, MD overall official affiliation InCaveo overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Pain, Postoperative condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse 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full study rank 61934 study protocol section identification module n c t id NCT04830007 org study id info org study id NOCONTRAIVG secondary id info list secondary id info secondary id 2021-A00298-33 secondary id type Other Identifier secondary id domain ID-RCB organization org full name Centre Hospitalier Intercommunal Creteil org class OTHER brief title Factors Associated With the Absence of Contraception at Women Seeking a Voluntary Termination of Pregnancy official title Factors Associated With the Absence of Contraception at the Time of Unplaned Pregnancy Among Women Seeking a Voluntary Termination of Pregnancy status module status verified date January 2022 overall status Suspended why stopped Investigator coordinatoor left the site and the trial expanded access info has expanded access No start date struct start date November 2022 start date type Anticipated primary completion date struct primary completion date November 2022 primary completion date type Anticipated completion date struct completion date November 2022 completion date type Anticipated study first submit date February 11, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date January 31, 2022 last update post date struct last update post date February 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Centre Hospitalier Intercommunal Creteil lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The study will be offered to all women who are consultant for an abortion plan are seen in consultation at the orthogeny center where the study will be conducted. Of these 700 women, about 10% will not agree to participate in the study and 10% will not meet the inclusion criteria. Thus it's plane to include 560 patients in the study. detailed description In 1967, the Neuwirth law allowed women to control their fertility by establishing the right to contraception as a principle. Since then, they have continued to take ownership of the various contraceptive methods, which are regularly renewed. Contraceptive coverage is important in France as it is estimated that 92% of women of childbearing age use a contraceptive method. The pill remains the most widely used method of contraception (36.5%), ahead of the intrauterine device (25.6%) condoms (15.5%) Several laws have been introduced from 1967 to today to facilitate access to sexual health care: screening for sexually transmitted infections, free provision of emergency contraception to minors, non-prescription delivery of emergency contraception, free consultation at a family planning and education center, voluntary termination of pregnancy 100%, reimbursement of condoms by social security. Despite all the measures put in place, it is now clear that the number of unplanted pregnancies is decreasing slightly and the number of abortion has remained stable since 2001. According to the latest literature data, several socio-demographic factors appear to play a role in the rate of use of voluntary termination of pregnancy., including age, socio-cultural level, marital and economic status and ethnic origin. All the more striking, it appears that while voluntary termination of pregnancy are mainly related to contraceptive failures, one third of them involve women who do not have contraception. According to the latest Ined survey, and in accordance with other data from the literature, the factors associated with the absence of contraceptive use are multiple: ignorance about fertility, family or cultural context, cost of contraceptive methods or lack of information related to them. While these studies have looked at the reasons given by women for the lack of contraception, with little data on the characteristics of these women, particularly socio-demographics and their reproductive history and in particular in the context of unwanted pregnancy. This finding leads us to question the factors associated with the absence of contraception among women in demand of a voluntary termination of pregnancy. conditions module condition list condition Pregnancy, Unwanted keyword list keyword Contraception Abortion Unplanned pregnancy Unintended pregnancy design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 560 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Association between absence of contraception and socio-demographic factors, characteristics of pregnancy abortion and medical follow-up primary outcome description Statistically significant association between the absence of contraception in patients consulting for a voluntary termination of pregnancy and socio-demographic factors, characteristics of voluntary termination of pregnancy abortion and characteristics related to medical follow-up primary outcome time frame 1 hour secondary outcome list secondary outcome secondary outcome measure Prescription and dispensing of contraception secondary outcome description Prevalence of patients informed about the prescription and dispensing of contraception including emergency contraception secondary outcome time frame 1 hour secondary outcome measure Existence of family planning centers secondary outcome description Prevalence of patients informed about the existence of family planning centers secondary outcome time frame 1 hour secondary outcome measure Emergency contraception secondary outcome description Prevalence of women who have used emergency contraception secondary outcome time frame 1 hour secondary outcome measure Price and reimbursement of condoms secondary outcome description Prevalence of women informed about the price and reimbursement of condoms secondary outcome time frame 1 hour secondary outcome measure Knowledge of conception secondary outcome description Estimate the percentage of women who thought they could get pregnant at the time of the intercourse that led to this pregnancy secondary outcome time frame 1 hour secondary outcome measure Fertile window secondary outcome description Prevalence of women who use a method to track their fertile window secondary outcome time frame 1 hour secondary outcome measure Affection of fertility secondary outcome description Estimate the percentage of women who think that contraception can affect their fertility secondary outcome time frame 1 hour eligibility module eligibility criteria Inclusion Criteria: woman of 18 years of age or older; Being French-speaking; request for a medical or instrumental voluntary termination of pregnancy No opposition to participation in the protocol Be affiliated with a social security plan Exclusion Criteria: desired pregnancy healthy volunteers No gender Female gender based Yes gender description Only pregant women minimum age 18 Years std age list std age Adult Older Adult study population Protocol proposed to woman who wanted a voluntary termination of pregnancy sampling method Non-Probability Sample contacts locations module location list location location facility CHI Villeneuve St Georges location city Villeneuve-Saint-Georges location country France derived section misc info module version holder December 02, 2022	NCT04830007	[ 101, 1554, 2025, 3997, 5391, 1580, 23124, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 13144, 7629, 1559, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 24819, 15678, 15681, 9664, 2240, 2559, 2349, 3718, 25021, 23992, 2190, 3718, 25021, 23992, 3718, 25021, 17881, 1475, 118, 138, 7629, 26752, 1604, 118, 3081, 3718, 25021, 2076, 2189, 146, 11951, 17792, 3718, 25021, 5777, 10999, 118, 25157, 2064, 2369, 8916, 1554, 1271, 2961, 3355, 2852, 11300, 8178, 13601, 7050, 21070, 2723, 8916, 1705, 152, 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full study rank 61774 study protocol section identification module n c t id NCT04832100 org study id info org study id KMUHIRB-G(I)-20170012 organization org full name Kaohsiung Medical University Chung-Ho Memorial Hospital org class OTHER brief title Bio-significance of LPC16:0 in Fibromyalgia official title A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 1, 2017 start date type Actual primary completion date struct primary completion date July 31, 2025 primary completion date type Anticipated completion date struct completion date July 31, 2027 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 16, 2022 last update post date struct last update post date August 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Kaohsiung Medical University Chung-Ho Memorial Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Fibromyalgia (FM) is a very common but mysterious pain disorder characterized by chronic widespread muscular pain. Fatigue, anxiety and depression are common comorbidities. The syndrome is commonly associated with several symptoms, including fatigue, sleeping disturbance, cognitive impairment, and comorbid pain syndrome, especially irritable bowel symptoms and temporomandibular disease. Anxiety and depression are common psychiatric co-morbidies. Daily stress is believed to trigger or aggravate pain conditions. These symptoms can markedly affect patients' quality of life, and even lead to disability. So far, the etiology and pathogenesis are largely unknown, and diagnostic biomarkers and curative treatment remain to be developed. Recent technological advances enable scientists to explore mechanisms by genetic, transcriptomic, proteomic, and metabolomic researches. However, no definitive result has been concluded for clinical practice so far. In this study, the investigators use tailored questionnaires to evaluate fibromyalgia and associated symptoms, including numeric rating scale for soreness, widespread soreness index, Fibromyalgia impact questionnaire, Hospital Anxiety and Depression Scale, and perceived stress scale. The investigators also use metabolomics and lipidomic approach to probe the potential pathophysiology of fibromyalgia. In our prior translation research (PMID: 32907805), the investigators found that excessive LPC16:0 resulting from lipid oxidization inflicts psychological stress-induced chronic non-inflammatory pain via activating ASIC3. In this content, our prior translational research identified a potential nociceptive ligand that causes fibromyalgia symptoms, which is likely to function as biomarkers for diagnosis or disease monitor. In the current clinical investigation, the investigators aim to reversely translate the novel findings in animal studies and validate the bio-significance of LPC16:0 for fibromyalgia with clinical approaches. conditions module condition list condition Fibromyalgia, Primary Pain Soreness, Muscle Oxidative Stress Metabolomics Lipidomics keyword list keyword lysophosphotidylcholine fibromyalgia pain soreness metabolomics design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description collection of blood samples for metabolomic and genetic investigations enrollment info enrollment count 400 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with primary fibromyalgia arm group description Adults with complaints of chronic widespread pain at the outpatient department of KMUH were consecutively enrolled over a 5-year period from July 2017 to June 2022. Participants were interviewed by experienced neurologists , and those who fulfilled the 2011 American College of Rheumatology (ACR) criteria for FM were recruited . arm group intervention list arm group intervention name Drug: Pregabalin 150mg, imipramine 25mg arm group label Healthy controls arm group description Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls. intervention list intervention intervention type Drug intervention name Pregabalin 150mg, imipramine 25mg intervention description Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then. intervention arm group label list intervention arm group label Patients with primary fibromyalgia outcomes module primary outcome list primary outcome primary outcome measure Questionnaire: Numeric rating scale (NRS) for pain and soreness primary outcome description assessment of pain and soreness severity. Score: 0(no symptom) ~10 (worst symptom) primary outcome time frame Changes from baseline NRS at 2 weeks are assessed primary outcome measure Questionnaire: Numeric rating scale (NRS) for pain and soreness primary outcome description assessment of pain and soreness severity. Score: 0(no symptom) ~10 (worst symptom) primary outcome time frame Changes from baseline NRS at 4 weeks are assessed primary outcome measure Questionnaire: widespread pain index and widespread soreness index primary outcome description assessment of pain and soreness diffuseness. Score: 0(no symptom) ~19 (mostly diffused symptom) primary outcome time frame Change from baseline widespread index at 2 weeks are assessed primary outcome measure Questionnaire: widespread pain index and widespread soreness index primary outcome description assessment of pain and soreness diffuseness. Score: 0(no symptom) ~19 (mostly diffused symptom) primary outcome time frame Change from baseline widespread index at 4 weeks are assessed primary outcome measure Questionnaire: Fibromyalgia impact questionnaire (FIQR) primary outcome description assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) ~100 (worst symptom) primary outcome time frame Change from baseline FIQR at 2 weeks are assessed primary outcome measure Questionnaire: Fibromyalgia impact questionnaire (FIQR) primary outcome description assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) ~100 (worst symptom) primary outcome time frame Change from baseline FIQR at 4 weeks are assessed primary outcome measure Questionnaire: Hospital Anxiety and Depression Scale (HADS) primary outcome description assessment of psychological distress. Score: 0 (no symptom) ~42 (worst symptom) primary outcome time frame Change from baseline HADS at 2 weeks are assessed primary outcome measure Questionnaire: Hospital Anxiety and Depression Scale (HADS) primary outcome description assessment of psychological distress. Score: 0 (no symptom) ~42 (worst symptom) primary outcome time frame Change from baseline HADS at 4 weeks are assessed primary outcome measure Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) primary outcome description assessment of sleep quality. Score: 0 (no symptom) ~21 (worst sleep quality) primary outcome time frame Change from baseline PSQI at 2 weeks are assessed primary outcome measure Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) primary outcome description assessment of sleep quality. Score: 0 (no symptom) ~21 (worst sleep quality) primary outcome time frame Change from baseline PSQI at 4 weeks are assessed primary outcome measure Questionnaire: Perceived stress scale (PSS) primary outcome description assessment of perceived stress loading. Score: 0 (no stress) ~40 (highest stressed level) primary outcome time frame Change from baseline PSS at 2 weeks are assessed primary outcome measure Questionnaire: Perceived stress scale (PSS) primary outcome description assessment of perceived stress loading. Score: 0 (no stress) ~40 (highest stressed level) primary outcome time frame Change from baseline PSS at 4 weeks are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 3 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 3 months are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 6 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 6 months are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 9 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 9 months are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 12 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 12 months are assessed eligibility module eligibility criteria Inclusion Criteria: 1. Clinical diagnosis of fibromyalgia Exclusion Criteria: Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis), Systemic use of corticosteroids, Pregnancy, Chronic diseases under poor control Malignancies. gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult study population Patient group: participants with primary fibromyalgia Control group: healthy controls sampling method Probability Sample contacts locations module location list location location facility Kaohsiung Medical University Hospital location status Recruiting location city Kaohsiung location zip 80756 location country Taiwan location contact list location contact location contact name Chih-Hsien Hung location contact role Contact location contact phone 073121101 location contact phone ext 5851 location contact e mail jasonhung0701@hotmail.com location contact name Chih-Hsien Hung, MD, PhD location contact role Principal Investigator i p d sharing statement module i p d sharing Undecided i p d sharing description Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005356 condition mesh term Fibromyalgia condition mesh id D000009209 condition mesh term Myofascial Pain Syndromes condition mesh id D000063806 condition mesh term Myalgia condition ancestor list condition ancestor condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000059352 condition ancestor term Musculoskeletal Pain condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M7638 condition browse leaf name Fibromyalgia condition browse leaf as found Fibromyalgia condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M11313 condition browse leaf name Myofascial Pain Syndromes condition browse leaf as found Fibromyalgia condition browse leaf relevance high condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M29309 condition browse leaf name Myalgia condition browse leaf as found Soreness, Muscle condition browse leaf relevance high condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M28597 condition browse leaf name Musculoskeletal Pain condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000069583 intervention mesh term Pregabalin intervention mesh id D000007099 intervention mesh term Imipramine intervention ancestor list intervention ancestor intervention ancestor id D000000700 intervention ancestor term Analgesics intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000000927 intervention ancestor term Anticonvulsants intervention ancestor id D000002121 intervention ancestor term Calcium Channel Blockers intervention ancestor id D000049990 intervention ancestor term Membrane Transport Modulators intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000077264 intervention ancestor term Calcium-Regulating Hormones and Agents intervention ancestor id D000014151 intervention ancestor term Anti-Anxiety Agents intervention ancestor id D000014149 intervention ancestor term Tranquilizing Agents intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000011619 intervention ancestor term Psychotropic Drugs intervention ancestor id D000000929 intervention ancestor term Antidepressive Agents, Tricyclic intervention ancestor id D000000928 intervention ancestor term Antidepressive Agents intervention ancestor id D000018759 intervention ancestor term Adrenergic Uptake Inhibitors intervention ancestor id D000014179 intervention ancestor term Neurotransmitter Uptake Inhibitors intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M476 intervention browse leaf name Pregabalin intervention browse leaf as found Repair intervention browse leaf relevance high intervention browse leaf id M9299 intervention browse leaf name Imipramine intervention browse leaf as found Ph+ intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M3398 intervention browse leaf name Anticonvulsants intervention browse leaf relevance low intervention browse leaf id M4533 intervention browse leaf name Calcium intervention browse leaf relevance low intervention browse leaf id M4550 intervention browse leaf name Calcium, Dietary 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full study rank 61307 study protocol section identification module n c t id NCT04838171 org study id info org study id QEL-RP-001 organization org full name Quell Therapeutics Limited org class INDUSTRY brief title Prospective Study of White Blood Cells official title Investigation of White Blood Cells to Support the Development of Engineered Regulatory T Cell (Treg) Therapies status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 24, 2021 start date type Actual primary completion date struct primary completion date December 2024 primary completion date type Anticipated completion date struct completion date December 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 7, 2022 last update post date struct last update post date September 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Quell Therapeutics Limited lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to investigate white blood cells from volunteering donors to support the development of engineered regulatory T cell therapies. conditions module condition list condition Autoimmune Diseases Inflammation Rejection; Transplant, Liver design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 10 enrollment type Anticipated arms interventions module arm group list arm group arm group label Specimen collection to support development of engineering Treg arm group intervention list arm group intervention name Other: White blood cell and blood collection intervention list intervention intervention type Other intervention name White blood cell and blood collection intervention description Mononucleocytes will be collected via apheresis intervention arm group label list intervention arm group label Specimen collection to support development of engineering Treg outcomes module primary outcome list primary outcome primary outcome measure WBC characterisation to support the development of engineered regulatory T cells. primary outcome description number, type and function of white blood cells in healthy controls and in patients primary outcome time frame 5 years eligibility module eligibility criteria No additional inclusion/ exclusion criteria will be applied by Quell other than those specified by the consenting institutions. healthy volunteers No gender All std age list std age Child Adult Older 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full study rank 61204 study protocol section identification module n c t id NCT04839510 org study id info org study id MRG002-006 organization org full name Shanghai Miracogen Inc. org class INDUSTRY brief title A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer official title An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 20, 2021 start date type Actual primary completion date struct primary completion date June 2022 primary completion date type Anticipated completion date struct completion date September 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date December 13, 2021 last update post date struct last update post date December 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Shanghai Miracogen Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive unresectable locally advanced or metastatic urothelium cancer. detailed description The study consists of two stages. In Phase IIa, approximately 25 subjects will be enrolled to evaluate the safety and preliminarily efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of second stage Phase IIb single-arm study either will be continued or the trail will be terminated. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 33 subjects will be enrolled to further evaluate the efficacy and safety of MRG002. conditions module condition list condition Locally Advanced Urothelial Cancer Metastatic Urothelial Carcinoma keyword list keyword MRG002 Antibody Drug Conjugate (ADC) HER2 Urothelium Cancer design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 58 enrollment type Anticipated arms interventions module arm group list arm group arm group label MRG002 arm group type Experimental arm group description MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle). arm group intervention list arm group intervention name Drug: MRG002 intervention list intervention intervention type Drug intervention name MRG002 intervention description Administrated intravenously intervention arm group label list intervention arm group label MRG002 outcomes module primary outcome list primary outcome primary outcome measure Objective Response Rate (ORR) by Independent Review Committee (IRC) primary outcome description ORR is defined as the percentage of patients with complete response (CR) and partial response (PR) as assessed by Independent Review Committee (IRC) according to RECIST v1.1. primary outcome time frame Baseline to study completion, up to 12 months secondary outcome list secondary outcome secondary outcome measure ORR by Investigator secondary outcome description ORR is defined as the percentage of patients with CR and PR as assessed by Investigator according to RECIST v1.1. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Duration of Response (DoR) secondary outcome description DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Time to Response (TTR) secondary outcome description TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Disease Control Rate (DCR) secondary outcome description DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Progression Free Survival (PFS) secondary outcome description PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Overall Survival (OS) secondary outcome description OS is defined as the duration from the start of treatment to death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Adverse Events (AEs) secondary outcome description Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug. secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve secondary outcome description Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS). secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Incidence of anti-drug antibody (ADA) secondary outcome description The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment. secondary outcome time frame Baseline to 30 days after the last dose of study treatment eligibility module eligibility criteria Inclusion Criteria: Willing to sign the ICF and follow the requirements specified in the protocol. Aged 18 to 75 (including 18 and 75), both genders. Expected survival time ≥ 12 weeks. Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology. Failed in the prior one or more line of systemic chemotherapy. HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test. Archival or biopsy tumor specimens should be provided (primary or metastatic). Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ECOG performance score 0 or 1. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities). No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%. Organ function must meet the basic requirements. Coagulation function must meet the basic requirements. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab. Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose MRG002 treatment. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage. Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis. Any severe or uncontrolled systemic diseases. Patients with poorly controlled heart diseases. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection. History of other primary malignancies. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc. Peripheral neuropathy greater than Grade 1. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C). Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials. Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator. healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Program Director central contact role Contact central contact phone 86-21-61637960 central contact e mail clinicaltrials@miracogen.com.cn overall official list overall official overall official name Aiping Zhou, MD overall official affiliation Cancer Institute and Hospital, Chinese Academy of Medical Sciences overall official role Principal Investigator location list location location facility Anhui provincial Cancer Hospital location status Recruiting location city Hefei location state Anhui location zip 230031 location country China location contact list location contact location contact name Changlu Hu location contact role Contact location contact phone 15555426636 location contact e mail 13955116061@139.com location facility The Second Hospital of Anhui Medical University location status Recruiting location city Hefei location state Anhui location zip 230601 location country China location contact list location contact location contact name Dexin Yu location contact role Contact location contact phone 13705690883 location contact e mail yudx_urology@126.com location facility Cancer Hospital Chinese Academy of Medical Sciences location status Recruiting location city Beijing location state Beijing location zip 100000 location country China location contact list location contact location contact name Aipingv Zhou, MD location contact role Contact location contact phone 86-10-87788800 location contact e mail zhouap1825@126.com location facility Beijing hospital location status Not yet recruiting location city Beijing location state Beijing location zip 100005 location country China location contact list location contact location contact name Ben Wan location contact role Contact location contact phone 13701257342 location contact e mail Wanben2000@sina.com location facility Beijing Chao-Yang Hospital，Capital Medical University location status Recruiting location city Beijing location state Beijing location zip 100020 location country China location contact list location contact location contact name Yinong Niu location contact role Contact location contact phone 18601020160 location contact e mail 18601020160@163.com location facility The Fifth Medical Center of the PLA location status Recruiting location city Beijing location state Beijing location zip 100039 location country China location contact list location contact location contact name Lijun Chen location contact role Contact location contact phone 13910777307 location contact e mail chenlj829@163.com location facility Chongqing University Cancer Hospital location status Recruiting location city Chongqing location state Chongqing location zip 400030 location country China location contact list location contact location contact name Hong Luo location contact role Contact location contact phone 13883029913 location contact e mail luodashu@sohu.com location facility Army Medical Center of PLA location status Terminated location city Chongqing location state Chongqing location zip 400042 location country China location facility Fujian Cancer Hospital location status Not yet recruiting location city Fuzhou location state Fujian location zip 350014 location country China location contact list location contact location contact name Yu Chen location contact role Contact location contact phone 13859089836 location contact e mail 833392476@qq.com location facility SUN Yat-sen university Cancer center location status Recruiting location city Guangzhou location state Guangdong location zip 510060 location country China location contact list location contact location contact name Fangjian Zhou location contact role Contact location contact phone 13922735659 location contact e mail zhoufj@sysucc.org.cn location facility The First Affiliated Hospital of Guangzhou Medical University location status Recruiting location city Guangzhou location state Guangdong location zip 510120 location country China location contact list location contact location contact name Yongda Liu location contact role Contact location contact phone 18922347906 location contact e mail 13719007083@163.com location facility ShenZhen Luohu People's Hospital location status Terminated location city ShenZhen location state Guangdong location zip 518005 location country China location facility The Fifth Affiliated Hospital of Sun Yat-sen University location status Not yet recruiting location city Zhuhai location state Guangdong location zip 519000 location country China location contact list location contact location contact name Hongyu Zhang location contact role Contact location contact phone 13928075391 location contact e mail zdwyzhy@163.com location facility Liuzhou People's Hospital location status Recruiting location city Liuzhou location state Guangxi location zip 545026 location country China location contact list location contact location contact name Pei Lu location contact role Contact location contact phone 18037132111 location contact e mail lylpnh@126.com location facility Haerbin medical university cancer hospital location status Recruiting location city Haerbin location state Heilongjiang location zip 150081 location country China location contact list location contact location contact name Hui Chen location contact role Contact location contact phone 13603612355 location contact e mail erchenhui@hotmail.com location facility Henan Cancer Hospital location status Recruiting location city Zhengzhou location state Henan location zip 450003 location country China location contact list location contact location contact name Shujun Yang location contact role Contact location contact phone 13803869419 location contact e mail nykang@126.com location facility Union hospital tongji medical college huazhong univerity ofscience and technology location status Recruiting location city Wuhan location state Hubei location zip 430022 location country China location contact list location contact location contact name Guiling Li location contact role Contact location contact phone 13307187507 location contact e mail Lgl6714@163.com location facility Tongji Hospital location status Terminated location city Wuhan location state Hubei location zip 430030 location country China location facility Xiangya hospital central south university location status Recruiting location city Changsha location state Hunan location zip 410008 location country China location contact list location contact location contact name Minfeng Chen location contact role Contact location contact phone 13517319380 location contact e mail chenminfeng1999@163.com location facility The Affiliated Cancer Hospital of Xiangya School of Medicine(Hunan Cancer Hospital ) location status Recruiting location city Changsha location state Hunan location zip 410031 location country China location contact list location contact location contact name Weiqing Han location contact role Contact location contact phone 13875825253 location contact e mail md70210@sina.com location facility Nantong Tumor Hospital location status Terminated location city Nantong location state Jiangsu location zip 226006 location country China location facility The First Hospital of Jilin University location status Recruiting location city Changchun location state Jilin location zip 130061 location country China location contact list location contact location contact name Ziling Liu location contact role Contact location contact phone 13943001600 location contact e mail drzilingliu@163.com location facility JiLinGuoWen Hospital location status Recruiting location city Siping location state Jilin location zip 136199 location country China location contact list location contact location contact name Jizhong Quan location contact role Contact location contact phone 15774496522 location contact e mail quanjizhong@jlguowen.com location facility Liaoning Cancer hospital location status Recruiting location city Shenyang location state Liaoning location zip 110042 location country China location contact list location contact location contact name Cheng Fu location contact role Contact location contact phone 18900917622 location contact e mail 13840219900@163.com location facility Qinghai University Affiliated Hospital location status Recruiting location city Xining location state Qinghai location zip 810012 location country China location contact list location contact location contact name Guojun Chen location contact role Contact location contact phone 13897283691 location contact e mail chenguojun68@126.com location facility Qilu Hospital of Shandong University location status Recruiting location city Jinan location state Shandong location zip 250012 location country China location contact list location contact location contact name Benkang Shi location contact role Contact location contact phone 13969006388 location contact e mail bkshi68@163.com location facility Rui jin hospital location status Recruiting location city Shanghai location state Shanghai location zip 200025 location country China location contact list location contact location contact name Danfeng Xu location contact role Contact location contact phone 13901734568 location contact e mail xu-danfeng@hotmail.com location facility Zhongshan Hospital Affiliated to Fudan University location status Terminated location city Shanghai location state Shanghai location zip 200125 location country China location facility Changhai Hospital location status Not yet recruiting location city Shanghai location state Shanghai location zip 200433 location country China location contact list location contact location contact name Chuanliang Xu location contact role Contact location contact phone 13816323268 location contact e mail chuanliang_xu@126.com location facility First Affiliated Hospital of Xi'an Jiaotong University location status Recruiting location city Xian location state Shanxi location zip 710061 location country China location contact list location contact location contact name Lei Li location contact role Contact location contact phone 15991752560 location contact e mail Lilydr@163.com location facility Sichuan provincial people's hospital location status Recruiting location city Chengdu location state Sichuan location zip 610072 location country China location contact list location contact location contact name Yong Liao location contact role Contact location contact phone 18981838513 location contact e mail liaoyong616@sina.com location facility Tianjin Medical University Cancer Institute and Hospital location status Recruiting location city Tianjin location state Tianjin location zip 300181 location country China location contact list location contact location contact 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full study rank 61564 study protocol section identification module n c t id NCT04834830 org study id info org study id Version 1.1 26.01.2021 organization org full name University of Vienna org class OTHER brief title Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study official title Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date April 1, 2022 primary completion date type Anticipated completion date struct completion date April 1, 2022 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Daniela Gompelmann responsible party investigator title Prof. Dr. med. responsible party investigator affiliation University of Vienna lead sponsor lead sponsor name University of Vienna lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate the concentrations of interleukin-2, interleukin-10, interferon-gamma, PD1+ lymphocytes, and the interleukin-10 receptor expression in malignant and benign effusions. detailed description In this prospective trial, 80 patients with pleural effusions and indication for thoracocentesis, drainage, indwelling pleural catheter (IPC) management and/or video-assisted thoracoscopic surgery are enrolled. The pleural effusion will be examined for different cytokines, cytokine-receptors, PD1-lymphocytes and CD4+/CD25+/Foxp3+ regulatory T cell. conditions module condition list condition Pleural Effusion design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with pleural effusion arm group description In patients with pleural effusion and indication for diagnostic and/or therapeutic procedures (thoracocentesis, drainage of fluid, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery), pleural fluid will be examined for various cytokines and PD1-lymphoctyes. arm group intervention list arm group intervention name Diagnostic Test: Pleural effusion will be examined for various cytokines and PD1-lymphocytes. intervention list intervention intervention type Diagnostic Test intervention name Pleural effusion will be examined for various cytokines and PD1-lymphocytes. intervention description Examination of pleural effusion intervention arm group label list intervention arm group label Patients with pleural effusion outcomes module primary outcome list primary outcome primary outcome measure To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions primary outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: age >18 years radiologically confirmed pleural effusion with an indication for puncture, pleural drain insertion, or video-assisted thoracoscopy for diagnostic and/or therapeutic reasons Signed declaration of consent Exclusion Criteria: Withdrawal or cessation of participation gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients with malignant or benign pleural effusions requiring diagnostic and/or therapeutic procedures including thoracocentesis, drainage insertion, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery sampling method Non-Probability Sample contacts locations module location list location location facility Medical University of Vienna location status Recruiting location city Vienna location country Austria location contact list location contact location contact name Daniela Gompelmann location contact role Contact location contact phone 0043 1 40400 47730 location contact e mail daniela.gompelmann@meduniwien.ac.at i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010996 condition mesh term Pleural Effusion condition ancestor list condition ancestor condition ancestor id D000010995 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full study rank 61358 study protocol section identification module n c t id NCT04837508 org study id info org study id MRG002-002 organization org full name Shanghai Miracogen Inc. org class INDUSTRY brief title A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer official title An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date June 7, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date August 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 8, 2021 last update post date struct last update post date December 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Shanghai Miracogen Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior stand therapy. detailed description The study consists of two stages. In Phase IIa, 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002. conditions module condition list condition Advanced or Metastatic Biliary Tract Cancer keyword list keyword MRG002 Antibody Drug Conjugate (ADC) HER2 Biliary Tract Cancer design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 86 enrollment type Anticipated arms interventions module arm group list arm group arm group label MRG002 arm group type Experimental arm group description MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle). arm group intervention list arm group intervention name Drug: MRG002 intervention list intervention intervention type Drug intervention name MRG002 intervention description Administrated intravenously intervention arm group label list intervention arm group label MRG002 outcomes module primary outcome list primary outcome primary outcome measure Objective Response Rate (ORR) by Independent Review Committee (IRC) primary outcome description ORR is defined as the percentage of patients with a complete response (CR) and partial response (PR) as assessed by Independent Review Committee (IRC) according to RECIST v1.1. primary outcome time frame Baseline to study completion, up to 12 months secondary outcome list secondary outcome secondary outcome measure ORR by Investigator secondary outcome description ORR is defined as the percentage of patients with a CR and PR as assessed by Investigator according to RECIST v1.1. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Duration of Response (DoR) secondary outcome description DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Time to Response (TTR) secondary outcome description TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Disease Control Rate (DCR) secondary outcome description DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Progression Free Survival (PFS) secondary outcome description PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Overall Survival (OS) secondary outcome description OS is defined as the duration from the start of treatment to death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Adverse Events (AEs) secondary outcome description Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug. secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve secondary outcome description Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS). secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Incidence of anti-drug antibody (ADA) secondary outcome description The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment. secondary outcome time frame Baseline to 30 days after the last dose of study treatment eligibility module eligibility criteria Inclusion Criteria: Willing to sign the ICF and follow the requirements specified in the protocol. Aged 18 to 75 (including 18 and 75), both genders. Expected survival time ≥ 12 weeks. Patients with unresectable locally advanced or metastatic biliary tract cancer confirmed by histopathology. Failed in the prior one or more standard therapies. HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test. Archival or biopsy tumor specimens should be provided (primary or metastatic). Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ECOG performance score 0 or 1. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities). No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%. Organ function must meet the basic requirements. Coagulation function must meet the basic requirements. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab. Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment. Presence of clinical manifestation of biliary obstruction. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage. Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis. Any severe or uncontrolled systemic diseases. Patients with poorly controlled heart diseases. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection. History of other primary malignancies. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc. Peripheral neuropathy greater than Grade 1. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C). Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials. Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator. healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Program Director central contact role Contact central contact phone 86-21-61637960 central contact e mail clinicaltrials@miracogen.com.cn overall official list overall official overall official name Aiping Zhou, MD overall official affiliation Cancer Institute and Hospital, Chinese Academy of Medical Sciences overall official role Principal Investigator location list location location facility The first affiliated hospital of bengbu medical college location status Recruiting location city Bengbu location state Anhui location zip 233004 location country China location contact list location contact location contact name Mingxi Wang location contact role Contact location contact phone 0552-3086943 location contact e mail drwmx@126.com location facility Cancer Hospital Chinese Academy of Medical Sciences location status Recruiting location city Beijing location state Beijing location zip 100000 location country China location contact list location contact location contact name Aiping Zhou, MD location contact role Contact location contact phone 86-10-87788800 location contact e mail zhouap1825@126.com location facility Peking Union Medical College Hospital location status Recruiting location city Beijing location state Beijing location zip 100730 location country China location contact list location contact location contact name Mei Guan location contact role Contact location contact phone 010-69158353 location contact e mail guanmei71@126.com location facility ZhuJiang Hospital of Southern Medical University location status Recruiting location city Guangzhou location state Guangdong location zip 510280 location country China location contact list location contact location contact name Weimin Ding location contact role Contact location contact phone 020-62783372 location contact e mail DWM-2001@163.com location facility Harbin Medical University Cancer Hospital location status Recruiting location city Harbin location state Heilongjiang location zip 150081 location country China location contact list location contact location contact name Yanqiao Zhang location contact role Contact location contact phone 0451-86298192 location contact e mail yanqiaozhang@126.com location facility Henan Cancer Hospital location status Recruiting location city Zhengzhou location state Henan location zip 450003 location country China location contact list location contact location contact name Ying Liu location contact role Contact location contact phone 0371-65588007 location contact e mail yaya7207@126.com location facility Liaoning Cancer Hospital&Institute location status Recruiting location city Shenyang location state Liaoning location zip 110801 location country China location contact list location contact location contact name Jingdong Zhang location contact role Contact location contact phone 024-31916651 location contact e mail 13804027878@163.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001661 condition mesh term Biliary Tract Neoplasms condition ancestor list condition ancestor condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001660 condition ancestor term Biliary Tract Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M4099 condition browse leaf name Biliary Tract 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full study rank 61402 study protocol section identification module n c t id NCT04836936 org study id info org study id STUDY20120027 organization org full name University of Pittsburgh org class OTHER brief title Auriculotherapy in the Treatment of Pre-Operative Anxiety official title Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 13, 2021 start date type Actual primary completion date struct primary completion date January 31, 2023 primary completion date type Anticipated completion date struct completion date January 31, 2023 completion date type Anticipated study first submit date March 9, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date February 14, 2022 last update post date struct last update post date February 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Jacques E. Chelly responsible party investigator title Professor of Anesthesiology (with Tenure) and Orthopedic Surgery responsible party investigator affiliation University of Pittsburgh lead sponsor lead sponsor name Jacques E. Chelly lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary The goal of this clinical trial is to use the validated PROMIS Emotional Distress - Anxiety - Short Form 8a and PROMIS Emotional Distress-Depression-Short Form pre-and post-intervention to establish a superior correlation between the auriculotherapy treatment and the reduction of perioperative anxiety. Subject population will include those having a partial or total nephrectomy for cancer. Drawing the role that auriculotherapy may play in reducing perioperative anxiety related requirement after surgery may also help in reducing the risk of opioid use disorders (OUD) since anxiety has been found to be a major risk factor for OUD in surgical patients. Therefore, this trial will also examine the effect of the auriculotherapy intervention in reducing opioid requirement after surgery. detailed description Sixty subjects undergoing total or partial nephrectomies will be asked to participate in this IRB approved placebo-controlled randomized study. Potential subjects will be recruited out of the surgeon's office or at a preoperative clinical visit prior to surgery. The clinical care team will introduce the study and request permission for the research team to speak with the patient. If the subject agrees to be approached by a member of the research team, then the research team will approach the subject. During the Informed Consent, a PI or Co-I will be available to answer final questions and facilitate the process. After signing an informed consent, the subjects will be equally randomized to either active auriculotherapy treatment (with nitrogen gas) or placebo auriculotherapy treatment (without nitrogen gas). Each subject will be asked to complete the PROMIS Emotional Distress - Anxiety - Short Form 8a, the PROMIS Emotional Distress-Depression-Short Form and Pain Catastrophizing Scale (PCS) in the pre-operative setting. Those whose anxiety scores are ≥19 and ≤29 will be included in the study and randomly distributed to either treatment allocation. Randomization will occur by assigning the participant a subject ID number, and this ID number will correspond to a treatment allocation based on a pre-designed randomization schema. This treatment allocation (intervention/control) will be contained in a sealed, opaque, envelope with the subject ID number that is designated on envelope. The master randomization list will be created and held by an independent data monitor who will both create and hold the master randomization list. A data manager research associate will confidentially reveal the randomization to the PI or Amy Monroe so that the study coordinators, Co-Is and subjects will be blinded. PI or Amy Monroe, and the data managing associate will be the only individuals who are unblinded. Study assessments will be conducted on the day of surgery, in the pre-operative setting. This will include the PROMIS Emotional Distress - Anxiety - Short Form 8a as this is the first assessment conducted after obtaining Informed Consent. It is used to assess eligibility for the study. This assessment will take roughly 5 minutes. Auriculotherapy treatment will also occur in the pre-operative setting, within one hour of surgery and after the patient has received a peripheral nerve block. For the active treatment group, a nitrogen gas canister will be applied to a cryopuncture device (manual attached), and the tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of gas for 2 seconds on each point (7 points total). For the sham device, an empty canister will be applied to the cryopuncture device, and in exactly the same fashion as the treatment group, the tip of the cryopuncture will be sanitized and placed on each treatment point of the ear. Instead of releasing a spurt of nitrogen gas, the empty canister will make the same noise as a full canister, but without the expulsion of gas. We are not expecting any adverse events from performing this technique. The only "adverse event" that is expected is a mild local blistering/scab, which may occur within 24 hours after the treatment. In our experience in our ongoing auriculotherapy study (24 subjects enrolled), we did not observe this adverse event. In the experience of Dr. Chelly(11 years) and Dr. Alimi (30 years), any local blistering or ulceration is extremely mild, and resolves in days without any intervention. No potential adverse effect would require immediate treatment or delay the surgery. After surgery, the subject will be assessed for pain medication requirement and pain scores in the post-anesthesia care unit (PACU) and then assessed daily until discharge. Upon discharge, subjects will repeat the PROMIS Emotional Distress questionnaires and the PCS. Additionally, subjects will be asked to complete an overall satisfaction questionnaire measured on a scale to 0-10. The subjects will take home a diary where they will record daily NRS pain scores (scale 0-10), daily anxiety level (scale 0-10) and daily analgesic/opioid requirement for one-week post-op. The subject will be contacted daily after discharge until completion of the pain diary at Day 7 post-op, and will also be contacted once at 30-day and 90-day post-op to report the PROMIS Emotional Distress -Anxiety- Short Form 8a, the PROMIS Emotional Distress-Depression-Short Form, and Pain Catastrophizing Scale (PCS) verbally over the telephone. The subject will be contacted via phone daily to gather their responses post op to the surveys, a maximum of three times. If we are unable to reach the subject after 3 days they will be considered lost to follow up. If In addition to this, the subject will be asked to assess their functional recovery using the SF-12 questionnaire, and to report their VAS pain score/opioid consumption for the previous week. conditions module condition list condition Anxiety Preoperative keyword list keyword Nephrectomy Auriculotherapy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A Randomized, Double-Blind, Placebo-Controlled trial involving patients undergoing partial or total nephrectomy. design primary purpose Treatment design masking info design masking Triple design masking description The only person unblinded to treatment allocation will be the Principal investigator or individual who will perform the auriculotherapy treatment. design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Auriculotherapy cryopuncture device without nitrogen gas arm group type Placebo Comparator arm group description Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using an empty cryopuncture device without nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management. arm group intervention list arm group intervention name Device: Auriculotherapy cryopuncture device without nitrogen gas arm group label Auriculotherapy cryopuncture device with nitrogen gas arm group type Active Comparator arm group description Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using a cryopuncture device with nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management. arm group intervention list arm group intervention name Device: Auriculotherapy cryopuncture device with nitrogen gas intervention list intervention intervention type Device intervention name Auriculotherapy cryopuncture device without nitrogen gas intervention description Auriculotherapy cryopuncture device without nitrogen gas will be administered. Application of this placebo device will be performed in the same manner as the treatment, but without the expulsion of nitrogen gas. intervention arm group label list intervention arm group label Auriculotherapy cryopuncture device without nitrogen gas intervention type Device intervention name Auriculotherapy cryopuncture device with nitrogen gas intervention description Auriculotherapy cryopuncture device with nitrogen gas will be administered. The tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of nitrogen gas for 2 seconds on each point (6 points total). intervention arm group label list intervention arm group label Auriculotherapy cryopuncture device with nitrogen gas outcomes module primary outcome list primary outcome primary outcome measure Opioid Consumption primary outcome description Demonstrate how auriculotherapy using the cryopuncture device changes participant's total opioid consumption following nephrectomy surgery. primary outcome time frame Day of surgery through discharge or post-operative day 30, whichever came first secondary outcome list secondary outcome secondary outcome measure Pre-operative emotional distress related to anxiety secondary outcome description Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Screening visit secondary outcome measure Post-operative emotional distress related to anxiety secondary outcome description Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Pre-operative emotional distress related to depression secondary outcome description Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant many have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Screening visit secondary outcome measure Post-operative emotional distress related to depression secondary outcome description Post-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire. There are 8 questions about how the participant many have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Pre-operative pain rating using the Pain Catastrophizing Scale secondary outcome description Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome. secondary outcome time frame Screening visit secondary outcome measure Post-operative pain rating using the Visual Analog Scale (VAS) secondary outcome description Post-operative pain ratings will be measured by the assessment of the participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Post-operative pain rating using the Pain Catastrophizing Scale secondary outcome description Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Post-operative analgesic utilization secondary outcome description Post-operative analgesic utilization will be measured using electronic medical records and patient-recorded diaries of daily analgesic/opioid requirements. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Functional Recovery secondary outcome description Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1).These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and well-being). Overall score can range from 12 to 53. Higher scores present a better outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Overall patient satisfaction secondary outcome description Participants will be asked to assess their overall satisfaction upon discharge on a scale of 0 (least satisfaction) to 10 (highest satisfaction) at the time of discharge secondary outcome time frame Day of surgery through discharge or post-operative day 30, whichever came first eligibility module eligibility criteria Inclusion Criteria: Greater than 18 years of age Scheduled to undergo partial or full elective nephrectomy Subject is willing and able to provide informed consent Anxiety score ≥ 19 and ≤ 29 on the PROMIS Emotional Distress-Anxiety-Short Form 8a. Exclusion Criteria: Opioid dependence, based on the DSM definition of Opioid Use Disorder (OUD) Chronic pain condition where daily opioid use is needed History of fibromyalgia Anatomical malformation of ear (genetic or trauma-induced) Vasculopathy of ear Raynaud's disease Patient Refusal healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Amy Monroe central contact role Contact central contact phone 412-623-6382 central contact e mail monroeal@upmc.edu central contact name Brittany Norton central contact role Contact central contact e mail nortonbe@upmc.edu overall official list overall official overall official name Jacques E Chelly, MD overall official affiliation University of Pittsburgh overall official role Principal Investigator location list location location facility UPMC Shadyside Hospital location status Recruiting location city Pittsburgh location state Pennsylvania location zip 15232 location country United States location contact list location contact location contact name Jacque E Chelly, MD location contact role Contact location contact phone 412-623-6904 location contact e mail chelje@anes.upmc.edu location contact name Amy Monroe location contact role Contact location contact phone 412-623-6382 location contact e mail monroeal@upmc.edu location contact name Jacques E Chelly, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf as found Anxiety condition browse leaf relevance high condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions	NCT04836936	[ 101, 1554, 2025, 3997, 5391, 12882, 1477, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 22997, 1580, 22997, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 23676, 2591, 2137, 3663, 10973, 11964, 7629, 24458, 2369, 8916, 1554, 1271, 1239, 1104, 5610, 8916, 1705, 152, 24162, 9637, 4094, 1641, 27758, 4907, 22806, 8420, 11478, 1183, 1107, 1103, 19165, 1104, 11689, 118, 5434, 3946, 1760, 8745, 20656, 2078, 1641, 27758, 4907, 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full study rank 61173 study protocol section identification module n c t id NCT04839913 org study id info org study id COVID-SER organization org full name University of Cagliari org class OTHER brief title Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study official title Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Update From an Unicentric, Regional Study acronym COVID-19 status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 1, 2020 start date type Actual primary completion date struct primary completion date December 10, 2020 primary completion date type Actual completion date struct completion date January 10, 2021 completion date type Actual study first submit date April 7, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Fabio Medas responsible party investigator title Surgical researcher responsible party investigator affiliation University of Cagliari lead sponsor lead sponsor name University of Cagliari lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of seroprevalence between Spring and Fall seasons in a cohort of patients undergoing surgery. conditions module condition list condition SARS-CoV Infection Seroprevalence Covid19 design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 121 enrollment type Actual arms interventions module intervention list intervention intervention type Diagnostic Test intervention name Antibodies testing intervention description Serologic test for both SARS-COV-2 IgG and IgM outcomes module primary outcome list primary outcome primary outcome measure SARS-COV-2 seroprevalence primary outcome description SARS-COV-2 IgG and IgM seroprevalence between spring and fall period primary outcome time frame 1St September - 10Th December 2020 eligibility module eligibility criteria Inclusion Criteria: Patient admitted to our unit who had performed SARS-COV-2 serologic test Exclusion Criteria: age < 18 healthy volunteers No 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full study rank 61781 study protocol section identification module n c t id NCT04832009 org study id info org study id 00147066 organization org full name University of Kansas Medical Center org class OTHER brief title Reversing Glucose and Lipid-mediated Vascular Dysfunction official title Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL) acronym REGAL status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 9, 2022 start date type Actual primary completion date struct primary completion date May 9, 2023 primary completion date type Anticipated completion date struct completion date January 1, 2024 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 9, 2022 last update post date struct last update post date May 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Seth Holwerda PhD responsible party investigator title Principal Investigator responsible party investigator affiliation University of Kansas Medical Center lead sponsor lead sponsor name University of Kansas Medical Center lead sponsor class OTHER oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of our study is to understand the extent to which the blood vessels are affected by glucose and fat (lipids) in lean healthy adults and if these changes in the blood vessels contribute to the development of high blood pressure. detailed description Hypertension, obesity, and insulin resistance are associated with elevated muscle sympathetic nerve activity (MSNA), which is important for blood pressure regulation. The measurement of MSNA is safely performed in humans using the microneurographic technique that involves recording sympathetic nerve activity projecting to skeletal muscle using a small microelectrode at the peroneal nerve near the knee. The health of your blood vessels will be tested in this study, in addition to the activity of the nerves that control the blood vessels. The function of the nerves and blood vessels can be diminished by high blood glucose and lipids, and we will test the ability of a well-known antioxidant, ascorbic acid (vitamin C), to restore the function of the nerves and blood vessels. conditions module condition list condition Blood Pressure Hypertension design module study type Interventional phase list phase Early Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Comparisons of outcome variables will be made using a mixed model ANOVA. design primary purpose Other design masking info design masking Triple design masking description Randomized, double-blinded, parallel-design approach study. design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 46 enrollment type Anticipated arms interventions module arm group list arm group arm group label Glucose Infusion arm group type Experimental arm group description Hyperglycemia (glucose infusion) will receive an I.V. Glucose infusion with a co-infusion of ascorbic acid or placebo at your visit 2 and the alternative treatment of ascorbic acid or placebo will be given on the subsequent study visit 3. arm group intervention list arm group intervention name Drug: Dextrose 20 % in 500 ML Injection Drug: Saline Drug: Ascorbic acid arm group label Lipid Infusion arm group type Experimental arm group description Hyperlipidemia (lipid infusion) will receive an I.V. Lipid infusion with a co-infusion of ascorbic acid or placebo at your visit 2 and the alternative treatment of ascorbic acid or placebo will be given on the subsequent study visit 3. arm group intervention list arm group intervention name Drug: Intralipid Drug: Saline Drug: Ascorbic acid intervention list intervention intervention type Drug intervention name Dextrose 20 % in 500 ML Injection intervention description Dextrose (20% intravenous solution) will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, dextrose will be administered via antecubital vein at a standard rate of 4 mg/kg/min for 2 hours. intervention arm group label list intervention arm group label Glucose Infusion intervention other name list intervention other name Glucose intervention type Drug intervention name Intralipid intervention description Intralipid ® 20% will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, Intralipid ® 20% will be administered via antecubital vein at 0.75 mL/min for 2 hours Increases in circulating markers of oxidative stress peak within 2 hours of Intralipid ® 20% infusion in healthy adults (42). An initial heparin bolus of 1000 UL followed by 200 U/hr infusion will be included to activate endothelial lipoprotein lipase and accelerate hydrolysis of fatty acids. intervention arm group label list intervention arm group label Lipid Infusion intervention other name list intervention other name Lipid intervention type Drug intervention name Saline intervention description Saline will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. Will be administered via antecubital vein at 75 to 150 mL/hour for 2 hours. intervention arm group label list intervention arm group label Glucose Infusion Lipid Infusion intervention other name list intervention other name Placebo intervention type Drug intervention name Ascorbic acid intervention description (ASCOR) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min. The KU Investigational Pharmacy will randomize ascorbic acid or placebo (saline) for each participant. intervention arm group label list intervention arm group label Glucose Infusion Lipid Infusion outcomes module primary outcome list primary outcome primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame Baseline primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 30 minutes primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 60 minutes primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 90 minutes primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 120 minutes eligibility module eligibility criteria Inclusion Criteria: Lean: BMI < 25 kg/m Normal insulin sensitivity: (calculation based on fasting glucose and insulin concentrations in blood) Middle-aged: 18-79 years Blood pressure: < 140 (systolic) and < 90 mmHg (diastolic Weight stable (+/- 5 lbs) for the previous 3 months Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior. Able and willing to provide written informed consent Exclusion Criteria: Diabetes mellitus Type I or Type II: fasting glucose < 126 mg/dL and/or HbA1c < 6.5% Current smoker or History of smoking in the past 3 months. Hyperlipidemia: Fasting triglycerides < 250 mg/dL Hypertension: >130/80 mmHg History of heart disease (e.g., myocardial infarction, stent, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy) History of vascular disease (e.g., bypass, stroke) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 79 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Seth W Holwerda, PhD central contact role Contact central contact phone 9729223230 central contact e mail sholwerda@kumc.edu central contact name Davina A Clonch central contact role Contact central contact phone 9132266009 central contact e mail shoggirl@gmail.com overall official list overall official overall official name Seth W. W Holwerda, PhD overall official affiliation University of Kansas Medical Center overall official role Principal Investigator location list location location facility University of Kansas Medical Center location status Recruiting location city Kansas City location state Kansas location zip 66103 location country United States location contact list location contact location contact name Seth W. 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full study rank 61615 study protocol section identification module n c t id NCT04834167 org study id info org study id UTAR-45-2021 organization org full name Universiti Tunku Abdul Rahman org class OTHER brief title OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women official title OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 24, 2022 last update post date struct last update post date May 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yang Mooi Lim responsible party investigator title Deputy Director (Institute of Postgraduate Studies and Research), Professor responsible party investigator affiliation Universiti Tunku Abdul Rahman lead sponsor lead sponsor name Universiti Tunku Abdul Rahman lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma. detailed description This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma. conditions module condition list condition Skin Diseases Skin Disorder Melanoma (Skin) keyword list keyword Melasma Skin treatment Picopulse Malaysian women design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 37 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment arm group type Experimental arm group description Eligible patients will receive ten picopulse treatments for bi-monthly. arm group intervention list arm group intervention name Device: OneDoc Picopulse intervention list intervention intervention type Device intervention name OneDoc Picopulse intervention description Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly. intervention arm group label list intervention arm group label Treatment outcomes module primary outcome list primary outcome primary outcome measure Acceptability of the treatment primary outcome description Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied) primary outcome time frame One month secondary outcome list secondary outcome secondary outcome measure Feasibility of the recruitment and measurement tools secondary outcome description Number of patients referred from OneDoc and eligible for screening Number of patients recruited Follow-up response rates (2 weeks and 1 month follow-ups) secondary outcome time frame Pre-treatment, two weeks and one month secondary outcome measure Treatment adherence secondary outcome description Number of treatments attended secondary outcome time frame five months secondary outcome measure Melasma secondary outcome description Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma) secondary outcome time frame Through study completion, an average of 24 weeks secondary outcome measure Quality of life of patients secondary outcome description Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life secondary outcome time frame Pre-treatment, two weeks and one month post-treatment secondary outcome measure Safety evaluation secondary outcome description Incidence and severity of side effects caused by treatments secondary outcome time frame immediately after and before each subsequent treatment eligibility module eligibility criteria Inclusion Criteria: Women presenting dermal melasma with Fritzpatrick skin type III to V Malaysian citizen Agreed to participate Provide informed consent Exclusion Criteria: Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months. Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders Patients who photosensitivity or taking drugs known to induce photosensitivity, Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity Patients who could not attend follow-up treatments healthy volunteers No gender Female minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Yang Mooi Lim, PhD central contact role Contact central contact phone 60390860288 central contact e mail ymlim@utar.edu.my central contact name Chai Nien Foo, PhD central contact role Contact central contact phone 60390860288 central contact e mail foocn@utar.edu.my overall official list overall official overall official name Yang Mooi Lim, PhD overall official affiliation Universiti Tunku Abdul Rahman overall official role Principal Investigator location list location location facility OneDoc location status Recruiting location city Cheras location country Malaysia references module reference list reference reference p m i d 30215845 reference type result reference citation Amini F, Thazin Oo NM, Okechukwu PN, Seghayat MS, Ng ESC. Polymorphisms in P53 and VEGFA genes in different subtypes of periorbital hyperpigmentation in a Malaysian Chinese population. Australas J Dermatol. 2019 May;60(2):e99-e104. doi: 10.1111/ajd.12918. Epub 2018 Sep 14. reference p m i d 29020467 reference type result reference citation Chalermchai T, Rummaneethorn P. Effects of a fractional picosecond 1,064 nm laser for the treatment of dermal and mixed type melasma. J Cosmet Laser Ther. 2018 Jun;20(3):134-139. doi: 10.1080/14764172.2017.1376098. Epub 2017 Dec 4. reference p m i d 30320904 reference type result reference citation Labadie JG, Krunic AL. Long pulsed dye laser with a back-to-back double-pulse technique and compression for the treatment of epidermal pigmented lesions. Lasers Surg Med. 2019 Feb;51(2):136-140. doi: 10.1002/lsm.23009. Epub 2018 Oct 15. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012871 condition mesh term Skin Diseases condition mesh id D000008548 condition mesh term Melanosis condition ancestor list condition ancestor condition ancestor id D000017495 condition ancestor term Hyperpigmentation condition ancestor id D000010859 condition ancestor term Pigmentation Disorders condition browse leaf list condition browse leaf condition browse leaf id M10680 condition browse leaf name Melanoma condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf as found Skin Diseases condition browse leaf relevance high condition browse leaf id M10683 condition browse leaf name Melanosis condition browse leaf as found Melasma condition browse leaf relevance high condition browse leaf id M18912 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full study rank 61512 study protocol section identification module n c t id NCT04835506 org study id info org study id 2021P000391 organization org full name Beth Israel Deaconess Medical Center org class OTHER brief title Proactive Infliximab Optimization Using a PK Dashboard Versus SOC in Patients With Crohn's Disease: The OPTIMIZE Trial official title Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Crohn's Disease: The OPTIMIZE Trial status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 4, 2022 last update post date struct last update post date October 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Adam Cheifetz responsible party investigator title Professor of Medicine responsible party investigator affiliation Beth Israel Deaconess Medical Center lead sponsor lead sponsor name Beth Israel Deaconess Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name The Leona M. and Harry B. Helmsley Charitable Trust collaborator class OTHER collaborator name Icahn School of Medicine at Mount Sinai collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in moderately to severely active CD. detailed description Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) characterized by transmural inflammation of the intestine. CD is a global disease in the 21st century with increasing incidence in newly industrialized countries. One of the most effective therapies to treat patients with moderate to severe CD is the antitumor necrosis factor (TNF) agent infliximab (IFX) either as monotherapy or as a combination therapy with an immunomodulator (IMM), such as azathioprine or methotrexate (MTX). Although more effective, combination therapy is associated with more serious adverse events, such as serious opportunistic infections and cancers, as well as potential treatment adherence issues. Consequently, many patients and physicians choose to use IFX alone as safety is often prioritized over efficacy. Unfortunately, up to 30% of patients do not respond to induction therapy, and up to 50% of initial responders lose response over time. It is only if patients lose response that physicians check blood IFX concentrations (i.e., reactive therapeutic drug monitoring [TDM]), or empirically increase IFX dose. Reactive TDM helps to explain and better manage these patients with lack or loss of response to IFX. In many cases, the lack or LOR is due to low drug concentrations with or without development of antibodies to IFX (ATI). Unfortunately, reactive TDM or empiric dose escalation is often too late for patients who do not either respond to IFX induction therapy or lose response during maintenance. This reactive approach results in many patients losing IFX as a therapeutic option. Preliminary data show that proactive IFX optimization to achieve a threshold drug concentration during maintenance therapy (even if the patient is asymptomatic) compared to empiric dose escalation and/or reactive TDM is associated with better long-term outcomes including longer drug persistence, reduced risk of relapse, and fewer hospitalizations and surgeries. IFX dosing by weight only (i.e., mg/kg) may not be adequate for many patients as interindividual variability in drug clearance and other factors affecting IFX concentrations and PK are often not accounted for. Dosing calculators take into account all of these individual factors and improve the precision of dosing towards better personalized medicine. These systems have already been validated, and personalized dosing has shown clinical benefit in patients with IBD. This is a randomized, controlled, multicenter, open-label study that plans to enroll 196 participants with moderately to severely active CD. All eligible participants will be randomly assigned in a 1:1 ratio to receive either IFX monotherapy with proactive TDM or SOC IFX therapy, with or without concomitant IMM therapy, and empiric dose optimization or reactive TDM, at the discretion of the investigator. conditions module condition list condition Crohn Disease design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 196 enrollment type Anticipated arms interventions module arm group list arm group arm group label proactive infliximab optimization arm group type Experimental arm group description proactive infliximab optimization using a pharmacokinetic dashboard arm group intervention list arm group intervention name Drug: Infliximab arm group label standard of care infliximab dosing arm group type Experimental arm group description standard of care infliximab dosing arm group intervention list arm group intervention name Drug: Infliximab intervention list intervention intervention type Drug intervention name Infliximab intervention description infliximab intervention arm group label list intervention arm group label proactive infliximab optimization standard of care infliximab dosing outcomes module primary outcome list primary outcome primary outcome measure clinical remission primary outcome description Proportion of subjects with sustained corticosteroid-free (no corticosteroid (CS) use from Week 14 through 52) ) clinical remission (on the CDAI at Weeks 14, 26, 52) and no need for rescue therapy. primary outcome time frame 52 weeks secondary outcome list secondary outcome secondary outcome measure clinical remission secondary outcome description Proportion of subjects in CS-free clinical remission (CDAI <150 and no use of CS within previous 6 months) secondary outcome time frame 52 weeks secondary outcome measure deep remission secondary outcome description Proportion of subjects in deep remission (CDAI < 150 and SES-CD ≤ 4, with no individual subscore > 1) secondary outcome time frame 52 weeks secondary outcome measure composite biological and endoscopic remission secondary outcome description Proportion of subjects with a composite biological (hs-CRP<10 mg/L) and endoscopic remission (SES-CD ≤ 4) secondary outcome time frame 52 weeks secondary outcome measure sustained CS-free clinical remission secondary outcome description 4. Proportion of subjects with sustained CS-free clinical remission (CDAI <150 and no CS use from Week 14 through Week 52) secondary outcome time frame 52 weeks secondary outcome measure primary non-responders secondary outcome description Proportion of subjects who are primary nonresponders (≤ 70-point decrease in CDAI score and at least one of: hs-CRP ≥10 mg/L, FC > 250 μg/g, or SES-CD > 4; or need for rescue therapy prior to Week 14) secondary outcome time frame 14 weeks secondary outcome measure biological remission secondary outcome description Proportion of subjects with sustained biological remission (hs-CRP <10 mg/L) secondary outcome time frame 52 weeks secondary outcome measure endoscopic remission secondary outcome description Proportion of subjects with endoscopic remission (SES-CD ≤ 4, with no individual subscore > 1) secondary outcome time frame 52 weeks secondary outcome measure hs-CRP normalization secondary outcome description Proportion of subjects with normalization of hs-CRP (decrease from ≥ 10 at baseline to < 10 mg/L) secondary outcome time frame 52 weeks secondary outcome measure hs-CRP change from baseline secondary outcome description Hs-CRP change from baseline secondary outcome time frame week 14, week 26, and week 52 secondary outcome measure endoscopic response secondary outcome description Proportion of subjects with an endoscopic response (≥ 50% decrease from baseline SES-CD score) secondary outcome time frame 52 weeks secondary outcome measure fecal calprotectin secondary outcome description Proportion of subjects with normalization of fecal calprotectin (decrease from >250 µg/g at baseline to ≤ 250 µg/g) secondary outcome time frame 52 weeks secondary outcome measure fecal calprotectin change secondary outcome description fecal calprotectin change from baseline secondary outcome time frame 52 weeks eligibility module eligibility criteria Inclusion Criteria: Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive. Diagnosis of CD prior to screening using standard endoscopic, histologic, or radiologic criteria. Subjects with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD. Moderately to severely active CD, defined by a total Crohn's Disease Activity Index (CDAI) score between 220 and 450 points, and at least 1 of the following: Elevated CRP > upper limit of normal ) Elevated fecal calprotectin (FC) (> 250 μg/g) SES-CD > 6, or SES-CD > 3 for isolated ileal disease Physician intends to prescribe IFX as part of the usual care of the subject. No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol Able to participate fully in all aspects of this clinical trial. Written informed consent must be obtained and documented. Exclusion Criteria: Subjects with any of the following CD-related complications: Abdominal or pelvic abscess, including perianal Presence of stoma or ostomy Isolated perianal disease Obstructive disease, such as obstructive stricture Short gut syndrome Toxic megacolon or any other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of disease activity (CDAI or SES-CD) Total colectomy. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption. Current bacterial or parasitic pathogenic enteric infection, according to SOC assessments, including: Clostridioides difficile; tuberculosis; known infection with hepatitis B or C virus; known infection with HIV; sepsis; abscesses. History of the following: opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; more than 1 episode of herpes zoster or any episode of disseminated zoster; any other infection requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening. Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence within the last 5 years. Known primary or secondary immunodeficiency. PNR to adalimumab, defined as no objective evidence of clinical benefit after 14 weeks of therapy. Subjects with failure to a prior biologic, defined as PNR or SLR, will be excluded when a maximum of 40% of the planned enrollment (approximately 78 subjects) have failure to prior biologic exposure. Concomitant use of oral corticosteroid therapy exceeding prednisone 40 mg/day, budesonide 9 mg/day, or equivalent, unless a tapering schedule is initiated with a plan to be off CS by Week 14 Presence of any medical condition or use of any medication that is a contraindication for IFX use, as outlined on the product label. A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study. Pregnant or lactating women, to be excluded based on the physician's usual practice for determining pregnancy or lactation status. Known intolerance or hypersensitivity to IFX or other murine proteins. healthy volunteers No gender All minimum age 16 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Vivian Cheng central contact role Contact central contact phone 6176670682 central contact e mail OPTIMIZE@bidmc.harvard.edu location list location location facility University of Miami location status Enrolling by invitation location city Miami location state Florida location zip 33136 location country United States location facility University of Chicago Medicine location status Enrolling by invitation location city Chicago location state Illinois location zip 60637 location country United States location facility Northwestern University location status Enrolling by invitation location city Evanston location state Illinois location zip 60208 location country United States location facility Rockford GI location status Enrolling by invitation location city Rockford location state Illinois location zip 61107 location country United States location facility Beth Israel Deaconess Medical Center location status Recruiting location city Boston location state Massachusetts location zip 02215 location country United States location contact list location contact location contact name Vivian Cheng location contact role Contact location contact phone 617-667-0682 location contact e mail OPTIMIZE@bidmc.harvard.edu location contact name Adam Cheifetz, MD location contact role Principal Investigator location facility University of Minnesota location status Enrolling by invitation location city Minneapolis location state Minnesota location zip 55455 location country United States location facility Dartmouth-Hitchcock Medical Center location status Enrolling by invitation location city Lebanon location state New Hampshire location zip 03766 location country United States location facility NYU Langone Health location status Enrolling by invitation location city New York location state New York location zip 10016 location country United States location facility Icahn School of Medicine at Mount Sinai location status Enrolling by invitation location city New York location state New York location zip 10029 location country United States location facility Weill Cornell Medical College location status Enrolling by invitation location city New York location state New York location zip 10065 location country United States location facility Atrium Health Center for Digestive Health location status Enrolling by invitation location city Charlotte location state North Carolina location zip 28204 location country United States location facility Cleveland Clinic location status Enrolling by invitation location city Cleveland location state Ohio location zip 44195 location country United States location facility Children's Hospital of Philadelphia location status Enrolling by invitation location city Philadelphia location state Pennsylvania location zip 19104 location country United States location facility University of Texas Southwestern Medical Center location status Enrolling by invitation location city Dallas location state Texas location zip 75390 location country United States location facility University of Utah location status Enrolling by invitation location city Salt Lake City location state Utah location zip 84132 location country United States location facility Medical College of Wisconsin location status Enrolling by invitation location city Milwaukee location state Wisconsin location zip 53226 location country United States references module reference list reference reference p m i d 35365535 reference type derived reference citation Papamichael K, Jairath V, Zou G, Cohen B, Ritter T, Sands B, Siegel C, Valentine J, Smith M, Vande Casteele N, Dubinsky M, Cheifetz A. Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial). BMJ Open. 2022 Apr 1;12(4):e057656. doi: 10.1136/bmjopen-2021-057656. i p d sharing statement module i p d sharing Yes i p d sharing description De-identified participant data and trial-level data will be available on reasonable request. This data will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement i p d sharing time frame After completion and publication of primary study. i p d sharing access criteria This data will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003424 condition mesh term Crohn Disease condition ancestor list condition ancestor condition ancestor id D000015212 condition ancestor term Inflammatory Bowel Diseases condition ancestor id D000005759 condition ancestor term Gastroenteritis condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition browse leaf list condition browse leaf condition browse leaf id M5790 condition browse leaf name Crohn Disease condition browse leaf as found Crohn's Disease condition browse leaf relevance high condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M17069 condition browse leaf name Inflammatory Bowel Diseases condition browse leaf relevance low condition browse leaf id M8027 condition browse leaf name Gastroenteritis condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000069285 intervention mesh term Infliximab intervention ancestor list intervention ancestor intervention ancestor id D000003879 intervention ancestor term Dermatologic Agents intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M375 intervention browse leaf name Infliximab intervention browse leaf as found SARS-CoV-2 intervention browse leaf relevance high intervention browse leaf id M6226 intervention browse leaf name Dermatologic Agents intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M19757 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full study rank 61211 study protocol section identification module n c t id NCT04839419 org study id info org study id 2019-A02866-51 organization org full name SOS Oxygene Mediterranee org class INDUSTRY brief title Obesity-hypoventilation in Metabolic Syndrom Patients official title PREVALENCE OF OBESITY-HYPOVENTILATION SYNDROME IN PATIENTS WITH METABOLIC SYNDROME status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date August 1, 2020 start date type Actual primary completion date struct primary completion date August 1, 2023 primary completion date type Anticipated completion date struct completion date August 1, 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name SOS Oxygene Mediterranee lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom. detailed description After being informed about the study and potential risks, patient agreed to participate and undergo : a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night. conditions module condition list condition Metabolic Syndrome Obesity Hypoventilation Syndrome Capnography design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 400 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Capnia primary outcome description Arterial pression in CO2 and transcutaneous pression in CO2 primary outcome time frame Up to one mont after inclusion primary outcome measure Arterial pression in CO2 primary outcome description PaCO2 primary outcome time frame At the inclusion secondary outcome list secondary outcome secondary outcome measure BMI secondary outcome description body mass index secondary outcome time frame At the inclusion secondary outcome measure Arterial pression in oxygen secondary outcome description PaO2 secondary outcome time frame At the inclusion secondary outcome measure somnolence secondary outcome description EPWORTH questionnaire secondary outcome time frame At the inclusion secondary outcome measure Physical activity level secondary outcome description Ricci&Gagnon questionnaire secondary outcome time frame At the inclusion secondary outcome measure Arterial blood bicarbonates secondary outcome description HCO3- secondary outcome time frame At the inclusion secondary outcome measure Arterial blood gases secondary outcome description pH secondary outcome time frame At the inclusion secondary outcome measure Hemoglobin secondary outcome description Hb secondary outcome time frame At the inclusion secondary outcome measure obstructive sleep apnea items secondary outcome description Apnea-hypopnea index secondary outcome time frame Up to one mont after inclusion secondary outcome measure Night Oxygen saturation secondary outcome description SpO2 secondary outcome time frame Up to one mont after inclusion eligibility module eligibility criteria Inclusion Criteria: BMI>30 kg/m2 no treatment with CPAP nor NIV Exclusion Criteria: obstructive respiratory disease non-treated cardiac dysfunction healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients will be selected as part of their usual care, during a consultation for their respiratory and metabolic monitoring. sampling method Probability Sample contacts locations module central contact list central contact central contact name Delphine Delample, PhD central contact role Contact central contact phone 0612155648 central contact phone ext +33 central contact e mail d.delample@sosoxygene.com overall official list overall official overall official name Mathieu Despeaux, MD overall official affiliation Clinique du Chateau de Vernhes overall official role Principal Investigator location list location location facility Clinique du Château de Vernhes location status Recruiting location city Bondigoux location zip 31340 location country France location contact list location contact location contact name Mathieu Despeaux, MD location contact role Contact location contact phone 0561372727 location contact phone ext +33 location contact e mail m.despeaux@cliniquevernhes.fr derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007040 condition mesh term Hypoventilation condition mesh id D000010845 condition mesh term Obesity Hypoventilation Syndrome condition mesh id D000009765 condition mesh term Obesity condition mesh id D000024821 condition mesh term Metabolic Syndrome condition mesh id D000013577 condition mesh term Syndrome condition ancestor list condition ancestor condition ancestor id D000004194 condition ancestor term Disease condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000007333 condition ancestor term Insulin Resistance condition ancestor id D000006946 condition ancestor term Hyperinsulinism condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000012131 condition ancestor term Respiratory Insufficiency condition ancestor id D000012120 condition ancestor term Respiration Disorders condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000012818 condition ancestor term Signs and Symptoms, Respiratory condition ancestor id D000020181 condition ancestor term Sleep Apnea, Obstructive condition ancestor id D000012891 condition ancestor term Sleep Apnea Syndromes condition ancestor id D000001049 condition ancestor term Apnea condition ancestor id D000020919 condition ancestor term Sleep Disorders, Intrinsic condition ancestor id D000020920 condition ancestor term Dyssomnias condition ancestor id D000012893 condition ancestor term Sleep Wake Disorders condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf as found Syndrome condition browse leaf relevance high condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf as found Obesity condition browse leaf relevance high condition browse leaf id M22158 condition browse leaf name Metabolic Syndrome condition browse leaf as found Metabolic Syndrome condition browse leaf relevance high condition browse leaf id M9242 condition browse leaf name Hypoventilation condition browse leaf as found Hypoventilation condition browse leaf relevance high condition browse leaf id M12892 condition browse leaf name Obesity Hypoventilation Syndrome condition browse leaf as found Obesity Hypoventilation Syndrome condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M9522 condition browse leaf name Insulin Resistance condition browse leaf relevance low condition browse leaf id M9149 condition browse leaf name Hyperinsulinism condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M14120 condition browse leaf name 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full study rank 61172 study protocol section identification module n c t id NCT04839926 org study id info org study id NH101-11 organization org full name Jiangsu Nhwa Pharmaceutical Co., Ltd. org class INDUSTRY brief title A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects official title A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 2, 2021 start date type Actual primary completion date struct primary completion date August 1, 2021 primary completion date type Anticipated completion date struct completion date August 1, 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Jiangsu Nhwa Pharmaceutical Co., Ltd. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects. detailed description Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg). This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ). conditions module condition list condition Schizophrenia keyword list keyword Safety, Tolerability,Pharmacokinetics CY150112 Single Ascending Dose design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Sequential Assignment design primary purpose Basic Science design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label 0.5mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 0.5mg CY150112 arm group label 1.5mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 1.5mg CY150112 arm group label 4.5mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 4.5mg CY150112 arm group label 10mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 10mg CY150112 arm group label 18mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 18mg CY150112 arm group label 24mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 24mg CY150112 intervention list intervention intervention type Drug intervention name 0.5mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 0.5mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 1.5mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 1.5mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 4.5mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 4.5mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 10mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 10mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 18mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 18mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 24mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 24mg CY150112 intervention other name list intervention other name placebo outcomes module primary outcome list primary outcome primary outcome measure Incidence of AEs primary outcome description Incidence of Adverse Events primary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome list secondary outcome secondary outcome measure Cmax secondary outcome description Maximum (peak) observed drug serum concentration secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure AUC0-t secondary outcome description Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure AUC0-∞ secondary outcome description Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure %AUCex secondary outcome description Extrapolation percentage of AUC0-∞ secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure Tmax secondary outcome description Time of occurrence of Cmax secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure T1/2 secondary outcome description Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure Vd secondary outcome description Apparent volume of distribution secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure CL secondary outcome description Clearance secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure λz secondary outcome description Elimination rate constant secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose eligibility module eligibility criteria Inclusion Criteria: Male/female subjects are 18<age ≤45 years of age when signing the informed consent. Male Subjects with body weight of ≥50.0kg ，and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination. After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily. Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study. Exclusion Criteria: The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc. There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc. Subjects with past history of allergy to drugs or allergic disease. Subjects with currently or past history of mental disorders and brain functional disorders. According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior. Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior. Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior. Average amount of daily smoking>5 cigarettes at screening 3 months prior. Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing. Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study. Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ). Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg. Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative. Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit. Subjects who participated in any clinical trial within 3 months before medication. Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products. Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period. Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment. Subjects who directly related to this clinical trial. Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 45 Years std age list std age Adult contacts locations module central contact list central contact central contact name Hua Fang li, MD central contact role Contact central contact phone 021-34773107 central contact e mail lhlh_5@163.com central contact name Li Yan, Research Doctor central contact role Contact central contact phone 021-34773107 central contact e mail lhlh_5@163.com overall official list overall official overall official name Hua Fang li, MD overall official affiliation Shanghai Mental Health Center overall official role Principal Investigator location list location location facility Shanghai Mental Health Center location status Recruiting location city Shanghai location state Shanghai location zip 200030 location country China location contact list location contact location contact name Hua Fang li, MD location contact role Contact location contact phone 021-34773107 location contact e mail lhlh_5@163.com location contact name Li Yan, Research Doctor location contact role Contact location contact phone 021-34773107 location contact e mail lhlh_5@163.com location contact name Hua Fang Li, MD location contact role Principal Investigator location contact name Li Yan, Research Doctor location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012559 condition mesh term Schizophrenia condition ancestor list condition ancestor condition ancestor id D000019967 condition ancestor term Schizophrenia Spectrum and Other Psychotic Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M14528 condition browse leaf name 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full study rank 61415 study protocol section identification module n c t id NCT04836767 org study id info org study id GO21-178 organization org full name Hacettepe University org class OTHER brief title Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term official title Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term status module status verified date August 2022 overall status Completed expanded access info has expanded access No start date struct start date February 16, 2021 start date type Actual primary completion date struct primary completion date February 3, 2022 primary completion date type Actual completion date struct completion date February 3, 2022 completion date type Actual study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 6, 2022 last update post date struct last update post date August 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ebru Calik Kutukcu responsible party investigator title Associate Professor responsible party investigator affiliation Hacettepe University lead sponsor lead sponsor name Hacettepe University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, consciousness, work productivity, pain, fear of movement, and quality of life in patients with Covid-19 and to compare them with healthy individuals who have not had COVID-19. detailed description In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term exercise capacity, pain, kinesiophobia, peripheral muscle strength, balance, anxiety and depression level, cognitive status and quality of life in individuals with COVID-19. It will also be examined whether these parameters change according to the post-COVID functional restriction level. 3. Materials and Methods of the Research: 3.1. The place of the study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation and Hacettepe University Faculty of Medicine Department of General Internal Medicine 3.2. Time of the study: It is planned to collect data and write the study between February 2021 and February 2022. 3.3. Research population, sample, research group: The population of the study is individuals who have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19. The sample of the study is individuals in the long-term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study, and healthy individuals who have not had COVID-19. Study Design: Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65, whose education level is at least primary school, and whose local language is Turkish. A total of 40 participants, 20 healthy without COVID-19, and 20 with at least 12 weeks past the diagnosis of COVID-19, will be included in the study. The guidance of the participants will be provided by the relevant physicians of the General Internal Medicine Unit of Hacettepe University Internal Diseases Department. In accordance with the COVID-19 pandemic precautions, social distance rules will be followed in the tests to be carried out with individuals, care will be taken to use masks, and the materials to be used in tests and measurements will be disinfected before and after use. COVID-19 Group Inclusion Criteria Having been diagnosed with COVID-19 at least 12 weeks ago, Being literate, Being in the age range of 18-65, Volunteering to participate in research, To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19, Recent myocardial infarction and pulmonary embolism. Having accompanying chronic diseases, Those who have any orthopedic or neurological disorders that will prevent walking, Another COVID-19 PCR Test positivity in the last 12 weeks, Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, Healthy Group Inclusion Criteria Not having COVID-19, Being literate, Being in the age range of 18-65, Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study Those who have any orthopedic or neuromuscular disorders that will prevent walking, Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. Individuals participating in the study will be informed verbally and in writing about the study protocol and informed consent form will be obtained. conditions module condition list condition Corona Virus Infection Covid19 keyword list keyword COVID-19 SARS-CoV2 pandemic post-COVID-19 exercise capacity design module study type Observational patient registry Yes target duration 12 Weeks design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label people with a history of COVID-19 arm group description COVID-19 Group Inclusion Criteria Having been diagnosed with COVID-19 at least 12 weeks ago, Being literate, Being in the age range of 18-65, Volunteering to participate in research, To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19, Recent myocardial infarction and pulmonary embolism. Having accompanying chronic diseases, Those who have any orthopedic or neurological disorders that will prevent walking, Another COVID-19 PCR Test positivity in the last 12 weeks, Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, arm group label healthy people arm group description Healthy Group Inclusion Criteria Not having COVID-19, Being literate, Being in the age range of 18-65, Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study Those who have any orthopedic or neuromuscular disorders that will prevent walking, Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. outcomes module primary outcome list primary outcome primary outcome measure Incremental shuttle walking test primary outcome description It assesses maximal exercise capacity. primary outcome time frame January,2021 - December,2021 secondary outcome list secondary outcome secondary outcome measure Time up and Go Test secondary outcome description Functional balance and walking capacity secondary outcome time frame January,2021 - December,2021 secondary outcome measure Short form McGill-Melzack Pain Questionnaire secondary outcome description The pain rating index has 2 subscales: Sensory subscale with 11 words, and Affective subscale with 4 words. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10 cm visual analogue scale (VAS) for average pain. The higher the total score on the MPQ, the more the pain experience for the patient increases secondary outcome time frame January,2021 - December,2021 secondary outcome measure Tampa Kinesophobia Questionnaire secondary outcome description Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia secondary outcome time frame January,2021 - December,2021 secondary outcome measure Hospital Anxiety and Depression Scale secondary outcome description Assessment of anxiety and depression. Scores range from 0 to 21 for each of the two subscales. Higher scores indicate higher level of anxiety and depression secondary outcome time frame January,2021 - December,2021 secondary outcome measure SF-36 Quality of Life Scale secondary outcome description Assessment of life quality. The scores of each domain ranges from zero to 100 which higher scores indicating higher levels of functioning or well-being secondary outcome time frame January,2021 - December,2021 secondary outcome measure Fatigue Severity Scale secondary outcome description Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception. secondary outcome time frame January,2021 - December,2021 secondary outcome measure Cognitive Status Scale secondary outcome description Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure. secondary outcome time frame January,2021 - December,2021 secondary outcome measure Body Mass Index secondary outcome description Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. secondary outcome time frame January,2021 - December,2021 secondary outcome measure Body composition analysis with bioelectrical impedance analysis system secondary outcome description FM and FFM ratio secondary outcome time frame January,2021 - December,2021 eligibility module eligibility criteria COVID-19 Group Inclusion Criteria Having been diagnosed with COVID-19 at least 12 weeks ago, Being literate, Being in the age range of 18-65, Volunteering to participate in research, To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19, Recent myocardial infarction and pulmonary embolism. Having accompanying chronic diseases, Those who have any orthopedic or neurological disorders that will prevent walking, Another COVID-19 PCR Test positivity in the last 12 weeks, Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, Healthy Group Inclusion Criteria Not having COVID-19, Being literate, Being in the age range of 18-65, Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study Those who have any orthopedic or neuromuscular disorders that will prevent walking, Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult study population The population of the study is individuals who live in Ankara and have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19. The sample of the study is healthy individuals in the long term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 and healthy individuals who have not had COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study. sampling method Probability Sample contacts locations module overall official list overall official overall official name Gülay Sain-Guven, Professor overall official affiliation Hacettepe University, Faculty of Medicine overall official role Study Director location list location location facility Hacettepe University location city Ankara location country Turkey references module reference list reference reference p m i d 32475821 reference type result reference citation Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31. reference p m i d 32085846 reference type result reference citation Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available. Erratum In: Lancet Respir Med. 2020 Feb 25;: reference p m i d 32246917 reference type result reference citation Zhao H, Shen D, Zhou H, Liu J, Chen S. Guillain-Barre syndrome associated with SARS-CoV-2 infection: causality or coincidence? Lancet Neurol. 2020 May;19(5):383-384. doi: 10.1016/S1474-4422(20)30109-5. Epub 2020 Apr 1. No abstract available. reference p m i d 32064853 reference type result reference citation Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese. reference p m i d 32764112 reference type result reference citation Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4). pii: 2002096. doi: 10.1183/13993003.02096-2020. 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full study rank 61738 study protocol section identification module n c t id NCT04832568 org study id info org study id TJMZK202101 organization org full name Huazhong University of Science and Technology org class OTHER brief title Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery official title Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery: a Prospective Observational Study status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 17, 2021 start date type Actual primary completion date struct primary completion date May 2023 primary completion date type Anticipated completion date struct completion date December 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date September 30, 2022 last update post date struct last update post date October 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hua Zheng responsible party investigator title Principal Investigator responsible party investigator affiliation Huazhong University of Science and Technology lead sponsor lead sponsor name Huazhong University of Science and Technology lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram. conditions module condition list condition Delirium design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Delirium is determined by CAM or CAM-ICU score arm group label No delirium is determined by CAM or CAM-ICU score outcomes module primary outcome list primary outcome primary outcome measure Incidence of postoperative delirium primary outcome description The incidence of postoperative delirium was determined according to the Confusion Assessment Method (CAM) diagnostic algorithm. The algorithm consists of four clinical criteria: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. To define a patient as having delirium, both the first and the second criteria have to be present, as well as either the third or the fourth criteria. The CAM-ICU will be used for patients who are intubated in the postoperative period. primary outcome time frame After surgery through to postoperative day 7 secondary outcome list secondary outcome secondary outcome measure Relative power of each brain waves secondary outcome description Electroencephalogram data were acquired using a 32-channel electroencephalogram recording system (Brain Products, Germany). A 5 min, baseline, eyes-closed recording was conducted at the preoperative holding room when the patient was at rest. Recording of electroencephalogram was commenced before the start of anesthetic induction and was stopped before discharge of the patient from the operating room. We defied delta (1 to 3 Hz), theta (4 to 7 Hz), alpha (8 to 12 Hz), and beta (13 to 40 Hz) frequency bands. And then, the relative power of each frequency bands to the total power of the sum is calculated. secondary outcome time frame During the stay of the patient in the operating room, after surgery through to postoperative day 7 secondary outcome measure Duration of delirium secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Severity of delirium secondary outcome description Delirium severity is evaluated both as the peak (highest) and sum Confusion Assessment Method - Severity (CAM-S) score over all hospital days. The CAM-S includes two forms: a Short Form (CAM-S Short Form, based on the 4-item algorithm, the sum of score ranging from 0 to 7, with 7 being the most severe) and a Long Form (CAM-S Long Form, based on the 10-item CAM instrument, the sum of score ranging from 0 to 19, with 19 being the most severe). secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Worst daily pain scores at rest secondary outcome description Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain). secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Worst daily pain scores with exertion (deep breathing and cough) secondary outcome description Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain). secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Length of stay in the Intensive Care Unit (ICU) secondary outcome description Measured in days admitted in the ICU secondary outcome time frame through study completion, an average of 5 days secondary outcome measure Length of hospital stay secondary outcome description Measured in days admitted in the hospital secondary outcome time frame through study completion, an average of 10 days other outcome list other outcome other outcome measure Biomarkers other outcome description Identify biomarkers (such as Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), brain-derived neurotrophic factor (BDNF), and metalloproteases-9 (MMP-9) )of delirium and neural damage through changes in circulating plasma proteins and molecules other outcome time frame before and after surgery in operating room, after surgery through to postoperative day 7 eligibility module eligibility criteria Inclusion Criteria: age of at least 18 years normal cognitive function at the time of enrollment evidenced by a Mini-Mental State Examination (MMSE) score of more than 24 of 30 Chinese Mandarin as the native language providing informed consent Exclusion Criteria: pre-existing delirium assessed according to the Confusion Assessment Method (CAM) history of neurological or psychiatric disease impaired vision or auditory function which may effect the assessments unwillingness to participate in the study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients undergoing cardiovascular surgery sampling method Probability Sample contacts locations module central contact list central contact central contact name Hua Zheng, Dr. central contact role Contact central contact phone 0086-27-83663173 central contact e mail hzheng@hust.edu.cn location list location location facility Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology location status Recruiting location city Wuhan location state Hubei location zip 430030 location country China location contact list location contact location contact name Hua Zheng, Dr. location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003693 condition mesh term Delirium condition ancestor list condition ancestor condition ancestor id D000003221 condition ancestor term Confusion condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6046 condition browse leaf name Delirium condition browse leaf as found Delirium condition browse leaf relevance high condition browse leaf id M5598 condition browse leaf name Confusion condition browse leaf relevance low condition browse leaf id M20979 condition browse leaf name Neurobehavioral Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General 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full study rank 61577 study protocol section identification module n c t id NCT04834661 org study id info org study id multi-sites practice surgery organization org full name Shanghai Minimally Invasive Surgery Center org class OTHER brief title Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution official title Safety and Feasibility of Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution Under Multi-sites Practice (MSP) Policy, a Retrospective Comparative Study status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date October 20, 2021 start date type Actual primary completion date struct primary completion date October 31, 2021 primary completion date type Actual completion date struct completion date December 31, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 15, 2022 last update post date struct last update post date April 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Cai Zhenghao responsible party investigator title Attending surgeon of gastrointestinal surgery，Ruijin Hospital, Shanghai Jiaotong University School of Medicine responsible party investigator affiliation Shanghai Minimally Invasive Surgery Center lead sponsor lead sponsor name Shanghai Minimally Invasive Surgery Center lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy. This is a single practitioner, retrospective comparative study. The endpoints are peri-operative outcomes, pathological results, and medical costs. conditions module condition list condition Colorectal Cancer Gastric Cancer design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 1130 enrollment type Actual arms interventions module arm group list arm group arm group label inside group arm group description laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution arm group intervention list arm group intervention name Other: surgery inside the primary institution arm group label outside group arm group description laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution arm group intervention list arm group intervention name Other: surgery outside the primary institution intervention list intervention intervention type Other intervention name surgery inside the primary institution intervention description to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution intervention arm group label list intervention arm group label inside group intervention type Other intervention name surgery outside the primary institution intervention description to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution intervention arm group label list intervention arm group label outside group outcomes module primary outcome list primary outcome primary outcome measure overall postoperative complication rate primary outcome description postoperative complications evaluated according to Clavin-Dindo classification primary outcome time frame 30 days after surgery eligibility module eligibility criteria Inclusion Criteria: Age between 18 and 100 years diagnosed as colorectal cancer or gastric cancer undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng Exclusion Criteria: Emergency procedure without histopathological result of malignancy conventional open surgery healthy volunteers No gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult study population colorectal cancer and gastric cancer sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Zhenghao Cai, MD overall official affiliation Ruijin Hospital overall official role Principal Investigator location list location location facility Ruijin Hospital location city Shanghai location state Shanghai location zip 200020 location country China derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013274 condition mesh term Stomach Neoplasms condition ancestor list condition ancestor condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000013272 condition ancestor term Stomach Diseases condition browse leaf list condition browse leaf condition browse leaf id M15216 condition browse leaf name Stomach Neoplasms condition browse leaf as found Gastric Cancer condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse 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full study rank 61838 study protocol section identification module n c t id NCT04831268 org study id info org study id HRBD 24 04/04/2019 organization org full name Agricultural University of Athens org class OTHER brief title Effects of Traditional Greek Meals on Glycemic Responses official title Effects of Traditional Greek Meals: Lentils With Lupino, Trahanas With Tomato Sauce and Halva With Currants on Glycemic Responses: Randomized Clinical Trial in Healthy Humans status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 1, 2019 start date type Actual primary completion date struct primary completion date September 30, 2019 primary completion date type Actual completion date struct completion date September 30, 2019 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Aimilia Papakonstantinou responsible party investigator title Assistant Professor responsible party investigator affiliation Agricultural University of Athens lead sponsor lead sponsor name Agricultural University of Athens lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This study investigated the effects of Greek traditional meals in dehydrated form consumed after reconstitution with water on glycemic responses detailed description This study aimed at 1. to determined the glycemic index and glycemic load of three mixed meals and 2. to investigate the effects of these mixed meals on postprandial glycemic response in healthy subjects conditions module condition list condition Potential Abnormality of Glucose Tolerance Appetitive Behavior keyword list keyword blood glucose lentils trahanas halva glycemic index design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design intervention model description Crossover Assignment design primary purpose Other design masking info design masking Single design masking description Single (Investigator) design who masked list design who masked Investigator enrollment info enrollment count 12 enrollment type Actual arms interventions module arm group list arm group arm group label Glucose as reference food arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal arm group label Lentils and lupins mixed meal arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal arm group label Trahanas with tomato sauce mixed meal arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal arm group label Halva with currants mixed meal arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal intervention list intervention intervention type Other intervention name Glucose as reference food intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal intervention type Other intervention name Lentils and lupins mixed meal intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal intervention type Other intervention name Trahanas with tomato sauce mixed meal intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal intervention type Other intervention name Halva with currants mixed meal intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal outcomes module primary outcome list primary outcome primary outcome measure Capillary blood glucose responses primary outcome description Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test primary outcome time frame 2 hours secondary outcome list secondary outcome secondary outcome measure Subjective appetite ratings secondary outcome description Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120 min. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g hunger, satiety, desire to eat etc. secondary outcome time frame 2 hours secondary outcome measure Blood pressure secondary outcome description Useful change in systolic and diastolic blood pressure before and 2hr after consumption of three mixed meals secondary outcome time frame 2 hours eligibility module eligibility criteria Inclusion Criteria: healthy non-smoking non-diabetic men and women normal body mass index (BMI; between 18.5 and 25 kg/m2) Exclusion Criteria: severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions) gastrointestinal disorders pregnancy lactation competitive sports alcohol drug dependency healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Aimilia Papakonstantinou, PhD overall official affiliation Agricultural University of Athens overall official role Principal Investigator location list location location facility Agricultural University of Athens location city Athens location state Attica location zip 11855 location country Greece derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000013 condition mesh term Congenital Abnormalities condition browse leaf list condition browse leaf condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf as found Abnormalities condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T316 intervention browse leaf name Tomato intervention browse leaf as found STAT intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals	NCT04831268	[ 101, 1554, 2025, 3997, 5391, 1604, 23249, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 22639, 25129, 1604, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 145, 22672, 2137, 1572, 5129, 120, 5129, 120, 10351, 2369, 8916, 1554, 1271, 10705, 1239, 1104, 7055, 8916, 1705, 152, 24162, 9637, 4094, 1641, 23009, 1104, 12144, 2414, 2508, 7264, 1113, 144, 1193, 2093, 7257, 24187, 1116, 2078, 1641, 23009, 1104, 12144, 2414, 2508, 7264, 131, 22824, 19621, 1116, 1556, 14557, 6709, 1186, 117, 157, 10659, 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full study rank 61510 study protocol section identification module n c t id NCT04835532 org study id info org study id 2021-0050 organization org full name Second Affiliated Hospital, School of Medicine, Zhejiang University org class OTHER brief title Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation official title Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial status module status verified date February 2021 overall status Recruiting expanded access info has expanded access No start date struct start date August 10, 2021 start date type Actual primary completion date struct primary completion date October 1, 2022 primary completion date type Anticipated completion date struct completion date March 1, 2024 completion date type Anticipated study first submit date March 16, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 27, 2021 last update post date struct last update post date September 29, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Second Affiliated Hospital, School of Medicine, Zhejiang University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF. detailed description Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF. conditions module condition list condition Bone Loss, Alveolar keyword list keyword tenting screws advanced platelet rich fibrin injectable platelet rich fibrin guided bone regeneration design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 69 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control group arm group type Experimental arm group description Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane arm group intervention list arm group intervention name Procedure: guided bone gereration arm group label Treatment group 1 arm group type Experimental arm group description Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws arm group intervention list arm group intervention name Procedure: guided bone gereration arm group label Treatment group 2 arm group type Experimental arm group description Vertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF arm group intervention list arm group intervention name Procedure: guided bone gereration intervention list intervention intervention type Procedure intervention name guided bone gereration intervention description guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation. intervention arm group label list intervention arm group label Control group Treatment group 1 Treatment group 2 intervention other name list intervention other name tenting screws, A-PRF, I-PRF outcomes module primary outcome list primary outcome primary outcome measure Buccal bone augmentation, BBA(bone height changes between T0 and T2) primary outcome description The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter. primary outcome time frame T0(before surgery), T2(6 months after GBR) secondary outcome list secondary outcome secondary outcome measure Lingual bone augmentation, LBA(bone height changes between T0 and T2) secondary outcome description The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter. secondary outcome time frame T0(before surgery), T2(6 months after GBR) other outcome list other outcome other outcome measure Bone density, BD other outcome description in the area of bone regeneration, ranging 2mm × 2mm other outcome time frame T2(6 months after GBR) eligibility module eligibility criteria Inclusion Criteria: 18-80 years old; single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect ≥ 3mm; 4 weeks after extraction or missing teeth within 3-5 weeks; adjacent teeth exist and loosening is less than Ⅰ degree; periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%; thick gingival biological type. CBCT shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height ≥ 3mm and bone mineral density is sufficient); the patients and their families have informed consent and signed the informed consent form. Exclusion Criteria: pregnant and lactating women; smoking (> 10 cigarettes per day) and alcoholism; taking anticoagulants within 3 months before operation; suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases; patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection; patients who have been treated with bisphosphate / steroids for a long time; have received alveolar ridge bone augmentation surgery; previous history of radiotherapy in the head and neck; acute inflammation in edentulous sites; inability to maintain good oral hygiene or follow-up visits as required. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name 陈莉丽, Master central contact role Contact central contact phone +86 13606507966 central contact e mail chenlili_1030@163.com location list location location facility 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China location status Recruiting location city Hangzhou location state Zhejiang location zip 310000 location country China location contact list location contact location contact name 陈莉丽, Master location contact role Contact location contact phone +86 13606507966 location contact e mail chenlili_1030@163.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000016301 condition mesh term Alveolar Bone Loss condition ancestor list condition ancestor condition ancestor id D000001862 condition ancestor term Bone Resorption condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000055093 condition ancestor term Periodontal Atrophy condition ancestor id D000010510 condition ancestor term Periodontal Diseases condition ancestor id D000009059 condition ancestor term Mouth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition browse leaf list condition browse leaf condition browse leaf id M17899 condition browse leaf name Alveolar Bone Loss condition browse leaf as found Bone Loss, Alveolar condition browse leaf relevance high condition browse leaf id M4293 condition browse leaf name Bone Resorption condition browse leaf relevance low condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M3741 condition browse leaf name Atrophy condition browse leaf relevance low condition browse leaf id M27178 condition 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full study rank 61283 study protocol section identification module n c t id NCT04838483 org study id info org study id 2/25 organization org full name Okan University org class OTHER brief title Clinical Performance of Posterior Indirect Adhesive Restorations official title Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date September 1, 2021 primary completion date type Anticipated completion date struct completion date September 15, 2021 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Gulsah YENIER responsible party investigator title Assist.Prof. responsible party investigator affiliation Okan University lead sponsor lead sponsor name Okan University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated. detailed description Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent. This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study. Restorations will be evaluated clinically according to FDI World Dental Federation criteria. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p <0.05). conditions module condition list condition Dental Caries Endodontically Treated Teeth Dental Restoration Failure of Marginal Integrity Wear, Occlusal keyword list keyword Indirect restoration Adhesive restoration Cementation Composite resin design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 83 enrollment type Anticipated arms interventions module arm group list arm group arm group label Indirect restorations luted with light-cured composite resin. arm group type Experimental arm group description Subjects for the study will be identified from patients who had treated with indirect adhesive restorations onlay or overlay during the period 2016 to 2017 was performed at Istanbul Okan University Faculty of Dentistry by an experienced clinician. Local anesthesia was applied if necessary. After caries and/or failed restorations were removed, the preparations were performed according to defined principles for adhesive onlays/overlays. At least one cuspal coverage was required for each restoration. All undercuts were eliminated using composite resin. Following the cavity preparation, immediate dentin sealing was applied and polymerized prior to impression taking. Indirect restorations were designed and fabricated with CEREC system. Surface treatments and clinical protocols were performed under manufacturer's instructions. Adhesive cementation with composite resin procedure was carried out with the rubber-dam isolation. arm group intervention list arm group intervention name Device: Indirect adhesive restoration of posterior teeth intervention list intervention intervention type Device intervention name Indirect adhesive restoration of posterior teeth intervention description Indirect restoration of significant loss of dental hard tissue intervention arm group label list intervention arm group label Indirect restorations luted with light-cured composite resin. intervention other name list intervention other name Ceramic onlay or overlay outcomes module primary outcome list primary outcome primary outcome measure Survival rate primary outcome description FDI World Dental Federation criteria functional properties primary outcome time frame at 5 years secondary outcome list secondary outcome secondary outcome measure Esthetic properties secondary outcome description FDI World Dental Federation criteria secondary outcome time frame at 5 years eligibility module eligibility criteria Inclusion Criteria: Significant loss of dental hard tissue Endodontically treated teeth in posterior region Replacement of large compromised existing restoration Large Class II restoration Age of 18-60 years Good oral hygiene Presence of interproximal contact to at least one neighboring teeth • In occlusion with antagonist teeth Cavity preparation with at least one cuspal coverage Exclusion Criteria: Serious medical problems or allergies to substances and/or products to be used Severe periodontal problems Poor oral hygiene Direct pulp capping Presence of parafunctional behaviors Pregnant or breast feeding healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 60 Years std age list std age Adult contacts locations module central contact list central contact central contact name Gülşah Yenier, DDS, PhD central contact role Contact central contact phone +905547810176 central contact e mail gulsahyenier@gmail.com central contact name Elif Ciftcioglu, DDS, PhD central contact role Contact central contact phone +902166771630 central contact e mail elifcif@yahoo.com overall official list overall official overall official name Gülşah Yenier, DDS, PhD overall official affiliation Istanbul Okan University Faculty of Dentistry overall official role Principal Investigator location list location location facility Istanbul Okan University Faculty of Dentistry location status Recruiting location city Istanbul location state Tuzla location zip 34959 location country Turkey location contact list location contact location contact name Gulsah YENIER, DDS, PhD location contact role Contact location contact phone +905547810176 location contact e mail gulsahyenier@gmail.com location contact name Gulsah YENIER, DDS,PhD location contact role Principal Investigator references module reference list reference reference p m i d 23695612 reference type background reference citation D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22. reference p m i d 28653051 reference type background reference citation Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230. reference p m i d 20628774 reference type background reference citation Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. reference p m i d 30073216 reference type background reference citation Magne P, Razaghy M, Carvalho MA, Soares LM. Luting of inlays, onlays, and overlays with preheated restorative composite resin does not prevent seating accuracy. Int J Esthet Dent. 2018;13(3):318-332. reference p m i d 26355440 reference type background reference citation D'Arcangelo C, Vanini L, Casinelli M, Frascaria M, De Angelis F, Vadini M, D'Amario M. Adhesive Cementation of Indirect Composite Inlays and Onlays: A Literature Review. Compend Contin Educ Dent. 2015 Sep;36(8):570-7; quiz 578. Review. reference p m i d 18350945 reference type background reference citation Naeselius K, Arnelund CF, Molin MK. Clinical evaluation of all-ceramic onlays: a 4-year retrospective study. Int J Prosthodont. 2008 Jan-Feb;21(1):40-4. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003731 condition mesh term Dental Caries condition mesh id D000019553 condition mesh term Tooth, Nonvital condition mesh id D000019217 condition mesh term Tooth Attrition condition mesh id D000057085 condition mesh term Tooth Wear condition ancestor list condition ancestor condition ancestor id D000017001 condition ancestor term Tooth Demineralization condition ancestor id D000014076 condition ancestor term Tooth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000003788 condition ancestor term Dental Pulp Diseases condition browse leaf list condition browse leaf condition browse leaf id M6080 condition browse leaf name Dental Caries condition browse leaf as found Dental Caries condition browse leaf relevance high condition browse leaf 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full study rank 61735 study protocol section identification module n c t id NCT04832607 org study id info org study id TRACE secondary id info list secondary id info secondary id 2018-000853-29 secondary id type EudraCT Number secondary id DRKS00018985 secondary id type Other Identifier secondary id domain Deutsches Register Klinischer Studien organization org full name LMU Klinikum org class OTHER brief title Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections official title Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial acronym TRACE status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 27, 2019 start date type Actual primary completion date struct primary completion date June 2024 primary completion date type Anticipated completion date struct completion date December 2024 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 21, 2022 last update post date struct last update post date November 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Prof. Tobias Feuchtinger responsible party investigator title Prof. Dr. med Tobias Feuchtinger responsible party investigator affiliation LMU Klinikum lead sponsor lead sponsor name Prof. Tobias Feuchtinger lead sponsor class OTHER collaborator list collaborator collaborator name European Commission collaborator class OTHER collaborator name Simbec-Orion Group collaborator class INDUSTRY collaborator name Miltenyi Biotec B.V. & Co. KG collaborator class INDUSTRY collaborator name Leiden University Medical Center collaborator class OTHER collaborator name Central Hospital, Nancy, France collaborator class OTHER collaborator name University Hospital, Ghent collaborator class OTHER collaborator name Bambino Gesù Hospital and Research Institute collaborator class OTHER collaborator name University of Newcastle Upon-Tyne collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults. detailed description For a growing number of patients suffering from various conditions as, e.g., haematological malignancies or diverse genetic disorders, haematopoietic stem cell transplantation (HSCT) or bone marrow transplantation offer the only possible curative options. However, HSCT is associated with three major risks: graft rejection, graft-versus-host disease (GvHD) and opportunistic, mostly viral, infections or reactivations resulting from delayed immune reconstitution. Delayed immune reconstitution, however, often is the direct result of the severe pre-transplantation conditioning treatment and T-cell depletion of the transplant necessary to fight the risks of graft rejection and GvHD. Therefore, the risk for life-threatening opportunistic, mostly viral, infections is increased in post-transplantation patients. The most common infections after HSCT are Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Adenovirus (AdV). The standard treatment approach for viral infections/reactivations is chemotherapy which shows limited efficacy and does not restore immunity. Therefore, effective new treatment options are required for this condition. Previous investigations have shown that sufficient T-cell immunity is essential for the control and prevention of viral reactivations and newly occurring infections after HSCT. The infusion of T-cells is therefore a promising new approach to treat immune-comprised patients. However, infusion with unselected T cells is associated with an increased risk for GvHD due to the high content of alloreactive T cells. A very promising approach to minimize this problem is to remove alloreactive T cells and enrich, isolate and purify virus-specific T cells. This approach has been studied for nearly two decades and the data published up to date indicate that virus-specific T-cell responses after adoptive T-cell transfer protect against virus-related complications post HSCT and restore T-cell immunity, in particular for AdV-, CMV- and EBV-infections. Despite these promising results, virus-specific T-cell transfer is not yet translated into daily clinical practice due to the lack of prospective clinical trials confirming the efficacy of this treatment approach. The overall goal of this Phase III, double-blind placebo-controlled study is to test efficacy of multivirus-specific T cells to bring this treatment method in clinical routine. Multivirus-specific T cells generated in this study will be directed against all three most common post-HSCT viral infections: AdV, CMV and EBV. Thus, T-cell immunity will be restored to fight and prevent new viral infections. After an initial screening visit, patients eligible to participate in the study will be treated within 28 days after screening. Patients will be randomized in a 2:1 (treatment: placebo) ratio and receive a single infusion with either multivirus-specific T cells or placebo. Patients will be followed up on the day of treatment, 1 day after and 1, 2, 4, 8 and 15 weeks after treatment. Treatment success will be measured by assessing different parameters including symptoms, quality of life, viral load and T-cell immunity in blood samples. Patients eligible to participate in this study are adult and paediatric patients who have received allogeneic stem cell transplantation and suffer from new or reactivated EBV, AdV or CMV infection refractory to standard antiviral treatment for two weeks. Patients from the six European countries Germany, Belgium, Netherlands, UK, France and Italy will be enrolled. In total 130 patients plus 19 screening failures are expected to participate in the study. conditions module condition list condition AdV Infection EBV Infection CMV Infection Stem Cell Transplant Complications design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 2 (verum): 1 (Placebo) randomization design primary purpose Treatment design masking info design masking Quadruple design masking description Randomization will be stratified with respect to three age groups: Children up to 6 years, children >6 and up to 18 years, and adults >18 years. Accordingly, for each stratum, a separate randomization list will be provided. Randomization will be performed by a representative of the Simbec-Orion Group who will be independent in the sense that he / she will otherwise not be involved in the TRACE trial. design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 149 enrollment type Anticipated arms interventions module arm group list arm group arm group label Multivirus (CMV, EBV, AdV)-specific T cells arm group type Experimental arm group description Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of Cytomegalovirus, Adenovirus and Epstein-Barr Virus Max dose: HLA-matched (8/8) donors: 1.0 x 10e5 T cells/kg recipient BW HLA-mismatched donors: 2.5 x 10e4 T cells/kg recipient BW Min. dose: - 10 T cells/kg recipient BW arm group intervention list arm group intervention name Other: Multivirus (CMV, EBV, AdV)-specific T cells arm group label Sodium chloride arm group type Placebo Comparator arm group description Suspension of multivirus-specific T cells in 20 mL of 0.9% NaCl + 0.5% HSA arm group intervention list arm group intervention name Other: Multivirus (CMV, EBV, AdV)-specific T cells intervention list intervention intervention type Other intervention name Multivirus (CMV, EBV, AdV)-specific T cells intervention description Cell therapy product which is individually produced for each patient and administered via IV bolus injection. intervention arm group label list intervention arm group label Multivirus (CMV, EBV, AdV)-specific T cells Sodium chloride outcomes module primary outcome list primary outcome primary outcome measure Viral clearance primary outcome description Percentage of patients with viral clearance (defined as two consecutive negative PCRs) to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation primary outcome time frame 8 weeks after treatment primary outcome measure Disease Progression primary outcome description Percentage of patients with progression between Day 7 and Week 8 after T-cell Transfer to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation primary outcome time frame day 7 until week 8 after treatment secondary outcome list secondary outcome secondary outcome measure Incidence of acute GvHD secondary outcome description Incidence of newly occurring acute GvHD grade I from Day 0 to Week 8 and Week 15. secondary outcome time frame 15 weeks after treatment secondary outcome measure Incidence of chronic GvHD secondary outcome description Incidence of chronic GvHD from Day 7 to Week 8 and to Week 15 after treatment. secondary outcome time frame 15 weeks after treatment secondary outcome measure Time to newly occuring GvHD secondary outcome description Time to newly occurring acute and chronic GvHD. secondary outcome time frame 15 weeks after treatment secondary outcome measure Severity of GvHD secondary outcome description Severity of acute GvHD ≥ grade II until Week 8 and Week 15. secondary outcome time frame week 8 and 15 week after treatment secondary outcome measure Incidence of acute toxicity secondary outcome description Acute maximum toxicity on the day of T-cell transfer evaluated by measuring vital signs prior to and at different times after the T-cell transfer from 1 hour prior to T-cell transfer to 4 hours post infusion. secondary outcome time frame 15 minutes, 30 minutes, 2 hours and 4 hours post T-cell/placebo transfer secondary outcome measure Severity of acute toxicity secondary outcome description Monitoring of adverse events infusion. secondary outcome time frame 15 minutes, 30 minutes, 2 hours and 4 hours post T-cell/placebo transfer secondary outcome measure Change in viral load of underlying viral infection secondary outcome description Change in viral load of underlying viral infection as assessed by quantitative PCR analysis of peripheral blood; samples taken weekly from Day 7 to Week 8 after IMP transfer as compared to samples taken at Day 0. secondary outcome time frame 8 weeks after treatment secondary outcome measure Time to viral load change of underlying viral infection secondary outcome description Time to 1 log change in viral load. secondary outcome time frame 15 weeks after treatment secondary outcome measure Percentage of viral decrease secondary outcome description Percentage of patients with ≥1 log decrease in CMV, EBV or AdV viral load at Week 8. secondary outcome time frame 8 weeks after treatment secondary outcome measure Viral reactivations secondary outcome description Number of reactivations of the underlying viral infection following initial viral clearance until end of follow-up. secondary outcome time frame 15 weeks after treatment secondary outcome measure Clinical response/resolution of symptoms of underlying viral infection secondary outcome description Number of patients with reduction or clearance of clinical symptoms of underlyingviral infection from Day 7 to Week 8 after IMP transfer as compared to Day 0. secondary outcome time frame 8 weeks after treatment secondary outcome measure Overall survival secondary outcome description Overall survival rate (OS): From Day 0 to end of follow-up. secondary outcome time frame 15 weeks after treatment secondary outcome measure Necessity of antiviral chemotherapy secondary outcome description Number of days requiring antiviral chemotherapy after T-cell transfer from Day 7 to Week 8 after T-cell transfer. secondary outcome time frame Day 7 until Week 8 secondary outcome measure Duration of antiviral chemotherapy secondary outcome description Time to last administration of defined antiviral medication or switch to prophylactic treatment from Day 0 to Week 8 after IMP transfer. secondary outcome time frame 8 weeks after treatment secondary outcome measure Incidence of viral infections other than underlying viral infection secondary outcome description Number of new viral reactivations (CMV, AdV or EBV) other than the underlying viral infection per patient as assessed by PCR analysis and clinical symptoms throughout the study to evaluate the putative prophylactic effect of the treatment. secondary outcome time frame 15 weeks secondary outcome measure Days of hospitalization secondary outcome description Number of days hospitalized after IMP transfer from Day 7 to Week 8. secondary outcome time frame 8 weeks secondary outcome measure Life quality in adults secondary outcome description EQ-5D for adult patients (≥18 years) at Screening and Week 8 to evaluate life quality in adults. A scale from 0 to 100 is used with 100 being best value and 0 the worst. secondary outcome time frame Screening and Week 8. secondary outcome measure Life quality in adults secondary outcome description FACT-BMT for adult patients (≥18 years) at Screening and Week 8 to evaluate life quality in adults. The patients have to answer questions about their physicial, social, emotional and functional wellbeing. A scale from 0 to 4 is used with 0= not at all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much. secondary outcome time frame Screening and Week 8 secondary outcome measure Life quality in children secondary outcome description PEDS-QL for paediatric patients (<18 years) at Screening and Week 8 to evaluate life quality in children. The patients and /or their parents have to answer questions about pain and hurt, fatigue and sleep, nausea, worry, Nutrition, thinking and communication. A scale from 0 to 4 is used with 0=never a Problem, 1=almost never a problem, 2= sometimes a problem, 3=often a problem, 4= almost always a problem. secondary outcome time frame Screening and Week 8 secondary outcome measure Effect on the patient's T-cell phenotype in vivo secondary outcome description T-cell phenotyping, samples taken at Screening, Day 0 and each visit from Day 7 to Week 15 after treatment. secondary outcome time frame Screening until Week 15 secondary outcome measure Effect on the patient's number of expanded T cells secondary outcome description Analysis of virus-specific T cells: frequencies of in vivo expanded virus-specific T cells in peripheral blood samples taken at Screening, Day 0, Day 7 to Week 15 after treatment. secondary outcome time frame Screening until Week 15 secondary outcome measure Quality of the IMP and performance of the CliniMACS® Prodigy secondary outcome description Assessment of the cellular composition, in particular the percentage of IFN-gamma+ cells, in the IMP. secondary outcome time frame Before IMP release (between Screening and Day 0) secondary outcome measure Evaluation of the drop-out rate secondary outcome description Drop-out rate at Day 0 and reasons for drop-out. secondary outcome time frame at Day 0 (planned treatment day) secondary outcome measure Time from inclusion to administration of the IMP secondary outcome description Number of days from Screening to Day 0 (day of IMP transfer) to evaluate the required time frame. secondary outcome time frame Screening until Day 0 (treatment day) secondary outcome measure Adverse events secondary outcome description Documentation of incidence, severity and type of adverse events from Day 0 to Week 8 and serious adverse events throughout the study to evaluate safety. secondary outcome time frame 15 weeks secondary outcome measure Physical examination secondary outcome description Physical examinations will be conducted to identify possible clinically significant pathologies. These findings will be recorded at each visit. The Karnofsky/Lansky index will be included in the physical examination at Screening and at Week 8 only. secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Sign - blood pressure secondary outcome description supine systolic and diastolic blood preasure in mm Hg secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - heart rate secondary outcome description The resting heart rate in beats/min secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - body temperature secondary outcome description Body temperature in °C (aural) secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - body weight secondary outcome description body weight in kg secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - respiratory rate secondary outcome description respiratory rate in breaths/min. secondary outcome time frame Screening to Week 8 secondary outcome measure Incidence of abnormal laboratory values secondary outcome description haemoglobin, leukocytes, thrombocytes, dirfferential blood count (neutrophil granulocytes, lymphocytes, monocytes and easinophil granulocytes), total and conjugated Bilirubin, C reactive Protein (CRP), creatinine, Alanin aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyl Transferase (GGT), Lactate Dehydrase (LDH), Urea. A list of normal ranges will be provided from each site. secondary outcome time frame Screening to Week 8 secondary outcome measure Concomitant medication until Week 8 secondary outcome description All concomitant medication will be recorded from Screening until Week 8. The generic name, indication, route of administration, dose/ unit, start and stop date or ongoing, way of application will be documented. secondary outcome time frame 8 weeks after treatment secondary outcome measure Concomitant medication until Week 15 secondary outcome description During follow-up Week 15, only antiviral therapy, immunosuppression and SAE-related concomitant medication as well as chemotherapy will be documented. The generic name, indication, route of administration, dose/ unit, start and stop date or ongoing, way of application will be documented. Cellular treatment also has to be documented as concomitant medication. secondary outcome time frame 15 weeks after treatment eligibility module eligibility criteria Inclusion Criteria: Adult or paediatric patients (> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection. Written informed consent given (patient or legal representative) prior to any study-related procedures. Exclusion Criteria: Patient with acute GvHD > grade II or extensive chronic GvHD at the time of IMP transfer Patient receiving steroids (>1 mg/kg BW Prednisone equivalent) at Screening. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells/kg BW in case of T-cell depleted HSCT is not considered an exclusion criterion. Patient with organ dysfunction or failure as determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrolment in another clinical trial interfering with the endpoints of this study Any medical condition which could compromise participation in the study according to the investigator's assessment Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab until 8 weeks after IMP Infusion or prophylactic Treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test. Female patient who is pregnant or breast-feeding. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8). Note: Women of childbearing potential must have a negative serum pregnancy test at study entry ≤7 days before IMP administration on Day 0. Acceptable birth control methods are hormonal oral contraceptive ('pill'), contraceptive injection or patch, intrauterine pessar or the combination of two barrier methods. The combination of female and male condomes is NOT acceptable. If the male partner is sterilized, no further contraceptive is required. Women of post-menopausal status (no menses for 12 months without an alternative medical cause) are also not required to use contraceptives during the study. Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent. healthy volunteers No gender All minimum age 2 Months std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Tobias Feuchtinger, Prof central contact role Contact central contact phone 0049 (0)89 4400 central contact phone ext 57945 central contact e mail onkostudien.hauner@med.uni-muenchen.de central contact name Theresa Käuferle, Dr central contact role Contact central contact phone 0049 (0)89 4400 central contact phone ext 52338 central contact e mail info@trace-study.de overall official list overall official overall official name Tobias Feuchtinger, Prof overall official affiliation Klinikum der Universität München overall official role Principal Investigator location list location location facility Jules Bordet Institut (JBI) location status Recruiting location city Brussels location zip 1000 location country Belgium location contact list location contact location contact name Philippe Lewalle, Prof location contact role Contact location contact phone 0032 25417208 location contact e mail philippe.lewalle@bordet.be location contact name Sabrina Constantini location contact role Contact location contact e mail sabrina.costantini@bordet.be location facility UZ Brussel location status Recruiting location city Brussels location zip 1090 location country Belgium location contact list location contact location contact name Ann De Becker, Dr. location contact role Contact location contact e mail ann.debecker@uzbrussel.be location facility Ghent Universal Hospital (UZG) location status Recruiting location city Ghent location zip 9000 location country Belgium location contact list location contact location contact name Tessa Kerre, Prof location contact role Contact location contact phone 0032 93326654 location contact e mail tessa.kerre@ugent.be location contact name Jonas Saegert location contact role Contact location contact phone 0032 93324912 location contact e mail jonas.segaert@uzgent.be location contact name Tessa Kerre, Prof location contact role Principal Investigator location facility Ghent Universal Hospital (UZG) location status Recruiting location city Ghent location zip 9000 location country Belgium location contact list location contact location contact name Tessa Kerre, Prof. location contact role Contact location contact phone 0032 93326654 location contact e mail tessa.kerre@ugent.be location facility UZ Leuven location status Recruiting location city Leuven location zip 3000 location country Belgium location contact list location contact location contact name Johann Maertens, Prof. Dr. location contact role Contact location contact e mail johan.maertens@uzleuven.be location facility Center Hospitalier Universitaire de Liège (CHU) location status Recruiting location city Liège location zip 4000 location country Belgium location contact list location contact location contact name Yves Beguin, Prof location contact role Contact location contact phone 0032 43668855 location contact e mail yves.beguin@chu.ulg.ac.be location contact name Yves Beguin, Prof location contact role Principal Investigator location facility Université de Liège location status Recruiting location city Liège location zip 4000 location country Belgium location contact list location contact location contact name Yves Beguin, Prof. Dr. location contact role Contact location contact e mail yves.beguin@chu.ulg.ac.be location facility Hospital Jeanne de Flandres, CHU de Lille location status Recruiting location city Lille location zip 59037 location country France location contact list location contact location contact name Bénédicte Bruno, Dr. location contact role Contact location contact e mail benedicte.bruno@chru-lille.fr location facility Hôpital Necker Enfantes Malades location status Recruiting location city Lyon location zip 69003 location country France location contact list location contact location contact name Yves Bertrand, Prof. Dr. location contact role Contact location contact e mail Yves.Betrand@ihope.fr location facility Centre Hospitalier Régional Universitaire de Nancy (CHRU) location status Recruiting location city Nancy location zip 54035 location country France location contact list location contact location contact name Daniele Bensoussan, Dr location contact role Contact location contact e mail d.bensoussan@chru-nancy.fr location contact name Maud d'Aveni-Piney, Dr location contact role Contact location contact e mail m.daveni-piney@chru-nancy.fr location facility Hôpital de la Pitie-Salpêtrière location status Recruiting location city Paris location zip 75013 location country France location contact list location contact location contact name Stéphanie Nguyen Quoc, Prof. Dr. location contact role Contact location contact e mail stephanie.nguyen-quoc@aphp.fr location facility Hôpital Robert Debré location status Recruiting location city Paris location zip 75019 location country France location contact list location contact location contact name Jean Hugues Dalle, Prof. Dr. location contact role Contact location contact e mail jean-hugues.dalle@aphp.fr location facility Universitätsklinikum Freiburg location status Not yet recruiting location city Freiburg location state Baden-Württemberg location zip 79106 location country Germany location contact list location contact location contact name Brigitte Strahm, PD Dr. med. location contact role Contact location contact phone 00490761270 location contact phone ext 46280 location contact e mail brigitte-strahm@uniklinik-freiburg.de location facility Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS) location status Recruiting location city Tübingen location state Baden-Württemberg location zip 72076 location country Germany location contact list location contact location contact name Peter Lang, Prof location contact role Contact location contact phone 07071 29 location contact phone ext 81386 location contact e mail peter.lang@med.uni-tuebingen.de location contact name Sabine Edele-Fiedler location contact role Contact location contact e mail Sabine.Edele-Fiedler@med.uni-tuebingen.de location contact name Peter Lang, Prof location contact role Principal Investigator location facility Universitätsklinikum Regensburg location status Not yet recruiting location city Regensburg location state Bavaria location zip 93053 location country Germany location contact list location contact location contact name Jürgen Foll, Prof location contact role Contact location contact e mail juergen.foell@klinik.uni-regensburg.de location contact name Jürgen Föll, Prof location contact role Principal Investigator location facility Universitätsklinikum Würzburg, Pädiatrische Hämatologie/ Onkologie location status Not yet recruiting location city Würzburg location state Bavaria location zip 97080 location country Germany location contact list location contact location contact name Matthias Wölfl, Prof location contact role Contact location contact phone 0049931201 location contact phone ext 27114 location contact e mail Woelfl_M@kw.de location contact name Matthias Wölfl, Prof location contact role Principal Investigator location facility Klinikum der Universität München - Medizinische Klinik und Poliklinik III location status Recruiting location city München location state Bayern location zip 81377 location country Germany location contact list location contact location contact name Johanna Tischer, Prof location contact role Contact location contact phone 089 4400 location contact phone ext 74240 location contact e mail johanna.tischer@med.uni-muenchen.de location contact name Johanna Tischer location contact role Principal Investigator location facility Klinikum rechts der Isar der Technischen Universität location status Recruiting location city München location state Bayern location country Germany location contact list location contact location contact name Mareike Verbeek, Prof location contact role Contact location contact phone 089 4140 location contact phone ext 4879 location contact e mail Mareike.Verbeek@tum.de location contact name Mareike Verbeek location contact role Principal Investigator location facility Universitätsklinikum Würzburg location status Recruiting location city Würzburg location state Bayern location zip 97080 location country Germany location contact list location contact location contact name Hermann Einsele, Prof location contact role Contact location contact phone 09131 201 location contact phone ext 40001 location contact e mail einsele_h@klinik.uni-wuerzburg.de location contact name Sabrina Kraus, Dr location contact role Contact location contact phone 09131201 location contact phone ext 40967 location contact e mail Kraus_s3@ukw.de location contact name Hermann Einsele, Prof location contact role Principal Investigator location contact name Sabrina Kraus, Dr location contact role Sub-Investigator location facility Medizinische Hochschule Hannover location status Recruiting location city Hannover location state Niedersachsen location zip 30625 location country Germany location contact list location contact location contact name Britta Maecker-Kolhoff, Prof location contact role Contact location contact phone 0 511 532 location contact phone ext 9120 location contact e mail Maecker.Britta@MH-Hannover.de location contact name Britta Maecker-Kolhoff, Prof location contact role Principal Investigator location facility Universitätsklinikum Berlin location status Recruiting location city Berlin location zip 13353 location country Germany location contact list location contact location contact name Johannes Schulte, Prof location contact role Contact location contact phone 0049 30450666658 location contact e mail johannes.schulte@charite.de location contact name Johannes Schulte, Prof location contact role Principal Investigator location facility Universitätsklinikum Dresden location status Recruiting location city Dresden location zip 01307 location country Germany location contact list location contact location contact name Friedrich Stölzel, PD Dr. med. habil. location contact role Contact location contact e mail Friedrich.Stoelzel@uniklinikum-dresden.de location contact name Martin Bornhäuser, Prof. Dr. med. location contact role Contact location contact e mail Martin.Bornhaeuser@uniklinikum-dresden.de location facility Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie location status Recruiting location city Düsseldorf location zip 40225 location country Germany location contact list location contact location contact name Roland Meisel, Prof location contact role Contact location contact e mail meisel@med.uni-duesseldorf.de location contact name Roland Meisel, Prof location contact role Principal Investigator location facility Universitätsklinikum Essen location status Recruiting location city Essen location zip 85147 location country Germany location contact list location contact location contact name Stefan Schönberger, Dr. med. location contact role Contact location contact e mail Stefan.Schoenberger@uk-essen.de location contact name Michaela Höfs, Dr. med. location contact role Contact location contact e mail Michaela.Hoefs@uk-essen.de location facility Universitäsklinikum Leipzig location status Recruiting location city Leipzig location zip 04103 location country Germany location contact list location contact location contact name Vladan Vucinic, Dr. med. location contact role Contact location contact e mail Vladan.Vucinic@medizin.uni-leipzig.de location contact name Georg-Nikolaus Franke, Dr. med. location contact role Contact location contact e mail Georg-Nikolaus.Franke@medizin.uni-leipzig.de location facility Klinikum der Universität München - Dr. v. Haunersches Kinderspital location status Recruiting location city Munich location zip 80337 location country Germany location contact list location contact location contact name Tobias Feuchtinger, Prof location contact role Contact location contact phone 0049894400 location contact phone ext 57945 location contact e mail info@trace-study.de location contact name Tobias Feuchtinger, Prof location contact role Principal Investigator location facility Klinikum für Kinder- und Jugenndmedizin location status Recruiting location city Munich location zip 80804 location country Germany location contact list location contact location contact name Irende Teichert-von Lüttichau, PD Dr. med. location contact role Contact location contact e mail Irene.Teichert-vonluettichau@mri.tum.de location contact name Angela Wawer, Dr. med. location contact role Contact location facility Ospedale Pediatrico Bambino Gesù location status Recruiting location city Rom location zip 00165 location country Italy location contact list location contact location contact name Giuseppina Li Pira, Dr. location contact role Contact location contact e mail giuseppina.lipira@opbg.net location facility Leiden University Medical Centre (LUMC) location status Recruiting location city Leiden location state ZA location zip 2333 location country Netherlands location contact list location contact location contact name Peter van Balen, Dr location contact role Contact location contact phone 003171526 location contact phone ext 2267 location contact e mail P.van_Balen@lumc.nl location contact name Peter van Balen, Dr location contact role Principal Investigator location facility Hospital Clínic Barcelona location status Not yet recruiting location city Barcelona location zip 08036 location country Spain location contact list location contact location contact name Maria Suarez-Liedo Grande, Dr location contact role Contact location contact e mail MSUAREZL@clinic.cat location facility Vall d'Hebron Institute of Oncology location status Not yet recruiting location city Barcelona location zip 119-129 location country Spain location contact list location contact location contact name Laura Segura Martinez location contact role Contact location contact e mail lsegura@vhio.net location contact name Pere Barba, Dr location contact role Contact location contact e mail pbarba@vhio.net location contact name Pere Barba, Dr location contact role Principal Investigator location facility Hospital General Universitario Gregorio Marañón location status Not yet recruiting location city Madrid location zip 28007 location country Spain location contact list location contact location contact name Mi Kwon, Dr location contact role Contact location contact e mail mi.kwon@salud.madrid.org location facility Hospital Universitario La Paz location status Not yet recruiting location city Madrid location zip 28046 location country Spain location contact list location contact location contact name Antonio Perez-Martinez, Dr location contact role Contact location contact e mail aperezmartinez@salud.madrid.org location facility Hospital Virgen del Rocío location status Recruiting location city Sevilla location zip 41013 location country Spain location contact list location contact location contact name Jose Antonio Perez Simon, Dr location contact role Contact location contact e mail josea.perez.simon.sspa@juntadeandalucia.es location facility Hospital Universitario Politécnico La Fe location status Not yet recruiting location city Valencia location zip 46026 location country Spain location contact list location contact location contact name Juan Montoro Gomez, Dr location contact role Contact location facility Newcastle University location status Not yet recruiting location city Newcastle location zip NE14LP location country United Kingdom location contact list location contact location contact name Andrew Gennery, Dr. location contact role Contact location contact e mail 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full study rank 61891 study protocol section identification module n c t id NCT04830566 org study id info org study id 2021-3572 organization org full name Université de Sherbrooke org class OTHER brief title Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults official title Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Paraspinal Muscle and Thoracolumbar Fascia in Chronic Low Back Pain Adults Assessed by Elastography, Ultrasonography and Myometry status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date March 19, 2021 start date type Actual primary completion date struct primary completion date July 8, 2022 primary completion date type Actual completion date struct completion date July 15, 2022 completion date type Actual study first submit date March 19, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 31, 2022 last update post date struct last update post date November 2, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mélanie Morin responsible party investigator title Research director responsible party investigator affiliation Université de Sherbrooke lead sponsor lead sponsor name Université de Sherbrooke lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties. The main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity. conditions module condition list condition Chronic Low Back Pain keyword list keyword Low back pain Fascia properties Thoracolumbar fascia Myofascial release Manual therapy Osteopathy Ultrasound imaging Sonoelastography design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 49 enrollment type Actual arms interventions module arm group list arm group arm group label Myofascial release technique group arm group type Experimental arm group intervention list arm group intervention name Other: Myofascial release technique arm group label Simulated myofascial release technique group arm group type Sham Comparator arm group intervention list arm group intervention name Other: Simulated Myofascial Release technique intervention list intervention intervention type Other intervention name Myofascial release technique intervention description Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles intervention arm group label list intervention arm group label Myofascial release technique group intervention type Other intervention name Simulated Myofascial Release technique intervention description Superficial hands contact on the lumbar area intervention arm group label list intervention arm group label Simulated myofascial release technique group outcomes module primary outcome list primary outcome primary outcome measure Changes in elastography features of the myofascial unit primary outcome description Evaluated with a shear wave sonoelastography device. primary outcome time frame Baseline (before treatment), post-treatment (immediately after treatment) secondary outcome list secondary outcome secondary outcome measure Changes in ultrasonography features of the myofascial unit secondary outcome description Evaluated with a B-mode ultrasound imaging device secondary outcome time frame Baseline (before treatment) post-treatment (immediately after treatment) secondary outcome measure Changes in myometry features of the myofascial unit secondary outcome description Evaluated with a myotonometer secondary outcome time frame Baseline (before treatment) post-treatment (immediately after treatment) secondary outcome measure Changes in pain intensity secondary outcome description Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome) secondary outcome time frame Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention eligibility module eligibility criteria Inclusion Criteria: adults over 18 years of age, lumbar pain and/or referred pain above or below the gluteal fold , with intensity > 3/10, persisting for > 6 months and presenting during the day > 50% of the time. Exclusion Criteria: history of serious spinal or lower extremity injury or surgery in the last year identifiable back pain or known pathology known rheumatological condition oral or injectable corticosteroids in the lumbar spine within the last 3 months psychiatric disorder pregnancy manual treatment of the lumbo-sacral region 1 month prior to the experimentation and during the week of the study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Nathaly Gaudreault, PhD overall official affiliation Université de Sherbrooke overall official role Study Director overall official name Mélanie Morin, PhD overall official affiliation Université de Sherbrooke overall official role Study Director location list location location facility Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke location city Sherbrooke location state Quebec location zip J1H 5N4 location country Canada i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001416 condition mesh term Back Pain condition mesh id D000017116 condition mesh term Low Back Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M18585 condition browse leaf name Low Back Pain condition browse leaf as found Low Back Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M3866 condition browse leaf name Back Pain condition browse leaf as found Back Pain condition browse leaf relevance high condition browse leaf id M11556 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full study rank 61566 study protocol section identification module n c t id NCT04834804 org study id info org study id 23032015 organization org full name University of Bologna org class OTHER brief title Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men official title Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 2, 2019 start date type Actual primary completion date struct primary completion date December 2, 2019 primary completion date type Actual completion date struct completion date December 2, 2019 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Francesco Campa responsible party investigator title Principal investigator responsible party investigator affiliation University of Bologna lead sponsor lead sponsor name University of Bologna lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The present investigation lasted a total of 16 weeks, of which 4 were employed for assessment and measurements and 12 weeks were used for the exercise treatment. The participants underwent two different training programs carried out in three weekly 75-min sessions, on alternate days (Mondays, Wednesdays and Fridays, in the morning). Each session of both training programs consisted of a warm-up at the beginning and general stretching at the end. The exercises used in the suspension training program were: squat, rear deltoid row, biceps curl, chest press, low row, rotational ward, split squat whit Y deltoid fly, triceps pushdown. The exercises used in the free weight training program were: squat with support, unilateral squat, hip adduction and abduction, calves, hip flexor, alternating curl, French triceps press, and high row. Eleven participants were included in the control group. conditions module condition list condition Effect of Different Exercise Programs on Body Composition design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 36 enrollment type Actual arms interventions module arm group list arm group arm group label Suspension training group arm group type Experimental arm group intervention list arm group intervention name Other: Physical activity arm group label Free weight training group arm group type Experimental arm group intervention list arm group intervention name Other: Physical activity arm group label Control group arm group type No Intervention intervention list intervention intervention type Other intervention name Physical activity intervention description 12 weeks of exercise training intervention arm group label list intervention arm group label Free weight training group Suspension training group outcomes module primary outcome list primary outcome primary outcome measure Body composition primary outcome description Fat mass primary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria: not having chronic disabling diseases not being bedridden institutionalized or hospitalized have their own mobility, without assistance from people, even if they have the aid of devices -without amputations. Exclusion Criteria: the use of pacemakers and the presence of chronic and uncontrolled metabolic diseases healthy volunteers Accepts Healthy Volunteers gender Male minimum age 65 Years std age list std age Older Adult contacts locations module location list location location facility Francesco Campa location city Bologna location zip 40126 location country Italy i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions	NCT04834804	[ 101, 1554, 2025, 3997, 5391, 1571, 1545, 1545, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 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full study rank 61915 study protocol section identification module n c t id NCT04830254 org study id info org study id TENS21 organization org full name Cairo University org class OTHER brief title Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients official title Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date January 20, 2021 start date type Actual primary completion date struct primary completion date May 12, 2021 primary completion date type Actual completion date struct completion date May 20, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 26, 2021 last update post date struct last update post date July 27, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Heba Ahmed Ali Abdeen responsible party investigator title Assistant professor responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Cairo University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist. detailed description The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation. conditions module condition list condition Peripheral Arterial Disease design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label study group(A) arm group type Active Comparator arm group description Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks. arm group intervention list arm group intervention name Device: Transcutaneous Electrical Nerve Stimulation(TENS) device arm group label Control group(B) arm group type Sham Comparator arm group description The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation arm group intervention list arm group intervention name Device: Transcutaneous Electrical Nerve Stimulation(TENS) device intervention list intervention intervention type Device intervention name Transcutaneous Electrical Nerve Stimulation(TENS) device intervention description The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks. intervention arm group label list intervention arm group label Control group(B) study group(A) intervention other name list intervention other name TENS outcomes module primary outcome list primary outcome primary outcome measure Red cell distribution width (RDW) primary outcome description Peripheral venous blood samples were obtained from each patient. primary outcome time frame change from baseline to after 12 weeks primary outcome measure Mean platelet volume(MPV) primary outcome description Peripheral venous blood samples were obtained from each patient. primary outcome time frame change from baseline to after 12 weeks primary outcome measure Ankle peak systolic velocity (APSV) primary outcome description is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography primary outcome time frame change from baseline to after 12 weeks primary outcome measure Arterial diameter primary outcome description Diameter of lower limb arteries measured by doppler ultrasonography primary outcome time frame change from baseline to after 12 weeks secondary outcome list secondary outcome secondary outcome measure Actual claudication distance secondary outcome description Claudication pain distance was measured after running on a treadmill constant walking speed of 2 mile/hour at 0% grade, with gradual increases in grade of 2.0% every 2 minutes. secondary outcome time frame change from baseline to after 12 weeks eligibility module eligibility criteria Inclusion Criteria: Unilateral Leriche-Fontaine stage-II PAD Both sexes Aged 50 to 60 years Outpatients Clinically stable Sedentary Not participating in any physical activity last 3 months Exclusion Criteria: Walking disorders related to orthopedic or neuromuscular disease Renal insufficiency requiring dialysis (Renal diseases) Known and documented myopathy Progressive cancer Associated progressive disease causing a deterioration in general health Participation in another research protocol Skin disorder making it impossible to use TENS Absolute contraindication to physical activity Presence of a pacemaker/defibrillator healthy volunteers No gender All minimum age 50 Years maximum age 60 Years std age list std age Adult contacts locations module location list location location facility Faculty of Physical Therapy location city Cairo location zip 12316 location country Egypt i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000058729 condition mesh term Peripheral Arterial Disease condition mesh id D000016491 condition mesh term Peripheral Vascular Diseases condition ancestor list condition ancestor condition ancestor id D000050197 condition ancestor term Atherosclerosis condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M28366 condition browse leaf name Peripheral Arterial Disease condition browse leaf as found Peripheral Arterial Disease condition browse leaf relevance high condition browse leaf id M18046 condition browse leaf name Peripheral Vascular Diseases condition browse leaf as found Peripheral Arterial Disease condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition 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full study rank 61932 study protocol section identification module n c t id NCT04830033 org study id info org study id SHIELD COVID - ENO sub-study 2 organization org full name Imperial College London org class OTHER brief title ENO Breathe vs Usual Care in COVID-19 Recovery official title A Randomised Controlled Trial of the English National Opera Breathe Programme Compared With Usual Care in People Recovering From COVID-19 acronym SHIELD ENO status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date April 28, 2021 start date type Actual primary completion date struct primary completion date September 23, 2021 primary completion date type Actual completion date struct completion date September 23, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date November 22, 2021 last update post date struct last update post date December 3, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Imperial College London lead sponsor class OTHER collaborator list collaborator collaborator name Imperial College Healthcare NHS Trust collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A randomised clinical trial to assess the impact of an online singing, breathing and wellbeing programme (ENO Breathe) developed specifically for people recovering from COVID-19. detailed description BACKGROUND: ENO Breathe is a breathing and wellbeing programme developed specifically for people recovering from COVID-19, who are still suffering from breathlessness and associated anxiety. Delivered by ENO in collaboration with Imperial College Healthcare teams entirely online, the programme focuses on breathing re-training through singing. Initial evaluation of the project suggested health improvements related to participation, however, a properly conducted efficacy study is needed. DESIGN: An assessor blind, parallel group, randomised controlled trial, to assess the effects of ENO Breathe compared to usual care on health status. The study will also evaluate the impact on respiratory symptoms, anxiety, depression, and breathlessness perception to investigate the mechanisms involved. RESEARCH QUESION AND OUTCOME MEASURES: The primary outcome will be change in health status, assessed using the RAND-36 tool (RAND SF-36), comparing ENO Breathe and Usual Care arms. Additional endpoints will be: the COPD assessment test score (CAT), 0-100 Visual Analogue Scales (VAS) for breathlessness (at rest, walking around the house, climbing stairs, and running), Dyspnoea-12, anxiety (GAD-7), and depression (PHQ-9). Assessments: The outcomes outlined above will be recorded at baseline prior to randomisation, and then repeated after 6 weeks. POPULATION: Adult patients recovering from COVID-19 will be recruited from specialist COVID-19 clinics, where participants will have been fully assessed and investigated by referring healthcare professionals. Participants in the active arm will attend once weekly ENO online workshop sessions for 6 weeks, and have access to bespoke online digital resources, designed to support participants between sessions. The comparison arm will receive usual care. Randomization will be 1:1. SAMPLE SIZE Sample size: Based on pilot data in people with COPD, where the standard deviation (SD) for change in SF-36 was 15 points, to identify a clinically relevant 10 point difference in SF-36 responses at a 0.05 level of significance with a 90% power would require 48 patients in each treatment arm. Allowing for 20% dropout, we will therefore recruit 120 patients. Primary analysis will be on an intention to treat basis. Change in parameters will be assessed comparing ENO Breathe and Usual Care, using Generalised Linear Models to estimate treatment effects. In order to better understand changes in the RAND-36 "anchor measure", the investigator will relate this to changes in measures of anxiety, depression, breathlessness, and other respiratory symptoms. An additional responder analysis will compare the proportion in each treatment arm achieving a clinically important (10%) improvement in RAND-36 scores. Update 21 JUNE 2021 To calculate the sample size, pilot data from a singing-based intervention in COPD, (considered the most relevant data available at study inception) was used, as outlined above, where the researchers aimed to recruit 120 patients. Data subsequently became available from ENO Breathe participants that rook part in the program prior to the research study, in which the SD was 8 for change in SF-36 scores. We have also decided using an MCID of 5 for the SF-36 is more appropriate, as this is not specific to a particular medical condition. As such, a total sample of 108 participants is required, using 1 to 1 study arm allocation. Allowing for 30% dropout, which is more appropriate, 158 participants will be recruited. Additionally, as a higher than expected number of participants were considered, study withdrawals due to be unable to attend the session times they were allocated, or despite meeting inclusion criteria, 1-to-1 meeting with the session leaders highlighted issues related excessive fatigue precipitated by exertion, so were not deemed appropriate at that point in time. As such, the researchers will also conduct a modified intention to treat analysis including all participants who were randomised and were deemed appropriate to participate following their 1-to-1. This consideration had not been included in the original exclusion criteria, due to limited awareness of its relevance at that time. These changes have been made, and here documented, before any baseline data has been sent to the analysis team, and before any follow up data has been collected. conditions module condition list condition COVID-19 Recovery design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design masking description Masking of participants not possible due to the nature of the intervention. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 153 enrollment type Actual arms interventions module arm group list arm group arm group label ENO Breathe group arm group type Experimental arm group description Participation in the online ENO Breathe programme for 6 weeks. arm group intervention list arm group intervention name Other: ENO Breathe group arm group label Usual Care Group arm group type No Intervention arm group description Participants continue with usual care. intervention list intervention intervention type Other intervention name ENO Breathe group intervention description Six weekly group online workshop sessions, led by an ENO vocal specialist. Workshops will encourage participants to take part in exercises and activities especially designed to support breathing control, providing tools for self-management of breath and anxiety. They will also have access to bespoke online digital resources, designed to support participants between sessions. These will include exercises, song sheets and audio and video materials, especially recorded by the ENO for participants on the programme. intervention arm group label list intervention arm group label ENO Breathe group outcomes module primary outcome list primary outcome primary outcome measure Change from baseline in RAND-36 (RAND SF-36) primary outcome description A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability. primary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome list secondary outcome secondary outcome measure Changes in COPD assessment test (CAT) secondary outcome description A respiratory disease health status measure that has been validated in people recovering from COVID-19. This includes 8 items, scored 0-5 with a possible score from 0 (best) to 40 (worst). secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Generalised Anxiety Disorder Assessment (GAD-7) secondary outcome description Self-administered questionnaire to assess for symptoms, and severity, of anxiety. Includes seven questions scored from 0 to 3, giving a total score out of 21. Lower scores indicate less symptoms of anxiety. secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Patient Health Questionnaire 9 (PHQ-9) secondary outcome description Self-administered questionnaire to assess for symptoms, and severity, of depression. Includes nine questions scored from 0 to 3, giving a total score out of 27. Lower scores indicate less symptoms of depression. secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Dyspnoea-12 questionnaire secondary outcome description Assessment of dyspnoea. Includes 12 descriptors scored from 0 to 3, giving a total score of 36. Lower scores indicate less severe dyspnoea. secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Visual Analogue Scale ratings of breathlessness secondary outcome description Four Visual Analogue Scales, scored from 0 to 100, for participants to rate their breathlessness while i) at rest, ii) walking around the house, iii) climbing stairs, iv) running. Higher scores indicate more severe dyspnoea (breathlessness). secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in SF-6D (Short-Form Six-Dimension) scores secondary outcome description The SF-6D uses data from the RAND SF-36 to generate a continuous index for health that can be used to create a quality-of-life score for cost utility analysis. secondary outcome time frame At baseline, then repeated after 6 weeks. eligibility module eligibility criteria Inclusion Criteria: Adults recovering from COVID-19 with ongoing breathlessness and/or anxiety. Referred from a specialist COVID-19 clinics aligned with the project, after appropriate clinical evaluation and investigation Internet access with appropriate device (e.g. computer or tablet) Exclusion Criteria: - Unable to participate due to comorbidity (e.g. life limiting illness, cognitive impairment) healthy volunteers No gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Nicholas S Hopkinson overall official affiliation Imperial College London overall official role Principal Investigator location list location location facility National Heart and Lung Institute, Imperial College London location city London location zip SW3 6NP location country United Kingdom references module reference list reference reference p m i d 35489367 reference type derived reference citation Philip KEJ, Owles H, McVey S, Pagnuco T, Bruce K, Brunjes H, Banya W, Mollica J, Lound A, Zumpe S, Abrahams AM, Padmanaban V, Hardy TH, Lewis A, Lalvani A, Elkin S, Hopkinson NS. An online breathing and wellbeing programme (ENO Breathe) for people with persistent symptoms following COVID-19: a parallel-group, single-blind, randomised controlled trial. Lancet Respir Med. 2022 Sep;10(9):851-862. doi: 10.1016/S2213-2600(22)00125-4. Epub 2022 Apr 27. i p d sharing statement module i p d sharing Yes i p d sharing description Data will be shared on reasonable request. i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame The data will be available from the date of publication of the main study, and will remain available for at least 2 years. i p d sharing access criteria Data will be shared on reasonable request. derived section misc info module version holder December 02, 2022 submission tracking submission info list submission info submission release date September 27, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id 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full study rank 61309 study protocol section identification module n c t id NCT04838145 org study id info org study id 2015-003350-41 organization org full name Oslo University Hospital org class OTHER brief title The Diabetes Virus Detection and Intervention Trial official title The Diabetes Virus Detection and Intervention Trial acronym DiViDInt status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date August 30, 2018 start date type Actual primary completion date struct primary completion date October 25, 2020 primary completion date type Actual completion date struct completion date October 25, 2020 completion date type Actual study first submit date January 4, 2019 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lars Krogvold responsible party investigator title Consultant responsible party investigator affiliation Oslo University Hospital lead sponsor lead sponsor name Oslo University Hospital lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary A randomized, double-blind, placebo-controlled study in 96 children and adolescents age 6-15 newly diagnosed with type 1 diabetes to describe the influence of antiviral treatment (Pleconaril and Ribavirin) on progression of disease and residual insulin secretion. detailed description If antiviral treatment is efficient in halting the disease progression, it will be to great benefit for the participating patients. Maintenance or even an increase in beta cell mass due to regeneration will lead to improved endogenous insulin production and give a milder course of the disease with improved glycemic control. This will in a substantial way improve the long-term prognosis with less severe long term vascular complications.Some patients may have close to complete remission and be able to stop insulin treatment. If antiviral treatment is effective, it would add proof to the concept that type 1 diabetes in its origin is a viral disease. This would be an important milestone in medical research and a breakthrough in the understanding of the etiopathogenesis of autoimmune diseases. It may promote the development of vaccines to prevent the disease. T1D seems more aggressive in children than in adults, and the beta cell function decline rapidly compared to adults. As a consequence, the effect of antiviral treatment will potentially be more significant in children than in adults. Children have higher HbA1c which increases the risk of complications. Thus, T1D is a more aggressive disease in children than in adults and hence it's important to do this study in children. Pharmaceuticals are usually studied in different age intervals, commonly 1-6 years, 6-12 years and 12-15 years. For safety reasons and simplicity, the investigators want to start with the two older groups. The investigators will treat the participants with two antiviral medications (Pleconaril and ribavirin) or placebo in a double blind, randomized, placebo controlled, parallel group study. Pleconaril has previously been given in doses of 5-10mg/kg x 2-3 in clinical trials in children, thus achieving serum levels high enough for killing the majority of the viruses. The investigators have, due to the long treatment period, reduced the doses to 5 mg/kg x 2. Ribavirin will be given in dosages according to Summariy of product characteristics (SmPC). The investigators have chosen to administer Investigational Medicinal Product (IMPs) as an oral solution as this will make it easier to give the medication according to weight. conditions module condition list condition Type1 Diabetes Mellitus Enterovirus keyword list keyword Type 1 diabetes Children Enterovirus Recent onset design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A double-blind, placebo controlled, prospective, randomized trial examining the effect of antiviral treatment given for 6months on residual insulin secretion design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 96 enrollment type Actual arms interventions module arm group list arm group arm group label Active treatment arm group type Active Comparator arm group description Pleconaril: 5 mg/kg x2 times a day for 26 weeks up to 40 kg. Max dose 300mg x2. Ribavirin:15 (7.5) mg/kg/day divided in two doses daily for 26 weeks: Max dose 1000mg/24h if body weight<75kg and 1200mg if body weight>75kg. arm group intervention list arm group intervention name Drug: Ribavirin + Pleconaril arm group label Placebo arm group type Placebo Comparator arm group description Receives placebo, on a double blind basis arm group intervention list arm group intervention name Drug: Placebos intervention list intervention intervention type Drug intervention name Ribavirin + Pleconaril intervention description Randomized to treatment with study drugs (ribavirin and pleconaril) intervention arm group label list intervention arm group label Active treatment intervention type Drug intervention name Placebos intervention description Randomized to treatment with placebo intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Insulin secretion primary outcome description Change in mean residual insulin secretion in the Insulin tolerance test (ITT)-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to12 months after initiation of study treatment. primary outcome time frame 12 months secondary outcome list secondary outcome secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 3 months after initiation of study treatment. secondary outcome time frame 3 months secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 6 months after initiation of study treatment. secondary outcome time frame 6 months secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 24 months after initiation of study treatment. secondary outcome time frame 24 months secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 36 months after initiation of study treatment. secondary outcome time frame 36 months secondary outcome measure Stimulated c-peptide secondary outcome description Proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide >0.2 pmol/L secondary outcome time frame 36 months secondary outcome measure C-peptide filter paper secondary outcome description Fasting and meal stimulated C-peptide from blood sampled on filter paper at home at 4 weekly intervals throughout the study period secondary outcome time frame 36 months secondary outcome measure Insulin dose secondary outcome description Mean Insulin dosage per kilo bodyweight per 24 hours secondary outcome time frame 36 months secondary outcome measure HbA1c secondary outcome description HbA1c at every control secondary outcome time frame 36 months secondary outcome measure Hypoglycemic events secondary outcome description Number of severe hypoglycaemic events and less severe events requiring assistance from others with blood glucose values ≤ 3.9 mmol/L will be registered at each control secondary outcome time frame 36 months secondary outcome measure Insulin-dose-adjusted HbA1c (IDAA1c) secondary outcome description HbA1c adjusted to insulin dose secondary outcome time frame 36 months secondary outcome measure Proinsulin/c-peptide ratio in serum secondary outcome description Proinsulin/c-peptide ratio in serum as a measure of beta cell stress secondary outcome time frame 36 months secondary outcome measure Presence of enterovirus secondary outcome description Presence of enterovirus and rhinovirus and/or neutralizing antibodies against those viruses in nose, blood, saliva and stool secondary outcome time frame 36 months eligibility module eligibility criteria Inclusion Criteria: Diagnosed type 1 Diabetes (E10.9). First injection of insulin maximum three weeks prior to inclusion. Must be willing and capable of taking the study drugs and meet for tests and follow up as described. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice (ICH GCP), and national/local regulations. Aged 6.00-15.99 years at inclusion Exclusion Criteria: Treatment with any oral or injected anti-diabetic medications other than insulin. A history of haemolytic anaemia or significantly abnormal haematology results at screening. History of severe cardiac disease previous six months. Impaired renal function Patients taking ethinyl estradiol Participation in other clinical trials with a new chemical entity within the previous 3 months. Inability or unwillingness to comply with the provisions of this protocol Females who are lactating or pregnant. Males or females (after menarche) not willing to use highly effective contraception (progesterone-only hormonal anticonception with inhibition of ovulation or sexual abstinence) and barrier contraception (condoms), if sexually active during the treatment period and in the following 7 months Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study. healthy volunteers No gender All minimum age 6 Years maximum age 15 Years std age list std age Child contacts locations module overall official list overall official overall official name Knut Dahl-Jørgensen, MD, PhD overall official affiliation Professor overall official role Principal Investigator location list location location facility Pediatric department, Oslo University Hospital location city Oslo location zip 0514 location country Norway i p d sharing statement module i p d sharing No i p d sharing description The data and material collected from the placebo-group will be shared with the "Innodia" consortium derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004769 condition mesh term Enterovirus Infections condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003922 condition mesh term Diabetes Mellitus, Type 1 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000010850 condition ancestor term Picornaviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007239 condition ancestor term Infections condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M6269 condition browse leaf name Diabetes Mellitus, Type 1 condition browse leaf as found Type 1 Diabetes condition browse leaf relevance high condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M7082 condition browse leaf name Enterovirus Infections condition browse leaf as found Enterovirus condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M12897 condition browse leaf name Picornaviridae Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000012254 intervention mesh term Ribavirin intervention mesh id C000115201 intervention mesh term Pleconaril intervention ancestor list intervention ancestor intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M14235 intervention browse leaf name Ribavirin intervention browse leaf as found Type 2 intervention browse leaf relevance high intervention browse leaf id M340095 intervention browse leaf name Pleconaril intervention browse leaf as found Tourniquet cuff intervention browse leaf relevance high intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs 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full study rank 61776 study protocol section identification module n c t id NCT04832074 org study id info org study id CamiloJcU21 organization org full name Camilo Jose Cela University org class OTHER brief title Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling official title Immediate Stiffness Changes in Upper Trapezius Active Myofascial Trigger Points After Dry Needling in Patients With Neck Pain: A Randomized, Double-Blinded, Placebo-Controlled Trial acronym ELECTROP status module status verified date May 2021 overall status Completed expanded access info has expanded access No start date struct start date May 5, 2021 start date type Actual primary completion date struct primary completion date May 18, 2021 primary completion date type Actual completion date struct completion date May 19, 2021 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date February 20, 2022 last update post date struct last update post date February 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Camilo Jose Cela University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Shear-wave elastography (SWE) is considered as a useful tool for quantifying muscle stiffness. Considering that Myofascial Trigger Points (MTrP) are defined as "hyperirritable zones in contracted bands of muscle, thought to be caused by muscle overload or stress" and the effectiveness of dry needling applied to active MTrP for reducing pain and disability, the aim of this study is to assess the effects of sham and real dry needling, applied to active MTrP in the upper trapezius muscle in patients with chronic neck pain, on the muscle stiffness in two areas: 1) the most symptomatic area and 2) a control point. conditions module condition list condition Myofascial Pain Syndrome Neck Pain Trigger Point Pain, Myofascial design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized, Double-Blinded, Placebo-Controlled Trial design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Dry Needling arm group type Experimental arm group description Dry needling will be performed with 'solid filiform needles'. The procedure is as follows: The participant will lie in the prone position. The overlying skin will be cleaned with antiseptic spray. The taut band and MTrP, will be localized manually. After measuring the Pain Pressure Thresholds in this location and the control (located 3 cm lateral to the MTrP), the needle within its plastic guide tube will be placed over the MTrP. After a tapping movement to insert the needle, the needle will be moved to the muscle around the bundle and moved forward and backward to the tissue to elicit a small muscle twitch. After eliciting LTR, needling will be stopped. If no twitch were elicited, needling will stopped after two or three stellate movements arm group intervention list arm group intervention name Other: Dry Needling arm group label Sham Dry Needling arm group type Sham Comparator arm group description The same approach will be used with the exception of piercing the skin. The guide tube will press against the tissue and the sham needle will be allowed to drop against the skin. The handle will be tapped briskly but not breaking the skin. The sham needle will stay within the guide tube and will be pressed against the skin twice so as to mimic the quick "in and out" technique. arm group intervention list arm group intervention name Other: Sham Dry Needling intervention list intervention intervention type Other intervention name Dry Needling intervention description Real Dry Needling in the most active Myofascial Trigger Point intervention arm group label list intervention arm group label Dry Needling intervention type Other intervention name Sham Dry Needling intervention description Sham Dry Needling in the same location, but not piercing the skin intervention arm group label list intervention arm group label Sham Dry Needling outcomes module primary outcome list primary outcome primary outcome measure SWE - Young modulus primary outcome description KPa primary outcome time frame Baseline primary outcome measure SWE - Young modulus primary outcome description KPa primary outcome time frame 10 minutes primary outcome measure SWE - Local shear wave speed primary outcome description m/s primary outcome time frame Baseline primary outcome measure SWE - Local shear wave speed primary outcome description m/s primary outcome time frame 10 minutes primary outcome measure Pain Pressure Thresholds primary outcome description kg/cm2 primary outcome time frame Baseline primary outcome measure Pain Pressure Thresholds primary outcome description kg/cm2 primary outcome time frame 10 minutes secondary outcome list secondary outcome secondary outcome measure Visual Analogue Scale secondary outcome description 0-10 secondary outcome time frame Baseline secondary outcome measure Neck Disability Index secondary outcome description 0-100 secondary outcome time frame Baseline eligibility module eligibility criteria Inclusion Criteria: Patients between 18 and 65 and Presence of mechanical neck pain for at least three months duration Presence of at least one active MTrP in the Upper Trapezius muscle Exclusion Criteria: Neck pain of traumatic origin (such as whiplash-associated disorder) Current use of any kind of analgesic therapy Presenting any condition usually considered a perpetuating factor of MTrPs, such as fibromyalgia, hypothyroidism, or iron deficiencies Presenting any contraindication for Dry Needling application Neuropathies (e.g., radiculopathy) Bilateral Pain healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Juan Antonio Valera-Calero, PhD overall official affiliation Camilo José Cela University overall official role Principal Investigator location list location location facility Francisco de Vitoria University location city Pozuelo De Alarcón location state Madrid location zip 28223 location country Spain references module reference list reference reference p m i d 35765779 reference type derived reference citation Valera-Calero JA, Sanchez-Jorge S, Buffet-Garcia J, Varol U, Fernandez-de-Las-Penas C, Alvarez-Gonzalez J. Changes in stiffness at active myofascial trigger points of the upper trapezius after dry needling in patients with chronic neck pain: a randomized controlled trial. Acupunct Med. 2022 Jun 28:9645284221104831. doi: 10.1177/09645284221104831. Online ahead of print. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009209 condition mesh term Myofascial Pain Syndromes condition mesh id D000005356 condition mesh term Fibromyalgia condition mesh id D000019547 condition mesh term Neck Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M7638 condition browse leaf name Fibromyalgia condition browse leaf as found Myofascial Pain Syndrome condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M20638 condition browse leaf name Neck Pain condition browse leaf as found Neck Pain condition browse leaf relevance high condition browse leaf id M11313 condition browse leaf name Myofascial Pain Syndromes condition browse leaf as found Myofascial Pain Syndrome condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3367 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full study rank 61300 study protocol section identification module n c t id NCT04838262 org study id info org study id MH123928 organization org full name The University of Texas at Arlington org class OTHER brief title Stress and the Sympathetic Nervous System in Adults With Depression official title Daily Stress Processes and Sympathetic Reactivity in Depression status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Actual primary completion date struct primary completion date March 2023 primary completion date type Anticipated completion date struct completion date March 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 26, 2022 last update post date struct last update post date May 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name The University of Texas at Arlington lead sponsor class OTHER collaborator list collaborator collaborator name Penn State University collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To test our hypotheses, we will enroll healthy adults having no history of mood disorders and adults with major depressive disorder (MDD) having a broad range of depressive symptom severity. After screening, subjects will meet with the research coordinator or an investigator for a discussion, with opportunity for questions, before applicable consent forms are obtained. Daily stress processes will be assessed using an ecological momentary assessment approach for 8 consecutive days. On the last day of the daily stress assessment, we will directly measure muscle sympathetic nerve activity, blood pressure, and heart rate during acute laboratory-based cognitive, emotional, and physiological interventions to induce a stress response. A venous blood sample will be taken for measurements of metabolic and renal health and systemic inflammation. Aim 1: To examine the effect of daily psychosocial stressor exposure on acute sympathetic stress reactivity in MDD. Two stressor exposure indicators will be calculated: stressor frequency (i.e., percentage of interview days during which at least one stressor occurred) and total stress (i.e., total number of stressors reported across all interview days) and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults. Aim 2: To determine the relation between negative affective reactivity to daily psychosocial stressor exposure and acute sympathetic stress reactivity in MDD. Negative affective reactivity will be calculated as the change in affect on days when stressors occurred compared to one's typical affect on non-stressor days and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults. conditions module condition list condition Major Depressive Disorder design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Assessment of Daily Stress Processes arm group type Experimental arm group description Subjects will report cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. arm group intervention list arm group intervention name Other: Acute Stressors intervention list intervention intervention type Other intervention name Acute Stressors intervention description Sympathetic nervous system activity and blood pressure will be measured before, during, and after several acute laboratory-based cognitive (Stroop Color Word Test), emotional (International Affective Picture System), and physiological (Cold Pressor Test) stressors. intervention arm group label list intervention arm group label Assessment of Daily Stress Processes outcomes module primary outcome list primary outcome primary outcome measure total number of daily stressors primary outcome description measured each day via self-report using ecological momentary assessment primary outcome time frame 8 days before intervention primary outcome measure change in negative affect in response to daily stressors primary outcome description measured each day via self-report using ecological momentary assessment primary outcome time frame 8 days before intervention primary outcome measure change in muscle sympathetic nerve activity in response to acute stress (compared to resting baseline activity) primary outcome description measured using microneurography primary outcome time frame during laboratory-based intervention (3 minutes) eligibility module eligibility criteria Inclusion Criteria: All participants will be 18-30 yrs. Healthy non-depressed men and women will have no history or evidence of psychiatric illness and will not have a family history of MDD or major psychiatric illness. Men and women with MDD will have symptomatic depression that meets diagnostic criteria and will be non-medicated. The capacity and willingness to provide written informed consent, to attend all study related visits, and to comply with the study protocol. Exclusion Criteria: Subjects will be excluded at the discretion of the PI/collaborating clinician or for any of the following reasons: psychiatric illness aside from MDD (including current or past psychotic disorders, bipolar disorder, schizophrenia or schizoaffective disorder, panic disorder, post-traumatic stress disorder, obsessive compulsive disorder) subthreshold depression current use of psychotropic medications (including major classes of antidepressants, anxiolytics, antipsychotics, mood stabilizers) active suicidal or homicidal ideation active substance dependence or eating disorders current use of any medications that could alter sympathetic reactivity diagnosed or suspected cardiovascular, renal, or metabolic disease (hypertension, heart disease, diabetes, hyperlipidemia) autonomic disorders tobacco use (including electronic cigarettes) obesity (body mass index > 30 kg/m2) breastfeeding or pregnancy <18 or >30 yrs healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module central contact list central contact central contact name Jody Greaney, PhD central contact role Contact central contact phone 817-272-7891 central contact e mail jody.greaney@uta.edu location list location location facility The University of Texas at Arlington location status Recruiting location city Arlington location state Texas location zip 76010 location country United States location contact list location contact location contact name Jody Greaney, PhD location contact role Contact location contact phone 817-272-7891 location contact e mail jody.greaney@uta.edu location contact name Jody Greaney, PhD location contact role Principal Investigator i p d sharing statement module i p d sharing Yes i p d sharing description Per the data sharing policy of the National Institute of Mental Health (NIMH), we will deposit all phenotypic, psychosocial stress, and sympathetic reactivity data from this study to the NIMH Data Archive. We will use standard data dictionaries (NIH Toolbox Cognition Battery, NIH Toolbox Emotion Battery, PHQ-9) and will collect the data necessary to generate global unique identifiers for each study subject. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000003865 condition mesh term Depressive Disorder, Major condition ancestor list condition ancestor condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf relevance low condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depressive Disorder condition browse leaf relevance high condition browse leaf id M6212 condition browse leaf name Depressive Disorder, Major condition browse leaf as found Major Depressive Disorder condition browse leaf relevance high condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions	NCT04838262	[ 101, 1554, 2025, 3997, 5391, 13144, 1568, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23249, 25129, 1477, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 150, 27012, 22737, 1580, 24606, 2369, 8916, 1554, 1271, 1109, 1239, 1104, 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full study rank 61799 study protocol section identification module n c t id NCT04831775 org study id info org study id 00000464 organization org full name University of Texas at Austin org class OTHER brief title Cognitive Training for Diabetes Self-Management official title Cognitive Training for Diabetes Self-Management status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Actual primary completion date struct primary completion date March 28, 2023 primary completion date type Anticipated completion date struct completion date March 28, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 16, 2022 last update post date struct last update post date May 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Texas at Austin lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes. detailed description Aim 1: Test the efficacy of the MAPSS-DM intervention for improving cognitive function, A1C, and DM-SM. Based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved DM-SM immediately post-intervention and at three and six-months post-intervention. Aim 2: To explore changes in glycemic variability and their association with changes in cognitive function. The working hypothesis here is that MAPSS-DM participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance. conditions module condition list condition Diabetes Mellitus, Type 2 keyword list keyword cognitive function glucose variability design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design masking description The intervention will be delivered by a research assistant and outcome data collection will be done by two other research assistants design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Memory, Attention, and Problem Solving Skills for Diabetes arm group type Experimental arm group description The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice over 8 weeks. Classes 1 & 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. The computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on. The intervention group will be asked to practice 20 minutes, 7 days a week. arm group intervention list arm group intervention name Behavioral: Memory, Attention, and Problem Solving Skills for Diabetes arm group label Brain Games Only arm group type Active Comparator arm group description An active control group will be used. The differing variable between the two groups is the class sessions. Those randomized to the control group will only receive a link to the BrainHQ games site. A specific amount of practice will not be prescribed, but the frequency and duration of participant's practice will be obtained from BrainHQ. Participants will receive a weekly phone call to maintain connection to the study. Data collection will be on the same schedule as the intervention group. arm group intervention list arm group intervention name Behavioral: Brain Games intervention list intervention intervention type Behavioral intervention name Memory, Attention, and Problem Solving Skills for Diabetes intervention description The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice and will be held over 8 weeks. The classes will be taught by a GRA. Classes 1 & 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. Each online class will follow the same format: (1) introduction/revisiting content from the previous class; (2) review of progress on computer exercises; (3) practicing cognitive strategies in class; and (4) a weekly topic. The GRA will also prescribe exercises for the following weeks. intervention arm group label list intervention arm group label Memory, Attention, and Problem Solving Skills for Diabetes intervention type Behavioral intervention name Brain Games intervention description The computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Participants will only need a computer, smart phone, or tablet with Internet access to securely log onto the website. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on. intervention arm group label list intervention arm group label Brain Games Only intervention other name list intervention other name BrainHQ outcomes module primary outcome list primary outcome primary outcome measure Change in A1C at week 22 primary outcome description Measure of average glucose over 3 months primary outcome time frame Baseline, and week 22 primary outcome measure Change in diabetes self-management adherence at week 22 primary outcome description Summary of Diabetes Self-Care Activities: 8 items; Brief assessment of diabetes related psychosocial self-efficacy. Responses are made on a 5-point scale (1 = strongly disagree to 4 = strongly agree) to items such as "I believe that I am able to turn my diabetes goals into a workable plan." Cronbach's alphas range from 0.81 to 0.96. Higher scores indicate higher levels of self-management adherence. primary outcome time frame Baseline, week 8, and week 22 primary outcome measure Change in glucose variability at week 22 primary outcome description Continuous Glucose Monitor (CGM): To be worn for 2 weeks at baseline and week 22; The following glucose composites will be calculated: (1) the overall mean, (2) the proportion of readings indicating hypoglycemia (%<70mg/dL), (3) the proportion of readings indicating hyperglycemia (% >160mg/dL), (4) the proportion of out of range readings (% either <70mg/dL or >160mg/dL) and (5) the SD of CGM glucose readings. primary outcome time frame Baseline, week 8, and week 22 primary outcome measure Change in attention, visual scanning and motor speed at week 22 primary outcome description Symbol Digit Modalities Test: Participants are given a series of symbols and digits and instructed to verbalize the digit associated with each symbol. The number of correct responses in 90 sec constitutes the score, and higher scores reflect better cognitive function. primary outcome time frame Baseline, week 8, and week 22 secondary outcome list secondary outcome secondary outcome measure Change in perceived cognitive function at week 22 secondary outcome description PROMIS v2.0 - Cognitive Function: 32 items; assess patient-perceived cognitive deficits including the areas of mental acuity, concentration, verbal and nonverbal memory, and verbal fluency. Reliability has been measured at 0.94 and test-retest correlation at 0.83. Higher scores indicate more perceived difficulty with cognitive function. secondary outcome time frame Baseline, week 8, and week 22 eligibility module eligibility criteria Inclusion Criteria: age 50 years old or greater T2DM diagnosis for 2 years access to phone and Internet Score of ≥10 on the Perceived Deficits Questionnaire (PDQ) A1C of >7%. Exclusion Criteria: a diagnosis of dementia/head injury score of >5 on the Mini-Cog inability to speak English, and T1DM diagnosis healthy volunteers Accepts Healthy Volunteers gender All minimum age 50 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Heather E Cuevas, PhD central contact role Contact central contact phone 15124226059 central contact e mail hcuevas@mail.nur.utexas.edu overall official list overall official overall official name Heather E Cuevas, PhD overall official affiliation The University of Texas at Austin overall official role Principal Investigator location list location location facility The University of Texas at Austin location status Recruiting location city Austin location state Texas location zip 78712 location country United States location contact list location contact location contact name Heather E Cuevas, PhD location contact role Contact location contact phone 512-422-6059 location contact e mail hcuevas@mail.nur.utexas.edu i p d sharing statement module i p d sharing No i p d sharing description Only de-identified quantitative and qualitative data will be available to other qualified researchers upon request from the PI two years after completion of the study. After review of the purpose of the data request to make sure it is consistent with the original project goals and verification that the request meets IRB approval, de-identified data may be shared with researchers two years after completion of the study. It is recognized that the government reserves the right to identify repositories for submission of data for archive as stated in the grant instructions. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003924 condition mesh term Diabetes Mellitus, Type 2 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf as found Diabetes Mellitus, Type 2 condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse 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full study rank 61783 study protocol section identification module n c t id NCT04831983 org study id info org study id ABRUPT organization org full name University of Milano Bicocca org class OTHER brief title ABlative Radiotherapy (for) Unfavorable Prostate Tumors official title Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer acronym ABRUPT status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date April 1, 2029 primary completion date type Anticipated completion date struct completion date April 1, 2029 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 21, 2022 last update post date struct last update post date July 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Stefano Arcangeli responsible party investigator title Associate Professor responsible party investigator affiliation University of Milano Bicocca lead sponsor lead sponsor name University of Milano Bicocca lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. detailed description Patients enrolled in this observational prospective trial will be offered image-guided, volumetric modulated radiotherapy (IGRT-VMAT) in a single session (SDRT) of 21 Gy to the whole gland with a simultaneous boost of 24 Gy to the macroscopic PI-RADS driven (4-5) tumour(s). ADT will be prescribed concomitantly, as per standard of care. A real time non-ionizing prostate monitoring will be used to account for intra-fractional errors. If the dose constraints to the normal tissues are at risk, these will be prioritised over the aimed boost dose. The primary endpoint of the trial is the treatment related toxicity measured by the CTCAE v5.0. Secondary endpoints are quality of life in different domains (sexual, rectal , urinary) and biochemical outcome. Patients will be followed at one month, then every 3 months for the first 12 months and every 6 months thereafter. Quality of Life will be prospectively evaluated through validated tools (ECOG, EPIC, IIEF-5, IPSS, ICIQ-SF) at various timepoints. Percentage or total mean score will be reported according the questionnaires, whether they grade values in a scale or use descriptive statistics. Kaplan-Meier curve analysis of biochemical relapse free survival (b-RFS) at 2 and 5-year bRFS for all patients will be estimated. conditions module condition list condition Prostate Cancer keyword list keyword Unfavorable Prostate Tumors Stereotactic Body Radiotherapy (SBRT) Volumetric Modulated Arc Therapy (VMAT) Prostate Imaging Reporting and Data System (PI-RADS) Toxicity Quality of Life design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 30 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 primary outcome description To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SD RT with focal boost on dominant lesion(s) for intermediate unfavorable and selected high risk organ-confined prostate cancer. primary outcome time frame 60 months secondary outcome list secondary outcome secondary outcome measure QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL secondary outcome description To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-26 Questionnaire secondary outcome time frame 60 months secondary outcome measure Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best) secondary outcome description To assess erectile function after SDRT using IIEF 5 secondary outcome time frame 60 months secondary outcome measure Number of participants with voiding symptoms assessed by International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst) secondary outcome description To assess voiding symptoms after SDRT using IPSS secondary outcome time frame 60 months secondary outcome measure Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst) secondary outcome description To assess urinary continence after SDRT using ICIQ-SF secondary outcome time frame 60 months secondary outcome measure Number of participants with biochemical relapse assessed by PSA (Phoenix definition) secondary outcome description To assess biochemical outcome after SDRT using serum PSA levels secondary outcome time frame 60 months eligibility module eligibility criteria INCLUSION CRITERIA Histologically proven prostate adenocarcinoma; Intermediate and High risk disease, as per the NCCN definition; N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) Choline or PSMA PET-CT; ECOG performance status between 0 and 2; Life expectancy of > 5 years, in the opinion of the investigator; IPSS score must be ≤ 19 (alpha blockers allowed); EXCLUSION CRITERIA: ≥T3b disease according to the 8th AJCC classification; PSA>20 ng/ml at any time point; Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy); Previous radiotherapy to the pelvis; Previous invasive malignancy unless disease free for a minimum of 5 years; Active Crohn's Disease or Ulcerative Colitis; healthy volunteers No gender Male minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult study population Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA > 20 ng/mL allowed), as per NCCN definition sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name STEFANO ARCANGELI, MD central contact role Contact central contact phone +39 039-2333663 central contact e mail stefano.arcangeli@unimib.it location list location location facility Radiation Oncology, ASST Monza (University of Milan Bicocca) location status Recruiting location city Monza location state MB location zip 20900 location country Italy location contact list location contact location contact name Stefano Arcangeli, MD location contact role Contact location contact phone +39 0 39 2333663 location contact e mail stefano.arcangeli@unimib.it references module reference list reference reference p m i d 30480549 reference type result reference citation Bodo S, Campagne C, Thin TH, Higginson DS, Vargas HA, Hua G, Fuller JD, Ackerstaff E, Russell J, Zhang Z, Klingler S, Cho H, Kaag MG, Mazaheri Y, Rimner A, Manova-Todorova K, Epel B, Zatcky J, Cleary CR, Rao SS, Yamada Y, Zelefsky MJ, Halpern HJ, Koutcher JA, Cordon-Cardo C, Greco C, Haimovitz-Friedman A, Sala E, Powell SN, Kolesnick R, Fuks Z. 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full study rank 61653 study protocol section identification module n c t id NCT04833673 org study id info org study id 333 organization org full name Hacettepe University org class OTHER brief title The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial official title The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial status module status verified date June 2020 overall status Completed expanded access info has expanded access No start date struct start date June 22, 2020 start date type Actual primary completion date struct primary completion date December 30, 2020 primary completion date type Actual completion date struct completion date March 15, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Gülşah Kesik responsible party investigator title res.ass. responsible party investigator affiliation Hacettepe University lead sponsor lead sponsor name Hacettepe University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Even though, current treatments including IVIG, corticosteroids, biological agents can provide positive effects on MS symptoms, MS cannot be cured completely today. Therefore, in addition to the available medical treatment options, patients may tend towards complementary and integrative therapies. Relaxation techniques are one of the non-pharmacological and side-effect-free therapy options that are currently used to alleviate the symptoms of many different chronic diseases. Progressive muscle relaxation exercise (PMR) and Benson relaxation technique (BRT) are two common types of relaxation techniques recommended for symptom management in chronic diseases owing to simple to learn and apply compared to other complementary and integrative methods for patients. PMR is uncomplicated and low-cost method, originally designed by Jacobson (1938), which helps individuals to feel calmer through consecutive muscle tension and relaxation of a muscle group. This method can relieve muscle tension, facilitate sleep, and reduce severity of pain and fatigue. There are studies in the literature reporting the positive effects of PMR on fatigue, sleep quality, quality of life, anxiety and stress in MS patients. One of these techniques which is well tolerated is BRT, designed by Herbert Benson in the 1970s as a nonpharmacologic and behavioral method. This technique led to relaxation using mental imagery and mediation. BRT creates a relaxation influence in the body by decreasing the sympathetic nervous system activity and increasing the parasympathetic nervous system activity. There are few studies in the literature reporting that BRT is beneficial on pain and fatigue in MS patients.To the best of our knowledge, there is no study on the impact of relaxation techniques on pain, fatigue and kinesophobia in MS patients. The aim of this study was to examine and compare the effects of PMR and BRT on abovementioned symptoms in MS patients. conditions module condition list condition Multiple Sclerosis, Relapsing-Remitting Pain, Chronic Fatigue Syndrome, Chronic Kinesiophobia keyword list keyword multiple sclerosis pain fatigue kinesiophobia relaxation techniques muscle relaxation design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A Three Arms Randomized Trial design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 80 enrollment type Actual arms interventions module arm group list arm group arm group label PMR arm group type Experimental arm group description The PMR intervention involving tensing and relaxing the body muscles accompanied with deep breathing. The researchers told each participant to sit in a soundless and breathable room and in a comfortable position before each session at their home. The participants performed tensing and relaxing for each body part in order, starting with the facial muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet; all muscle tension and relaxation procedures were performed with deep breathing. The participants were instructed to tense a specified group of muscles for 5 s and relax it for 10 s while breathing out. Moreover, throughout this exercise, the participants imagined a wave of relaxation flowing over their body. arm group intervention list arm group intervention name Behavioral: PMR: Progressive Muscle Relaxation arm group label BRT arm group type Experimental arm group description Within the scope of this technique, first of all, the participants were asked to focus on a word that relieves them such as love, health or well-being. And so, the participants were asked to be in comfortable position in a silent and breathable room with the closed eyes, relax their muscles from the sole of their feet and progressing up to their face gradually, keep them relaxed, accompanied with deep breathing, be aware of their breathing, exhale gently. They continue these practices for 20 minutes and try to relax their muscles. After finishing the duration, they sit quietly for several minutes with eyes closed and later with eye opened. arm group intervention list arm group intervention name Behavioral: BRT:Benson Relaxation Technique arm group label CG arm group type No Intervention arm group description Regarding CG, the participants were invited to the same room and received only a single time attention-matched education on "Living with MS"; including definition of MS, dietary advices for MS patients. The attention-matched education was performed face to face and lasted for 10 min. All participants in the three study groups also received usual treatment and care. intervention list intervention intervention type Behavioral intervention name PMR: Progressive Muscle Relaxation intervention description tensing and relaxing the body muscles accompanied with deep breathing intervention arm group label list intervention arm group label PMR intervention type Behavioral intervention name BRT:Benson Relaxation Technique intervention description relaxation using mental imagery and mediation intervention arm group label list intervention arm group label BRT outcomes module primary outcome list primary outcome primary outcome measure Fatigue primary outcome description Fatigue Severity Scale primary outcome time frame 12 weeks secondary outcome list secondary outcome secondary outcome measure Chronic Pain secondary outcome description VAS secondary outcome time frame 12 weeks secondary outcome measure Kinesiophobia secondary outcome description Tampa Scale for Kinesophobia secondary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria: over the age of 18 having relapsing-remitting MS type and not had an attack during the study not receiving any other complementary and integrative therapy during the research, with an Expanded Disability Status Scale score of 5.5 and below, volunteer to participate in study Exclusion Criteria: having physical or mental health problems that can interfere with communication having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis, rheumatoid arthritis, deep anemia (hmg <8 mg / dl) or oncological diagnoses not having undergone any surgical operation in the last 3 months healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name gulsah kesik, MSc overall official affiliation research assisstant overall official role Principal Investigator location list location location facility Hacettepe University location city Ankara location state None Selected location zip 06100 location country Turkey references module reference list reference reference p m i d 35149625 reference type derived reference citation Kesik G, Ozdemir L, Mungan Ozturk S. The Effects of Relaxation Techniques on Pain, Fatigue, and Kinesiophobia in Multiple Sclerosis Patients: A 3-Arm Randomized Trial. J Neurosci Nurs. 2022 Apr 1;54(2):86-91. doi: 10.1097/JNN.0000000000000620. i p d sharing statement module i p d sharing No i p d sharing description Private and personal information of the participants is not open to sharing. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015673 condition mesh term Fatigue Syndrome, Chronic condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000020529 condition mesh term Multiple Sclerosis, Relapsing-Remitting condition mesh id D000012598 condition mesh term Sclerosis condition mesh id D000005221 condition mesh term Fatigue condition mesh id D000059350 condition mesh term Chronic Pain condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003711 condition ancestor term Demyelinating Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000004679 condition ancestor term Encephalomyelitis condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf as found Sclerosis condition browse leaf relevance high condition browse leaf id M17412 condition browse leaf name Fatigue Syndrome, Chronic condition browse leaf as found Fatigue Syndrome, Chronic condition browse leaf relevance high condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf as found Fatigue condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M21467 condition browse leaf name Multiple Sclerosis, Relapsing-Remitting condition browse leaf as found Multiple Sclerosis, Relapsing-Remitting condition browse leaf relevance high condition browse leaf id M28595 condition browse leaf name Chronic Pain condition browse leaf as found Pain, Chronic condition browse leaf relevance high condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M6994 condition browse leaf name Encephalomyelitis condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low 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full study rank 61855 study protocol section identification module n c t id NCT04831047 org study id info org study id 20210199 organization org full name University of Miami org class OTHER brief title The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance official title The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance status module status verified date May 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date June 8, 2021 start date type Actual primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date April 1, 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 11, 2022 last update post date struct last update post date May 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Wendy Lee responsible party investigator title Associate Professor of Ophthalmology and Dermatology responsible party investigator affiliation University of Miami lead sponsor lead sponsor name University of Miami lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes. conditions module condition list condition Ptosis, Eyelid Conjunctiva Inflamed Eye Manifestations design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 114 enrollment type Actual arms interventions module arm group list arm group arm group label Upneeq Group arm group type Experimental arm group description Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) arm group intervention list arm group intervention name Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution arm group label Control Group arm group type Sham Comparator arm group description Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Oxymetazoline hydrochloride 0.1% ophthalmic solution intervention description One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. intervention arm group label list intervention arm group label Upneeq Group intervention other name list intervention other name Upneeq intervention type Drug intervention name Placebo intervention description One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. intervention arm group label list intervention arm group label Control Group intervention other name list intervention other name Balanced saline solution outcomes module primary outcome list primary outcome primary outcome measure Change in palpebral fissure height primary outcome description Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation. primary outcome time frame Baseline, Day 1 secondary outcome list secondary outcome secondary outcome measure Change in eye redness secondary outcome description Scoring of ocular redness from clinical photographs will be performed by investigators on a 0 - 4 unit scale as compared to standardized reference photographs (0 = no redness, 4 = very red) before and after drop instillation. secondary outcome time frame Baseline, Day 1 secondary outcome measure Patient-reported eye appearance secondary outcome description Patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey, which includes scales assessing eye appearance and upper eyelid apperarance, each with a sum score of 7 (worst) to 28 (best). Additionally, patients will be queried regarding their perception of the drop effects including changes in eye appearance after drop instillation. secondary outcome time frame Day 1 eligibility module eligibility criteria Inclusion Criteria: Adults age 18 and above able to provide informed consent to participate Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention Exclusion Criteria: Adults unable to consent Individuals less than 18 years of age Prisoners Pregnant women. Known contradictions or sensitivities to study medication (oxymetazoline) Ocular surgery within the past 3 months or refractive surgery within the past six months Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm) Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters Presence of an active ocular infection Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents Inability to sit comfortably for 15 - 30 minutes healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Wendy W. Lee, MD overall official affiliation University of Miami Bascom Palmer Eye Institute overall official role Principal Investigator location list location location facility University of Miami Bascom Palmer Eye Institute location city Miami location state Florida location zip 33136 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001763 condition mesh term Blepharoptosis condition mesh id D000005132 condition mesh term Eye Manifestations condition mesh id D000003231 condition mesh term Conjunctivitis condition ancestor list condition ancestor condition ancestor id D000005141 condition ancestor term Eyelid Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000003229 condition ancestor term Conjunctival Diseases condition browse leaf list condition browse leaf condition browse leaf id M13413 condition browse leaf name Prolapse condition browse leaf relevance low condition browse leaf id M7196 condition browse leaf name Erythema condition browse leaf relevance low condition browse leaf id M5607 condition browse leaf name Conjunctivitis condition browse leaf as found Conjunctiva Inflamed condition browse leaf relevance high condition browse leaf id M7427 condition browse leaf name Eye Manifestations condition browse leaf as found Eye Manifestations condition browse leaf relevance high condition browse leaf id M4196 condition browse leaf name Blepharoptosis condition browse leaf as found Ptosis, Eyelid condition browse leaf relevance high condition browse leaf id M7436 condition browse leaf name Eyelid Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id M5605 condition browse leaf name Conjunctival Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC11 condition browse branch name Eye Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000010656 intervention mesh term Phenylephrine intervention mesh id D000010109 intervention mesh term Oxymetazoline intervention mesh id D000019999 intervention mesh term Pharmaceutical Solutions intervention mesh id D000009883 intervention mesh term Ophthalmic Solutions intervention ancestor list intervention ancestor intervention ancestor id D000000316 intervention ancestor term Adrenergic alpha-Agonists intervention ancestor id D000000322 intervention ancestor term Adrenergic Agonists intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000013566 intervention ancestor term Sympathomimetics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000014663 intervention ancestor term Nasal Decongestants intervention ancestor id D000014662 intervention ancestor term Vasoconstrictor Agents intervention ancestor id D000019141 intervention ancestor term Respiratory System Agents intervention ancestor id D000002316 intervention ancestor term Cardiotonic Agents intervention ancestor id D000009184 intervention ancestor term Mydriatics intervention ancestor id D000058646 intervention ancestor term Adrenergic alpha-1 Receptor Agonists intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M11966 intervention browse leaf name Ophthalmic Solutions intervention browse leaf as found Matching intervention browse leaf relevance high intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf as found During intervention browse leaf relevance high intervention browse leaf id M12183 intervention browse leaf name Oxymetazoline intervention browse leaf as found Endometrial Ablation intervention browse leaf relevance high intervention browse leaf id M12713 intervention browse leaf name Phenylephrine intervention browse leaf as found Endometrial Ablation intervention browse leaf relevance high intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M2820 intervention browse leaf name Adrenergic alpha-Agonists intervention browse leaf relevance low intervention browse leaf id M2825 intervention browse leaf name Adrenergic Agonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M15497 intervention browse leaf name Sympathomimetics intervention browse leaf relevance low intervention browse leaf id M7118 intervention browse leaf name Ephedrine intervention browse leaf relevance low intervention browse leaf id M26739 intervention browse leaf name Pseudoephedrine intervention browse leaf relevance low intervention browse leaf id M16562 intervention browse leaf name Nasal Decongestants intervention browse leaf relevance low intervention browse leaf id M16561 intervention browse leaf name Vasoconstrictor Agents intervention browse leaf relevance low intervention browse leaf id M20290 intervention browse leaf name Respiratory System Agents intervention browse leaf relevance low intervention browse leaf id M4724 intervention browse leaf name Cardiotonic Agents intervention browse leaf relevance low intervention browse leaf id M11291 intervention browse leaf name Mydriatics intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev VaCoAg intervention browse branch name Vasoconstrictor Agents intervention browse branch abbrev Resp intervention browse branch 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full study rank 61694 study protocol section identification module n c t id NCT04833140 org study id info org study id 2021P001506 organization org full name Massachusetts General Hospital org class OTHER brief title Estrogen Administration for the Treatment of NASH in Postmenopausal Women official title Estrogen Administration for the Treatment of NASH in Postmenopausal Women status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date December 2, 2021 start date type Actual primary completion date struct primary completion date March 31, 2027 primary completion date type Anticipated completion date struct completion date March 31, 2027 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 8, 2022 last update post date struct last update post date April 15, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Karen Klahr Miller, MD responsible party investigator title Chief, Neuroendocrine Unit, Massachusetts General Hospital responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH. conditions module condition list condition NASH - Nonalcoholic Steatohepatitis design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Estradiol arm group type Active Comparator arm group description Estradiol in the form of a transdermal patch 100 mcg daily (Vivelle-Dot generic). Women with an intact uterus will also receive progesterone (100 mg) in the form of a vaginal tablet (Endometrin, Ferring Pharmaceuticals, Inc.) inserted daily for endometrial protection arm group intervention list arm group intervention name Drug: Estradiol patch arm group label Placebo arm group type Placebo Comparator arm group description Placebo patch (containing no estradiol) Women with an intact uterus will also receive vaginal placebo capsules (containing no progesterone) arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Estradiol patch intervention description The patch will provide 100mcg of estradiol daily. intervention arm group label list intervention arm group label Estradiol intervention type Drug intervention name Placebo intervention description Placebo patch will contain no estradiol. intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Liver fibrosis primary outcome description Reduction in degree of liver fibrosis primary outcome time frame 12 months primary outcome measure Liver fat primary outcome description Reduction in amount of fat in the liver primary outcome time frame 12 months eligibility module eligibility criteria Inclusion criteria: Postmenopausal women 45-70 years old NASH by biopsy or NAFLD by imaging within 6 months of screen Hepatitis C antibody and hepatitis B surface antigen negative Negative mammogram within 1 year Exclusion criteria: Heavy alcohol use Use of NASH pharmacotherapies within 12 months of study entry Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam Participation in NASH clinical trial within 6 months of study entry Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry Known diagnosis of chronic liver disease other than NAFLD or found on biopsy Contraindication to liver biopsy including INR > 1.5, platelets < 50,000/mL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes Hgb < 10.0 g/dL or glomerular filtration rate < 60 mL/min Contraindications to estrogen therapy Any vaginal bleeding, including spotting, within the last year Active malignancy Severe chronic illness Use of estrogen or progesterone within a year of baseline visit Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip healthy volunteers No gender Female minimum age 45 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Anu Gerweck, NP central contact role Contact central contact phone 617-724-1837 central contact e mail avgerweck@mgh.harvard.edu overall official list overall official overall official name Karen K. Miller, MD overall official affiliation Massachsuetts General Hospital overall official role Principal Investigator location list location location facility Massachusetts General Hospital location status Recruiting location city Boston location state Massachusetts location zip 02114 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005234 condition mesh term Fatty Liver condition mesh id D000065626 condition mesh term Non-alcoholic Fatty Liver Disease condition ancestor list condition ancestor condition ancestor id D000008107 condition ancestor term Liver Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M7527 condition browse leaf name Fatty Liver condition browse leaf as found Steatohepatitis condition browse leaf relevance high condition browse leaf id M10259 condition browse leaf name Liver Diseases condition browse leaf relevance low condition browse leaf id M29693 condition browse leaf name Non-alcoholic Fatty Liver Disease condition browse leaf as found Nonalcoholic Steatohepatitis condition browse leaf relevance high condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id T5868 condition browse leaf name Visceral Steatosis condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000004958 intervention mesh term Estradiol intervention ancestor list intervention ancestor intervention ancestor id D000004967 intervention ancestor term Estrogens intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M7260 intervention browse leaf name Estradiol intervention browse leaf as found Resection intervention browse leaf relevance high intervention browse leaf id M7268 intervention browse leaf name Estrogens intervention browse leaf relevance low intervention browse leaf id M13397 intervention browse leaf name Progesterone intervention browse leaf relevance low intervention browse leaf id M266205 intervention browse leaf name 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full study rank 61821 study protocol section identification module n c t id NCT04831489 org study id info org study id Microaspiration in ERCP organization org full name Theodor Bilharz Research Institute org class OTHER brief title Microaspiration in ERCP official title Risk of Pulmonary Micro-aspiration in Intubated vs Sedated Patients Undergoing ERCP status module status verified date April 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date December 2021 primary completion date type Anticipated completion date struct completion date February 2022 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Moshira sayed mohamed responsible party investigator title Lecturer of Anasthesia and intensive care responsible party investigator affiliation Theodor Bilharz Research Institute lead sponsor lead sponsor name Theodor Bilharz Research Institute lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. apparent aspiration is noticeable however microaspiration is hard to detect clinically. our study aims at determining whether general anesthesia with endotracheal intubation or deep sedation is safer in ERCP patients. detailed description Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. In fact, with the wide use of ERCP, many critical patients in whom conventional surgery was a high-risk procedure could be managed by endoscopic treatment. Compared to other endoscopic procedures, ERCP is considered a relatively longer and more complex one, with a substantially higher complication rate. Anesthetic techniques must facilitate the success of this procedure without adding to morbidity. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. Many anesthetic techniques are used, ranging from conscious sedation to general anesthesia. The worldwide accepted method is deep sedation in the presence of an anesthetist without endotracheal intubation. Intubation is recommended in very exceptional cases, for example is morbidly obese patients. According to some authors, general anesthesia is less used as an anesthetic technique in ERCP; drawbacks of GA include: the lengthier time required for induction of and recovery from anesthesia which affects patients' turnover, the risk of residual neuromuscular blockade, the higher cost as well as ERCP is usually a day case procedure favoring the sedation technique. On the other hand, monitored anesthesia care or deep sedation in remote locations can avoid these drawbacks. For ERCP cases, which can be very challenging, few studies have addressed what is the best anesthetic choice, i.e. deep sedation or general anesthesia with intubation. Significant complications such as aspiration, hypoxemia, and hypotension are potential risks in patients undergoing ERCP procedures, and important factors that can modify these events' severity include patients' ASA status, patients' hydration and oxygenation status, and monitoring techniques used during the procedure. Perioperative pulmonary aspiration (POPA) may lead to clinically significant morbidities and/or mortality. The risk factors for pulmonary aspiration are usually overlooked unless the patient has a history of gastrointestinal diseases (for example gastroesophageal reflux disease, upper gastrointestinal bleeding, or intestinal obstruction). However, aspiration pneumonia is seldom observed in healthy patients undergoing regular endoscopy. On the other hand, prolonged or difficult procedures may be associated with increased risks of regurgitation and aspiration. Apparent aspiration is a notable adverse event during gastrointestinal endoscopy, on the other hand, microaspiration is an underreported complication, and data about it is scarce. Since hypoxemia is a common manifestation of pulmonary aspiration and pulse oximetry monitoring is a routine practice, therefore, postoperative hypoxemia (POH) can be used as a potential signal for POPA. There is no conclusive data to support or refuse the need for endotracheal intubation to avoid microaspiration during ERCP; therefore, the participants in the study decided to prospectively compare both techniques as regards the risk of microaspiration. conditions module condition list condition Pulmonary Microaspiration design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Retrospective enrollment info enrollment count 50 enrollment type Anticipated arms interventions module arm group list arm group arm group label deep sedation arm group description Anesthesia will be induced using titrated doses of propofol (0.5-1.5 mg/kg) and fentanyl (25-50 μg) initially to carefully maintain spontaneous breathing yet maintaining airway patency. Once adequate jaw relaxation is achieved, the endoscopy probe will be inserted. Maintenance of sedation will be carried out using propofol infusion between 80-120 mcg/kg/min. Additional dose 25-50 mg propofol will be given to the patient if spontaneous movement occurs arm group intervention list arm group intervention name Radiation: Imaging arm group label Genral anesthesia arm group description After mask pre-oxygenation, anesthesia will be induced with (2 mg/kg) propofol and (1 μg /kg) fentanyl. The neuromuscular blockade will be achieved with (0.5 mg/kg) atracurium followed by tracheal intubation. Anesthesia will be maintained to keep the end-tidal anesthetic concentrations within 1 MAC for sevoflurane. The neuromuscular blockade will be maintained with intermittent doses of atracurium (0.1mg/kg). Mechanical ventilation is adjusted with fresh gas flow oxygen in air 30-40% at a rate of 2 L/min to maintain end-tidal carbon dioxide of 35-40 mm Hg. Reversal of neuromuscular blockade will be achieved by intravenous administration of neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. arm group intervention list arm group intervention name Radiation: Imaging intervention list intervention intervention type Radiation intervention name Imaging intervention description pre and postoperative CT scan of lung intervention arm group label list intervention arm group label Genral anesthesia deep sedation outcomes module primary outcome list primary outcome primary outcome measure POPA primary outcome description Perioperative Pulmonary Aspiration (POPA), which will be defined as the presence of an acute pulmonary infiltrate on chest CT within the 24 hours period following ERCP. primary outcome time frame 24 hours postoperatively secondary outcome list secondary outcome secondary outcome measure Number of intraoperative hypoxic episodes. secondary outcome description Number of intraoperative hypoxic episodes in postoperative period secondary outcome time frame 24 hours postoperative. eligibility module eligibility criteria Inclusion Criteria: ASA 1-3. Age above 18 years old. Preoperative pulmonary stability criteria (defined as a respiratory rate 12-24 breaths per minute, SpO2 ≥ 94% on room air) - Exclusion Criteria: Age < 18 years. Morbid obesity BMI ≥ 40 Kg/ m2. Pregnancy. Fasting ≤ 6 hours for solid food and ≤ 2 hours for clear liquids. 4 A pre-existing lung condition in patients requiring supplemental oxygen, inhalational bronchodilator, or systemic bronchodilator or steroid. Patients in the intensive care unit and/or requiring mechanical ventilation prior to the procedure. Previously intubated patients during the same hospitalization. Tracheostomized patients. Patients with swallowing disorders. Bowel obstruction. Anticipated difficult intubation. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population the population of the study will be randomly selected from the daily scheduled cases undergoing ERCP in the Gastroenterology department of Theodor Bilhrarz research institute. sampling method Probability Sample contacts locations module location list location location facility Theodor Bilharz research institute location city Cairo location country Egypt references module reference list reference reference p m i d 11778129 reference type background reference citation Shah SK, Mutignani M, Costamagna G. Therapeutic biliary endoscopy. Endoscopy. 2002 Jan;34(1):43-53. doi: 10.1055/s-2002-19395. reference p m i d 27708522 reference type background reference citation Motiaa Y, Bensghir M, Jaafari A, Meziane M, Ahtil R, Kamili ND. Anesthesia for endoscopic retrograde cholangiopancreatography: target-controlled infusion versus standard volatile anesthesia. Ann Gastroenterol. 2016 Oct-Dec;29(4):530-535. doi: 10.20524/aog.2016.0071. Epub 2016 Jul 14. reference p m i d 23635608 reference type background reference citation Garewal D, Vele L, Waikar P. Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures. Curr Opin Anaesthesiol. 2013 Aug;26(4):475-80. doi: 10.1097/ACO.0b013e3283620139. reference p m i d 21295639 reference type background reference citation Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005. reference p m i d 24202650 reference type background reference citation Sorser SA, Fan DS, Tommolino EE, Gamara RM, Cox K, Chortkoff B, Adler DG. Complications of ERCP in patients undergoing general anesthesia versus MAC. Dig Dis Sci. 2014 Mar;59(3):696-7. doi: 10.1007/s10620-013-2932-2. Epub 2013 Nov 8. No abstract available. reference p m i d 23877477 reference type background reference citation Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M17459 intervention browse leaf name Propofol intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M7570 intervention browse leaf name Fentanyl intervention browse leaf relevance low intervention browse leaf id M1673 intervention browse leaf name Sevoflurane intervention browse leaf relevance low intervention browse leaf id M3742 intervention browse leaf name Atropine intervention browse leaf relevance low intervention browse leaf id M11485 intervention browse leaf name Neostigmine intervention browse leaf relevance low intervention browse leaf id M3736 intervention browse leaf name Atracurium intervention browse leaf relevance low intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse leaf id T433 intervention browse leaf name Tannic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AdjAn intervention browse branch name Adjuvants, Anesthesia intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev PlAggInh intervention browse branch name Platelet Aggregation Inhibitors intervention browse branch abbrev AnArAg intervention browse branch name Anti-Arrhythmia Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention 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full study rank 61322 study protocol section identification module n c t id NCT04837976 org study id info org study id F.20.09.02 organization org full name Oxford Brookes University org class OTHER brief title Lifestyle and Non-motor Symptom Management in Parkinson's Disease official title Views and Priorities of Lifestyle Factors in the Management of Non-motor Symptoms in Parkinson's Disease: Qualitative Interviews and Consensus Workshops With Patients, Caregivers, and Healthcare Professionals status module status verified date February 2022 overall status Terminated why stopped Recruitment for the first stage has been completed. However the research team no longer has the staff or resources to complete stage 2 of the research. expanded access info has expanded access No start date struct start date May 14, 2021 start date type Actual primary completion date struct primary completion date October 7, 2021 primary completion date type Actual completion date struct completion date October 7, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date February 23, 2022 last update post date struct last update post date March 11, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Sophie Lawrie responsible party investigator title PhD Candidate responsible party investigator affiliation Oxford Brookes University lead sponsor lead sponsor name Oxford Brookes University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Parkinson's Disease (PD) has generally been thought of as a movement disorder however other health-related symptoms, known as non-motor symptoms, are also very common. Non-motor symptoms can be very broad and present in numerous conditions, making identifying the symptoms of early-stage Parkinson's disease very difficult. Non-motor symptoms, including fatigue, and problems with sleep and mood, can happen decades before motor symptoms and have a greater impact on quality of life and psychological wellbeing. Despite this treatment options for non-motor symptoms are limited and therefore the development and testing of new treatments is a main priority. Due to the limited treatments options available, self-management of symptoms through positive lifestyle changes is a warranted area of research. The perspectives amongst patients, caregivers, and HCP's regarding lifestyle behavior change and its impact on fatigue and related non-motor symptoms has yet to be investigated in detail. This study includes two stages: telephone interviews and online consensus workshops. Patients with PD whom have experience of fatigue, partners/caregivers and Healthcare professionals will be able to participate in interviews only, workshops only or both. The interviews will investigate patients, partners/caregivers and Healthcare Professionals views and priorities of lifestyle factors in the management of non-motor symptoms in Parkinson's disease as well as identifying factors that influence lifestyle changes amongst PD patients. Stage 2 will involve small consensus workshops to generate ideas and feedback related to the design and content of the soon-to be developed lifestyle program. Results from both stages of this study will be used to help develop and design a lifestyle management program for fatigue and associated non-motor symptoms in Parkinson's Disease. detailed description Global aim: To assess stakeholders (patients, supportive individuals, and HCP's) views and priorities of lifestyle factors in the management of fatigue and related non-motor symptoms in Parkinson's disease, in addition to identifying facilitators and barriers to lifestyle-related behavior change, in order to inform the development of a subsequent lifestyle intervention. The study consists of two stages: Semi-structured interviews (lasting around 60 minutes) Online consensus workshops using a nominal group technique (2x 60 minute sessions) Setting: Both stages will be conducted remotely. For Stage 1 interviews will be conducted over the telephone (with or without videoconferencing). Stage 2 will use an online brainstorming platform to run the consensus workshop with concurrent videoconferencing. Participants: For both stages' participants will include individuals with Parkinson's Disease, supportive individual's (partners/caregivers/family members/significant others) and healthcare professionals. Analysis: Stage 1- Interviews will be analyzed using thematic analysis and framework mapping onto the COM-B model. Themes will be deductively mapped onto the categories and its associated constructs of the Capability, Opportunity and Motivation to Behaviour (COM-B) model to identify specific targetable aspects of behavior that may need to be addressed in the subsequent lifestyle intervention. A secondary categorical form narrative analysis of the interviews will also be conducted to supplement the main group analysis by providing a detailed insight into the experiences and stories of participants in relation to lifestyle changes on an individual level. Stage 2- Responses during the consensus workshop will be analyzed using frequency counts and descriptive. Data will include a complete list of ideas, scores allocated to each idea, the overall rank of each idea and any additional comments made by participants. conditions module condition list condition Parkinson Disease Fatigue keyword list keyword Qualitative Semi-structured interviews Thematic analysis Framework Nominal Group Technique Consensus methods design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 41 enrollment type Actual arms interventions module arm group list arm group arm group label Individuals with Parkinson's Disease arm group intervention list arm group intervention name Other: Semi-structured interviews and a consensus workshops using nominal group techniques. arm group label Supportive individuals arm group description For example carers, family members or any other individual providing regular support or care to the person with Parkinson's. arm group intervention list arm group intervention name Other: Semi-structured interviews and a consensus workshops using nominal group techniques. arm group label Healthcare Professionals arm group intervention list arm group intervention name Other: Semi-structured interviews and a consensus workshops using nominal group techniques. intervention list intervention intervention type Other intervention name Semi-structured interviews and a consensus workshops using nominal group techniques. intervention description Stage 1 of the study includes individual remote semi-structured interviews (one per participant). Stage 2 involves taking part in a consensus workshop with around 7 other Parkinson's experts, consisting of patients, supportive individuals and healthcare professionals. intervention arm group label list intervention arm group label Healthcare Professionals Individuals with Parkinson's Disease Supportive individuals outcomes module primary outcome list primary outcome primary outcome measure Themes related to the views and priorities of lifestyle factors in relation to fatigue and non-motor symptom management in Parkinson's Disease. primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure Facilitators to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease. primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure Barriers to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease. primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure Identified behavioral targets for the intervention as indicated by the mapping of themes onto the COM-B model (capability, opportunity or motivation) primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure A list of potential methods of intervention delivery, structure and content, ranked in order of preference created during consensus workshops. primary outcome time frame From participation in the first consensus session after enrollment until session 2 (around 1-2 weeks later) other outcome list other outcome other outcome measure Parkinson's Fatigue Scale (PFS-16) other outcome description A patient-rated scale that measures fatigue in Parkinson's disease ranging from 0 to 80.. A Score of 8 or above indicates the presence of significant fatigue. Higher scores correspond to worse fatigue. other outcome time frame Once prior to the interview and/or consensus workshop. other outcome measure Becks Depression Inventory (BDI-II) other outcome description A 21-item self-reported questionnaire with scores for each item ranging from 0 (absence of symptoms) to 3 (severe symptoms). Total scores range between 0 and 63 with higher scores indicating greater severity of depressive symptoms. other outcome time frame Once after enrollment, prior to the interview- patients only other outcome measure Geriatric Anxiety Scale (GAS) other outcome description Self-reported assessment of anxiety symptoms amongst older adults. Scores range from 0 to 20, with scores of 0-8 indicating an absence of clinically significant anxiety and scores of 9 and above indicating the presence of clinically significant anxiety. other outcome time frame Once after enrollment, prior to the interview- patients only other outcome measure Apathy Evaluation Scale (AES) other outcome description Self-reported assessment of apathy symptoms. The total AES score ranges between 18 to 72 with a lower score indicating greater apathy. other outcome time frame Once after enrollment, prior to the interview- patients only other outcome measure Parkinson's Disease Sleep Scale (PDSS-2) other outcome description Self-rated assessment to quantify the level of sleep disruption in Parkinson's Disease. Scores range from 0 to 60, with higher scores representing more severe nocturnal disturbance. other outcome time frame Once after enrollment, prior to the interview- patients only. eligibility module eligibility criteria Inclusion criteria A) Patients A diagnosis of idiopathic Parkinson's Disease Age of 18 years or above Current or previous experience of persistent fatigue Able to communicate clearly in English over the telephone/online for over an hour Have access to a working computer and internet connection (required for stage 2 only). B) Supportive person (partner/family member/caregiver) Age of 18 years or above A supportive person of an individual with Parkinson's Disease whom has already consented to take part in the research. Supportive individuals cannot take part without an associated individual with Parkinson's Disease having already consented. Has regular contact with and is involved in the care and/or support of an individual diagnosed with Idiopathic Parkinson's Disease. Able to communicate clearly in English over the telephone/online for over an hour Have access to a working computer and internet connection (required for stage 2 only). C) Healthcare Professionals Healthcare Professional with at least 2 years experience of Parkinson's disease treatment/management/clinical care and/or an academic currently working in the area of Parkinson's Disease treatment. Have access to a working computer and internet connection (required for stage 2 only). Exclusion criteria A) Patients Reduced cognition that would preclude active involvement and capacity to consent to participate Unable to communicate clearly in English over the telephone/online for over an hour. B) Partners/Caregivers Reduced cognition that would preclude active involvement and capacity to consent to participate Unable to communicate clearly in English over the telephone/online for over an hour. C) Health Care Professional Less than 2 years' experience in the treatment/management/clinical care of individuals with Parkinson's disease as determined by self-report They have worked in this field but have stopped for two years or more. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients and Supportive Individuals will be recruited from a Neurology clinic at Oxford University Hospitals NHS Foundation Trust (OUHFT) and from the Parkinson's UK website. Healthcare proffesionals will be recruited via the Parkinson's UK Excellence Network. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Sophie Lawrie overall official affiliation Oxford Brookes University overall official role Principal Investigator location list location location facility Oxford Brookes University location city Oxford location state Oxfordshire location zip OX3 0BP location country United Kingdom i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010300 condition mesh term Parkinson Disease condition ancestor list condition ancestor condition ancestor id D000020734 condition ancestor term Parkinsonian Disorders condition ancestor id D000001480 condition ancestor term Basal Ganglia Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000009069 condition ancestor term Movement Disorders condition ancestor id D000080874 condition ancestor term Synucleinopathies condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition browse leaf list condition browse leaf condition browse leaf id M12365 condition browse leaf name Parkinson Disease condition browse leaf as found Parkinson's Disease condition browse leaf relevance high condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf relevance low condition browse leaf id M21647 condition browse leaf name Parkinsonian Disorders condition browse leaf relevance low condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M3926 condition browse leaf name Basal Ganglia Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11181 condition browse leaf name Movement Disorders condition browse leaf relevance low condition browse leaf id M2217 condition browse leaf name Synucleinopathies condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition 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full study rank 61337 study protocol section identification module n c t id NCT04837781 org study id info org study id 178420 organization org full name University of Baghdad org class OTHER brief title The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement official title The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement (Conventional and Accelerated): Clinical Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 23, 2019 start date type Actual primary completion date struct primary completion date February 2, 2021 primary completion date type Actual completion date struct completion date March 8, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 12, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mushriq F. Abid responsible party investigator title Assistant Professor responsible party investigator affiliation University of Baghdad lead sponsor lead sponsor name University of Baghdad lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both lower anterior teeth alignment and the rate of maxillary canine retraction. detailed description To evaluate the effect of vitamin D deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic, additionally find the effect of vitamin D deficiency on molar anchorage loss, canine rotation, lower incisor crowding alignment time, pain experienced by the patient during OTM and rate of orthodontically induce apical root resorption. conditions module condition list condition Tooth Position Anomalies keyword list keyword Orthodontic, tooth movement, acceleration design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design masking description Blinding to treatment allocation was possible only for the investigator and data analyst because the clinicians could know the intervention as osteo-perforation can be obviously seen clearly. Masking the intervention for the participants were not possible because micro-osteoperforation is a surgical procedure. All the trial documents were labeled with the study ID number, which was used for participant identification and data collection without unmasking the allocation group. This allowed the investigator to complete data collection and measurements blindly. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 45 enrollment type Actual arms interventions module arm group list arm group arm group label Normal vitamin D arm group type Experimental arm group description Include patients with normal vitamin D level (above 30ng/ml). Vitamin D level will be measured at the beginning of treatment if there is deficiency then the patient refer to specialized physician to be supplied with vitamin D supplement to optimized the level to normal then start orthodontic treatment arm group intervention list arm group intervention name Procedure: Micro-osteoperforation arm group label Vitamin D deficiency arm group type Experimental arm group description Include patients with unknown vitamin D level until time of canine retraction where we measure level if deficiency exist (below 30ng/ml) then the patient will be referred to specialized physician to be supplied with vitamin D supplement. arm group intervention list arm group intervention name Procedure: Micro-osteoperforation arm group label Control arm group type Experimental arm group description includes patients with unknown vitamin D level until the completion of canine retraction where we measure level. If deficiency exists (below 30ng/ml) then we will refer the patient to specialized physician to be supplied with vitamin D supplement arm group intervention list arm group intervention name Procedure: Micro-osteoperforation intervention list intervention intervention type Procedure intervention name Micro-osteoperforation intervention description Micro-osteoperforation Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental side before canine retraction. Three MOPs were placed distal to canine on experimental sides in all group. intervention arm group label list intervention arm group label Control Normal vitamin D Vitamin D deficiency intervention other name list intervention other name MOP outcomes module primary outcome list primary outcome primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 4 weeks primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 8 weeks primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 12 weeks primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 16 weeks secondary outcome list secondary outcome secondary outcome measure Alignment efficiency secondary outcome description 3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished. secondary outcome time frame 4 weeks secondary outcome measure Alignment efficiency secondary outcome description 3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished. secondary outcome time frame 8 weeks secondary outcome measure Alignment efficiency secondary outcome description 3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished. secondary outcome time frame 12 weeks secondary outcome measure Root resorption secondary outcome description The amount of root resorption was measured at the start of treatment and after 12 weeks, the length of the root was recoded at these time intervals. Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds. secondary outcome time frame 12 weeks secondary outcome measure pain perception secondary outcome description Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10- point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment secondary outcome time frame 7 days eligibility module eligibility criteria Inclusion Criteria: Age ranged from 18 to 30 years, from both sex. Healthy general medical condition, healthy periodontal condition. Malocclusion that requires extraction of the maxillary first premolars, followed by canine retraction, with moderate lower incisor crowding (Little's irregularity index 3-6mm). Normal shape and structure of maxillary canine, with no history of filling or root canal treatment and normal shape and structure of maxillary first molar. Exclusion Criteria: Pregnant women. Patient with renal or liver disease. Patient taking corticosteroid or anticonvulsant drugs. Patient with thyroid or parathyroid problems. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module overall official list overall official overall official name Mushriq Abid, MSc, PhD overall official affiliation University of Baghdad overall official role Principal Investigator location list location location facility College of Dentisry-University of Baghdad location city Baghdad location state Al-Rusafa location country Iraq references module reference list reference reference p m i d 35198025 reference type derived reference citation Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022. derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16702 intervention browse leaf name Vitamin D intervention browse leaf relevance low intervention browse leaf id M5155 intervention browse leaf name Cholecalciferol intervention browse leaf relevance low intervention browse leaf id M16710 intervention browse leaf name Vitamins intervention browse leaf relevance low intervention browse leaf id T442 intervention browse leaf name Cholecalciferol intervention browse leaf relevance low intervention browse leaf id T440 intervention browse leaf name Calciferol intervention browse leaf relevance low intervention browse leaf id T479 intervention browse leaf name Vitamin D3 intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev BDCA intervention browse branch name Bone Density Conservation Agents intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Vi intervention browse branch name Vitamins	NCT04837781	[ 101, 1554, 2025, 3997, 5391, 23493, 1559, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 26303, 1559, 1604, 1475, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 17521, 10973, 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full study rank 61484 study protocol section identification module n c t id NCT04835870 org study id info org study id ZR-CHOP organization org full name The First Affiliated Hospital of Soochow University org class OTHER brief title Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL official title Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date October 1, 2025 primary completion date type Anticipated completion date struct completion date October 1, 2025 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 14, 2022 last update post date struct last update post date September 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name The First Affiliated Hospital of Soochow University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients detailed description Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients. conditions module condition list condition Non-GCB/ABC Diffuse Large B-Cell Lymphoma keyword list keyword Zanubrutinib, R-CHOP, Newly diagnosed Non-GCB DLBCL design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 78 enrollment type Anticipated arms interventions module arm group list arm group arm group label R-CHOP + Zanubrutinib arm group type Experimental arm group description Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) arm group intervention list arm group intervention name Drug: Zanubrutinib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone intervention list intervention intervention type Drug intervention name Zanubrutinib intervention description Zanubrutinib-160mg bid PO d0-d20(1-21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name BTK inhibitors intervention type Drug intervention name Rituximab intervention description Rituximab-375 mg/m2 i.v d0 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name MabThera intervention type Drug intervention name Cyclophosphamide intervention description Cyclophosphamide-750 mg/m2 i.v d1 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name CTX intervention type Drug intervention name Doxorubicin intervention description Doxorubicin-50 mg/m2 i.v d1 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name ADM intervention type Drug intervention name Vincristine intervention description Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name VCR intervention type Drug intervention name Prednisone intervention description Prednisone-100 mg p.o d1-d5 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name Prednisonum outcomes module primary outcome list primary outcome primary outcome measure Progression-free Survival(PFS) primary outcome description To measure the duration of response to ZR-CHOP over a follow-up period of 18 months primary outcome time frame up to 18 months secondary outcome list secondary outcome secondary outcome measure Overall Response Rate (ORR) secondary outcome description To measure the duration of response to ZR-CHOP over a follow-up period of 18 months secondary outcome time frame up to 18 months secondary outcome measure Complete Response Rate secondary outcome description Number of patients who achieved complete response after treatment by ZR-CHOP secondary outcome time frame up to 18 months secondary outcome measure Duration of Response secondary outcome description Duration of overall response will be assessed from the first ZR-CHOP given to progression,death or last follow-up. secondary outcome time frame up to 18 months secondary outcome measure Overall Survival secondary outcome description OS will be assessed from the first ZR-CHOP given to death or last follow-up. secondary outcome time frame up to 18 months secondary outcome measure Adverse events profile secondary outcome description Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated secondary outcome time frame Measured from start of treatment until 28 days after last dose eligibility module eligibility criteria Inclusion Criteria: Histologically confirmed Non-GCB DLBCL with extrinsic involvement Age ≥ 18 years Measurable disease of at least 15mm(node)/10mm（extranodal） ECOG performance status 0-2 Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L) Estimated survival time ≥3 months Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study Exclusion Criteria: Accepted major surgery within 4 weeks before treatment; Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma; Previous history of indolent lymphoma; Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ; History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists; Requires treatment with a strong/medium CYP3A inducer; The previous use of anthracycline-based drugs > 150 mg/m2; Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease; HIV infection and/or active hepatitis B or active hepatitis C; Uncontrolled systemic infection; Pregnant or breasting-feeding women; According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Caixia Li, M.D central contact role Contact central contact phone +86 512 67781856 central contact e mail licaixia@suda.edu.cn central contact name Jia Chen, M.D central contact role Contact central contact phone +86 512 67781856 central contact e mail chenjiasuzhou@gmail.com overall official list overall official overall official name Depei Wu, M.D overall official affiliation The First Affiliated Hospital of Soochow University overall official role Study Chair location list location location facility The First Affiliated Hospital of USTC Anhui Provincial Hospital location status Recruiting location city Hefei location state Anhui location country China location contact list location contact location contact name Xingbing Wang location contact role Contact location contact phone +86-0551-62283160 location contact e mail wangxingbing@ustc.edu.cn location facility Fujian Medical University Union Hospital location status Recruiting location city Fuzhou location state Fujian location country China location contact list location contact location contact name Jianda Hu location contact role Contact location contact phone +86-0591-83357896 location contact e mail drjiandahu@163.com location facility The First Affiliated Hospital of Xiamen University location status Recruiting location city Xiamen location state Fujian location country China location contact list location contact location contact name Bing Xu location contact role Contact location contact phone 0592-2137275 location contact e mail xubingzhangjian@126.com location facility The First People's Hospital of Changzhou location status Recruiting location city Changzhou location state Jiangsu location country China location contact list location contact location contact name Weiying Gu location contact role Contact location contact phone 0519-68870000 location contact e mail guweiying2001@163.com location facility Jiangsu Cancer Hospital location status Recruiting location city Nanjing location state Jiangsu location country China location contact list location contact location contact name Jianqiu Wu location contact role Contact location contact phone +86-025-83283597 location contact e mail wujq211@163.com location facility Nanjing Drum Tower Hospital location status Recruiting location city Nanjing location state Jiangsu location country China location contact list location contact location contact name Jingyan Xu location contact role Contact location contact phone +86-025-83106666 location contact e mail xjy1967@sina.com location facility Zhongda Hospital Southeast University location status Recruiting location city Nanjing location state Jiangsu location country China location contact list location contact location contact name Zheng Ge location contact role Contact location contact phone +86-025-8372111 location contact e mail gezheng2008@163.com location facility Nantong Tumor Hospital location status Recruiting location city Nantong location state Jiangsu location country China location contact list location contact location contact name Xiaohong Xu location contact role Contact location contact phone +86-0513-86712105 location contact e mail xhx107@163.com location facility The First Affiliated Hospital of Soochow University location status Recruiting location city Suzhou location state Jiangsu location zip 215000 location country China location contact list location contact location contact name Caixia Li location contact role Contact location facility Changshu No.1 People's Hospital location status Recruiting location city Suzhou location state Jiangsu location country China location contact list location contact location contact name Guifang Zhang location contact role Contact location contact phone +86-0512-52773259 location contact e mail 1194366857@qq.com location facility Suzhou Hongci Hematology Hospital location status Recruiting location city Suzhou location state Jiangsu location country China location contact list location contact location contact name Ting Xu location contact role Contact location contact phone +86-0512-83837999 location contact e mail 21132075@qq.com location contact name Xiaochen Chen location contact role Contact location contact phone +86-0512-83837999 location contact e mail chenxiabcd100@163.com location facility Zhangjiagang First Peoples Hospital location status Recruiting location city Suzhou location state Jiangsu location country China location contact list location contact location contact name Qiurong Zhang location contact role Contact location contact phone +86-0512-56919999 location contact e mail zhangqr1982@163.com location facility Affiliated Hospital Of Jiangnan University location status Recruiting location city Wuxi location state Jiangsu location country China location contact list location contact location contact name Haiying Hua location contact role Contact location contact phone +86-0510-68088900 location contact e mail huahy007@163.com location facility Wuxi People's Hospital location status Recruiting location city Wuxi location state Jiangsu location country China location contact list location contact location contact name Xin Zhou location contact role Contact location contact phone +86-0510-82700775 location contact e mail 13358111962@189.com location facility Xuzhou Central Hospital location status Recruiting location city Xuzhou location state Jiangsu location country China location contact list location contact location contact name Yan Xue location contact role Contact location contact phone +86-0516-85790126 location contact e mail xueyanxz@163.com location facility Shandong Provincial Hospital Affiliated to Shandong First Medical University location status Recruiting location city Jinan location state Shandong location country China location contact list location contact location contact name Xin Wang location contact role Contact location contact phone +86-0531-82169114 location contact e mail xinw007@126.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000016403 condition mesh term Lymphoma, Large B-Cell, Diffuse condition ancestor list condition ancestor condition ancestor id D000016393 condition ancestor term Lymphoma, B-Cell condition ancestor id D000008228 condition ancestor term Lymphoma, Non-Hodgkin condition ancestor id D000008223 condition ancestor term Lymphoma condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf relevance low condition browse leaf id M17980 condition browse leaf name Lymphoma, B-Cell condition browse leaf relevance low condition browse leaf id M17983 condition browse leaf name Lymphoma, Large B-Cell, Diffuse condition browse leaf as found Diffuse Large B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id M10374 condition browse leaf name Lymphoma, Non-Hodgkin condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf relevance low condition browse leaf id T640 condition browse leaf name B-cell Lymphoma condition browse leaf as found B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id T1866 condition browse leaf name Diffuse Large B-Cell Lymphoma condition browse leaf as found Diffuse Large B-Cell Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000011241 intervention mesh term Prednisone intervention mesh id D000003520 intervention mesh term Cyclophosphamide intervention mesh id D000069283 intervention mesh term Rituximab intervention mesh id D000004317 intervention mesh term Doxorubicin intervention mesh id D000014750 intervention mesh term Vincristine intervention mesh id C000629551 intervention mesh term Zanubrutinib intervention ancestor list intervention ancestor intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000018906 intervention ancestor term Antineoplastic Agents, Alkylating intervention ancestor id D000000477 intervention ancestor term Alkylating Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000019653 intervention ancestor term Myeloablative Agonists intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000903 intervention ancestor term Antibiotics, Antineoplastic intervention ancestor id D000059005 intervention ancestor term Topoisomerase II Inhibitors intervention ancestor id D000059003 intervention ancestor term Topoisomerase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000018931 intervention ancestor term Antineoplastic Agents, Hormonal intervention ancestor id D000000972 intervention ancestor term Antineoplastic Agents, Phytogenic intervention ancestor id D000050257 intervention ancestor term Tubulin Modulators intervention ancestor id D000050256 intervention ancestor term Antimitotic Agents intervention ancestor id D000050258 intervention ancestor term Mitosis Modulators intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M373 intervention browse leaf name Rituximab intervention browse leaf as found Test intervention browse leaf relevance high intervention browse leaf id M236470 intervention browse leaf name Zanubrutinib intervention browse leaf as found Muscle relaxation intervention browse leaf relevance high intervention browse leaf id M5879 intervention browse leaf name Cyclophosphamide intervention browse leaf as found Based intervention browse leaf relevance high intervention browse leaf id M6644 intervention browse leaf name Doxorubicin intervention browse leaf as found Biological intervention browse leaf relevance high intervention browse leaf id M13273 intervention browse leaf name Prednisone intervention browse leaf as found Until intervention browse leaf relevance high intervention browse leaf id M227311 intervention browse leaf name Liposomal doxorubicin intervention browse leaf relevance low intervention browse leaf id M16647 intervention browse leaf name Vincristine intervention browse leaf as found Undergoing intervention browse leaf relevance high intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M20095 intervention browse leaf name Antineoplastic Agents, Alkylating intervention browse leaf relevance low intervention browse leaf id M2972 intervention browse leaf name Alkylating Agents intervention browse leaf relevance low intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf relevance low intervention browse leaf id M3376 intervention browse leaf name Antibiotics, Antitubercular intervention browse leaf relevance low intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M20119 intervention browse leaf name Antineoplastic Agents, Hormonal intervention browse leaf relevance low intervention browse leaf id M25350 intervention browse leaf name Tubulin Modulators intervention browse leaf relevance low intervention browse leaf id M25349 intervention browse leaf name Antimitotic Agents intervention browse leaf relevance low intervention browse leaf id M24973 intervention browse leaf name Protein Kinase Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents	NCT04835870	[ 101, 1554, 2025, 3997, 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full study rank 61701 study protocol section identification module n c t id NCT04833049 org study id info org study id TAK-994-1004 organization org full name Takeda org class INDUSTRY brief title Study to Evaluate Absorption, Metabolism, and Excretion, of TAK-994 in 6 Healthy Male Adults official title A Phase 1 Study to Assess Absolute Bioavailability of TAK-994 and to Characterize Mass Balance, Pharmacokinetics, Absorption, Metabolism, and Excretion of [14C]TAK-994 in Male Healthy Subjects status module status verified date June 2021 overall status Completed expanded access info has expanded access No start date struct start date April 14, 2021 start date type Actual primary completion date struct primary completion date June 20, 2021 primary completion date type Actual completion date struct completion date June 20, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 28, 2021 last update post date struct last update post date June 29, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Takeda lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994. detailed description The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy male participants. This study will characterize how TAK -994 is absorbed, metabolize, excreted by the body, after single oral administration by collecting plasma, urine, and feces samples for testing. The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and Part B. In Part A, all participants will receive TAK-994 as tablet and [14C]TAK-994 as intravenous infusion. In Part B, all participants will receive a single dose of [14C]TAK-994 as an oral suspension. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 67 days, including a 28-day screening period plus approximately 30 days for follow up. conditions module condition list condition Healthy Volunteers keyword list keyword Drug Therapy design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Sequential Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 6 enrollment type Actual arms interventions module arm group list arm group arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 arm group type Experimental arm group description TAK-994 Dose 1, tablet, orally, on Day 1, followed by [14C]TAK-994 Dose 2, infusion, intravenously, on Day 1 of Part A, followed by a washout period of at least 8 days, further followed by [14C]TAK-994 Dose 3, suspension, orally, on Day 1 of Part B. arm group intervention list arm group intervention name Drug: TAK-994 Oral Tablet Drug: [14C]TAK-994 Intravenous Infusion Drug: [14C]TAK-994 Oral Suspension intervention list intervention intervention type Drug intervention name TAK-994 Oral Tablet intervention description TAK-994 tablet. intervention arm group label list intervention arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 intervention type Drug intervention name [14C]TAK-994 Intravenous Infusion intervention description [14C]TAK-994 intravenous infusion. intervention arm group label list intervention arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 intervention type Drug intervention name [14C]TAK-994 Oral Suspension intervention description [14C]TAK-994 oral suspension. intervention arm group label list intervention arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 outcomes module primary outcome list primary outcome primary outcome measure Part A: Percent Absolute Bioavailability (%F) for TAK-994 primary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose primary outcome measure Part B: Percentage of Total Radioactivity (TRA) in Urine (Cum Percent [%] Dose [UR]) Relative to the Administered Radioactive Dose primary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose primary outcome measure Part B: Percentage of TRA in Feces (Cum%Dose[FE]) Relative to the Administered Radioactive Dose primary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose primary outcome measure Part B: Percentage of TRA Recovered in in the Urine and Feces Combined (Combined Cum%Dose) Relative to the Administered Radioactive Dose primary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome list secondary outcome secondary outcome measure Part A, Ceoi: Plasma Concentration at the end of Infusion for [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, CL: Total Clearance for [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, Vss: Volume of Distribution at Steady State After Intravenous Administration for [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 and [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994 and [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, t(1/2z): Terminal Disposition Half-life for TAK-994 and [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, Cmax: Maximum Observed Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part B, Cmax: Maximum Observed Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, t(1/2z): Terminal Disposition Half-life for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUClast: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUC∞: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Infinity for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUCt: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Time t for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood TRA Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose eligibility module eligibility criteria Inclusion Criteria: Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 32.0 kilogram per square meter (kg/m^2) at the screening. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing and throughout the study, based on participant self-reporting. Agrees to comply with any applicable contraceptive requirements of the protocol. Agree not to donate sperm from the first dosing until 95 days after the last dosing. Agree and able to remain in the clinical research unit (CRU) for the duration of the study. Understands the study procedures in the ICF, and be willing and able to comply with the protocol. Able to swallow oral suspensions. Exclusion Criteria: Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee. History or presence of gastritis, gastrointestinal tract, hepatic disorder, cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease, or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug. History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing per the Diagnostic and Statistical Manual of Mental Disorders-V criteria. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. Current or past history of epilepsy, seizure, convulsion, tremor, or related symptoms. Positive urine drug or alcohol results at screening or check-in. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening. Seated heart rate is lower than 45 beats per minute (bpm) or higher than 100 bpm at screening. Orthostatic vital sign results with a decrease in systolic greater than (>) 20 mmHg or decrease in diastolic >10 mmHg, and increase in pulse of >20 bpm. QT interval corrected for heart rate using Frederica's equation (QTcF) is >450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening. Liver function tests including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5*upper limit of normal (ULN) at screening or check-in. Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening. Tattoo(s) or scarring at or near the site of IV infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator of designee; Infrequent bowel movements (less than approximately once per day) within 30 days prior to dosing. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of dosing. Lactose intolerance. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of last dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is, weighted annual limit recommended by the International Commission on Radiological Protection [ICRP] of 3000 millirem [mrem]). Unable to refrain from or anticipates the use of: Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After first dosing and throughout the study, ibuprofen (up to 1.2 gram [g] per 24 hours) may be administered at the discretion of the Investigator or designee. Milk of Magnesia (that is, magnesium hydroxide) (less than or equal to [<=] 60 milliliter [mL] per day) may be administered from Day 3 of each study part, at discretion of the Investigator, to ensure defecation. Any drugs known to be significant inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study, including the follow-up period. Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of pharmacokinetics (PK)/pharmacodynamics interaction with study drug. Participation in another clinical study treated with the radiolabeled drug within 6 months prior to the first dosing. Participants has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer [354 mL/12 Ounce [oz]], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day). Participant consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study. Donation of blood or significant blood loss within 56 days prior to the first dosing. Plasma donation within 7 days prior to the first dosing. Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Part A of the current study. healthy volunteers Accepts Healthy Volunteers gender Male minimum age 19 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name Study Director overall official affiliation Takeda overall official role Study Director location list location location facility Celerion location city Lincoln location state Nebraska location zip 68502 location country United States references module see also link list see also link see also link label To obtain more information on the study, click here/on this link see also link u r l https://clinicaltrials.takeda.com/study-detail/606d6838620b3b001e9dbb5c i p d sharing statement module i p d sharing Yes i p d sharing description Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing access criteria IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. i p d sharing u r l https://vivli.org/ourmember/takeda/ derived section misc info module version holder December 02, 2022	NCT04833049	[ 101, 1554, 2025, 3997, 5391, 20829, 1475, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23493, 1568, 1527, 1580, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 157, 1592, 2428, 118, 4850, 1527, 118, 1620, 1527, 2369, 8916, 1554, 1271, 5055, 1810, 8916, 1705, 15969, 2137, 13329, 23313, 3663, 4094, 1641, 8690, 1106, 9734, 7535, 2193, 138, 4832, 1766, 18225, 117, 19415, 6639, 25694, 1306, 117, 1105, 16409, 13782, 2116, 117, 1104, 157, 1592, 2428, 118, 4850, 1527, 1107, 127, 3225, 1183, 10882, 15584, 2078, 1641, 138, 12278, 122, 8690, 1106, 1249, 8830, 1116, 138, 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full study rank 61642 study protocol section identification module n c t id NCT04833816 org study id info org study id 2019-48 secondary id info list secondary id info secondary id 2020-004812-81 secondary id type EudraCT Number organization org full name Assistance Publique Hopitaux De Marseille org class OTHER brief title Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient official title Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient acronym KLOE status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 5, 2022 start date type Actual primary completion date struct primary completion date May 5, 2024 primary completion date type Anticipated completion date struct completion date August 4, 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 6, 2022 last update post date struct last update post date August 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Assistance Publique Hopitaux De Marseille lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group. conditions module condition list condition Traumatic Injury keyword list keyword ketamine analgesia ISS trauma design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 140 enrollment type Anticipated arms interventions module arm group list arm group arm group label Ketamin arm group type Experimental arm group description Patient will get a bolus of ketamine at 0.1 mg / kg followed by a continuous infusion of ketamine at a dose of 0.15 mg / kg / hour arm group intervention list arm group intervention name Drug: Administration of drug arm group label Placebo arm group type Placebo Comparator arm group description Patient will get a bolus of NaCL at 0.1 mg / kg followed by a continuous infusion of NaCl at a dose of 0.15 mg / kg / hour arm group intervention list arm group intervention name Drug: Administration of drug intervention list intervention intervention type Drug intervention name Administration of drug intervention description Administration of ketamin during the 48h after trauma intervention arm group label list intervention arm group label Ketamin Placebo outcomes module primary outcome list primary outcome primary outcome measure Total dose of sufentanil primary outcome description All doses of sufentanil and opiods administration primary outcome time frame 48 hours secondary outcome list secondary outcome secondary outcome measure Total amount of opiods secondary outcome time frame 5 days secondary outcome measure Pain assessment secondary outcome time frame 5 days secondary outcome measure Delirium secondary outcome description Scale CAM-ICU (confusion assesment method) secondary outcome time frame 5 days secondary outcome measure Global Quality of life secondary outcome description SF-36 score secondary outcome time frame 3 months secondary outcome measure Chronical pain secondary outcome description SF-MPQ-2 secondary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: Male or female adult Trauma patient presenting at least 2 lesions in two different regions as defined by the ISS (injury severity score) (Head or neck, Face, Thorax, Abdomen and pelvic contents, Upper limbs or pelvic girdle, Lower limbs, External (any skin surface). Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)> 1. Patient having signed an informed consent Exclusion Criteria: Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome). Patient in whom the infusion could not be started within the first 6 hours of initial treatment. Patient whose state of consciousness is incompatible with understanding the protocol. Patient with chronic unbalanced arterial hypertension. Patient with severe heart failure. Patient with a BMI> 35 kg / m² or a weight of more than 120 kg. Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness. Presence of a history of chronic pain. Presence of a history of epilepsy. Presence of a history of psychosis or drug addiction. Presence of a history of stroke. Patients with an allergy to the molecule or excipients composing ketamine Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol. Pregnant or breastfeeding woman. Patient not understanding French. Protected adult patient (under guardianship, curatorship or legal protection). healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Gary Duclos, MD central contact role Contact central contact phone 0491965531 central contact phone ext 33 central contact e mail gary.duclos@ap-hm.fr overall official list overall official overall official name Jean Olivier ARNAUD overall official affiliation AP-HM overall official role Study Director location list location location facility Service Anesthésie Réanimation - Hôpital nord location status Recruiting location city Marseille location zip 13015 location country France location contact list location contact location contact name Gary Duclos location contact role Contact location contact phone 0491965531 location contact e mail gary.duclos@ap-hm.fr i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014947 condition mesh term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Traumatic Injury condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11134 intervention browse leaf name Morphine intervention browse leaf relevance low intervention browse leaf id M9826 intervention browse leaf name Ketamine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev 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full study rank 61814 study protocol section identification module n c t id NCT04831580 org study id info org study id GOG-3043 organization org full name GOG Foundation org class NETWORK brief title A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer official title A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC) acronym ROCC status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 22, 2022 start date type Actual primary completion date struct primary completion date August 2028 primary completion date type Anticipated completion date struct completion date August 2029 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 13, 2022 last update post date struct last update post date April 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name GOG Foundation lead sponsor class NETWORK collaborator list collaborator collaborator name Intuitive Foundation collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary This is a randomized controlled trial to compare survival for patients who undergi robotic assisted laparoscopy versus open radical hysterectomy and lymph node assessment for the treatment of early stage cervical cancer. detailed description This is a multi-center, open-label, randomized, non-inferiority clinical trial with the hypothesis that robotically assisted radical hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal radical hysterectomy with respect to disease free survival. A t the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the radical hysterectomy is abandoned will be deemed non-evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted. Standard arm: Radical hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device). Study arm: Radical hysterectomy is performed as per standard robotic technique (Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10) conditions module condition list condition Cervical Cancer design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 840 enrollment type Anticipated arms interventions module arm group list arm group arm group label Open radical hysterectomy arm group type Active Comparator arm group intervention list arm group intervention name Other: open surgery arm group label Robotic radical hysterectomy arm group type Experimental arm group intervention list arm group intervention name Device: da Vinci intervention list intervention intervention type Device intervention name da Vinci intervention description Minimally invasive robotic-assisted surgical device intervention arm group label list intervention arm group label Robotic radical hysterectomy intervention type Other intervention name open surgery intervention description open radical hysterectomy intervention arm group label list intervention arm group label Open radical hysterectomy outcomes module primary outcome list primary outcome primary outcome measure Survival primary outcome description 3 year disease-free survival primary outcome time frame 36 months eligibility module eligibility criteria Inclusion Criteria: Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell) Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator. Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard. Patient must be age 18 years or older. Patient must have ECOG performance status 0-1. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women. Patient must have signed an approved informed consent and authorization permitting the release of personal health information. Exclusion Criteria: Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation) Patients with FIGO stage 1A1, IB3, II-IV (2018 staging). Patient with inability to receive an MRI. Patients with a tumor size ≥4cm or with definite evidence of vaginal/parametrial involvement on MRI (if MRI findings are not definitive, then clinical examination must also reveal parametrial or vaginal extension). Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes). Patients with a history of prior pelvic or abdominal radiotherapy. Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg. Patient compliance and geographic proximity that do not allow adequate follow-up. Patients with poorly controlled HIV with CD4 counts <500. healthy volunteers No gender Female gender based Yes minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jennifer Klein, MEd central contact role Contact central contact phone 215-854-0770 central contact e mail jklein@gog.org overall official list overall official overall official name Kristin Bixel, MD overall official affiliation The Ohio State Unversity overall official role Study Chair location list location location facility Mount Sinai Comprehensive Cancer Center location status Recruiting location city Miami location state Florida location zip 33140 location country United States location contact list location contact location contact name Irina Bakura Caso location contact role Contact location contact e mail irina.bakuracaso@msmc.com location contact name Brian Slomovitz, MD location contact role Principal Investigator location facility St. Vincent Hospital and Health Care Center Inc location status Recruiting location city Indianapolis location state Indiana location zip 46260 location country United States location contact list location contact location contact name Cynthia Cruz Rivera location contact role Contact location contact e mail cynthia.cruzrivera@ascension.org location contact name Sarah Goodrich, MD location contact role Principal Investigator location facility Willis-Knighton Physician Network Gynecologic Oncology Associates location status Recruiting location city Shreveport location state Louisiana location zip 71118 location country United States location contact list location contact location contact name Carrie Key, RN location contact role Contact location contact e mail ckay@wkhs.com location contact name Destin Black, MD location contact role Principal Investigator location facility Baystate Medical Center location status Recruiting location city Springfield location state Massachusetts location zip 01199 location country United States location contact list location contact location contact name Laura Sorci location contact role Contact location contact e mail Laura.Sorci@baystatehealth.org location contact name Tashanna Myers, MD location contact role Principal Investigator location facility FirstHealth Outpatient Cancer Center location status Recruiting location city Pinehurst location state North Carolina location zip 28374 location country United States location contact list location contact location contact name Tina Thompson location contact role Contact location contact e mail tpthompson@firsthealth.org location contact name Michael Sundborg, MD location contact role Principal Investigator location facility Kettering Health Cancer Center location status Recruiting location city Kettering location state Ohio location zip 45429 location country United States location contact list location contact location contact name Julie Carstens location contact role Contact location contact e mail julie.carstens@ketteringhealth.org location contact name Thomas Reid, MD location contact role Principal Investigator location facility Chattanooga's Program in Women's Oncology location status Recruiting location city Chattanooga location state Tennessee location zip 37403 location country United States location contact list location contact location contact name Kimberly Donelson location contact role Contact location contact e mail Kimberly.Donelson@erlanger.org location contact name Stephen Depasquale, MD location contact role Principal Investigator i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002583 condition mesh term Uterine Cervical Neoplasms condition ancestor list condition ancestor condition ancestor id D000014594 condition ancestor term Uterine Neoplasms condition ancestor id D000005833 condition ancestor term Genital Neoplasms, Female condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000002577 condition ancestor term Uterine Cervical Diseases condition ancestor id D000014591 condition ancestor term Uterine Diseases condition browse leaf list condition browse leaf condition browse leaf id M4982 condition browse leaf name Uterine Cervical Neoplasms condition browse leaf as found Cervical Cancer condition browse leaf relevance high condition browse leaf id M16494 condition browse leaf name Uterine Neoplasms condition browse leaf relevance low condition browse leaf id M8097 condition browse leaf name Genital Neoplasms, Female condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M4977 condition browse leaf name Uterine Cervical Diseases condition browse leaf relevance low condition browse leaf id M16491 condition browse leaf name Uterine Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions	NCT04831580	[ 101, 1554, 2025, 3997, 5391, 1604, 17175, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 22639, 1571, 18910, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 27157, 2349, 118, 26714, 1495, 2369, 8916, 1554, 1271, 27157, 2349, 2974, 8916, 1705, 26546, 1942, 2924, 9565, 2428, 4094, 1641, 138, 12819, 1104, 20354, 1596, 159, 1468, 1361, 3353, 145, 21878, 10294, 18778, 1183, 17910, 1107, 24664, 1197, 5086, 1775, 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full study rank 61878 study protocol section identification module n c t id NCT04830748 org study id info org study id MT & TE & 1ry KOA organization org full name Cairo University org class OTHER brief title Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis official title Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis status module status verified date June 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 1, 2022 start date type Actual primary completion date struct primary completion date January 1, 2023 primary completion date type Anticipated completion date struct completion date May 1, 2023 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 3, 2022 last update post date struct last update post date June 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name moaaz ragab riyad amin responsible party investigator title Teaching assistant at faculty of physical therapy responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Cairo University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to compare between therapeutic exercises and therapeutic exercises preceded by mechanical traction in treatment of patients with primary knee osteoarthritis attributed to the outcomes of pain, muscle strength, functional disability and functional performance. Hypotheses There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of knee pain severity in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of functional disability in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric quadriceps muscle strength in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric hamstring muscle strength in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing walking time in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing ascending and descending stairs time in patients with primary knee osteoarthritis. detailed description Knee osteoarthritis is the most common cause of musculoskeletal pain and disability, resulting in major disability and pain in affected individuals. It is a chronic degenerative disorder of multifactorial aetiology, including acute and/or chronic insults from normal wear and tear, age, obesity and joint injury. It nearly affects about one in each eight adults worldwide, its prevalence rates vary from 7.8 to 9.3% in Egyptian population. Current clinical guidelines recommend non pharmacological conservative strategies including physical therapy given their ease of application and relatively low cost with minimal adverse effects (e.g.: strengthening exercises, aerobic exercises, stretching exercises, hydrotherapy, manual therapy, massage therapy, thermotherapy, electrotherapy, ultrasound therapy, external support braces and taping). It was reported that therapeutic exercise is beneficial for patients with knee osteoarthritis in terms of outcomes of pain, function, performance and quality of life. In addition, it was reported that strengthening, flexibility and neuromotor skill exercises have a large efficacy over aerobic and mind body exercise. Unloading strategies should be proposed as a first line of therapy for the patient with knee osteoarthritis before any attempts are made at tissue regeneration, repair or replacement. Manual or mechanical knee joint distraction is a conservative technique that provides transient joint separation and unloading that aids in improving clinical symptoms of patients. Addition of mechanical knee distraction to therapeutic exercises helps in gaining the positive effects of both exercise and unloading techniques. Although this approach has not been used extensively or applied pragmatically, several studies were found showing promising results in terms of reducing pain at both rest and movement, improving knee flexion and extension range of motion, reducing disability, increasing functional abilities and improving the quality of life of patients. Forty male and female patients with the diagnosis of primary knee osteoarthritis will be recruited in this study. All patients will be assessed and treated in the outpatient clinic of the faculty of physical therapy, Cairo University. Patients will be randomly distributed into 2 equal experimental groups: the first experimental group will receive therapeutic exercises (stretching and strengthening exercise) while the second experimental group will receive mechanical traction of the knee followed by therapeutic exercises. All patients will be treated for 12 sessions, 3 times per week each other day for 4 weeks. Clinical assessments will include assessment of pain severity, functional disability, isometric muscle strength, and functional performance. conditions module condition list condition Knee Osteoarthritis keyword list keyword Traction Distraction Therapeutic exercises design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 2 groups The first group will include 20 patients and will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. The second group will include 20 patients and will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee. design primary purpose Treatment design masking info design masking Single design masking description Patients will be blinded to study hypotheses and informed only about comparing different programs of treatment of knee osteoarthritis. After randomization, participants will only be provided with details of the program they will be undertaking. design who masked list design who masked Participant enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Therapeutic exercises group arm group type Active Comparator arm group description The first group will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. arm group intervention list arm group intervention name Other: Therapeutic exercises arm group label Therapeutic exercises and mechanical traction group arm group type Experimental arm group description The experimental group will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee. arm group intervention list arm group intervention name Other: Mechanical knee traction Other: Therapeutic exercises intervention list intervention intervention type Other intervention name Mechanical knee traction intervention description Continuous knee joint mechanical traction will be applied to the patients positioned in supine lying position with the affected knee flexed at 25-30 degrees by a wedge placed under the affected knee. The thigh will be secured with a strap for stabilization and the leg will be held by the specially designed greave with the weight of traction hanging throughout a pulley system. The amount of traction will be set to about 10% of body weight. The treatment will be applied for 20 minutes continuously, once a day, 3 times per week for 4 weeks. The traction force will be progressed gradually during the program ( e.g.: weekly increase force by 1% of body weight if the patient can tolerate the duration of 20 min with the preset force). intervention arm group label list intervention arm group label Therapeutic exercises and mechanical traction group intervention type Other intervention name Therapeutic exercises intervention description Therapeutic exercises will be divided into stretching and strengthening exercises: Stretching will be done passively for the hamstring, rectus femoris and calf muscles. Each exercise will be done for 3 reps each with a hold period of 30-60 secs with a 30-60 rest period between reps. Strengthening exercises will be done for the quadriceps and hamstring muscles ( inner range knee extension- knee extension in sitting- straight leg raise in flexion- prone hamstring curl- standing hamstring curl- straight leg raise in extension). Exercise will be done for 3 sets each will consist of 10 reps with a rest period of 2-3 minutes between sets. The starting weight should be 50% of the patient's 1 RM. The end position will be held for 5 seconds. Progression will be achieved by increasing the exercise rep and intensity gradually throughout the program. E.g.: weekly increase force by 5% if patient can tolerate an increased repetition of 20 rep with the preset force. intervention arm group label list intervention arm group label Therapeutic exercises and mechanical traction group Therapeutic exercises group outcomes module primary outcome list primary outcome primary outcome measure Measurement of knee pain severity change after 4 weeks of intervention primary outcome description Knee pain severity will be measured on an 11-point numerical pain rating scale, where 0= no pain and 10= worst possible pain. primary outcome time frame baseline, 4 weeks secondary outcome list secondary outcome secondary outcome measure Measurement of Functional Disability change after 4 weeks of intervention secondary outcome description The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered patient reported measure that is both valid and disease-specific.It has been translated and validated into Arabic language. It is a 24-item questionnaire, grouped into three subscales including pain; stiffness; and physical function. Total score ranges from 0 (best) to 96 (worst) points. secondary outcome time frame baseline, 4 weeks secondary outcome measure Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention secondary outcome description Isometric muscle strength (Nm/kg) will be recorded for quadriceps and hamstring muscle groups. Using a hand held dynamo-meter the torque generated by the muscle is measured in newton-metre (Nm) which is later normalised to body mass in kilograms (kg). muscle strength = Torque (Nm) / body mass (kg). secondary outcome time frame baseline, 4 weeks secondary outcome measure Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test secondary outcome description The 40 meter fast paced walk test is a performance-based test that measures short distance walking activity. Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests. secondary outcome time frame baseline, 4 weeks secondary outcome measure Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test secondary outcome description The 12 step stair climb test is a performance-based test that measures the time required to go up and down 12 stairs (step height, 17 cm; step depth, 30 cm). Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests. secondary outcome time frame baseline, 4 weeks eligibility module eligibility criteria Inclusion Criteria: Patients will have grade II of primary knee osteoarthritis. Patients with bilateral primary knee osteoarthritis, the more painful knee will be selected as the affected knee in this study. Age of patients will range from 45 years to 65 years old. Duration of illness will range from 3- 12 months. Exclusion Criteria: Malignancy presence of skin lesions or infections at the treatment sites healthy volunteers No gender All minimum age 45 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Moaaz Ragab Amin, T.A. central contact role Contact central contact phone 01007210132 central contact e mail moaaz.elsakka@gmail.com central contact name Karima Hassan, lecturer central contact role Contact central contact phone 01223359644 central contact e mail Karima_hassan2008@yahoo.com overall official list overall official overall official name Karima Abdelaty Hassan, lecturer overall official affiliation Cairo University overall official role Study Director overall official name Ibrahim Magdy Elnaggar, Prof overall official affiliation Cairo University overall official role Study Director location list location location facility Faculty of physical therapy Cairo university location status Recruiting location city Cairo location state Giza location zip 12613 location country Egypt location contact list location contact location contact name Karima Hassan, Phd location contact role Contact location contact phone 012-233-59644 location contact e mail Karima_hassan2008@yahoo.com references module reference list reference reference p m i d 22960239 reference type background reference citation Alpayci M, Ozkan Y, Yazmalar L, Hiz O, Ediz L. A randomized controlled trial on the efficacy of intermittent and continuous traction for patients with knee osteoarthritis. Clin Rehabil. 2013 Apr;27(4):347-54. doi: 10.1177/0269215512459062. Epub 2012 Sep 7. reference p m i d 9415651 reference type background reference citation Bellamy N, Campbell J, Stevens J, Pilch L, Stewart C, Mahmood Z. Validation study of a computerized version of the Western Ontario and McMaster Universities VA3.0 Osteoarthritis Index. J Rheumatol. 1997 Dec;24(12):2413-5. reference p m i d 11138949 reference type background reference citation Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004. reference p m i d 28183213 reference type background reference citation Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part two: strengthening exercise programs. Clin Rehabil. 2017 May;31(5):596-611. doi: 10.1177/0269215517691084. Epub 2017 Feb 1. reference p m i d 18783739 reference type background reference citation Chopra A, Abdel-Nasser A. Epidemiology of rheumatic musculoskeletal disorders in the developing world. Best Pract Res Clin Rheumatol. 2008 Aug;22(4):583-604. doi: 10.1016/j.berh.2008.07.001. reference p m i d 26405113 reference type background reference citation Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24. Review. reference p m i d 19182026 reference type background reference citation Guermazi A, Hunter DJ, Roemer FW. Plain radiography and magnetic resonance imaging diagnostics in osteoarthritis: validated staging and scoring. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:54-62. doi: 10.2106/JBJS.H.01385. reference p m i d 15135142 reference type background reference citation Guermazi M, Poiraudeau S, Yahia M, Mezganni M, Fermanian J, Habib Elleuch M, Revel M. Translation, adaptation and validation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for an Arab population: the Sfax modified WOMAC. Osteoarthritis Cartilage. 2004 Jun;12(6):459-68. doi: 10.1016/j.joca.2004.02.006. reference p m i d 15679884 reference type background reference citation Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. reference p m i d 25440203 reference type background reference citation Khademi-Kalantari K, Mahmoodi Aghdam S, Akbarzadeh Baghban A, Rezayi M, Rahimi A, Naimee S. Effects of non-surgical joint distraction in the treatment of severe knee osteoarthritis. J Bodyw Mov Ther. 2014 Oct;18(4):533-9. doi: 10.1016/j.jbmt.2013.12.001. Epub 2013 Dec 11. reference p m i d 29950778 reference type background reference citation Lee DK, Lee NY. Case study of continuous knee joint traction treatment on the pain and quality of life of patients with degenerative gonarthritis. J Phys Ther Sci. 2018 Jun;30(6):848-849. doi: 10.1589/jpts.30.852. Epub 2018 Jun 12. reference p m i d 21655421 reference type background reference citation Maher S, Creighton D, Kondratek M, Krauss J, Qu X. The effect of tibio-femoral traction mobilization on passive knee flexion motion impairment and pain: a case series. J Man Manip Ther. 2010 Mar;18(1):29-36. doi: 10.1179/106698110X12595770849560. reference p m i d 24462672 reference type background reference citation McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. reference p m i d 19350249 reference type background reference citation Palhais NS, Guntern D, Kagel A, Wettstein M, Mouhsine E, Theumann N. Direct magnetic resonance arthrography of the knee: utility of axial traction. Eur Radiol. 2009 Sep;19(9):2225-31. doi: 10.1007/s00330-009-1389-3. Epub 2009 Apr 7. reference p m i d 29997112 reference type background reference citation Rausch Osthoff AK, Niedermann K, Braun J, Adams J, Brodin N, Dagfinrud H, Duruoz T, Esbensen BA, Gunther KP, Hurkmans E, Juhl CB, Kennedy N, Kiltz U, Knittle K, Nurmohamed M, Pais S, Severijns G, Swinnen TW, Pitsillidou IA, Warburton L, Yankov Z, Vliet Vlieland TPM. 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis. Ann Rheum Dis. 2018 Sep;77(9):1251-1260. doi: 10.1136/annrheumdis-2018-213585. Epub 2018 Jul 11. reference p m i d 25200270 reference type background reference citation Sato T, Sato N, Masui K, Hirano Y. Immediate effects of manual traction on radiographically determined joint space width in the hip joint. J Manipulative Physiol Ther. 2014 Oct;37(8):580-5. doi: 10.1016/j.jmpt.2014.08.002. Epub 2014 Sep 4. reference p m i d 21298256 reference type background reference citation Waller C, Hayes D, Block JE, London NJ. Unload it: the key to the treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1823-9. doi: 10.1007/s00167-011-1403-6. Epub 2011 Feb 5. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010003 condition mesh term Osteoarthritis condition mesh id D000020370 condition mesh term Osteoarthritis, Knee condition ancestor list condition ancestor condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf as found Osteoarthritis condition browse leaf relevance high condition browse leaf id M21321 condition browse leaf name Osteoarthritis, Knee condition browse leaf as found Knee Osteoarthritis 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full study rank 61232 study protocol section identification module n c t id NCT04839146 org study id info org study id NL76192.000.20 organization org full name Radboud University Medical Center org class OTHER brief title Safety and Tolerability of COVID-19 Vaccine (ABNCoV2) official title First-in-human Trial of the Coronavirus Virus-like Particle Subunit Vaccine ABNCoV2 in SARS-CoV-2-naïve Adult Volunteers in Good Health acronym COUGH-1 status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date March 11, 2021 start date type Actual primary completion date struct primary completion date December 30, 2021 primary completion date type Actual completion date struct completion date February 25, 2022 completion date type Actual study first submit date March 11, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 16, 2022 last update post date struct last update post date March 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Radboud University Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name European Union collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the immunogenicity-tolerability ratio 14 days following first vaccination with ABNCoV2. detailed description This first-in-human phase 1 trial of ABNCoV2 is a single center, sequential dose-escalation, open labelled trial to establish the safety and tolerability of two doses of ABNCoV2, formulated with and without MF59 in healthy, adult, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-naïve volunteers. The immunological objective of this trial is to identify a dosage that optimizes the immunogenicity-tolerability ratio 14 days following first vaccination with ABNCoV2. The trial will be carried out by the Radboud University Medical Center (Radboudumc). The trial involves first-in-human administration, dose escalation of ABNCoV2 and adjuvant selection. Volunteers will be screened for eligibility and receive two vaccinations by intramuscular injection. While we cannot predict with certainty the safety in human subjects, we have adopted a safety-orientated staggered trial design with ascending doses of ABNCoV2. Seven groups of volunteers (n=6) will receive a given dose of ABNCoV2, either with or without MF59, followed by a booster with the same dose and formulation four weeks after the first vaccination. All vaccinations will be given as intramuscular injection. The pre-defined escalation schedule will start with 6 μg ABNCoV2, with a maximum dose of 70 μg. Dose-escalation will proceed only in absence of protocol-defined safety signals. MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel at the first three escalation steps (Group 1-3) to detect superiority or futility of the MF59-adjuvanted against the non-adjuvanted formulation. Up to forty-two (n=42) subjects will be enrolled, as well as one reserve subject per group. Safety follow-up will be done at following timepoints: baseline, day 1, day 2, day 7, day 14, day 25, day 29, day 30, day 35, day 42, day 70, day 119 and day 196 after first ABNCoV2 administration. conditions module condition list condition Covid19 Severe Acute Respiratory Syndrome SARS-CoV-2 Infection design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description ABNCoV2 is a virus-like particle vaccine. It will be administered as two intramuscular injections in groups of up to 9 volunteers. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. The pre-defined escalation schedule will start with 6 μg ABNCoV2, followed by 12, 25 and 50 μg with a maximum dose of 70 μg. MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel to detect superiority or futility of the MF59-adjuvanted against the non-adjuvanted formulation at the 6, 12 and 25 μg dosage. Approval for further dose escalation and choice of adjuvant use will be provided by a safety monitoring committee (SMC), supported by pre-defined analyses of safety, tolerability and immunogenicity data at day 14 post-first-vaccination. Recruitment for the two best (safe, tolerable and most immunogenic) regimens will continue until 12 volunteers per regimen have been immunized. design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 45 enrollment type Actual arms interventions module arm group list arm group arm group label Group 1: 6 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 2: 12 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 3: 25 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 4: 50 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted or MF59-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 5: 70 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted or MF59-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 6: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description The subjects in Group 6 (n=6) will receive the next lower dosage of the highest non-adjuvanted or MF59-adjuvanted ABNCoV2 dose achieved intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 7: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description The subjects in Group 7 (n=6) will receive the highest non-adjuvanted or MF59-adjuvanted ABNCoV2 dose achieved intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine intervention list intervention intervention type Biological intervention name ABNCoV2 Vaccine intervention description SARS-CoV-2 vaccine intervention arm group label list intervention arm group label Group 1: 6 microgram ABNCoV2 with/without MF59 adjuvant Group 2: 12 microgram ABNCoV2 with/without MF59 adjuvant Group 3: 25 microgram ABNCoV2 with/without MF59 adjuvant Group 4: 50 microgram ABNCoV2 with/without MF59 adjuvant Group 5: 70 microgram ABNCoV2 with/without MF59 adjuvant Group 6: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant Group 7: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant intervention other name list intervention other name cVLP-RBD RBDn-CLP ABNCoV2 outcomes module primary outcome list primary outcome primary outcome measure Primary safety endpoint: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE) primary outcome description Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE) primary outcome time frame up to 28 weeks primary outcome measure Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies primary outcome description Concentration of ABNCoV2-specific antibodies primary outcome time frame 14 days following first vaccination. secondary outcome list secondary outcome secondary outcome measure Secondary study endpoint: Number and severity of at least possibly related solicited AEs secondary outcome description Number and severity of at least possibly related solicited AEs secondary outcome time frame within one week following administration of ABNCoV2. other outcome list other outcome other outcome measure Concentration of ABNCoV2-specific antibodies at baseline and during immunization and follow up. other outcome description ABNCoV2-specific antibody concentrations will be measured by ELISA during immunisation and follow-up. other outcome time frame up to 28 weeks other outcome measure Inhibitory titre in invasion inhibition assay at baseline and during immunization and follow up. other outcome description Inhibitory titres will be measured in an in vitro SARS-CoV-2 invasion inhibition assay. other outcome time frame up to 28 weeks other outcome measure Cellular immune responses (T and B cell) at baseline and during immunization and follow up. other outcome description Cellular responses will be analysed by cytometry and enzyme-linked absorbent spot (ELISpot) assay. other outcome time frame up to 28 weeks other outcome measure Correlation of response vaccine to habitual sleep using the Pittsburgh Sleep Quality Index (PSQI) other outcome description The PSQI will be used to investigate if sleep quality is associated with immune responses to the vaccine. other outcome time frame one month prior first ABNCoV2 immunization eligibility module eligibility criteria Inclusion Criteria: Subject must sign written informed consent to participate in the trial. Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of the study by passing a quiz (assessment of understanding). Subjects must score at least 80% correct on a multiple-choice quiz. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them, and they will have the opportunity to retest. In the opinion of the investigator, the subject can and will comply with the requirements of the protocol. Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -1 until 24 weeks following last vaccination (end of study). Subject is a male or non-pregnant and non-lactating female age ≥ 18 and ≤ 55 years and in good health at time of ABNCoV2 administration. Subject agrees to their general practitioner (GP) being informed about participation in the study and agrees to sign a form to request the release by their GP, and medical specialist when necessary, of any relevant medical information concerning possible contra-indications for participation in the study to the investigator(s). The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period according to current Sanquin guidelines. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. All other female subjects must agree to use continuous adequate contraception2 for the duration of the study. Female subjects must have a negative pregnancy test at the inclusion visit. Exclusion Criteria: Any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the US Food and Drug Administration (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials [30]. 2. History of COVID-19 infection. 3. Chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 4. Positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion. 5. Screening tests positive for SARS-CoV-2, SARS-CoV-2 antibodies, Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV). 6. Receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period. 7. Participation in any other clinical study in the 30 days prior to the start of the study or during the study period. 8. Immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed SARS-CoV-2 vaccine, given within the framework of the national SARS-CoV-2 vaccination campaign. The time between last vaccination with ABNCoV2 and a SARS-CoV-2 vaccine provided by the campaign shall be at least 4 weeks. 9. Known hypersensitivity to any of the vaccine components (adjuvant or protein). 10. Administration of immunoglobulins and/or any blood products within the three months prior to the first dose of ABNCoV2 or planned administration during the study period. 11. Previous participation in a COVID-19 vaccine study. 12. Body Mass Index (BMI) >35 kg/m2. 13. Pregnancy, lactation or intention to become pregnant during the study period. 14. History of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment. 15. Being an employee or student of the department of Medical Microbiology of the Radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only. 16. Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name Benjamin Mordmüller, Prof overall official affiliation Stichting Radboud university medical center overall official role Principal Investigator location list location location facility Radboud univserity medical center location city Nijmegen location state Gelderland location zip 6525GA location country Netherlands derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000045169 condition mesh term Severe Acute Respiratory Syndrome condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M24598 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T5186 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse leaf id M35114 intervention browse leaf name MF59 oil emulsion intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention 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full study rank 61371 study protocol section identification module n c t id NCT04837339 org study id info org study id 2019_0015 organization org full name Hopital Foch org class OTHER brief title Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation official title Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation acronym DATACOL status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 17, 2022 start date type Actual primary completion date struct primary completion date March 2037 primary completion date type Anticipated completion date struct completion date March 2037 completion date type Anticipated study first submit date November 2, 2020 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 2, 2022 last update post date struct last update post date August 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hopital Foch lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation. Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample. conditions module condition list condition Lung Transplant Rejection Lung Transplant Failure Lung Transplant; Complications Lung Transplant Failure and Rejection keyword list keyword DATACOL design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 900 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with lung disease requiring transplantation or who have undergone lung transplantation arm group type Other arm group description There is no intervention to be administered. arm group intervention list arm group intervention name Other: Collection of biological samples intervention list intervention intervention type Other intervention name Collection of biological samples intervention description Blood sample, biopsies sample, hair sample. intervention arm group label list intervention arm group label Patients with lung disease requiring transplantation or who have undergone lung transplantation outcomes module primary outcome list primary outcome primary outcome measure Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers). primary outcome description Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection. primary outcome time frame 15 years secondary outcome list secondary outcome secondary outcome measure Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression). secondary outcome description Correlation of biomarkers (graft) with the functionality of the allograft secondary outcome time frame 15 years secondary outcome measure Stratify lung transplant recipients using non-invasive biomarkers and a gene expression profile for risk of allograft loss based on first year post-transplant data secondary outcome description Assessment of the risk of graft loss based on biomarker variations in repeated measurements. secondary outcome time frame 15 years secondary outcome measure Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection secondary outcome description Correlation between gene expression in lung transplants and response to treatment of rejection secondary outcome time frame 15 years secondary outcome measure Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection. secondary outcome description Costs incurred to define the risk of allograft rejection secondary outcome time frame 15 years secondary outcome measure Assessing patient acceptability and well-being using invasive and non-invasive biomarkers secondary outcome description Variation in patient well-being with the use of a non-invasive strategy to define the risk of allograft rejection secondary outcome time frame 15 years eligibility module eligibility criteria Inclusion Criteria: Men or women over 15 years of age Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent. Be affiliated with a Health Insurance plan. Exclusion Criteria: Pregnant, parturient and/or lactating woman Hemoglobin level less than or equal to 8g/dl Persons of full age who are subject to a legal protection measure or who are unable to express their consent Persons under the protection of justice Not being able to follow the study requirements for geographical, social or psychological reasons Patient refusal. healthy volunteers No gender All minimum age 15 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Antoine ROUX, Dr central contact role Contact central contact phone 0146252635 central contact phone ext +33 central contact e mail a.roux@hopital-foch.com central contact name Elisabeth HULLIER-AMMAR, Dr central contact role Contact central contact phone 0146251175 central contact e mail drci-promotion@hopital-foch.com location list location location facility Roux location status Recruiting location city Suresnes location country France location contact list location contact location contact name Antoine Roux location contact role Contact i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022	NCT04837339	[ 101, 1554, 2025, 3997, 5391, 26303, 1475, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 26303, 23493, 1580, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 10351, 168, 3135, 16337, 2369, 8916, 1554, 1271, 12965, 19058, 143, 9962, 8916, 1705, 152, 24162, 9637, 4094, 1641, 12120, 8517, 14226, 2941, 1105, 5096, 25566, 5668, 139, 2660, 8519, 1468, 1104, 13809, 1643, 9180, 141, 6834, 26420, 1107, 1103, 16752, 17380, 1104, 14557, 2118, 13809, 1643, 9180, 1891, 2078, 1641, 12120, 8517, 14226, 2941, 1105, 5096, 25566, 5668, 139, 2660, 8519, 1468, 1104, 13809, 1643, 9180, 141, 6834, 26420, 1107, 1103, 16752, 17380, 1104, 14557, 2118, 13809, 1643, 9180, 1891, 22478, 141, 13821, 8101, 13901, 2781, 13196, 2781, 22480, 2236, 1360, 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full study rank 61198 study protocol section identification module n c t id NCT04839588 org study id info org study id Telerehab CH Usability secondary id info list secondary id info secondary id R43CA232936 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R43CA232936 organization org full name Bright Cloud International Corp org class INDUSTRY brief title Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study official title Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments acronym TCIFCU status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date June 7, 2021 start date type Actual primary completion date struct primary completion date December 31, 2021 primary completion date type Actual completion date struct completion date December 31, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 27, 2022 last update post date struct last update post date April 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Bright Cloud International Corp lead sponsor class INDUSTRY collaborator list collaborator collaborator name National Cancer Institute (NCI) collaborator class NIH collaborator name Rutgers, The State University of New Jersey collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations. Perform usability study on 2 elderly healthy volunteers and 2 breast cancer survivors with lasting cognitive impairments following chemotherapy, so to improve the product design. The usability evaluation will be done at NJ Bioscience Center (North Brunswick, NJ). detailed description The study will generate data on ease of use of a system for subjects with stage II or stage III breast cancer survivors with lasting cognitive impairments subsequent to their first chemotherapy regimen. The usability component will uncover technical issues in its usability, as well as its rating on perceived usefulness. Data will also be collected on the ease of remote monitoring of the subjects by clinicians. This portion of the study is intended to provide information pertaining to the usability of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting chemotherapy related cognitive impairment (CRCI) subsequent to first chemotherapy regimen, living in the community. Specific aims are: testing of a added biosensors, new technology acceptance and ease of use at home by these individuals; a caregiver console and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review. Participants will each perform 4 usability evaluation sessions. At the end of each session participants will fill a custom evaluation form, using 5-point Likert scale scoring. At the end of the last session participants will also fill a USE standardized usability evaluation form. conditions module condition list condition Chemotherapy-Related Cognitive Impairment Healthy keyword list keyword chemotherapy cognitive impairments breast cancer design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Other enrollment info enrollment count 4 enrollment type Actual arms interventions module arm group list arm group arm group label Usability study, healthy volunteers and those with cognitive impairments following chemotherapy arm group description 2 elderly healthy volunteers and 2 participants with lasting cognitive impairments following chemotherapy for breast cancer. All will perform evaluation of a computer-based experimental system. Participants will be Female Either healthy or breast cancer survivor; Age 20 to 65 years; Have st least 12 years of formal education; Be English speakers; arm group intervention list arm group intervention name Other: Usability study intervention list intervention intervention type Other intervention name Usability study intervention description Participants will first be screened for propensity to simulation sickness and for cognitive state using the MoCA evaluation test. Those who passed the screening will perform 4 usability sessions rating the ease of use and perceived benefit of the experimental system and of a caregiver interface laptop. The 2 healthy volunteers will evaluate first, such that issues may be resolved before testing is done on the impaired participants. Each session will be compensated with a $35 payment. During each session participants will play a series of increasing difficulty simulated tasks, aimed to train primarily the executive functions domain. At the end of each session participants will rate their experience using custom subjective evaluation forms with multiple items. Each item will be scored using a 5-point Likert scale. At the end of the 4th session, participants will also fill the USE standardized usability form. This usability evaluation will be conducted at the NJ Bioscience Center. intervention arm group label list intervention arm group label Usability study, healthy volunteers and those with cognitive impairments following chemotherapy outcomes module primary outcome list primary outcome primary outcome measure USE questionnaire to assess the usability of a computerized system primary outcome description A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the experimental system [Lund, 2001] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max). Participants will also be able to comment in free form on aspects they liked most and least about the device. primary outcome time frame At the end of the 4th evaluation session (about 1 month from enrollment) secondary outcome list secondary outcome secondary outcome measure Subjective rating questionnaire of the device and therapy secondary outcome description Participants rate the usefulness, satisfaction issues, and ease of use of the experimental system and its therapeutic games, as well as ease of use of the Caregiver laptop. The Subjective Evaluation Form consists of questions, each rated on a 5-point Likert scale (1 worst to 5 best outcome). secondary outcome time frame At each of 4 evaluation sessions over 1 month from enrollment other outcome list other outcome other outcome measure Simulation Sickness Questionnaire for participant other outcome description Form used at screening post-consent to determine a participant's propensity for simulation sickness [Kennedy et al.,1993]. The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 48 (worst outcome - certainty that the participant will experience severe simulation sickness). other outcome time frame Screening at consent (one time) other outcome measure Cyber-sickness Susceptibility Questionnaire for participant other outcome description Form used at screening post-consent to determine a participant's propensity for simulation sickness [Freiwald et al., 2020]. The questionnaire asks participants 26 questions The first 13 questions ascertain the general heath and fitness of the subject, and have Yes/No answers The remaining 13 questions are score on a on a 5 point Likert scale, with five point Likert scales, referring to the frequency of each complaint's occurrence. These scales range from 0 to 4 with the labels "very rarely", "rarely", "occasionally", "frequently" and "very often". other outcome time frame Screening at consent (one time) other outcome measure Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment other outcome description Used at screening post-consent to determine level of cognitive impairment [Nasreddine et al 2005] for participants. The form has a score range from 0 (worst) to 30 (best) - no cognitive impairments. For the participants with early Alzheimer's Disease the form will confirm the participant is in the score range of 19-25. other outcome time frame Screening at consent (one time) other outcome measure Biosensor readings other outcome description Custom biosensors will provide additional data which will be used to gauge levels of cognitive engagement with the tasks performed during the evaluation. other outcome time frame At each of 4 evaluation sessions over 1 month from enrollment other outcome measure Game difficulty level other outcome description Game difficulty level when performing a simulated game task using the experimental system. Levels are 1 (easiest) to 16 (hardest) other outcome time frame At each of 4 evaluation sessions over 1 month from enrollment other outcome measure Heart rate other outcome description Heart rate (Pulse) measured with a medical meter at start and end of each usability evaluation session other outcome time frame Before and after each of 4 evaluation sessions over 1 month from enrollment other outcome measure Blood pressure (systolic and diastolic) other outcome description Blood pressure (Systolic and diastolic) measured with a medical meter before and after each Usability evaluation session. other outcome time frame Before and after each of 4 evaluation sessions over 1 month from enrollment eligibility module eligibility criteria At NJ Bioscience Center Healthy Volunteers Female Age 20 to 65; Good or corrected hearing; Good or corrected vision; No motor or cognitive impairments; English speakers; Those with low propensity for simulation sickness (as determined by the Simulation Sickness Questionnaire [Kennedy et al, 1993]). Either healthy or having had stage II or stage III breast cancer; Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment [Chapman 2016] or 26-30 indicating normal cognition; EXCLUSION CRITERIA Male; Female participants younger than 20 or older than 65; High propensity for simulation sickness (as determined by Simulation Sickness Questionnaire screening); Those with severe visual neglect or legally blind; Those with severe hearing loss or deafness; Those with uncontrolled hypertension (>190/100 mmHg); Those with severe cognitive impairment (MoCA score<10); Current diagnosis of moderate-severe depression (Beck Depression Inventory II score of 17-63); a history of psychiatric illness, defined as serious psychiatric illness such as bipolar mood disorder and schizophrenia, or requiring psychiatric hospitalization. a history of or current substance abuse; a previous head injury resulting in loss of consciousness; a prior diagnosis of neurological illness; a current or prior diagnosis of brain cancer; non-English speakers; Those unable to reliable participate in pre-study assessment due to any reason; Those with co-morbidities limiting arm and neck motor function (ex. lymphedema, chronic pain, severe arthritis); Less than 1 month post first chemotherapy regimen or starting chemotherapy during 16 weeks post screening (as chemotherapy during study participation is a confounding factor); Those with Stage IV (metastatic) breast cancer will be excluded; Those presenting with multiple cancers, such as breast and arm bone cancer, or breast and brain cancer; Those who are unwilling to allow a home inspection to ascertain Internet quality, determine best placement for the experimental or sham systems, for installation and removal of the systems and necessary repairs. healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description Since the study targets breast cancer survivors, participants will all be female. Breast cancer prevalence is overwhelmingly in women. minimum age 20 Years maximum age 65 Years std age list std age Adult Older Adult study population The targeted subjects will be either breast cancer survivors, living in the community, without requiring transfers, or healthy, age-matched volunteers. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Grigore C Burdea, PhD overall official affiliation Bright Cloud Int'l Corp overall official role Principal Investigator location list location location facility Bright Cloud Int'l Corp location city North Brunswick location state New Jersey location zip 08902 location country United States location facility New Jersey Bioscience Center location city North Brunswick location state New Jersey location zip 08902 location country United States references module see also link list see also link see also link label Description: BCI's corporate site showing therapeutic games used with the device see also link u r l http://www.BrightBrainer.com i p d sharing statement module i p d sharing No i p d sharing description We will not disclose data on individual participants. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000084202 condition mesh term Chemotherapy-Related Cognitive Impairment condition mesh id D000060825 condition mesh term Cognitive Dysfunction condition ancestor list condition ancestor condition ancestor id D000003072 condition ancestor term Cognition Disorders condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000064420 condition ancestor term Drug-Related Side Effects and Adverse Reactions condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition browse leaf list condition 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full study rank 61870 study protocol section identification module n c t id NCT04830852 org study id info org study id Pro00015510 secondary id info list secondary id info secondary id 21X125F1 secondary id type Other Identifier secondary id domain Leidos organization org full name Children's National Research Institute org class OTHER brief title Pediatric COVID Outcomes Study (PECOS) official title Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date July 23, 2021 start date type Actual primary completion date struct primary completion date July 1, 2027 primary completion date type Anticipated completion date struct completion date July 1, 2027 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date December 28, 2021 last update post date struct last update post date January 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Roberta DeBiasi responsible party investigator title MD, MS, Division Chief, Infectious Diseases, Co-Director of the Congenital Zika Program responsible party investigator affiliation Children's National Research Institute lead sponsor lead sponsor name Children's National Research Institute lead sponsor class OTHER collaborator list collaborator collaborator name National Institute of Allergy and Infectious Diseases (NIAID) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations. Participants aged 21 years and younger with laboratory confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection will visit the study sites for clinical and research evaluations and sample collection at schedules dependent on time since infection. Participants enrolled within 12 weeks after acute infection or positive test will be part of the "recovery group" and will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. Participants enrolled more than 12 weeks after acute infection or positive test will be in the "convalescent group" and will attend study visits at baseline and subsequently every 6 months for a total of 3 years. Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. This protocol will establish a cohort of pediatric patients recovered from SARS CoV-2 infection and a biorepository for evaluation of the potential roles of host genetics, immune response, and other possible factors influencing long-term outcomes. Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2. detailed description This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics of the immune response to SARS-CoV-2, genetic factors associated with long-term outcomes, and the extent and duration of protective immunity. The study procedures include: Non-contrast chest computed tomography (CT) or chest X-ray: All participants will undergo 2 chest imaging procedures, one at baseline and one at the final study visit (year 3). Non-contrast cardiac magnetic resonance imaging (MRI): All participants will undergo 2 to 3 non-contrast cardiac MRI procedures during this study. Echocardiogram Electrocardiography (EKG) Pulmonary Function Test (PFT) Questionnaires: To complete the questionnaires will take approximately 25 to 64 minutes. Collection of blood (including for optional genetic testing), nasopharyngeal (NP) swab, urine, and stool. Genetic testing (optional): This protocol involves genetic testing using whole genome sequencing (WGS) approaches for all participants. Clinical photography (optional): Participants may decline photographs or place any restrictions on their use. conditions module condition list condition Covid19 MIS-C Associated With COVID-19 MIS-C Multisystem Inflammatory Syndrome in Children SARS-CoV2 Infection keyword list keyword SARS-CoV-2 COVID-19 MIS-C Post-COVID Long-term effects Pediatric Children design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Blood, nasopharyngeal swab, stool and urine. enrollment info enrollment count 5000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Recovery Group arm group description Participants aged 21 years and younger and enrolled within 12 weeks after acute infection or positive test. These participants will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. arm group label Convalescent Group arm group description Participants aged 21 years and younger and enrolled more than 12 weeks after acute infection or positive test. These participants will attend study visits at baseline and subsequently every 6 months for a total of 3 years. arm group label Healthy contacts arm group description Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. arm group label Parents/guardians of participants arm group description Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2. outcomes module primary outcome list primary outcome primary outcome measure Incidence and prevalence of medical sequelae, study procedures analysis primary outcome description Incidence and prevalence of medical sequelae among symptomatic SARS-CoV-2 infection survivors, asymptomatic SARS CoV 2 infection survivors, and MIS-C survivors. primary outcome time frame 6 years primary outcome measure Risk factors for medical sequelae, study procedures analysis primary outcome description Risk factors for medical sequelae among symptomatic SARS CoV 2 infection survivors, asymptomatic SARS-CoV-2 infection survivors, and MIS-C survivors. primary outcome time frame 6 years secondary outcome list secondary outcome secondary outcome measure Quality of life and social impact, study procedures analysis secondary outcome description Health-related quality of life and social impact in children and adolescents recovered from SARS-CoV-2 infection including parent/guardian and child assessments. secondary outcome time frame 6 years secondary outcome measure Incidence and prevalence of reinfection, study procedures analysis secondary outcome description Incidence and prevalence of reinfection in previously infected and recovered SARS-CoV-2 and MIS-C survivors with and without vaccination. secondary outcome time frame 6 years secondary outcome measure Biorepository, study procedures analysis secondary outcome description Establishment of a biorepository for additional biomarker analysis. secondary outcome time frame 6 years eligibility module eligibility criteria Inclusion Criteria: Survivors and control cohorts: In order to be eligible to participate in this study as a survivor or as a control, an individual must meet all of the following criteria: Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years). Willing to allow storage of samples and data for future research. At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation. In addition, an individual must meet all criteria for one of the following cohorts. Symptomatic survivor cohort (including MIS-C): Documented prior COVID-19 or MIS-C as evidenced by one of the following: detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with Emergency Use Authorization (EUA)/approval from the US Food and Drug Administration (FDA) and a history of clinical manifestation compatible with COVID-19; or positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of clinical manifestation compatible with COVID-19; or meeting CDC case definition for MIS-C (see Appendix 1). Onset of COVID-19/MIS-C symptoms is at least 4 weeks before baseline visit. one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea. Asymptomatic survivor cohort: Documented prior SARS-CoV-2 infection as evidenced by one of the following: detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with EUA/approval from the FDA without history of clinical manifestation compatible with COVID-19; or positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA without history of clinical manifestation compatible with COVID-19. Positive SARS-CoV-2 RNA or antigen test is at least 4 weeks before baseline visit. one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea. Healthy contact (control) cohort: 1. No diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 and meets one of the following criteria: Lived in the same household as a participant with SARS-CoV-2 infection during the time of illness, or was within approximately 6 feet (2 meters) of the participant for a prolonged period of time, or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on). Lives in an area affected by SARS-CoV-2 infection Parents and guardians: In order to participate in this study as a parent or guardian, an individual must meet all of the following criteria: Is a parent or guardian of a participant enrolled as a survivor or as a control. Stated willingness to comply with all study procedures and availability for the duration of the study. Willing to allow storage of data for future research. Exclusion Criteria: Survivors and controls: An individual who meets any of the following criteria will be excluded from participation in this study: Any symptoms suggestive of an ongoing infection within 15 days of baseline visit, including but not limited to fever > 38.2 °C, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain). Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study. Pregnancy. Parents and guardians: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study. Co-enrollment: Participants may be co-enrolled in other clinical studies, including observational studies and therapeutic trials. However, the study staff should be informed of co-enrollment. healthy volunteers Accepts Healthy Volunteers gender All minimum age 0 Years maximum age 21 Years std age list std age Child Adult study population Patients aged 0 to 21 years with confirmed history of symptomatic SARS CoV-2 infection (including COVID-19), MIS C, or asymptomatic SARS CoV-2 infection (n = up to 1000), as well as healthy contacts (aged ≤21 years; n = up to 1000). Additionally, a parent or guardian of each participant will be enrolled to complete targeted questionnaires (n = up to 2000). Accrual ceiling is 5000 patients. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Roberta DeBiasi, MD, MS central contact role Contact central contact phone 2024761708 central contact e mail CN-NIAID-pedsCOVIDstudy@childrensnational.org central contact name Gina A. Montealegre Sanchez, MD, MS central contact role Contact overall official list overall official overall official name Roberta DeBiasi, MD, MS overall official affiliation Children's National Research Institute overall official role Principal Investigator overall official name Gina A. Montealegre Sanchez, MD, MS overall official affiliation National Institute of Allergy and Infectious Diseases (NIAID) overall official role Principal Investigator location list location location facility Children's National Hospital location status Recruiting location city Washington location state District of Columbia location zip 20010 location country United States location contact list location contact location contact name Roberta DeBiasi, MD, MS location contact role Contact location facility National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID) location status Recruiting location city Bethesda location state Maryland location zip 20852 location country United States location contact list location contact location contact name Gina A. Montealegre Sanchez, MD, MS location contact role Contact location contact e mail niaidpedscovid@niaid.nih.gov references module see also link list see also link see also link label If you are interested in participating in this study, please complete this form. A study team member will contact you with additional information. see also link u r l https://childrensnational.formstack.com/forms/covid_misc_study derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition 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full study rank 61500 study protocol section identification module n c t id NCT04835662 org study id info org study id 20575 organization org full name RTI International org class OTHER brief title Engaging Fathers for Improving Dietary Diversity in Kaduna State official title Engaging Fathers for Improving Dietary Diversity in Kaduna State status module status verified date February 2021 overall status Completed expanded access info has expanded access No start date struct start date May 31, 2019 start date type Actual primary completion date struct primary completion date September 25, 2020 primary completion date type Actual completion date struct completion date September 25, 2020 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name RTI International lead sponsor class OTHER collaborator list collaborator collaborator name FHI 360 collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children. detailed description This was pre-post study designed to measure changes in complementary feeding practices and document the feasibility and acceptability of an intervention to engage fathers in supporting dietary diversity in Kaduna State, Nigeria. This study was conducted as part of the Alive & Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design and implementation of the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study was carried out in 6 wards (2 urban, 4 rural) of Igabi local government area in Kaduna State. We collected survey data cross-sectionally from 495 cohabiting mothers and fathers of children 6-23 months at baseline and endline. Participants were randomly sampled within 99 clusters selected proportional to population size. The purpose of the surveys was to obtain data on children's complementary feeding, changes in fathers' and mothers' knowledge and attitudes related to complementary feeding, and fathers' support for complementary feeding, and to measure participants' exposure to the intervention components. To measure feasibility and acceptability of the intervention, we conducted 24 in-depth interviews at the end of the intervention with community and religious leaders and Community Health Extension Workers who were involved in implementing the intervention. In addition, we conducted separate focus group discussions with mothers and fathers (8 groups each) at the end of the intervention to learn about changes in social norms related to fathers' engagement in complementary feeding and their experiences with participating in the intervention. conditions module condition list condition Complementary Feeding keyword list keyword Minimum dietary diversity Minimum meal frequency design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 2168 enrollment type Actual arms interventions module arm group list arm group arm group label Complementary feeding promotion arm group type Other arm group description Intervention arm group intervention list arm group intervention name Behavioral: Complementary feeding promotion intervention list intervention intervention type Behavioral intervention name Complementary feeding promotion intervention description The intervention engaged fathers through community meetings, religious services, and mobile phone text and voice messages. Mothers received home visits from community health extension workers (CHEWs), which fathers also could attend. Social behavior change communication materials included TV and radio messages, sermon guides, counseling cards, pamphlets, posters, and feeding bowls. intervention arm group label list intervention arm group label Complementary feeding promotion outcomes module primary outcome list primary outcome primary outcome measure Minimum dietary diversity primary outcome description The proportion of children 6-23 months who consumed at least 4 food groups on the previous day (World Health Organization indicator definition) primary outcome time frame 24 hours secondary outcome list secondary outcome secondary outcome measure Minimum feeding frequency secondary outcome description The proportion of children 6-23 months who consumed minimum number of meals by age group and breastfeeding status (WHO indicator definition) secondary outcome time frame 24 hours secondary outcome measure Minimum acceptable diet secondary outcome description Proportion of children 6-23 months with both minimum dietary diversity and minimum meal frequency (WHO indicator definition) secondary outcome time frame 24 hours secondary outcome measure Consumption of specific food group secondary outcome description Proportion of children 6-23 months who consumed each of the 7 food groups that make up the dietary diversity indicator secondary outcome time frame 24 hours eligibility module eligibility criteria Inclusion Criteria: For the surveys, men were eligible to participate in the surveys if they were 18 years of age or older, had a child aged 6 to 23 months, and were living in the same household as the child's mother. Women were eligible to participate if they were aged 18 to 49 years or aged 15 to 17 years and married, had a child aged 6 to 23 months, and were living in the same household as the child's father. For the qualitative component, mothers, fathers, community and religious leaders, and community health extension workers who participated in the intervention were eligible. - Exclusion Criteria: Refusal to participate or provide consent. - healthy volunteers Accepts Healthy Volunteers gender All gender based Yes gender description Men were eligible to participate in the surveys if they were 18 years of age or older, had a child aged 6 to 23 months, and were living in the same household as the child's mother. Women were eligible to participate if they were aged 18 to 49 years or aged 15 to 17 years and married, had a child aged 6 to 23 months, and were living in the same household as the child's father minimum age 15 Years maximum age 49 Years std age list std age Child Adult contacts locations module overall official list overall official overall official name Valerie Flax overall official affiliation RTI International overall official role Principal Investigator location list location location facility Alive and Thrive location city Kaduna location country Nigeria references module reference list reference reference p m i d 35854939 reference type derived reference citation Allotey D, Flax VL, Ipadeola AF, Kwasu S, Adair LS, Valle CG, Bose S, Martin SL. Fathers' Complementary Feeding Support Strengthens the Association Between Mothers' Decision-Making Autonomy and Optimal Complementary Feeding in Nigeria. Curr Dev Nutr. 2022 Jun 2;6(7):nzac098. doi: 10.1093/cdn/nzac098. eCollection 2022 Jul. reference p m i d 35669047 reference type derived reference citation Flax VL, Ipadeola A, Schnefke CH, Kwasu S, Mikail AA, Bose S, Brower AO, Edwards S. Complementary Feeding Social and Behavior Change Communication for Fathers and Mothers Improves Children's Consumption of Fish and Eggs and Minimum Meal Frequency in Kaduna State, Nigeria. Curr Dev Nutr. 2022 Apr 8;6(5):nzac075. doi: 10.1093/cdn/nzac075. eCollection 2022 May. i p d sharing statement module i p d sharing Yes i p d sharing description The data will be open i p d sharing time frame January 31, 2022 derived section misc info module version holder December 02, 2022	NCT04835662	[ 101, 1554, 2025, 3997, 5391, 22682, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 19297, 1545, 1545, 1477, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 17342, 26253, 2369, 8916, 1554, 1271, 155, 21669, 1570, 8916, 1705, 152, 24162, 9637, 4094, 1641, 13832, 2571, 3375, 23010, 1111, 146, 8223, 20620, 22327, 3113, 12120, 17671, 1107, 14812, 7641, 1605, 1426, 2078, 1641, 13832, 2571, 3375, 23010, 1111, 146, 8223, 20620, 22327, 3113, 12120, 17671, 1107, 14812, 7641, 1605, 1426, 2781, 13196, 2781, 22480, 2236, 1428, 17881, 1475, 2905, 2781, 12735, 1181, 3631, 2469, 23992, 1144, 3631, 2469, 1302, 1838, 2236, 188, 23055, 1838, 2236, 1318, 1955, 117, 10351, 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full study rank 61249 study protocol section identification module n c t id NCT04838925 org study id info org study id Pro00106634 secondary id info list secondary id info secondary id 1R41DA053011-01 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/1R41DA053011-01 organization org full name CrossComm, Inc. org class INDUSTRY brief title Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain official title Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 22, 2022 start date type Actual primary completion date struct primary completion date April 2023 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 18, 2022 last update post date struct last update post date July 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name CrossComm, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Duke University collaborator class OTHER collaborator name National Institute on Drug Abuse (NIDA) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes is u s export No description module brief summary The purpose of this study is to develop and test the feasibility of a commercially-ready mobile neurofeedback app for individuals with chronic pain. Thirty (30) participants who are prescribed opioids for chronic pain will use the new mobile neurofeedback app and an EEG headset for 10 minutes at a time, 4 times a week for 12 weeks and provide feedback about using the app. detailed description In this STTR Phase I project, CrossComm will collaborate with Duke University to develop a commercial-ready mobile neurofeedback technology and test its feasibility among patients using opioids to treat chronic pain. Specific Aim 1 is to develop a commercial-ready mobile neurofeedback app and will be built according to commercial standards of robustness and maintainability. Specific Aim 2 is to test feasibility of the commercially available mobile app in N=30 patients with chronic pain prescribed opioids. Participants will be recruited for a baseline interview with the Duke Behavioral Health & Technology Lab after passing a preliminary telephone screen. After providing informed consent, participants will provide data on demographics, pain symptoms, and opioid consumption. Each participant will download the mobile neurofeedback app to their smartphone and be instructed to use the intervention for 10 minutes a day, 4 times a week for 12 weeks. Study coordinators will conduct four teleconference sessions (weeks 1, 3, 6 and 9) to reinforce training, troubleshoot difficulties, and support intervention utilization. After the 12-week mobile neurofeedback intervention, the investigators will collect follow-up data, including pain measures, mobile app (usage, satisfaction, & usability), and user feedback on the human-computer interface. Data from these will inform further app refinement preparing for STTR Phase II. conditions module condition list condition Chronic Pain Opioid Use keyword list keyword Chronic Pain Opioids Prescription Opioids Pain Musculoskeletal Pain Mobile Apps Mobile Health Neurofeedback EEG Feedback Biofeedback Alternative Therapy design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Device Feasibility design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Mobile Neurofeedback arm group type Experimental arm group description Participants engage in the use of a mobile neurofeedback intervention, which involves using a mobile app paired with an EEG headset, to achieve a calm, relaxed state. Participants will be instructed to use the intervention at a minimum of 10 minutes a day, 4 times a week for a total of 12 weeks. arm group intervention list arm group intervention name Device: Mobile Neurofeedback App intervention list intervention intervention type Device intervention name Mobile Neurofeedback App intervention description Neurofeedback intervention delivered via mobile app. Participants wear an EEG headset which is connected to a mobile app that delivers feedback about brainwave data indicating whether they are in a calm, relaxed state. Participants hear a lower/simple sound when they are below a target level and higher/richer sound when they approach or achieve their target. intervention arm group label list intervention arm group label Mobile Neurofeedback outcomes module primary outcome list primary outcome primary outcome measure Mobile App Usage primary outcome description Objective data on number of mobile neurofeedback sessions completed by participants. Intervention adherence data will inform the feasibility of real-world use of the commercial-ready mobile app. primary outcome time frame 12 weeks secondary outcome list secondary outcome secondary outcome measure Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) secondary outcome description Rating on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) of how satisfied participants were with the mobile neurofeedback app. secondary outcome time frame At 3 month follow-up (end of intervention) secondary outcome measure Mobile App Usability assessed by the System Usability Scale secondary outcome description The participant indicates level of agreement with 10 statements (1: strongly disagree - 5 strongly agree). Scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. (From: https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html) Higher scores indicate better usability. secondary outcome time frame At 3 month follow-up (end of intervention) eligibility module eligibility criteria Inclusion Criteria: Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months) Prescribed opioids for pain management Exclusion Criteria: History of seizures Plans to have pain-related surgery in the next 3 months Has an implanted medical device that could experience interference during EEG, such as a spinal cord stimulator or pacemaker healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Eric B Elbogen, PhD central contact role Contact central contact phone 919-684-9983 central contact e mail eric.elbogen@duke.edu central contact name Alex Thompson central contact role Contact central contact phone 919-681-1613 central contact e mail DBHTL@duke.edu overall official list overall official overall official name Eric B Elbogen, PhD overall official affiliation Duke University overall official role Principal Investigator overall official name Donald K Shin overall official affiliation CrossComm, Inc. overall official role Principal Investigator location list location location facility Duke University School of Medicine Department of Psychiatry location status Recruiting location city Durham location state North Carolina location zip 27705 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000059350 condition mesh term Chronic Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M28595 condition browse leaf name Chronic Pain condition browse leaf as found Chronic Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M28597 condition browse leaf name Musculoskeletal Pain condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals	NCT04838925	[ 101, 1554, 2025, 3997, 5391, 19598, 1580, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23249, 1580, 17600, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 5096, 7629, 10424, 1545, 1545, 23124, 3718, 25021, 23992, 2190, 3718, 25021, 23992, 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full study rank 61848 study protocol section identification module n c t id NCT04831138 org study id info org study id STU 032018-078 organization org full name University of Texas Southwestern Medical Center org class OTHER brief title Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma official title A Prospective Study to Evaluate Quantitative Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 24, 2021 start date type Actual primary completion date struct primary completion date March 24, 2026 primary completion date type Anticipated completion date struct completion date March 24, 2027 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 1, 2022 last update post date struct last update post date April 11, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ananth Madhuranthakam responsible party investigator title Director of MR Research and Associate Professor responsible party investigator affiliation University of Texas Southwestern Medical Center lead sponsor lead sponsor name University of Texas Southwestern Medical Center lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Magnetic Resonance Imaging (MRI) including Arterial Spin Labeling (ASL) will be performed before, during, and after the treatment, in a total of up to 6 MRI sessions until 7 months after the first session, or when progression is clinically indicated. Thereafter, patients will be followed through standard clinical examinations for the next 3 years or until demise, whichever occurs first. Clinically, metastatic renal cell carcinoma (RCC) patients are imaged every 2-3 months after the initiation of anti-angiogenic therapy, since morphological (i.e. size) changes are not anticipated earlier. However, our preliminary experience has shown functional changes including perfusion as early as 2-weeks after the initiation of the treatment. T0, T1, and T2 sessions will be performed for this proposal, while T3, T4, and T5 will be performed along with the clinical imaging sessions. All MR imaging sessions will be scheduled within ±1 or ±2 weeks of the target time period. The research MR imaging may take approximately an additional 15 minutes per each imaging session, when done in conjunction with the clinical imaging. The T0, T1, and T2 research MR imaging sessions will be performed additionally for the purpose of this study, with each taking approximately one hour. detailed description The incidence of kidney cancer has steadily increased over the past three to four decades and is among the 10 most frequently diagnosed cancers in the US. Approximately 63,990 new cases of kidney cancer are estimated in 2017 and the prognosis has been historically poor. The current 5-year survival rates are estimated at 74% overall, decreasing to 53% among patients with locally advanced diseases. The most common form of kidney cancer, renal cell carcinoma (RCC), occurs in 90% of all kidney cancers. Among patients with localized RCC who are treated with nephrectomy, approximately one quarter have relapses in distant sites. Among patients with metastatic RCC, the 5-year survival rates are approximately 8%. With better understanding of the pathogenesis of the most common type of RCC, clear-cell renal cell carcinoma (ccRCC), newer treatment options with new agents are being developed to increase survival rates. The high cost and potential risks associated with human trials for the newly developed experimental therapies have emphasized the need for sensitive monitoring of tumor response. Imaging approaches can play an important role in the evaluation and selection of potential new therapies with non-invasive longitudinal monitoring of treatment response. Currently, the radiological assessment of treatment outcomes predominantly relies on morphological (i.e. size) changes using the Response Evaluation Criteria in Solid Tumors (RECIST) and other similar scores. This is a major limiting factor as the effects of many therapeutic agents at the microscopic level precede the eventual changes in tumor size. One such tumor property that has gained increased attention is angiogenesis, which has been shown to support tumor proliferation and infiltration. Increasing numbers of clinical trials have begun targeting tumor vascular supplies by directly inhibiting angiogenesis (e.g. antiangiogenic therapy). Such clinical trials and the eventual clinical use of these therapies would be greatly assisted by the availability of robust imaging indicators of angiogenesis (i.e. tissue perfusion). Positron Emission Tomography (PET) using 15O-labeled water (15O-PET) is considered the gold standard for non-invasive measurement of tissue perfusion. However, the use of 15O-PET requires a cyclotron in close proximity to PET to produce short lived 15O-water (half life 2.4 min), limiting its applicability in clinical settings. Alternative imaging techniques include ultrasound using microbubbles, perfusion computed tomography (CT) using iodinated contrast agent and perfusion MRI using gadolinium based contrast agents. All of these techniques require exogenous agents, restricting their use in longitudinal monitoring of treatment response. ASL-MRI has recently emerged as a quantitative imaging (QI) method to measure perfusion (or capillary blood flow) without the administration of exogenous contrast agents. ASL magnetically "labels" the highly permeable water in the blood as a tracer and measures their accumulation in the tissue of interest, without injecting any exogeneous contrast. Various versions of ASL have been validated in animals using microspheres, and in humans using 15O-PET in the brain. ASL also has a number of advantages compared to dynamic contrast enhanced (DCE) and dynamic susceptibility contrast (DSC) based MR perfusion measurements. Specifically, ASL does not require exogenous agent alleviating the concerns of gadolinium accumulation or nephrogenic systemic fibrosis (NSF) in patients with impaired renal function and, unlike DCE/DSC, the contribution of vascular permeability to ASL measured perfusion is negligible enabling absolute perfusion quantification in physiological units. conditions module condition list condition Renal Cell Carcinoma keyword list keyword magnetic resonance imaging arterial spin labeling design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label RCC Patients arm group type Experimental arm group description Patients with locally advanced or metastatic renal cell carcinoma arm group intervention list arm group intervention name Procedure: MRI with ASL intervention list intervention intervention type Procedure intervention name MRI with ASL intervention description T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement. T1 (Day 7+-2): contrast-enhanced research MRI with ASL T2 (Day 14+-2): contrast-enhanced research MRI with ASL T3: MRI with ASL will be performed along with patient's standard of care imaging session. T4: MRI with ASL will be performed along with patient's standard of care imaging session. T5: MRI with ASL will be performed along with patient's standard of care imaging session. intervention arm group label list intervention arm group label RCC Patients outcomes module primary outcome list primary outcome primary outcome measure Change in perfusion in the tumor primary outcome description Will determine if changes in ASL measured tumor perfusion is associated with treatment response, measured as time to progression. One-sample correlation test will be used to determine the correlation between change in ASL measured tumor perfusion (baseline to 7+-2 days and 14+-2 days) and time to progression. The correlations will be measured and compared using Pearson's correlation coefficient along with 95% confidence interval. primary outcome time frame Baseline to 7 and 14 days primary outcome measure Progression Free Survival (PFS) primary outcome description Will determine if changes in ASL measured perfusion is associated with PFS. PFS will be correlated with baseline perfusion and post-treatment changes at 7-, and 14-days compared to baseline using univariable and multivariable Cox regression models. Will determine whether changes in ASL measured tumor perfusion as a continuous variable in the tumor from baseline to 7-, and 14-days after initiation of therapy is associated with PFS. The hazard ratio and its 95% confidence interval will be presented. primary outcome time frame Up to 3 years secondary outcome list secondary outcome secondary outcome measure ASL measured perfusion within enhancing tumor secondary outcome description Will determine if ASL measured tumor perfusion at baseline is associated with treatment response, measured as time to progression. One-sample correlation test will be used to determine the correlation between baseline ASL measured tumor perfusion and time to progression. The correlations will be measured and compared using Pearson's correlation coefficient along with 95% confidence interval. secondary outcome time frame Baseline secondary outcome measure Overall Survival (OS) secondary outcome description Will determine if changes in ASL measured perfusion is associated with OS. OS will be correlated with baseline perfusion and post-treatment changes at 7- and 14-days compared to baseline using univariable and multivariable Cox regression models. Will determine whether changes in ASL measured tumor perfusion as a continuous variable within the tumor from baseline to 7-, and 14-days after initiation of therapy is associated with OS. The hazard ratio and its 95% confidence interval will be presented. secondary outcome time frame Up to 3 years eligibility module eligibility criteria Inclusion Criteria: Patients with locally advanced or metastatic renal cell carcinoma. Patients scheduled to undergo anti-angiogenic treatment or immunotherapy Eastern Cooperative Oncology Group (ECOG) Status 0, 1 and 2. Women of child-bearing potential must agree to undergo a urine pregnancy screening per standard Radiology departmental protocol, in place to prevent imaging of pregnant patients. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Subjects may not be receiving any other anti-angiogenic agents, at the time of enrollment. Subjects must not be pregnant since pregnancy is a contraindication to administration of gadolinium-based contrast agents. Any contraindication to MRI per Radiology Department's routine protocol, e.g. MRI-incompatible objects, including but not limited to medical devices (e.g. pacemakers, automated implantable cardioverter defibrillators, etc.) and other foreign bodies. Known severe allergic reaction to Gadolinium-based contrast agents. Patients with sickle cell disease and patients with other hemolytic anemias (low red blood count in body). Patients with uncontrollable claustrophobia, severe lower back pain, and uncontrollable tremors, to the point that it would render them unable to tolerate an MRI study. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Kelli Key, PhD central contact role Contact central contact phone 214-648-8152 central contact e mail Kelli.Key@UTSouthwestern.edu central contact name Ananth Madhuranthakam, PhD central contact role Contact central contact phone 214-648-7737 central contact e mail Ananth.Madhuranthakam@UTSouthwestern.edu location list location location facility UT Southwestern Medical Center location status Recruiting location city Dallas location state Texas location zip 75390 location country United States location contact list location contact location contact name Kelli Key, PhD location contact role Contact location contact phone 214-648-8152 location contact e mail Kelli.Key@UTSouthwestern.edu derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002292 condition mesh term Carcinoma, Renal Cell condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000000230 condition ancestor term Adenocarcinoma condition ancestor id D000007680 condition ancestor term Kidney Neoplasms condition ancestor id D000014571 condition ancestor term Urologic Neoplasms condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition 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full study rank 61525 study protocol section identification module n c t id NCT04835337 org study id info org study id 202032 organization org full name Centers for Disease Control and Prevention, China org class OTHER_GOV brief title The Health Benefits of Indoor Air Filtration Among Children official title Investigating the Health Benefits of Indoor Air Filtration Among Children: a Randomized Crossover Trial in Jiaozuo, China status module status verified date July 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 10, 2021 start date type Actual primary completion date struct primary completion date November 15, 2021 primary completion date type Anticipated completion date struct completion date April 15, 2022 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 27, 2021 last update post date struct last update post date July 28, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Tiantian Li responsible party investigator title professor responsible party investigator affiliation Centers for Disease Control and Prevention, China lead sponsor lead sponsor name Tiantian Li lead sponsor class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study aims to explore the health benefits of air purifier on the impact of air pollutants on children's health. detailed description From April 2021 to November 2021, researchers conduct a randomized double-blind crossover trial on 110 healthy children in Jiaozuo City, Henan Province. The children are divided into two groups according to their classes and alternated the use of true or sham purifiers devices, including air purifiers and fresh air system. Air purifiers are installed in the classroom and bedrooms of the children. Fresh air system are installed in the classroom. A total of 6 epidemiological surveys are conducted on the subjects, with an interval of 60 days or more. All participants and research staffs were blinded to the group assignment. In addition, air pollutant exposure monitoring, questionnaire surveys, physical examinations, and biological sample collection are conducted on the research subjects each time. The biological samples are further tested for the concentration levels of related biomarkers such as the respiratory system, cardiovascular system, metabolic system, and nervous system. Furthermore, comprehensive evaluation of children's behavioral ability is also carried out. conditions module condition list condition Protective Effect of Air Purifier on Children's Health design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Prevention design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 110 enrollment type Anticipated arms interventions module arm group list arm group arm group label Air purifier arm group type Experimental arm group description Participants in this group receive an intervention of real air purifiers placed in the indoor environment. arm group intervention list arm group intervention name Behavioral: Air Purifiers arm group label Control arm group type Sham Comparator arm group description Participants in this group receive an intervention of sham air purifiers, we just remove the filter in the purifiers, and the other treatments are the same as the real purification group. arm group intervention list arm group intervention name Behavioral: Sham Air Purifiers intervention list intervention intervention type Behavioral intervention name Air Purifiers intervention description Students are divided into two groups: intervention group and control group. The intervention team places an air purifier in the indoor environment to intervene. All the indoor environment of the group use the same qualified air purifier, and all participants and research staffs are blinded to the group assignment. intervention arm group label list intervention arm group label Air purifier intervention type Behavioral intervention name Sham Air Purifiers intervention description The control group is also intervened. The intervention is to place a sham air purifier (remove the filter screen) in the indoor environment, and all the indoor environment use the same air purifier as the intervention group. All participants and research staffs are blinded to the group assignment. intervention arm group label list intervention arm group label Control outcomes module primary outcome list primary outcome primary outcome measure Changes of Forced Vital Capacity of Lung Function primary outcome description The pulmonary function measures are performed by the professional medical staff. Before the pulmonary function test, subjects practice several times by themselves. During the examination, each subject stand and clamp the nose clip, and repeat the test, with the best result as the criterion. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of FeNO primary outcome description Use NIOX VERO Sensor to measure fractional exhaled nitric oxide (FeNO) as a biomarker for formaldehyde inhalation exposure. After deep breathing, the subjects gently inhaled into the device. The instrument showed FeNO level of the subjects. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of FeCO primary outcome description Use Pico Smokerlyzer to measure fractional exhaled carbon monoxide (FeCO). After deep breathing, the subjects held their breath for 15 seconds and then gently inhaled into the device. The instrument showed FeCO level and the estimated value of carboxyhemoglobin in blood. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of Systolic Blood Pressure primary outcome description Systolic blood pressure for each subject is conducted by the same trained staff using the same instrument. Average levels are calculated by the treatments of intervention or control. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of LF/HF of HRV primary outcome description Use Nihon Kohden Electrocardiograph to measure heart rate variability and examine the ratio between low frequency and high frequency (LF/HF). To eliminate possible error, subjects are conducted by the same trained staff using the same instrument. primary outcome time frame Baseline and at the end of each 60 days intervention period secondary outcome list secondary outcome secondary outcome measure Changes of CRP secondary outcome description Detect the concentration of C-reactive protein in blood sample to examine the different level of inflammation between the group of intervention and control. secondary outcome time frame Baseline and at the end of each 60 days intervention period secondary outcome measure Changes of 8-OHdG secondary outcome description Detect the concentration of 8-hydroxydeoxyguanosine (8-OHdG) in urine sample as a marker of generalized, cellular oxidative stress to DNA. secondary outcome time frame Baseline and at the end of each 60 days intervention period secondary outcome measure Changes of PR secondary outcome description Examine persistent response (PR) as the index to test the focus ability of children. The test is performed by the Wsiconsin card sorting test through computer, and the index reflects the ability of cognitive transfer. The normal value is less than or equal to 27. secondary outcome time frame Baseline and at the end of each 60 days intervention period eligibility module eligibility criteria Inclusion Criteria: 8 ≤ 12 years old Volunteer to participate in this study Exclusion Criteria: Current and past medical history, including asthma, childhood diabetes, childhood hypertension, behavior-related diseases Students who plan to transfer or move within six months Unable to cooperate with follow-up healthy volunteers Accepts Healthy Volunteers gender All minimum age 8 Years maximum age 12 Years std age list std age Child contacts locations module central contact list central contact central contact name Tiantian Li central contact role Contact central contact phone 010-50930213 central contact e mail litiantian@nieh.chinacdc.cn overall official list overall official overall official name Tiantian Li overall official affiliation National Institute of Environmental Health, Chinese Center for Disease Control and Prevention overall official role Study Director location list location location facility National Institute of Environmental Health, Chinese Center for Disease Control and Prevention location status Recruiting location city Beijing location zip 100021 location country China location contact list location contact location contact name tiantian Li location contact role Contact location contact phone 010-50930213 location contact e mail litiantian@nieh.chinacdc.cn derived section misc info module version holder December 02, 2022	NCT04835337	[ 101, 1554, 2025, 3997, 5391, 1571, 17600, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 19297, 23493, 1559, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 12795, 17101, 2369, 8916, 1554, 1271, 22347, 1111, 20012, 6342, 1105, 18461, 117, 1975, 8916, 1705, 152, 24162, 9637, 168, 27157, 2559, 4094, 1641, 1109, 3225, 3096, 11470, 6439, 1104, 12617, 1806, 17355, 21875, 3841, 4288, 2078, 1641, 1130, 5710, 3121, 18401, 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full study rank 61587 study protocol section identification module n c t id NCT04834531 org study id info org study id ZLJN-V2.0 organization org full name China Academy of Chinese Medical Sciences org class OTHER brief title Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) official title Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis status module status verified date June 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date July 2021 start date type Anticipated primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date October 2023 completion date type Anticipated study first submit date September 21, 2020 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 13, 2021 last update post date struct last update post date June 15, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Zhong Wang responsible party investigator title Institute of Clinical Basic Medicine of Traditional Chinese Medicine responsible party investigator affiliation China Academy of Chinese Medical Sciences lead sponsor lead sponsor name Zhong Wang lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis. conditions module condition list condition Chronic Obstructive Pulmonary Disease Chronic Bronchitis design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 324 enrollment type Anticipated arms interventions module arm group list arm group arm group label Zhuli capsule arm group type Experimental arm group description Base on the standard medical treatment, the patients in this group will be used Zhuli capsule, 2 capsules (1.2 g) once, three time a day for 7 days. arm group intervention list arm group intervention name Drug: Zhuli capsule Other: Standard medical treatment arm group label Placebo arm group type Placebo Comparator arm group description Base on the standard medical treatment, the patients in this group will be used placebo capsule, 2 capsules (1.2 g) once, three time a day for 7 days. arm group intervention list arm group intervention name Drug: Placebo Other: Standard medical treatment intervention list intervention intervention type Drug intervention name Zhuli capsule intervention description This capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days. intervention arm group label list intervention arm group label Zhuli capsule intervention type Drug intervention name Placebo intervention description The placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days. intervention arm group label list intervention arm group label Placebo intervention type Other intervention name Standard medical treatment intervention description Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include: if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs; if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks. intervention arm group label list intervention arm group label Placebo Zhuli capsule outcomes module primary outcome list primary outcome primary outcome measure The clinical control rate of sputum primary outcome description Defined as the proportion of patients with the expectoration rate ≥90%. primary outcome time frame Day 7 secondary outcome list secondary outcome secondary outcome measure Time to sputum turn white secondary outcome time frame up to Day 7 secondary outcome measure Cough Symptom Score Scale secondary outcome description Cough Symptom Score Scale include Day Cough Symptom Score and Night cough symptom score. In Day Cough Symptom Score, zero means no cough,one means occasionally short cough,two means frequent cough, slightly affecting daily activities,three means frequent coughing seriously affects daily activities;In Night cough symptom score,zero means no cough,one means short-term cough when falling asleep or occasional night cough,two means cough slightly affects night sleep,three means cough seriously affects night sleep. secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure Use of Antibiotic secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure Chronic obstructive pulmonary disease Assessment Test secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure The Phlegm-heat Syndrome (Tan-re Zheng) scale secondary outcome description The Phlegm-heat Syndrome (Tan-re Zheng) scale include measures of the main symptoms and the secondary symptoms. The main symptom is about the color ，the characteristics and the amount of sputum.Each one includes four levels,0 represents normal，3 represents mild symptom,6 represents moderate symptom,9 represents Severe symptom.The secondary symptoms include Day cough，Night cough，Dry throat thirst，fever，blush，Dry stool，Yellow urine ，Red tongue and pulse.Each one includes different levels.The higher score represents the more meeting The Phlegm-heat Syndrome (Tan-re Zheng) ，the lower score means the opposite. secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure The change value about the volume of sputum after treatment secondary outcome description Monitor the sputum volume everyday and compare changes in sputum volume in the treatment. secondary outcome time frame 0,Day 3, Day 7 eligibility module eligibility criteria Inclusion Criteria: Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis; Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM Age from 18 to 75 years old, regardless of gender; The score of each dimension of the sputum assement scale is ≥1; Those who have not participated in other drug clinical research in the past one month; Sign the informed consent letter. Exclusion Criteria: Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases. Loose stools due to Spleen deficiency and stomachache caused by cold. Diabetes or severe cardiovascular, liver (ALT>1.5×ULN), kidney (Cr>1.5×ULN) and other primary diseases. Pregnant and lactating women. Patients with acute and chronic respiratory failure. Those who cannot give full informed consent due to mental disorders. People with disabilities recognized by law. People with allergies, or allergic to the ingredients of the drug used in this test. Those who have used drugs with expectorant effects within the day. Patients who are participating in clinical trials of other drugs. - healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Zhong Wang, M.D. central contact role Contact central contact phone 86-10-64093207 central contact e mail zhonw@vip.sina.com central contact name Jun Liu, Ph.D. central contact role Contact central contact phone 86-10-64093207 central contact e mail franlj1104@aliyun.com location list location location facility China-Japan Friendship Hospital location city Beijing location state Beijing location zip 100029 location country China location contact list location contact location contact name Hongchun Zhang, Prof. location contact role Contact location contact phone 86-10-84205298 location contact e mail 13701226664@139.com location facility Guangdong Provincial Hospital of Traditional Chinese Medicine location city Guangzhou location state Guangdong location zip 510120 location country China location contact list location contact location contact name Lin Lin, Prof location contact role Contact location contact phone 86-20-81887233-34430 location contact e mail drlinlin620@163.com location facility Sichuan Provincial Hospital of Traditional Chinese Medicine location city Chengdu location state Sichuan location zip 610075 location country China location contact list location contact location contact name Qing-Song Huang, Prof location contact role Contact location contact phone 86-28-87783481 location contact e mail 252465965@qq.com location facility Zhejiang Provincial Hospital of Chinese Medicine location city Hangzhou location state Zhejiang location zip 310006 location country China location contact list location contact location contact name Zhen Wang, Prof. location contact role Contact location contact phone 86-571-86620303 location contact e mail wangzhen610@sina.cn derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001991 condition mesh term Bronchitis condition mesh id D000029481 condition mesh term Bronchitis, Chronic condition mesh id D000008171 condition mesh term Lung Diseases condition mesh id D000008173 condition mesh term Lung Diseases, Obstructive condition mesh id D000029424 condition mesh term Pulmonary Disease, Chronic Obstructive condition ancestor list condition ancestor condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000001982 condition ancestor term Bronchial Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M22602 condition browse leaf name Pulmonary Disease, Chronic Obstructive condition browse leaf as found Chronic Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf as found Pulmonary Disease condition browse leaf relevance high condition browse leaf id M10322 condition browse leaf name Lung Diseases, Obstructive condition browse leaf as found Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M4419 condition browse leaf name Bronchitis condition browse leaf as found Bronchitis condition browse leaf relevance high condition browse leaf id M22605 condition browse leaf name Bronchitis, Chronic condition browse leaf as found Chronic Bronchitis condition browse leaf relevance high condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name 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full study rank 61424 study protocol section identification module n c t id NCT04836650 org study id info org study id FOSSIL organization org full name Universidad de Extremadura org class OTHER brief title Effect of Postural Insoles on Stability and Leg Muscular Activity official title Effect of Postural Metatarsal Bar Orthotic Element on Stability and Leg Muscular Activity. A Randomized Clinical Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date April 6, 2021 start date type Actual primary completion date struct primary completion date April 15, 2021 primary completion date type Actual completion date struct completion date April 22, 2021 completion date type Actual study first submit date February 26, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 23, 2021 last update post date struct last update post date April 26, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Alfonso Martínez Nova responsible party investigator title Clinical Professor responsible party investigator affiliation Universidad de Extremadura lead sponsor lead sponsor name Universidad de Extremadura lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Posturology allows to treat postural problems by using postural insoles, which will have an effect at the neurophysiological level. Pieces of 1 to 3 millimeters are inserted to stimulate specific receptors located on the sole of the foot, which will affect the muscular proprioception and modify the activation of the ascending muscle chains. The hypothesis of this work is based on the fact that the use of postural insoles with a 2 millimeters metatarsal bar will influence the displacement of the center of pressure and the muscle activity of the leg when compared with a placebo insoles. Participants will be healthy subjects and will be divided into two groups, control and experimental. Subjects in the control group will be given a pair of flat insoles (placebo insoles) with 1.2 millimeters polyester resin. Those of the experimental group will be made the same insoles but they will include by thermal fusion a metatarsal bar of 2 millimeters polyester resin in the metatarsal zone corresponding to the 1st, 2nd, 3rd and 4th metatarsal head. Postural stability analysis will be performed with the force platform of the Biomechanics Institute of Valencia (IBV-Spain) and at the same time an electromyographic analysis in the dominant leg with a surface electromyograph system. Subjects will be assessed with their eyes open and closed under two situations, with footwear and with footwear and insoles. conditions module condition list condition Postural Stability Muscular Activity keyword list keyword Metatarsal Bar Insoles Postural stability Electromyograph Activity design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label Flat Insole (no metatarsal bar) arm group type Placebo Comparator arm group description Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles. arm group intervention list arm group intervention name Diagnostic Test: Postural stability assessment with a force platform. Diagnostic Test: Muscular assessment with a electromyograph arm group label Flat Insole (with 2 millimeters metatarsal bar) arm group type Experimental arm group description Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles with a 2 millimeters polyester resin metatarsal bar. arm group intervention list arm group intervention name Diagnostic Test: Postural stability assessment with a force platform. Diagnostic Test: Muscular assessment with a electromyograph intervention list intervention intervention type Diagnostic Test intervention name Postural stability assessment with a force platform. intervention description The postural stability will be assessed in static by means of the antero-posterior and medio-lateral displacements of the center of pressure in Romberg open and closed eyes test measured with a force platform (NED/SVE-IBV-Spain). Three 30-second measurements will be made in each condition. intervention arm group label list intervention arm group label Flat Insole (no metatarsal bar) Flat Insole (with 2 millimeters metatarsal bar) intervention type Diagnostic Test intervention name Muscular assessment with a electromyograph intervention description The activity of the medial and lateral gastrocnemius, soleus and anterior tibial muscles of the dominant leg will be assessed with the mDurance surface electromiograph at the same time as postural stability analysis is performed.Three 30-second measurements will be made in each condition. intervention arm group label list intervention arm group label Flat Insole (no metatarsal bar) Flat Insole (with 2 millimeters metatarsal bar) outcomes module primary outcome list primary outcome primary outcome measure Change of postural balance primary outcome description The mediolateral and anteroposterior excursion of centre of pressures will be measured in millimeters with a force platform with and without the insoles primary outcome time frame From baseline to 10 minutes primary outcome measure Change of muscular activity primary outcome description The muscular activity in gastrocnemius, soleus and tibialis anterioris will be measured as a percentage (%) with a surface electromyograph in one leg with and without the insoles primary outcome time frame From baseline to 10 minutes eligibility module eligibility criteria Inclusion Criteria: Healthy subjects with no discomfort in gait Subjects with not muscle and skeletal diseases Exclusion Criteria: Subjects with balance disorders, pain at legs Subjects with loss of balance healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module location list location location facility Alfonso Martínez Nova location city Plasencia location state Cáceres location zip 10600 location country Spain i p d sharing statement module i p d 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full study rank 61634 study protocol section identification module n c t id NCT04833920 org study id info org study id 539 organization org full name Assiut University org class OTHER brief title Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy official title Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date January 2022 primary completion date type Anticipated completion date struct completion date June 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Shereen Mamdouh responsible party investigator title Associate professor responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) detailed description Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy. conditions module condition list condition Chemotherapy-induced Peripheral Neuropathy keyword list keyword brain stimulation chemotherapy induced peripheral neuropathy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 26 enrollment type Anticipated arms interventions module arm group list arm group arm group label active tDCS arm group type Active Comparator arm group description tDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days arm group intervention list arm group intervention name Device: transcranial dirrect current brain stimuation arm group label sham tDCS arm group type Sham Comparator arm group description tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds arm group intervention list arm group intervention name Device: transcranial dirrect current brain stimuation intervention list intervention intervention type Device intervention name transcranial dirrect current brain stimuation intervention description tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day), intervention arm group label list intervention arm group label active tDCS sham tDCS outcomes module primary outcome list primary outcome primary outcome measure changes in the visual analogue scale primary outcome description patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable primary outcome time frame 0 (prestimulation), on the 5th day, 15th days and one month after the last session secondary outcome list secondary outcome secondary outcome measure changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS) secondary outcome description the patients will be asked to describe his pain by answering questions in yes or no; score ≥ 12 suggests neuropathic pain is likely to be involved and score < 12 suggests that neuropathic pain is unlikely to be involved secondary outcome time frame 0 (prestimulation),on the 5th day, 15th days and one month after the last session eligibility module eligibility criteria Inclusion Criteria: any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment Exclusion Criteria: patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia, higher brain dysfunction, migraine headache, brain cancer or metastasis and those known to have epilepsy healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Shereen M Kamal, Associate professor central contact role Contact central contact phone 01006279209 central contact e mail sheridouh79@yahoo.com overall official list overall official overall official name Shereen M Kamal, Associate Professor overall official affiliation Assiut University overall official role Principal Investigator location list location location facility South Egypt Cancer Institute location status Recruiting location city Assiut location zip 11715 location country Egypt location contact list location contact location contact name Shereen M Kamal, Lecturer location contact role Contact location contact phone 01006279209 location contact e mail sheridouh79@yahoo.com i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010523 condition mesh term Peripheral Nervous System Diseases condition ancestor list condition ancestor condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M12584 condition browse leaf name Peripheral Nervous System Diseases condition browse leaf as found Peripheral Neuropathy condition browse leaf relevance high condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions	NCT04833920	[ 101, 1554, 2025, 3997, 5391, 1545, 23124, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23493, 1580, 10973, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 4389, 1580, 2369, 8916, 1554, 1271, 1249, 5053, 3818, 1239, 8916, 1705, 152, 24162, 9637, 4094, 1641, 27007, 189, 15556, 1708, 1104, 8226, 3291, 22460, 1775, 1113, 20394, 5521, 20939, 1130, 20196, 14286, 9717, 4679, 1348, 151, 8816, 4184, 23610, 2078, 1641, 27007, 1104, 8226, 3291, 22460, 1775, 1457, 4060, 6856, 1118, 16752, 24684, 2896, 10294, 8005, 2007, 13809, 1665, 23851, 1348, 15974, 9493, 1457, 4060, 6856, 1113, 20394, 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full study rank 61795 study protocol section identification module n c t id NCT04831827 org study id info org study id 20-012010 organization org full name Mayo Clinic org class OTHER brief title Promoting Equity for Cancer Screening and Follow-up official title Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS) status module status verified date October 2021 overall status Withdrawn why stopped Insufficient study resources and change in practice. expanded access info has expanded access No start date struct start date September 1, 2021 start date type Anticipated primary completion date struct primary completion date May 2023 primary completion date type Anticipated completion date struct completion date May 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 19, 2021 last update post date struct last update post date October 27, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Chyke A. Doubeni responsible party investigator title Principal Investigator responsible party investigator affiliation Mayo Clinic lead sponsor lead sponsor name Mayo Clinic lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a randomized trial to assess the efficacy of reminder mechanisms on colorectal cancer (CRC) screening uptake among a cohort of patients who were previously mailed a multitarget stool DNA (mt-sDNA) test and did not complete the screening. Patients will be identified as being due for CRC screening and will be mailed a mt-sDNA kit to their home. Patients who do not complete screening with mt-sDNA within 30 days will be identified and randomized into one of three study arms to receive reminders to complete the mt-sDNA screening. The primary outcome is the rate of completion of screening for colorectal cancer with mt-sDNA test. detailed description Colorectal cancer (CRC) is the third leading cause of cancer-related death in the United States, and screening has been shown to reduce mortality from CRC. Screening is underutilized in the United States, particularly in some communities such as Blacks/African Americans, American Indians/Alaskan Natives, and rural populations, contributing to disparities in mortality. For CRC screening, mt-sDNA testing is one of several tests that are recommended by the United States Preventive Services Task Force (USPSTF). As part of a quality improvement program at our institution, those who are due for CRC screening are identified using a validated electronic algorithm and a kit is mailed directly to each patient. Our intervention is initiated on non-respondents to the mailed mt-sDNA outreach by testing the use of a technology-enabled reminder system. Thirty days after being mailed a mt-sDNA kit, patients who have not completed the screening will be randomized to receive a reminder to complete the mt-sDNA screening by one of three mechanisms (time 0): Automated reminder using the EHR patient portal messaging system. Automated reminder using a customized interactive voice response (IVR) system Personalized reminder phone calls from the clinical team This will allow for an empirical test of processes that can be employed to improve delivery of CRC screening and reduce preventable deaths in populations that are underserved with evidence-based interventions. conditions module condition list condition Colorectal (Colon or Rectal) Cancer design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking Single design masking description Investigators will be blinded to study arm; research coordinators will not be blinded because it is not practical to do so, but steps will be taken to minimize their awareness about study hypotheses. design who masked list design who masked Investigator enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label IVR Reminder arm group type Experimental arm group description Participants will receive an interactive voice reminder arm group intervention list arm group intervention name Other: IVR Reminder arm group label Personalized Phone Call Reminder arm group type Active Comparator arm group description Participants will receive a personalized phone call arm group intervention list arm group intervention name Other: Phone call from research team arm group label Portal Message Only arm group type Active Comparator arm group description Participants will receive a online patient portal message reminder arm group intervention list arm group intervention name Other: EHR Portal message intervention list intervention intervention type Other intervention name IVR Reminder intervention description Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21. intervention arm group label list intervention arm group label IVR Reminder intervention type Other intervention name Phone call from research team intervention description Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21. intervention arm group label list intervention arm group label Personalized Phone Call Reminder intervention type Other intervention name EHR Portal message intervention description Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21. intervention arm group label list intervention arm group label Portal Message Only outcomes module primary outcome list primary outcome primary outcome measure Primary Endpoint (intention-to-treat) primary outcome description The completion rate of mt-sDNA among eligible patients. The primary comparison will be the return rate compared across intervention arms. primary outcome time frame Completion by 6 months post randomization secondary outcome list secondary outcome secondary outcome measure Secondary Outcome (per protocol analysis) secondary outcome description The completion rate of mt-sDNA among eligible patients. The comparison will be the return rate compared across intervention arms, excluding participants who received an alternative intervention due to not having appropriate portal access. secondary outcome time frame Completion by 6 months post randomization eligibility module eligibility criteria Inclusion Criteria: Adults, between 50 to 75 years old. Due for colorectal cancer screening based on not having a record of a colonoscopy within 10 years, sigmoidoscopy, or CT colonography within 5 years, mt-sDNA within 3 years, or FIT within 1 year. Asymptomatic for colorectal cancer such as rectal bleeding or reported abdominal mass. Exclusion Criteria: For the intervention study, patients will be restricted to those aged 50 to 75 years and are due for colorectal cancer screening. We will exclude any patient who has: Had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, mt-sDNA within 3 years, CT colonography within 5 years, and FOBT/FIT within twelve months of inclusion into the study; A diagnosis of CRC or other GI cancer; History of confirmed Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis) or other colitis; Had a colectomy, partial or total; A diagnosis of Lynch Syndrome; A diagnosis of Familial Adenomatous Polyposis (FAP); Iron deficiency anemia; Lower GI bleeding; A metastatic (Stage IV) blood or solid tumor cancer; End stage renal disease; A first degree relative with CRC prior to age 50 or 2+ first degree relatives diagnosed at any age. healthy volunteers Accepts Healthy Volunteers gender All minimum age 50 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Chyke Doubeni, MBBS, MPH overall official affiliation Mayo Clinic overall official role Principal Investigator location list location location facility Mayo Clinic in Rochester location city Rochester location state Minnesota location zip 55905 location country United States references module see also link list see also link see also link label Mayo Clinic Clinical Trials see also link u r l https://www.mayo.edu/research/clinical-trials i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition ancestor list condition ancestor condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal (Colon or Rectal) Cancer condition browse leaf relevance high condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M13996 condition browse leaf name Rectal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions	NCT04831827	[ 101, 1554, 2025, 3997, 5391, 1559, 1580, 1571, 2025, 11309, 2237, 9117, 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full study rank 61509 study protocol section identification module n c t id NCT04835545 org study id info org study id DP-2021-Nemec organization org full name Czech Technical University in Prague org class OTHER brief title Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency official title Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency status module status verified date July 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date April 1, 2024 primary completion date type Anticipated completion date struct completion date April 1, 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 20, 2022 last update post date struct last update post date July 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Czech Technical University in Prague lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of the study is to investigate Work of Breathing of a person in simulated avalanche snow and consequent use of the measured data for judging which one of three simulated scenarios are alike while increasing hypercapnia in the simulated avalanche snow. detailed description The study is a part of a university diploma thesis aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. The Investigator is measuring Work of Breathing in three scenarios: a) 2L air pocket, b) 2L air pocket with resistance compensation and c) no air pocket. The investigator hypothesize that the Work of Breathing during compensation of air pocket will be alike with no air pocket scenario, thus proving significance of the resistance reduction for survival. The aim of the study is to investigate the effect of Work of Breathing on gas exchange in subjects breathing into the simulated avalanche snow scenarios. conditions module condition list condition Accident Caused by Snow Avalanche keyword list keyword snow avalanche hypercapnia work of breathing design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Basic Science design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 13 enrollment type Actual arms interventions module arm group list arm group arm group label Wet Perlite, 2L air pocket arm group type Experimental arm group description Breathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket arm group intervention list arm group intervention name Other: extreme hypercapnia induced by ventilation insufficiency arm group label Wet Perlite 2L air pocket with resistance compensation arm group type Experimental arm group description Breathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation arm group intervention list arm group intervention name Other: extreme hypercapnia induced by ventilation insufficiency arm group label Wet Perlite, no air pocket arm group type Experimental arm group description Breathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket arm group intervention list arm group intervention name Other: extreme hypercapnia induced by ventilation insufficiency intervention list intervention intervention type Other intervention name extreme hypercapnia induced by ventilation insufficiency intervention description extreme hypercapnia intervention arm group label list intervention arm group label Wet Perlite 2L air pocket with resistance compensation Wet Perlite, 2L air pocket Wet Perlite, no air pocket outcomes module primary outcome list primary outcome primary outcome measure The length of breathing primary outcome description Time to termination of the breathing experiment due to the decision of the tested subject, or determined by high end-tidal carbon dioxide value or by the order by the clinician assessing the health status of the subjects. primary outcome time frame Continuously within up to 7 minute interval from the beginning of the breathing experiment eligibility module eligibility criteria Inclusion Criteria: healthy and fit volunteers, classified as The American Society of Anesthesiologists class I without a smoking history Exclusion Criteria: Tiffeneau Index less than 0.70 any cardiovascular or respiratory condition healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module overall official list overall official overall official name Karel Roubík, PhD overall official affiliation Czech Technical University in Prague, FBMI overall official role Study Director location list location location facility Czech Technical University, Faculty of Biomedical Engineering location city Kladno location zip 272 01 location country Czechia references module reference list reference reference p m i d 26666523 reference type background reference citation Roubik K, Sieger L, Sykora K. Work of Breathing into Snow in the Presence versus Absence of an Artificial Air Pocket Affects Hypoxia and Hypercapnia of a Victim Covered with Avalanche Snow: A Randomized Double Blind Crossover Study. PLoS One. 2015 Dec 14;10(12):e0144332. doi: 10.1371/journal.pone.0144332. eCollection 2015. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000053120 condition mesh term Respiratory Aspiration condition mesh id D000006935 condition mesh term Hypercapnia condition ancestor list condition ancestor condition ancestor id D000012120 condition ancestor term Respiration Disorders condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000012818 condition ancestor term Signs and Symptoms, Respiratory condition browse leaf list condition browse leaf condition browse leaf id M26290 condition browse leaf name Respiratory Aspiration condition browse leaf as found Breathing condition browse leaf relevance high condition browse leaf id M9138 condition browse leaf name Hypercapnia condition browse leaf as found Hypercapnia condition browse leaf relevance high condition browse leaf id M14109 condition browse leaf name Respiration Disorders condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M14775 condition browse leaf name Signs and Symptoms, Respiratory condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M5423 intervention browse leaf name Cocaine 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full study rank 61363 study protocol section identification module n c t id NCT04837443 org study id info org study id 217 organization org full name Gazi University org class OTHER brief title The Effect of the Rubber Hand Illusion on Sensory Thresholds official title The Effect of the Rubber Hand Illusion on Sensory Thresholds status module status verified date July 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 28, 2021 start date type Actual primary completion date struct primary completion date September 1, 2021 primary completion date type Anticipated completion date struct completion date October 1, 2021 completion date type Anticipated study first submit date March 18, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 26, 2021 last update post date struct last update post date July 27, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Zafer Günendi responsible party investigator title professor doctor responsible party investigator affiliation Gazi University lead sponsor lead sponsor name Gazi University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The rubber hand illusion (RHI) causes a change in body perception and awareness as a result of the integration of simultaneously perceived visual and tactile stimulation. In the rubber hand illusion (RHI), which was first described in 1998, a realistic hand model is perceived as a part of the body and body awareness is impaired. In the RHI, the participant's real hand is positioned behind a screen so that it is out of sight; The rubber model hand is placed in the field of vision and in the appropriate position with the real hand. Brush is applied simultaneously to the same parts of the real and rubber hands. He/she perceives the rubber hand as his own and the brush starts to feel as if it is being rubbed into his own hand. This method, which causes the illusion of body belonging, has been defined as the rubber hand illusion. During the rubber hand illusion, increased activity was observed in the ventral premotor cortex, infraparietal cortex and cerebellum in functional MRI. It is suggested that this phenomenon occurs with the integration of interrelated visual, tactile and proprioceptive senses reaching the premotor cortex. Quantitative sensory tests are standardized subjective clinical sensitivity tests that require the collaboration of the person to be examined. In the tests, calibrated stimuli are applied to capture perception and pain thresholds, thus providing information about sensory thresholds. The impairment of body perception caused by RHI contributes to the multi-faceted understanding of sensory perception, higher-level cognitive processes, brain mapping and functions. In the studies; It has been suggested that the conflict between visual and proprioceptive sensory information created during the rubber hand illusion is resolved by the attenuation of somatosensory input at the cortical level. As far as we know, tactile sensory threshold from quantitative sensory tests, two-point discrimination from cortical senses, pressure pain threshold measured by the algometer, and vibration threshold variation during and after rubber hand burning, which causes changes in body perception, have not been studied before. In this study, the relationship between the RHI phenomenon and sensory thresholds will be evaluated. conditions module condition list condition Healthy keyword list keyword sensory threshold rubber hand illusion design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Basic Science design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Synchronous working group arm group type Experimental arm group intervention list arm group intervention name Behavioral: Rubber hand illusion arm group label Asynchronous working group arm group type Sham Comparator arm group intervention list arm group intervention name Behavioral: Rubber hand illusion intervention list intervention intervention type Behavioral intervention name Rubber hand illusion intervention description Tactile sensory threshold from quantitative sensory tests, two point discrimination from cortical senses, pressure pain threshold measured by algometer will be examined during and after the rubber hand burning, which causes changes in body perception. intervention arm group label list intervention arm group label Asynchronous working group Synchronous working group outcomes module primary outcome list primary outcome primary outcome measure tactile sensation threshold primary outcome description Semmes-Weinstein monofilaments (SWM) are widely used for reproducible testing and measurement of tactile sensory threshold. The sizes of Semmes-Weinstein monofilaments increase on a logarithmic scale. It is made with nylon (line) monofilaments of approximately the same length. To apply, monofilaments are kept perpendicular to the skin and brought into contact. When the pressure is increased and the end point of the filament reaches the forcing threshold, the filament bends. Even if pressure is continued after the filaments are bent, there is no increase in the pressure felt on the skin. For this reason, when the monofilaments are inclined, since no more pressure can be applied with that filament, it is questioned whether the patient is felt or not. Three applications should be made to the patient with the same filament. primary outcome time frame one hour primary outcome measure two point discrimination primary outcome description Two point discrimination (TPD) is the ability to distinguish between two points that are brought into contact with the skin at the same time and with the same pressure, that they are actually two separate points, not one. It was described by Ernest Heinrich Weber (1846). Blunt tip static and mobile TPD is usually tested using Disk-Criminator. Two points are brought into contact with the skin with a compass-like instrument or a compass. It can randomly switch between touching and touching a point or two points in the area being tested. The person being tested is asked to say how many points he felt. The smallest distance resulting in the perception of two different stimuli is recorded as the patient's two point discrimination threshold. primary outcome time frame one hour primary outcome measure pressure pain threshold primary outcome description Pain pressure threshold is defined as the minimum pressure value that creates a perception of pain. The test determines the amount of pressure in a particular area as soon as an ever-increasing painless pressure stimulus turns into a painful feeling of pressure. The pressure algometer (dolorimeter) used for this test is a device used to evaluate sensitivity to pain. The mechanical method using the pressure sensor provides ease of use, is harmless to the patient, and has acceptable reliability and repeatability. Light pressure is applied to the body area to be tested with the algometer. The intensity of the pressure is increased gradually. The participant is asked to say the moment he feels the sensation of pain instead of pressure during the algometric measurement. The amount of pressure that causes pain is recorded as the pressure pain threshold (PPT) in kg / cm2. It has been shown that 3 measurements are required to maximize measurement properties. primary outcome time frame one hour eligibility module eligibility criteria Inclusion Criteria: Healthy 18-65 years old age Exclusion Criteria: Neuropathy Presence of any known neurological or psychiatric disease Inability to cooperate with the tests to be performed Amputation and nerve damage in the upper extremities Upper extremities dysfunction due to nerve damage healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name zafer günendi, MD central contact role Contact central contact phone +903122025219 central contact e mail zafergunendi@yahoo.com location list location location facility Gazi University Faculty of Medicine Department of PMR location status Recruiting location city Ankara location zip 06500 location country Turkey location contact list location contact location contact name hatice ceylan, MD location contact role Contact location contact phone +903122025219 references module reference list reference reference p m i d 16343947 reference type background reference citation Tsakiris M, Prabhu G, Haggard P. Having a body versus moving your body: How agency structures body-ownership. Conscious Cogn. 2006 Jun;15(2):423-32. doi: 10.1016/j.concog.2005.09.004. Epub 2005 Dec 15. reference p m i d 9486643 reference type background reference citation Botvinick M, Cohen J. Rubber hands 'feel' touch that eyes see. Nature. 1998 Feb 19;391(6669):756. doi: 10.1038/35784. No abstract available. reference p m i d 22000838 reference type background reference citation Ramakonar H, Franz EA, Lind CR. The rubber hand illusion and its application to clinical neuroscience. J Clin Neurosci. 2011 Dec;18(12):1596-601. doi: 10.1016/j.jocn.2011.05.008. Epub 2011 Oct 13. reference p m i d 23285026 reference type background reference citation Mohan R, Jensen KB, Petkova VI, Dey A, Barnsley N, Ingvar M, McAuley JH, Moseley GL, Ehrsson HH. No pain relief with the rubber hand illusion. PLoS One. 2012;7(12):e52400. doi: 10.1371/journal.pone.0052400. Epub 2012 Dec 20. reference p m i d 30967758 reference type background reference citation Fang W, Zhang R, Zhao Y, Wang L, Zhou YD. Attenuation of Pain Perception Induced by the Rubber Hand Illusion. Front Neurosci. 2019 Mar 22;13:261. doi: 10.3389/fnins.2019.00261. eCollection 2019. reference p m i d 3614975 reference type background reference citation Fischer AA. Pressure algometry over normal muscles. Standard values, validity and reproducibility of pressure threshold. Pain. 1987 Jul;30(1):115-126. doi: 10.1016/0304-3959(87)90089-3. reference p m i d 28877282 reference type background reference citation Won SY, Kim HK, Kim ME, Kim KS. Two-point discrimination values vary depending on test site, sex and test modality in the orofacial region: a preliminary study. J Appl Oral Sci. 2017 Jul-Aug;25(4):427-435. doi: 10.1590/1678-7757-2016-0462. reference p m i d 21712138 reference type background reference citation Haloua MH, Sierevelt I, Theuvenet WJ. Semmes-weinstein monofilaments: influence of temperature, humidity, and age. J Hand Surg Am. 2011 Jul;36(7):1191-6. doi: 10.1016/j.jhsa.2011.04.009. i p d sharing statement module i p d sharing No i p d sharing description Since the study is planned as a specialist thesis, the details of the study can be shared by the faculty administration. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007088 condition mesh term Illusions condition ancestor list condition ancestor condition ancestor id D000010468 condition ancestor term Perceptual Disorders condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M9288 condition browse leaf name Illusions condition browse leaf as found Illusion condition browse 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full study rank 61349 study protocol section identification module n c t id NCT04837625 org study id info org study id MC2020883 organization org full name Huashan Hospital org class OTHER brief title A Multicenter Prospective Registration Study of Myasthenic Crisis in China official title A Multicenter Prospective Registration Study of Myasthenic Crisis in China status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date October 1, 2020 start date type Actual primary completion date struct primary completion date September 30, 2026 primary completion date type Anticipated completion date struct completion date September 30, 2026 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Chongbo Zhao responsible party investigator title Professor responsible party investigator affiliation Huashan Hospital lead sponsor lead sponsor name Huashan Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study is a multicenter, prospective, observational research. It will register the basic demographic information, medical history characteristics, clinical features, auxiliary examinations, treatment, outcomes of tracheal intubation/ventilator related events, and clinical outcomes of Myasthenic Crisis patients. The objectives including: Obtain epidemiological data of MC in China; Establish a standardized registration system for MC patients in China; Explore the epidemiology, clinical characteristics, serological characteristics, clinical characteristics of MC, predisposing and predictive factors, extubation process/time, weaning/extubation outcome and predictors of clinical outcome in Chinese MC patients. conditions module condition list condition Myasthenia Gravis Myasthenic Crisis design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Myasthenic Crisis Cohort arm group intervention list arm group intervention name Other: no interventions intervention list intervention intervention type Other intervention name no interventions intervention description no interventions intervention arm group label list intervention arm group label Myasthenic Crisis Cohort outcomes module primary outcome list primary outcome primary outcome measure MG-ADL of 3 years after off-mechanical ventilation primary outcome time frame Sep,2026 eligibility module eligibility criteria Inclusion Criteria: (1)clinical history and signs of fluctuating weakness and fatigability; (2)seropositivityforAChR/MuSKantibodies; (3)If negative or the tested antibodies, positive repetitive nerve stimulation(RNS) at low frequency(2-5Hz) is required; (4)A serious, life-threatening, rapid worsening of MG and potential airway compromise from ventilatory or bulbar dysfunction. Exclusion Criteria: the RNS had over 100% increase after high frequency stimulation or R2 repeats,to differentiate from lambert-Eaton syndrome and congenital MG. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population The study population will be recruited from multiple centers across China. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Xiao Huan, MD central contact role Contact central contact phone +8618351973910 central contact e mail hx941223@163.com central contact name Susan Luo, MD;PHD central contact role Contact central contact e mail SusanRo_36@hotmail.com location list location location facility Huashan Hospital Fudan University location status Recruiting location city Shanghai location state Shanghai location zip 200040 location country China location contact list location contact location contact name Xiao Huan, MD location contact role Contact location contact e mail hx941223@163.com location contact name Susan Luo, MD；PHD location contact role Contact location contact e mail SusanRo_36@hotmail.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009157 condition mesh term Myasthenia Gravis condition ancestor list condition ancestor condition ancestor id D000020361 condition ancestor term Paraneoplastic Syndromes, Nervous System condition ancestor id D000009423 condition ancestor term Nervous System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000010257 condition ancestor term Paraneoplastic Syndromes condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000020511 condition ancestor term Neuromuscular Junction Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11264 condition browse leaf name Myasthenia Gravis condition browse leaf as found Myasthenia Gravis condition browse leaf relevance high condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M12322 condition browse leaf name Paraneoplastic Syndromes condition browse leaf relevance low condition browse leaf id M21313 condition browse leaf name Paraneoplastic Syndromes, Nervous System condition browse leaf relevance low condition browse leaf id M11519 condition browse leaf name Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M21450 condition browse leaf name Neuromuscular Junction Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3973 condition browse leaf name Myasthenia Gravis condition browse leaf as found Myasthenia Gravis condition browse leaf relevance high condition 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full study rank 61719 study protocol section identification module n c t id NCT04832815 org study id info org study id IRB_00125426 organization org full name VA Salt Lake City Health Care System org class FED brief title Equine Human Interaction With Veterans official title Equine Human Interaction With Veterans status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date December 19, 2019 start date type Actual primary completion date struct primary completion date December 19, 2023 primary completion date type Anticipated completion date struct completion date December 19, 2023 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 2, 2022 last update post date struct last update post date June 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name VA Salt Lake City Health Care System lead sponsor class FED collaborator list collaborator collaborator name Utah State University collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research purposes. conditions module condition list condition PTSD keyword list keyword Equine PTSD design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Equine Therapy arm group type Experimental arm group intervention list arm group intervention name Behavioral: Equine Therapy arm group label Treatment as Usual (TAU) arm group type No Intervention arm group label Therapeutic Horsemanship Program arm group type Experimental arm group intervention list arm group intervention name Behavioral: Therapeutic Horsemanship Program intervention list intervention intervention type Behavioral intervention name Equine Therapy intervention description Aim 1: Six session equine interventions. Intervention will be provided one day per week for four weeks. During the first two weeks, each intervention day with consist of two sessions with a lunch break in between. Weeks four and five consist of one trail riding session per intervention day followed by lunch. Each session will be approximately 1.5 hours in length. Sessions 1-4 will occur at the USU Equine Education Center, and session 5-6 will occur on local trails. Optional transportation for participants will be provided from the VA to the intervention site. intervention arm group label list intervention arm group label Equine Therapy intervention type Behavioral intervention name Therapeutic Horsemanship Program intervention description Aim 2: Therapeutic Horsemanship program utilizes the USU Pathways to Horsemanship model and covers levels of equestrian training from basic groundwork to more advanced riding techniques. Training occurs in a three or six-session format with once weekly sessions over three or six weeks. Mindfulness and mindful self-compassion training may be included. intervention arm group label list intervention arm group label Therapeutic Horsemanship Program outcomes module primary outcome list primary outcome primary outcome measure Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program primary outcome description AAQII measures psychological flexibility. The total AAQII score can range from 7 to 49, with higher values indicating greater psychological inflexibility. Mixed Effect Modeling will be used for the analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome at multiple time points: pre-intervention, post-intervention for selected or all sessions, and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Heart Rate (HR) Indices primary outcome description To determine correlations between physiological responses of the rider and horse, the following heart rate (HR) indices will be computed: Mean HR, standard deviation of the beat-to-beat intervals (SDRR) and the root mean square of successive beat-to-beat differences (rMSSD). Both SDRR and rMSSD are measures of HR variability and reflect shifts between sympathetic (e.g., decrease in HR variability) or parasympathetic (e.g., increase in HR variability) drive. These measures will be taken during each equine intervention session. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Positive and Negative Affect Scale (PANAS) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program primary outcome description PANAS measures short-term positive and negative emotions. The total PANAS-C score can range from 12 to 60 for the positive affect (PA) scale, with higher values indicating greater PA. Similarly, the score range from 15 to 75 for the negative affect (NA) scale, with higher values indicating greater NA. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the primary outcome at multiple time points: pre-intervention, post-intervention sessions, and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Physical Activity Enjoyment Scale (PACES) for Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program primary outcome description PACES measures enjoyment of activity. The total PACES score can range from 18 to 126, with higher values indicating greater enjoyment. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome after the intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Posttraumatic Stress Disorder Checklist (PCL) for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description PCL measures PTSD symptoms. The total PCL score can range from 17 to 85, with higher values indicating greater PTSD symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Beck Depression Inventory (BDI) for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description BDI measures depressive symptoms. The total BDI score can range from 0 to 63, with higher values indicating greater depressive symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description Q-LES-Q-SF measures quality of, and satisfaction with, life. The total Q-LES-Q-SF score can range from 14 to 70, with higher values indicating greater satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean and Standard Deviation of Personal Satisfaction Program Survey for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description Personal Satisfaction Program Survey measures satisfaction with the program. The total Personal Satisfaction Program Survey score can range from 0 to 210, with higher values indicating greater program satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Toronto Mindfulness Scale (TMS) for Equine Therapy + TAU cohort primary outcome description TMS measures state mindfulness. The total TMS score can range from 0 to 52, with higher values indicating greater state mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome pre-intervention, post-intervention sessions, post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Five Facet Mindfulness Questionnaire (FFMQ) for Horsemanship Skills Training Program. primary outcome description The total FFMQ score can range from 8 to 40 for each of the facets (observe, describe, act aware, nonjudge, nonreact), with higher values indicating greater levels of mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention. primary outcome time frame through study completion, an average of 2 years secondary outcome list secondary outcome secondary outcome measure Mean and Standard Deviation of Demographic information including medical and psychiatric diagnoses secondary outcome description Demographic information as well as medical and psychiatric diagnoses of the participants will be extracted from the electronic medical record. Demographic information includes age, race, ethnicity, and service connection. Numbers of psychiatric hospitalizations and emergency department visits for 6 months pre- and 6 months post-intervention will be extracted from the electronic medical record. secondary outcome time frame through study completion, an average of 2 years eligibility module eligibility criteria Inclusion Criteria: For Aim 1: Currently enrolled for services at the VA Salt Lake City Health Care System At least one mental health service encounter within the preceding 12 months Diagnosed with PTSD by a clinician within the preceding 24 months Have a doctor release to participate in equine activities For Aim 2: Currently enrolled for services at the VA Salt Lake City Health Care System Have a doctor release to participate in equine activities Exclusion Criteria: Pregnancy Diagnoses of a psychotic spectrum illness and/or cognitive impairment Physical disability that would prevent horseback riding Weight >= 250 lbs. Potentially the severity of and psychological and/or behavioral symptoms will be considered healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name William R Marchand, MD overall official affiliation Salt Lake City Veterans' Administration Medical Center overall official role Principal Investigator location list location location facility VA Salt Lake City Health Care System location city Salt Lake City location state Utah location zip 84148 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022	NCT04832815	[ 101, 1554, 2025, 3997, 5391, 1559, 16382, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 17101, 1604, 16337, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 146, 22672, 168, 3135, 11964, 1571, 23117, 1545, 2369, 8916, 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full study rank 61829 study protocol section identification module n c t id NCT04831385 org study id info org study id CREC 2021.266 organization org full name Chinese University of Hong Kong org class OTHER brief title The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia official title The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia status module status verified date March 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2022 start date type Anticipated primary completion date struct primary completion date August 31, 2024 primary completion date type Anticipated completion date struct completion date August 31, 2025 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 18, 2022 last update post date struct last update post date March 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Alice Pik Shan KONG responsible party investigator title Professor responsible party investigator affiliation Chinese University of Hong Kong lead sponsor lead sponsor name Chinese University of Hong Kong lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is a RCT aiming to use CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D comorbid with insomnia. detailed description Insomnia is the most common sleep disorders affecting 10% to 30% of the population, imposing a huge burden on healthcare systems. While the amount of deep sleep (slow wave and rapid eye movement) declines with age, older people are known to be at escalated risk of sleep disturbances with 20-50% adults aged more than 65 years suffering from insomnia. Cognitive behavioral therapy (CBT-I) is the recommended first line treatment of chronic insomnia. However, only 40% Hong Kong Chinese adults seek help for insomnia and most of them have treatment from Complementary Alternative Medicine (CAM) or western doctors for hypnotics and none for CBT-I. Furthermore, there are increasing concerns regarding the potential negative effects of hypnotics on glycemic control. From a meta-analysis including 17 studies involving 36,938,981 individuals with insomnia followed up for a mean period of 11.6 years, there was a tendency of increased risk of mortality associated with hypnotic use. CBT-I is well recognized as an efficacious treatment modality in people with chronic insomnia. From the results of a systemic review and meta-analysis including 20 randomized controlled trials (RCT) involving 1,162 participants with insomnia, intervention with CBT-I, incorporated at least 3 of the following elements: cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation, CBT-I is demonstrated to improve sleep outcomes namely sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE). From another meta-analysis including 37 studies aiming to examine the effect of CBT-I for insomnia comorbid with psychiatric and/or medical conditions including alcohol dependence, depression, post-traumatic stress disorders, chronic pain, cancer, Parkinson disease, coronary artery disease, pulmonary and renal diseases, CBT-I is also shown to improve sleep parameters with beneficial effects greater in those comorbid with psychiatric than in medical conditions. Although CBT-I is considered the first line treatment for chronic insomnia, the effect of CBT-I on the functional outcomes of the comorbid medical conditions is unclear. To date, there was one RCT in United States including 109 older adults (mean age 64.8 ±6.0 years) randomized to 2-hours group sessions (7-10 subjects per group) weekly over 4 months of CBT-I (n=47), Tai Chi Chih (n=39) and sleep seminar (n=23), which found that participants randomized to CBT-I had a lower risk of having increased biological risk (defined as having ≥4 biomarkers out of a total of 8) at 16-months ie 12 months post-intervention when compared to those in sleep seminar only (odd ratio, OR=0.06, 95% confidence interval, CI 0.005-0.67, p<0.01). However, the effect of CBT-I on changes of glycemia had not been reported in this study. There is another pilot RCT (ClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996), enrolled 28 type 2 diabetes (T2D) with insomnia symptoms and recruitment was completed by 1 June 2019 (for 6-weeks intervention including six 1-hour sessions of CBT-I versus health education), in which insomnia severity was the primary outcome and random glucose by glucometer and glycated haemoglobin (HbA1c) were the other outcomes measures; but the results of this pilot RCT are still pending. Taken together, the effect of CBT-I on glycemic control and other outcomes in people with T2D comorbid with insomnia are under-explored. Diabetes is one of the most prevalent non-communicable diseases affecting up to 463 million people worldwide and this figure is estimated to rise to 700 million by 2045, accounting for 10.9% of world population. From the United Kingdom Prospective Diabetes Study (UKPDS), the landmark trial of T2D, 0.9% difference in HbA1c between intensive treatment and conventional treatment arms (HbA1c 7% versus 7.9%), resulted in 12% reduction of any diabetes related endpoints (p=0.029). Although diabetes is prevalent and there is a wealth of evidence supporting that good glycemic control can prevent diabetes related complications, many people with diabetes across the globe do not reach glycemic goals. Our group has reported that <50% T2D reached glycemic goal of HbA1c <7% in Hong Kong. Behavioral changes, along with lifestyle modifications, are the cornerstones of diabetes management. Healthy diet and regular exercise not only have beneficial effects on glycemic control in T2D, but also improves sleep in T2D with insomnia. Sleep plays a pivotal role in regulating energy metabolism and updated guidelines have included adequate sleep, on average 7 hours per night, as one of the key elements of lifestyle therapy in diabetes management. Apart from quantity, quality of sleep is also essential for well-being of an individual. Optimal treatment of insomnia in diabetes may potentially help to improve glycemia although the importance of management of insomnia has not received adequate clinical attention. Of note, there are higher percentage of people with chronic insomnia suffering from diabetes than those without insomnia (13.1% versus 5%). Our team has reported that, among 3,753 Hong Kong Chinese with T2D, around one out of ten T2D had insomnia and insomnia is more commonly found in women than in men (11.4% versus 8.2%, p=0.01). Interestingly, we found that T2D men with comorbid insomnia have worse glycemic control, in terms of higher fasting plasma glucose (FPG) and HbA1c, than their counterpart without insomnia whereas such difference was not observed in women. Although insomnia is more common in women, men with insomnia is at higher risk for insomnia related glycemic problems. Other researchers have reported that people with T2D and insomnia symptoms have worse self-care than their counterparts without insomnia symptoms and the suboptimal self-care behavior in people with T2D comorbid insomnia is potentially the hurdle to achieve glycemic goals. Not only insomnia may worsen glycemic control of T2D, insomnia may also increase the risk of development of cognitive impairment. From 981 Hong Kong Chinese T2D aged ≥60 years, without cognitive impairment at baseline (58.1% men, mean age: 62.5±2.5 years, mean HbA1c 7.4±2.2%), 3.1% developed cognitive impairment after a median follow-up of 6.8 years (interquartile range: 1.7 years), and T2D comorbid with insomnia has a 4-fold risk of development of cognitive impairment compared to their counterpart without insomnia [unpublished data, presented as poster in European Association for the Study of Diabetes (EASD) in Barcelona in 2019, https://www.easd.org/annual-meeting/easd-2019.html]. While CBT-I improves sleep in people suffering from chronic insomnia, there is a lack of evidence regarding the impact of CBT-I on cognitive function. Against this background and based on a multidisciplinary team experienced in CBT-I, including endocrinologist, geriatrician, psychiatrist, clinical psychologist, behavioural therapist and statistician, we propose to conduct a RCT with CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D men comorbid with insomnia. conditions module condition list condition Diabetes Mellitus, Type 2 Insomnia design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 214 enrollment type Anticipated arms interventions module arm group list arm group arm group label CBT-i arm group type Experimental arm group intervention list arm group intervention name Behavioral: Cognitive Behavioural Therapy arm group label Control (Usual Care) arm group type No Intervention arm group description Control intervention list intervention intervention type Behavioral intervention name Cognitive Behavioural Therapy intervention description CBT is a first line therapy for insomnia intervention arm group label list intervention arm group label CBT-i outcomes module primary outcome list primary outcome primary outcome measure The primary outcome measure will be changes in glycemic control, as measured by HbA1c, from baseline. primary outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: Aged ≥60 years; T2D with suboptimal glycemic control defined as HbA1c 7.5-10%; Chinese ethnicity; Comorbid with insomnia having ISI score >14; Able and willing to give informed written consen Exclusion criteria: Cognitive impairment (HK-MoCA score of ≤22); Depression (GDS-15 score >8) and other psychiatric disorders e.g. generalized anxiety disorder, restless leg syndrome, schizophrenia to be elucidated by history from research nurse and questionnaires; OSA as defined as apnoea-hypopnoea index (AHI) ≥15 events per night; Benign prostatic hypertrophy by history and/or elevated PSA and any other chronic medical condition that is likely to affect sleep e.g. chronic pain; Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep; Cerebrovascular accidents, vascular dementia, or any condition that are known to affect cognitive function; Shift workers; Haemoglobinopathies, renal failure, need of regular blood transfusion or any other conditions which will affect the validity of HbA1c in measurement of glycemia; Any condition, as judged by the investigators, as ineligible to participate in this study. healthy volunteers No gender All minimum age 60 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Alice Kong, MD central contact role Contact central contact phone 3505 2648 central contact e mail alicekong@cuhk.edu.hk i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007319 condition mesh term Sleep Initiation and Maintenance Disorders condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003924 condition mesh term Diabetes Mellitus, Type 2 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000020919 condition ancestor term Sleep Disorders, Intrinsic condition ancestor id D000020920 condition ancestor term Dyssomnias condition ancestor id D000012893 condition ancestor term Sleep Wake Disorders condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf as found Diabetes Mellitus, Type 2 condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M9508 condition browse leaf name Sleep Initiation and Maintenance Disorders condition browse leaf as found Insomnia condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M21395 condition browse leaf name Parasomnias condition browse leaf relevance low condition browse leaf id M21807 condition browse leaf name Sleep Disorders, Intrinsic condition browse leaf relevance low condition browse leaf id M21808 condition browse leaf name Dyssomnias condition browse leaf relevance low condition browse leaf id M14848 condition browse leaf name Sleep Wake Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology	NCT04831385	[ 101, 1554, 2025, 3997, 5391, 1604, 26752, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 22639, 23249, 1571, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 15531, 8231, 17881, 1475, 119, 1744, 1545, 2369, 8916, 1554, 1271, 1922, 1239, 1104, 3475, 3462, 8916, 1705, 152, 24162, 9637, 4094, 1641, 1109, 13788, 1104, 3291, 22152, 3946, 4108, 2328, 17564, 1348, 23789, 1111, 1130, 7301, 1306, 5813, 113, 18893, 1942, 118, 146, 114, 1113, 144, 1193, 2093, 7257, 6342, 1107, 26694, 6902, 123, 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full study rank 61683 study protocol section identification module n c t id NCT04833283 org study id info org study id 101499310010796 organization org full name I.M. Sechenov First Moscow State Medical University org class OTHER brief title The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass. official title The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass and Its Impact on Postoperative Complications. status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date January 25, 2021 start date type Actual primary completion date struct primary completion date September 2, 2022 primary completion date type Anticipated completion date struct completion date February 28, 2023 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date May 31, 2022 last update post date struct last update post date June 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name I.M. Sechenov First Moscow State Medical University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The aim of the study is to evaluate the effects of intermittent hypoxic-hyperoxic training (IHHT) to protect myocardium against perioperative myocardial injury during cardiac surgery using cardiopulmonary bypass. detailed description This is a prospective, single-center, randomized controlled clinical trial, which will involve patients over 18 years old who would be recruited consecutively during pre-admission consultation at the I.M Sechenov First Moscow State Medical University Cardiac Surgery Department. All patients with a diagnosis of valvular heart disease, or aortic arch disease and indications for cardiac surgery, according to the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines. Five days before the operation, patients will be randomly assigned into two groups using a computer-generated randomization table: intermittent hypoxic-hyperoxic training and an intermittent hypoxic-hyperoxic training control group. For both groups laboratory testing (specific biomarkers - C-reactive protein, troponin I, fatty acid-binding protein (FABPs) and lactate) will be performed before training and after the surgery, and the hypoxic-inducible factor (HIF 1 alpha) would be implemented before and after the trainings. Patients in the intermittent hypoxic-hyperoxic training group will undergo four daily procedures of interval hypoxic-hyperoxic training before cardiac surgery, using a normobaric device to obtain hypoxic and hyperoxic gas mixtures (ReOxy Cardio; Aimediq S.A., Luxemburg, Registration certificate in RU P3H 2014/1486). Before the start of the training, each patient would undergo a hypoxic test to assess the individual response to hypoxia, and to determine the rate of reduction of blood oxygen saturation (SpO2) with a finger pulse oximeter (Masimo SET, measurement accuracy ±2%). During 5 minutes the patient will receive air with reduced oxygen content (12%), through a mask under constant monitoring of the heart rate (HR) and SpO2. As a safety measure, minimal SpO2 would be set at 82% and maximal accepted increase of heart rate would be set to +50% of the initial heart rate. When these values would be reached, the supply of oxygen automatically would be switched to a hyperoxic gas mixture (35%-40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 was lower before the procedure), therefore depending on the rate of saturation reduction, will be taken 1 to 3 minutes (mean 1 min and 50 seconds). The intention is to create hyperoxic arterial oxygen tension and not to simply reduce the time required to recover from hypoxia. Intermittent hypoxic hyperoxic training would be considered successful if there were no significant side effects during the procedure such as angina pain, loss of consciousness, severe dizziness or other variants of significant subjective deterioration of the patient's condition. In the case of successfully passing the test, patients will proceed to the basic intermittent hypoxic hyperemic training. During the training, the hypoxic gas mixture will be given to the patient again in intermittent mode, based on the individual test parameters and alternating with the supply of a hyperoxic gas mixture. One cycle of the procedure consists of hypoxic and hyperoxygenated intervals, the duration of which will be regulated automatically according to the biofeedback principle, based on monitoring of individual values of SpO2 and heart rate. The duration of the hypoxic period ranges from 3 to 5 minutes, and the duration of the hyperoxic period ranges from 1 to 3 minutes, depending on the SpO2 recovery rate. The total time of the hypoxic gas mixture inhaled during one procedure will be 20-30 min. A final training would be conducted in the evening before the surgery. Patients in the intermittent hypoxic-hyperoxic training - control group also will undergo four daily procedures before surgery, using 40 min training periods with simulation of intermittent hypoxic-hyperoxic training by using the same equipment, the patient receives moistened air through a placebo mask under constant monitoring of heart rate and SpO2. Only the person who will conduct the training would know about the patient's allocation to a particular intervention group, the anesthesiologists and cardiac surgeons will not have access to this information. Episodes of cardiac arrhythmias, hypotension with a need for inotropic drug prescription, changes in electrocardiogram, pulse values and blood pressure levels will be recorded during surgery and the postoperative period. Patients will be monitored for 7 days in the hospital, and 30 days after discharge to evaluate the complications. Differences between groups will be assessed using the unpaired Student's t-test or the one-tailed Anova test followed by the Bonferroni post-test. Baseline corrected logistic regression models will be used to estimate the training effect in relation to primary and secondary endpoints. Statistical significance will be set at 0.05 to test hypotheses. conditions module condition list condition Valvular Heart Disease Aortic Arch Aneurysm Surgery keyword list keyword cardiac pulmonary bypass reperfusion interval hypoxic-hyperoxic training preconditioning valvular heart disease, aortic arch aneurysm design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label the intervention group intermittent hypoxic-hyperoxic training arm group type Experimental arm group description the intervention group is patients performing intermittent hypoxic-hyperoxic training before operation. ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) Intervention Description: Perform 4 trainings daily of intermittent hypoxic hyperoxic trainings before surgery, using 40 min trainings periods, the patient will receive air with reduced oxygen content (12 %) through a mask under constant monitoring of heart rate (HR) and SpO2. As a safety measure, minimal SpO2 was set at 82 % and maximal accepted increase of heart rate was set to + 50 % of the initial HR. When these values would be reached, the supply of oxygen automatically switched to a hyperoxic gas mixture (35% - 40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 would be lower before the procedure), which, depending on the rate of saturation reduction, will takes 1 to 3 min (mean 1 min and 50 s). arm group intervention list arm group intervention name Device: ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) arm group label the control group arm group type Placebo Comparator arm group description intermittent hypoxic-hyperoxic training control group will be identical to the main group, also underwent four daily procedures before surgery using 40 min training periods with simulation of intermittent hypoxic-hyperoxic trainings by using the same equipment, whereas moistened air will be delivered through a placebo mask arm group intervention list arm group intervention name Device: ReOxy Cardio device intervention list intervention intervention type Device intervention name ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) intervention description Perform 4 trainings daily of intermittent hypoxic hyperoxic trainings before surgery, using 40 min trainings periods, the patient will receive air with reduced oxygen content (12 %) through a mask under constant monitoring of heart rate (HR) and SpO2. As a safety measure, minimal SpO2 was set at 82 % and maximal accepted increase of heart rate was set to + 50 % of the initial HR. When these values would be reached, the supply of oxygen automatically switched to a hyperoxic gas mixture (35% - 40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 would be lower before the procedure), which, depending on the rate of saturation reduction, will takes 1 to 3 min (mean 1 min and 50 s). intervention arm group label list intervention arm group label the intervention group intermittent hypoxic-hyperoxic training intervention type Device intervention name ReOxy Cardio device intervention description Perform 4 trainings daily of intermittent hypoxic-hyperoxic trainings before surgery, using 40 min trainings periods, whereas moistened air will be delivered through a mask under constant monitoring of heart rate (HR) and SpO2. intervention arm group label list intervention arm group label the control group outcomes module primary outcome list primary outcome primary outcome measure Death from a cardiac cause primary outcome description Death from cardiac causes during the current hospitalization or 30 days after discharge primary outcome time frame The first 30 days from the date of discharge primary outcome measure Myocardial infarction primary outcome description Myocardial infarction after current surgery and one month after discharge primary outcome time frame through study completion, an average of 1 month after discharge primary outcome measure Stroke primary outcome description Stroke in postoperative period until the date of the discharge primary outcome time frame through study completion, an average of 1 month after discharge secondary outcome list secondary outcome secondary outcome measure Electrocardiogram deterioration caused by myocardial ischemia; secondary outcome description Electrocardiogram deterioration caused by myocardial ischemia (ST segment elevation or depression, Q wave, negative T wave ) during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Angina pectoris - typical chest pain III - IV functional class (Canadian Cardiovascular Society classification) secondary outcome description Having an angina pectoris during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Documented episodes of atrial fibrillation/ atrial flutter. secondary outcome description Documented episodes of atrial fibrillation or atrial flutter during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Ventricular proarrhythmia requiring additional therapy secondary outcome description Detection of ventricular proarrhythmia during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Atrioventricular block 2-3 degrees secondary outcome description Atrioventricular block 2-3 degree during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Episodes of hypotension requiring additional therapy secondary outcome description Episodes of hypotension (systolic blood pressure of less than 90 mmHg/ diastolic of less than 60 mmHg) requiring additional therapy during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Length of stay in the intensive care unit secondary outcome time frame through study completion, an average of 1month eligibility module eligibility criteria Inclusion Criteria: 1. Written consent to participate in the study 2. Male or female patients over 18 years 3. Indications for planned replacement of the aortic or mitral valves or operations on the aortic arch. Exclusion Criteria: 1. Individual intolerance to the intermittent hypoxic-hyperoxic training 2. Acute coronary syndrome after hospitalization and before the surgery 3. The presence of an acute infectious process after hospitalization and before the surgery (fever, leukocytosis with a shift leukocyte formula to the left, increased erythrocyte sedimentation rate (ESR), increased C-reactive protein) 4. Uncompensated hypertension at the time of the procedure (systolic blood pres-sure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg) 5. Loss of consciousness, severe dizziness Non-inclusion criteria: Occlusive atherosclerotic disease of lower limbs, Acute coronary syndrome within 4 weeks before entry Preoperative renal insufficiency (serum creatinine higher than 200 mmol/L), Acute infectious diseases Partial and secondary generalized forms of epilepsy, Uncompensated hypertension (Blood pressure at the time of the procedure: systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg) Severe bronchial asthma with the development of respiratory failure of the II-III degree and individual intolerance to oxygen deficiency. 9. Severe hepatic impairment (class C child-Pugh) Intervention type 10. Mental illness (if patients are not capable of understanding the nature, significance and implications of the clinical trial) 11. Myocardial insufficiency as a component of multiple organ failure in decompensation of liver and kidney diseases healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Philipp Kopylov, Professor central contact role Contact central contact phone +7-903-687-72-64 central contact e mail fjk@inbox.ru central contact name Ines Dhif, MD central contact role Contact central contact phone +7-929-020-55-98 central contact e mail ines.dhif@hotmail.fr location list location location facility University Clinical Hospital №1 location status Recruiting location city Moscow location zip 119991 location country Russian Federation location contact list location contact location contact name Ines Dhif, MD location contact role Contact location contact phone +79290205598 location contact e mail ines.dhif@hotmail.fr i p d sharing statement module i p d sharing No i p d sharing description Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006331 condition mesh term Heart Diseases condition mesh id D000000783 condition mesh term Aneurysm condition mesh id D000006349 condition mesh term Heart Valve Diseases condition ancestor list condition ancestor condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M3337 condition browse leaf name Hypoxia condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf as found Heart Disease condition browse leaf relevance high condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M3265 condition browse leaf name Aneurysm condition browse leaf as found Aneurysm condition browse leaf relevance high condition browse leaf id M8589 condition browse leaf name Heart Valve Diseases condition browse leaf as found Valvular Heart Disease condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases	NCT04833283	[ 101, 1554, 2025, 3997, 5391, 1545, 1604, 1495, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23493, 24606, 1495, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 7393, 1527, 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6457, 1104, 1103, 2025, 1110, 1106, 17459, 1103, 3154, 1104, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 113, 146, 3048, 18784, 114, 1106, 3244, 1139, 13335, 2881, 3656, 1222, 1679, 2660, 3365, 5838, 1139, 13335, 2881, 2916, 3773, 1219, 17688, 6059, 1606, 3621, 2660, 16091, 13505, 7637, 1616, 13981, 119, 6448, 6136, 1188, 1110, 170, 19916, 117, 1423, 118, 2057, 117, 7091, 2200, 4013, 7300, 3443, 117, 1134, 1209, 8803, 4420, 1166, 1407, 1201, 1385, 1150, 1156, 1129, 8443, 4776, 1193, 1219, 3073, 118, 10296, 18261, 1120, 1103, 146, 119, 150, 22087, 10415, 3292, 1752, 4116, 1426, 3875, 1239, 10103, 12571, 17910, 1951, 119, 1398, 4420, 1114, 170, 12645, 1104, 191, 1348, 25247, 5815, 1762, 3653, 117, 1137, 170, 12148, 1596, 9072, 3653, 1105, 12754, 1116, 1111, 17688, 6059, 117, 2452, 1106, 1103, 1735, 2015, 1104, 10103, 17288, 120, 1735, 1791, 1111, 10103, 2660, 118, 16261, 7409, 1596, 17910, 13112, 119, 4222, 1552, 1196, 1103, 2805, 117, 4420, 1209, 1129, 19729, 3346, 1154, 1160, 2114, 1606, 170, 2775, 118, 6455, 7091, 2734, 1952, 131, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1105, 1126, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1654, 1372, 119, 1370, 1241, 2114, 8087, 5193, 113, 2747, 25128, 8519, 1468, 118, 140, 118, 26844, 4592, 117, 189, 12736, 11153, 1179, 146, 117, 24862, 5190, 118, 7861, 4592, 113, 6820, 2064, 17598, 114, 1105, 2495, 5822, 2193, 114, 1209, 1129, 1982, 1196, 2013, 1105, 1170, 1103, 6059, 117, 1105, 1103, 177, 1183, 26466, 1596, 118, 1107, 7641, 16240, 5318, 113, 145, 15499, 122, 11164, 114, 1156, 1129, 7042, 1196, 1105, 1170, 1103, 2013, 1116, 119, 7195, 24767, 1107, 1103, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1372, 1209, 13971, 1300, 3828, 8826, 1104, 14235, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1196, 17688, 6059, 117, 1606, 170, 18570, 12809, 7710, 1665, 4442, 1106, 6268, 177, 1183, 26466, 1596, 1105, 177, 24312, 10649, 1596, 3245, 7759, 1116, 113, 11336, 2346, 16844, 10103, 2660, 132, 19294, 4611, 28101, 156, 119, 138, 119, 117, 14557, 16056, 12913, 15243, 117, 25510, 18794, 10890, 1107, 155, 2591, 153, 1495, 3048, 1387, 120, 17474, 1545, 114, 119, 2577, 1103, 1838, 1104, 1103, 2013, 117, 1296, 5351, 1156, 13971, 170, 177, 1183, 26466, 1596, 2774, 1106, 15187, 1103, 2510, 2593, 1106, 177, 1183, 26466, 1465, 117, 1105, 1106, 4959, 1103, 2603, 1104, 7234, 1104, 1892, 7621, 2068, 23022, 113, 156, 1643, 2346, 1477, 114, 1114, 170, 3602, 8561, 184, 8745, 19401, 113, 7085, 5053, 3702, 12342, 1942, 117, 11842, 10893, 212, 1477, 110, 114, 119, 1507, 126, 1904, 1103, 5351, 1209, 3531, 1586, 1114, 3549, 7621, 3438, 113, 1367, 110, 114, 117, 1194, 170, 7739, 1223, 4836, 9437, 1104, 1103, 1762, 2603, 113, 145, 2069, 114, 1105, 156, 1643, 2346, 1477, 119, 1249, 170, 3429, 4929, 117, 10298, 156, 1643, 2346, 1477, 1156, 1129, 1383, 1120, 5787, 110, 1105, 12477, 23984, 3134, 2773, 1104, 1762, 2603, 1156, 1129, 1383, 1106, 116, 1851, 110, 1104, 1103, 3288, 1762, 2603, 119, 1332, 1292, 4718, 1156, 1129, 1680, 117, 1103, 3880, 1104, 7621, 7743, 1156, 1129, 6759, 1106, 170, 177, 24312, 10649, 1596, 3245, 7759, 113, 2588, 110, 118, 1969, 110, 152, 1477, 114, 117, 1107, 16036, 1104, 1134, 1156, 1129, 1598, 1235, 156, 1643, 2346, 1477, 1680, 1620, 110, 113, 1256, 1191, 156, 1643, 2346, 1477, 1108, 2211, 1196, 1103, 7791, 114, 117, 3335, 5763, 1113, 1103, 2603, 1104, 2068, 23022, 7234, 117, 1209, 1129, 1678, 122, 1106, 124, 1904, 113, 1928, 122, 11241, 1105, 1851, 3071, 114, 119, 1109, 6247, 1110, 1106, 2561, 177, 24312, 10649, 1596, 1893, 19860, 7621, 6646, 1105, 1136, 1106, 2566, 4851, 1103, 1159, 2320, 1106, 8680, 1121, 177, 1183, 26466, 1465, 119, 11300, 9084, 5208, 1204, 177, 1183, 26466, 1596, 177, 24312, 10649, 1596, 2013, 1156, 1129, 1737, 2265, 1191, 1175, 1127, 1185, 2418, 1334, 3154, 1219, 1103, 7791, 1216, 1112, 1126, 10533, 1161, 2489, 117, 2445, 1104, 8418, 117, 5199, 4267, 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122, 1106, 124, 1904, 117, 5763, 1113, 1103, 156, 1643, 2346, 1477, 7593, 2603, 119, 1109, 1703, 1159, 1104, 1103, 177, 1183, 26466, 1596, 3245, 7759, 16957, 1219, 1141, 7791, 1209, 1129, 1406, 118, 1476, 11241, 119, 138, 1509, 2013, 1156, 1129, 3303, 1107, 1103, 3440, 1196, 1103, 6059, 119, 7195, 24767, 1107, 1103, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 118, 1654, 1372, 1145, 1209, 13971, 1300, 3828, 8826, 1196, 6059, 117, 1606, 1969, 11241, 2013, 6461, 1114, 14314, 1104, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1118, 1606, 1103, 1269, 3204, 117, 1103, 5351, 7881, 11758, 4772, 1586, 1194, 170, 1282, 4043, 7739, 1223, 4836, 9437, 1104, 1762, 2603, 1105, 156, 1643, 2346, 1477, 119, 2809, 1103, 1825, 1150, 1209, 5880, 1103, 2013, 1156, 1221, 1164, 1103, 5351, 112, 188, 18205, 1106, 170, 2440, 9108, 1372, 117, 1103, 1126, 2556, 16090, 19840, 25976, 1116, 1105, 17688, 10690, 1116, 1209, 1136, 1138, 2469, 1106, 1142, 1869, 119, 8112, 1116, 1104, 17688, 170, 11096, 7889, 1582, 8191, 1116, 117, 177, 1183, 11439, 5026, 1988, 1114, 170, 1444, 1111, 1107, 3329, 27098, 3850, 24259, 117, 2607, 1107, 24266, 10542, 2660, 12139, 117, 8561, 4718, 1105, 1892, 2997, 3001, 1209, 1129, 1802, 1219, 6059, 1105, 1103, 2112, 19807, 5838, 1669, 119, 7195, 24767, 1209, 1129, 19232, 1111, 128, 1552, 1107, 1103, 2704, 117, 1105, 1476, 1552, 1170, 12398, 1106, 17459, 1103, 13522, 119, 12120, 20954, 1116, 1206, 2114, 1209, 1129, 14758, 1606, 1103, 8362, 25033, 1174, 7646, 112, 188, 189, 118, 2774, 1137, 1103, 1141, 118, 15376, 1760, 8625, 2774, 1723, 1118, 1103, 17182, 6732, 3484, 1182, 2112, 118, 2774, 119, 14562, 2042, 13808, 9366, 5562, 1231, 24032, 3584, 1209, 1129, 1215, 1106, 10301, 1103, 2013, 2629, 1107, 6796, 1106, 2425, 1105, 3718, 1322, 21521, 119, 12121, 7467, 1209, 1129, 1383, 1120, 121, 119, 4991, 1106, 2774, 177, 1183, 11439, 18769, 119, 2975, 13196, 3879, 2190, 3879, 12226, 25247, 5815, 4641, 20012, 138, 12148, 1596, 19797, 1760, 8816, 6834, 1306, 17910, 2501, 12565, 2190, 2501, 12565, 17688, 26600, 13981, 1231, 3365, 17149, 14235, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 3073, 7235, 14669, 1158, 191, 1348, 25247, 5815, 1762, 3653, 117, 170, 12148, 1596, 9072, 1126, 8816, 6834, 1306, 1902, 13196, 2025, 2076, 11300, 21987, 1348, 4065, 2190, 4065, 1753, 138, 8661, 9538, 2165, 1902, 23992, 1902, 18205, 19441, 2200, 1902, 9108, 2235, 23994, 4838, 1233, 1249, 19638, 1880, 1902, 2425, 3007, 18461, 1902, 7739, 1158, 23992, 1902, 7739, 1158, 8353, 1902, 1150, 19970, 2190, 1902, 1150, 19970, 4539, 27989, 10224, 1204, 10803, 23992, 10803, 5099, 1620, 10803, 2076, 8329, 6617, 16963, 1181, 1739, 22496, 13196, 1981, 1372, 2190, 1981, 1372, 1981, 1372, 3107, 1103, 9108, 1372, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1981, 1372, 2076, 17635, 1981, 1372, 6136, 1103, 9108, 1372, 1110, 4420, 4072, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1196, 2805, 119, 11336, 2346, 16844, 10103, 2660, 4442, 117, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 113, 146, 3048, 18784, 114, 11300, 21987, 14177, 27530, 131, 14286, 13199, 125, 2013, 1116, 3828, 1104, 27946, 177, 1183, 26466, 1596, 177, 24312, 10649, 1596, 2013, 1116, 1196, 6059, 117, 1606, 1969, 11241, 2013, 1116, 6461, 117, 1103, 5351, 1209, 3531, 1586, 1114, 3549, 7621, 3438, 113, 1367, 110, 114, 1194, 170, 7739, 1223, 4836, 9437, 1104, 1762, 2603, 113, 145, 2069, 114, 1105, 156, 1643, 2346, 1477, 119, 1249, 170, 3429, 4929, 117, 10298, 156, 1643, 2346, 1477, 1108, 1383, 1120, 5787, 110, 1105, 12477, 23984, 3134, 2773, 1104, 1762, 2603, 1108, 1383, 1106, 116, 1851, 110, 1104, 1103, 3288, 145, 2069, 119, 1332, 1292, 4718, 1156, 1129, 1680, 117, 1103, 3880, 1104, 7621, 7743, 6759, 1106, 170, 177, 24312, 10649, 1596, 3245, 7759, 113, 2588, 110, 118, 1969, 110, 152, 1477, 114, 117, 1107, 16036, 1104, 1134, 1156, 1129, 1598, 1235, 156, 1643, 2346, 1477, 1680, 1620, 110, 113, 1256, 1191, 156, 1643, 2346, 1477, 1156, 1129, 2211, 1196, 1103, 7791, 114, 117, 1134, 117, 5763, 1113, 1103, 2603, 1104, 2068, 23022, 7234, 117, 1209, 2274, 122, 1106, 124, 11241, 113, 1928, 122, 11241, 1105, 1851, 188, 114, 119, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 15545, 2093, 131, 11336, 2346, 16844, 10103, 2660, 4442, 117, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 113, 146, 3048, 18784, 114, 1981, 1372, 3107, 1103, 1654, 1372, 1981, 1372, 2076, 5033, 4043, 3291, 8223, 4626, 2772, 1981, 1372, 6136, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1654, 1372, 1209, 1129, 6742, 1106, 1103, 1514, 1372, 117, 1145, 9315, 1300, 3828, 8826, 1196, 6059, 1606, 1969, 11241, 2013, 6461, 1114, 14314, 1104, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1116, 1118, 1606, 1103, 1269, 3204, 117, 6142, 11758, 4772, 1586, 1209, 1129, 4653, 1194, 170, 1282, 4043, 7739, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 15545, 2093, 131, 11336, 2346, 16844, 10103, 2660, 4442, 9108, 2190, 9108, 9108, 2076, 15545, 2093, 9108, 1271, 11336, 2346, 16844, 10103, 2660, 4442, 117, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 113, 146, 3048, 18784, 114, 9108, 6136, 14286, 13199, 125, 2013, 1116, 3828, 1104, 27946, 177, 1183, 26466, 1596, 177, 24312, 10649, 1596, 2013, 1116, 1196, 6059, 117, 1606, 1969, 11241, 2013, 1116, 6461, 117, 1103, 5351, 1209, 3531, 1586, 1114, 3549, 7621, 3438, 113, 1367, 110, 114, 1194, 170, 7739, 1223, 4836, 9437, 1104, 1762, 2603, 113, 145, 2069, 114, 1105, 156, 1643, 2346, 1477, 119, 1249, 170, 3429, 4929, 117, 10298, 156, 1643, 2346, 1477, 1108, 1383, 1120, 5787, 110, 1105, 12477, 23984, 3134, 2773, 1104, 1762, 2603, 1108, 1383, 1106, 116, 1851, 110, 1104, 1103, 3288, 145, 2069, 119, 1332, 1292, 4718, 1156, 1129, 1680, 117, 1103, 3880, 1104, 7621, 7743, 6759, 1106, 170, 177, 24312, 10649, 1596, 3245, 7759, 113, 2588, 110, 118, 1969, 110, 152, 1477, 114, 117, 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full study rank 61236 study protocol section identification module n c t id NCT04839094 org study id info org study id Q2059 organization org full name Centre Hospitalier Universitaire Vaudois org class OTHER brief title Dry Versus Wet Nasopharyngeal Rapid Test for the Detection of COVID-19. official title Dry Nasopharyngeal Swab Versus Transported in Viral Transport Media Rapid Antigen Test Comparison for the Detection of SARS-CoV-2: a Comparative Trial (RESTART). acronym RESTART status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date December 10, 2020 start date type Actual primary completion date struct primary completion date February 1, 2021 primary completion date type Actual completion date struct completion date February 1, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Antonios Kritikos responsible party investigator title Principal Investigator responsible party investigator affiliation Centre Hospitalier Universitaire Vaudois lead sponsor lead sponsor name Centre Hospitalier Universitaire Vaudois lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Saliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen testing (RAT) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Thus, in the RESTART study the investigators compare antigen and RT-PCR testing methods on nasopharyngeal (NP) swabs and salivary samples. The investigators conducted a prospective observational study among COVID-19 hospitalized patients between 10th December 2020 and 1st February 2021. Paired saliva and NP samples were investigated by RT-PCR (Cobas 6800, Roche-Switzerland) and by two rapid antigen tests: One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland). detailed description In response to the growing SARS-CoV-2 pandemic and shortages of laboratory based rapid molecular testing capacity and reagents on a worldwide scale, multiple manufacturers have developed rapid testing kits to use out of laboratory settings. These simple kits are based either on detection of proteins from the SARS-CoV-2 virus on respiratory samples (e.g. nasopharyngeal or throat swabs), or detection, in blood or serum, of human antibodies generated in response to infection. On 28 October 2020 the Swiss Federal Council decided that as of 2 November 2020, in addition to polymerase chain reaction (PCR) tests, which are considered the "Gold standard" for SARS-CoV-2 diagnosis, it would be possible to conduct nasopharyngeal rapid antigen tests all over Switzerland, also outside licensed laboratories. In a hospital care setting rapid tests are intended to help physicians on prompt clinical management of cases with COVID-19 compatible symptoms upon admission and facilitate patient triage and flow, notably in a period marked of transition to higher incidence rates and enormous pressure on health system. This strategy was subsequently adopted by the University Hospital of Lausanne as well. Roche's SARS-CoV-2 Rapid Antigen Test (which is the actual test employed by our institution) is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. This test is performed using a nasopharyngeal swab collected from a patient with a result available after 10-15 minutes. While the manufacturer reports very good diagnostic performances of the test, literature shows high variability of sensitivity and specificity.Rapid antigen test's diagnostic performances can be high enough to detect cases with high viral load (i.e. pre-symptomatic and early symptomatic cases up to five days from symptom onset. Because of the intense but short-lived nature of SARS-CoV-2 shedding form the upper respiratory tract, the clinical use of rapid antigen testing requires great attention to the timing of infection because testing late in the course of infection will cause an apparently low clinical sensitivity. There is a significant decline of the viral load after 5-7 days of symptoms. In order to account for this possible drawback and compensate the loss of rapid antigen test's diagnostic performance on late infection, a confirmatory RT-PCR is systematically performed by the microbiology laboratory of Lausanne University Hospital. So as to avoid multiple sampling of the same patient and accelerate time-to-final-results, a single nasopharyngeal swab is performed on each patient and soaked on a viral transport medium. From this transport medium both tests are performed (rapid antigen test and RT-PCR). This procedure, introduces a pre-dilution step (in contrast to the usual rapid antigen testing procedure using a dry nasopharyngeal swab) but is in accordance to the specifications of the manufacturers' instructions. While current literature advocates against a significant decrease of tests' analytical performances due to this strategy, there is no strong consensus regarding the influence of transport medium on viral load stability and on test's analytical and clinical sensitivity conditions module condition list condition SARS-CoV-2 keyword list keyword SARS-CoV-2 diagnosis RT-PCR rapid antigen testing saliva viral transport medium design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 58 enrollment type Actual arms interventions module intervention list intervention intervention type Diagnostic Test intervention name rapid antigen testing versus RT-PCR intervention description Sensitivity of rapid antigen testing and RT-PCR performed on nasopharyngeal swabs versus saliva samples in COVID-19 hospitalized patients. outcomes module primary outcome list primary outcome primary outcome measure Diagnostic assessment primary outcome description Comparison of diagnostic performances (sensitivity, specificity, positive and negative predictive value) of the different strategies on patients hospitalised with a SARS-CoV-2 infection. primary outcome time frame On the day of inclusion secondary outcome list secondary outcome secondary outcome measure Limit of detection determination. secondary outcome description - Define the limit of detection viral load and lowest dilution with the highest positivity rate of both strategies. secondary outcome time frame On the day of inclusion eligibility module eligibility criteria Inclusion Criteria: Hospitalized patients aged above 18 years with confirmed SARS-CoV-2 infection by RT-PCR assay. Provide informed consent. Exclusion Criteria: Patient's refusal to participate in the study. Patients with negative RT-PCR if already performed for patient's follow up as part of standard care. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population All hospitalized patients with a confirmed SARS-CoV-2 infection will be screened for inclusion criteria. sampling method Non-Probability Sample contacts locations module location list location location facility Centre Hospitalier Universitaire Vaudois location city Lausanne location state Vaud location country Switzerland i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 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full study rank 61274 study protocol section identification module n c t id NCT04838600 org study id info org study id PN-00025 organization org full name RLS Global org class INDUSTRY brief title A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv® official title A Multicenter, Prospective, Observational, Post-Market Clinical Follow-up Investigation to Confirm Clinical Performance and Safety of ChloraSolv® When Used on Chronic Leg Ulcers and Chronic Diabetic Foot Ulcers in Need of Debridement acronym ChloraSolv02 status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 7, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 12, 2022 last update post date struct last update post date July 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name RLS Global lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users. Approximately 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound. detailed description As above conditions module condition list condition Chronic Leg Ulcer Chronic Diabetic Foot Ulcer keyword list keyword Leg ulcer DFU ChloraSolv Debridement design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 65 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name ChloraSolv intervention description Debridement with ChloraSolv until the wound is visually assessed as clean. outcomes module primary outcome list primary outcome primary outcome measure Incidence of clean wound bed at End of Treatment, as assessed by investigator primary outcome description When the investigator judges that the wound is clean primary endpoint is reached and confirmed by planimetry. primary outcome time frame 1 - 24 weeks secondary outcome list secondary outcome secondary outcome measure Relative change in devitalized tissue and wound size at End of Treatment, compared to Baseline, assessed by planimetry secondary outcome description Assessed by planimetry secondary outcome time frame 1 - 24 weeks eligibility module eligibility criteria Inclusion Criteria: Chronic leg ulcers and chronic diabetic foot ulcers in need of debridement Male or female, 18 years of age and above Able to read and understand the Patient Informed Consent and to provide meaningful written informed consent Exclusion Criteria: Known allergy/hypersensitivity to any of the components of ChloraSolv Renal insufficiency defined as serum creatinine >200 μmol/L Macroangiopathy expected to demand vascular intervention or percutaneous angioplasty performed less than 3 months after start of treatment; toe pressure <30mm Hg Kidney or pancreas transplanted Patient under cortisone treatment >60mg/day Patient treated with chemotherapy or any other immune-inhibiting drugs 12 months before start of treatment Other identified on-going pathologies in the area of wound, such as cancer Pregnancy or breastfeeding Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator Subjects not suitable for the investigation according to the investigator's judgment or other significant medical conditions that the investigator determines could interfere with compliance or investigation assessments. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population The investigation population will comprise of 65 subjects fulfilling the eligibility criteria of the PMCF investigation. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Caroline Gröndahl, MSc central contact role Contact central contact phone +46764194910 central contact e mail caroline.grondahl@rlsglobal.se overall official list overall official overall official name Anders Jönsson, MD overall official affiliation Orthopedic Clinic Mölndal Hospital Sweden overall official role Principal Investigator location list location location facility Vårdcentralen Tunafors location status Recruiting location city Eskilstuna location country Sweden location contact list location contact location contact name Carina Hartin location contact role Contact location contact e mail carina.hartin@regionsormland.se location contact name Ban Paulus, MD location contact role Principal Investigator location facility Carlanderska Hospital location status Active, not recruiting location city Göteborg location country Sweden location facility Wästerläkarna location status Recruiting location city Göteborg location country Sweden location contact list location contact location contact name Henrik von Sydow, MD location contact role Contact location contact e mail henrik.von.sydow@wasterlakarna.se location contact name Henrik von Sydow, MD location contact role Principal Investigator location facility Wetterhälsan Munksjöstaden location status Recruiting location city Jönköping location country Sweden location contact list location contact location contact name Marina Ivanova location contact role Contact location contact e mail marina.ivanova@rjl.se location contact name Patrik Andersson, MD location contact role Principal Investigator location facility Orthopedic Clinic Mölndal Hospital location status Recruiting location city Mölndal location country Sweden location contact list location contact location contact name Anders Jönsson, MD location contact role Contact location contact e mail anders.k.jonsson@vgregion.se location contact name Anders Jönsson, MD location contact role Principal Investigator location facility Framtidens vårdavdelning location status Recruiting location city Trelleborg location country Sweden location contact list location contact location contact name Veronica Himanen location contact role Contact location contact e mail veronica.himanen@skane.se location contact name Nadine Fadhel Dhaher, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No i p d sharing description This is an observational study required by the notified body to confirm clinical performance and safety. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000017719 condition mesh term Diabetic Foot condition mesh id D000016523 condition mesh term Foot Ulcer condition mesh id D000007871 condition mesh term Leg Ulcer condition mesh id D000014456 condition mesh term Ulcer condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000003925 condition ancestor term Diabetic Angiopathies condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000012883 condition ancestor term Skin Ulcer condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000048909 condition ancestor term Diabetes Complications condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000003929 condition ancestor term Diabetic Neuropathies condition ancestor id D000005534 condition ancestor term Foot Diseases condition browse leaf list condition browse leaf condition browse leaf id M16358 condition browse leaf name Ulcer condition browse leaf as found Ulcer condition browse leaf relevance high condition browse leaf id M19085 condition browse leaf name Diabetic Foot condition browse leaf as found Diabetic Foot condition browse leaf relevance high condition browse leaf id M18071 condition browse leaf name Foot Ulcer condition browse leaf as found Foot Ulcers condition browse leaf relevance high condition browse leaf id M10035 condition browse leaf name Leg Ulcer condition browse leaf as found Leg Ulcers condition browse leaf relevance high condition browse leaf id M6272 condition browse leaf name Diabetic Angiopathies condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M14838 condition browse leaf name Skin Ulcer condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M25157 condition browse leaf name Diabetes Complications condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M6276 condition browse leaf name Diabetic Neuropathies condition browse leaf relevance low condition browse leaf id M7810 condition browse leaf name Foot Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC19 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full study rank 61641 study protocol section identification module n c t id NCT04833829 org study id info org study id STUDY00000560 secondary id info list secondary id info secondary id R34MH124638 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R34MH124638 organization org full name Emory University org class OTHER brief title Cross-disciplinary HIV Integrated Mental Health Support Intervention official title Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) Intervention acronym CHIMES status module status verified date June 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date November 1, 2020 start date type Actual primary completion date struct primary completion date January 1, 2023 primary completion date type Anticipated completion date struct completion date January 1, 2023 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 7, 2022 last update post date struct last update post date June 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Sophia Hussen responsible party investigator title Associate Professor responsible party investigator affiliation Emory University lead sponsor lead sponsor name Emory University lead sponsor class OTHER collaborator list collaborator collaborator name National Institute of Mental Health (NIMH) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The proposed project seeks to develop and test an intervention to improve engagement in HIV and mental health care for young Black gay, bisexual and other men who have sex with men (YB-GBMSM) in Ryan White clinics. detailed description Young Black gay, bisexual and other men who have sex with men (YB-GBMSM) are disproportionately impacted by HIV, with suboptimal rates of engagement across the HIV Continuum of Care (HIV-CoC). Mental health (MH) comorbidities contribute to poor HIV care engagement for many YB-GBMSM; however, effective treatment for these conditions is hindered by barriers including logistical challenges, medical mistrust, and MH stigma. The Ryan White Care act supports integration of HIV and MH services; however, preliminary studies demonstrate low rates of MH referrals and MH care engagement among YB-GBMSM living with HIV, even in these ostensibly integrated care settings. The objective of this study is to develop and implement CHIMES (Cross-disciplinary HIV Integrated with Mental Health Support), a clinic- and provider-level intervention to improve HIV-MH care integration and MH care engagement among YB-GBMSM attending Ryan White clinics. The rationale for this study is that efforts to improve integration of services, particularly if they are culturally tailored, are likely to increase MH and HIV care engagement for YB-GBMSM. The proposed study will pursue two specific aims: (1) to develop the CHIMES intervention; and (2) to conduct a hybrid type 2 implementation-effectiveness pilot trial of CHIMES in two Health Resources and Services Administration (HRSA)/Ryan White-funded clinics in Atlanta, Georgia - a city in the heart of the Southern HIV epidemic. For the first aim, the researchers will work collaboratively with provider and patient stakeholders, adapt existing evidence-based interventions, and build on formative data to refine intervention content, informed by the Capability- Opportunity-Motivation-Behavior (COM-B) Model. For the second aim, the researchers will implement CHIMES in the two clinic settings and conduct a mixed-methods assessment in which continuous data collection informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework will be used to evaluate effectiveness and implementation processes. The effectiveness of the CHIMES intervention will be measured by change in HIV and MH care engagement before, during, and after CHIMES implementation. The researchers will abstract clinic-level aggregate data to characterize change in HIV-CoC and MH care engagement outcomes for YB-GBMSM. conditions module condition list condition Human Immunodeficiency Virus HIV Infections keyword list keyword Mental health design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 850 enrollment type Anticipated arms interventions module arm group list arm group arm group label Clinic Patients During the Pre-implementation Period arm group type Active Comparator arm group description Patients visiting one of the study clinics prior to implementation of the CHIMES intervention. The Baseline time period consists of study Months 1 - 12. Data are retroactively abstracted from medical records of patients who had clinic visits that occurred between January 1, 2019 and December 31, 2019. arm group intervention list arm group intervention name Behavioral: Standard of Care arm group label Clinic Patients During the Implementation Period arm group type Experimental arm group description Patients visiting one of the study clinics during the Implementation period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 13 - 27. arm group intervention list arm group intervention name Behavioral: CHIMES Intervention arm group label Clinic Patients During the Maintenance Period arm group type Experimental arm group description Patients visiting one of the study clinics during the Maintenance period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 28 - 33. arm group intervention list arm group intervention name Behavioral: CHIMES Intervention intervention list intervention intervention type Behavioral intervention name CHIMES Intervention intervention description There are six components to the intervention: Posters and other print materials to prompt providers and patients to discuss MH care engagement. Brief verbal scripts to help HIV providers facilitate patient MH engagement and discuss barriers to MH utilization. Expanded MH screening procedures, including at initial intake. Case management, emphasizing MH care engagement. Interactive trainings for all HIV providers on MH needs, screening/treatment, and barriers to MH service utilization specific to YB-GBMSM. Regular case review meetings. intervention arm group label list intervention arm group label Clinic Patients During the Implementation Period Clinic Patients During the Maintenance Period intervention type Behavioral intervention name Standard of Care intervention description The standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study. intervention arm group label list intervention arm group label Clinic Patients During the Pre-implementation Period outcomes module primary outcome list primary outcome primary outcome measure Number of Mental Health Visits primary outcome description The number of mental health visits by clinic patients during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Percentage of Mental Health Visits by YB-GBMSM primary outcome description The percentage of mental health visits by YB-GBMSM clinic patients during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Number of Patients Attending Two HIV Care Visits primary outcome description The number of patients who come to two HIV Care visits in a 12 month period, during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Number of Patients with HIV RNA Viral Suppression primary outcome description The number of patients with HIV RNA less than 200 Copies, during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Number of Mental Health Care Referrals primary outcome description The number of referrals to mental health care during a 12 month period, during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Percentage of Mental Health Referrals for YB-GBMSM primary outcome description The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 eligibility module eligibility criteria Inclusion Criteria: young Black gay, bisexual and other men who have sex with men (YB-GBMSM) living with HIV patient at Grady Health System Infectious Disease Program or Emory University Hospital Midtown Infectious Disease Clinic Exclusion Criteria: none healthy volunteers No gender Male minimum age 18 Years maximum age 29 Years std age list std age Adult contacts locations module overall official list overall official overall official name Sophia Hussen, MD, MPH overall official affiliation Emory University overall official role Principal Investigator location list location location facility Grady Infectious Diseases Clinic (Ponce Clinic) location city Atlanta location state Georgia location zip 30308 location country United States location facility Emory Midtown Hospital Infectious Disease Outpatient Clinic location city Atlanta location state Georgia location zip 30322 location country United States i p d sharing statement module i p d sharing Yes i p d sharing description De-identified participant data will be made available to other researchers, using established public repositories. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame Participant data will be made available for sharing after publication of this study. i p d sharing access criteria Data will be available to other researchers using established public repositories. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015658 condition mesh term HIV Infections condition mesh id D000000163 condition mesh term Acquired Immunodeficiency Syndrome condition ancestor list condition ancestor condition ancestor id D000086982 condition ancestor term Blood-Borne Infections condition ancestor id D000003141 condition ancestor term Communicable Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000015229 condition ancestor term Sexually Transmitted Diseases, Viral condition ancestor id D000012749 condition ancestor term Sexually Transmitted Diseases condition ancestor id D000016180 condition ancestor term Lentivirus Infections condition ancestor id D000012192 condition ancestor term Retroviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007153 condition ancestor term Immunologic Deficiency Syndromes condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000012897 condition ancestor term Slow Virus Diseases condition browse leaf list condition browse leaf condition browse leaf id M17402 condition browse leaf name HIV Infections condition browse leaf as found Human Immunodeficiency Virus condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M9351 condition browse leaf name Immunologic Deficiency Syndromes condition browse leaf relevance low condition browse leaf id M2674 condition browse leaf name Acquired Immunodeficiency Syndrome condition browse leaf as found Human Immunodeficiency Virus condition browse leaf relevance high condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2595 condition browse leaf name Blood-Borne Infections condition browse leaf relevance low condition browse leaf id M14710 condition browse leaf name Sexually Transmitted Diseases condition browse leaf relevance low condition browse leaf id M17085 condition browse leaf name Sexually Transmitted Diseases, Viral condition browse leaf relevance low condition browse leaf id M17792 condition browse leaf name Lentivirus Infections condition browse leaf relevance low condition browse leaf id M14178 condition browse leaf name Retroviridae Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M14852 condition browse leaf name Slow Virus Diseases condition browse leaf relevance low condition browse leaf id T4202 condition browse leaf name Oculocerebral Syndrome With Hypopigmentation condition browse leaf relevance low condition browse branch list 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full study rank 61826 study protocol section identification module n c t id NCT04831424 org study id info org study id NYSPI 7424 organization org full name Columbia University org class OTHER brief title Mitochondrial Stress, Brain Imaging, and Epigenetics official title The Mitochondrial Stress, Brain Imaging, and Epigenetics Study acronym MiSBIE status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 12, 2018 start date type Actual primary completion date struct primary completion date December 31, 2024 primary completion date type Anticipated completion date struct completion date April 30, 2025 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 18, 2022 last update post date struct last update post date July 19, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Martin Picard responsible party investigator title Associate Professor of Behavioral Medicine (in Psychiatry and Neurology) responsible party investigator affiliation Columbia University lead sponsor lead sponsor name Columbia University lead sponsor class OTHER collaborator list collaborator collaborator name Dartmouth College collaborator class OTHER collaborator name Centre National de la Recherche Scientifique, France collaborator class OTHER collaborator name Massachusetts General Hospital collaborator class OTHER collaborator name Technische Universität Dresden collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The MiSBIE study collects biological, behavioral, psychosocial, neuropsychological, and brain imaging data in participants with either: normal mitochondrial function, individuals with the m.3243A>G mitochondrial DNA (mtDNA) mutation, and individuals a single large-scale mtDNA deletion. These defects induce mitochondrial allostatic load (MAL). The 2-day protocol, plus home-based data collection, will provide a comprehensive assessment of the multi-systemic dysregulation associated with MAL or mitochondrial dysfunction, and the link to physical and mental health-related symptoms. Aim 1: Determine the influence of MAL on systemic AL biomarkers. Aim 2: Establish the influence of MAL on stress reactivity profiles. Aim 3. Examine the association between MAL and psychological functioning. detailed description Age-related physical and cognitive decline, as well as the risk of neurological diseases, are increased by the effects of psychosocial stress. Psychosocial stress triggers neuroendocrine, metabolic, cardiovascular, and inflammatory changes in the body. These changes vary in nature and magnitude between individuals, and are associated with long-term disease risk. However, the biological determinants of the stress response are not well understood. This project aims to translate the preclinical findings (how mitochondria regulate the different organ systems and major stress response axes are activated during psychological stress) by studying a population of individuals with varying degree of mitochondrial dysfunction, and to test potential neural mechanism, and why some individuals respond more strongly than others to the same stressor. Each participant will be studied over two consecutive days. Participants will be housed on campus to standardize study conditions. On Day 1, participants will donate blood and saliva, undergo a neuropsychological assessment, and complete questionnaires to assess psychosocial functioning and psychiatric symptoms. After lunch, the investigator will monitor dynamic changes in mental health-related biological outcomes (positive and negative affect, circulating levels of the inflammatory cytokine IL-6, and salivary cortisol) in response to a standardized laboratory challenge. On Day 2, participants will undergo a medical evaluation to assess clinical symptoms and undergo a whole brain neuroimaging session where both resting and stress elicited activity will be measured. A variant of the same stressor as on Day 1 will be used in the neuroimaging session. Participants will then be debriefed, concluding the individuals participation in the study. Participants also complete a home-based saliva and stool collection to examine diurnal variation in salivary hormones, and to examine microbiome composition. This translational project will generate a unique combination of complimentary molecular, cellular, and neuroimaging data that will advance our understanding of the links between mitochondria, the brain, and mental health-related outcomes. conditions module condition list condition Mitochondrial Diseases keyword list keyword Mitochondria Brain Imaging Psychophysiology Epigenetics Stress Metabolic rate Mitochondrial function design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description All participants will undergo TSST and have samples With DNA collected (blood plasma and serum, purified leukocytes, saliva, urine, buccal epithelial cells, hair are stored). design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label Healthy controls arm group type Experimental arm group description No diagnosis of mitochondrial disease arm group intervention list arm group intervention name Behavioral: Trier social stress test arm group label Mutation arm group type Experimental arm group description Participants carrying the m.3243A>G point mutation, without a diagnosis of MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) arm group intervention list arm group intervention name Behavioral: Trier social stress test arm group label Mutation with MELAS arm group type Experimental arm group description Participants carrying the m.3243A>G point mutation, with a diagnosis of MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) arm group intervention list arm group intervention name Behavioral: Trier social stress test arm group label Deletion arm group type Experimental arm group description Participants carrying a single, large-scale mtDNA deletion arm group intervention list arm group intervention name Behavioral: Trier social stress test intervention list intervention intervention type Behavioral intervention name Trier social stress test intervention description The Trier social stress test (TSST) is a tool for investigating psychobiological stress responses in a laboratory setting. It is a laboratory procedure used to reliably induce stress in human research participants. The study is not examining or validating the test itself but rather using it as a tool to measure the response/focus of study. intervention arm group label list intervention arm group label Deletion Healthy controls Mutation Mutation with MELAS intervention other name list intervention other name TSST outcomes module primary outcome list primary outcome primary outcome measure Average TSST-induced elevation in cortisol primary outcome description This is designed to measure cortisol reactivity to the trier social stress test (TSST), quantified from salivary cortisol (LC-MS) over an 8-timepoints timecourse. The elevation will be measured as the area under the curve (AUC) for the cortisol time course. primary outcome time frame Day 1 post challenge (approximately 2 hours) primary outcome measure Average allostatic load index primary outcome description Groups will be compared on a quantitative allostatic load (AL) index integrating baseline fasting measures of neuroendocrine, immune and metabolic systems, urinary catecholamines, hematological measures, and hair/diurnal cortisol levels. primary outcome time frame Blood collected on Day 1 secondary outcome list secondary outcome secondary outcome measure Average TSST-induced elevation in heart rate secondary outcome description Groups will be compared on heart rate (HR) as a measure of cardiovascular reactivity to stress, monitored using a continuous 3-lead ECG. The elevation will be computed from the baseline HR to the peak HR reached during the TSST. secondary outcome time frame Day 1 post challenge (approximately 2 hours) secondary outcome measure Correlation between anxiety and mitochondrial respiration secondary outcome description The association between mitochondrial respiration using extracellular flux analysis (Seahorse) on blood lymphocytes, and anxiety symptoms measured using the state and trait anxiety inventory (STAI), will be quantified by a linear regression across all study participants. secondary outcome time frame Day 1 secondary outcome measure Average neuropsychological function secondary outcome description Groups will be compared on the fluency/initiation domain of executive functioning assessed using the Delis-Kaplan Executive Function System (D-KEFS) test. secondary outcome time frame Day 2 neuropsychological session eligibility module eligibility criteria Inclusion Criteria: Men and women patients between 18 and 55 years of age Willing to provide saliva samples and have venous catheter installed for blood collection during the hospital visit Willing to provide informed consent and capacity to consent Use of effective method of birth control for women of childbearing capacity English Speaking Exclusion Criteria: Individuals with cognitive deficit incapable of providing informed consent will not be included Symptoms of flu or other seasonal infection four weeks preceding hospital visit Raynaud's syndrome (Raynaud phenomenon) Involvement in any therapeutic trials listed on clinicaltrials.gov, including exercise Metal inside or outside the body or claustrophobia prohibitive to MRI testing Diagnosed with mitochondrial disease m.3243A>G, or large scale mtDNA deletion (for healthy controls) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module central contact list central contact central contact name Martin Picard, PhD central contact role Contact central contact phone 6467748967 central contact e mail mp3484@columbia.edu overall official list overall official overall official name Martin Picard, PhD overall official affiliation Columbia University overall official role Principal Investigator location list location location facility Columbia University Irving Medical Center location status Recruiting location city New York location state New York location zip 10032 location country United States location contact list location contact location contact name Martin Picard, PhD location contact role Contact location contact phone 646-774-8967 location contact e mail mp3484@columbia.edu location contact name Martin Picard, PhD location contact role Principal Investigator location contact name Michio Hirano, MD location contact role Sub-Investigator location contact name Richard Sloan, PhD location contact role Sub-Investigator location contact name Caroline Trumpff, PhD location contact role Sub-Investigator references module see also link list see also link see also link label Study Brochure see also link u r l http://www.picardlab.org/uploads/7/7/8/4/77845210/1_misbie_brochure_2018-06-26.pdf i p d sharing statement module i p d sharing Yes i p d sharing description All data will be deposited to the NIMH Data Archive. i p d sharing info type list i p d sharing info type Study Protocol Informed Consent Form (ICF) i p d sharing time frame Data will be made available at the end of the study, without a expiry date. i p d sharing access criteria Access will be handled through the NIMH Data Archive (NDA) i p d sharing u r l https://nda.nih.gov derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000028361 condition mesh term Mitochondrial Diseases condition ancestor list condition ancestor condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition browse leaf 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full study rank 61399 study protocol section identification module n c t id NCT04836975 org study id info org study id D4191R00036 organization org full name AstraZeneca org class INDUSTRY brief title Reveal the Patterns of Presentation, Management and Outcome of Patients With SCLC and Stage III NSCLC in Saudi Arabia: official title A Multicenter Retrospective Observational Study to Reveal the Patterns of Presentation, Management and Outcome of Patients With Small Cell Lung Cancer (SCLC) and Stage III Non-Small Cell Lung Cancer (NSCLC) in Saudi Arabia acronym REVEAL status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 9, 2022 start date type Actual primary completion date struct primary completion date November 30, 2022 primary completion date type Anticipated completion date struct completion date November 30, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 25, 2022 last update post date struct last update post date August 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name AstraZeneca lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A retrospective, multi-centre, observational study to describe the treatment patterns, the demographic, clinical outcomes, treatment effectiveness, and healthcare resource utilization (HCRU) for patients diagnosed with primary Small Cell Lung Cancer SCLC (Extensive stage & Limited Stage)and stage III NSCLC in a real-world setting. detailed description A retrospective, multi-centre, observational study to describe the treatment patterns, the demographic, clinical outcomes, treatment effectiveness, and healthcare resource utilization (HCRU) for patients diagnosed with primary Small Cell Lung Cancer SCLC (Extensive stage & Limited Stage)and stage III NSCLC in a real-world setting Cohort of patients diagnosed with primary SCLC (limited or extensive stage) or stage III NSCLC, aims to characterize the treatment patterns from the index date (defined as the date of initial diagnosis of locally advanced stage III NSCLC and SCLC) to the end of follow-up (defined as the earliest of death, last available medical record or end of the observation period "defined as the date of data abstraction") including the type of treatment received, duration of each treatment regimen, and reasons for stopping treatment regimen. The study population will be identified by participating physicians involved in the diagnosis, treatment and management of these patients through the review of established patient medical records. Eligible patients (both alive and deceased) will have their data anonymously abstracted from their medical records into a centrally designed electronic case report form (eCRF). conditions module condition list condition Lung Cancer keyword list keyword Small Cell Lung Cancer (SCLC) Stage III Non-Small Cell Lung Cancer (NSCLC) design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 150 enrollment type Anticipated arms interventions module arm group list arm group arm group label SCLC arm group description Patient Diagnosed with Small Cell Lung Cancer- (extensive or limited) arm group label NSCLC arm group description Patient diagnosed with primary stage III Non-Small cell lung Cancer outcomes module primary outcome list primary outcome primary outcome measure Treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" primary outcome description To characterize the treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" (Extensive stage & Limited Stage) through recoding type of treatment received primary outcome time frame 9 Month primary outcome measure To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". primary outcome description To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". through recoding type of treatment received primary outcome time frame 9 Month secondary outcome list secondary outcome secondary outcome measure Patient demographic for the patients diagnosed with primary SCLC secondary outcome description Recording Patient demographic for the patients diagnosed with primary SCLC (Age, gender, etc..) secondary outcome time frame 9 Months secondary outcome measure Clinical characteristics for the patients diagnosed with primary SCLC secondary outcome description Recording Clinical characteristics for the patients diagnosed with primary SCLC(Diagnosis, extent of the disease, etc...) secondary outcome time frame 9 Months secondary outcome measure Patient demographic for patients diagnosed with primary stage III NSCLC secondary outcome description Recording Patient demographic for patients diagnosed with primary stage III NSCLC(Age, gender, etc..) secondary outcome time frame 9 Months secondary outcome measure Clinical characteristics for the patients diagnosed with primary stage III NSCLC secondary outcome description Recording Clinical characteristics for the patients diagnosed with primary stage III NSCLC(Diagnosis, extent of the disease, etc...) secondary outcome time frame 9 Months other outcome list other outcome other outcome measure Determining treatment effectiveness outcomes other outcome description Determining treatment effectiveness outcomes: - Objective response rate [ORR]: is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease other outcome time frame 9 Months other outcome measure Healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC other outcome description Recording healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC treatment. HCRU will be assessed by describing the following: Hospitalizations, Outpatient visits, Emergency department visits, Number of medical and surgical treatments received, Use of imaging studies and other procedures other outcome time frame 9 Months other outcome measure Determining treatment effectiveness outcomes other outcome description Determining treatment effectiveness outcomes: - Disease control rate [DCR]: is a composite of ORR and stable disease other outcome time frame 9 Months eligibility module eligibility criteria Inclusion Criteria: 1. Adult male or female (≥18 years old or according to the age of majority as defined by local regulations). 2. First-ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including SCLC and NSCLC) in the patient's medical records. 3. Patients either diagnosed with a primary diagnosis of SCLC (extensive or limited) or stage III NSCLC, confirmed by pathology, between 1st of January 2015 and 31st of December 2019. 4. Medical records available at the participating site reflect at least nine months of follow-up from the index date (unless the patient died within the first nine months of diagnosis) Exclusion Criteria: 1. Patients with concomitant cancer at the time of diagnosis other than SCLC or stage III NSCLC, except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms. Cancer will be considered concomitant if it occurs within five years of NSCLC or SCLC diagnosis 2. Patients initially diagnosed with stage I to II NSCLC who have progressed to stage III 3. Current or prior use of "Durvalumab" treatment healthy volunteers No gender All std age list std age Child Adult Older Adult study population patients who were diagnosed with primary Small Cell Lung Cancer (Extensive stage & Limited Stage) or stage III Non-Small Cell Lung Cancer sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name AstraZeneca Clinical Study Information Center central contact role Contact central contact phone 1-877-240-9479 central contact e mail information.center@astrazeneca.com location list location location facility Research Site location status Not yet recruiting location city Dammam location country Saudi Arabia location facility Research Site location status Recruiting location city Riyadh location country Saudi Arabia location facility Research Site location status Not yet recruiting location city Riyadh location country Saudi Arabia i p d sharing statement module i p d sharing Yes i p d sharing description Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. i p d sharing time frame AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. i p d sharing access criteria When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. i p d sharing u r l https://astrazenecagroup-dt.pharmacm.com/DT/Home derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008175 condition mesh term Lung Neoplasms condition ancestor list condition ancestor condition ancestor id D000012142 condition ancestor term Respiratory Tract Neoplasms condition ancestor id D000013899 condition ancestor term Thoracic Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M10324 condition browse leaf name Lung Neoplasms condition browse leaf as found Lung Cancer condition browse leaf relevance high condition browse leaf id M4698 condition browse leaf name Carcinoma, Non-Small-Cell Lung condition browse leaf relevance low condition browse leaf id M27476 condition browse leaf name Small Cell Lung Carcinoma condition browse leaf relevance low condition browse leaf id M14131 condition browse leaf name Respiratory Tract Neoplasms condition browse leaf relevance low condition browse leaf id M15810 condition browse leaf name Thoracic Neoplasms condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T5271 condition browse leaf name Small Cell Lung Cancer condition browse leaf relevance low condition browse branch list condition browse branch condition browse 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full study rank 61310 study protocol section identification module n c t id NCT04838132 org study id info org study id K-2021-009-01 organization org full name Guangzhou First People's Hospital org class OTHER brief title Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery official title Application of Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery : Study Protocol of a Randomized Double-blind Controlled Trial status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 16, 2021 start date type Actual primary completion date struct primary completion date October 31, 2021 primary completion date type Anticipated completion date struct completion date November 30, 2021 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Guangzhou First People's Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Bilateral transverse thoracic muscle plane( TTP) block is expected to be a new analgesic mode in perioperative of cardiac surgery via sternotomy. detailed description This is a single-center, randomized, double-blind, parallel controlled clinical trial. Eighty patients planning to undergo coronary artery bypass grafting or heart valve surgery via median sternotomy were randomly assigned 1:1 to the experimental group or control group. After general anesthesia, all subjects were injected with 0.3% ropivacaine (experimental group) or 0.9% normal saline (control group) 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound by anesthesiologist. The main outcome indicators were the threshold of incision pain and the total amount of analgesics used during the operation and 48h after the operation. Secondary outcome measures were as follows: postoperative VAS score, duration of mechanical ventilation, days in ICU, total days of hospitalization, and hospitalization cost. This study will provide evidence-based medical evidence and clinical data support for the application of TTP block in cardiac surgery. conditions module condition list condition Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Transversus thoracis muscle plane and rectus sheath block with ropivacaine arm group type Experimental arm group description Using the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.3% ropivacaine respectively. arm group intervention list arm group intervention name Procedure: Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine arm group label Transversus thoracis muscle plane and rectus sheath puncture with saline arm group type Experimental arm group description Using the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.9% saline respectively. arm group intervention list arm group intervention name Procedure: Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline intervention list intervention intervention type Procedure intervention name Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine intervention description A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.3% ropivacaine 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound. intervention arm group label list intervention arm group label Transversus thoracis muscle plane and rectus sheath block with ropivacaine intervention type Procedure intervention name Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline intervention description A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.9% saline 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound. intervention arm group label list intervention arm group label Transversus thoracis muscle plane and rectus sheath puncture with saline outcomes module primary outcome list primary outcome primary outcome measure Incidence of hyperalgesia primary outcome description a 180mN von-Frey wire (Touch Test™ Sensory Evaluator, USA) was used to test the pain sensitivity of the area around the wound primary outcome time frame Surgery to 48 hours after primary outcome measure The total amount of analgesics used in the perioperative period. primary outcome description During the perioperation, the amount of analgesics during the operation, the total amount of analgesic pump drugs used and the frequency of pressing the additional bolus trigger in the patient's analgesia system at 48 hours after the operation, and the amount of remedial analgesics primary outcome time frame Surgery to 48 hours after secondary outcome list secondary outcome secondary outcome measure Visual Analogue Scale secondary outcome description A scale with a length of about 10cm is used. One side is marked with 10 scales, and the two ends are marked with "0" and "10" points respectively. 0 points mean painless, and 10 points mean the most intense pain that is unbearable secondary outcome time frame Extubation to 24 hours after secondary outcome measure Length of stay in hospital secondary outcome description record how many days doses the patient spends in hospital secondary outcome time frame the day before hospital discharge secondary outcome measure Postoperative complications secondary outcome description such as nausea and vomiting, pulmonary infection, wound infection, delayed healing, renal insufficiency, etc. secondary outcome time frame the day before hospital discharge secondary outcome measure incidence of postoperative delirium secondary outcome description Changes in postoperative state of consciousness were assessed secondary outcome time frame Day 7 after operation eligibility module eligibility criteria Inclusion Criteria: Patients voluntarily cooperate with the study and sign an informed consent form; Ages between 18 and 65; American Society of Anesthesiologists (ASA) classification: I-III; Undergo coronary artery bypass grafting (CABG) or heart valve surgery with midsternal incision. Exclusion Criteria: Refuse to participate in the trial; Allergic to the anesthetics or analgesics; Suffering with serious systemic diseases (kidney, liver, lungs and endocrine system); American Association of Anesthesiologists (ASA) classification: IV-V; Unstable hemodynamics; History of drug abuse or chronic pain; Mental disorders or communication difficulties; Died during or immediately after the operation. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jierong Luo, master central contact role Contact central contact phone +8615802031110 central contact e mail jierongluo@outlook.com central contact name Bin Zheng, doctor central contact role Contact overall official list overall official overall official name Bin Zheng, doctor overall official affiliation Guangzhou First People's Hospital overall official role Study Chair location list location location facility Guangzhou First People's Hospital location status Recruiting location city Guangzhou location state Guangdong location zip 510180 location country China location contact list location contact location contact name Jierong Luo, MD location contact role Contact location contact phone 86-20-81048306 location contact e mail jierongluo@outlook.com location contact name Jierong Luo, MD location contact role Sub-Investigator location contact name Bin Zheng, MD location contact role Principal Investigator location contact name Guokun Ou, MD location contact role Sub-Investigator location contact name Haitao Zhou, MD location contact role Sub-Investigator location contact name Xiaoqing Xie, MD, Msc location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000077212 intervention mesh term Ropivacaine intervention ancestor list intervention ancestor intervention ancestor id D000000779 intervention ancestor term Anesthetics, Local intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention browse leaf list intervention browse leaf 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full study rank 61693 study protocol section identification module n c t id NCT04833153 org study id info org study id mjpakk73645 organization org full name University of Turku org class OTHER brief title Continuing Education Intervention Named "Person First - Please" official title Continuing Education Intervention "Person First - Please" of Person-Centred Care Targeted to Nurses in Older People Long-term Care acronym PFP status module status verified date November 2022 overall status Completed expanded access info has expanded access No start date struct start date August 30, 2021 start date type Actual primary completion date struct primary completion date January 2, 2022 primary completion date type Actual completion date struct completion date March 31, 2022 completion date type Actual study first submit date March 13, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 5, 2022 last update post date struct last update post date November 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Mari Pakkonen responsible party investigator title PhD-candidate responsible party investigator affiliation University of Turku lead sponsor lead sponsor name Mari Pakkonen lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC. Research question 1: What is the effectiveness of the PFP intervention on the PCC collective competency of nurses in older people LTC? Hypothesis for research question 1 are: 1. Nurses in intervention group will have higher level of competence of PCC than control. Research question 2: How PCC climate has been maintained in older people LTC from the point of view of the nurses, next of kin and older people? Hypothesis for research question 2 are: PCC climate will be better in intervention group than control from point of view of the nurses, next of kin and older people. The higher competence of nurses the higher level of PCC climate from point of view of the next of kin and older people. The higher collective competence of the nurses the higher level of the PCC climate from point of view of the next of kin and older people. detailed description The study takes place in older people long-term care on two cities in western part of Finland. The long-term care units are similar as stuff structure, nurse/resident ration, working ideology and quality management. The research design is quasi-experimental research with pre- and post- test measurements in the intervention and control groups. The intervention group will follow the protocol and the control group participants will follow the usually care. Data are being collected at baseline, immediately after 10 weeks intervention and at follow-up 6 weeks after intervention. Continuing education named "Person First - Please" (PFP) based on Person-Centered Care (PCC) Practice Framework and Theory of Collective Competence and it consist of four modules: Information, Person, Autonomy and Dignity. Information module will take one hour in the first intervention week, and it will include information about the study; informed consent; short clarification about concept PCC and prerequisites for PCC. Tree other modules takes 4 hours contact with researcher in every three weeks. Power analyses for the sample size showed that for 0.8 effect size, power of 0.8 and statistical significance of 0.05 with three main hypotheses, for intervention group n=64 and for control group n=128. ICC of 0.1 was used based on previous sample of the primary outcome measurement. The sampling based on cluster sampling. Two cities will be constituting the clusters in western part of Finland. From these cities will be selected first all public long-term care units for the older people. To avoid contamination, one of the cities will be selected to participate in the intervention and the other in the control. Participants in the study consist of nurses (Registered Nurses, Licensed Practice Nurses, Caregiver Assistants) who work in older people LTC and older people from the same units participate alone or with their next of kin. Nurses background questions are age, education, working experience. Older people and next of kin background questions are age, length of the living in LTC, relationship, number of visits per week in LTC. The effectiveness of an intervention is measured by validated measurements that have been properly licensed. The data will be analysed by latest version of the Software Platform for Statistical Analysis (SPSS). Descriptive statistic will be calculated for the numerical and categorical data. The normal distribution of the data and 95% confidence intervals will be calculated for the numerical and categorical data. Intervention and control group will be statistically compared, and differences will be measured at each time point. At the baseline will be ensure the similarity of intervention and control group for background variables. Cross-tabulations will be done for categorical and numerical variables. The sum variable of the measurements during the three different measurement time will be analysed using hierarchical linear mixed models will compare the changes over time between the groups. Each participant will be informed before about the purpose of the study, issues related to research ethics, reporting of the findings and they will sign informed consent. Since the study involves research participants who are vulnerable due to cognitive impairment, researcher have clear protocol and special attention will be paid to ethical issues during the study. conditions module condition list condition Nurse-Patient Relations keyword list keyword Person-centred care Continuing education Long-term care Older people design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 250 enrollment type Actual arms interventions module arm group list arm group arm group label PFP intervention arm group type Experimental arm group description PFP 10 week continuing education intervention arm group intervention list arm group intervention name Behavioral: Person-First - Please (PFP) arm group label Control arm arm group type No Intervention arm group description Usual care intervention list intervention intervention type Behavioral intervention name Person-First - Please (PFP) intervention description PFP takes 10 weeks and consist of four modules: Information, Person, Autonomy and Dignity. Information module takes 1 hour contact on first week. The other modules will follow every third weeks, starting from week 2. So that on week 2, 5 and 8 researcher meet nurses in 4 hours education session. Between the modules, nurses can take contact online to the researcher. intervention arm group label list intervention arm group label PFP intervention outcomes module primary outcome list primary outcome primary outcome measure Changes in nurses PCC competency primary outcome description The competence data will be collected by the Patient-centred Care Competency (PCC) scale as primary outcome. The PCC scale consists of 17 items with 5-point Likert scale (1 = minimal, 2 = below average, 3 = average, 4 = good, 5 = excellent), divided subscales: respecting patients' perspectives, promoting patient involvement in care processes, providing for patient comfort, and advocating for patients. primary outcome time frame baseline - after the intervention - 6 week follow up secondary outcome list secondary outcome secondary outcome measure Changes in PCC climate in lens of nurses, older people and next of kin secondary outcome description The PCC climate data will be collected by Person-centred questionnaire (PCQ-S) staff version and (PCQ-P) patient version (6- point Likert scale: 0 = No, I disagree completely; 1 = No, I disagree; 2 = No, I partly disagree, 3 = Yes, I partly agree; 4 = Yes, I agree; 5 = Yes, I agree completely). Scales are divided subscales: hospitality, safety and everydayness. Data will be collect from nurses, older people and their next of kin. secondary outcome time frame baseline - after the intervention - 6 week follow up secondary outcome measure Evaluation of the continuing education named PFP in lens of the nurses secondary outcome description A feasibility tool has been developed for this intervention. Data will be collected from the nurses in end of the every PFP-modules, excluded information module. Tool consist of the subscales: content of the PFP; evaluation about the pedagogical methods; utilization of the PFP; evaluation of the PFP dosage; evaluation of the trainer. There is 5-point Likert scale: 1 = disagree; 2 = partly disagree; 3 = no disagree/no agree; 4 = agree; 5 = agree completely. secondary outcome time frame during the intervention eligibility module eligibility criteria Inclusion Criteria: Nurses (RNs, Licensed Practice Nurses, Caregiver Assistants) who works in older people LTC. The inclusion criteria for nurses are that they work permanently or on a long-term deputy (at least 6 months) in units. The criteria for older people participating alone are that older people have enough cognitive capacity assessed by managers of the units. The criteria for next of kin participating is they will visit at least weekly in LTC. Exclusion Criteria: short- time deputy nurses older people in terminal care healthy volunteers No gender All maximum age 110 Years std age list std age Child Adult Older Adult contacts locations module overall official list overall official overall official name Suhonen, Professor overall official affiliation University of Turku overall official role Study Director location list location location facility Social services and health care location city Rauma location state Satakunta location zip 26100 location country Finland i p d sharing statement module i p d sharing No i p d sharing description small sample size and vulnerable participants derived section misc info module version holder December 02, 2022	NCT04833153	[ 101, 1554, 2025, 3997, 5391, 1545, 1580, 1495, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23493, 16337, 1495, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 182, 3361, 4163, 1377, 1377, 1559, 22997, 21336, 2369, 8916, 1554, 1271, 1239, 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full study rank 61679 study protocol section identification module n c t id NCT04833335 org study id info org study id APHP190736 organization org full name Assistance Publique - Hôpitaux de Paris org class OTHER brief title ASL in Brain Metastasis MRI Following Gamma Knife Treatment official title ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment. acronym GK-ASL status module status verified date October 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date December 1, 2022 start date type Anticipated primary completion date struct primary completion date July 1, 2023 primary completion date type Anticipated completion date struct completion date July 1, 2024 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date October 28, 2022 last update post date struct last update post date October 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Assistance Publique - Hôpitaux de Paris lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment. The primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment detailed description The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion. conditions module condition list condition Brain Metastases keyword list keyword ASL MRI Metastasis Gamma knife Radionecrosis design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus arm group type Experimental arm group description Inclusion visit, 1 month later, 6 month later arm group intervention list arm group intervention name Other: MRI perfusion sequence intervention list intervention intervention type Other intervention name MRI perfusion sequence intervention description Quantitative analysis intervention arm group label list intervention arm group label Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus intervention other name list intervention other name Arterial Spin Labeling (ASL) outcomes module primary outcome list primary outcome primary outcome measure Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence primary outcome description Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after. primary outcome time frame Evolution between Baseline MRI, 1 and 6 month follow up MRI secondary outcome list secondary outcome secondary outcome measure ASL Perfusion: Cerebral blood flow measurements secondary outcome time frame Baseline MRI, 1 and 6 month follow up MRI secondary outcome measure Interreader correlation secondary outcome description Two neuroradiologists secondary outcome time frame Baseline MRI, 1 and 6 month follow-up MRI secondary outcome measure Morphological analysis of the lesions secondary outcome description Lesion size, oedema secondary outcome time frame Baseline MRI, 1 and 6 month follow-up MRI eligibility module eligibility criteria Inclusion Criteria: Brain metastasis from histologically proven tumor GK treatment within 4 month prior to the inclusion Lesions suspected of progression/ radionecrosis : i.e.≥ 25% of the size progression Lesion size: gadolinium enhanced part of the tumour ≥1 cm Exclusion Criteria: Pregnancy Medical history of primitive brain tumour MRI incompatibility/ medical history of contrast agent allergy Claustrophobia Patient unable to consent Epilepsia/recent stroke Patients participating in other studies Patients without health care insurance healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Natalia SHOR, MD central contact role Contact central contact phone +330661884335 central contact e mail shor.natalia@icloud.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009362 condition mesh term Neoplasm Metastasis condition mesh id D000001932 condition mesh term Brain Neoplasms condition ancestor list condition ancestor condition ancestor id D000009385 condition ancestor term Neoplastic Processes condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000016543 condition ancestor term Central Nervous System Neoplasms condition ancestor id D000009423 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full study rank 61459 study protocol section identification module n c t id NCT04836195 org study id info org study id PCLX-001-01 organization org full name Pacylex Pharmaceuticals org class INDUSTRY brief title Phase I Trial of PCLX-001 in B-cell Non-Hodgkin Lymphoma and Advanced Solid Malignancies official title Phase I Trial of PCLX-001 in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma and Advanced Solid Malignancies status module status verified date September 2021 overall status Recruiting expanded access info has expanded access No start date struct start date September 14, 2021 start date type Actual primary completion date struct primary completion date February 28, 2023 primary completion date type Anticipated completion date struct completion date July 31, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 26, 2022 last update post date struct last update post date September 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Pacylex Pharmaceuticals lead sponsor class INDUSTRY collaborator list collaborator collaborator name Ozmosis Research Inc. collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a phase I dose-escalation study of oral PCLX-001, conducted in a multicenter, non-randomized, open-label, non-controlled design. The study is comprised of two parts: Part A (single-agent dose escalation) and Part B (single-agent expansion cohorts). detailed description This is a phase I dose-escalation study of oral PCLX-001, conducted in a multicenter, non-randomized, open-label, non-controlled design. The study is comprised of two parts: Part A (single-agent dose escalation) and Part B (single-agent expansion cohorts). For Part A dose-escalation, patients will be accrued in cohorts of 3 to 6 patients to each dose level. A new dose level cannot open to accrual until toxicity has been determined in the preceding dose level (i.e. all patients have completed their first cycle of therapy and data for all patients in that dose level have been reviewed at a safety cohort review meeting). Six patients will be treated at the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). If required, the MTD cohort may be expanded by an additional 10 patients for further toxicity and response assessment. The MTD cohort expansion may be restricted to B-cell lymphoma or advanced solid tumours to ensure there is proper distribution during dose escalation. For Part B (single agent expansion cohorts), two expansion cohorts (N=20 each) will be opened to determine the preliminary clinical activity of PCLX-001 at the RP2D: Expansion Cohort A: Participants with advanced solid malignancies showing preclinical sensitivity or molecular markers of sensitivity to PCLX-001. This includes breast, nonsmall cell lung (NSCLC), small-cell lung (SCLC), colorectal (CRC), and bladder cancers Expansion Cohort B: Participants with relapsed/refractory (R/R) B-cell lymphoma: diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and Burkitt lymphoma. Transformed large B-cell lymphoma will also be included. conditions module condition list condition B-cell Non Hodgkin Lymphoma Advanced Solid Tumor design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Sequential Assignment design intervention model description For Part A dose-escalation, patients will be accrued in cohorts of 3 to 6 patients to each dose level. A new dose level cannot open to accrual until toxicity has been determined in the preceding dose level (i.e. all patients have completed their first cycle of therapy and data for all patients in that dose level have been reviewed at a safety cohort review meeting). Six patients will be treated at the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label PCLX-001 intervention arm group type Experimental arm group description The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level. Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle. The starting dose of PCLX-001 will be 20 mg daily Expansion Cohort Once the MTD has been defined, preliminary activity will be further evaluated in the expansion part of the study. The RP2D may be the MTD but not necessarily as not only safety data will be taken into account prior to its determination. arm group intervention list arm group intervention name Drug: PCLX-001 treated intervention list intervention intervention type Drug intervention name PCLX-001 treated intervention description To ensure maximal safety in this first-in-human trial, the starting dose level was chosen to be 20 mg daily. PCLX-001 will be provided as an oral flat daily dose on a 28-day cycle. Missed doses for any reason will not be administered at a later time. The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. If DLT attributable to the treatment is experienced in 1/3 patients, three more patients (for a total of six patients) will be treated at that dose level. If no additional DLT is observed at the expanded dose level (i.e. 1/6 with DLT), the dose will be escalated. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level. DLT and determination of MTD will be based on cycle 1 toxicities. intervention arm group label list intervention arm group label PCLX-001 intervention outcomes module primary outcome list primary outcome primary outcome measure To determine, during the dose escalation phase, the recommended dose of PCLX-001 for the dose expansion phase of the trial. primary outcome description The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT. primary outcome time frame Cycle length is 28 days primary outcome measure To determine the time to maximum plasma level (Tmax) of PCLX-001 primary outcome description Tmax is the time at which the maximum plasma concentration of PCLX-001 is achieved. primary outcome time frame Measured on Cycle 1: Pre-dose on Days 1,2,8(±2), 15 (±2), 22 (±2), Day 1 and Day 15 will also measure at 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours; Cycle 2 pre-dose on Day 1 & 15; Cycle 3 pre-dose on Day 1 (Each cycle is 28 days) primary outcome measure To determine the maximum plasma level (Cmax) of PCLX-001 primary outcome description Cmax is the maximum plasma concentration of PCLX-001. primary outcome time frame Measured on Cycle 1: Pre-dose on Days 1,2,8(±2), 15 (±2), 22 (±2), Day 1 and Day 15 will also measure at 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours; Cycle 2 pre-dose on Day 1 & 15; Cycle 3 pre-dose on Day 1 (Each cycle is 28 days) secondary outcome list secondary outcome secondary outcome measure To evaluate the clinical response rate in patients treated with PCLX-001 with advanced solid malignancies secondary outcome description Tumor response and progression of solid tumors and NHL will be evaluated by the investigator at each study center consistent with RECIST 1.1 criteria. secondary outcome time frame Tumor measurements for efficacy evaluation will be made at initiation and at the end of every 2nd cycle (each cycle is 28 days) secondary outcome measure To evaluate the clinical response rate in patients treated with PCLX-001 with relapsed/refractory (R/R) B-cell lymphoma secondary outcome description Tumor response and progression of solid tumors and NHL will be evaluated by the investigator at each study center consistent with Lugano Classification of Lymphoma response. secondary outcome time frame Tumour assessment will be done at the end of every second cycle (each cycle is 28 days). other outcome list other outcome other outcome measure Assess the pharmacodynamic (PD) effects of PCLX-001 in patients with B-cell lymphomas other outcome description Collection of blood samples for exploratory biomarker research is also a part of this trial. Specimens will be stored and may be used for research purposes to identify biomarkers useful for predicting and monitoring PCLX-001. other outcome time frame Cycle 1 Days 1, 2, 8, 15, 22; Cycle 2 Days 1 & 15, Cycle ≥ 3 Day 1 (Cycle is 28 days) other outcome measure Assess the pharmacodynamic (PD) effects of PCLX-001 in patients with advanced solid tumours other outcome description Archived tissue samples will be requested from all patients and pre-treatment biopsies will be optional for patients enrolled in whom an archival biopsy is older than 6 months. These will be collected for response prediction analyses and exploratory research. Archived tumour blocks will be returned to the clinical investigator at the end of the study or, if requested, once sections have been obtained for biomarker analysis. other outcome time frame Access either archived biopsies or at patient screening eligibility module eligibility criteria Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained before any study-specific procedures are performed. Male or female patients aged ≥ 18 years Dose Escalation Participants with histologically-confirmed advanced solid tumor who have failed at least one prior therapy and/or are not eligible for therapies expected to provide clinical benefit. Histologically-confirmed B-cell lymphomas that are expected to express CD20 including DLBCL, HGBL, FL (grades 1 to 3b), MCL, and Burkitt lymphoma who have failed at least two prior therapies and/or are not eligible for therapies expected to provide clinical benefit (including autologous stem cell transplantation). Transformed large B-cell lymphoma patients are eligible. FL patients should meet criteria for requiring treatment. Dose Expansion Cohort A: Participants with histologically-confirmed advanced breast, NSCLC, SCLC, colorectal, and bladder cancers who have failed at least one prior therapy and/or are not eligible for therapies expected to provide clinical benefit. Cohort B: Participants with histologically-confirmed R/R B-cell lymphomas that are expected to express CD20 including DLBCL, HGBL, FL (grades 1-3a), FL (grade 3b), MCL, and Burkitt lymphoma who have failed at least two prior therapies and/or are not eligible for therapies expected to provide clinical benefit. Transformed large B-cell lymphoma patients are eligible. FL patients should meet criteria for requiring treatment. Patients must have evaluable or measurable disease (as per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1], or the Lugano lymphoma classification. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (Appendix A). Life expectancy of at least 12 weeks Patients must have adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 (±3) days before the first dose of study drug: Hemoglobin ≥ 85 g/L Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L for Dose Escalation and ≥ 75 x 109/L for Dose Expansion NOTE: For Dose Expansion, patient who do not meet the above hematological criteria, because of bone marrow suppression from prior therapies and/or extensive tumour involvement in the marrow, may be considered for enrollment in the trial after consultation with the Medical Monitor. Patients must have adequate liver function as assessed by the following laboratory tests to be conducted within 7 (±3) days before the first dose of study drug: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times ULN or ≤ 5 times ULN for patients with malignant liver involvement Patients must have adequate kidney function, as assessed by the estimated glomerular filtration rate (eGFR) >50 mL/min within 7 (±3) days before the first dose of study drug (eGFR to be calculated by the Cockcroft-Gault formula) or creatinine ≤ 1.5 times the ULN Patients must have adequate coagulation, as assessed by the following laboratory tests to be conducted within 7 (±3) days before the first dose of study drug: Prothrombin time/International normalized ratio (PT/INR) ≤ 1.5 for patients not on anticoagulation Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN for patients not on anticoagulation Note: Patients on anticoagulation with an agent such as heparin (eg. enoxaparin, dalteparin, etc.) will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Adequate cardiac function per institutional normal measured by echocardiography or multigated acquisition (MUGA) scan (LVEF ≥ 50%) Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 (±3) days before the start of administration of study drug. Note: A woman is of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active from signing of the informed consent form for the full study until at least 6 months after the last study drug administration. Patients must agree to utilize 2 reliable and acceptable methods of contraception simultaneously. A man is considered fertile after puberty unless permanently sterile by bilateral orchiectomy. Men being treated with PCLX-001 are advised not to father a child during and up to 6 months after treatment; prior to treatment, advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with PCLX-001. Female partners of childbearing potential from male study participants have to use adequate contraception / birth control between signing of the informed consent and 6 months after the last administration of the study drug if the male study participant is not sterilized. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control. Highly effective (failure rate of less than 1% per year) contraception methods, when used consistently and correctly, include: Combined (estrogen and progestin containing: oral, intravaginal transdermal and progestin-only (oral, injectable, implantable) hormonal contraception associated with inhibition of ovulation. Intra-uterine device (IUD) or intrauterine hormone-releasing system (IUS). Bilateral tubal occlusion or vasectomized partner (provided that partner is the sole sexual partner and has received medical assessment of the surgical success). Sexual abstinence (reliability to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient). Male patients with a female partner of reproductive potential must use a condom and ensure that an additional form of contraception is also used during treatment and until 6 months after last study drug administration. Patients must agree to utilize reliable and acceptable methods of contraception simultaneously Exclusion Criteria: Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class > II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry, or uncontrolled cardiac arrhythmias Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion) Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C Patients with known human immunodeficiency virus (HIV) infection Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Patients with chronic HBV or HCV infection are eligible at the investigator's discretion provided that the disease is stable and sufficiently controlled under treatment. Infections of CTCAE Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade > 2 Symptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a stable imaging study within 4 weeks prior to the first dose of study drug and is clinically stable with respect to the tumor at the time of study entry. Patients with asymptomatic brain metastases must not be on steroid therapy. Patients with neurological symptoms should undergo a CT / MRI scan of the brain to exclude new or progressive brain metastases. Current or past history of central nervous system (CNS) lymphoma Uncontrolled seizure disorder requiring therapy (e.g. strong CYP3A4 inducers such as carbamazepine and phenytoin) History of organ allograft transplantation or autologous stem cell transplantation ≤ 3 months prior to the first dose of study drug. Patients who received prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to study drug administration Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE Grade > 2 within 4 weeks before the first dose of study drug Serious, non-healing wound, ulcer, or bone fracture Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, with the exception of the following previous or concurrent cancer types: Curative treatment for localized cancer completed without signs of recurrence and treatment-related toxicity and low risk of recurrence as assessed by the investigator, In-situ prostate cancer, Gleason Score <7, prostate-specific antigen <10 ng/mL (very low risk and low risk, according to therapy guidelines, e.g. the National Comprehensive Cancer Network guideline; active surveillance / observation is a recommended option). Any clinical condition that is considered unstable or might jeopardize the safety of the patient and his / her compliance in the study Inability to swallow oral medications Any malabsorption condition Breastfeeding. Female patients must not breastfeed during treatment and until 4 months after last study drug administration. Treatment with anticancer chemotherapy or immunotherapy during the study or within 3 weeks before the first dose of study drug. For small-molecule drugs, a period of at least 3 half-lives before the first dose of study drug is acceptable. Mitomycin C or nitrosoureas should not be given within 6 weeks before the first dose of study drug. Treatment with systemic steroids (prednisone dose ≥10 mg/day or equivalent dose). Acute toxic effects (CTCAE Grade ≥2) of previous anticancer chemotherapy or immunotherapy that have not yet stabilized or if significant post-treatment toxicities have been observed. (Note however that toxic effects of previous anticancer therapy considered as chronic, such as chemotherapy-induced neuropathy, fatigue, alopecia, or anorexia of CTCAE Grade <2, for which further resolution is not expected, do not prevent participation in this study.) Radiotherapy for target lesions during study or within 3 weeks before the first dose of study drug. Palliative radiotherapy is allowed for non-target lesions. Major surgery or significant trauma within 4 weeks before the first dose of study drug Previous assignment to treatment during this study Concomitant participation in another clinical study with investigational medicinal product(s) Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site) Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug. Strong CYP3A4 inhibitors and inducers are prohibited during the study and until the active FU visit. Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex > 120 ms (except for bundle branch block pattern), or prolongation of the of the QTc interval (Fridericia) over 450 ms unless agreed otherwise between the investigator and the sponsor's medically responsible person healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Pacylex central contact role Contact central contact phone 1 (888) 580-4483 central contact e mail info@pacylex.com overall official list overall official overall official name Randeep Sangha overall official affiliation Cross Cancer Institute overall official role Principal Investigator location list location location facility Cross Cancer Institute location status Recruiting location city Edmonton location state Alberta location zip T6G 1Z2 location country Canada location contact list location contact location contact name Randeep Sangha location contact role Contact location contact e mail info@pacylex.com location contact name Randeep Sangha, MD location contact role Principal Investigator location facility Princess Margaret Hospital location status Recruiting location city Toronto location state Ontario location zip M5G 2M9 location country Canada location contact list location contact location contact name Swati Singla, M Sc location contact role Contact location contact phone 416-946-4501 location contact phone ext 5742 location contact e mail CCRUkitsquad@uhn.ca location contact name John Kuruvilla, MD location contact role Principal Investigator location facility Centre Hospitalier de l'Université de Montréal - CHUM location status Recruiting location city Montréal location state Quebec location zip H2X 0C1 location country Canada location contact list location contact location contact name Adeline Hamon location contact role Contact location contact phone 514-890-8000 location contact phone ext 30737 location contact e mail uit.eligibilite.chum@ssss.gouv.qc.ca references module reference list reference reference p m i d 33093447 reference type background reference citation Beauchamp E, Yap MC, Iyer A, Perinpanayagam MA, Gamma JM, Vincent KM, Lakshmanan M, Raju A, Tergaonkar V, Tan SY, Lim ST, Dong WF, Postovit LM, Read KD, Gray DW, Wyatt PG, Mackey JR, Berthiaume LG. Targeting N-myristoylation for therapy of B-cell lymphomas. Nat Commun. 2020 Oct 22;11(1):5348. doi: 10.1038/s41467-020-18998-1. avail i p d list avail i p d avail i p d type Study Protocol avail i p d u r l https://drive.google.com/file/d/19vOgkQi8xSyNo1PcQqGaMbt_x3pLUcLs/view?usp=sharing avail i p d type Informed Consent Form avail i p d u r l https://drive.google.com/file/d/1t_PLSn7mFnndj1Ha9X2wVp9oitY3kgSu/view?usp=sharing i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008223 condition mesh term Lymphoma condition mesh id D000008228 condition mesh term Lymphoma, Non-Hodgkin condition mesh id D000016393 condition mesh term Lymphoma, B-Cell condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id M17980 condition browse leaf name Lymphoma, B-Cell condition browse leaf as found B-Cell Non-Hodgkin Lymphoma condition browse leaf relevance high condition browse leaf id M10374 condition browse leaf name Lymphoma, Non-Hodgkin condition browse leaf as found Non-Hodgkin's Lymphoma condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id T640 condition browse leaf name B-cell Lymphoma condition browse leaf as found B-Cell Non-Hodgkin Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 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full study rank 61654 study protocol section identification module n c t id NCT04833660 org study id info org study id YUMC 2021-03-043 organization org full name Yeungnam University College of Medicine org class OTHER brief title rTMS on Diabetic Peripheral Neuropathic Pain official title The Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain: A Randomized Controlled Trial status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 30, 2021 start date type Anticipated primary completion date struct primary completion date May 25, 2021 primary completion date type Anticipated completion date struct completion date June 15, 2021 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 21, 2021 last update post date struct last update post date April 22, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Min Cheol Chang responsible party investigator title Associate Professor responsible party investigator affiliation Yeungnam University College of Medicine lead sponsor lead sponsor name Min Cheol Chang lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Background: Approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (DPN). Pain from DPN deteriorates the quality of life and hinders daily life activities. Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN. Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores [PCSs and MCSs]), at 1-week post-treatment. conditions module condition list condition Diabetic Peripheral Neuropathic Pain keyword list keyword diabetic peripheral neuropathy diabetes repetitive transcranial magnetic stimulation pain quality of life design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 22 enrollment type Anticipated arms interventions module arm group list arm group arm group label rTMS group arm group type Experimental arm group description Each patient will receive five consecutive sessions (Monday to Friday for 1 week). Patients in the rTMS group will administer rTMS over the optimal scalp site at 10 Hz, with an intensity of 90% of the MT and a duration of 5 seconds, for a total of 20 trains separated by 55-second intertrain pauses (a total of 1,000 pulses). The coil will be placed tangentially to the scalp at an approximate angle of 45° tilted backward and laterally. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods. arm group intervention list arm group intervention name Device: repetitive transcranial magnetic stimulation arm group label sham group arm group type Sham Comparator arm group description Patients in the sham group will administer sham stimulation using the same protocol, except that the angle of the coil is 90° (i.e., perpendicular, rather than tangential) to the skull. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods. arm group intervention list arm group intervention name Device: repetitive transcranial magnetic stimulation intervention list intervention intervention type Device intervention name repetitive transcranial magnetic stimulation intervention description Repetitive transcranial magnetic stimulation (rTMS) is a safe, noninvasive, and effective therapeutic intervention that uses an electromagnetic coil applied to the scalp to produce a magnetic field. rTMS induces changes in cortical excitability at the stimulation site and transsynaptically at distant areas. Cortical excitability is increased by high-frequency (≥5 Hz) stimulation and is decreased by low-frequency (1 Hz) stimulation. The application of high-frequency unilateral rTMS to the motor cortex in patients is reported to have a potential to control various types of pain, such as neuropathic pain, fibromyalgia, and musculoskeletal origin pain (myofascial pain syndrome, shoulder pain, and lower back pain). intervention arm group label list intervention arm group label rTMS group sham group outcomes module primary outcome list primary outcome primary outcome measure Pain before intervention to be assessed with Numeric Rating Scale primary outcome description We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain). primary outcome time frame The NRS score will be assessed the day before starting the stimulation sessions (pre-treatment). primary outcome measure Pain after intervention to be assessed with Numeric Rating Scale primary outcome description We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain). primary outcome time frame The NRS score will be assessed 1 day after the completion of the sessions. primary outcome measure Pain after intervention to be assessed with Numeric Rating Scale primary outcome description We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain). primary outcome time frame The NRS score will be assessed 1 week after the completion of the sessions. primary outcome measure Quality of life before intervention to be assessed with Short Form 36-Item Health Survey primary outcome description We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. primary outcome time frame The SF-36 PCS and SF-36 MCS will be measured the day before starting the stimulation sessions. primary outcome measure Quality of life after intervention to be assessed with Short Form 36-Item Health Survey primary outcome description We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. primary outcome time frame The SF-36 PCS and SF-36 MCS will be measured 1 week after the completion of the sessions. eligibility module eligibility criteria Inclusion Criteria: diabetes neuropathic pain (stocking glove distribution) of a numeric rating scale (NRS) score of ≥3 (where 0 indicates no pain and 10 indicates the most intense pain imaginable) in the lower extremities pain duration of ≥3 months age between 21 and 80 years Exclusion Criteria: presence of contraindications for TMS, such as a history of epileptic seizure, presence of metal in the skull, and presence of a cardiac pacemaker. healthy volunteers No gender All minimum age 21 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chang central contact role Contact central contact phone +82-10-9362-1220 central contact e mail wheel633@ynu.ac.kr overall official list overall official overall official name Min Cheol Chang overall official affiliation Yuengnam University overall official role Study Director location list location location facility Yeungnam University Hospital location city Daegu location zip 705-717 location country Korea, Republic of location contact list location contact location contact name Staff location contact role Contact location contact phone +82-053-624-8352 location contact e mail irb@ymc.yu.ac.kr references module reference list reference reference p m i d 17226897 reference type background reference citation Dobretsov M, Romanovsky D, Stimers JR. 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condition browse leaf relevance low condition browse leaf id M25157 condition browse leaf name Diabetes Complications condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental 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full study rank 61911 study protocol section identification module n c t id NCT04830306 org study id info org study id Pro00108027 organization org full name Duke University org class OTHER brief title Step, Walk, Bike: Comparisons of Fitness Assessments official title Comparison of Submaximal Exercise Tests With Maximal Exercise Test status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date April 6, 2022 start date type Actual primary completion date struct primary completion date September 21, 2022 primary completion date type Actual completion date struct completion date September 21, 2022 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 4, 2022 last update post date struct last update post date October 5, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Duke University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To compare cardiorespiratory fitness parameters (oxygen consumption and respiratory ventilation) measured during two sub-maximal exercise tests (six minute step test, 6MST & six minute walk test, 6 MWT) with maximal exercise test (cardiopulmonary exercise test, CPET) detailed description After enrollment, the subjects will complete each of the following CRF assessments: Sub-maximal exercise test Six Minute Step Test (6MST): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. The subject will be given a standardized set of instructions on how to complete the test by raising each knee to 90 degrees of hip flexion. The total number of steps completed during the timed 6-minute period will be recorded. Sub-maximal exercise test Six Minute Walk Test (6MWT): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. A 30-m unobstructed hallway with turning points marked with small cones will be used. The subject will be given a standardized set of instructions on how to complete the test. The total distance walked during the timed 6-minute period will be recorded. Maximal exercise cardiopulmonary exercise test (CPET): The CPET is performed using an electromagnetically-braked cycle ergometer, 12-lead continuous ECG, continuous pulse oximetry, continuous expired gas analysis (oxygen and carbon dioxide) with ventilation [termed 'metabolic cart'] and intermittent non-invasive blood pressure measurement every 2 minutes. Once the subject is seated comfortably on the bike and adjusted for optimum cycling position, the face mask is fitted. The subjects are instructed on how to perform the incremental ramp test, starting with a baseline rest phase (no leg turnover) for 2 mins followed by reference phase of 2 mins of leg turnover with no resistance (0 watts). The incremental rise in work-rate from baseline is pre-determined by using the equation derived by Wasserman and colleagues in which the same work-rate is increased throughout the test to the limit of tolerance. A work-rate is selected by study staff to aim for a test duration of between 8 and 12 minutes. The subjects are instructed to maintain a cycling cadence of 55 - 65 revolutions per minute (rpm) during the exercise phase. One the limit of tolerance (maximal watts) is reached the resistance on the bike is removed () watts) and the subjects are encouraged to continue cycling for a further 2 mins during the recovery phase. The order in which 6MST and 6MWT are performed will be randomized. Between test the subjects will be allowed to rest in a chair until the heart rate is within 5 beats per min of resting values and blood pressure in within 10 mmHg of resting values. The CPET will be conducted once both 6MWT and 6MST have been completed. If the subject expresses fatigue after either 6MWT and 6MST, then the subject may elect to re-attend on a separate day to complete the evaluation. At completion of exercise evaluations the subjects will be discharged from study participation. No further follow up will be performed. Up to 40 subjects aged 18 or older will be enrolled. Inclusion Criteria: Age 18 and older Able to speak English Ambulatory [assistive devices ok] Able to provide informed consent Exclusion Criteria: Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET Inmate of correctional facility (i.e. prisoner) Diagnosed history of dementia Inability to ambulate independently Considered inappropriate to participate by Principal Investigator conditions module condition list condition Cardiorespiratory Fitness keyword list keyword aerobic power CPET CPEX cardiopulmonary exercise testing exercise capacity functional capacity physical activity design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Crossover Assignment design intervention model description All subjects will be asked to complete the three exercise tests design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label 6MST arm group type Active Comparator arm group description Six minute step test arm group intervention list arm group intervention name Behavioral: Exercise arm group label 6MWT arm group type Active Comparator arm group description Six minute walk test arm group intervention list arm group intervention name Behavioral: Exercise arm group label CPET arm group type Active Comparator arm group description Cardiopulmonary exercise test arm group intervention list arm group intervention name Behavioral: Exercise intervention list intervention intervention type Behavioral intervention name Exercise intervention description Completion of exercise in accordance with assigned protocol intervention arm group label list intervention arm group label 6MST 6MWT CPET outcomes module primary outcome list primary outcome primary outcome measure Total amount of oxygen consumed per minute as measured by wearable face mask primary outcome description Oxygen measured in mL/min primary outcome time frame Up to 15 minutes secondary outcome list secondary outcome secondary outcome measure Total amount of respiratory ventilation per minute as measured by wearable face mask secondary outcome description Respiratory ventilation measured in liters per minute secondary outcome time frame Up to 15 minutes eligibility module eligibility criteria Inclusion Criteria: Age 18 and older Able to speak English Ambulatory [assistive devices ok] Able to provide informed consent Exclusion Criteria: Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET Inmate of correctional facility (i.e. prisoner) Diagnosed history of dementia Inability to ambulate independently Considered inappropriate to participate by Principal Investigator healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name David MacLeod, FRCA overall official affiliation Duke University overall official role Principal Investigator location list location location facility Duke University Health System location city Durham location state North Carolina location zip 27710 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11134 intervention browse leaf name Morphine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev 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full study rank 61176 study protocol section identification module n c t id NCT04839874 org study id info org study id NHS Grampian organization org full name NHS Grampian org class OTHER_GOV brief title Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes? official title Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes? status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date December 1, 2021 start date type Actual primary completion date struct primary completion date March 31, 2023 primary completion date type Anticipated completion date struct completion date March 31, 2023 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 8, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name NHS Grampian lead sponsor class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study will focus on speaking to women who have been diagnosed with one of the five main gynaecological cancers: ovarian, endometrial (womb), cervical, vulval and vaginal. Too many women are dying from gynaecological cancer in the UK. There are many reasons for this, but the study investigators think that embarrassment might be one of the reasons. It can be embarrassing to talk about gynaecological cancers or the symptoms that they cause. This might lead some women to delay going to their doctor when they have symptoms. This study will speak with women who have been diagnosed with a gynaecological cancer to ask them what they did before they were diagnosed; when did they realise something was wrong; what made them go to their doctor; did having gynaecological symptoms make them think differently about going to the doctor? This information will be used to find ways of making it as easy as possible for women to go to their doctors as early as possible. This will hopefully see fewer women dying from these cancers. detailed description The study will explore the research questions using qualitative semi-structured interviews with women diagnosed with gynaecological cancer. A study information sheet, reply slip and a reply-paid envelope will be sent to eligible patients by their secondary care clinician, with reminders sent after two weeks. Recruitment and interviewing will take place until data saturation occurs (three interviews with no new shared beliefs) on the main themes. Interviews will take place at a mutually convenient time and place, ideally face to face but could be conducted over the telephone if preferred by the interviewee or if social distancing measures are still in place due to Covid-19. Further verbal and written information regarding the study will be provided prior to interview commencement and participants will be given the opportunity to ask questions. Those agreeing to take part in a face to face interview will sign a consent form in duplicate (one for the participant and one copy for the research team). Those participating in a telephone interview will be read each point of the consent form and asked to agree to each one. This will be recorded, transcribed and used as evidence of consent. Interviews will be conducted flexibly allowing for shorter interviews where necessary and participants will be reminded that the interviews can be terminated at any time. The participant can withdraw from the study at any time: data already collected with consent will be retained and used in the study. No further data will be collected, or any other research procedures carried out on or in relation to the participant. All interviews will be digitally audio recorded and transcribed verbatim by the CI or NHSG approved transcription service. The data will be stored and managed using NVivo software. Interviews will follow a semi-structured topic guide based on the COM-B behaviour change model concepts of capability, opportunity and motivation. Changes can be made to the topic guide as interviews are conducted. Data familiarisation will be by reading and rereading transcripts and by listening to the recorded interviews. Data will be analysed using iterative deductive and inductive methods combining Framework analysis and thematic analysis. A contact will be provided for patients should they become distressed because of contact by or participation in the study. Although all data collected will stored and analysed with the strictest of confidence in line with the General Data Protection Regulations (2018), if details of any improper conduct or poor practice are disclosed the research team may be obliged to report this. The participant's GP will not be informed. Study participants will have any travel costs reimbursed. conditions module condition list condition Gynaecological Cancer keyword list keyword Health seeking behaviour Pelvic examination design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 15 enrollment type Anticipated arms interventions module intervention list intervention intervention type Other intervention name No intervention intervention description Semi-structured qualitative interviews outcomes module primary outcome list primary outcome primary outcome measure Description of the facilitators and barriers to health seeking behaviour in women diagnosed with gynaecological cancer using semi-structured qualitative interviews. primary outcome description Semi-structured interviews will be used to explore the facilitators and barriers to health seeking behaviour in women who have been diagnosed with a gynaecological cancer. Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model. primary outcome time frame 2 years secondary outcome list secondary outcome secondary outcome measure Description of the perceptions of pelvic examination in women diagnosed with gynaecological cancer using semi-structured interviews. secondary outcome description Semi-structured interviews will be used to explore the perceptions to pelvic examination in women who have been diagnosed with a gynaecological cancer. Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model. secondary outcome time frame 2 years eligibility module eligibility criteria Inclusion Criteria: Clinical diagnosis of gynaecological cancer Exclusion Criteria: Non-English speaking participants Cognitive impairment Terminal stage of illness Diagnosis through screening programmes gender Female gender based Yes gender description Gynaecological cancers which are female sex dependant minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult study population Women who have been diagnosed with a gynaecological cancer sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Pauline Williams central contact role Contact central contact phone 07528085261 central contact e mail pauline.williams@abdn.ac.uk location list location location facility NHS Grampian location status Recruiting location city Aberdeen location state Aberdeen City location country United Kingdom i p d sharing statement module i p d sharing No i p d sharing description Identifiable patient data will not be shared. 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full study rank 61813 study protocol section identification module n c t id NCT04831593 org study id info org study id 2019-167 organization org full name Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital org class OTHER_GOV brief title The Rate of Full and Empty Stomach in Elective and Emergency Pediatric Patients official title The Rate of Full and Empty Stomach in a Large Cohort of Elective and Emergency Pediatric Patients by Preoperative Ultrasound Examination: a Prospective Observational Study status module status verified date July 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date October 30, 2022 primary completion date type Anticipated completion date struct completion date October 30, 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 19, 2022 last update post date struct last update post date July 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Feyza Sever responsible party investigator title Specialist physician responsible party investigator affiliation Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital lead sponsor lead sponsor name Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital lead sponsor class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Background and Aim: Pulmonary aspiration of gastric content in the perioperative period is rare, but it is an important cause of morbidity and mortality that anesthetists never want to encounter. Due to reasons such as emergency surgical procedures, communication problems with pediatric patients or their parents, impaired cognitive function, obesity, diabetes mellitus, chronic liver and kidney diseases, it is observed that there is sometimes inconsistency between the periods defined in the preoperative fasting guidelines in pediatric patients and the state of gastric content and volume encountered in clinical practice. There is a lack of data on children on this issue. In this study, primary we aimed to evaluate the incidence of empty and full stomach in pediatric patients who underwent elective and emergency surgery in our routine anesthesia practice. Also we want to determine the relationship between fasting time and qualitative assessment of gastric content. Secondary this study sought to examine whether correlation between gastric ultrasound finding and fasting time, and also to determine relationship with the current comorbidities. Design: This is a prospective, single blinded, observational study. The minimum sample size required to determine the prevalence of full stomach, 0.05, within the limits of ± 0.025 with 0.95 confidence, was calculated as 292. When calculating with the proposed equation of n = 100 + 50i to determine the factors affecting by logistic regression (here i is the number of variables in the model), the minimum number of samples required for logistic regression analysis was calculated as 300 in case of 4 independent variables in the model. n=100+50*4= 300 Methods: Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia at our hospital are enrolled in this prospective observational study between April and December 2021. Preoperative ultrasound examination of the gastric antrum are performed by one anesthesiologist who has been instructed and supervised by an experienced pediatric radiologist and who is blind to the patient's history. Ultrasonographic measurement of the gastric antral cross-sectional area (CSA) are performed in supine position and right lateral decubitus position (RLD). The gastric antrum is imaged in a sagittal plane, between the left lobe of the liver and the pancreas, at the level of the aorta, as previously described [1]. This examination allowed qualitative assessment of gastric contents according to the three-point grading scale previously described by Perlas and colleagues[2]. Grade 0 was defined by the absence of appearance of any content in a flat antrum in both the supine and the RLD positions. Grade 1 was defined by the appearance of any gastric content in the RLD position only, and Grade 2 was defined by the appearance of any content in both the RLD and the supine positions. The antral cross-sectional area is also calculated in both position, by measuring the longitudinal diameter (D1) and the anteroposterior diameter (D2) of the antrum, from serosa to serosa using this formula [3] Antral area= (π x D1 X D2) / 4. Patients' characteristic data ( age, gender, weight, height, BMI and ASA physical status classification), fasting duration, type of elective and emergency surgery, chronic disease and complications (regurgitation, pulmonary aspiration, etc.) that may develop during the peroperative period are recorded. conditions module condition list condition Ultrasound Children Surgery keyword list keyword Ultrasound Antrum Children Surgery design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 600 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group Elective arm group description In our clinic, pediatric patients who will undergo elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in elective pediatric patients before general anesthesia. arm group intervention list arm group intervention name Other: Group El arm group label Group Emergency arm group description In our clinic, pediatric patients who will undergo emergency surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in emergency pediatric patients before general anesthesia. arm group intervention list arm group intervention name Other: Group Em intervention list intervention intervention type Other intervention name Group El intervention description Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid. intervention arm group label list intervention arm group label Group Elective intervention other name list intervention other name Gastric ultrasound in elective pediatric patients before general anesthesia. intervention type Other intervention name Group Em intervention description Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid. intervention arm group label list intervention arm group label Group Emergency intervention other name list intervention other name Gastric ultrasound in emergency pediatric patients before general anesthesia. outcomes module primary outcome list primary outcome primary outcome measure Prevalence of full stomach primary outcome description In our clinic, pediatric patients who will undergo emergency and elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach in pediatric patients before general anesthesia. primary outcome time frame 30 minutes primary outcome measure The relationship between fasting time and qualitative assessment of gastric content primary outcome description We would like to determine the relationship (and correlation with preoperative fasting guidelines) between the fasting time that pediatric patients and their parents reported to us and the qualitative assessment of gastric content in our clinical practice primary outcome time frame 30 minutes secondary outcome list secondary outcome secondary outcome measure Demographic data and comorbidities secondary outcome description The secondary objective of this study is to examine correlation between gastric ultrasound finding and the demographic data ( age, gender, weight, height, BMI, ASA physical status classification), and type of elective and emergency surgery ) and current comorbidities of pediatric patients. secondary outcome time frame 30 minutes eligibility module eligibility criteria Inclusion Criteria: Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia are included in the study. Exclusion Criteria: Exclusion criteria will be, having a nasogastric tube inserted and patient refusal. healthy volunteers Accepts Healthy Volunteers gender All maximum age 18 Years std age list std age Child Adult study population Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia sampling method Probability Sample contacts locations module overall official list overall official overall official name Feyza Sever overall official affiliation Ankara City Hospital Childrens' Hospital overall official role Principal Investigator location list location location facility Ankara City Hospital Childrens' Hospital location city Ankara location state Çankaya location zip 06800 location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004630 condition mesh term Emergencies condition ancestor list condition ancestor 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full study rank 61188 study protocol section identification module n c t id NCT04839718 org study id info org study id 1421043 organization org full name Kaiser Permanente org class OTHER brief title Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program official title Evaluating the Implementation and Outcomes of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Collaborative Care Program in A Large, Integrated Healthcare System: A Mixed Methods Observational Study Protocol acronym ADAPT status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2019 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 15, 2022 last update post date struct last update post date March 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Kaiser Permanente lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Depression and anxiety are increasingly common conditions for which primary care providers (PCPs) serve as the initial healthcare contact for most patients. Comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care. Collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs. ADAPT is a novel collaborative care model. By using technology-driven appointments with providers, ADAPT increases access to mental healthcare, and reduces member wait times. This mixed methods study will assess implementation measures of the ADAPT program and the components of ADAPT related to patient mental health improvement compared to specialty mental health care. The hypothesis is that: ADAPT program will have good program reach and efficacy. We will examine program implementation and maintenance. Further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization. conditions module condition list condition Depression Anxiety keyword list keyword Depression Anxiety design module study type Observational patient registry No design info design observational model list design observational model Ecologic or Community design time perspective list design time perspective Retrospective enrollment info enrollment count 10000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control arm group description Patients receiving referral to specialty mental healthcare arm group label ADAPT arm group description ADAPT arm group intervention list arm group intervention name Behavioral: ADAPT intervention list intervention intervention type Behavioral intervention name ADAPT intervention description The Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program is a novel collaborative psychiatric care model that is designed to unburden PCPs and psychiatrists, increase access to quality specialty mental healthcare for Kaiser Permanente members, and improve patient depression and anxiety treatment outcomes by utilizing technology-driven appointments. This program uses principles of collaborative care, including patient-centered care, population-based care, evidence-based care, measurement-based treatment to target, and accountable care. intervention arm group label list intervention arm group label ADAPT outcomes module primary outcome list primary outcome primary outcome measure Patient reach primary outcome description Examine and compare patients eligible and enrolled in ADAPT versus those eligible but not enrolled in ADAPT primary outcome time frame through study completion, 2 years secondary outcome list secondary outcome secondary outcome measure Member characteristics associated with depression remission secondary outcome description Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience). secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Member characteristics associated with anxiety remission secondary outcome description Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience). secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient therapy engagement secondary outcome description number of therapy contacts (individual, group and combined) secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient medication provider engagement secondary outcome description number of clinical pharmacy contacts secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient medication engagement secondary outcome description medication length of treatment secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient psychiatry engagement secondary outcome description number of contact with psychiatrist secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient time to care secondary outcome description average time from ADAPT referral to first appointment with therapist or pharmacist secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Depression outcomes secondary outcome description Examine if patients enrolled in ADAPT demonstrate non-inferior depression outcomes defined by change in the patient health questionnaire (PHQ-9) score compared to treatment as usual. secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Anxiety outcomes secondary outcome description Examine if patients enrolled in ADAPT demonstrate non-inferior anxiety outcomes defined by generalized anxiety disorder (GAD-2) score compared to treatment as usual. secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Time to clinical improvement secondary outcome description Compare time to clinical improvement as defined by change in Adult Outcomes Questionnaire (AOQ score) from baseline to 3, and 6 months for members in ADAPT compared to treatment as usual. secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Implementation: measurement-based care secondary outcome description Examine provider use of measurement-based care secondary outcome time frame through study completion, 2 years secondary outcome measure Implementation: Diagnosis secondary outcome description Examine provider use of a specific depression or anxiety diagnosis secondary outcome time frame through study completion, 2 years secondary outcome measure Maintenance: Measurement-based care secondary outcome description Examine provider use of measurement-based care over time secondary outcome time frame through study completion, 2 years secondary outcome measure Maintenance: Diagnosis secondary outcome description Examine provider use of a specific depression or anxiety diagnosis over time secondary outcome time frame through study completion, 2 years eligibility module eligibility criteria Inclusion Criteria: Adult Outcomes Questionnaire (AOQ) score between 10-30 English-Speaking Exclusion Criteria: High risk for suicide defined by answer to question 9 on PHQ-9 of 1 or more Diagnosis of bipolar disorder Diagnosis of a psychotic disorder Dementia diagnosis Active substance use disorder diagnosis Current hospice Current home-based palliative care Residing in a skilled nursing facility Residing in an assisted living facility Non-Kaiser Permanente Member Established psychiatric care outside of Kaiser Permanente gender All minimum age 18 Years std age list std age Adult Older Adult study population Kaiser Permanente Northern California adult members who screen positive for depression or anxiety in primary care and are referred to treatment. sampling method Probability Sample contacts locations module central contact list central contact central contact name Kathryn K Erickson-Ridout, MD PhD central contact role Contact central contact phone 7075713778 central contact e mail Kathryn.Erickson-Ridout@kp.org overall official list overall official overall official name Kathryn K Erickson-Ridout, MD PhD overall official affiliation Kaiser Permanente overall official role Principal Investigator location list location location facility Kaiser Permanente Northern California Division of Research location status Recruiting location city Oakland location state California location zip 94612 location country United States location contact list location contact location contact name Kathryn K Erickson-Ridout, PhD location contact role Contact location contact phone 707-571-3778 location contact e mail Kathryn.Erickson-ridout@kp.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depression condition browse 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full study rank 61758 study protocol section identification module n c t id NCT04832308 org study id info org study id 61023 organization org full name Palo Alto Veterans Institute for Research org class OTHER brief title Mobile Intervention Supervised Exercise Therapy Study 1 official title Mobile Intervention Supervised Exercise Therapy Study 1 acronym MiSET-1 status module status verified date November 2022 overall status Withdrawn why stopped Lack of grant funding expanded access info has expanded access No start date struct start date August 20, 2021 start date type Actual primary completion date struct primary completion date June 1, 2022 primary completion date type Actual completion date struct completion date June 1, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 2, 2022 last update post date struct last update post date November 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Oliver Aalami responsible party investigator title Clinical Associate Professor of Surgery responsible party investigator affiliation Stanford University lead sponsor lead sponsor name Palo Alto Veterans Institute for Research lead sponsor class OTHER collaborator list collaborator collaborator name Society for Vascular Surgery collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life. detailed description This is a national randomized controlled study with approximately 10-15 sites enrolling patients with Rutherford II peripheral artery disease (PAD) in total. Patients will be randomized between the SVS SET Program and "usual care" for each site. The primary outcome will be to study the site-specific effect on utilization of exercise therapy. Secondary outcomes will be the effect on the 6-minute-walk test, passive activity and quality of life. conditions module condition list condition Peripheral Artery Disease Claudication, Intermittent design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Block randomization stratified by site. design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label SVS SET Program arm group type Experimental arm group description Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription. arm group intervention list arm group intervention name Behavioral: Exercise Therapy arm group label Usual Care arm group type No Intervention arm group description This usual care arm will allow sites to direct patients as they usually do. This could include an in-person exercise therapy program or simply exercise instruction during an office visit. intervention list intervention intervention type Behavioral intervention name Exercise Therapy intervention description This is a health coach driven exercise prescription for patients recommending 30 minutes or more of moderate effort walking 3-5 days a week with expected walk-rest-walk-rest intervals. intervention arm group label list intervention arm group label SVS SET Program outcomes module primary outcome list primary outcome primary outcome measure Number of Participants Who Complete a 12-week Exercise Therapy Program primary outcome description Completion of a 12-week program in the treatment group will be completion of the remote SVS SET Program while the "usual care" group may have an in-person 12-week exercise therapy program. primary outcome time frame 12 weeks. secondary outcome list secondary outcome secondary outcome measure Mobile Phone Delivered 6-Minute Walk Test secondary outcome description Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points. secondary outcome time frame Weeks 0, 6 and 12 secondary outcome measure Passive Activity as Measured on Mobile Device secondary outcome description Daily passive step count activity as measured by sensors in mobile phone. secondary outcome time frame 12 weeks. secondary outcome measure Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ) secondary outcome description QoL questionnaires will be asked on the mobile phone at three time points. secondary outcome time frame Weeks 1, 6, and 12 secondary outcome measure Adherence as Measured by Completion of Scheduled Daily Walks secondary outcome description Adherence to the recommended exercise therapy frequency (3 walks per week) and duration (for at least 30 minutes or more) will be measured secondary outcome time frame 12 weeks. secondary outcome measure Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year secondary outcome description Freedom from any surgical intervention will be reported at one year by performing a chart review. secondary outcome time frame 1 year. eligibility module eligibility criteria Inclusion Criteria: 18 years of Age Rutherford Class I-II PAD (claudication) Ambulatory Exercise Therapy Naive (>18 mo) Primary Owner of an Android or iOS device Willingness to participate (text, call, fill out surveys) via a mobile phone Exclusion Criteria: Symptomatic coronary artery disease Oxygen dependent COPD Significant osteoarthritis limiting ambulation healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000058729 condition mesh term Peripheral Arterial Disease condition mesh id D000007383 condition mesh term Intermittent Claudication condition ancestor list condition ancestor condition ancestor id D000050197 condition ancestor term Atherosclerosis condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000016491 condition ancestor term Peripheral Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M28366 condition browse leaf name Peripheral Arterial Disease condition browse leaf as found Peripheral Artery Disease condition browse leaf relevance high condition browse leaf id M9570 condition browse leaf name Intermittent Claudication condition browse leaf as found Claudication, Intermittent condition browse leaf relevance high condition browse leaf id M18046 condition browse leaf name Peripheral Vascular Diseases condition browse leaf relevance low condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology	NCT04832308	[ 101, 1554, 2025, 3997, 5391, 26253, 1604, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 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full study rank 61291 study protocol section identification module n c t id NCT04838379 org study id info org study id 01210861577 organization org full name Assiut University org class OTHER brief title Ultrasound Guided Rectus Sheath Block in Pediatric Single Port Laparoscopic Appendectomy official title Ultrasound Guided Rectus Sheath Block by Bupivacaine With or Without Dexmedetomidine in Pediatric Single Port Laparoscopic Appendectomy status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 2021 start date type Anticipated primary completion date struct primary completion date May 2022 primary completion date type Anticipated completion date struct completion date August 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 13, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kirolos Gamal Reda responsible party investigator title Principal Investigator responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The current study aimed to assess the analgesic effect of ultrasound guided RSB with dexmedetomidine in the perioperative period of the surgical site after appendectomy In comparing only the postoperative outcome detailed description laparoscopic appendectomy is one of the most frequently performed pediatric surgeries. Although minimally invasive, this technique is still associated with a significant amount of pain and anxiety in children . Indeed, children who are highly anxious prior to surgery tend to have more postoperative pain, delayed hospital discharge, and higher incidence of emergence delirium, sleep disturbances, and other mal-adaptive behavior changes that can last up to a few weeks following surgery . To improve analgesia and decrease postoperative anxiety in children undergoing laparoscopic appendectomies multimodal approach for pain control can be employee; Over the past years, the concept of pain management has extended from simply decreasing pain intensity to optimizing patient's condition. The goal is to decrease pain scores, stress response that should be avoided in patients, particularly cardiac patients, together with a decrease in analgesics-related adverse effects like nausea, vomiting, retention of urine and over sedation. By achieving these goals, we can certainly facilitate patient recovery and minimize the hospital stay. Improved pain control can be achieved by a combination of different types of regional analgesia with systemic analgesics. The main contributor to pain post abdominal operations is the pain from abdominal wall incision . Many procedures were followed to decrease this intense postoperative pain such as, epidural catheter analgesia, Transverse Abdominis Plane (TAP) block, local wound infiltration, Patient-Controlled Analgesia (PCA), peripheral nerve blocks, in addition to Systemic administration of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or opioids. The Rectus Sheath Block (RSB) is one of these regional techniques that are suitable for operations with a midline incision or laparoscopic surgery with the main incision at the umbilical port. A previous study showed the analgesic efficacy of ultrasound guided rectus sheath block for laparoscopic appendectomy compared to a control group injected with saline instead of a local anesthetic in addition to the usefulness of traditional local anesthetics to provide analgesia during the course of the postoperative period is restricted by their short duration of action. Dexmedetomidine (DEX) has been shown as a valuable additive to local anesthetics in neuraxial blocks and peripheral nerve blocks leading to prolongation of postoperative analgesia and better pain control . . dexmedetomidine (DEX) α-2 adrenergic receptor consists of three α-2 isoacceptors (α-2a, α-2b and α-2c), which regulate the various pharmacodynamic effects of this drug . The α-2a receptor seems to promote sedation and anxiolysis in the locus coeruleus, as well as to generate bradycardia and peripheral vasodilation by stimulation of the cerebral vasomotor center. The α-2b receptor prevents tremor, generates analgesia in the dorsal horns of the spinal cord and determines peripheral vasoconstriction. The α-2c receptor modulates the mental stat. conditions module condition list condition Appendicitis Acute keyword list keyword us guided rectus sheath block laparscopic appendectomy regional anesthesia design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Age: 3-8years. Weight: 10-60 kg. Sex: both males and females. ASA physical status: I-II. design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label group Bupivacaine arm group type Placebo Comparator arm group description will include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision arm group intervention list arm group intervention name Procedure: Ultrasound guided rectus sheath block arm group label group bupivacaine&dex arm group type Active Comparator arm group description 2 will include 30 patients: each one will receive 2.5mg/kg of 0.25% bupivacaine plus 2 µ/kg of dexmedetomidine diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision arm group intervention list arm group intervention name Procedure: Ultrasound guided rectus sheath block intervention list intervention intervention type Procedure intervention name Ultrasound guided rectus sheath block intervention description Sixty patients were randomized to receive ultrasound-guided RSB After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block (BRSB) was performed intervention arm group label list intervention arm group label group Bupivacaine group bupivacaine&dex outcomes module primary outcome list primary outcome primary outcome measure evaluate the first call for rescue analgesia primary outcome description the time of the first call for analgesia is recorded primary outcome time frame 24 hours after recovery from anesthesia eligibility module eligibility criteria Inclusion Criteria: ● Age: 3-8years. Weight: 10-60 kg. Sex: both males and females. ASA physical status: I-II. Exclusion Criteria: • Patient's guardian refusal to participate in the study. Patients having known hypersensitivity to dexametomidine will be excluded. Patients with cardiovascular, liver or renal disease, unsatisfactory preoperative peripheral arterial oxygen saturation, neurological or psychiatric disease and coagulation disturbances. Any perioperative cardiovascular or respiratory event occurred or difficulties in pain perception and assessment which make the study intervention clinically unacceptable. Patients on regular use of analgesic or who received analgesic 24 h before surgery healthy volunteers No gender All minimum age 3 Years maximum age 8 Years std age list std age Child contacts locations module central contact list central contact central contact name Kirolos Gamal central contact role Contact central contact phone 01210861577 central contact e mail kokojemy72@gmail.com central contact name wesam nashat central contact role Contact central contact phone 01002416772 central contact e mail dr.wesamnashat2015@gmail.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001064 condition mesh term Appendicitis condition ancestor list condition ancestor condition ancestor id D000059413 condition ancestor term Intraabdominal Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000005759 condition ancestor term Gastroenteritis condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000002429 condition ancestor term Cecal Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition browse leaf list condition browse leaf condition browse leaf id M3528 condition browse leaf name Appendicitis condition browse leaf as found Appendicitis condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M28618 condition browse leaf name Intraabdominal Infections condition browse leaf relevance low condition browse leaf id M8027 condition browse leaf name Gastroenteritis condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M4831 condition browse leaf name Cecal Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse 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full study rank 61617 study protocol section identification module n c t id NCT04834141 org study id info org study id 09.2020.897 organization org full name Marmara University org class OTHER brief title Correlation Between Thoracic Kyphosis Posture and Static Balance official title Correlation Between Thoracic Kyphosis Posture and Static Balance status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date October 13, 2020 start date type Actual primary completion date struct primary completion date December 30, 2020 primary completion date type Actual completion date struct completion date February 10, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Marmara University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The effects of balanced posture and postural changes have been evaluated in specific populations with different factors that can affect body postures and balance, such as age, musculoskeletal system, and other metabolic diseases. Studies on postural kyphosis and balance involvement are very few in the literature especially in the health population. Of the few studies that have evaluated kyphosis and balance, most are limited by small sample size and the exclusion of men. Many have focused primarily on the geriatric population. The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance. detailed description Background: Kyphosis is roughly a slight forward curvature of the spine. A slight kyphosis or posterior curvature is normal throughout the human body and is present in every individual. Hyperkyphotic is a kyphotic angle greater than 40° commonly measured on a lateral X-ray measured by the Cobb method between C7 and T12. Postural stability or balance is the ability to keep the center of mass within the boundaries of the support base. Moving the center of mass beyond the boundaries of the support base may cause postural instability and loss of balance. There are studies showing that kyphotic posture affects the center of gravity and affects fall in the elderly, but there are limited studies on the effect of balance in young individuals. The Aim of This Study Is: To study the correlation between the balance and severity of thoracic kyphosis will be investigated conditions module condition list condition Kyphosis Balance; Distorted Postural Kyphosis Spine Disease Balance design module study type Observational patient registry Yes target duration 1 Day design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 46 enrollment type Actual arms interventions module arm group list arm group arm group label Kyphotic Group arm group description Participants with kyphosis angle ≥ 40 degrees joined the kyphosis group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting. Static balance Assessment: Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) arm group intervention list arm group intervention name Other: FlexiCurve ruler method to assess thoracic kyphosis angle arm group label Control Group arm group description Participants with kyphosis angle < 40 degrees for the control group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting. Static balance Assessment: Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) arm group intervention list arm group intervention name Other: FlexiCurve ruler method to assess thoracic kyphosis angle intervention list intervention intervention type Other intervention name FlexiCurve ruler method to assess thoracic kyphosis angle intervention description The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance. intervention arm group label list intervention arm group label Control Group Kyphotic Group intervention other name list intervention other name NeuroCom Balance Manager System ® static posturography device to assess static balance outcomes module primary outcome list primary outcome primary outcome measure Kyphosis Angle primary outcome description Kyphosis angle will be measured by felxicurve ruler, normally kyphosis angle below 40 degrees recognized as normal. For participants with kyphosis angle above 40 degrees recognized as hyperkyphotic posture. FlexiCurve ruler method is valid and reliable to the gold standard. primary outcome time frame 2 Months primary outcome measure Static Balance Measures primary outcome description NeuroCom Balance Manager System ® static posturography device to assess static balance, which is objective evaluating system. The system compare the values reported for participants assessment then compare them to pre-recorded data base. The values of the test is assessed according to the percentage to the normal (average) values matched with the age group and gender. Above 80% determined as normal, and below this value determine balance disturbance. primary outcome time frame 2 Months eligibility module eligibility criteria Inclusion Criteria: Adults aged 18 and over willing to attend the study. For those who join the thoracic kyphosis group, individuals with a kyphosis angle ≥ 40 degrees. Individuals with a kyphosis angle < 40 degrees for the control group. Exclusion Criteria: Spine trauma, surgery, bone pathology, arthritis etc. have a history of illness Kyphotic deformity types are rounded back, Scheuermann's disease, hunched back, flat back and Dowager hump. Any spinal deformity, bone abnormality, postural deformity and disc herniation with / without peripheral symptoms. Body mass index (BMI), which is an indicator of obesity, is more than > 30. Complaining of balance problems, coordination problems, other neurological or vestibular diseases that affect body balance and posture. Having any orthopedic or neurological disease that affects the body joints or the integrity of the musculoskeletal system. Use of any medication that can cause dizziness or drowsiness in the last months. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Fourty-six subjects who joined the study were healthy without any disease might affect balance, body posture, and denied a past history of vestibular disorders, syncope, seizures, or neurological disorders such as stroke or Parkinson's disease. The study take place in Marmara university, Başıbüyük campus, between the period September 2020 to December 2020. Participants were recruited through online poster announcement, they directly contacted the primary investigator for booking an appointment. An appointment were made for the participants in the Faculty of Health Sciences, Physiotherapy and Rehabilitation Department, Biomechanics and Performance Analysis Laboratory, Marmara University. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name AYSEL yildiz, Ass. Prof. overall official affiliation Marmara University overall official role Principal Investigator location list location location facility Marmara University location city Istanbul location zip 34854 location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007738 condition mesh term Kyphosis condition mesh id D000013122 condition mesh term Spinal Diseases condition ancestor list condition ancestor condition ancestor id D000013121 condition ancestor term Spinal Curvatures condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M15071 condition browse leaf name Spinal Diseases condition browse leaf as found Spine Disease condition browse leaf relevance high condition browse leaf id M9910 condition browse leaf name Kyphosis condition browse leaf as found Kyphosis condition browse leaf relevance high condition browse leaf id M15070 condition browse leaf name Spinal Curvatures condition browse leaf relevance low condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions	NCT04834141	[ 101, 1554, 2025, 3997, 5391, 1545, 16770, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23124, 17175, 1475, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 4925, 119, 12795, 119, 5840, 1559, 2369, 8916, 1554, 1271, 9751, 20377, 1239, 8916, 1705, 152, 24162, 9637, 4094, 1641, 3291, 18337, 1891, 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full study rank 61521 study protocol section identification module n c t id NCT04835389 org study id info org study id AT-2021-001 organization org full name VIVEX Biologics, Inc. org class INDUSTRY brief title Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis official title A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis status module status verified date July 2021 overall status Withdrawn why stopped Company decision start date struct start date June 1, 2021 start date type Anticipated primary completion date struct primary completion date March 1, 2022 primary completion date type Anticipated completion date struct completion date June 30, 2022 completion date type Anticipated study first submit date December 11, 2020 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 2, 2021 last update post date struct last update post date July 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name VIVEX Biologics, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name MCRA collaborator class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary A randomized, double-blind, placebo-controlled trial comparing a single intra-articular injection of 2.0 mL AlloGen vs 2.0 mL sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks. detailed description This is a Phase 1, randomized, double-blind, placebo-controlled trial comparing a single intra-articular 2.0 mL injection of either AlloGen or sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks. The patient will remain blinded to his or her treatment throughout the study duration. The investigator/assessor will also remain blinded throughout the treatment period. Only the individual(s) preparing the injection will not be blinded. Black tape over the injection syringe will mask the study treatment. Up to 30 adult patients with osteoarthritis of one knee that has failed to adequately respond to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen, will be enrolled at up to 5 sites in the US. The first 6 subjects will be staggered to evaluate any significant toxicity. Any adverse event data collected will be reviewed by the Data Safety Monitoring Board (DSMB) prior to treating the subsequent subject. Cumulative safety data from these 6 subjects will be reviewed by the DSMB. conditions module condition list condition Osteoarthritis, Knee keyword list keyword osteoarthritis biologic design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized, Placebo-Controlled, Double-Blinded design primary purpose Treatment design masking info design masking Triple design masking description Subjects and investigators (including outcomes assessment) will be blinded to the treatment arm that is assigned. design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label AlloGen Liquid arm group type Experimental arm group description A single-dose, intra-articular (IA) injection of 2.0 mL of AlloGen Liquid administered to the affected knee. arm group intervention list arm group intervention name Biological: AlloGen Liquid arm group label Saline arm group type Placebo Comparator arm group description A single-dose, intra-articular (IA) injection of 2.0 mL of saline administered to the affected knee. arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Biological intervention name AlloGen Liquid intervention description Amniotic fluid intervention arm group label list intervention arm group label AlloGen Liquid intervention type Drug intervention name Placebo intervention description 0.9% normal saline intervention arm group label list intervention arm group label Saline outcomes module primary outcome list primary outcome primary outcome measure Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee primary outcome description The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events primary outcome time frame Baseline to 12 weeks secondary outcome list secondary outcome secondary outcome measure Evaluate preliminary efficacy of the injection by assessing pain subscale scores secondary outcome description Composite change from baseline in WOMAC-A (pain subscale) scores secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing function subscale scores secondary outcome description Composite change from baseline in WOMAC-C (function subscale) score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing pain secondary outcome description Change from baseline in WOMAC-A scores secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing function secondary outcome description Change from baseline in WOMAC-C score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by Visual Analog Scale secondary outcome description Change from baseline in Visual Analog Scale (VAS) secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing total WOMAC secondary outcome description Change from baseline in total WOMAC score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee secondary outcome description Incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 26 weeks secondary outcome time frame 26 Weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing Patient-Reported Outcomes Measurement Information System (PROMIS) secondary outcome description Change from baseline in PROMIS pain interference and physical function scores secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing total SF-12 score secondary outcome description Change from baseline in total SF-12 score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing total KOOS score secondary outcome description Change from baseline in total KOOS score secondary outcome time frame Baseline, 6, 12 and 26 weeks eligibility module eligibility criteria Inclusion Criteria: Subject has both clinical and radiographic findings consistent with osteoarthritis of the knee: Subject has clinical findings including (but not limited to) tenderness to palpation, swelling/effusion, stiffness, chronic limited range of motion. Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 2 to 3 using the Kellgren-Lawrence grading scale. Failed conservative care over the past 3 months of at least 2 conservative treatments including oral pain medication [analgesics, steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs)] and structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of knee osteoarthritis. Subject has a BMI less than 40 kg/m2 Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study. Subject must have a VAS pain score of 4 or greater on a 100-mm scale. All subjects of reproductive age or capacity must use adequate contraception (abstinence, surgically sterilized, postmenopausal, or consistently use an effective contraception method) during the study. Subject agrees not to take additional knee symptom-modifying drugs (e.g., glucosamine, collagen, hyaluronic acid) during the study without reporting the use to the study team. Exclusion Criteria: Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 4 on the Kellgren-Lawrence grading scale. Subject has active infection at the injection site. Subject has symptomatic OA of the contralateral knee or of either hip (VAS≥40) that is not responsive to acetaminophen (Tylenol®) and/or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, e.g. Ibuprofen) and requires other therapy. Subject has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer. Subject has documented history of gout or pseudo-gout. Subject has a known allergy to local anesthetics. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or Human Immunodeficiency Virus (HIV). Subject has diagnosis of hematologic, renal, hepatic, or coagulation abnormalities based on medical history and laboratory results. Subject has received any of the following to the target knee: Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening; Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening; Has had or is planning to have major surgery in the target knee within 26 weeks of treatment; or History of unicondylar or total knee arthroplasty. Subject is currently participating in another clinical trial or has used an investigational drug, device or biologic within 12 weeks prior to treatment. Subject has a history of immunosuppressive use or chemotherapy in the last 12 months. Subject has had prior radiation to the index knee. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin). Subject is breast feeding or pregnant or plans to become pregnant within 12 weeks of treatment. Subject has any significant medical condition that, in the opinion of the Investigator, would increase the chances of an adverse event and/or would interfere with protocol evaluation and participation. Subject is a worker's compensation patient. Subject has taken pain medication <48 hours prior to the injection or has received pain medicine other than acetaminophen and/or NSAIDs for conditions unrelated to OA of the index knee. Subject has a history of alcohol or substance abuse. Physical or IA injection exclusion criteria include: Frank mechanical symptoms such as locking, intermittent block to range of motion, or loose body sensations (meniscal displacement or IA loose body), Knee surgery on index knee within 12 months or on contralateral knee within 6 months, and/or Acute injury to the knee within 3 months. Subject has uncontrolled, unstable diabetes mellitus with HbA1C =/>8%. History within preceding 5 years of solid organ or hematologic transplantation or diagnosis of non-basal cell malignancy. History within the preceding 6 months of septic arthritis in the affected knee or sepsis/bacteremia. History within the preceding 3 months of infection requiring antibiotic treatment . healthy volunteers No gender All minimum age 18 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Brian Cole, MD overall official affiliation Brian Cole MD overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010003 condition mesh term Osteoarthritis condition mesh id D000020370 condition mesh term Osteoarthritis, Knee condition ancestor list condition ancestor condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf as found Osteoarthritis condition browse leaf relevance high condition browse leaf id M21321 condition browse leaf name Osteoarthritis, Knee condition browse leaf as found Osteoarthritis, Knee condition browse leaf relevance high condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse branch 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full study rank 61457 study protocol section identification module n c t id NCT04836221 org study id info org study id 00003543 organization org full name Medstar Health Research Institute org class OTHER brief title Comorbidities And Reducing inEquitieS official title Multi-level Interventions to Manage Co-morbidities Among Black Breast and Prostate Cancer Patients acronym CARES status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 5, 2021 start date type Actual primary completion date struct primary completion date November 30, 2022 primary completion date type Anticipated completion date struct completion date November 30, 2022 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 9, 2021 last update post date struct last update post date December 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hannah Arem responsible party investigator title Scientific Director, Implementation Science responsible party investigator affiliation Medstar Health Research Institute lead sponsor lead sponsor name Medstar Health Research Institute lead sponsor class OTHER collaborator list collaborator collaborator name Pfizer collaborator class INDUSTRY collaborator name American Cancer Society, Inc. collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Black cancer patients tend to have worse outcomes than White cancer patients. Some of this disparity may be due to comorbidities. The purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity. Comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. This study will offer additional support and tools to manage cancer patient's health needs. First, the study will use a mobile health application, managed by a company called Welldoc, to monitor patient progress in real time and to provide ongoing guidance. Second, the study will connect patients with a Community Health Worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. Lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed. conditions module condition list condition Cancer, Breast Diabetes Mellitus Hypertension Cancer Prostate keyword list keyword Prostate Cancer Breast Cancer Diabetes Mellitus Hypertension Community Health Workers mHealth design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description Will receive mHealth support for comorbidity and support from a Community Health Worker by phone arm group intervention list arm group intervention name Behavioral: Support intervention list intervention intervention type Behavioral intervention name Support intervention description Community Health Workers will conduct weekly phone calls to monitor blood pressure or blood glucose, to check in on patient need for social, practical or emotional supports, and to encourage healthy lifestyle modification. Participants will also have access to a mobile app to support chronic disease management (Either diabetes or hypertension). intervention arm group label list intervention arm group label Intervention outcomes module primary outcome list primary outcome primary outcome measure Feasibility of study protocol primary outcome description Accrual of >50 patients into the study primary outcome time frame Study recruitment period will be approximately 12 months primary outcome measure Feasibility of an active management strategy for comorbidities primary outcome description >80% recording blood pressure and/or blood glucose 3+ times per week primary outcome time frame Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months) primary outcome measure Feasibility of an active management strategy for comorbidities primary outcome description >80% completion of weekly phone calls with community health workers primary outcome time frame Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months) secondary outcome list secondary outcome secondary outcome measure Provider perspectives on acceptability of active management of comorbidities secondary outcome description >80% reporting agree to completely agree on the scale: Acceptability of Intervention Measure (FIM) measure. secondary outcome time frame Beginning and end of study (approximately 18 months) other outcome list other outcome other outcome measure Preliminary changes in self-efficacy other outcome description PROMIS Self-Efficacy for Managing Chronic Conditions other outcome time frame To be assess at baseline and end of study; approximately 6-7 months per participant other outcome measure Preliminary changes in social support other outcome description PROMIS Social Support other outcome time frame To be assess at baseline and end of study; approximately 6-7 months per participant eligibility module eligibility criteria Inclusion Criteria: Black women with a diagnosis of stage 0-IV breast cancer and within a month of treatment initiation or with 6+ months of treatment left OR Black men with a history of prostate cancer who are on long-term androgen deprivation therapy; Blood pressure >=120/80 OR diagnosis of diabetes Individuals who develop these conditions during treatment such as those scheduled to initiate steroid-containing chemotherapy or targeted PI3K inhibitor therapies Access to a smartphone and/or internet for the duration of the study. Can understand and communicate in English Exclusion Criteria: - Unwilling to participate in a 6-month study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Hannah Arem, PhD central contact role Contact central contact phone 202-893-2430 central contact e mail Hannah.Arem@medstar.net overall official list overall official overall official name Hannah Arem, PhD overall official affiliation Medstar Health Research Institute overall official role Principal Investigator location list location location facility MedStar Washington Hospital Center location status Recruiting location city Washington location state District of Columbia location zip 20010 location country United States location contact list location contact location contact name Andrea Lopez location contact role Contact location contact e mail andrea.j.lopez@medstar.net derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001943 condition mesh term Breast Neoplasms condition mesh id D000006973 condition mesh term Hypertension condition mesh id D000003920 condition mesh term Diabetes Mellitus condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf as found Cancer, Breast condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes Mellitus condition browse leaf relevance high condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf relevance low condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf as found Hypertension condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch 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full study rank 61411 study protocol section identification module n c t id NCT04836819 org study id info org study id SGPAM-DKL11 organization org full name Ondokuz Mayıs University org class OTHER brief title Analgesia Management in Bariatric Surgery official title Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date April 8, 2021 start date type Actual primary completion date struct primary completion date June 5, 2021 primary completion date type Actual completion date struct completion date July 1, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 1, 2021 last update post date struct last update post date July 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yasemin Burcu Ustun responsible party investigator title Associate Professor responsible party investigator affiliation Ondokuz Mayıs University lead sponsor lead sponsor name Ondokuz Mayıs University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated. detailed description Patients will be divided into three groups. Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation. Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation. Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation. Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively. Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group will be placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group mentioned in the envelope. conditions module condition list condition Morbid Obesity Bariatric Surgery Candidate Pain Postoperative keyword list keyword Dexmedetomidine Ketamine Lidocaine Obesity Morbid Pain Postoperative design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description The patients will be randomly classified into three groups. design primary purpose Supportive Care design masking info design masking Double design masking description Drugs to be used will be prepared 30 minutes before the surgery in the drug preparation room by a nurse who is not involved in the study. Investigators and patients will be blinded to the group assignments. design who masked list design who masked Participant Investigator enrollment info enrollment count 78 enrollment type Actual arms interventions module arm group list arm group arm group label Group L arm group type Active Comparator arm group description IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours. arm group intervention list arm group intervention name Drug: Lidocain arm group label Group K arm group type Active Comparator arm group description IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. arm group intervention list arm group intervention name Drug: Ketamine arm group label Group D arm group type Active Comparator arm group description IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. arm group intervention list arm group intervention name Drug: Dexmedetomidine intervention list intervention intervention type Drug intervention name Lidocain intervention description IV lidocaine infusion (2 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 1 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. intervention arm group label list intervention arm group label Group L intervention type Drug intervention name Ketamine intervention description IV ketamine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. intervention arm group label list intervention arm group label Group K intervention type Drug intervention name Dexmedetomidine intervention description IV dexmedetomidine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. intervention arm group label list intervention arm group label Group D outcomes module primary outcome list primary outcome primary outcome measure Postoperative pain: VAS scores at rest and movement primary outcome description Pain status at rest and movement will be assessed by VAS scores. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain imaginable). primary outcome time frame Up to 15 days after the surgery. secondary outcome list secondary outcome secondary outcome measure Postoperative Rescue Analgesic Requirement secondary outcome description After the end of surgery 25-50 mg meperidine (maximum dose 200 mg) will be administered i.m. as rescue analgesia when requested by the patient and if VAS>4. the Rescue analgesic dosage will be recorded. secondary outcome time frame Up to three days after surgery secondary outcome measure Postoperative nausea, retching and vomiting secondary outcome description The number of patients who has complained of nausea, retching and vomiting will be recorded. secondary outcome time frame Up to 3 days after surgery. secondary outcome measure Time to first mobilization secondary outcome description The patients first mobilization time after the operation will be recorded. secondary outcome time frame Up to 24 hours after surgery. secondary outcome measure Time to discharge secondary outcome description The length of hospital stay will be recorded. secondary outcome time frame Trough hospital stay, an average of 1 week. eligibility module eligibility criteria Inclusion Criteria: Body mass index>35 kg/m2 The American Society of Anaesthesiologists (ASA) physical status class II III Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG) Exclusion Criteria: refusal to participate allergy to the study drugs chronic kidney disease (creatinine>150 μmol/L) mental illness liver, respiratory or oncological disease, cardiac dysfunction (ejection fraction <40%), uncontrolled hypertension, preoperative analgesic use, chronic pain, history of alcohol or drug addiction healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Ersin Koksal overall official affiliation Ondokuz Mayıs University overall official role Principal Investigator location list location location facility Ondokuz Mayis University location city Samsun location state Atakum location zip 55270 location country Turkey references module reference list reference reference p m i d 31256367 reference type background reference citation Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3. Review. reference p m i d 16517328 reference type background reference citation Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009. reference p m i d 21773855 reference type background reference citation Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20. Review. reference p m i d 30474791 reference type background reference citation Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1. reference p m i d 28120147 reference type background reference citation Bamgbade OA, Oluwole O, Khaw RR. Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. Obes Surg. 2017 Jul;27(7):1828-1834. doi: 10.1007/s11695-017-2562-4. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009767 condition mesh term Obesity, Morbid condition ancestor list condition ancestor condition ancestor id D000009765 condition ancestor term Obesity condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M11854 condition browse 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full study rank 61596 study protocol section identification module n c t id NCT04834414 org study id info org study id CHIPS secondary id info list secondary id info secondary id W81XWH2090021 secondary id type Other Grant/Funding Number secondary id domain DoD organization org full name University of Pittsburgh org class OTHER brief title CHIlled Platelet Study "CHIPS" official title CHIlled Platelet Study acronym CHIPS status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date October 21, 2021 start date type Actual primary completion date struct primary completion date March 1, 2024 primary completion date type Anticipated completion date struct completion date March 31, 2024 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 22, 2022 last update post date struct last update post date November 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Philip Spinella responsible party investigator title Professor- Surgery and Critical Care Medicine, Co- Director- Trauma and Transfusion Medicine Research Center, Associate Medical Director- Center for Military Medicine Research responsible party investigator affiliation University of Pittsburgh lead sponsor lead sponsor name Philip Spinella lead sponsor class OTHER collaborator list collaborator collaborator name University of Utah collaborator class OTHER collaborator name University of Minnesota collaborator class OTHER collaborator name Washington University School of Medicine collaborator class OTHER collaborator name United States Department of Defense collaborator class FED oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets. conditions module condition list condition Acute Blood Loss keyword list keyword platelets cold-stored platelets bleeding hemostasis complex cardiac surgery design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Sequential Assignment design intervention model description Adaptive Design design primary purpose Treatment design masking info design masking Triple design masking description Partial Blind design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Room Temperature Platelets arm group type Active Comparator arm group description Platelets stored at 20-24 degrees Celsius arm group intervention list arm group intervention name Biological: Room Temperature Platelets arm group label Cold Stored Platelets arm group type Experimental arm group description Platelets stored at 1-6 degree Celsius arm group intervention list arm group intervention name Biological: Cold Stored Platelets intervention list intervention intervention type Biological intervention name Cold Stored Platelets intervention description Platelets stored at 1-6 degree Celsius intervention arm group label list intervention arm group label Cold Stored Platelets intervention type Biological intervention name Room Temperature Platelets intervention description Platelets stored at 20-24 degrees Celsius intervention arm group label list intervention arm group label Room Temperature Platelets outcomes module primary outcome list primary outcome primary outcome measure Hemostatic efficacy primary outcome description Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome. primary outcome time frame 24 hours after first study platelet transfusion secondary outcome list secondary outcome secondary outcome measure Chest tube output secondary outcome description Assessed by volume secondary outcome time frame 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) other outcome list other outcome other outcome measure Blood product administration other outcome description The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood other outcome time frame 24 and 72 hours from start time of first study platelet transfusion other outcome measure Total Dose of individual hemostatic adjuncts other outcome description Antifibrinolytic and coagulation factor concentrates other outcome time frame 24 and 72 hours from start time of first study platelet transfusion other outcome measure Mechanical ventilation other outcome description Duration of mechanical ventilation days other outcome time frame up to 28 days after first study platelet transfusion other outcome measure Length of stay other outcome description ICU and hospital length of stay other outcome time frame up to 28 days other outcome measure Relative change in hemostatic parameters other outcome description CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG other outcome time frame 6 and 24 hours after first study platelet transfusion other outcome measure Unplanned sternal closure delay other outcome description Sternum left open after cardiac surgery other outcome time frame prior to ICU admission other outcome measure Re-exploration for bleeding other outcome description Return to OR after ICU admission other outcome time frame 24 hours first study platelet transfusion other outcome measure Unplanned extracorporeal support post operatively other outcome description Placed on ECMO other outcome time frame within 48 hours of first study platelet transfusion other outcome measure Morbidities after ICU admission other outcome description Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock other outcome time frame within 7 days of first study platelet transfusion other outcome measure Measures of end organ injury other outcome description If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically. other outcome time frame within 48 hours of first study platelet transfusion other outcome measure Transfusion associated adverse events other outcome description As per CDC guidelines other outcome time frame within 7 days of first study platelet transfusion other outcome measure Arterial thrombotic event other outcome description Stroke, MI other outcome time frame within 7 days of first study platelet transfusion other outcome measure Venous thrombotic event other outcome description Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram other outcome time frame within 7 days of first study platelet transfusion other outcome measure All cause mortality other outcome description Death for any reason other outcome time frame up to 28 days eligibility module eligibility criteria Inclusion Criteria: Age greater than 28 days and less than 85 years Planned complex cardiac surgery with planned use of cardiopulmonary bypass Exclusion Criteria: Expected order for washed or volume reduced platelets Patient with known anti-platelet antibodies Platelet transfusion refractoriness due to anti-HLA antibodies Known or suspected pregnancy Previously randomized in this study Conscious objection or unwillingness to receive blood products Known IgA deficiency Known congenital platelet disorder Known congenital bleeding disorder Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis Patients intended to receive whole blood either intra-operative or post-operative for bleeding Platelet transfusion (of any type) within 24 hours prior to the date of surgery Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery. healthy volunteers No gender All minimum age 29 Days maximum age 84 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Meghan Huff, BSN central contact role Contact central contact phone 314-362-1319 central contact e mail meghanhuff@wustl.edu central contact name Christina Daniel, BSN central contact role Contact central contact e mail christina.daniel@wustl.edu overall official list overall official overall official name Philip C Spinella, MD overall official affiliation University of Pittsburgh overall official role Principal Investigator overall official name Marie E Steiner, MD overall official affiliation University of Minnesota overall official role Principal Investigator overall official name Nicole D Zantek, MD overall official affiliation University of Minnesota overall official role Principal Investigator location list location location facility Ronald Reagan UCLA Medical Center location status Recruiting location city Los Angeles location state California location zip 90095 location country United States location contact list location contact location contact name Jennifer Scovotti location contact role Contact location facility University of Florida location status Recruiting location city Gainesville location state Florida location zip 32608 location country United States location contact list location contact location contact name Jessica Cobb location contact role Contact location facility Northwestern Memorial Hospital location status Recruiting location city Chicago location state Illinois location zip 60611 location country United States location contact list location contact location contact name Nora Ibrahim location contact role Contact location facility University of Kansas Medical Center location status Recruiting location city Kansas City location state Kansas location zip 66103 location country United States location contact list location contact location contact name Rachel Henning location contact role Contact location facility John Hopkins location status Recruiting location city Baltimore location state Maryland location zip 21287 location country United States location contact list location contact location contact name Colleen Mennie location contact role Contact location facility University of Michigan location status Recruiting location city Ann Arbor location state Michigan location zip 48109 location country United States location contact list location contact location contact name Wajid Kahn location contact role Contact location facility Mayo Clnic location status Recruiting location city Rochester location state Minnesota location zip 55905 location country United States location contact list location contact location contact name Beth Montonye location contact role Contact location facility Wake Forest location status Recruiting location city Winston-Salem location state North Carolina location zip 27157 location country United States location contact list location contact location contact name Lynn Harris location contact role Contact location facility Cincinnati Children's Hospital location status Recruiting location city Cincinnati location state Ohio location zip 45229 location country United States location contact list location contact location contact name Paula Casson location contact role Contact location facility Children's Hospital of Philadelphia location status Recruiting location city Philadelphia location state Pennsylvania location zip 19104 location country United States location contact list location contact location contact name Paula Hu location contact role Contact location facility University of Pittsburgh Pennsylvania location status Recruiting location city Pitts location state Pennsylvania location zip 15232 location country United States location contact list location contact location contact name Kristin Konopka location contact role Contact location facility Rhode Island Hospital location status Recruiting location city Providence location state Rhode Island location zip 02910 location country United States location contact list location contact location contact name Tracey Cheves location contact role Contact location facility University of Texas Children's Medical Center location status Recruiting location city Dallas location state Texas location zip 75235 location country United States location contact list location contact location contact name Delaney Evans location contact role Contact location facility University of Texas Medical Center Clements location status Recruiting location city Dallas location state Texas location zip 75235 location country United States location contact list location contact location contact name Kenni Landgraf location contact role Contact location facility Baylor Texas Children's location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Menard Elizabeth location contact role Contact location facility University of Wisconsin- Madison location status Recruiting location city Madison location state Wisconsin location zip 53792 location country United States location contact list location contact location contact name Daniel Griese location contact role Contact location facility Children's Hosptial of Wisconsin location status Recruiting location city Milwaukee location state Wisconsin location zip 53226 location country United States location contact list location contact location contact name Regina Cole location contact role Contact references module reference list reference reference p m i d 29521797 reference type background reference citation Krachey E, Viele K, Spinella PC, Steiner ME, Zantek ND, Lewis RJ. The design of an adaptive clinical trial to evaluate the efficacy of platelets stored at low temperature in surgical patients. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S41-S46. doi: 10.1097/TA.0000000000001876. reference p m i d 32902572 reference type background reference citation Strandenes G, Sivertsen J, Bjerkvig CK, Fosse TK, Cap AP, Del Junco DJ, Kristoffersen EK, Haaverstad R, Kvalheim V, Braathen H, Lunde THF, Hervig T, Hufthammer KO, Spinella PC, Apelseth TO. A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery. Anesthesiology. 2020 Dec 1;133(6):1173-1183. doi: 10.1097/ALN.0000000000003550. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006470 condition mesh term Hemorrhage condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M8708 condition browse leaf name Hemorrhage condition browse leaf as found Blood Loss condition browse leaf relevance high condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name 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full study rank 61772 study protocol section identification module n c t id NCT04832126 org study id info org study id PRJ1801 organization org full name D'Or Institute for Research and Education org class OTHER brief title Genetic Analysis of Heart Channelopathies in Brazilian Patients and Their Relatives official title Genetic Analysis of Heart Channelopathies in Brazilian Patients and Their Relatives status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2018 start date type Actual primary completion date struct primary completion date August 1, 2021 primary completion date type Anticipated completion date struct completion date July 31, 2024 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Nilson Araújo de Oliveira Junior responsible party investigator title Dr. responsible party investigator affiliation D'Or Institute for Research and Education lead sponsor lead sponsor name D'Or Institute for Research and Education lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary several genes have been associated with ion channel diseases, but a large number of families do not yet have an identified genetic cause. There is a lack of information on the genetic characteristics of channelopathies in Brazilians affected by these diseases. This study aims to carry out a comprehensive genetic analysis of cardiac channelopathies in Brazilian patients and their families. The study will involve 20 patients and 80 family members (a total of 100 individuals) accompanied by the Rede D'Or arrhythmia group in Rio de Janeiro. Individuals will be recruited and subjected to DNA sequencing and phenotypic evaluation, including clinical evaluation, echocardiography, 24-hour Holter or longer electrocardiographic monitoring. An integrated analysis of phenotype-genotype will be made in all individuals included in the study. Patients and their families will be followed up annually for 2 to 5 years through clinical evaluations and the same complementary methods described. The DNA sequencing of patients and their families may contribute to improve the diagnosis of channelopathies and allow the determination of the pattern of occurrence of the disease in the cases involved. Besides, this study may lead to the discovery of new genetic variants associated with channelopathies that will serve as a basis for designing and carrying out broader molecular epidemiological studies. The study of the molecular genetics of channelopathies is important mainly so that patients can avoid sudden death, but also for the medical community, researchers, laboratories, companies involved in the production of medical devices, and public health authorities detailed description Inherited arrhythmias are characterized by variable expressiveness and incomplete penetrance. Extensive genotype-phenotype studies are needed to elucidate the genetic basis of these diseases. There are several reasons for studying the molecular genetics of channelopathies, such as determining the molecular epidemiology of these diseases, offering evidence for a better understanding of the molecular basis of diseases, determining the genetic patterns of occurrence (inherited or again), and improving the diagnosis and genetic counseling. Besides, the genetic study of these diseases can lead to the discovery of new genetic variants associated with these diseases and to the creation of experimental models. Genetic testing is recommended (Class I) for any patient with a strong clinical suspicion of genetically inherited channelopathies including long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome, and short QT syndrome. Specific genetic testing for the mutation identified in the index case is also recommended (Class I) for family members. The molecular genetics of cardiac channelopathies has been extensively studied in populations in developed countries. In the past, the most frequently used methods were the sequencing of a single or a few suspect genes. More recently, wider panels or even the sequencing of the complete exome have been increasingly used. This procedure has allowed the discovery of an increasing number of genetic variants. Although the genetic basis for many cases of these diseases is known, many families do not yet have a definite genetic cause. Besides, it is difficult to predict the pathogenicity and clinical evolution of individual mutations. Recent advances in the generation of induced pluripotent stem cells (iPS) may allow considerable progress in the translational research of arrhythmias. Since the discovery of the first channelopathy in 1995 , the use of genetic tests for diagnostic and prognostic purposes has evolved considerably and is now being used in clinical practice and not just for research purposes. Despite all these advances, the use of DNA sequencing to determine the presence or absence of some diseases is a challenge, since all these clinical syndromes can be associated with different mutations, many of which have not yet been described. The genetic sequencing of patients with genetically inherited arrhythmias is essential not only to provide clinical information related to well-characterized mutations but also to contribute to the discovery of new genetic alterations. In Brugada syndrome, for example, although 12 genotypes have been described so far, genetic changes have been identified in only 30% of cases. The reason for these discrepancies is related to still incomplete knowledge of all the pathways involved in the function and regulation of cardiac ion channels. Brief descriptions of the most studied channelopathies are presented below. Long QT syndrome (LQTS) This disease has been identified in different areas of the world, in different ethnic groups. Although at least 13 forms of the disease have been described so far, the cause in approximately 20% of cases is not yet defined. The disease is characterized by a prolongation of the QT interval and arrhythmic events. The arrhythmias usually found in these patients are episodes of polymorphic ventricular tachycardia (torsades de pointes) that causes dizziness and syncope and may progress to ventricular fibrillation and sudden death. Individuals affected by LQTS are more susceptible to atrial fibrillation than the general population This being the most studied channelopathy, the correlation between genetic variants and clinical evolution is very high. Currently, it is known that exercise and emotional stress trigger arrhythmias in patients with LQT1 and that patients with LQT3 usually have episodes of arrhythmia during sleep. It is also known that LQT8 is extremely aggressive with symptoms appearing early and a poor response to treatment. At least 20% of genetically proven LQTS cases have normal ECG. For all these reasons, LQTS is an example of how genetic characterization can help in understanding the pathophysiology of a clinical condition and improve treatment. Brugada Syndrome (BRS) This clinical syndrome is characterized by spontaneous episodes of polymorphic ventricular tachycardia that can degenerate into ventricular fibrillation and a typical electrocardiographic pattern of elevation of the ST segment from V1 to V3. The prevalence of this disease is higher in Asia where, in some locations, it is considered the most common cause of natural death among men under 50 years old. The syndrome usually begins in adulthood, being rare in children. Several genotypes have already been described, typically involving a decrease in the currents of sodium (Na) or an increase in the currents of potassium (K). The pattern of inheritance is autosomal dominant, so half of the family members are expected to be affected. As mentioned earlier for LQTS, the molecular genetics of several cases with clinical criteria for Brugada syndrome has not yet been elucidated. The treatment of choice is the implantation of a defibrillator. No pharmacological treatment is safe, although isoproterenol or quinidine can be used in cases of electrical storms. Ablation is being investigated to control some of these patients. The diagnosis is made from the electrocardiogram (ECG) with a typical pattern associated with the clinical evidence of the disease. Occasionally a provocative drug test may be necessary, as the typical pattern may be transient. Blockers of Na channels such as ajmaline can help to identify these patients. Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) This disease is characterized by arrhythmic events of bidirectional or polymorphic ventricular tachycardia triggered by an adrenergic stimulus. Baseline ECG and imaging tests are nonspecific. Ventricular arrhythmias are observed exclusively during efforts so that the stress test and the Holter are important diagnostic methods. Two types of mutations have been described so far. One at the ryanodine receptor and the other at the gene encoding calsequestrin. Only 60% of diagnosed individuals carry one of these mutations and, therefore, other genes must be involved. Other conditions Several other arrhythmic genetic syndromes have been described, such as short QT syndrome, sudden unexplained death syndrome, idiopathic ventricular fibrillation, early repolarization, and some genetic forms of atrial fibrillation. Many patients are diagnosed after an episode of sudden aborted death. Better genetic categorization of these cases could help to better understand the mechanisms involved in these diseases and improve treatment. Family screening and adequate genetic counseling are essential. OBJECTIVES PRIMARY OBJECTIVE This study aims to carry out a comprehensive genetic analysis of cardiac channelopathies in Brazilian patients and their families. SECONDARY OBJECTIVES Discover new genetic variants that are causal or associated with arrhythmias. Determine the molecular epidemiology of these diseases. Find evidence for a better understanding of the molecular basis of these diseases. Allow the creation of experimental models. Determine the genetic patterns of occurrence (inherited or new, among others). Allow an improvement in the diagnosis. Enable an improvement in genetic counseling. HYPOTHESES Genetic analysis will improve the diagnosis and genetic counseling of patients and their families. Early diagnosis can prevent sudden death in some cases. There is a possibility to detect new genetic variants associated with channelopathies. METHODS STUDY DESIGN AND POPULATION 20 patients and 80 family members (a total of 100 individuals) accompanied by the arrhythmia group of Rede D'Or will be recruited. The total number of individuals to include in the study refers to a convenience sample based on patients currently followed by the group of specialists from Rede D'Or who are part of the study and their families. The choice of up to 4 family members per proband is justified by the fact that this number of related individuals is, in most cases, sufficient to determine the pattern of occurrence and segregation of phenotypes. The specification of the family members of each proband that will be included will be made on a case-by-case basis depending on the pattern of genetic inheritance, the family composition, and the availability of samples from other family members. The inheritance pattern of causal genetic variants or those associated with phenotypes jointly defined as cardiac channelopathies is, more commonly, autosomal dominant. In this context, the genetic testing of both parents and, whenever possible, of first-degree relatives affected or not by the phenotype is sufficient for the establishment or exclusion of causality. Although less common, sporadic cases can also be seen. In such cases, the pathogenic genetic variant should not be detected in the parents but testing them is necessary to confirm the sporadic pattern. In these cases, siblings and/or first-degree relatives should only be tested in the absence of the parents. This is a pilot study that will provide information on the population affected by these diseases in our country. All eligible patients, affected by channelopathies and followed up in hospitals and clinics belonging to Rede D'Or São Luiz in Rio de Janeiro and selected family members, will be invited to participate in the study. DNA sequencing will be performed 3 ± 2 months after inclusion. The phenotypic analysis will be performed 2 ± 1 months after inclusion and will consist of a clinical evaluation, echocardiography, 24-hour Holter, or prolonged electrocardiographic monitoring (data collection form - Appendix B). A complete and integrated genotype-phenotype analysis of the cases included will be performed. Patients and their families will be followed for a minimum of 2 years and a maximum of 5 years and they will be evaluated annually with clinical consultations and with the same complementary methods described above. PROCEDURES Collection and purification of DNA samples Genomic DNA will be purified from peripheral blood or mouth swabs. Whole blood will be collected by peripheral phlebotomy in tubes containing K2EDTA as an anticoagulant. Blood samples will be stored at 4-8 oC for up to a week before DNA purification. Mouth swabs will be collected using the ORAcollect • DNA kit (OCR-100) (DNA Genotek Inc., Canada). Genomic DNA from whole blood or mouth swab samples will be purified using DNeasy Blood & Tissue Kit (QIAGEN). The analysis of germline genetic variants (inherited or de novo) through DNA sequencing, either by the Sanger method or by new generation sequencing, is not influenced by the tissue or body fluid from which the DNA is purified. Therefore, peripheral blood or oral smears/saliva can be used as a source of DNA without any technical compromise or introduction of bias. Thus, the choice of blood or oral swab will be determined essentially by the comfort and convenience for the research participant and aiming at the rational use of the available resources. DNA quantification and quality control The purified genomic DNA will be quantified by ultraviolet spectrophotometry using the NanoDrop microvolume spectrophotometer (ThermoFisher Scientific). DNA integrity will be measured by agarose gel electrophoresis and using the Agilent 4200 TapeStation system. Genetic analysis strategy In the initial discovery phase, 20 probands will be selected for analysis of sequence and copy number variants within a panel of selected candidate genes. The suspicious causal variables identified in this initial phase will later be analyzed in up to 4 family members or first-degree relatives for each proband. Genetic panel and gene selection criteria Candidate genes included in the panel were selected from searches in the Online Mendelian Inheritance in Man (OMIM) database, by reviewing the literature and consensus, recommendations, and guidelines issued by panels and specialist societies. The final list of candidate genes was established to include clinically informative genes, i.e., which assist in diagnostic or therapeutic decisions, and experimental evidence indicative of genetic involvement in the pathophysiology of arrhythmias. New generation sequencing Candidate genes will be analyzed for the detection of sequence and copy number variants using new generation sequencing. The entire coding region and intron-exon boundaries will be sequenced using Ampliseq ™ technology. The oligonucleotides for the amplification of the regions of interest will be designed using the online tool Ion AmpliSeq Designer. The sequencing libraries will be generated using the Ion AmpliSeq ™ Library Kit on the Ion OneTouch 2 System (ThermoFisher Scientific). The sequencing will be performed on an Ion Personal Genome Machine (PGM) sequencer using the Ion 318 ™ Chip v2 BC and the Ion PGM ™ Hi-Q ™ View Sequencing reagents (ThermoFisher Scientific). Sequencing analysis will be performed using the Ion Reporter ™ software (ThermoFisher Scientific). Interpretation and reporting of sequence variants. The interpretation and registration of sequence variants will be performed according to the consensual recommendation of the American College of Medical Genetics and Genomics, the Association for Molecular Pathology, and the College of American Pathologists. Briefly, to describe variants identified in genes that cause Mendelian disorders, this consensus recommends the use of standard terms: pathogenic, probably pathogenic, uncertain meaning, likely benign and benign. According to this recommendation, the process of classifying variants in these five categories is based on a series of different types of evidence, such as population data, computer simulations, functional data, and genetic segregation data. The evaluation of the pathogenicity of the genetic variants that are detected will be done independently, i.e., "blind", by the specialists. The clinical evaluation of the patients and determination of the phenotype will be carried out by the arrhythmia specialists in the group under the supervision of Dr. Nilson Araújo. The genetic evaluation will be done in a 'blind' way by Dr. Marcelo Reis. In case of divergence between the variant found and the phenotype, the findings will be reviewed by Dr. Luciana Sacilotto (specialist in arrhythmia with experience in clinical genetics) and by Dr. Carolina Bustamante (specialist in molecular genetics). Computational prediction of the functional effect of genetic variants To estimate the functional effects of the sequence variants, a series of publicly available tools will be used. These algorithms consider the evolutionary conservation of amino acid residues and conserved protein domains, protein structure and function, Hiden Markov models, and position-dependent logic. Whenever available, functional experimental data in vitro on the effect of specific sequence variants will also be considered for interpretation. conditions module condition list condition Channelopathies keyword list keyword channelopathies arrhythmia genetic analysis Sudden cardiac death design module study type Observational patient registry No design info design observational model list design observational model Family-Based design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Genomic DNA is purified from peripheral blood or mouth swabs enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patient arm group description patients with channelopathies arm group intervention list arm group intervention name Genetic: Genetic analysis arm group label Family arm group description relatives of patients with channelopathies arm group intervention list arm group intervention name Genetic: Genetic analysis intervention list intervention intervention type Genetic intervention name Genetic analysis intervention description Genomic DNA will be purified from peripheral blood or mouth swabs. Whole blood will be collected by peripheral phlebotomy in tubes containing K2EDTA as an anticoagulant. Blood samples will be stored at 4-8 oC for up to a week before DNA purification. Mouth swabs will be collected using the ORAcollect • DNA kit (OCR-100) (DNA Genotek Inc., Canada). Genomic DNA from whole blood or mouth swab samples will be purified using DNeasy Blood & Tissue Kit (QIAGEN). intervention arm group label list intervention arm group label Family Patient outcomes module primary outcome list primary outcome primary outcome measure phenotypic analysis primary outcome description by genomic DNA purified from peripheral blood or mouth swabs. primary outcome time frame Patients and their families will be followed up to 5 years eligibility module eligibility criteria Inclusion Criteria: Patients from Rede D'or São Luiz and their relatives Patients whit arrhythmia and their relatives Presence of inheritance pattern of causal genetic variants or those associated with phenotypes jointly defined as cardiac channelopathies and their relatives Exclusion Criteria: None healthy volunteers No gender All std age list std age Child Adult Older Adult study population patients and family members accompanied by the arrhythmia group of Rede D'Or, Rio de Janeiro, Brazil. The number of individuals we intend to include in the study refers to a convenience sample based on patients currently followed by the group of specialists from Rede D'Or who are part of the study and their families. The choice of up to 4 family members per proband is justified by the fact that this number of related individuals is, in most cases, sufficient to determine the pattern of occurrence and segregation of phenotypes. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Nilson O Araujo, Dr. central contact role Contact central contact phone + 55 21 3883-6000 central contact e mail nilson.ojunior@rededor.com.br central contact name Renata J Moll, Dr. central contact role Contact central contact phone +55 21 3883-6000 central contact e mail renata.moll@idor.org overall official list overall official overall official name Nilson O Araujo, Dr overall official affiliation D'Or Institute for Research and Education (IDOR) overall official role Principal Investigator location list location location facility D'Or Institute for Research and Education (IDOR) location status Recruiting location city Rio De Janeiro location zip 22281-100 location country Brazil location contact list location contact location contact name Nilson O Araujo, Dr. location contact role Contact location contact e mail nilson.oaraujo@rededor.com.br location contact name Renata J Moll, Dr. location contact role Contact location contact e mail renata.moll@idor.org references module reference list reference reference p m i d 23266818 reference type result reference citation Abriel H, Zaklyazminskaya EV. 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Epub 2008 Oct 27. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000053447 condition mesh term Channelopathies condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M3605 condition browse leaf name Arrhythmias, Cardiac condition browse leaf relevance low condition browse leaf id M5997 condition browse leaf name Death condition browse leaf relevance low condition browse leaf id M18270 condition browse leaf name Death, Sudden, Cardiac condition browse leaf relevance low condition browse leaf id M26404 condition browse leaf name Channelopathies condition browse leaf as found Channelopathies condition browse leaf relevance high condition browse branch list condition browse branch condition browse 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full study rank 61933 study protocol section identification module n c t id NCT04830020 org study id info org study id CampusBioMedico secondary id info list secondary id info secondary id 1ZIDES102465 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/1ZIDES102465 organization org full name Campus Bio-Medico University org class OTHER brief title Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes official title Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes acronym HA-COVID status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date February 26, 2021 start date type Actual primary completion date struct primary completion date June 30, 2021 primary completion date type Actual completion date struct completion date September 30, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date March 1, 2022 last update post date struct last update post date March 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Campus Bio-Medico University lead sponsor class OTHER collaborator list collaborator collaborator name National Institute of Environmental Health Sciences (NIEHS) collaborator class NIH oversight module is f d a regulated drug No is f d a regulated device No description module brief summary To determine whether inhaled Yabro protects against progression of COVID19-induced respiratory failure preventing the passage to non-invasive ventilation (NIV) and promotes recovery from COVID19 lung disease in hospitalized patients. detailed description All patients will be treated with state of the art COVID19 treatment as per the treating clinician (Remdesivir, systemic corticosteroids, monoclonal antibodies, convalescent plasma, biologic cytokine inhibitors and other interventions as per the latest guidelines). Patients randomized to the active intervention group will also receive HMW-HA (Yabro®, 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer, while patients randomized in the control group will receive a matching placebo two times daily. Due to increased risk for SARS-CoV-2 transmission via the usual mask nebulization procedure, patients will receive the nebulized treatment via high-flow oxygen tubing as described in the literature 36-38. Patients will be treated until there is a qualitative change in oxygen requirement, i.e. either progression to assisted ventilation (non-invasive or invasive), or weaning from oxygen supplementation. Because COVID19 may result in long-term O2 dependency, the study and treatment period will be limited to a maximum of 10 days. Moreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment. conditions module condition list condition Covid19 design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 180 enrollment type Actual arms interventions module arm group list arm group arm group label HMW-HA arm group type Active Comparator arm group description HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) arm group intervention list arm group intervention name Drug: HMW-HA arm group label placebo arm group type Placebo Comparator arm group description 5 ml of saline via nebulizer b.i.d. arm group intervention list arm group intervention name Drug: HMW-HA intervention list intervention intervention type Drug intervention name HMW-HA intervention description Aerolized administration b.i.d. intervention arm group label list intervention arm group label HMW-HA placebo intervention other name list intervention other name Yabro outcomes module primary outcome list primary outcome primary outcome measure Cumulative time on oxygen primary outcome description cumulative duration of oxygen treatment primary outcome time frame 10 days secondary outcome list secondary outcome secondary outcome measure Need for advanced airway intervention or death due to COVID19; secondary outcome description need of intubation or death due to COVID19 secondary outcome time frame 10 days secondary outcome measure Rate of change of respiratory rate; secondary outcome description rapidity of decrease of respiratory rate secondary outcome time frame 10 days secondary outcome measure Change in PaO2 /FiO2 ratio during treatment secondary outcome description improvement of PaO2/FiO2 ratio after 10 days of treatment secondary outcome time frame 10 days secondary outcome measure Time to discharge from hospital secondary outcome description decrease of cumulative days of hospitalization secondary outcome time frame 10 days eligibility module eligibility criteria Inclusion Criteria: Age ≥ 18 Diagnosis of COVID19 by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) and no alternative explanation for current clinical condition. Respiratory failure requiring oxygen therapy Has symptoms consistent with COVID-19, and is in non-fibroproliferative stage of disease, as determined by investigator. Exclusion Criteria: Respiratory arrest or the need for immediate intubation; Upper airway obstruction; Facial trauma; Inability to cooperate (e.g. agitation or dementia) Inability to give informed consent Participation in another study for COVID19 treatments Deterioration due to other reasons than progressive COVID19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc. Palliative care or expectation that patient will not survive > 72 hours post randomization per clinical judgment of the investigator. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Raffaele Antonelli Incalzi, MD overall official affiliation Università Campus-Biomedico di Roma overall official role Principal Investigator location list location location facility Università Campus Biomedico di Roma location city Roma location zip 00128 location country Italy i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus 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full study rank 61565 study protocol section identification module n c t id NCT04834817 org study id info org study id 20216401 organization org full name University of California, Irvine org class OTHER brief title Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment official title The Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment status module status verified date November 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date October 2023 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 2, 2022 last update post date struct last update post date November 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kristen Kelly responsible party investigator title Professor responsible party investigator affiliation University of California, Irvine lead sponsor lead sponsor name University of California, Irvine lead sponsor class OTHER collaborator list collaborator collaborator name BioPhotas collaborator class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment. detailed description This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application. conditions module condition list condition Wound Heal design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label LED treatment arm group type Experimental arm group description LED treatment with Celluma POD device after laser test area arm group intervention list arm group intervention name Device: Celluma POD arm group label Control arm group type No Intervention arm group description No treatment after laser test area intervention list intervention intervention type Device intervention name Celluma POD intervention description A blue and near infrared handheld LED device intervention arm group label list intervention arm group label LED treatment outcomes module primary outcome list primary outcome primary outcome measure Days to healing primary outcome description The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment. primary outcome time frame 56 days secondary outcome list secondary outcome secondary outcome measure Pain level secondary outcome description A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome. secondary outcome time frame 56 days eligibility module eligibility criteria Inclusion Criteria: Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla. Subjects shall have given written informed consent for both the LED therapy and for clinical photography. Exclusion Criteria: Patients will be excluded if any of the exclusion criteria applies Subjects refuse to give informed consent for either the phototherapy or the clinical photography. Subjects have previous photosensitivity problems (solar urticaria, etc.). Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties. Subjects taking any systemic drug with known immunosuppressant properties. Subjects applying any medications to the research site (inner biceps, close to the axilla). Subjects have medical or psychosocial conditions associated with a risk of poor protocol compliance. Subjects are smokers or have smoked within the last 30 days prior to the trial. Subjects have epilepsy or a history of seizures Subjects currently taking cortisone injections or any other kind of steroid injections(s) Subjects with known cancer tumor in the treatment area or metastasis healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Kristen Kelly, MD overall official affiliation University of California, Irvine overall official role Principal Investigator location list location location facility UCI Beckman Laser Institute and Medical Clinic location city Irvine location state California location zip 92697 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition 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full study rank 61404 study protocol section identification module n c t id NCT04836910 org study id info org study id 8032-20-SMC organization org full name Sheba Medical Center org class OTHER_GOV brief title Microbiome and Polycystic Ovaries official title The Change in Microbiome Following Treatment of Women With Polycystic Ovaries status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 1, 2023 start date type Anticipated primary completion date struct primary completion date March 30, 2026 primary completion date type Anticipated completion date struct completion date March 30, 2026 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2022 last update post date struct last update post date April 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dr. Aya Mohr-Sasson responsible party investigator title Principal Investigator responsible party investigator affiliation Sheba Medical Center lead sponsor lead sponsor name Sheba Medical Center lead sponsor class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome. detailed description Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. It seems there are both genetic, epigenetic and environmental contributors (almost 100 susceptible genes were identified). The quality of life (QQL) of women suffering from PCOS is significantly reduced in all domains (functional ability, physical and emotional) and major health problems is correlated to PCOS. Women with PCOS demonstrate hyperinsulinemia and insulin resistance. They have an increased risk for type 2 diabetes and impaired glucose tolerance. Studies have shown that adipocyte function is considerably aberrant in women with PCOS including: lower lipase activity, defective glucose transport and dyslipidemia. Obesity is more prevalent in women with PCOS. They are also exposed to long term risk for additional disorders like cardiovascular diseases (atherosclerosis) or even cancer (endometrial or ovarian) . PCOS is the primary cause of anovulatory subfertility. Furthermore, women with PCOS are at risk for pregnancy and obstetrical complications including preterm birth, pre- eclampsia and meconium aspiration syndrome of neonates after birth. PCOS is diagnosed according the Rotterdam criteria . It requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen)- clinical and/ or biochemical (presence of hirsutism, acne or alopecia). 2. Oligo or anovulation (including menstrual dysfunction). 3. PCO-M polycystic ovaries morphology (over 12 follicles, 2-9 mm or increased ovarian volume). The term microbiome describes the genetic material of all the microbes (bacteria, fungi, protozoa and viruses) that live onside and inside the human body. It is important for development of the body, immunity and nutrition. The microbiome may influence the susceptibility to different infectious diseases and contribute to chronic illnesses. The gut microbiota contains 100 trillion microbes. When discussing gut bacteria, it is primarily referred to the large intestine (colon). Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Preliminary studies have shown that different bacterial species colonize the gut of PCOS induced animals compared to controls. A novel theory was developed concerning the development of PCOS. A diet high of sugars sets as a convenient platform for gram negative bacteria ("bad" bacteria) while reducing "good" bacteria. The cell wall of the gram negative bacteria is comprised of lipopolysaccharide (LPS) which stimulates the immune system. The high sugar diet increases the permeability of the gut ("leaky gut") leading to chronic inflammation which produces impaired insulin receptor function. The insulin facilitates an increase in the production of androgens by the ovaries which leads to PCOS . The dysbiosis was correlated with sex hormone levels and ovarian changes. In addition, treating PCOS using lactobacillus ("good" bacteria) transplantation showed improved ovarian functions. Even though, several studies established the connection between the dysbiosis of the gut and PCOS, only a few studies were conducted on the association between the vaginal microbiome and the development of PCOS. To detail, the vaginal microbiome in PCOS is more diverse and heterogeneous, with the relative abundance of certain species (such as Mycoplasma) and lower level of others (such as Lactobacillus which keeps the vagina acidic) . Moreover, should this association be strengthen between the microbiome of the gut and vagina to PCOS, it could serve as grounds to new horizons for treatment. There are several therapies for PCOS treatment (Life style interventions, improving metabolic dysfunction and medical treatment ), however, currently, there is no ideal therapy that fully treats all the clinical features. Due to all the aforementioned, we aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome. Study design A prospective longitudinal case control study that will be conducted at Sheba Medical Center (tertiary medical center). Study group will include 20 women in fertility age (age 18-42) diagnosed with PCOS according to the Rotterdam Criteria who haven't started any kind of treatment. The control group would be healthy women matched by age. Women in both groups will be recruited at the Endocrine outpatient's clinics. All women will sign informed consent form after receiving information on the study from one of the research team members. Vaginal and rectal samples will be collected during the regular clinic visits that will be set by the medical interventions requirements (including: dietary recommendations, physical activity, hormonal contraception, insulin resistance treatment, fertility treatment, pregnancy follow-up): at first visit after recruitment 1 month following first intervention 3 month following first intervention conditions module condition list condition Polycystic Ovary Syndrome Microbial Colonization keyword list keyword polycystic ovaries, microbiome design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description Stool samples for microbiome analysis, vaginal swab enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Study Group: Women with Polycystic Ovary Syndrome arm group description Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment arm group intervention list arm group intervention name Other: Dietary recommendations Drug: Oral contraceptive pills Drug: Metformin arm group label Cohort Group: Women without Polycystic Ovary Syndrome intervention list intervention intervention type Other intervention name Dietary recommendations intervention description Fruit, vegetables, legumes (e.g. lentils and beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat and brown rice). At least 400 g (i.e. five portions) of fruit and vegetables per day excluding potatoes, sweet potatoes, cassava and other starchy roots. Less than 10% of total energy intake from free sugars Less than 30% of total energy intake from fats. Unsaturated fats (found in fish, avocado and nuts, and in sunflower, soybean, canola and olive oils) are preferable to saturated fats. Less than 5 g of salt (equivalent to about one teaspoon) per day. intervention arm group label list intervention arm group label Study Group: Women with Polycystic Ovary Syndrome intervention other name list intervention other name World Health Organisation (WHO) recommendations intervention type Drug intervention name Oral contraceptive pills intervention description Hormonal treatment intervention arm group label list intervention arm group label Study Group: Women with Polycystic Ovary Syndrome intervention type Drug intervention name Metformin intervention description Insulin resistance treatment intervention arm group label list intervention arm group label Study Group: Women with Polycystic Ovary Syndrome outcomes module primary outcome list primary outcome primary outcome measure Vaginal and gut microbiota composition before and after intervention recommended and in comparison to women without PCOS. primary outcome description Evaluated by PCR ( ng/microl) primary outcome time frame Through study completion, an estimated period of 1 year secondary outcome list secondary outcome secondary outcome measure Hirsutism secondary outcome description Change in hirsutism - subjectively reported by the women during clinic visits, on scale 0-4 (0-no change, 4-substantial improvement), and additionally evaluated before and after treatment by the Modified Ferriman-Gallwey Scoring (evaluating 9 body areas to assess hair growth (on 0-4 scale: 0-no hair growth to 4- extensive hair growth) secondary outcome time frame Through study completion, an estimated period of 1 year secondary outcome measure Acne secondary outcome description Change in Acne sevirity - subjectively reported by the women during clinic visits - Mild/ Moderate /Severe secondary outcome time frame Through study completion, an estimated period of 1 year secondary outcome measure Fertility secondary outcome description Sucess achieving pregnancy secondary outcome time frame Through study completion, an estimated period of 1 year eligibility module eligibility criteria Inclusion Criteria: Study group: Untreated women diagnosed with PCOS that are planned for intervention. Control group: Women without PCOS visiting the gynecologic outpatient's clinics. Exclusion Criteria: Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor). Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week). 4. Vaginitis/ Pelvic Inflammatory Disease (PID) gender Female minimum age 18 Years maximum age 42 Years std age list std age Adult study population Study group will include 20 women in fertility age (age 18-42) diagnosed with PCOS according to the Rotterdam Criteria who haven't started any treatment. The control group would include healthy women matched by age. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Aya Mohr-Sasson, M.D central contact role Contact central contact phone 0523692906 central contact e mail mohraya@gmail.com location list location location facility Sheba Medical Center location status Recruiting location city Ramat-Gan location zip 52621 location country Israel location contact list location contact location contact name Aya Sasson location contact role Contact location contact phone 0523692906 location contact e mail mohraya@gmail.com references module reference list reference reference p m i d 29794677 reference type background reference citation American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 194: Polycystic Ovary Syndrome. Obstet Gynecol. 2018 Jun;131(6):e157-e171. doi: 10.1097/AOG.0000000000002656. 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Obstet Gynecol. 2018 Aug;132(2):321-336. doi: 10.1097/AOG.0000000000002698. Review. reference p m i d 27510637 reference type background reference citation Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57. Review. reference p m i d 28045919 reference type background reference citation Lindheim L, Bashir M, Munzker J, Trummer C, Zachhuber V, Leber B, Horvath A, Pieber TR, Gorkiewicz G, Stadlbauer V, Obermayer-Pietsch B. Alterations in Gut Microbiome Composition and Barrier Function Are Associated with Reproductive and Metabolic Defects in Women with Polycystic Ovary Syndrome (PCOS): A Pilot Study. PLoS One. 2017 Jan 3;12(1):e0168390. doi: 10.1371/journal.pone.0168390. eCollection 2017. reference p m i d 32311120 reference type background reference citation Hong X, Qin P, Huang K, Ding X, Ma J, Xuan Y, Zhu X, Peng D, Wang B. 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full study rank 61202 study protocol section identification module n c t id NCT04839536 org study id info org study id MREC: 2021116-9722 organization org full name University of Malaya org class OTHER brief title Comparing Sevoflurane With Propofol Sedation in ESRF Patients official title A Comparative Study of Sevoflurane Sedation With TCI Propofol Sedation in Dialysis Dependent End Stage Renal Failure Patients for Transposition of Brachiocephalic Fistula Repair status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date March 31, 2022 primary completion date type Anticipated completion date struct completion date April 30, 2022 completion date type Anticipated study first submit date March 28, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Malaya lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary End-stage renal failure (ESRF) cohorts undergo brachiocephalic fistula(BCF) transposition with supraclavicular block. However, this is inadequate because the incision may extend to the axillary region which requires intercostobrachial (T2) dermatome blockage. Sedation is commonly indicated to allay anxiety whilst allowing intraprocedural lignocaine infiltration. It is challenging to administer safe sedation to ESRF patients due to multiple comorbidities, polypharmacy, altered pharmacokinetic drug handling. Intraoperative hypotension can be common and evident from the residual effect of antihypertensive and intravascular hypovolemia from regular hemodialysis. Midazolam is metabolized to an active metabolite which can accumulate causes apnea and delayed recovery. TCI propofol needs higher induction doses to achieve hypnosis causes exaggerated hypotension which may jeopardize organ perfusion. The investigators are exploring the potential benefit of sevoflurane sedation which are independent of renal clearance, rapid onset and offset, and ischemic preconditioning property in ESRF cohorts. detailed description Regional anesthesia has been shown to be superior to general anesthesia in end-stage renal disease (ESRF) patients undergoing brachiocephalic transposition by ensuring graft patency, reducing pharmacokinetic (pK) and pharmacodynamic (pD) unpredictability, and minimize hemodynamic instability. However, a supraclavicular nerve block is inadequate in BCF transposition where surgical incision may extend to the axillary region which requires intercostobrachial nerve (T2) dermatome to be blocked. Intraprocedural lignocaine infiltration or pectoralis minor (PEC 2) block may be required to anaesthetize this region. Hence, sedation is commonly indicated to allay anxiety and to blunt sympathetic stress response to surgery. ESRF patient is a challenging cohort to administer safe sedation due to multiple comorbidities, polypharmacy, altered pK handling of drug with a high proportion of total body water, the altered volume of distribution, protein binding, drug metabolism and excretion[3]. Commonly used intravenous midazolam causes delayed recovery and apnoea due to loss of renal ability to clear active metabolite α1-hydroxymidazolam. Target controlled infusion (TCI) propofol needs a higher induction dose to achieve clinical end-point of hypnosis in ESRF patient and causes hemodynamic disturbances. Dialysis dependent ESRF patients are commonly hypertensive and adapted to a higher baseline blood pressure. Intraoperative hypotension is exaggerated from residual effect of antihypertensive, relative intravascular hypovolemia from pre-op haemodialysis and pre-operative fasting with no replacement fluid. Blood pressure determine perfusion, and existing evidence suggests intraoperative hypotension is associated with stroke, myocardial injury and delirium. Major hypertension guidelines have recommended target blood pressure level of 140/90 mm Hg for patients with renal disease. Volatile sedation with sevoflurane in intensive care has been widely appraised for significant shorten and superior awakening time and reduced incidence of delirium compared with conventional midazolam/ propofol intravenous sedation. Sevoflurane has rapid onset of action with no significant concern of tolerance and tachyphylaxis. Drug clearance is via pulmonary exhalation which is independent of hepatic and renal function. Volatile agent is a mild analgesia with opioid sparing effect via N methyl-D-aspartate receptor blockade, thus provide a more stable sedation profile.ESRF patients are prone to develop ischemic heart disease due to calcification of intima. Sevoflurane also possess ischemic preconditioning and end organ cytoprotective properties along with anti-inflammatory mechanism. conditions module condition list condition Sevoflurane Kidney Diseases Procedural Hypotension keyword list keyword Sevoflurane Sedation, ESRF design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 36 enrollment type Anticipated arms interventions module arm group list arm group arm group label Target controlled infusion (TCI) propofol arm group type Active Comparator arm group description For TCI propofol group, all patients will receive nasal CPAP mask and nasal breathing with oxygen of 3 litre/min. We will utilize the Schneider model to target effect-site (Cet) starting from 0.5 mcg/ml and with a gradual 0.5mcg/ml increment every 30s until OAAS score of 3 is achieved. For any patients with OAAS score < 3, Cet will be decreased by a decremental 0.5 mcg/ml. The deepest level of sedation will be recorded. arm group intervention list arm group intervention name Drug: Sevoflurane inhalant product arm group label Sevoflurane sedation arm group type Experimental arm group description Patients randomised to this arm will be given time to familiarise with the nasal continuous positive airway pressure (CPAP) mask and nasal breathing with oxygen 3 litre/min via a Bain anaesthetic circuit before the introduction of sevoflurane. Once the patient starts to adapt to nasal CPAP mask, sevoflurane will be delivered, starting with a concentration of 0.2% and increase stepwise by 0.2% every 30s until sedation score of OAAS of 3 is achieved. Anaesthetist in charge will assess and maintain sedation endpoint to OAAS 3. If patient is over sedated, sevoflurane concentration will be reduced by 0.2% until OAAS 3. The deepest level of sedation will be recorded. arm group intervention list arm group intervention name Drug: Sevoflurane inhalant product intervention list intervention intervention type Drug intervention name Sevoflurane inhalant product intervention description Sevoflurane will be delivered in an incremental dose to throughout procedure to achieve clinical sedation endpoint OAAS 3. intervention arm group label list intervention arm group label Sevoflurane sedation Target controlled infusion (TCI) propofol intervention other name list intervention other name Ultane, 74412392 outcomes module primary outcome list primary outcome primary outcome measure Change in mean arterial pressure from baseline following sedation primary outcome description Hemodynamic instability is defined as event below: Hypotension- Drop in mean arterial pressure (MAP) from baseline by more than 20% Hypotension - Drop in systolic blood pressure (sBP < 140 mmHg) and diastolic blood pressure (dBP < 90 mmHg) primary outcome time frame At baseline, pre-, and immediately after intervention secondary outcome list secondary outcome secondary outcome measure Number of hemodynamic interventions required during sedation secondary outcome description administration of vasoactive drugs to maintain hemodynamic within target (sBP> 140 mmHg, dBP > 80 mmHg, MAP within 20% baseline) secondary outcome time frame At baseline, pre-, and immediately after intervention secondary outcome measure Duration of hemodynamic instability secondary outcome description Time course of drop in mean arterial pressure more than 20% secondary outcome time frame At baseline, pre-, and immediately after intervention and surgery secondary outcome measure Onset time and recovery time secondary outcome description Onset time: time from starting sedation to Observer Assessment of Alertness/ Sedation (OAAS) score 3 (maintain at 3 for a consecutive 15 mins) Recovery time: Time from cessation of sedation to return to OAAS score 5 secondary outcome time frame At baseline, pre-, and immediately after intervention and surgery eligibility module eligibility criteria Inclusion Criteria: Patient with end stage renal failure, dialysis dependent undergoing transposition of brachiocephalic fistula repair American Society of Anesthesiology Physical Status Classification System (ASA) II or III Exclusion Criteria: Patient refusal History or family history of malignant hyperthermia Known allergy to propofol or local anaesthetic agent Patients who have taken neuroleptics, benzodiazepine over 2 weeks within 1 month Chronic use of alcohols/ opioid Active lungs disease (eg. acute exacerbation of chronic obstructive pulmonary disease) Active and significant cardiac disease (eg. decompensated congestive cardiac failure, recent myocardial infarction) End-stage heart failure with left ventricular ejection fraction < 30% Recent (< 3 months) cerebrovascular accident healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chao Chia Cheong, MMed Master central contact role Contact central contact phone +60163113597 central contact e mail chaochia@um.edu.my central contact name Chew Yin Y Wang, FRCA central contact role Contact central contact phone +60192340232 central contact e mail wangcy1836@gmail.com overall official list overall official overall official name Chao Chia Cheong, MMed Master overall official affiliation University Malaya overall official role Principal Investigator references module reference list reference reference p m i d 29359313 reference type background reference citation Quek KH, Low EY, Tan YR, Ong ASC, Tang TY, Kam JW, Kiew ASC. Adding a PECS II block for proximal arm arteriovenous access - a randomised study. Acta Anaesthesiol Scand. 2018 May;62(5):677-686. doi: 10.1111/aas.13073. Epub 2018 Jan 22. reference p m i d 19550340 reference type background reference citation Rutkowska K, Knapik P, Misiolek H. The effect of dexmedetomidine sedation on brachial plexus block in patients with end-stage renal disease. Eur J Anaesthesiol. 2009 Oct;26(10):851-5. doi: 10.1097/EJA.0b013e32832a2244. reference p m i d 29782787 reference type background reference citation Virmani S, Onuchic A, El-Ali IM, Trivedi RD. Propofol Induced Hyperkalemia and Its Management in End Stage Renal Disease Patients. Conn Med. 2016 Sep;80(8):491-493. reference p m i d 29247451 reference type background reference citation Zhong W, Zhang Y, Zhang MZ, Huang XH, Li Y, Li R, Liu QW. Pharmacokinetics of dexmedetomidine administered to patients with end-stage renal failure and secondary hyperparathyroidism undergoing general anaesthesia. J Clin Pharm Ther. 2018 Jun;43(3):414-421. doi: 10.1111/jcpt.12652. Epub 2017 Dec 16. reference p m i d 26559744 reference type background reference citation Xie X, Atkins E, Lv J, Bennett A, Neal B, Ninomiya T, Woodward M, MacMahon S, Turnbull F, Hillis GS, Chalmers J, Mant J, Salam A, Rahimi K, Perkovic V, Rodgers A. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet. 2016 Jan 30;387(10017):435-43. doi: 10.1016/S0140-6736(15)00805-3. Epub 2015 Nov 7. reference p m i d 31725024 reference type background reference citation Maheshwari K, Ahuja S, Khanna AK, Mao G, Perez-Protto S, Farag E, Turan A, Kurz A, Sessler DI. Association Between Perioperative Hypotension and Delirium in Postoperative Critically Ill Patients: A Retrospective Cohort Analysis. Anesth Analg. 2020 Mar;130(3):636-643. doi: 10.1213/ANE.0000000000004517. reference p m i d 24352797 reference type background reference citation James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427. Erratum in: JAMA. 2014 May 7;311(17):1809. reference p m i d 29245269 reference type background reference citation Kim HY, Lee JE, Kim HY, Kim J. Volatile sedation in the intensive care unit: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Dec;96(49):e8976. doi: 10.1097/MD.0000000000008976. Review. i p d sharing statement module i p d sharing Yes i p d sharing description All collected individual participant data (IPD) and all IPD that underlie results in a publication i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing time frame Starting 6 months after publication i p d sharing access criteria Personal enquiry via email derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007674 condition mesh term Kidney Diseases condition mesh id D000007022 condition mesh term Hypotension condition ancestor list condition ancestor condition ancestor id D000014570 condition ancestor term Urologic Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse 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full study rank 61518 study protocol section identification module n c t id NCT04835428 org study id info org study id AGN-CIP-201 secondary id info list secondary id info secondary id STAND secondary id type Other Identifier secondary id domain AgNovos organization org full name AgNovos Healthcare, LLC org class INDUSTRY brief title STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures official title A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment status module status verified date November 2022 overall status Recruiting start date struct start date May 31, 2022 start date type Actual primary completion date struct primary completion date December 31, 2024 primary completion date type Anticipated completion date struct completion date December 31, 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 28, 2022 last update post date struct last update post date November 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name AgNovos Healthcare, LLC lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes description module brief summary This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement. conditions module condition list condition Vertebral Compression Fracture Compression Fracture Vertebral Compression keyword list keyword LOEP AGN1 design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Four hundred eight (408) eligible subjects at up to twenty (20) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group). design primary purpose Treatment design masking info design masking Single design masking description Study subjects will not be informed of their treatment group assignment at the time of randomization or at any time before the subject's last office visit. The blind will be broken only if it is necessary to protect the safety or welfare of the subject as determined by the Investigator. design who masked list design who masked Participant enrollment info enrollment count 408 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment with AGN1 LOEP SV Kit arm group type Experimental arm group description The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone. arm group intervention list arm group intervention name Device: Treatment Group: AGN1 LOEP SV Kit arm group label Treatment with PMMA bone cement arm group type Active Comparator arm group description High viscosity PMMA bone cement will be used for vertebral augmentation. arm group intervention list arm group intervention name Device: Control Group: PMMA bone cement intervention list intervention intervention type Device intervention name Treatment Group: AGN1 LOEP SV Kit intervention description The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone. intervention arm group label list intervention arm group label Treatment with AGN1 LOEP SV Kit intervention type Device intervention name Control Group: PMMA bone cement intervention description High viscosity PMMA bone cement will be used for vertebral augmentation. intervention arm group label list intervention arm group label Treatment with PMMA bone cement outcomes module primary outcome list primary outcome primary outcome measure Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS) primary outcome description Change in VCF-related pain by > 20 mm from baseline as measured by a 100 mm Visual Analogue Scale (VAS) where 0mm is no pain, and 100mm is worst pain possible. primary outcome time frame 24 months primary outcome measure Change in function primary outcome description change of function from baseline as measured by the Oswestry Disability Index (ODI) primary outcome time frame 24 months primary outcome measure Radiographic evidence of implant resorption (Intervention Group only) primary outcome description change in resorption from procedure as assessed by independent radiographer primary outcome time frame 24 months primary outcome measure Radiographic evidence of bone formation (Intervention Group only) primary outcome description change in bone formation from procedure as assessed by independent radiographer primary outcome time frame 24 months primary outcome measure Adverse events primary outcome description Occurrence of device-related serious adverse events, device-related adverse events or serious adverse events categorized as failure or surgical intervention at the target level occurring post-treatment primary outcome time frame 24 months eligibility module eligibility criteria Inclusion Criteria: Subject is a male or female aged 55 and 85 years, inclusive, of age at time of study treatment. Subject has only one (1) acute VCF. Note that subjects are eligible if they have an asymptomatic, chronic VCF(s) at any non-target, non-adjacent vertebral level. The acute VCF meets all of the following criteria: Due to diagnosed or presumed underlying osteoporosis T1 to L5 inclusively Target VCF-related pain ≤ 6 months at time of study treatment Target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline. Target VCF is acute or persistent (not healed), as demonstrated on imaging, including T2 weighted STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or other serial imaging demonstrating acuity. Focal tenderness to palpation of the spinal process of the target VCF on the physical exam correlates with imaging. Subject has failed conservative medical therapy (bed rest, observation, chiropractic care, orthotics, opioid and non-opioid analgesics, and/or physical therapy), defined as either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after more than 6 weeks of conservative care. Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline. Subject is capable of giving written informed consent to participate in the study. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented. Exclusion Criteria: Target VCF is unstable, including split or burst fracture. Subject has a bleeding disorder. Subject has an active infection of the spine or has an infection being actively treated with antibiotics. Target VCF is due to underlying or suspected tumor. Target VCF is due to high-energy trauma. Target VCF is due to osteonecrosis. Target VCF has a local kyphotic angle of > 30 degrees, measured as the angle between the superior endplate and inferior endplate at the target VCF. Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels. The pedicle(s) in the target vertebral body appear unable to safely accommodate transpedicular access instrumentation. Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF. Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated. Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis. Subject has spondylolisthesis > Grade 1 at target vertebral body. Subject requires daily opioid medication for pain not related to the target VCF. Subject has severe cardiopulmonary deficiencies. Subject has a Body Mass Index (BMI) > 35. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia). Subject has a history of tuberculous spondylitis. Subject has a history of invasive malignancy within the last five (5) years, other than non-melanoma skin cancer. Subject is not excluded if they have a history of malignancy over 5 years ago treated with curative intent and without clinical signs or symptoms since then. Subject is on oral or parenteral immune-suppressive drugs. Subject has uncontrolled diabetes mellitus. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min. Subject has a diagnosed calcium metabolism disorder. Subject has known allergies to calcium-based bone void fillers. Subject is pregnant or planning to become pregnant during participation in the study. In the judgment of the Investigator, the subject is not a good study candidate. (e.g. substance abuse or chemical dependency, inability to adhere to follow-up schedule, progression of the fracture between screening and the procedure visit). Subject is currently enrolled in another interventional clinical study. healthy volunteers No gender All minimum age 55 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Allison Gorman central contact role Contact central contact phone 2407536424 central contact e mail agorman@agnovos.com overall official list overall official overall official name Kern Singh overall official affiliation Midwest Orthopedics at Rush overall official role Principal Investigator location list location location facility Alabama Clinical Therapeutics location status Recruiting location city Birmingham location state Alabama location zip 35235 location country United States location contact list location contact location contact name Brittany Fry location contact role Contact location contact phone 205-833-2228 location contact e mail brittany.fry@actstudy.net location contact name Jill Andringa location contact role Contact location contact e mail jill.andringa@actstudy.net location contact name Bradley Goodman, MD location contact role Principal Investigator location contact name Srinivas Mallempati, MD location contact role Sub-Investigator location facility Mayo Clinic location status Not yet recruiting location city Phoenix location state Arizona location zip 85054 location country United States location contact list location contact location contact name Allyson Jensen location contact role Contact location contact phone 480-342-6922 location contact e mail jensen.allyson1@mayo.edu location contact name Chandan Krishna, MD location contact role Principal Investigator location contact name Brian Chong, MD location contact role Sub-Investigator location facility GW Medical Faculty Associates location status Not yet recruiting location city Washington location state District of Columbia location zip 20037 location country United States location contact list location contact location contact name Alejandro Jaco location contact role Contact location contact phone 202-741-3519 location contact e mail aljaco@mfa.gwu.edu location contact name Wayne Olan, MD location contact role Principal Investigator location facility Cleveland Clinic Florida location status Recruiting location city Stuart location state Florida location zip 34994 location country United States location contact list location contact location contact name Irene Ball location contact role Contact location contact phone 772-419-2146 location contact e mail BallI@ccf.org location contact name Angelic Gamez location contact role Contact location contact phone 772-223-5945 location contact e mail gameza3@ccf.org location contact name Jeffrey Miller, MD location contact role Principal Investigator location contact name Oszkar Szentirmai, MD location contact role Sub-Investigator location facility Rush University Medical Center location status Not yet recruiting location city Chicago location state Illinois location zip 60612 location country United States location contact list location contact location contact name Kavita Ahuja location contact role Contact location contact phone 224-229-2988 location contact e mail kavita.ahuja@rushortho.com location contact name Mukesh Ahuja location contact role Contact location contact phone 312-805-8456 location contact e mail mukesh.ahuja@rushortho.com location contact name Kern Singh, MD location contact role Principal Investigator location facility NorthShore University HealthSystem location status Recruiting location city Evanston location state Illinois location zip 60201 location country United States location contact list location contact location contact name Boris Jancan location contact role Contact location contact phone 847-570-3674 location contact e mail bjancan@northshore.org location contact name Robert Frech location contact role Contact location contact phone 847-570-4046 location contact e mail rfrech@northshore.org location contact name Michael Musacchio, MD location contact role Principal Investigator location contact name Shakeel Chowdhry, MD location contact role Sub-Investigator location contact name William Ares, MD location contact role Sub-Investigator location facility University of Kansas Medical Center Research Institute, Inc. location status Recruiting location city Kansas City location state Kansas location zip 66160 location country United States location contact list location contact location contact name Rachel Henning location contact role Contact location contact phone 913-945-8072 location contact e mail rhenning2@kumc.edu location contact name Daewood Sayed, MD location contact role Principal Investigator location contact name Chris Lam, MD location contact role Sub-Investigator location contact name Andrew Sack, MD location contact role Sub-Investigator location contact name Timothy Sowder, MD location contact role Sub-Investigator location facility Louisiana Spine Institute location status Recruiting location city Shreveport location state Louisiana location zip 71101 location country United States location contact list location contact location contact name Heather Bowman location contact role Contact location contact phone 318-629-6337 location contact e mail HBowman@louisianaspine.org location contact name Marcus Stone, PhD location contact role Contact location contact phone 318-629-5585 location contact e mail MStone@louisianaspine.org location contact name Pierce Nunley, MD location contact role Principal Investigator location facility Anne Arundel Medical Center (AAMC) location status Recruiting location city Annapolis location state Maryland location zip 21401 location country United States location contact list location contact location contact name Brook Fowler location contact role Contact location contact phone 443-481-5757 location contact e mail mfowler3@luminishealth.org location contact name Chad Patton, MD location contact role Principal Investigator location facility Lahey Medical Center location status Not yet recruiting location city Burlington location state Massachusetts location zip 01805 location country United States location contact list location contact location contact name Patricia Bruff location contact role Contact location contact phone 781-744-8011 location contact e mail patricia.m.bruff@lahey.org location contact name Neil Patel, MD location contact role Principal Investigator location facility Washington University St. Louis location status Recruiting location city Saint Louis location state Missouri location zip 63130 location country United States location contact list location contact location contact name Robin Haverman location contact role Contact location contact phone 314-747-1624 location contact e mail rlhaverman@wustl.edu location contact name Theo VanderVelde, MD location contact role Principal Investigator location contact name Jack Jennings, MD location contact role Sub-Investigator location facility Montefiore location status Recruiting location city Bronx location state New York location zip 10467 location country United States location contact list location contact location contact name Aureliana Toma, MD location contact role Contact location contact phone 973-934-0042 location contact e mail atoma@montefiore.org location contact name Seon Kyu Lee, MD location contact role Principal Investigator location contact name Allen Brook, MD location contact role Sub-Investigator location facility Mt. Sinai location status Not yet recruiting location city New York location state New York location zip 10029 location country United States location contact list location contact location contact name Serina Deeba location contact role Contact location contact phone 212-241-1297 location contact e mail srina.deeba@mountsinai.org location contact name Sukaina Davdani location contact role Contact location contact phone 212-241-1297 location contact e mail sukaina.davdani@mountsinai.org location contact name Reade De Leacy, MD location contact role Principal Investigator location contact name Amish Doshi, MD location contact role Sub-Investigator location facility Neuroradiology and Pain Solutions of Oklahoma location status Not yet recruiting location city Oklahoma City location state Oklahoma location zip 73134 location country United States location contact list location contact location contact name Michelle Bovee location contact role Contact location contact phone 405-286-2060 location contact e mail mbovee@npsdoc.com location contact name Dan Nguyen, MD location contact role Principal Investigator location facility Texas Back Institute location status Recruiting location city Plano location state Texas location zip 75093 location country United States location contact list location contact location contact name Shannon Rusch location contact role Contact location contact phone 972-608-5000 location contact e mail srusch@texasback.com location contact name David Enenebeaku location contact role Contact location contact phone 972-608-5000 location contact e mail denebeaku@texasback.com location contact name Mark Kayanja, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000050723 condition mesh term Fractures, Bone condition mesh id D000050815 condition mesh term 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full study rank 61830 study protocol section identification module n c t id NCT04831372 org study id info org study id IRB-20-1004 organization org full name Carilion Clinic org class OTHER brief title On-Table Versus Off-Table Total Hip Arthroplasty official title Comparing On-Table vs Off-Table Total Hip Arthroplasty Via the Direct Anterior Approach: A Prospective Randomized Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 7, 2021 start date type Actual primary completion date struct primary completion date April 10, 2023 primary completion date type Anticipated completion date struct completion date April 10, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 27, 2021 last update post date struct last update post date April 28, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Carilion Clinic lead sponsor class OTHER collaborator list collaborator collaborator name Virginia Tech Carilion School of Medicine and Research Institute collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The first method is the "on-table" method, which uses a specialized surgical table, called a traction table. This table involves placing both feet in specialized boots that are then hooked up to the table, and allows for positioning of the operative leg with aid of the table. The major limitations associated with the traction table are the need for two additional staff members and the purchase of said table. The second method is the "off-table" method. In this method the patient is placed on a standard operating room table and the operative leg is manually positioned by the surgeon during the procedure . This obviates the need for the additional staff members or purchase of a specialized table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method. detailed description BACKGROUND: The Direct Anterior Approach (DAA) for total hip arthroplasty (THA) has become increasingly popular in the US over the last decade (Berry & Bozic, 2010). Major limitations of the DAA with traction table include the need for an additional surgeon's assistant, a traction table operator, and the purchase of said table. To counter these limitations, some surgeons advocate for the performing the DAA with a conventional operating room table {Cohen, 2017;Molenaers, 2017}. However to date, there are no studies directly comparing the efficiency and efficacy of these two techniques for DAA. OBJECTIVE: Currently, it is unclear which surgical technique is more efficient and effective for total hip arthroplasties (THA). We hypothesize that there will be an increase in efficiency as measured by time when performing a standard operating table (Off-Table) DAA THA when compared to a purpose built traction table (On-Table) DAA THA. In addition, there will be less pain and faster functional recovery in the early post-operative period for patients who underwent an "Off-Table" DAA THA when compared to an "On-Table" DAA THA. SPECIFIC AIMS: 1) Determine whether there is a difference in operating room efficiency between surgeries after a THA via DAA with a standard OR table versus a purpose-built traction table; 2) examine whether there is a difference in early post-operative pain and clinical outcomes when comparing patients who underwent a THA via the DAA with a standard OR table versus a purpose built traction table. 3) report differences in complication rates between those two. METHODS: This is a prospective randomized clinical trial that will evaluate adult patients admitted to Carilion Clinic undergoing primary unilateral total hip arthroplasty. Off and on table DAA procedures will be performed by a single surgeon with multiple years of training and experience in both. Cluster randomization will be performed where patients will be randomized through scheduling. Demographic data will be collected. Operative records will be used to record operative times for each approach. Radiographs to assess implant positioning on postoperative day 0. The primary outcome variables are intra-operative data such as time the patient enters the operating room, time of incision, time of dressing application, exit room time, implants used, operative report. For secondary outcome variables, we will assess at 2 and 6 week follow ups routine Patient-Reported Outcome Measures including narcotic utilization based on pill count and MEq, and the PROMIS and HOOS, JR. measures. EXPECTED OUTCOMES: We expect that the Off-table DAA technique will be associated with faster set up, surgical time, and overall room time when compared to the On-table approach. Additionally, we expect less early post-operative pain in the groin, knee and ankle. We expect that the patient report outcome measures at 2 and 6 weeks post-op for the off-table DAA group will be equivalent or better than the on-table DAA group. Finally we expect no difference in complication rate. conditions module condition list condition Arthroplasty, Replacement, Hip Osteoarthritis, Hip keyword list keyword Direct anterior approach Hip arthroplasty On table Off table design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Primary Objectives- Determine whether there is a difference in operating room efficiency when preparing for, positioning, performing and turning over an operating room after a total hip arthroplasty (THA) via the direct anterior approach (DAA) when using a purpose built traction table ("On-Table") vs a standard operating table ("Off-Table")? Secondary Objective- Examine whether there is a difference in early post-operative pain, mobilization, complication rates and clinical outcomes when comparing patients who underwent a THA via the DAA when using an "On-Table" vs "Off-Table" technique. design primary purpose Treatment design masking info design masking None (Open Label) design masking description BLINDING: none It is impossible to blind the surgeon to the arm as the techniques and instruments required for on-table vs off-table are substantially different. All subjects will be patients of Dr. Owen and he is the only operating surgeon for this study. The patient will see the beds when they are rolled into the operating room and are positioned. Thorough informed consent will make it apparent which table they are using. enrollment info enrollment count 130 enrollment type Anticipated arms interventions module arm group list arm group arm group label On Table Group arm group type Active Comparator arm group description The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The control group will be using the first method, which is the "on-table" method, which uses a specialized surgical table, called a traction table. This table involves placing both feet in specialized boots that are then hooked up to the table, and allows for positioning of the operative leg with aid of the table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method. arm group intervention list arm group intervention name Procedure: On Table Group arm group label Off Table Group arm group type Experimental arm group description The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The experimental group will be using the second method, which is the "off-table" method. In this method the patient is placed on a standard operating room table and the operative leg is manually positioned by the surgeon during the procedure . This obviates the need for the additional staff members or purchase of a specialized table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method. arm group intervention list arm group intervention name Procedure: Off Table Group intervention list intervention intervention type Procedure intervention name Off Table Group intervention description Total Hip arthroplasty being performed via the Direct Anterior Approach using a standard operating room table intervention arm group label list intervention arm group label Off Table Group intervention type Procedure intervention name On Table Group intervention description Total Hip arthroplasty being performed via the Direct Anterior Approach using a traction table intervention arm group label list intervention arm group label On Table Group outcomes module primary outcome list primary outcome primary outcome measure Set Up Time primary outcome description Time point that patient enters room to time point of first incision primary outcome time frame Time point that patient enters room to time point of first incision primary outcome measure Surgery Time primary outcome description Time point of first incision to time point of dress application primary outcome time frame Time point of first incision to time point of dress application primary outcome measure Takedown Time primary outcome description Time point of Dress application to Time point of exiting operating room primary outcome time frame Time point of Dress application to Time point of exiting operating room primary outcome measure Total Room Time primary outcome description Time point that patient enters room to time point of exiting operating room primary outcome time frame Time point that patient enters room to time point of exiting operating room secondary outcome list secondary outcome secondary outcome measure Patient Reported Outcomes Measurement Information System/Hip Disability and Osteoarthritis Outcome Score, Joint Replacement scores secondary outcome description Hip pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = extreme pain secondary outcome time frame pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op secondary outcome measure Visual Analog Scale scores secondary outcome description Hip, knee, ankle pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = worst pain secondary outcome time frame pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op secondary outcome measure Narcotic Utillization secondary outcome description Measured by pill count usage and converted into MME secondary outcome time frame 2 weeks post op pill count eligibility module eligibility criteria Inclusion Criteria: All patients undergoing primary unilateral THA Patient 18 years of age and older Patients who are able to provide consent Exclusion Criteria: Bilateral procedure Non-Primary arthroplasty Prior non-arthroplasty operation requiring removal of hardware Inability to have spinal anesthesia (blood thinners) BMI > 40 Active Smoking HbA1c > 8.0 Failure to meet medical clearance Pregnant women per standard of care healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Trevor M Owen, MD central contact role Contact central contact phone (540) 510-6200 central contact e mail tmowen@carilionclinic.org overall official list overall official overall official name Trevor M Owen, MD overall official affiliation Carilion Clinic overall official role Principal Investigator location list location location facility Carilion Institute for Orthopaedics & Neurosciences location status Recruiting location city Roanoke location state Virginia location zip 24014 location country United States location contact list location contact location contact name Trevor Owen, MD location contact role Contact location contact phone 540-510-6200 location contact e mail tmowen@carilionclinic.org references module reference list reference reference p m i d 30852068 reference type background reference citation Abdel MP, Berry DJ. Current Practice Trends in Primary Hip and Knee Arthroplasties Among Members of the American Association of Hip and Knee Surgeons: A Long-Term Update. J Arthroplasty. 2019 Jul;34(7S):S24-S27. doi: 10.1016/j.arth.2019.02.006. Epub 2019 Feb 12. reference p m i d 19576399 reference type background reference citation Bender B, Nogler M, Hozack WJ. Direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009 Jul;40(3):321-8. doi: 10.1016/j.ocl.2009.01.003. reference p m i d 15062700 reference type background reference citation Berger RA. Mini-incision total hip replacement using an anterolateral approach: technique and results. Orthop Clin North Am. 2004 Apr;35(2):143-51. reference p m i d 20580196 reference type background reference citation Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2010 Sep;25(6 Suppl):2-4. doi: 10.1016/j.arth.2010.04.033. Epub 2010 Jul 1. reference p m i d 28511947 reference type background reference citation Cohen EM, Vaughn JJ, Ritterman SA, Eisenson DL, Rubin LE. Intraoperative Femur Fracture Risk During Primary Direct Anterior Approach Cementless Total Hip Arthroplasty With and Without a Fracture Table. J Arthroplasty. 2017 Sep;32(9):2847-2851. doi: 10.1016/j.arth.2017.04.020. Epub 2017 Apr 21. reference p m i d 16330993 reference type background reference citation Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb. reference p m i d 28087159 reference type background reference citation Molenaers B, Driesen R, Molenaers G, Corten K. The Direct Anterior Approach for Complex Primary Total Hip Arthroplasty: The Extensile Acetabular Approach on a Regular Operating Room Table. J Arthroplasty. 2017 May;32(5):1553-1559. doi: 10.1016/j.arth.2016.12.016. Epub 2016 Dec 22. reference p m i d 18555653 reference type background reference citation Nakata K, Nishikawa M, Yamamoto K, Hirota S, Yoshikawa H. A clinical comparative study of the direct anterior with mini-posterior approach: two consecutive series. J Arthroplasty. 2009 Aug;24(5):698-704. doi: 10.1016/j.arth.2008.04.012. Epub 2008 Jun 13. reference p m i d 25157041 reference type background reference citation Post ZD, Orozco F, Diaz-Ledezma C, Hozack WJ, Ong A. Direct anterior approach for total hip arthroplasty: indications, technique, and results. J Am Acad Orthop Surg. 2014 Sep;22(9):595-603. doi: 10.5435/JAAOS-22-09-595. reference p m i d 20378307 reference type background reference citation Restrepo C, Parvizi J, Pour AE, Hozack WJ. Prospective randomized study of two surgical approaches for total hip arthroplasty. J Arthroplasty. 2010 Aug;25(5):671-9.e1. doi: 10.1016/j.arth.2010.02.002. Epub 2010 Apr 8. reference p m i d 30448326 reference type background reference citation Tian S, Goswami K, Manrique J, Blevins K, Azboy I, Hozack WJ. Direct Anterior Approach Total Hip Arthroplasty Using a Morphometrically Optimized Femoral Stem, a Conventional Operating Table, Without Fluoroscopy. J Arthroplasty. 2019 Feb;34(2):327-332. doi: 10.1016/j.arth.2018.10.023. 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full study rank 61269 study protocol section identification module n c t id NCT04838665 org study id info org study id OVS 2010-08-10-109 organization org full name University of the Philippines org class OTHER brief title Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study official title Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 30, 2011 start date type Actual primary completion date struct primary completion date September 30, 2011 primary completion date type Actual completion date struct completion date September 30, 2011 completion date type Actual study first submit date February 18, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of the Philippines lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Retinopathy of prematurity (ROP) is one of the common anatomic causes of blindness among Filipinos, accounting for 47.7% of the cases. With this retinopathy being preventable and treatable, ROP screening has been proven to be effective in preventing blindness, which is achieved with the usage of mydriatics. Even if the regimen of multiple alternate instillations of 0.5% tropicamide and 2.5% phenylephrine is the one recommended by international guidelines for ROP screening, the mydriatic regimen used by many of the country's institutions is the single instillation of 0.5% tropicamide + 0.5% phenylephrine applied via a cotton wick placed in the inferior fornix (SIW). There have been no studies yet on the safety and efficacy in premature infants of this mydriatic preparation and method, although it is hypothesized that the usage of a cotton wick promotes the possible systemic effects of the mydriatic combination used. This study then aims to determine the safety and efficacy of different mydriatic regimens in premature infants referred for screening of ROP using (1) multiple alternate instillations of 0.5% cyclopentolate hydrochloride and 2.5% phenylephrine (MAI), (2) single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI), and (3) single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick placed in the inferior fornix (SIW) in a tertiary Philippine hospital. This study was designed as a randomized, double blind, clinical study which enrolled sixty preterm infants referred for ROP Screening from January to July 2011. With instillations via MAI, SI, and SIW, systolic blood pressure (SBP), diastolic pressure (DBP), mean arterial pressure (MAP), heart rate, and oxygen saturation were monitored from ten minutes prior to instillation up to forty-five minutes after instillation. Pupil dilations were also measured at the forty-fifth minute. detailed description I. Introduction Retinopathy of prematurity (ROP) is one of the common anatomic causes of blindness among Filipinos, accounting for 47.7% of the cases. With this retinopathy being preventable and treatable, ROP screening has been proven to be effective in preventing blindness, which is achieved with the usage of mydriatics. Even if the regimen of multiple alternate instillations of 0.5% tropicamide and 2.5% phenylephrine is the one recommended by international guidelines for ROP screening, the mydriatic regimen usually used by many of the country's institutions is the regimen of 0.5% tropicamide + 0.5% phenylephrine applied via a cotton wick placed in the inferior fornix. There have been no studies yet on the safety and efficacy in premature infants of this mydriatic preparation and method, although it is hypothesized that the usage of a cotton wick promotes the possible systemic effects of the mydriatic combination used. II. Significance It is the aim of this study to evaluate the safety and efficacy of the mydriatic regimens we use in our institution and compare it to the recommendation by the UK ROP Guidelines. In doing so, this study aims to (1) document vital sign changes in the infant during dilation, (2) identify adverse systemic changes due to the mydriatic regimen and (3) provide appropriate interventions and recommendations to address these adverse effects. These will greatly improve the ROP screening process in our institution. III. Objectives The general objective is to determine vital sign changes related to Pupil Dilation among preterm infants referred for ROP Screening from Neonatal Intensive Care Unit, Pediatric Wards and Eye Instrumentation Center of the Philippine General Hospital (PGH). Specifically, its objective is to compare the vital sign changes and mydriasis in (1) multiple alternate instillations of 0.5% Cyclopentolate Hydrochloride + 2.5% Phenylephrine (MAI) (2) single instillation of 0.5%/0.5% Phenylephrine + Tropicamide (SI) and (3) single instillation of 0.5%/0.5% Phenylephrine + Tropicamide with a cotton wick placed in the inferior fornix (SIW). IV. Methodology This study was designed as a randomized, double blind, clinical study which enrolled sixty preterm infants referred for ROP Screening from January to July 2011. Each subject was randomly distributed into the standard, instillation, and packing group. To avoid observer bias, two investigators were involved per monitoring during dilation. The first investigator was assigned only to place the monitoring devices and to administer the mydriatics contained in unmarked 1 mL syringe which content was unknown to him. The vital signs monitored during dilation were blood pressures (systolic, diastolic and mean arterial pressure (MAP)), heart rates and oxygen saturations using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors. A digital camera and a millimeter rule were used to approximate size of pupil dilatation. Measurement of all the vital signs and pupil dilation from a subject was derived from a single dilation session only. Prior to data collection up to the end of monitoring, other factors that may affect the vital signs of the preterm infants were addressed. This included hunger, cold temperature, and soiled diapers. Baseline vital signs determination was then performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is a significant difference in the vital signs between 10 and 5 minutes prior to the initial drop. For the MAI, multiple alternate drops of 0.5% cyclopentolate then 2.5% phenylephrine every 5 minutes in two doses were instilled (total of 0.2 milliliter of 0.5% cyclopentolate and 0.2 millimeter of 2.5% Phenylephrine). Vital signs were continuously recorded at time 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45. At the 45th minute, a lid retractor was placed in the eyes of the subject after a drop of topical anesthesia. Pictures of the eyes were taken with a millimeter rule to serve as measurement reference. For the SI, only a drop of 0.5%/0.5% tropicamide + phenylephrine was properly instilled at time 0 (total of 0.1 milliliter). Vital signs were continuously recorded at time 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45. At the 45th minute, a lid retractor was placed in the eyes of the subject after a drop of topical anesthesia. Pictures of the eyes were taken with a millimeter rule to serve as measurement reference. For the SIW, a cotton wisp soaked with a drop of 0.5%/0.5% tropicamide + phenylephrine was placed on the lower fornix in each eye of the infant (total of 0.1 milliliter). The weight of the cotton wisp was standardized at 0.02 milligram using a digital weighing scale. Vital signs were continuously recorded at time 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45. At the 45th minute, a lid retractor is placed in the eyes of the subject after a drop of topical anesthesia. Pictures of the eyes were taken with a millimeter rule to serve as measurement reference. Pictures were uploaded into the computer monitor for the actual measurement. Vital sign changes were monitored using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors. In the presence of significant vital sign changes, immediate intervention will be done. In the presence of a significant increase in BP or heart rate, the infant will be observed. Both changes are expected from undergoing a stressful procedure such as placing a lid retractor in measuring the pupil dilation. The infant will be referred to the NICU ROD for further work up should tachycardia persist even after the examination. The blood pressure, heart rate and sensorium will be continuously monitored so as to avoid any ensuing bradycardia. In the presence of a significant drop in BP, the infant will be referred to the NICU ROD for further work up to determine the possible source. Fluid challenge will be done to check if the cause of hypotension is just attributable to hypovolemia. The investigator will determine body temperature to check for hypothermia. If hypothermic, slow rewarming will be done by placing back the infant inside a close incubator or beside a radiant warmer. Blood glucose will be checked for hypoglycemia. Should hyperglycemia be detected, the infant can be started on 2cc/kg D5water. Infant will be worked up for infection as well. During events of hypoxia or oxygen desaturation of less than 85%, the infant will be given supportive ventilation as required. Oxygen saturation will be monitored using the pulse oximeter. In the event of an apnea happening, supportive ventilation will be provided immediately, together with significant stimulation. The infant will be referred to the NICU ROD for possible intubation. In the event of bradycardia, significant stimulation will be started on the infant. The infant will be referred to the NICU ROD for further work-up to determine the cause. The investigator is also to determine body temperature to check for hypothermia. If hypothermic, slow rewarming will be done by placing back the infant inside a close incubator or beside a radiant warmer. Blood glucose will be determined to check for hypoglycemia. Should hyperglycemia be detected, the infant can be started on 2cc/kg D5water. Infant can be worked up for infection as well. In the event that a subject suffers from any of the abovementioned adverse effects, the appropriate interventions cited will be administered free of charge. Should the adverse effects believed by the investigators to be secondary to the ROP screening only and additional expenses are needed to procure medicines or equipment, the investigators will shoulder the expenses. If the medicine or equipment is immediately needed, the relative may spend first for them and have the expenses reimbursed with the investigators later. Should the amount to procure the said medicine or equipment cannot be produced by the relative, the investigators can be immediately contacted to assist the relatives immediately. All other expenses will be shouldered by the investigators through reimbursements. Expenses amounting to P500 for the medicine and P1000 for the equipment will be shouldered by the investigators. Should it exceed these limits, the infant will be referred to any charitable institution for further assistance. The blood pressure (systole, diastole and MAP), HR and oxygen saturation obtained during dilatation were analyzed. They were graphed to determine patterns from baseline up to 45 minutes. Wilcoxon signed rank test was used to assess statistical significance for oxygen saturation, being a non-parametric variable. Poor dilatation among ROP patients with the advanced disease will be noted. A subgroup analysis was also done to determine the any relationship between the amounts of mydriatic used to the weight of the infant. An interim analysis was done within the study to assess if the two mydriatic regimens were particularly beneficial or harmful compared to the concurrent standard group. Either the Pocock or the Flemming method will be used to decide if this study needed to terminate earlier than planned. Unblinding can be done should it be made necessary during the interim analysis or during course of the study. This protocol was submitted to the PGH ERB for ethics review and approval. It was conducted only upon approval from the ERB. All patient information were anonymized and are confidential. There is no funding received by the investigators for the conduct of this research. conditions module condition list condition Retinopathy of Prematurity design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Diagnostic design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) arm group type Active Comparator arm group description 20 infants were enrolled in Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) arm group intervention list arm group intervention name Drug: 0.5% cyclopentolate and 2.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick arm group label Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) arm group type Experimental arm group description Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) arm group intervention list arm group intervention name Drug: 0.5% cyclopentolate and 2.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix arm group type Experimental arm group description Single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick placed in the inferior fornix (SIW) arm group intervention list arm group intervention name Drug: 0.5% cyclopentolate and 2.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick intervention list intervention intervention type Drug intervention name 0.5% cyclopentolate and 2.5% phenylephrine intervention description Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) dropped every 5 minutes for two doses intervention arm group label list intervention arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) intervention other name list intervention other name Multiple Alternate Instillation of Cyclopentolate Hydrochloride Dilate® Micro Labs Limited Bangalore and Phenylephrine Hydrochloride Mydfrin™ 25mg/mL (2.5%) Alcon Fort Worth Texas intervention type Drug intervention name 0.5% tropicamide + 0.5% phenylephrine intervention description Single instillation of 0.5% tropicamide + 0.5% phenylephrine intervention arm group label list intervention arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) intervention other name list intervention other name Single instillation of Tropicamide + Phenylephrine Hydrochloride Sanmyd-P 0.5%/0.5% Santen Osaka Japan intervention type Drug intervention name 0.5% tropicamide + 0.5% phenylephrine with a cotton wick intervention description Single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick weighing 0.02 milligrams placed in the inferior fornix for the entire 45 minutes intervention arm group label list intervention arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) intervention other name list intervention other name Single instillation of Tropicamide + Phenylephrine Hydrochloride Sanmyd-P 0.5%/0.5% Santen Osaka Japan with a cotton wick placed in the inferior fornix weighing 0.02 milligrams outcomes module primary outcome list primary outcome primary outcome measure Systolic blood pressure and systolic blood pressure changes primary outcome description Measured in mmHg using a well-fitted neonatal cuff placed in the arm connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline systolic blood pressure determination was performed 10 and 5 minute prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the v/s between 10 and 5 minutes primary outcome measure Diastolic blood pressure and diastolic blood pressure changes primary outcome description Measured in mmHg using a well-fitted neonatal cuff placed in the arm connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline diastolic blood pressure determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 primary outcome measure Mean arterial blood pressure and mean arterial blood pressure changes primary outcome description Measured in mmHg using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline mean arterial blood pressure determination was performed 10 and 5 mins. prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 an primary outcome measure Heart rate primary outcome description Measured in beats per minute using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline heart rate determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 minutes prior primary outcome measure Oxygen saturation primary outcome description Measured in percent saturation using a pulse oximeter connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline heart rate determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 minutes prior primary outcome measure Pupil diameter primary outcome description Measuring using a digital camera and a millimeter ruler primary outcome time frame Measured at the 45th minute post-instillation of the specified intervention secondary outcome list secondary outcome secondary outcome measure Successful retinopathy of prematurity screening secondary outcome description Whether or not a successful ROP screening was carried out secondary outcome time frame After the 45th minute measurement of pupil diameter eligibility module eligibility criteria Inclusion criteria: birth weight of less than 1500 g gestational age of 32 weeks or less an unstable clinical course who are believed to be at high risk for Retinopathy of Prematurity, as assessed by their individual attendings Exclusion criteria cited that infants with cardiac abnormalities directly affecting the heart rate and oxygen saturation infants with inotropic medications infants with ventilatory support healthy volunteers Accepts Healthy Volunteers gender All minimum age 1 Week maximum age 32 Weeks std age list std age Child contacts locations module overall official list overall official overall official name Roland Joseph D Tan, MD overall official affiliation University of the Philippines Manila overall official role Principal Investigator i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012178 condition mesh term Retinopathy of Prematurity condition mesh id D000015878 condition mesh term Mydriasis condition ancestor list condition ancestor condition ancestor id D000012164 condition ancestor term Retinal Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000007235 condition ancestor term Infant, Premature, Diseases condition ancestor id D000007232 condition ancestor term Infant, Newborn, Diseases condition ancestor id D000011681 condition ancestor term Pupil Disorders condition browse leaf list condition browse leaf condition browse leaf id M25022 condition browse leaf name Premature Birth condition browse leaf relevance low condition browse leaf id M14151 condition browse leaf name Retinal Diseases condition browse leaf relevance low condition browse leaf id M14165 condition browse leaf name Retinopathy of Prematurity condition browse leaf as found Retinopathy of Prematurity condition browse leaf relevance high condition browse leaf id M17572 condition browse leaf name Mydriasis condition browse leaf as found Mydriasis condition browse leaf relevance high condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id M9431 condition browse leaf name Infant, Premature, Diseases condition browse leaf relevance low condition browse leaf id M9428 condition browse leaf name Infant, Newborn, Diseases condition browse leaf relevance low condition browse leaf id M13687 condition browse leaf name Pupil Disorders condition browse leaf relevance low condition browse leaf id T4981 condition browse leaf name Retinopathy of Prematurity condition browse leaf as found Retinopathy of Prematurity condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000010656 intervention mesh term Phenylephrine intervention mesh id D000010109 intervention mesh term Oxymetazoline intervention mesh id D000014331 intervention mesh term Tropicamide intervention mesh id D000003519 intervention mesh term Cyclopentolate intervention ancestor list intervention ancestor intervention ancestor id D000002316 intervention ancestor term Cardiotonic Agents intervention ancestor id D000009184 intervention ancestor term Mydriatics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000013566 intervention ancestor term Sympathomimetics intervention ancestor id D000014662 intervention ancestor term Vasoconstrictor Agents intervention ancestor id D000014663 intervention ancestor term Nasal Decongestants intervention ancestor id D000019141 intervention ancestor term Respiratory System Agents intervention ancestor id D000058646 intervention ancestor term Adrenergic alpha-1 Receptor Agonists intervention ancestor id D000000316 intervention ancestor term Adrenergic alpha-Agonists intervention ancestor id D000000322 intervention ancestor term Adrenergic Agonists intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000018727 intervention ancestor term Muscarinic Antagonists intervention ancestor id D000018680 intervention ancestor term Cholinergic Antagonists intervention ancestor id D000018678 intervention ancestor term Cholinergic Agents intervention ancestor id D000010276 intervention ancestor term Parasympatholytics intervention browse leaf list intervention browse leaf intervention browse leaf id M5878 intervention browse leaf name Cyclopentolate intervention browse leaf as found Hepatic vein intervention browse leaf relevance high intervention browse leaf id M16235 intervention browse leaf name Tropicamide intervention browse leaf as found Natural History Study intervention browse leaf relevance high intervention browse leaf id M12183 intervention browse leaf name Oxymetazoline intervention browse leaf as found Chantix intervention browse leaf relevance high intervention browse leaf id M12713 intervention browse leaf name Phenylephrine intervention browse leaf as found Migraine intervention browse leaf relevance high intervention browse leaf id M252669 intervention browse leaf name Dipivefrin intervention browse leaf relevance low intervention browse leaf id M4724 intervention browse leaf name Cardiotonic Agents intervention browse leaf relevance low intervention browse leaf id M11291 intervention browse leaf name Mydriatics intervention browse leaf relevance low intervention browse leaf id M15497 intervention browse leaf name Sympathomimetics intervention browse leaf relevance low intervention browse leaf id M16561 intervention browse leaf name Vasoconstrictor Agents intervention browse leaf relevance low intervention browse leaf id M7118 intervention browse leaf name Ephedrine intervention browse leaf relevance low intervention browse leaf id M26739 intervention browse leaf name Pseudoephedrine intervention browse leaf relevance low intervention browse leaf id M16562 intervention browse leaf name Nasal Decongestants intervention browse leaf relevance low intervention browse leaf id M20290 intervention browse leaf name 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leaf name Cholinergic Agents intervention browse leaf relevance low intervention browse leaf id M12341 intervention browse leaf name Parasympatholytics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev VaCoAg intervention browse branch name Vasoconstrictor Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention browse branch abbrev CaAg intervention browse branch name Cardiotonic Agents intervention browse branch abbrev CNSSti intervention browse branch name Central Nervous System Stimulants	NCT04838665	[ 101, 1554, 2025, 3997, 5391, 25129, 1580, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23249, 1545, 27677, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 152, 27127, 1333, 118, 4775, 118, 1275, 118, 11523, 2369, 8916, 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full study rank 61480 study protocol section identification module n c t id NCT04835922 org study id info org study id 615-2020 secondary id info list secondary id info secondary id REF/2021/01/000059 secondary id type Registry Identifier secondary id domain NHRC trial registry number organization org full name Tribhuvan University Teaching Hospital, Institute Of Medicine. org class OTHER brief title Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in PCNL official title Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in Percutaneous Nephrolithotomy: A Prospective Randomized Clinical Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date November 9, 2020 start date type Actual primary completion date struct primary completion date November 9, 2021 primary completion date type Anticipated completion date struct completion date November 12, 2021 completion date type Anticipated study first submit date February 20, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dr Sushil Gyawali responsible party investigator title MS Resident responsible party investigator affiliation Tribhuvan University Teaching Hospital, Institute Of Medicine. lead sponsor lead sponsor name Tribhuvan University Teaching Hospital, Institute Of Medicine. lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Percutaneous nephrolithotomy (PCNL) is the preferred treatment for renal stones >2 cm or resistant to ESWL. Postoperative pain following this invasive surgery adds to the morbidity of patient which requires additional analgesia and can affect the quality of care. To lower the morbidity of PCNL, proper and adequate management of postoperative pain remains an integral component of PCNL. There are many ways to reduce the postoperative pain following PCNL including mini PCNL, tubeless PCNL, use of regional analgesia etc. However the modality of analgesic technique is still a matter of debate. The aim of this study is to evaluate the efficacy of intercostal nerve block compared with peritract infiltration in patient undergoing PCNL. Specifically, the study will look on to the demography of patients undergoing PCNL and their indications. The study will also compare the intensity of pain in two groups using visual analogue scale (VAS). The study will be a prospective double blinded randomized clinical trial done at Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching hospital (TUTH). The time frame of this study will be of 1 year or when sample size is fulfilled including all the patients who visit the hospital for PCNL and fulfils the inclusion criteria. At the end of our study we expect to conclude that the use of intercostal nerve block is superior or inferior than or equal to peritract infiltration in alleviating the postoperative pain following PCNL. detailed description Introduction: The incidence and prevalence of renal calculi have increased globally across all ages, sex, and race, probably due to change in dietary habits and global warming. PCNL is considered 'gold standard' for the management of large renal calculi because it is less invasive and morbid than the open surgery. Currently, the indications for PCNL include large size renal calculi (>1.5-2 cm), staghorn calculi, upper tract calculi not responding to other modalities of treatment, lower pole stones, cystine nephrolithiasis, and stones in anatomically abnormal kidneys. However, the procedure causes postoperative pain, mostly due to dilatation of the renal capsule, the parenchyma and pain along the tract of the nephrostomy tube. So the postoperative pain remains an integral part of management. Postoperative pain management not only reduces patient suffering but also improve patient satisfaction, reduces morbidity and in parallel enhances recovery, improves rehabilitation, reduces hospital stay and thereby overall hospital cost. The postoperative pain due to the procedure may vary with individual pain perception, use of percutaneous nephrostomy (PCN) tubes, comorbid conditions, choice of analgesic route, anesthetic agents and postoperative course. Small calibers of tubes, even mini PCNL or tubeless PCNL and regional analgesia such as intercostal nerve block, peritract infiltration, paravertebral block etc. could further decrease postoperative pain and analgesic requirement and hence improving postoperative patient comfort. However, studies on these techniques have produced conflicting results due to the use of different local anesthetics, various regional techniques, and different study designs. So this study aims to compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in alleviating postoperative pain following the procedure with the subjective assessment of pain Rational/justification : • The optimal method of pain control after percutaneous nephrolithotomy remains controversial till now. We need better technique of analgesia to decrease the pain following PCNL. Intercostal nerve block and peritract infiltration are common regional analgesic methods used by most of the investigators that had shown to be adequate for postoperative pain control. This study may be helpful in providing evidence for a clinical guideline to manage postoperative pain that will eventually help to decrease the morbidity and bring better outcome. General Objective : To compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy. Specific Objective : To analyse the demography of the patient [age, sex, BMI, stone size and laterality, renal function test, stone burden (size, Guy's Stone score etc.)] undergoing PCNL. To compare the intensity of pain using visual analogue score, resting and dynamic VAS scores, following PCNL between two groups (ICNB and PTI). To compare the time to first rescue analgesia and total analgesic requirement between both groups. To document the complications of both groups. Research Hypothesis Is Intercostal nerve block more efficacious than peritract infiltration following PCNL in alleviating pain? Study Variables Independent Variables: Age, Sex, BMI, stone location, laterality and size, Guys Stone score (burden), ASA grade, comorbidity, Group I (ICBN), Group P (PTI) nephrostomy tract size (mini vs standard), no of Tracts (single vs multiple), use to tube (tube vs tubeless), length of hospital stay, stone clearance, complications Dependent Variables R-VAS score, D-VAS score, Time to first analgesic demand, Total analgesic requirement conditions module condition list condition Kidney Stone keyword list keyword PCNL Intercostal nerve block Peritract Infiltration Bupivacaine Kidney stone design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description the study will be prospective double blind randomized trial using 0.25% bupivacaine in patients undergoing PCNL under one of the two arms: Intercostal Nerve block or Peritract Infiltration. design primary purpose Treatment design masking info design masking Double design masking description Double blinded study : participants and investigator will be blinded using sealed enveloped method. design who masked list design who masked Participant Investigator enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intercostal Nerve Block arm group type Experimental arm group description • In Group I (ICBN group): Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine at the termination of PCNL under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each). arm group intervention list arm group intervention name Procedure: Intercostal Nerve Block arm group label Peritract infiltration arm group type Active Comparator arm group description In Group P (PTI): Single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given on completion of PCNL by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). Then the surgical wound and intervention site will be covered with an occlusive dressing. arm group intervention list arm group intervention name Procedure: Peritract Infiltration intervention list intervention intervention type Procedure intervention name Intercostal Nerve Block intervention description : Following PCNL Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each) intervention arm group label list intervention arm group label Intercostal Nerve Block intervention other name list intervention other name Regional anesthesia intervention type Procedure intervention name Peritract Infiltration intervention description At the end of PCNL a single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). intervention arm group label list intervention arm group label Peritract infiltration intervention other name list intervention other name Regional anesthesia outcomes module primary outcome list primary outcome primary outcome measure Postoperative Pain Score (VAS score) primary outcome description Patients undergoing PCNL who fulfil the inclusion criteria will be identified at the time of admission. • Patients will be randomized in two groups using sealed envelope method into ICNB (group I) and PTI (group P) prior to surgery. After the procedure (intervention) the intensity of pain will be evaluated by an independent observer (the researcher or an independent ward nurse) blinded to the allocated groups at postoperative 2, 8, 12 and 24 hours. The pain score will be assessed separately by Visual Analogue Scale (VAS), a 10-point scale ranging from 0, minimum or no pain, to 10, the maximum pain score perceived or imagined by the patient, at rest (RVAS) and on deep breathing or coughing known as dynamic VAS (DVAS). • primary outcome time frame up to 24 hours secondary outcome list secondary outcome secondary outcome measure Time to First Rescue analgesia secondary outcome description Pain score will be recorded after the intervention as described earlier. Patients who will have VAS score of > 4 or intractable pain will be given rescue analgesia, that is injection ketorolac intravenously. The usual dose is 30 mg 4-6 hourly by the intravenous route. The time after procedure that patient needs first dose of rescue analgesia i.e Inj Ketorolac will be recorded. Dosage will be adjusted according to pain severity and response. secondary outcome time frame up to 24 hours secondary outcome measure Total Analgesic Requiremennt secondary outcome description Total Analgesia requirement of Inj Ketorolac required by the patient for the first 24 hours up to the discharge will be added up and recorded along with the time given. secondary outcome time frame up to 24-48 hours eligibility module eligibility criteria Inclusion Criteria: All patients above 16 yrs of age undergoing PCNL in Tribhuvan University Teaching Hospital. Exclusion Criteria: Patient ≤16 years of age, known history of hypersensitivity/anaphylaxis/ contraindications to bupivacaine, Systemic Diseases (CKD, active UTI, untreated sepsis), Relook surgery, high ASA grade ( >2) unfit for anesthesia/PCNL , Contraindications for PCNL (pregnancy, coagulopathy) , Patients who decline to participate healthy volunteers No gender All minimum age 17 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Sushil Gyawali, MS Resident central contact role Contact central contact phone +9779849742715 central contact e mail drsushilgyawali@gmail.com central contact name Bhojraj Luitel, MCh Urology central contact role Contact central contact phone +9779851222344 central contact e mail drbhojraj@gmail.com overall official list overall official overall official name Uttam Sharma, MS Surgery overall official affiliation HOD, Department of Urology and Kidney Transplant Surgery, TUTH overall official role Study Chair location list location location facility Tribhvan University Teaching Hospital location status Recruiting location city Kathmandu location state Bagmati location zip 00977 location country Nepal location contact list location contact location contact name Sushil Gyawali, MS Resident location contact role Contact location contact phone +9779849742715 location contact e mail drsushilgyawali@gmail.com location contact name Bhojraj Luitel, MCh Urology location contact role Contact location contact phone +9779851222344 location contact e mail drbhojraj@gmail.com location contact name Bhojraj Luitel, MCh Urology location contact role Sub-Investigator location contact name Sushil Gyawali, MS Resident location contact role Principal Investigator location contact name Amit Sharma Bhattarai, MD Anesthesia location contact role Sub-Investigator location contact name Uttam Sharma, MS Surgery location contact role Sub-Investigator references module reference list reference reference p m i d 28890561 reference type background reference citation Jonnavithula N, Chirra RR, Pasupuleti SL, Devraj R, Sriramoju V, Pisapati MV. A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study. Indian J Anaesth. 2017 Aug;61(8):655-660. doi: 10.4103/ija.IJA_88_17. reference p m i d 31649454 reference type background reference citation Singh I, Yadav OK, Gupta S. Efficacy of intercostal nerve block with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Urol Ann. 2019 Oct-Dec;11(4):363-368. doi: 10.4103/UA.UA_141_18. reference p m i d 29288788 reference type result reference citation Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27. see also link list see also link see also link label choi et al , Pubmed article, PCNL see also link u r l https://pubmed.ncbi.nlm.nih.gov/29288788/ i p d sharing statement module i p d sharing No i p d sharing description After the research is completed, results will be published as Original Article in Journal. Relevant Individual data will be published in Journal itself as a part of the article. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007669 condition mesh term Kidney Calculi condition mesh id D000053040 condition mesh term Nephrolithiasis condition ancestor list condition ancestor condition ancestor id D000007674 condition ancestor term Kidney Diseases condition ancestor id D000014570 condition ancestor term Urologic Diseases condition ancestor id D000052878 condition ancestor term Urolithiasis condition ancestor id D000014545 condition ancestor term Urinary Calculi condition ancestor id D000002137 condition ancestor term Calculi condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition browse leaf list condition browse leaf condition browse leaf id M9845 condition browse leaf name Kidney Calculi condition browse leaf as found Kidney Stone condition browse leaf relevance high condition browse leaf id M26279 condition browse leaf name Nephrolithiasis condition browse leaf as found Kidney Stone condition browse leaf relevance high condition browse leaf id M4551 condition browse leaf name Calculi condition browse leaf relevance low condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse leaf id M16447 condition browse leaf name Urinary Calculi condition browse leaf relevance low condition browse leaf id M26256 condition browse leaf name Urolithiasis condition browse leaf relevance low condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000000777 intervention mesh term Anesthetics intervention ancestor list intervention ancestor intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M4467 intervention browse leaf name Bupivacaine intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf as found Response intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse 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full study rank 61917 study protocol section identification module n c t id NCT04830228 org study id info org study id C1903 organization org full name Biotronik AG org class INDUSTRY brief title BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions official title BIOTRONIK Dynetic-35 for the Treatment of Peripheral Iliac Lesions, Using the Cobalt Chromium Balloon-expandable Dynetic-35 Stent in Association With Passeo-35 Xeo Peripheral Dilation Catheter acronym BIONETIC-I status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 10, 2021 start date type Actual primary completion date struct primary completion date September 2023 primary completion date type Anticipated completion date struct completion date September 2027 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 19, 2022 last update post date struct last update post date July 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Biotronik AG lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions detailed description Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries conditions module condition list condition Peripheral Artery Disease keyword list keyword Iliac arteries design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 159 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name Ballon expandable stent and PTA intervention description Endovascular treatment for the peripheral artery disease of the Iliac artery outcomes module primary outcome list primary outcome primary outcome measure MAE at 12 months post-index procedure. primary outcome description The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure. primary outcome time frame 12 Months eligibility module eligibility criteria Inclusion Criteria: Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements De novo, restenotic, occluded or in-stent lesion(s) representing atherosclerotic lesion(s) in the iliac arteries Reference lumen (vessel) diameter between 5mm and 10 mm The target lesion can be successfully crossed with a guide wire The target lesion length is ≤ 100 mm Subjects has more than 70% stenosis in target lesion Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb or limbs Exclusion Criteria: Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study. Subject is with a current medical condition with a life expectancy of less than one year. Pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, has intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring EVAR (Endovascular Aneurysm Repair) treatment The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet. Refuses blood transfusion Chronic renal insufficiency (eGFR < 30 mL/min within 72 hours prior to index procedure) Subject has IFU listed contraindication(s) healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population The study will enroll subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo, restenotic and in-stent atherosclerotic lesions in iliac arteries sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Damon Judges central contact role Contact central contact phone 0754295286 central contact phone ext +41 central contact e mail damon.judges@biotronik.com overall official list overall official overall official name Marianne Brodmann, Prof. Dr. overall official affiliation Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine overall official role Principal Investigator location list location location facility LKH Univ.-Klinikum Graz, Ambulanz für Angiologie location status Recruiting location city Graz location country Austria location contact list location contact location contact name Marianne Brodmann, Prof Dr location contact role Contact location facility Zol Genk location status Recruiting location city Genk location zip 3600 location country Belgium location contact list location contact location contact name Wouter Lansink, Dr location contact role Contact location facility UZ Gent location status Recruiting location city Gent location zip 9000 location country Belgium location contact list location contact location contact name Nathlie Moreels, Dr location contact role Contact location facility Regionaal Ziekenhuis Heilig Hart Tienen location status Recruiting location city Tienen location country Belgium location contact list location contact location contact name Koen Keirse, MD location contact role Principal Investigator location facility Az Jan Potaels Vilvoorde location status Recruiting location city Vilvoorde location zip 1800 location country Belgium location contact list location contact location contact name Jorn Robijn, Dr location contact role Contact location facility Hôpital Privé du grand Narbonne location status Recruiting location city Narbonne location zip 11100 location country France location contact list location contact location contact name Bertrand Saint-Lebes, Dr location contact role Contact location facility Hôpital Ambroise Paré location status Recruiting location city Paris location country France location contact list location contact location contact name Raphaël Coscas, Prof. Dr location contact role Principal Investigator location facility Klinikum Bayreuth location status Recruiting location city Bayreuth location zip 95445 location country Germany location contact list location contact location contact name Thomas Hüttner, Dr. location contact role Contact location facility Diakonissenkrankenhaus location status Recruiting location city Flensburg location zip 24939 location country Germany location contact list location contact location contact name Stefan Müller-Hülsbeck, Prof. Dr. location contact role Contact location facility St. Franziskushospital Münster location status Recruiting location city Münster location zip 48145 location country Germany location contact list location contact location contact name Martin Austermann, Prof. Dr. location contact role Contact location facility Universitätsklinikum Tübingen location status Recruiting location city Tübingen location zip 72076 location country Germany location contact list location contact location contact name Gerd Grözinger, Prof. Dr. location contact role Contact location facility Semmelweis University Hospital location status Not yet recruiting location city Budapest location country Hungary location contact list location contact location contact name Balázs Nemes, Dr location contact role Principal Investigator location facility Pauls Stradins Clinical University Hospital location status Recruiting location city Riga location country Latvia location contact list location contact location contact name kārlis kupčs, Prof. location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000058729 condition mesh term Peripheral Arterial Disease condition ancestor list condition ancestor condition ancestor id D000050197 condition ancestor term Atherosclerosis condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000016491 condition ancestor term Peripheral Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M28366 condition browse leaf name Peripheral Arterial Disease condition browse leaf as found Peripheral Artery Disease condition browse leaf relevance high condition browse leaf id M6444 condition browse leaf name Dilatation, Pathologic condition browse leaf relevance low condition browse leaf id M18046 condition browse leaf name Peripheral Vascular Diseases condition browse leaf relevance low condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M5249 intervention browse leaf name Chromium intervention browse leaf relevance low intervention browse leaf id M5417 intervention browse leaf name Cobalt intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04830228

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full study rank 61396 study protocol section identification module n c t id NCT04837014 org study id info org study id F11-70846 organization org full name McGill University Health Centre/Research Institute of the McGill University Health Centre org class OTHER brief title Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery official title Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial acronym eNARCOS status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 4, 2022 start date type Actual primary completion date struct primary completion date April 2023 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 6, 2022 last update post date struct last update post date September 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Andrew Zakhari responsible party investigator title Principal Investigator responsible party investigator affiliation McGill University Health Centre/Research Institute of the McGill University Health Centre lead sponsor lead sponsor name McGill University Health Centre/Research Institute of the McGill University Health Centre lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Laparoscopic gynecologic surgeries are generally very well tolerated procedures, and patients are able to go home on the same day, with a prescription for pain control. There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery, and patients are going home with anything from zero to 5 or even 20 tabs of narcotics. Aside from negative side effect of opioids (like nausea/vomiting, dizziness, constipation, and possibly addiction), unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community, worsening an ongoing nationwide opioid crisis. Although most patients report low pain level following these kinds of procedure, there are no current standard prescriptions after gynecologic laparoscopy. In an effort to standardize discharge prescriptions following gynecologic laparoscopy, this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery. There will be 2 standardized set of discharge prescriptions to which patient will be randomized; both containing multimodal medications for pain control. Pain control, and patients satisfaction will be measured in the first post-operative week. detailed description Narcotic prescribing patterns vary greatly among gynecologists performing minimally invasive gynecologic surgery (MIGS). There is no clear consensus or established guideline regarding the choice of narcotic or total amount to be prescribed, if any, for MIGS. These represent a generally well-tolerated group of procedures that are less painful than conventional open surgery. Unnecessary opioid prescriptions and excess unused narcotics have been identified as major contributors to narcotic abuse in the community, and efforts geared towards minimizing unnecessary narcotic prescriptions may help curb the growing opioid crisis. This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients. Given the general tolerability and low pain associated with MIGS, the investigators hypothesize that elimination of narcotics from post-operative pain control, in conjunction with regular use of non-narcotic analgesics, will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription. Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria. Patients will be randomly allocated to either intervention or control groups in a one to one fashion. Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol. Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability. Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone, with regular non-opioid analgesic use. All patient will be contacted on day one and seven after surgery to evaluate pain scores, mobility, adequacy of analgesia, adherence to treatment, side-effects, and total opioid consumption. conditions module condition list condition Pain, Postoperative Opioid Use keyword list keyword Gynecology Minimally invasive surgery Laparoscopy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description In this randomized controlled trial, consented patient will be randomly allocated to either intervention or control groups in a 1:1 fashion. Allocation will be determined by a computerized randomization generator with block randomization in groups of four. Allocations will be placed in sequentially numbered, sealed, opaque envelopes to be opened only upon completion of surgery of consenting patients. design primary purpose Prevention design masking info design masking Double design masking description Although the patient and operative team will not be blinded to the allocation, the research team member completing the post-operative questionnaires as well as the statistician responsible for data analysis will remain blinded to the allocation. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Acetaminophen and naproxen only arm arm group type Experimental arm group description Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. arm group intervention list arm group intervention name Other: prescription for regular acetaminophen and naproxen arm group label Acetaminophen, naproxen and dilaudid arm arm group type Active Comparator arm group description Patient allocated to the control group will be discharged home with a prescription for regular acetaminophen, naproxen, and 5 tabs of hydromorphone 1 mg, with instruction to prioritize non opioid analgesic as first line. arm group intervention list arm group intervention name Other: prescription for regular acetaminophen , naproxen and dilaudid intervention list intervention intervention type Other intervention name prescription for regular acetaminophen and naproxen intervention description Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then prn for one week's duration. No narcotic will be prescribed at discharge post-operatively. intervention arm group label list intervention arm group label Acetaminophen and naproxen only arm intervention type Other intervention name prescription for regular acetaminophen , naproxen and dilaudid intervention description prescription for regular acetaminophen , naproxen and dilaudid intervention arm group label list intervention arm group label Acetaminophen, naproxen and dilaudid arm outcomes module primary outcome list primary outcome primary outcome measure Pain score on post-operative day one primary outcome description The primary outcome of this study is patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day two, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control). primary outcome time frame Post-operative day one secondary outcome list secondary outcome secondary outcome measure Patient mobility and satisfaction of analgesia secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be asked a standardised set of questions binary question (Yes / No) to evaluate patient mobility and satisfaction of analgesia. secondary outcome time frame Post-operative day one and seven secondary outcome measure Total narcotic consumption in the first post-operative week secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be asked total amount of narcotic consumed since discharge from the hospital, including need for rescue prescription secondary outcome time frame Post-operative day seven secondary outcome measure Opioid related side effect secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be inquired about specific opioid side effect. secondary outcome time frame First post-operative week (Day 7) secondary outcome measure Unplanned return to emergency room / clinic secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be inquired about any unplanned visit to emergency room / clinic since discharged from the hospital. secondary outcome time frame First post-operative week (Day 7) secondary outcome measure Overall satisfaction with pain control secondary outcome description Patients will receive a phone call on post-operative day one and seven and will be asked about overall satisfaction with pain control via standardised questionnaire. secondary outcome time frame First post-operative week (Day 7) secondary outcome measure Pain score on post-operative day one secondary outcome description Patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day one, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control). secondary outcome time frame Post-operative day 7 eligibility module eligibility criteria Inclusion Criteria: Women undergoing elective outpatient gynecologic laparoscopy Able to provide informed consent Planned for same day discharge Exclusion Criteria: Chronic pain conditions including, but not limited to: chronic pelvic pain, fibromyalgia, connective tissue disorders, migraines on medication, severe osteoarthritis, sciatica, degenerative disk disease Regular use of analgesia or narcotics. Defined as use of pain medication on most days of the week, most weeks of the month History of substance abuse (opioid addiction, IV drug use, etc.) Known depression or anxiety conditions with or without medication Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater Current or recent use of pain modulators such as pregabalin or gabapentin (one month pre-operatively). Allergy or contraindication to acetaminophen or NSAIDs or hydromorphone/narcotics Intraoperative complications : Conversion to laparotomy or mini-laparotomy > 4 cm Intra-operative gastrointestinal or urologic injury Intra-operative hemorrhage or need for blood transfusion Need for admission healthy volunteers Accepts Healthy Volunteers gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Andrew Zakhari, M.D. central contact role Contact central contact phone 5142288889 central contact e mail andrew.zakhari@mcgill.ca central contact name Jade Desilets, M.D. central contact role Contact central contact phone 5143583147 central contact e mail jade.desilets@mail.mcgill.ca overall official list overall official overall official name Andrew Zakhari, M.D. overall official affiliation McGill University Health Centre/Research Institute of the McGill University Health Centre overall official role Principal Investigator location list location location facility McGill University Health Center location status Recruiting location city Montreal location state Quebec location zip H4A 3J1 location country Canada location contact list location contact location contact name Andrew Zakhari, M.D. location contact role Contact location contact phone (514) 228-8889 location contact e mail andrew.zakhari@mcgill.ca location contact name Andrew Zakhari, M.D. location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Pain, Postoperative condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000000082 intervention mesh term Acetaminophen intervention mesh id D000009288 intervention mesh term Naproxen intervention mesh id D000004091 intervention mesh term Hydromorphone intervention ancestor list intervention ancestor intervention ancestor id D000018712 intervention ancestor term Analgesics, Non-Narcotic intervention ancestor id D000000700 intervention ancestor term Analgesics intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000058633 intervention ancestor term Antipyretics intervention ancestor id D000000894 intervention ancestor term Anti-Inflammatory Agents, Non-Steroidal intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000006074 intervention ancestor term Gout Suppressants intervention ancestor id D000016861 intervention ancestor term Cyclooxygenase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000701 intervention ancestor term Analgesics, Opioid intervention ancestor id D000009294 intervention ancestor term Narcotics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention browse leaf list intervention browse leaf intervention browse leaf id M2341 intervention browse leaf name Acetaminophen intervention browse leaf as found Of each intervention browse leaf relevance high intervention browse leaf id M11391 intervention browse leaf name Naproxen intervention browse leaf as found Mode intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M6427 intervention browse leaf name Hydromorphone intervention browse leaf as found Spatial intervention browse leaf relevance high intervention browse leaf id M11397 intervention browse leaf name Narcotics intervention browse leaf relevance low intervention browse leaf id M19939 intervention browse leaf name Analgesics, Non-Narcotic intervention browse leaf relevance low intervention browse leaf id M28329 intervention browse leaf name Antipyretics intervention browse leaf relevance low intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M3370 intervention browse leaf name Anti-Inflammatory Agents, Non-Steroidal intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M18361 intervention browse leaf name Cyclooxygenase Inhibitors intervention browse leaf relevance low intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Antipy intervention browse branch name Antipyretics intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants

NCT04837014

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full study rank 61655 study protocol section identification module n c t id NCT04833647 org study id info org study id 0239-14-RMB organization org full name Rambam Health Care Campus org class OTHER brief title Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood official title Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date April 1, 2016 start date type Actual primary completion date struct primary completion date August 1, 2020 primary completion date type Actual completion date struct completion date February 1, 2021 completion date type Actual study first submit date April 3, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ori Hochwald , MD responsible party investigator title Director, NICU responsible party investigator affiliation Rambam Health Care Campus lead sponsor lead sponsor name Rambam Health Care Campus lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Prospective study comparing hemodynamic and respiratory changes and exercise capacity during Cardio-Pulmonary-Exercise-Testing (CPET) in 4 groups of infants; Three different groups of premature infants and term controls detailed description The study population included 4 groups of infants; preterm infants born < 300 weeks' gestation with BPD (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants born < 300 weeks' gestation without BPD, late preterm infants (born at 340-366 weeks' gestation) and term controls. Pulmonary function testing and spirometry were measured Participants performed CPET on an electronically braked cycle ergometer. During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study. conditions module condition list condition The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description Participants performed CPET on an electronically braked cycle ergometer . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study. A CPET technician and a senior pediatrician were present and monitored the participants' condition during the study. design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 83 enrollment type Actual arms interventions module arm group list arm group arm group label Term arm group type Other arm group description 7-10 years old born at 37-42 weeks gestation arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) arm group label Late preterms arm group type Other arm group description 7-10 years old born at 34.0-36.6 weeks gestation arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) arm group label Preterms with BPD arm group type Other arm group description 7-10 years old born before 30 weeks gestation with the diagnosis of BPD: the need for oxygen at 36 weeks gestation and/or flow or 3LPM or more, and/or the need for CPAP or invasive ventilation arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) arm group label pretermas without BPD arm group type Other arm group description 7-10 years old born before 30 weeks gestation without the diagnosis of BPD (without the need for oxygen at 36 weeks gestation and/or flow or 3LPM or more, and/or the need for CPAP or invasive ventilation) arm group intervention list arm group intervention name Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) intervention list intervention intervention type Diagnostic Test intervention name Cardio-Pulmonary-Exercise-Testing (CPET) intervention description Cardio-Pulmonary-Exercise-Testing (CPET) . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study intervention arm group label list intervention arm group label Late preterms Preterms with BPD Term pretermas without BPD outcomes module primary outcome list primary outcome primary outcome measure The peak oxygen consumption (VO2max) primary outcome description The peak oxygen consumption (VO2max) primary outcome time frame During the 1 day test eligibility module eligibility criteria Inclusion Criteria: 7-10 years of age The ability to ride stationary bicycles as assessed by the parents. Exclusion Criteria: Immobility An acute febrile or upper respiratory illness in the last 2 weeks The use systemic or inhaled steroids or antiepileptic drugs in the previous month Inhaled bronchodilator use in the previous 24 hours A chronic lung illness (with the exception of BPD and asthma) Congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale). healthy volunteers Accepts Healthy Volunteers gender All minimum age 7 Years maximum age 10 Years std age list std age Child i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000047928 condition mesh term Premature Birth condition ancestor list condition ancestor condition ancestor id D000007752 condition ancestor term Obstetric Labor, Premature condition ancestor id D000007744 condition ancestor term Obstetric Labor Complications condition ancestor id D000011248 condition ancestor term Pregnancy Complications condition browse leaf list condition browse leaf condition browse leaf id M25022 condition browse leaf name Premature Birth condition browse leaf as found Prematurity condition browse leaf relevance high condition browse leaf id M9924 condition browse leaf name Obstetric Labor, Premature condition browse leaf relevance low condition browse leaf id M9916 condition browse leaf name Obstetric Labor Complications condition browse leaf relevance low condition browse leaf id M13279 condition browse leaf name Pregnancy Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions

NCT04833647

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full study rank 61601 study protocol section identification module n c t id NCT04834349 org study id info org study id 2020-0354 secondary id info list secondary id info secondary id NCI-2021-00123 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) secondary id 2020-0354 secondary id type Other Identifier secondary id domain M D Anderson Cancer Center organization org full name M.D. Anderson Cancer Center org class OTHER brief title Re-irradiation With NBTXR3 in Combination With Pembrolizumab for the Treatment of Inoperable Locoregional Recurrent Head and Neck Squamous Cell Cancer official title A Phase II Study of Reirradiation With NBTXR3 in Patients With Inoperable Locoregional Recurrent Head and Neck Squamous Cell Carcinoma status module status verified date May 2022 overall status Active, not recruiting start date struct start date March 9, 2021 start date type Actual primary completion date struct primary completion date May 18, 2025 primary completion date type Anticipated completion date struct completion date May 18, 2025 completion date type Anticipated study first submit date March 5, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 23, 2022 last update post date struct last update post date May 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name M.D. Anderson Cancer Center lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary This phase II trial studies the effect of re-irradiation with NBTXR3 in combination with pembrolizumab in treating patients with head and neck squamous cell cancer that cannot be removed by surgery (inoperable) and has come back (recurrent). NBTXR3 is a drug that is designed to improve the effectiveness (how well something works) of radiation therapy. The drug is injected into a tumor and activated (turned on) by radiation. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Radiation therapy, such as intensity modulated radiation therapy or intensity modulated proton therapy, uses high energy to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3 activated by radiation together with pembrolizumab may help to control head and neck squamous cell cancer. detailed description PRIMARY OBJECTIVES: I. To estimate progression free survival (PFS) and early clinical benefit in patients treated with hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by stereotactic body radiation therapy (SBRT) reirradiation, with concurrent pembrolizumab. II. To assess the safety profile and estimate early clinical benefit of NBXTR3 activated by dose reduction intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) reirradiation with concurrent pembrolizumab, in subjects with locoregional recurrent head and neck squamous cell carcinoma (HNSCC) not eligible for SBRT. SECONDARY OBJECTIVES: I. To evaluate tumor response after NBTXR3 activated by SBRT reirradiation with concurrent pembrolizumab. II. To evaluate tumor response after NBTXR3 activated by dose reduction IMRT/IMPT reirradiation with concurrent pembrolizumab. III. To evaluate the safety profile of NBTXR3 activated by SBRT reirradiation with concurrent pembrolizumab. IV. To evaluate time-to-event outcomes of NBTXR3 activated by SBRT reirradiation with concurrent pembrolizumab. V. To evaluate time-to-event outcomes of NBTXR3 activated by dose reduction IMRT/IMPT reirradiation with concurrent pembrolizumab. EXPLORATORY OBJECTIVES: I. To evaluate lymphedema/fibrosis & dysphagia-related toxicities and functional outcomes of treatment with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. II. To assess functional and patient reported outcomes (PRO) of treatment with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. III. To associate radiomic measurements with outcomes of treatment with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. IV. To evaluate biomarkers of response in subjects treated with NBTXR3 activated by SBRT or IMRT or IMPT reirradiation and concurrent pembrolizumab. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients receive NBTXR3 intratumorally (IT) on day 1. Patients then undergo SBRT every other day (QOD) on days 15-29. Beginning the first day of radiation therapy, patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. COHORT II: Patients receive NBTXR3 IT on day 1. Patients then undergo IMRT/IMPT every day (QD) on days 15-50. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 5 years. conditions module condition list condition Recurrent Head and Neck Squamous Cell Carcinoma Unresectable Head and Neck Squamous Cell Carcinoma design module study type Interventional phase list phase Phase 2 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) arm group type Experimental arm group description Patients receive NBTXR3 IT on day 1. Patients then undergo SBRT QOD on days 15-29. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Other: Hafnium Oxide-containing Nanoparticles NBTXR3 Biological: Pembrolizumab Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy arm group label Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) arm group type Experimental arm group description Patients receive NBTXR3 IT on day 1. Patients then undergo IMRT/IMPT QD on days 15-50. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Other: Hafnium Oxide-containing Nanoparticles NBTXR3 Procedure: Intensity-Modulated Proton Therapy Radiation: Intensity-Modulated Radiation Therapy Biological: Pembrolizumab Other: Quality-of-Life Assessment Other: Questionnaire Administration intervention list intervention intervention type Other intervention name Hafnium Oxide-containing Nanoparticles NBTXR3 intervention description Given IT intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name NBTXR3 intervention type Procedure intervention name Intensity-Modulated Proton Therapy intervention description Undergo IMPT intervention arm group label list intervention arm group label Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name IMPT intervention type Radiation intervention name Intensity-Modulated Radiation Therapy intervention description Undergo IMRT intervention arm group label list intervention arm group label Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy intervention type Biological intervention name Pembrolizumab intervention description Given IV intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name Keytruda Lambrolizumab MK-3475 SCH 900475 intervention type Other intervention name Quality-of-Life Assessment intervention description Ancillary studies intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention other name list intervention other name Quality of Life Assessment intervention type Other intervention name Questionnaire Administration intervention description Ancillary studies intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) intervention type Radiation intervention name Stereotactic Body Radiation Therapy intervention description Undergo SBRT intervention arm group label list intervention arm group label Cohort I (NBTXR3, SBRT, pembrolizumab) intervention other name list intervention other name SABR SBRT Stereotactic Ablative Body Radiation Therapy outcomes module primary outcome list primary outcome primary outcome measure Progression free survival (PFS) primary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. primary outcome time frame From NBTXR3 injection to local or regional recurrence, local or regional progression, distant (outside the head and neck region) progression, or death from any cause, whichever occurs first, assessed up to 5 years primary outcome measure Early clinical benefit activated by SBRT reirradiation primary outcome description Defined as radiographic evidence of complete response (CR), partial response (PR) or stable disease (SD) primary outcome time frame At 6-months post radiation therapy (RT) primary outcome measure Incidence of acute adverse events activated by dose reduction IMRT or IMPT reirradiation primary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 adverse event (AE), excluding dermatitis and mucositis as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. primary outcome time frame Up to 90 days post RT primary outcome measure Incidence of late adverse events activated by dose reduction IMRT or IMPT reirradiation primary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 AE, excluding dermatitis and mucositis as per NCI CTCAE v 5.0. primary outcome time frame From 90 days post RT to end of study (up to 5 years) From 90 days post RT to end of study (up to 5 years) primary outcome measure Incidence of late adverse events activated by SBRT reirradiation primary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 AE, excluding dermatitis and mucositis as per NCI CTCAE v 5.0. primary outcome time frame From 90 days post RT to end of study (up to 5 years) secondary outcome list secondary outcome secondary outcome measure Objective response rate secondary outcome description Defined as complete or partial response per RECIST v1.1 in the target lesion(s), which are those injected with NBTXR3 and irradiated. All other malignant lesions that have not received NBTXR3 injection will be evaluated as per RECIST v1.1, i.e. as measurable or non-measurable lesions (according to their characteristics) and included for the determination of best objective response. secondary outcome time frame Up to 5 years post treatment secondary outcome measure Overall response secondary outcome description Evaluated as per RECIST v1.1 secondary outcome time frame Up to 5 years post treatment secondary outcome measure Incidence of acute adverse events activated by SBRT reirradiation secondary outcome description Will assess treatment related acute and late onset toxicities defined as any grade >= 3 AE, excluding dermatitis and mucositis as per NCI CTCAE v 5.0. secondary outcome time frame Up to 90 days post RT secondary outcome measure Local PFS secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to the radiographic and/or histological confirmation of local (within 2 cm of the high-dose reirradiation treatment volume [PTV]) disease recurrence, local progression, or death from any cause, assessed up to 5 years secondary outcome measure Regional PFS secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to the radiographic and/or histological confirmation of regional disease recurrence, regional progression, or death from any cause, whichever occurs first, assessed up to 5 years secondary outcome measure Distant PFS secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to the radiographic and/or histological confirmation of a new lesion outside the head and neck region, or death from any cause, whichever occurs first, assessed up to 5 years secondary outcome measure Overall survival secondary outcome description Will be estimated using the method of Kaplan-Meier. Median times and 95% confidence intervals will also be estimated. secondary outcome time frame From NBTXR3 injection to death from any cause or EoS, whichever occurs first, assessed up to 5 years other outcome list other outcome other outcome measure Evaluation of the clinical-grading of lymphedema/fibrosis other outcome description Evaluation of the clinical-grading of lymphedema/fibrosis according to the Head and Neck-Lymphedema Fibrosis (HN-LEF) Lymphedema/Fibrosis Grading: Clinician-grading of lymphedema/fibrosis will be conducted according to the published Head and Neck-Lymphedema Fibrosis (HN-LEF) per physical examination of the patient. Clinical grading is a brief assessment that can be completed in < 5 minutes. other outcome time frame Up to 5 years post treatment other outcome measure Evaluation of the clinical-grading of lymphedema/fibrosis other outcome description Evaluation of the clinical-grading of lymphedema/fibrosis according Cervical range of motion (CROM) per physical examination of patient. Cervical range of motion (CROM): A goniometer will measure CROM (degrees) to assess active cervical spine ROM. Five core CROM measures will be collected, including cervical extension, sagittal plane at rest, lateral flexion (left/right), coronal plane at rest, and lateral rotation (left/right). The primary CROM measure of interest is cervical extension. Cervical extension measures are highly reliable (ICC=.90). Average extension measures in healthy adults aged 60 to 69 range from 57 degrees in males (SD: 10.5) to 65 degrees in females (SD: 13.3). Cervical extension measures decrease by approximately 5 degrees for each decade of life[41]. other outcome time frame Up to 5 years post treatment other outcome measure Evaluation of the clinical-grading of lymphedema/fibrosis other outcome description Evaluation of the clinical-grading of lymphedema/fibrosis according to the Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H&N). Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H&N)25 is a 64-item instrument designed to assess lymphedema symptoms in head and neck cancer patients. Survey items were selected to address six domains (head and neck-specific functioning, systemic symptoms, psychosocial issues, altered sensation symptoms, neck-shoulder musculoskeletal/skin symptoms, and miscellaneous symptoms) identified by an expert panel. Preliminary testing of LSIDS-H&N demonstrated both feasibility and readability. other outcome time frame Up to 5 years post treatment other outcome measure Patient reports outcomes other outcome description Questionnaires measuring the patients' views of their health status other outcome time frame Up to 5 years post treatment other outcome measure Biomarkers of response other outcome description Multiplex IHC (mIHC) analysis of tumor microenvironment (i.e. CD8, PD-L1, PD1, CD3, CD68, FoxP3, etc.) in biopsies Flow cytometry analysis (cell counts) of the immune cell biomarkers in blood. other outcome time frame Up to 5 years post treatment eligibility module eligibility criteria Inclusion Criteria: Patients with biopsy proven locoregional recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC Previous documented receipt of at least 30 Gy and up to 70 Gy of radiation for HNSCC with overlapping fields based on actual dose, prescription percentage 30 Gy for conventional fractionation 15 Gy for hypofractionation 10 Gy for single fraction Time interval from prior radiotherapy to NBTXR3 injection (day 1) of at least 6 months Not eligible (unresectable) or poor candidate or patient refusal of surgery for HNSCC recurrence Amenable to undergo the image guided intratumoral/intranodal injection of NBTXR3 by Interventional Radiologist or ear, nose, and throat (ENT) surgeon, as per investigator or treating physician The target lesion(s) in the head and neck should be measurable as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 on cross sectional imaging and repeated measurements at the same anatomical location should be achievable Up to 3 target lesions may be injected with NBTXR3 and radiated, including the primary tumor and involved lymph node(s) SBRT cohort: =< 60 cm^3 per site, total volume =< 120 cm^3 IMRT/IMPT cohort: =< 120 cm^3 per site, total volume =< 200 cm^3 Nodal target lesions must be >= 15mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI) Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Hemoglobin >= 9.0 g/dL Absolute neutrophil count (ANC) >= 1,000/mm^3 Platelet count >= 100,000/mm^3 Leukocytes >= 1500/mm^3 Creatinine =< 1.5 x upper limit of normal (ULN) Calculated (Calc.) creatinine clearance > 30 mL/min Total bilirubin =< 1.5 mg/dL Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) Serum albumin > 3.5 g/L Negative urine or serum pregnancy test =< 7 days prior to NBTXR3 injection in all women of child-bearing potential (WOCBP). WOCBP must agree to follow instructions for method(s) of contraception for the duration the entire study period and 6 months after the last dose of pembrolizumab treatment. Local laws and regulations may require use of alternative and/or additional contraception methods. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but should still undergo pregnancy testing Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study Exclusion Criteria: Locoregional relapse with skin ulceration Head and neck carcinoma with radiographic evidence of metastasis at screening Surgery to the head and neck Excluding diagnostic biopsy History of severe immune-related adverse events observed with previous immunotherapy (anti-PD-1/L1) or known sensitivity (grade >= 3) to any excipients Has received any approved or investigational anti-neoplastic agent within 4 weeks prior to NBTXR3 injection Except anti-PD-1 therapy, which will not require a washout window Note: a reduced washout window may be considered for therapies with short half-lives (i.e., kinase inhibitors) after discussion with Nanobiotix and investigator Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement [=< 10 mg prednisone] therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has not recovered from adverse events (AEs) due to previous anti-neoplastic or immune-oncology therapy and/or interventions (including radiation) to =< grade 1 Participants with alopecia and =< grade 2 neuropathy may be eligible Any live-virus vaccine therapy used for prevention of infectious diseases administered within 4 weeks prior to NBTXR3 injection Except killed-virus Influenza vaccine Exception of other vaccines (e.g. pneumonia) is at the discretion of the treating physician after conducting a personalized risk assessment on a case by case basis Prior allogenic stem cell transplantation or organ allograft Known contraindication to iodine-based or gadolinium-based IV contrast Active malignancy, in addition to head and neck carcinoma, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year since diagnosis or low risk prostate cancer Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection Female patients who are pregnant or breastfeeding Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months, for females, and 220 days for males after the last dose of pembrolizumab Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Jack Phan, MD overall official affiliation M.D. Anderson Cancer Center overall official role Principal Investigator location list location location facility M D Anderson Cancer Center location city Houston location state Texas location zip 77030 location country United States references module see also link list see also link see also link label M D Anderson Cancer Center see also link u r l http://www.mdanderson.org derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002294 condition mesh term Carcinoma, Squamous Cell condition mesh id D000077195 condition mesh term Squamous Cell Carcinoma of Head and Neck condition mesh id D000012008 condition mesh term Recurrence condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000018307 condition ancestor term Neoplasms, Squamous Cell condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf as found Recurrent condition browse leaf relevance high condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4702 condition browse leaf name Carcinoma, Squamous Cell condition browse leaf as found Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M1689 condition browse leaf name Squamous Cell Carcinoma of Head and Neck condition browse leaf as found Head and Neck Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id M19604 condition browse leaf name Neoplasms, Squamous Cell condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms intervention browse module intervention mesh list intervention mesh intervention mesh id C000582435 intervention mesh term Pembrolizumab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M289070 intervention browse leaf name Pembrolizumab intervention browse leaf as found Cognitive intervention browse leaf relevance high intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04834349

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full study rank 61537 study protocol section identification module n c t id NCT04835181 org study id info org study id HBPCIC-2020-05 organization org full name Hubei Hospital of Traditional Chinese Medicine org class OTHER brief title Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency official title Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency: A Study Protocol for a Randomized Controlled Trial status module status verified date February 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date December 1, 2021 primary completion date type Anticipated completion date struct completion date January 31, 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hubei Hospital of Traditional Chinese Medicine lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Obesity is a chronic metabolic disease that seriously harms human health, while abdominal obesity is more closely related to diseases such as type 2 diabetes, cardiovascular disease, and tumors, and has a higher risk. In recent years, traditional Chinese medicine therapy has become the choice of more and more obese patients, and acupuncture therapy is also known as a green therapy for weight loss due to its safety and no side effects. Through the analysis of the TCM physique types of obese people, it is found that Yang-deficiency constitution is one of the TCM constitution types closely related to simple obesity. This topic is based on the constitution theory of traditional Chinese medicine, and on the basis of the earlier research that has clarified the weight loss and lipid-lowering effects of electroacupuncture, it further aims at the type of yang deficiency in obese people, and clarifies the regulation and improvement of umbilical moxibustion on the constitution of obese patients with yang deficiency. In this project, patients with abdominal obesity with yang-deficiency constitution were divided into electro-acupuncture + umbilical moxibustion group and electro-acupuncture group to observe and analyze the advantages and effects of electro-acupuncture combined with umbilical moxibustion on the improvement of obesity symptoms and physical fitness of patients. The ELISA method was used to determine the metabolic indexes related to yang-deficiency constitution, to further clarify the material basis of electroacupuncture combined with umbilical moxibustion to improve the yang-deficiency constitution of patients with abdominal obesity, and to provide scientific and reasonable theoretical guidance for clinical treatment. conditions module condition list condition Obesity, Abdominal design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 68 enrollment type Anticipated arms interventions module arm group list arm group arm group label Electroacupuncture combined with umbilical moxibustion arm group type Experimental arm group intervention list arm group intervention name Behavioral: Electroacupuncture combined with umbilical moxibustion arm group label Electroacupuncture arm group type Active Comparator arm group intervention list arm group intervention name Behavioral: Electroacupuncture intervention list intervention intervention type Behavioral intervention name Electroacupuncture combined with umbilical moxibustion intervention description ①Umbilical moxibustion intervention: point selection: Shenque point Operation: Place the aconite cake on the Shenque point, place the Aizhu in the middle of the aconite cake, ignite the Aizhu and apply moxibustion to make the local warm sensation without burning pain, until the skin is flushed. ②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot. Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points. Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance. intervention arm group label list intervention arm group label Electroacupuncture combined with umbilical moxibustion intervention type Behavioral intervention name Electroacupuncture intervention description ②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot. Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points. Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance. intervention arm group label list intervention arm group label Electroacupuncture outcomes module primary outcome list primary outcome primary outcome measure Change from baseline Waist circumference(WC) at week 12 primary outcome description The horizontal girth through the center of the umbilicus primary outcome time frame Baseline and Week 12 secondary outcome list secondary outcome secondary outcome measure Weight(WG) secondary outcome description Weight(WG) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure BMI(weight/(height) secondary outcome description BMI (weight/(height) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure hip circumference(HC) secondary outcome description hip circumference(HC) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure Waist-to-hip ratio(waist circumference/hip circumference) secondary outcome description waist-to-hip ratio(waist circumference/hip circumference) will be measured. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure The impact of weight on quality of life (IWQOL)-Lite scale secondary outcome description The impact of weight on quality of life (IWQOL)- Lite scale will be measured to assess the improvement in the quality of life of participants. The minimum value is 31，the maximum value is 155. The lower the total score, the lighter the clinical symptoms of the patient. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure The 10-item Kessler Psychological Distress (K10) Scale secondary outcome description The 10-item Kessler Psychological Distress (K10) Scale will be measured to assess participant's mental state. The minimum value is 10，the maximum value is 50. The lower the total score, the lighter the clinical symptoms of the patient. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure TCM Physique Classification and Judgment Table secondary outcome description Refer to the physical characteristics in the "Traditional Chinese Medicine Physique Classification and Judgment Table" to determine the changes in the yang deficiency constitution of the participants. The symptom score is quantified in 5 levels: always, 5 points; often, 4 points; sometimes, 3 points; very Less, 2 points, no, 1 point. Then calculate the constitutional symptom conversion score, and the change value of the constitutional symptom conversion score compared with the baseline.The minimum value is 0，the maximum value is 100. The lower the total score, the lighter the clinical symptoms of the patient. secondary outcome time frame Week 0, Week 4, Week 8, Week 12 secondary outcome measure Serum cortisol (FC) secondary outcome description Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. secondary outcome time frame Week 0, Week 8 secondary outcome measure Serum corticosterone (CORT) secondary outcome description Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. secondary outcome time frame Week 0, Week 8 secondary outcome measure Serum adrenocorticotropic hormone (ACTH) secondary outcome description Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. secondary outcome time frame Week 0, Week 8 eligibility module eligibility criteria Inclusion Criteria: 1. People who meet the following diagnostic criteria and are diagnosed with abdominal obesity due to yang deficiency: Diagnostic criteria for abdominal obesity: Refer to the criteria in the "Guidelines for the Comprehensive Medical Management of Obese People" jointly issued by the American Academy of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) in May 2016: male waist circumference ≥85cm, female Waist circumference ≥80cm can be diagnosed as abdominal obesity. Yang Deficiency Quality Criteria: Meet the diagnostic criteria of Yang Deficiency in the "Classification and Judgment Table of Traditional Chinese Medicine Constitution". Common manifestations are chills, cold limbs, swollen face, pale complexion, pale tongue, white slippery fur, and weak pulse. 2. Age: 18 to 55 years old; 3. Sign the informed consent and voluntarily accept the intervention method of this project. Exclusion Criteria: Severe lung, heart, liver, kidney and other diseases; Combined endocrine diseases (polycystic ovary syndrome, hypothyroidism, Cushing syndrome, etc.); Have a history of surgery to lose weight; have a history of adhesions after previous surgery; Have taken drugs that are known to affect weight or appetite in the past 3 months, such as weight loss drugs, corticosteroids, etc.; have used hormone drugs, lipid-lowering drugs, and hypoglycemic drugs in the past 3 months; Women during pregnancy, lactation and menopause; Participated in clinical research on weight loss in the past 3 months; Those who meet any of the above will be excluded from the study. healthy volunteers No gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module central contact list central contact central contact name Kou Xu, MM central contact role Contact central contact phone +8613667248326 central contact e mail 1932707307@stmail.hbtcm.edu.cn overall official list overall official overall official name Zhong-Yu Zhou, MD overall official affiliation Hubei Hospital of Traditional Chinese Medicine overall official role Principal Investigator references module reference list reference reference p m i d 30364290 reference type background reference citation Park BY, Lee MJ, Kim M, Kim SH, Park H. 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Review. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009765 condition mesh term Obesity condition mesh id D000056128 condition mesh term Obesity, Abdominal condition mesh id D000016711 condition mesh term Yang Deficiency condition ancestor list condition ancestor condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf as found Obesity condition browse leaf relevance high condition browse leaf id M27580 condition browse leaf name Obesity, Abdominal condition browse leaf as found Obesity, Abdominal condition browse leaf relevance high condition browse leaf id M18226 condition browse leaf name Yang Deficiency condition browse leaf as found Yang Deficiency condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions

NCT04835181

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full study rank 61706 study protocol section identification module n c t id NCT04832984 org study id info org study id PRIME organization org full name Monash University org class OTHER brief title Prevention and Treatment of Diabetes in Adults official title Addressing Disparity in Diabetes Prevention Through Digital Health Supported PRe-diabetes Intervention, Management and Evaluation (PRIME) Program Based in Malaysian Community Pharmacies status module status verified date June 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 23, 2022 start date type Actual primary completion date struct primary completion date June 30, 2024 primary completion date type Anticipated completion date struct completion date June 30, 2024 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 13, 2022 last update post date struct last update post date June 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Shaun Lee Wen Huey responsible party investigator title Associate Professor responsible party investigator affiliation Monash University Malaysia lead sponsor lead sponsor name Monash University lead sponsor class OTHER collaborator list collaborator collaborator name Caring Pharmacy collaborator class UNKNOWN collaborator name Bionime Corporation collaborator class INDUSTRY collaborator name Tigas Pharma collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Currently, an estimated 3.9 million Malaysians continue to live with diabetes with many more who live with prediabetes. Diabetes was the one of the leading causes of death in the Malaysia and the leading cause for kidney failure, lower-limb amputations, and adult-onset blindness. Heart disease and stroke are two to four times more likely for individuals with diabetes. The use of mHealth or mobile health application can reduce blood sugar among individuals with prediabetes but also prevent a later occurrence of diabetes. In this study, the investigators aim to develop and evaluate the effectiveness of a digital health supported pre-diabetes management program based in an urban community pharmacy setting detailed description Pre-diabetes is an intermediate state of hyperglycaemia with glycaemic parameters above normal but below the type 2 diabetes mellitus (T2DM) threshold. It was estimated that >25% of individuals who are pre-diabetic convert to T2DM within 3-5 years and 70% of individuals with pre-diabetes will develop into full-fledge T2DM within their lifetimes. According to the 2017 estimate, the disease burden of pre-diabetes at Western Pacific region was 7.6% (126.7 millions). The situation is more alarming in Malaysia where a national pre-diabetes prevalence of 22.1% was noted. Currently available support and self-care services offered in Public Hospitals such as the Diabetes Mellitus Treatment Adherence Clinics (DMTAC) are managed based on the in-person appointment basis. Most of the clinics are available only in specific locations. The need to travel long distance as well as long waiting hours has deterred the success of the programs. This is particularly true for the urban poor who are less likely to take time off from work than those from the higher income group. It is also noteworthy to state that the management program when available, generally target the diagnosed T2DM patients. Studies have shown that individuals with pre-diabetes can substantially reduce their risk of progression to T2DM via participation in evidence-based lifestyle change programs. Previous reports have recorded 54-58% reduction in risk for development to T2DM over 1-3 years with the protective benefit persisting up to 10 years following completion of the program. However, there are several considerations when implementing effective lifestyle intervention program among the pre-diabetes populations in Malaysia. The intervention program should easily be accessible and not confined to public primary and secondary healthcare centres which are already suffering from an overcapacity. Furthermore, consultation should be provided by properly trained healthcare professionals while the ease of communication between the patients and the "lifestyle coach" should be made available. The advancement of information technology coupled with the increasing availability and acceptance of internet and mobile devices provide useful opportunities for application of wireless and mobile technology in order to enhance self-management of chronic conditions. The incorporation of digital technologies can improve patient adherence and facilitate real-time monitoring of vital biological measurements (i.e. via wearable). Additionally, the "mobile health" (mHealth) services are easily scalable, thus providing opportunities to a greater public accessibility and narrow the disparity in access to disease management. In this study, the investigators propose to pilot a digital health supported pre-diabetes management program based in an urban community pharmacy setting conditions module condition list condition PreDiabetes keyword list keyword digital health mobile health lifestyle program design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Double design masking description Cluster randomisation with blinding of statisticians design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 300 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm arm group type Experimental arm group description Participants receiving the phone app together with a fitness tracker. All participants will receive the educational curriculum through the app over a period of 24 weeks. The mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve goals. The participants can use the app to log their food intake, weight, steps, exercise, in addition to participating in the peer support via the chat function. Participants will also receive regular care and follow up in community pharmacies for support. arm group intervention list arm group intervention name Behavioral: Mobile health arm group label Usual care arm arm group type Active Comparator arm group description The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period. Participants will be given physical tracking sheets to record their food intake, weight, steps and exercises. arm group intervention list arm group intervention name Behavioral: Usual care intervention list intervention intervention type Behavioral intervention name Mobile health intervention description Participants will be issued a fitness tracker, Bluetooth enabled glucometer, and a custom developed app which they can communicate digitally to the study investigators either as a group or individually. In the beginning of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (biweekly bite-sized content over 24 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis. intervention arm group label list intervention arm group label Intervention arm intervention type Behavioral intervention name Usual care intervention description Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app. All participants will be given physical tracking sheets to log in their food intake, blood glucose levels and food diary but will not have access to a personal coaching. Participants are free to seek any assistance for their medical care during the study period. intervention arm group label list intervention arm group label Usual care arm outcomes module primary outcome list primary outcome primary outcome measure Change in body weight primary outcome description Weight Loss by % of change and total weight change (kg) primary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome list secondary outcome secondary outcome measure Incidence of diabetes secondary outcome description Number of participants who develop diabetes after 12 months secondary outcome time frame 12 months secondary outcome measure Change in hemoglobin A1c secondary outcome description Haemoglobin A1c measured during follow-up appointments secondary outcome time frame Baseline, 3 months, 6 months, 12 months secondary outcome measure Change in health related quality of life secondary outcome description EuroQol (EQ-5D-5L) to assess quality of life, with higher scores indicating better quality of life. Hospital Anxiety Depression Scale, Perceived Stress Scale and Brief Illness Perception Questionnaire to access mood and mental health. secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in dietary practice secondary outcome description 3-day diet recall to assess changes in food intake secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in physical activity secondary outcome description Physical Activity Questionnaire (short form) (IPAQ) to obtain internationally comparable data on health-related physical activity secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in cardiovascular risks secondary outcome description Blood pressure and lipid profile will be collected to assess cardiovascular risks. secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months secondary outcome measure Change in anthropometry measures secondary outcome description Body fat composition in % change, and change in waist-to-hip ratio. secondary outcome time frame Baseline, 1 month, 3 months, 6 months, 12 months eligibility module eligibility criteria Inclusion Criteria: Aged 18 years and above BMI 23 and above HbA1c 5.7 - 6.4% or FPG 5.6mmol/L - 6.9mmol/L Exclusion Criteria: Unable to give informed consent Pregnant or lactating Established diabetes Terminal illness Does not own a mobile phone Plans to relocate to an area or travel plans that do not permit full participation in the study healthy volunteers No gender All minimum age 18 Years maximum age 99 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chun Wie Chong, PhD central contact role Contact central contact phone 0355146688 central contact e mail chong.chun.wie@monash.edu central contact name Shaun Lee, PhD central contact role Contact central contact phone 0355145890 central contact e mail shaun.lee@monash.edu overall official list overall official overall official name Shaun Lee overall official affiliation Monash University Malaysia overall official role Principal Investigator overall official name Chun Wie Chong overall official affiliation Monash University Malaysia overall official role Principal Investigator location list location location facility Shaun Lee location status Recruiting location city Subang Jaya location state Selangor location zip 47500 location country Malaysia location contact list location contact location contact name Shaun Lee location contact role Contact location contact e mail shaun.lee@monash.edu i p d sharing statement module i p d sharing Undecided i p d sharing description We plan to share any related individual participant data within reasonable request which can be obtained from the principal investigators derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011236 condition mesh term Prediabetic State condition ancestor list condition ancestor condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M13269 condition browse leaf name Prediabetic State condition browse leaf as found Prediabetes condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M19447 condition browse leaf name Glucose Intolerance condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04832984

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full study rank 61486 study protocol section identification module n c t id NCT04835844 org study id info org study id IRB 20-461 organization org full name The Cleveland Clinic org class OTHER brief title RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation official title RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation: MAP-AF Study acronym MAP-AF status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 24, 2020 start date type Actual primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date July 1, 2024 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 22, 2022 last update post date struct last update post date March 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name The Cleveland Clinic lead sponsor class OTHER collaborator list collaborator collaborator name Boston Scientific Corporation collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes. detailed description Pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (AF). Identifying gaps in prior ablation lines is essential to achieve successful outcomes. High density mapping systems have been proposed to allow the identification of such gaps with speed and accuracy. The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes. conditions module condition list condition Paroxysmal Atrial Fibrillation design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 70 enrollment type Anticipated arms interventions module arm group list arm group arm group label Mapping with CARTO arm group description CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter arm group intervention list arm group intervention name Device: CARTO arm group label Mapping with RHYTHMIA arm group description RHYTHMIA (Boston Scientific) in conjunction with the 64-electrodes ORION mini-basket catheter. arm group intervention list arm group intervention name Device: RHYTHMIA intervention list intervention intervention type Device intervention name CARTO intervention description Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter intervention arm group label list intervention arm group label Mapping with CARTO intervention type Device intervention name RHYTHMIA intervention description Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter. intervention arm group label list intervention arm group label Mapping with RHYTHMIA outcomes module primary outcome list primary outcome primary outcome measure System is able to accurately identify gaps primary outcome description Incidence of accurate identification of gaps in prior ablation lines by the system primary outcome time frame At the time of procedure secondary outcome list secondary outcome secondary outcome measure Treatment success secondary outcome description Freedom from AF recurrence secondary outcome time frame Up to 12 months eligibility module eligibility criteria Inclusion Criteria: Adult patients (18-90 years of age) undergoing redo ablation procedures for paroxysmal AF regardless of the systems or energy sources used during the pre-study ablation procedure(s). Paroxysmal AF: defined as AF terminating within 7 days of onset either spontaneously or with electrical or medical cardioversion. Exclusion Criteria: Persistent AF Prior cardiac surgery Patients with only AFL or AT as the documented recurrent arrhythmia after the pre-study AF ablation(s). healthy volunteers No gender All minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult study population Electrophysiology clinic patients who are considered candidates for redo paroxysmal AF ablation. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Ayman Hussein, MD central contact role Contact central contact phone 216-444-6171 central contact e mail husseia@ccf.org overall official list overall official overall official name Ayman Hussein, MD overall official affiliation The Cleveland Clinic overall official role Principal Investigator location list location location facility Cleveland Clinic location status Recruiting location city Cleveland location state Ohio location zip 44195 location country United States location contact list location contact location contact name Ayman Hussein, MD location contact role Contact location contact phone 216-444-6171 location contact e mail husseia@ccf.org location contact name Ayman Hussein, MD location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001281 condition mesh term Atrial Fibrillation condition ancestor list condition ancestor condition ancestor id D000001145 condition ancestor term Arrhythmias, Cardiac condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M3738 condition browse leaf name Atrial Fibrillation condition browse leaf as found Atrial Fibrillation condition browse leaf relevance high condition browse leaf id M3605 condition browse leaf name Arrhythmias, Cardiac condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions

NCT04835844

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full study rank 61853 study protocol section identification module n c t id NCT04831073 org study id info org study id 100968 organization org full name Helsinki University Central Hospital org class OTHER brief title European Registry of Type A Aortic Dissection official title European Registry of Type A Aortic Dissection acronym ERTAAD status module status verified date May 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date July 1, 2021 start date type Anticipated primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 27, 2021 last update post date struct last update post date June 1, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Fausto Biancari responsible party investigator title Professor responsible party investigator affiliation Helsinki University Central Hospital lead sponsor lead sponsor name Helsinki University Central Hospital lead sponsor class OTHER collaborator list collaborator collaborator name University Hospitals, Leicester collaborator class OTHER collaborator name University Hospital Southampton NHS Foundation Trust collaborator class OTHER collaborator name Azienda Ospedaliera Universitaria Integrata Verona collaborator class OTHER collaborator name Centre Hospitalier Universitaire de Besancon collaborator class OTHER collaborator name Assistance Publique - Hôpitaux de Paris collaborator class OTHER collaborator name Ziekenhuis Oost-Limburg collaborator class OTHER collaborator name University Hospital Muenster collaborator class OTHER collaborator name University of Hamburg-Eppendorf collaborator class OTHER collaborator name Institute for Clinical and Experimental Medicine collaborator class OTHER_GOV collaborator name Northern General Hospital, Herries Road, Sheffield collaborator class UNKNOWN collaborator name Liverpool Heart and Chest Hospital NHS Foundation Trust collaborator class OTHER collaborator name University Hospital, Udine, Italy collaborator class OTHER collaborator name Heart Center Leipzig - University Hospital collaborator class OTHER collaborator name Cliniques universitaires Saint-Luc- Université Catholique de Louvain collaborator class OTHER collaborator name AZ Sint-Jan AV collaborator class OTHER collaborator name University Hospital, Antwerp collaborator class OTHER collaborator name Universitaire Ziekenhuizen KU Leuven collaborator class OTHER collaborator name University of Turin, Italy collaborator class OTHER collaborator name University of Barcelona collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD. detailed description Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit. conditions module condition list condition Type A Aortic Dissection keyword list keyword Aortic dissection design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 4000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Acute type A aortic dissection arm group description Patients who underwent surgery for acute type A aortic dissection arm group intervention list arm group intervention name Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch intervention list intervention intervention type Procedure intervention name Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch intervention description Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch intervention arm group label list intervention arm group label Acute type A aortic dissection outcomes module primary outcome list primary outcome primary outcome measure Mortality rate primary outcome description All-cause mortality primary outcome time frame During the index hospital stay until last follow-up control primary outcome measure Cumulative incidence of reoperation on the aorta primary outcome description Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication primary outcome time frame During the index hospital stay until last follow-up control secondary outcome list secondary outcome secondary outcome measure Incidence of stroke secondary outcome description change in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke duration of a focal or global neurological deficit ≥ 24 h; OR <24 h if available neuroimaging documents a new brain hemorrhage or infarct; OR the neurological deficit results in death. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of acute kidney injury secondary outcome description It will be defined according to postoperative change in serum creatinine levels and its severity will be stratified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of surgical site infection secondary outcome description Proven infection involving deep sternal wound tissues and/or mediastinum. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of reoperation for bleeding secondary outcome description Chest reopening for excessive bleeding. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence and amount of blood transfusion secondary outcome description Transfusions of red blood cells secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Length of stay in the intensive care unit secondary outcome description Duration of stay in the intensive care unit secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of global brain ischemia secondary outcome description Diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months secondary outcome measure Incidence of paraplegia/paraparesis secondary outcome description Bilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion. secondary outcome time frame From date of procedure until the date of hospital discharge, assessed up to 3 months eligibility module eligibility criteria Inclusion Criteria: Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta; Patients aged > 18 years: Symptoms started within 7 days from surgery; Primary surgical repair of acute type A aortic dissection; Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection. Exclusion Criteria: Patients aged < 18 years; Onset of symptoms > 7 days from surgery; Prior procedure for type A aortic dissection; Retrograde type A aortic dissection (with primary tear located in the descending aorta); Concomitant endocarditis; Type A aortic dissection secondary to blunt or penetrating chest trauma. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients who underwent surgical repair for acute type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Fausto Biancari, Professor central contact role Contact central contact phone +358407333973 central contact e mail fausto.biancari@hus.fi central contact name Tatu Juvonen, Professor central contact role Contact central contact phone +358504080562 central contact e mail tatu.juvonen@hus.fi overall official list overall official overall official name Fausto Biancari overall official affiliation Helsinki University Hospital, Helsinki, Finland overall official role Principal Investigator location list location location facility AZ St-Jan location city Brugge location country Belgium location contact list location contact location contact name Marc Schepens location contact role Contact location facility Saint-Luc's Hospital location city Brussels location country Belgium location contact list location contact location contact name Stefano Mastrobuoni location contact role Contact location contact name Laurent De Kerchove location contact role Sub-Investigator location facility University Hospital Antwerp location city Edegem location country Belgium location contact list location contact location contact name Steve Laga location contact role Contact location facility Ziekenhuis Oost-Limburg location city Genk location country Belgium location contact list location contact location contact name Matteo Pettinari location contact role Contact location facility University Hospitals Leuven location city Leuven location country Belgium location contact list location contact location contact name Bart Meuris location contact role Contact location facility Institute of Clinical and Experimental Medicine location city Prague location country Czechia location contact list location contact location contact name Marek Pol location contact role Contact location contact name Peter Ivak location contact role Sub-Investigator location contact name Filip Schlosse location contact role Sub-Investigator location facility Helsinki University Hospital location city Helsinki location country Finland location facility Henri Mondor University Hospital location city Créteil location state Paris location country France location contact list location contact location contact name Antonio Fiore location contact role Contact location contact name Thierry Folliguet, Prof location contact role Sub-Investigator location facility University Hospital Jean Minjoz location city Besançon location country France location facility University Heart & Vascular Centre Hamburg location city Hamburg location country Germany location contact list location contact location contact name Till Demal location contact role Contact location contact name Lenard Conradi location contact role Sub-Investigator location contact name Christian Detter location contact role Sub-Investigator location facility Leipzig Heart Center location city Leipzig location country Germany location contact list location contact location contact name Michael Borger location contact role Contact location contact name Christian Etz location contact role Sub-Investigator location contact name Thilo Noack location contact role Sub-Investigator location facility Münster University Hospital location city Münster location country Germany location contact list location contact location contact name Angelo M Dell'Aquila location contact role Contact location facility University of Torino location city Torino location country Italy location contact list location contact location contact name Mauro Rinaldi, Professor location contact role Contact location contact name Luisa Ferrante location contact role Sub-Investigator location facility University of Udine location city Udine location country Italy location facility University of Verona Medical School location city Verona location country Italy location contact list location contact location contact name Francesco Onorati location contact role Contact location contact name Alessandra Francica location contact role Sub-Investigator location contact name Cecilia Rossetti location contact role Sub-Investigator location facility Hospital Clínic de Barcelona location city Barcelona location country Spain location contact list location contact location contact name Eduard Quintana location contact role Contact location contact name Manuel Castellá location contact role Sub-Investigator location facility University Hospitals of Leicester location city Leicester location country United Kingdom location facility Liverpool Heart and Chest Hospital location city Liverpool location country United Kingdom location contact list location contact location contact name Mark Field location contact role Contact location contact name Amer Harky location contact role Sub-Investigator location contact name Manoj Kuduvalli location contact role Sub-Investigator location facility Northern General Hospital location city Sheffield location country United Kingdom location contact list location contact location contact name Stefano Forlani location contact role Contact location contact name Govind Chetty location contact role Sub-Investigator location facility Southampton University Hospital location city Southampton location country United Kingdom location contact list location contact location contact name Geoffrey Tsang location contact role Contact location contact name Suvitesh Luthra location contact role Sub-Investigator references module reference list reference reference p m i d 34112230 reference type derived reference citation Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5. Erratum in: J Cardiothorac Surg. 2021 Aug 9;16(1):225. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000784 condition mesh term Aneurysm, Dissecting condition ancestor list condition ancestor condition ancestor id D000000783 condition ancestor term Aneurysm condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M3266 condition browse leaf name Aneurysm, Dissecting condition browse leaf as found Aortic Dissection condition browse leaf relevance high condition browse leaf id M3265 condition browse leaf name Aneurysm condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04831073

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full study rank 61733 study protocol section identification module n c t id NCT04832633 org study id info org study id 18MMHIS052e organization org full name Mackay Memorial Hospital org class OTHER brief title The Best Parameters for Imaging Agent Injection and Scanning Methods in Computed Tomography Angiography official title The Best Parameters for Imaging Agent Injection and Scanning Methods in Computed Tomography Angiography status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 1, 2018 start date type Actual primary completion date struct primary completion date February 28, 2020 primary completion date type Actual completion date struct completion date February 28, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Mackay Memorial Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Background: The contrast time-enhancement profiles of pulmonary artery (PA) and the aorta differ by using computed tomography (CT) angiography. Our purpose is to identify the optimal CT protocol for assessment of both vessels in one-time CT scan. Methods: The investigators prospectively enrolled 101 cases of CT angiography with suspicion of pulmonary embolism or aortic dissection in our center from 2018 to 2020. Forty cases receiving traditional two-time CT scans were collected retrospectively from 2015 to 2018. The investigators designed four groups: test bolus (TB) I, II and bolus-tracking (BT) I, II. The enhancement of the both vessels and the radiation dose of these four groups were collected. Traditional group was separated into traditional PA scan and traditional aorta scan. Data analyzed among the BT groups and the traditional groups were performed. detailed description Patients All cases with suspicion of PE or AD referred for CTA in our hospital between March 2018 and February 2020 had been reviewed. Those cases with known allergic history, poor renal function (creatinine level>1.5 mg/dl), pregnant women or age less than twenty years old were excluded from the study. The investigators finally enrolled and analyzed 101 cases of CTA. The collected data included age, sex, blood pressure, body mass index (BMI), Hounsfield unit (HU) at bifurcation of PA, HU at the descending aorta with the same level of PA bifurcation, time to peak enhancement, and radiation dose. This study had been approved by the institutional review board in our hospital. All patients signed informed consent. In addition, forty cases with suspicion of PE or AD performing traditional two-time CT scans were reviewed retrospectively. For controlling the dose of contrast media, the two-time CT scans in our hospital were performed with single 80ml contrast media injection at 3ml/sec, followed by 20ml normal saline injection at 3ml/sec. The CT PA angiography was performed when the density of the PA achieved baseline PA density plus 150 HU during tracking scans, followed immediately by the CT aortogram. The investigators compared the experimental groups and traditional groups. Experimental designs of contrast media injection After the contrast injection, the contrast media goes to the right heart via peripheral veins and then the contrast is pumped out to the PA. The interval from contrast injection to the peak enhancement of PA is defined as P seconds. After pulmonary circulation, the contrast media travels through the pulmonary veins, the left atrium, and the left ventricle and contracts into the aorta. The interval from contrast injection to the peak enhancement of aorta is defined as A seconds. Afterward, the contrast media starts a new cycle of systemic circulation. Based on the published data, for the pulmonary artery, adequate attenuation is known to be greater than 180 HU, and for the aorta, sufficient attenuation is known to be greater than 200 HU. However, the requirement of vascular enhancement for diagnosing PE is high because the size of the PA is significantly tapering and the thrombus in the distal PA branches will be vague if the enhancement of the PA is not vivid. Therefore, insufficient enhancement of the PA restricts the ability to diagnose PE. The investigators design a biphasic contrast media injection protocol, including a low rate(2ml/s) first phase injection and high rate(3ml/s) second phase injection, followed by high rate(3ml/s) normal saline injection. The first phase injection is kept for (A - P) seconds and the second phase injection is kept until the rest contrast media is completely injected. Theoretically, when the start time of the scan is at the A seconds, the first phase contrast media is about to significantly enhance the aorta, though the peak time and peak enhancement will not be optimal because the time intervals are calculated on the basis of high rate (3ml/s) injection. On the other hand, the second phase contrast media will maximally enhance the PA at the same time because the second phase contrast media has been injected for P seconds [A-(A-P)=P]. The pre-diagnostic axial CT images were set at the level of the PA bifurcation using 10ml test bolus contrast media injection at the 3ml/s rate. Radiology technologists in our team placed circular region of interest (ROI) within the areas of PA bifurcation and the descending aorta at the same level. The CT densities were collected and demonstrated the time-enhancement data. The peak enhancement time for the PA was chosen as P seconds and that for the aorta as A seconds. The investigators designed four groups, including two groups using the test bolus (TB) method and two groups using the bolus-tracking (BT) method. The two TB groups were different at the total amount of contrast media with 80ml and 70ml respectively. The P and A seconds were calculated from the pre-diagnostic images and the start time of scan was fixed at A seconds. Based on the results of initial 22 cases in the two TB groups, the mean interval between P and A seconds was approximately 9.5 seconds. Therefore, we roughly assumed the A-P interval in most cases was about 10 seconds and designed the two BT groups with a fixed 10-second first phase contrast media injection time. The start time of scan was based on the tracking method when the descending aorta at the PA bifurcation achieved the baseline density plus 150 HU. The tracking scan started after contrast injection was initiated for 15 seconds. The two BT groups were also different at the total amount of contrast media with 80ml and 70ml respectively, including the 10ml for the pre-diagnostic images in order to have the same condition before the diagnostic CT images. Details of the four experimental groups: TB I: The investigators use the TB method with biphasic injection, followed by the saline flush. Initially, the investigators inject the 10 ml of test contrast media with a velocity of 3ml/s and apply the ROI at the bifurcation of PA and descending aorta at the same level. The dynamic curve demonstrates the time to peak enhancement of P second and A second. The first phase of contrast media injection uses a velocity of 2ml/s and the volume of contrast is measured as 2ml/s multiply (A-P) second. The second phase of contrast media injection uses a velocity of 3ml/s and the volume of contrast media is 70ml minus the amount of first phase injection. The total volume of the contrast media is 80ml, including the 10ml for pre-diagnostic test bolus images. The investigators performed the saline flush following the administration of the contrast media with 20 ml normal saline. The start time of the diagnostic scan is at the A second. TB II: This group is similar to the TB I. However, the investigators use the lesser contrast media in the second phase of injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus the amount of first phase injection. The total volume of the contrast media is 70 ml, also including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The start time of the diagnostic scan is at the A second as well. BT I: Initially, 10ml of test contrast media was administrated but no calculation was performed for these pre-diagnostic test bolus images in this group. Unlike the TB method, the investigators use 10 seconds as the fixed interval of (A-P) in this group. The first phase of contrast media injection uses a velocity of 2ml/s and thus the volume of contrast is 20ml. The second phase of contrast media injection is administered with a velocity of 3ml/s and the volume of the contrast media is 70ml minus 20ml. The total volume of the contrast media is 80 ml. The following saline flush uses 20 ml of normal saline. The tracking scan started after contrast injection was initiated for 15 seconds. The ROI is placed in the descending aorta at the same level of PA bifurcation and the diagnostic CT scan is triggered when the density in the ROI achieves the baseline density plus 150HU. BT II: This group is similar to the BT I. The first phase of injection is the same as the BT I group. The investigators use lesser contrast media in the second phase of contrast injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus 20ml. The total volume of the contrast media is 70 ml, including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The protocol for triggering diagnostic CT scan is the same as that in BT I. CT scan technique and contrast medium administration CT was performed using a 320-MDCT (Canon Aquilion PRIME CT scanner, Toshiba Medical Systems, Otawara, Japan). Prior to the initiation of the diagnostic CT scan, a series of low-radiation sequential axial pre-diagnostic CT images were acquired at a fixed level of the PA bifurcation while the test bolus of contrast media was being injected at 3ml/s with 10ml amount. This pre-diagnostic CT scan was applied for all patients. The scan parameters were as the following: 5 mm section thickness, 100kVp, automatic exposure control of current (mA), and 0.5 second rotation time. Following the completion of the pre-diagnostic CT scan, the patient was given a breath-hold instruction for the standard diagnostic CT using either TB or BT method. Scanning was performed in the cranial-caudal direction. All cases were administrated contrast medium with 300 mg iodine (I)/ml Omnipaque using a dual-power injector (MEDRAD Stellant CT injector). All cases were administrated 10ml of contrast medium for establishment of pre-diagnostic CT images. The total volume of contrast media was fixed at 70 or 80 ml in accordance with the designed injection protocols. For all cases, a right upper limb antecubital venous access was achieved using an 18 or 20 Gauge venous catheter. The biphasic contrast injection protocol was conducted with two connected phases of contrast medium injection immediately followed by saline flush. The investigators performed the saline flush at the rate of 3ml/s following the administration of the contrast medium with different amounts (20 or 30 ml) to achieve 100ml fluid injection in total. Estimation of radiation dose The dose length product (DLP) of all cases was recorded. Effective radiation dose was estimated by multiplying the DLP by a conversion factor. The effective radiation dose correlates with different parts of the body which varies the radiation sensitivity of the tissue. Our study applied conversion factor of 0.014 mSV/(mGy x cm) based on the region of chest and abdomen. Statistical analysis: A one-way analysis of variance (ANOVA) test was used for comparing the data of different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. All statistical analysis was performed using software (SPSS version 25.0, IBM Corp.). conditions module condition list condition Enhancement of Aorta and Pulmonary Artery Radiation Exposure keyword list keyword computed tomography angiography aortic dissection pulmonary embolism contrast media design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Diagnostic design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 101 enrollment type Actual arms interventions module arm group list arm group arm group label test bolus(TB) I arm group type Experimental arm group description We use the TB method with biphasic injection, followed by the saline flush. Initially, we inject the 10 ml of test contrast media with a velocity of 3ml/s and apply the ROI at the bifurcation of PA and descending aorta at the same level. The dynamic curve demonstrates the time to peak enhancement of P second and A second. The first phase of contrast media injection uses a velocity of 2ml/s and the volume of contrast is measured as 2ml/s multiply (A-P) second. The second phase of contrast media injection uses a velocity of 3ml/s and the volume of contrast media is 70ml minus the amount of first phase injection. The total volume of the contrast media is 80ml, including the 10ml for pre-diagnostic test bolus images. We performed the saline flush following the administration of the contrast media with 20 ml normal saline. The start time of the diagnostic scan is at the A second. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods arm group label test bolus(TB) II arm group type Experimental arm group description This group is similar to the TB I. However, we use the lesser contrast media in the second phase of injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus the amount of first phase injection. The total volume of the contrast media is 70 ml, also including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The start time of the diagnostic scan is at the A second as well. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods arm group label bolus-tracking(BT) I arm group type Experimental arm group description Initially, 10ml of test contrast media was administrated but no calculation was performed for these pre-diagnostic test bolus images in this group. Unlike the TB method, we use 10 seconds as the fixed interval of (A-P) in this group. The first phase of contrast media injection uses a velocity of 2ml/s and thus the volume of contrast is 20ml. The second phase of contrast media injection is administered with a velocity of 3ml/s and the volume of the contrast media is 70ml minus 20ml. The total volume of the contrast media is 80 ml. The following saline flush uses 20 ml of normal saline. The tracking scan started after contrast injection was initiated for 15 seconds. The ROI is placed in the descending aorta at the same level of PA bifurcation and the diagnostic CT scan is triggered when the density in the ROI achieves the baseline density plus 150HU. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods arm group label bolus-tracking(BT) II arm group type Experimental arm group description This group is similar to the BT I. The first phase of injection is the same as the BT I group. We use lesser contrast media in the second phase of contrast injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus 20ml. The total volume of the contrast media is 70 ml, including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The protocol for triggering diagnostic CT scan is the same as that in BT I. arm group intervention list arm group intervention name Diagnostic Test: Different contrast media injection methods intervention list intervention intervention type Diagnostic Test intervention name Different contrast media injection methods intervention description Different contrast media injection methods intervention arm group label list intervention arm group label bolus-tracking(BT) I bolus-tracking(BT) II test bolus(TB) I test bolus(TB) II outcomes module primary outcome list primary outcome primary outcome measure Enhancement of the aorta primary outcome description The enhancement of the aorta at the level of pulmonary artery bifurcation will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows better enhancement of the aorta. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average enhancement of the aorta among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. primary outcome time frame Through study completion, an average of 1 year primary outcome measure Enhancement of the pulmonary artery primary outcome description The enhancement of the pulmonary artery at the level of pulmonary artery bifurcation will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows better enhancement of the pulmonary artery. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average enhancement of the pulmonary artery among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. primary outcome time frame Through study completion, an average of 1 year secondary outcome list secondary outcome secondary outcome measure Radiation dose secondary outcome description The overall radiation dose for the complete CT angiography will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows less radiation exposure. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average radiation dose among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant. secondary outcome time frame Through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria: All cases with suspicion of pulmonary embolism or aortic dissection referred for CT angiography in our hospital Exclusion Criteria: Those cases with known allergic history, poor renal function (creatinine level>1.5 mg/dl), pregnant women or age less than twenty years old were excluded from the study. healthy volunteers No gender All minimum age 20 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Chun Chao Huang, MD overall official affiliation Mackay Memorial Hospital overall official role Principal Investigator location list location location facility Mackay Memorial Hospital location city Taipei location zip 10449 location country Taiwan references module reference list reference reference p m i d 34717585 reference type derived reference citation Hsieh CC, Zeng AB, Chen CH, Jhou ZY, Wang CH, Yang YL, Hsieh FC, Lin JK, Yeh JY, Huang CC. A practical biphasic contrast media injection protocol strongly enhances the aorta and pulmonary artery simultaneously using a single CT angiography scan. BMC Med Imaging. 2021 Oct 30;21(1):160. doi: 10.1186/s12880-021-00691-4. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M13661 condition browse leaf name Pulmonary Embolism condition browse leaf relevance low condition browse leaf id M6936 condition browse leaf name Embolism condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04832633

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full study rank 61879 study protocol section identification module n c t id NCT04830735 org study id info org study id 0S-20-5 secondary id info list secondary id info secondary id NCI-2020-04367 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) secondary id 0S-20-5 secondary id type Other Identifier secondary id domain USC / Norris Comprehensive Cancer Center secondary id P30CA014089 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/P30CA014089 organization org full name University of Southern California org class OTHER brief title Dasatinib for the Treatment of Moderate and Severe COVID-19 official title A Phase II Randomized Double-Blind Trial of Dasatinib Modulation of Hyperinflammation in Moderate and Severe Patients With COVID-19 status module status verified date August 2022 overall status Withdrawn why stopped PI decided not to pursue study expanded access info has expanded access No start date struct start date August 5, 2022 start date type Actual primary completion date struct primary completion date December 15, 2023 primary completion date type Anticipated completion date struct completion date December 15, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 5, 2022 last update post date struct last update post date August 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Southern California lead sponsor class OTHER collaborator list collaborator collaborator name National Cancer Institute (NCI) collaborator class NIH oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary This phase II trial investigates how well dasatinib works in treating patients with moderate and severe COVID-19. Dasatinib is a drug used to treat chronic leukemia which may help reduce the strong inflammation caused by COVID-19 that can damage the lungs or other organs. detailed description PRIMARY OBJECTIVES: I. To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying. II. To determine 1 month survival. SECONDARY OBJECTIVES: I. To estimate the safety and tolerability of dasatinib anhydrous (dasatinib) in the setting of COVID-19 infection. II. To determine change in C-reactive protein (CRP) levels after starting therapy. III. To document activity of dasatinib in lessening cytokine release syndrome (CRS) and sequential organ failure assessment (SOFA) score. EXPLORATORY OBJECTIVES: I. Interleukin-6 /cytokine assay weekly on treatment protocol. II. Ferritin levels at study entry and every (q) 2 days on treatment protocol. III. D-dimer levels at study entry and q 2 days on treatment protocol. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dasatinib anhydrous orally (PO) once daily (QD) for 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days. conditions module condition list condition Symptomatic COVID-19 Infection Laboratory-Confirmed design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Arm I (dasatinib anhydrous) arm group type Experimental arm group description Patients receive dasatinib anhydrous PO QD for 14 days in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Drug: Dasatinib Anhydrous arm group label Arm II (placebo administration) arm group type Placebo Comparator arm group description Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Drug: Placebo Administration intervention list intervention intervention type Drug intervention name Dasatinib Anhydrous intervention description Given PO intervention arm group label list intervention arm group label Arm I (dasatinib anhydrous) intervention type Drug intervention name Placebo Administration intervention description Given PO intervention arm group label list intervention arm group label Arm II (placebo administration) outcomes module primary outcome list primary outcome primary outcome measure Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying primary outcome description Outcome reported as the number of patients requiring mechanical ventilation, requiring tocilizumab or dying. primary outcome time frame Up to 28 days secondary outcome list secondary outcome secondary outcome measure Absolute lymphocyte count secondary outcome description Assessment via standard blood chemistry and metabolic panel secondary outcome time frame Baseline, during treatment (day 1-14) up to 1 month secondary outcome measure CRP (C-reactive protein) level secondary outcome description Assessment via standard blood chemistry and metabolic panel secondary outcome time frame Baseline, during treatment (day 1-14) up to 1 month secondary outcome measure Change of the SOFA (Sequential Organ Failure Assessment) secondary outcome description The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine secondary outcome time frame Baseline, during treatment (day 1-14) up to 1 month secondary outcome measure Number of participants with treatment-related side effects secondary outcome description Outcome reported as the number of adverse events and serious adverse events that occurred. secondary outcome time frame During treatment and up to 30 days after the last treatment dose secondary outcome measure Radiological response secondary outcome description Will be evaluated by chest x-ray or pulmonary computed tomography (CT) secondary outcome time frame Baseline (optional), after seven days and if clinically indicated(up to 1 month) secondary outcome measure Duration of hospitalization secondary outcome description Outcome reported as the duration of hospitalization of patients secondary outcome time frame From baseline up to patient's discharge (up to 1 month) secondary outcome measure Remission of respiratory symptoms secondary outcome description Time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation. secondary outcome time frame Up to 1 month secondary outcome measure Remission of respiratory symptoms secondary outcome description Time to definitive extubation calculated from intubation (any time occurred) to extubation in days. secondary outcome time frame Up to 1 month secondary outcome measure Remission of respiratory symptoms secondary outcome description Time to independence from oxygen therapy in days. secondary outcome time frame Up to 1 month eligibility module eligibility criteria Inclusion Criteria: Patients must have laboratory test proven COVID19 and symptomatic disease requiring hospitalization: virological diagnosis of Sars-CoV2 infection (polymerase chain reaction [PCR]) within 14 days Able to sign informed consent for participation in the study Subject is hospitalized with one or more of the following: Moderate disease: peripheral capillary oxygen saturation (SpO2) >= 93% on room air with one of the following risk factors for developing severe disease: age >= 60 years, history of hypertension, diabetes mellitus, cardiac disease, chronic lung disease, obesity (calculated body mass index [BMI] >= 30 kg/m^2), and cardiovascular disease, clinical and/or radiological evidence of chest involvement, CRP > 2X upper limit of normal, doubling of CRP in 24 hours where chest findings and CRP elevation not explained by other underlying disease. After the first interim analysis, we may allow enrollment of severe disease COVID infected patients if safety and efficacy analysis appears favorable: Severe disease: Respiratory rate >= 30 breaths/ minute (min) SpO2 < 93% while breathing room air Partial pressure of oxygen measurement (PaO2)/fraction of inspired oxygen (FiO2) =< 300 mmHg Absolute neutrophil count (ANC) > 1000 (baseline blood counts) Platelets > 50,000 / mmc (baseline blood counts) Alanine aminotransferase/aspartate aminotransferase (ALT/AST) < 5 times the upper limit of the normality Total bilirubin < 3 x institutional upper limit of normal (IULN) Creatinine < 2.5 times the upper limit of the normality Azithromycin allowed but if on both drugs patient should be on constant cardiovascular (CV) monitoring Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessment/procedures being conducted Subject is willing and able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Pleural effusion > grade 2 evident on chest x-ray (CXR) or chest computed tomography (CT) Intubation/mechanical ventilation Known hypersensitivity to dasatinib Patient being treated with immunomodulators or anti-rejection drugs Known active infections or other clinical condition that contraindicate dasatinib and cannot be treated or solved according to the judgement of the clinician ALT/AST > 5 times the upper limit of the normality Total bilirubin > 3 x IULN Neutrophils < 1000 / mmc unless; platelets < 50,000 / mmc healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Ann Mohrbacher, MD overall official affiliation University of Southern California overall official role Principal Investigator location list location location facility USC / Norris Comprehensive Cancer Center location city Los Angeles location state California location zip 90033 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000007757 condition mesh term Laboratory Infection condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000009784 condition ancestor term Occupational Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M9929 condition browse leaf name Laboratory Infection condition browse leaf as found Infection Laboratory- condition browse leaf relevance high condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M11871 condition browse leaf name Occupational Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC24 condition browse branch name Occupational Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000069439 intervention mesh term Dasatinib intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M410 intervention browse leaf name Dasatinib intervention browse leaf as found Observation intervention browse leaf relevance high intervention browse leaf id M24973 intervention browse leaf name Protein Kinase Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04830735

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full study rank 61892 study protocol section identification module n c t id NCT04830553 org study id info org study id SONIFY organization org full name University Medicine Greifswald org class OTHER brief title Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial official title Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date March 26, 2021 start date type Actual primary completion date struct primary completion date April 1, 2022 primary completion date type Actual completion date struct completion date October 1, 2022 completion date type Actual study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 27, 2022 last update post date struct last update post date October 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Medicine Greifswald lead sponsor class OTHER collaborator list collaborator collaborator name Humboldt-Universität zu Berlin collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of immediate sound feedback for physical distance and touch between individuals as a potential means to complement existing methods in couple therapy. The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial. detailed description According to early 20th century psychoanalysis, the "unsaid" becomes apparent in the relationship between patient and therapist, as well as in metaphors and symbols revealed through unintended utterances, imaginative techniques, and dreams. To convey emotions and thoughts, this method relies on the use of spoken language. Likewise, spoken language remains central to the practice of psychotherapy in subsequent decades, as clinicians and researchers sought to translate and transform major claims of psychoanalysis into newer paradigms, the most prominent of them being cognitive-behavioral, client-centered and family-systems psychotherapy. Inspired by somatic psychology and neuroscience evidence, more recent approaches focus on body and movement to target the "unsaid" beyond spoken language. Funded by the German Federal Ministry of Education and Research, the "Sentire" project attempts to provide immediate sound feedback for physical distance and touch between individuals (www.sentire.me). The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of "Sentire" as a potential means to complement existing methods in couple therapy. The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial. conditions module condition list condition Depression design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label Music-based couple therapy. arm group type Experimental arm group description Each couple will receive five treatment sessions, including established methods from client-centered and family-systems psychotherapy as well as "Sentire," a technological approach providing immediate sound feedback for physical distance and touch. Duration of the treatment phase: five weeks. arm group intervention list arm group intervention name Behavioral: Music-based couple therapy. arm group label Waiting list. arm group type No Intervention arm group description Each couple will go through an initial waiting period before the treatment phase. Duration of the waiting period: five weeks. intervention list intervention intervention type Behavioral intervention name Music-based couple therapy. intervention description Each couple will receive five treatment sessions, including established methods from client-centered and family-systems psychotherapy as well as "Sentire," a technological approach providing immediate sound feedback for physical distance and touch. Duration of the treatment phase: five weeks. intervention arm group label list intervention arm group label Music-based couple therapy. outcomes module primary outcome list primary outcome primary outcome measure Change in Couples Satisfaction Index, CSI-32. primary outcome description This self-report questionnaire was conceived to quantify various aspects of a person's satisfaction in a couple relationship on a Likert scale ranging from 0 (very low satisfaction) to 6 (very high satisfaction). primary outcome time frame Change on the CSI-32, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up. secondary outcome list secondary outcome secondary outcome measure Change in Beck's Depression Inventory, BDI-II. secondary outcome description This self-report measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability. secondary outcome time frame Change on the BDI-II, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up. secondary outcome measure Change in ICD-10 Symptom Rating, ISR. secondary outcome description This self-report measure based on the ICD-10 criteria of mental disorders serves as a screening instrument for psychological syndromes. secondary outcome time frame Change on the ISR, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up. other outcome list other outcome other outcome measure Childhood Trauma Questionnaire, CTQ. other outcome description This self-report measure serves as a covariate to determine the relationship between childhood trauma and present issues in a couple relationship. other outcome time frame Beginning of the treatment phase. (Note: This outcome measure is only assessed once prior to the treatment phase.) other outcome measure Positive and Negative Affect Schedule, PANAS. other outcome description This self-report measure serves as an indicator of change in emotional arousal within each couple therapy session. other outcome time frame Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting). other outcome measure Standortbestimmung. other outcome description This self-report measure serves as an indicator of subjective benefit from the treatment experienced within each couple therapy session. other outcome time frame Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting). other outcome measure Working Alliance Inventory. other outcome description This self-report measure serves as an indicator of therapeutic relationship quality. other outcome time frame 12-month follow-up. (Note: This outcome measure is only assessed once at the 12-month follow-up.) eligibility module eligibility criteria Inclusion Criteria: In couple relationship for at least six months; Living in shared household or close daily contact. Exclusion Criteria: Currently acute episode of any mental disorder. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Benjamin Stahl, PhD overall official affiliation University Medicine of Greifswald overall official role Principal Investigator location list location location facility Humboldt-Universität zu Berlin location city Berlin location zip 10117 location country Germany references module see also link list see also link see also link label Study website. see also link u r l https://www.musikundmedien.hu-berlin.de/de/musikwissenschaft/systematik/projekte/sentire-soziale-interaktion-durch-klang-feedback/dr-benjamin-stahl i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions

NCT04830553

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full study rank 61461 study protocol section identification module n c t id NCT04836169 org study id info org study id InCaveoDanielandDaniel2021 organization org full name InCaveo org class INDUSTRY brief title Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy official title Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy to Lower Pain Catastrophizing Scores acronym P1RESPECT status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date October 2021 start date type Anticipated primary completion date struct primary completion date April 2022 primary completion date type Anticipated completion date struct completion date May 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name InCaveo lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes is u s export No description module brief summary The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo's EOA system with integrated mobile CBT but without tapering to improve The Pain Catastrophizing Scale (PCS) scores, and secondarily scores on the VNS pain scale, the Tampa Scale of Kinesiophobia (TSK), and patient satisfaction scores in the subacute period (defined as 2 weeks to 3 months post TKR). Statistically significant positive results on the Pain Catastrophizing Scale (PCS) will trigger phase 2. Phase 1 will also inform the detailed conditions and patient management algorithms for Phase II. detailed description The InCaveo End Opioid Addiction (EOA) System is an integrated pain management therapeutic and opioid tapering system providing alternate treatment options via self-service Cognitive Behavior Therapy (CBT) built into a mobile software app, patient medication usage, and tracking of patient PROs. It is designed to be used alongside Usual Standard of Care using Pill Bottles or to simplify, Usual Care with Pill Bottles (UCPB) treatment practices. The InCaveo EOA System is designed to improve a set of patient outcome measures, primarily Pain Catastrophizing Scale (PCS) and secondarily the Visual Numeric Pain (VNS), Kinesiophobia (TSK) and satisfaction scores while facilitating the ability of patients to taper off their pain medication faster than through the use of USPB in the management of post-operative pain. In order to reduce confounding variables, the study will focus on pain management following a single surgical procedure: Total Knee Replacement (TKR) surgery. conditions module condition list condition Pain, Postoperative Analgesics, Opioid keyword list keyword pain design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized parallel-group design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label InCaveo EOA System arm group type Experimental arm group description InCaveo EOA System (including integrated CBT but without tapering) group arm group intervention list arm group intervention name Device: InCaveo's EOA system with integrated mobile CBT arm group label Control Group-usual care with pill bottles arm group type No Intervention arm group description UCPB group-usual care with pill bottles intervention list intervention intervention type Device intervention name InCaveo's EOA system with integrated mobile CBT intervention description integrated pain management therapeutic and tapering system including a software apt that manages and tracks patient-reported outcomes, including pain levels, medication use, quality of life intervention arm group label list intervention arm group label InCaveo EOA System outcomes module primary outcome list primary outcome primary outcome measure Pain Catastrophizing Scale (PCS) primary outcome description A measure of the extent of catastrophizing primary outcome time frame 60 days eligibility module eligibility criteria Inclusion Criteria: Patient has a Pain Catastrophizing Score >16 55 years of age and older. English speaking. Has a smartphone (iPhone). Able to swallow oral medications. No continuous daily opioid as defined as more than 15 days in the 30 days before surgery. Undergoing TKR surgery. Patients who are willing and able to comply with scheduled visits and study procedures. Exclusion Criteria: Diagnosed with Opioid Use Disorder (OUD). Actively using illicit drugs. Allergy to opioids Older than 85 years healthy volunteers No gender All minimum age 55 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Cynthia Harris, BS central contact role Contact central contact phone 8326776747 central contact e mail cindy@clinregconsult.com central contact name Michael A Daniel, MBA central contact role Contact central contact phone 4154070223 central contact e mail madaniel@clinregconsult.com overall official list overall official overall official name Hoyman Hong, MD overall official affiliation InCaveo overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Pain, Postoperative condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases

NCT04836169

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full study rank 61934 study protocol section identification module n c t id NCT04830007 org study id info org study id NOCONTRAIVG secondary id info list secondary id info secondary id 2021-A00298-33 secondary id type Other Identifier secondary id domain ID-RCB organization org full name Centre Hospitalier Intercommunal Creteil org class OTHER brief title Factors Associated With the Absence of Contraception at Women Seeking a Voluntary Termination of Pregnancy official title Factors Associated With the Absence of Contraception at the Time of Unplaned Pregnancy Among Women Seeking a Voluntary Termination of Pregnancy status module status verified date January 2022 overall status Suspended why stopped Investigator coordinatoor left the site and the trial expanded access info has expanded access No start date struct start date November 2022 start date type Anticipated primary completion date struct primary completion date November 2022 primary completion date type Anticipated completion date struct completion date November 2022 completion date type Anticipated study first submit date February 11, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date January 31, 2022 last update post date struct last update post date February 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Centre Hospitalier Intercommunal Creteil lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The study will be offered to all women who are consultant for an abortion plan are seen in consultation at the orthogeny center where the study will be conducted. Of these 700 women, about 10% will not agree to participate in the study and 10% will not meet the inclusion criteria. Thus it's plane to include 560 patients in the study. detailed description In 1967, the Neuwirth law allowed women to control their fertility by establishing the right to contraception as a principle. Since then, they have continued to take ownership of the various contraceptive methods, which are regularly renewed. Contraceptive coverage is important in France as it is estimated that 92% of women of childbearing age use a contraceptive method. The pill remains the most widely used method of contraception (36.5%), ahead of the intrauterine device (25.6%) condoms (15.5%) Several laws have been introduced from 1967 to today to facilitate access to sexual health care: screening for sexually transmitted infections, free provision of emergency contraception to minors, non-prescription delivery of emergency contraception, free consultation at a family planning and education center, voluntary termination of pregnancy 100%, reimbursement of condoms by social security. Despite all the measures put in place, it is now clear that the number of unplanted pregnancies is decreasing slightly and the number of abortion has remained stable since 2001. According to the latest literature data, several socio-demographic factors appear to play a role in the rate of use of voluntary termination of pregnancy., including age, socio-cultural level, marital and economic status and ethnic origin. All the more striking, it appears that while voluntary termination of pregnancy are mainly related to contraceptive failures, one third of them involve women who do not have contraception. According to the latest Ined survey, and in accordance with other data from the literature, the factors associated with the absence of contraceptive use are multiple: ignorance about fertility, family or cultural context, cost of contraceptive methods or lack of information related to them. While these studies have looked at the reasons given by women for the lack of contraception, with little data on the characteristics of these women, particularly socio-demographics and their reproductive history and in particular in the context of unwanted pregnancy. This finding leads us to question the factors associated with the absence of contraception among women in demand of a voluntary termination of pregnancy. conditions module condition list condition Pregnancy, Unwanted keyword list keyword Contraception Abortion Unplanned pregnancy Unintended pregnancy design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 560 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Association between absence of contraception and socio-demographic factors, characteristics of pregnancy abortion and medical follow-up primary outcome description Statistically significant association between the absence of contraception in patients consulting for a voluntary termination of pregnancy and socio-demographic factors, characteristics of voluntary termination of pregnancy abortion and characteristics related to medical follow-up primary outcome time frame 1 hour secondary outcome list secondary outcome secondary outcome measure Prescription and dispensing of contraception secondary outcome description Prevalence of patients informed about the prescription and dispensing of contraception including emergency contraception secondary outcome time frame 1 hour secondary outcome measure Existence of family planning centers secondary outcome description Prevalence of patients informed about the existence of family planning centers secondary outcome time frame 1 hour secondary outcome measure Emergency contraception secondary outcome description Prevalence of women who have used emergency contraception secondary outcome time frame 1 hour secondary outcome measure Price and reimbursement of condoms secondary outcome description Prevalence of women informed about the price and reimbursement of condoms secondary outcome time frame 1 hour secondary outcome measure Knowledge of conception secondary outcome description Estimate the percentage of women who thought they could get pregnant at the time of the intercourse that led to this pregnancy secondary outcome time frame 1 hour secondary outcome measure Fertile window secondary outcome description Prevalence of women who use a method to track their fertile window secondary outcome time frame 1 hour secondary outcome measure Affection of fertility secondary outcome description Estimate the percentage of women who think that contraception can affect their fertility secondary outcome time frame 1 hour eligibility module eligibility criteria Inclusion Criteria: woman of 18 years of age or older; Being French-speaking; request for a medical or instrumental voluntary termination of pregnancy No opposition to participation in the protocol Be affiliated with a social security plan Exclusion Criteria: desired pregnancy healthy volunteers No gender Female gender based Yes gender description Only pregant women minimum age 18 Years std age list std age Adult Older Adult study population Protocol proposed to woman who wanted a voluntary termination of pregnancy sampling method Non-Probability Sample contacts locations module location list location location facility CHI Villeneuve St Georges location city Villeneuve-Saint-Georges location country France derived section misc info module version holder December 02, 2022

NCT04830007

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full study rank 61774 study protocol section identification module n c t id NCT04832100 org study id info org study id KMUHIRB-G(I)-20170012 organization org full name Kaohsiung Medical University Chung-Ho Memorial Hospital org class OTHER brief title Bio-significance of LPC16:0 in Fibromyalgia official title A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 1, 2017 start date type Actual primary completion date struct primary completion date July 31, 2025 primary completion date type Anticipated completion date struct completion date July 31, 2027 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 16, 2022 last update post date struct last update post date August 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Kaohsiung Medical University Chung-Ho Memorial Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Fibromyalgia (FM) is a very common but mysterious pain disorder characterized by chronic widespread muscular pain. Fatigue, anxiety and depression are common comorbidities. The syndrome is commonly associated with several symptoms, including fatigue, sleeping disturbance, cognitive impairment, and comorbid pain syndrome, especially irritable bowel symptoms and temporomandibular disease. Anxiety and depression are common psychiatric co-morbidies. Daily stress is believed to trigger or aggravate pain conditions. These symptoms can markedly affect patients' quality of life, and even lead to disability. So far, the etiology and pathogenesis are largely unknown, and diagnostic biomarkers and curative treatment remain to be developed. Recent technological advances enable scientists to explore mechanisms by genetic, transcriptomic, proteomic, and metabolomic researches. However, no definitive result has been concluded for clinical practice so far. In this study, the investigators use tailored questionnaires to evaluate fibromyalgia and associated symptoms, including numeric rating scale for soreness, widespread soreness index, Fibromyalgia impact questionnaire, Hospital Anxiety and Depression Scale, and perceived stress scale. The investigators also use metabolomics and lipidomic approach to probe the potential pathophysiology of fibromyalgia. In our prior translation research (PMID: 32907805), the investigators found that excessive LPC16:0 resulting from lipid oxidization inflicts psychological stress-induced chronic non-inflammatory pain via activating ASIC3. In this content, our prior translational research identified a potential nociceptive ligand that causes fibromyalgia symptoms, which is likely to function as biomarkers for diagnosis or disease monitor. In the current clinical investigation, the investigators aim to reversely translate the novel findings in animal studies and validate the bio-significance of LPC16:0 for fibromyalgia with clinical approaches. conditions module condition list condition Fibromyalgia, Primary Pain Soreness, Muscle Oxidative Stress Metabolomics Lipidomics keyword list keyword lysophosphotidylcholine fibromyalgia pain soreness metabolomics design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description collection of blood samples for metabolomic and genetic investigations enrollment info enrollment count 400 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with primary fibromyalgia arm group description Adults with complaints of chronic widespread pain at the outpatient department of KMUH were consecutively enrolled over a 5-year period from July 2017 to June 2022. Participants were interviewed by experienced neurologists , and those who fulfilled the 2011 American College of Rheumatology (ACR) criteria for FM were recruited . arm group intervention list arm group intervention name Drug: Pregabalin 150mg, imipramine 25mg arm group label Healthy controls arm group description Age- and sex-matched subjects without pain and soreness were also prospectively recruited as healthy controls. intervention list intervention intervention type Drug intervention name Pregabalin 150mg, imipramine 25mg intervention description Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then. intervention arm group label list intervention arm group label Patients with primary fibromyalgia outcomes module primary outcome list primary outcome primary outcome measure Questionnaire: Numeric rating scale (NRS) for pain and soreness primary outcome description assessment of pain and soreness severity. Score: 0(no symptom) ~10 (worst symptom) primary outcome time frame Changes from baseline NRS at 2 weeks are assessed primary outcome measure Questionnaire: Numeric rating scale (NRS) for pain and soreness primary outcome description assessment of pain and soreness severity. Score: 0(no symptom) ~10 (worst symptom) primary outcome time frame Changes from baseline NRS at 4 weeks are assessed primary outcome measure Questionnaire: widespread pain index and widespread soreness index primary outcome description assessment of pain and soreness diffuseness. Score: 0(no symptom) ~19 (mostly diffused symptom) primary outcome time frame Change from baseline widespread index at 2 weeks are assessed primary outcome measure Questionnaire: widespread pain index and widespread soreness index primary outcome description assessment of pain and soreness diffuseness. Score: 0(no symptom) ~19 (mostly diffused symptom) primary outcome time frame Change from baseline widespread index at 4 weeks are assessed primary outcome measure Questionnaire: Fibromyalgia impact questionnaire (FIQR) primary outcome description assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) ~100 (worst symptom) primary outcome time frame Change from baseline FIQR at 2 weeks are assessed primary outcome measure Questionnaire: Fibromyalgia impact questionnaire (FIQR) primary outcome description assessment of fibromyalgia impacts and disease severity. Score: 0(no symptom) ~100 (worst symptom) primary outcome time frame Change from baseline FIQR at 4 weeks are assessed primary outcome measure Questionnaire: Hospital Anxiety and Depression Scale (HADS) primary outcome description assessment of psychological distress. Score: 0 (no symptom) ~42 (worst symptom) primary outcome time frame Change from baseline HADS at 2 weeks are assessed primary outcome measure Questionnaire: Hospital Anxiety and Depression Scale (HADS) primary outcome description assessment of psychological distress. Score: 0 (no symptom) ~42 (worst symptom) primary outcome time frame Change from baseline HADS at 4 weeks are assessed primary outcome measure Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) primary outcome description assessment of sleep quality. Score: 0 (no symptom) ~21 (worst sleep quality) primary outcome time frame Change from baseline PSQI at 2 weeks are assessed primary outcome measure Questionnaire: The Pittsburgh Sleep Quality Index (PSQI) primary outcome description assessment of sleep quality. Score: 0 (no symptom) ~21 (worst sleep quality) primary outcome time frame Change from baseline PSQI at 4 weeks are assessed primary outcome measure Questionnaire: Perceived stress scale (PSS) primary outcome description assessment of perceived stress loading. Score: 0 (no stress) ~40 (highest stressed level) primary outcome time frame Change from baseline PSS at 2 weeks are assessed primary outcome measure Questionnaire: Perceived stress scale (PSS) primary outcome description assessment of perceived stress loading. Score: 0 (no stress) ~40 (highest stressed level) primary outcome time frame Change from baseline PSS at 4 weeks are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 3 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 3 months are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 6 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 6 months are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 9 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 9 months are assessed primary outcome measure Metabolomics investigation primary outcome description Laboratory investigation of metabolomic expression, including lactate, creatine, malondialdehyde, protein carbonyls and amino acids. primary outcome time frame Change from baseline metabolomics at 12 months are assessed primary outcome measure Lipidomics investigation primary outcome description Laboratory investigation of lipidomic expression, including phosphocholine, sphingomyelin, lysophosphatidylcholine and ceramide. primary outcome time frame Change from baseline metabolomics at 12 months are assessed eligibility module eligibility criteria Inclusion Criteria: 1. Clinical diagnosis of fibromyalgia Exclusion Criteria: Systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis), Systemic use of corticosteroids, Pregnancy, Chronic diseases under poor control Malignancies. gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult study population Patient group: participants with primary fibromyalgia Control group: healthy controls sampling method Probability Sample contacts locations module location list location location facility Kaohsiung Medical University Hospital location status Recruiting location city Kaohsiung location zip 80756 location country Taiwan location contact list location contact location contact name Chih-Hsien Hung location contact role Contact location contact phone 073121101 location contact phone ext 5851 location contact e mail jasonhung0701@hotmail.com location contact name Chih-Hsien Hung, MD, PhD location contact role Principal Investigator i p d sharing statement module i p d sharing Undecided i p d sharing description Raw and analyzed data will be shared upon written request to the corresponding author from any qualified investigator. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005356 condition mesh term Fibromyalgia condition mesh id D000009209 condition mesh term Myofascial Pain Syndromes condition mesh id D000063806 condition mesh term Myalgia condition ancestor list condition ancestor condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000059352 condition ancestor term Musculoskeletal Pain condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M7638 condition browse leaf name Fibromyalgia condition browse leaf as found Fibromyalgia condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M11313 condition browse leaf name Myofascial Pain Syndromes condition browse leaf as found Fibromyalgia condition browse leaf relevance high condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M29309 condition browse leaf name Myalgia condition browse leaf as found Soreness, Muscle condition browse leaf relevance high condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M28597 condition browse leaf name Musculoskeletal Pain condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000069583 intervention mesh term Pregabalin intervention mesh id D000007099 intervention mesh term Imipramine intervention ancestor list intervention ancestor intervention ancestor id D000000700 intervention ancestor term Analgesics intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000000927 intervention ancestor term Anticonvulsants intervention ancestor id D000002121 intervention ancestor term Calcium Channel Blockers intervention ancestor id D000049990 intervention ancestor term Membrane Transport Modulators intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000077264 intervention ancestor term Calcium-Regulating Hormones and Agents intervention ancestor id D000014151 intervention ancestor term Anti-Anxiety Agents intervention ancestor id D000014149 intervention ancestor term Tranquilizing Agents intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000011619 intervention ancestor term Psychotropic Drugs intervention ancestor id D000000929 intervention ancestor term Antidepressive Agents, Tricyclic intervention ancestor id D000000928 intervention ancestor term Antidepressive Agents intervention ancestor id D000018759 intervention ancestor term Adrenergic Uptake Inhibitors intervention ancestor id D000014179 intervention ancestor term Neurotransmitter Uptake Inhibitors intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M476 intervention browse leaf name Pregabalin intervention browse leaf as found Repair intervention browse leaf relevance high intervention browse leaf id M9299 intervention browse leaf name Imipramine intervention browse leaf as found Ph+ intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M3398 intervention browse leaf name Anticonvulsants intervention browse leaf relevance low intervention browse leaf id M4533 intervention browse leaf name Calcium intervention browse leaf relevance low intervention browse leaf id M4550 intervention browse leaf name Calcium, Dietary intervention browse leaf relevance low intervention browse leaf id M4536 intervention browse leaf name Calcium Channel Blockers intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M16057 intervention browse leaf name Anti-Anxiety Agents intervention browse leaf relevance low intervention browse leaf id M13626 intervention browse leaf name Psychotropic Drugs intervention browse leaf relevance low intervention browse leaf id M3399 intervention browse leaf name Antidepressive Agents intervention browse leaf relevance low intervention browse leaf id M3400 intervention browse leaf name Antidepressive Agents, Tricyclic intervention browse leaf relevance low intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ChanBlk intervention browse branch name Channel Blockers intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev AntiConv intervention browse branch name Anticonvulsants intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev PsychDr intervention browse branch name Psychotropic Drugs intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev BDCA intervention browse branch name Bone Density Conservation Agents

NCT04832100

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full study rank 61307 study protocol section identification module n c t id NCT04838171 org study id info org study id QEL-RP-001 organization org full name Quell Therapeutics Limited org class INDUSTRY brief title Prospective Study of White Blood Cells official title Investigation of White Blood Cells to Support the Development of Engineered Regulatory T Cell (Treg) Therapies status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 24, 2021 start date type Actual primary completion date struct primary completion date December 2024 primary completion date type Anticipated completion date struct completion date December 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 7, 2022 last update post date struct last update post date September 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Quell Therapeutics Limited lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to investigate white blood cells from volunteering donors to support the development of engineered regulatory T cell therapies. conditions module condition list condition Autoimmune Diseases Inflammation Rejection; Transplant, Liver design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 10 enrollment type Anticipated arms interventions module arm group list arm group arm group label Specimen collection to support development of engineering Treg arm group intervention list arm group intervention name Other: White blood cell and blood collection intervention list intervention intervention type Other intervention name White blood cell and blood collection intervention description Mononucleocytes will be collected via apheresis intervention arm group label list intervention arm group label Specimen collection to support development of engineering Treg outcomes module primary outcome list primary outcome primary outcome measure WBC characterisation to support the development of engineered regulatory T cells. primary outcome description number, type and function of white blood cells in healthy controls and in patients primary outcome time frame 5 years eligibility module eligibility criteria No additional inclusion/ exclusion criteria will be applied by Quell other than those specified by the consenting institutions. healthy volunteers No gender All std age list std age Child Adult Older Adult study population Volunteers willing to provide white blood cells for research. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name David Collin central contact role Contact central contact phone +4(0)2070969012 central contact e mail contact@quell-tx.com location list location location facility Quell Investigator Site 01 location status Recruiting location city London location country United Kingdom i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001327 condition mesh term Autoimmune Diseases condition mesh id D000007249 condition mesh term Inflammation condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M9445 condition browse leaf name Inflammation condition browse leaf as found Inflammation condition browse leaf relevance high condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf as found Autoimmune Diseases condition browse leaf relevance high condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases

NCT04838171

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full study rank 61204 study protocol section identification module n c t id NCT04839510 org study id info org study id MRG002-006 organization org full name Shanghai Miracogen Inc. org class INDUSTRY brief title A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer official title An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 20, 2021 start date type Actual primary completion date struct primary completion date June 2022 primary completion date type Anticipated completion date struct completion date September 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date December 13, 2021 last update post date struct last update post date December 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Shanghai Miracogen Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive unresectable locally advanced or metastatic urothelium cancer. detailed description The study consists of two stages. In Phase IIa, approximately 25 subjects will be enrolled to evaluate the safety and preliminarily efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of second stage Phase IIb single-arm study either will be continued or the trail will be terminated. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 33 subjects will be enrolled to further evaluate the efficacy and safety of MRG002. conditions module condition list condition Locally Advanced Urothelial Cancer Metastatic Urothelial Carcinoma keyword list keyword MRG002 Antibody Drug Conjugate (ADC) HER2 Urothelium Cancer design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 58 enrollment type Anticipated arms interventions module arm group list arm group arm group label MRG002 arm group type Experimental arm group description MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle). arm group intervention list arm group intervention name Drug: MRG002 intervention list intervention intervention type Drug intervention name MRG002 intervention description Administrated intravenously intervention arm group label list intervention arm group label MRG002 outcomes module primary outcome list primary outcome primary outcome measure Objective Response Rate (ORR) by Independent Review Committee (IRC) primary outcome description ORR is defined as the percentage of patients with complete response (CR) and partial response (PR) as assessed by Independent Review Committee (IRC) according to RECIST v1.1. primary outcome time frame Baseline to study completion, up to 12 months secondary outcome list secondary outcome secondary outcome measure ORR by Investigator secondary outcome description ORR is defined as the percentage of patients with CR and PR as assessed by Investigator according to RECIST v1.1. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Duration of Response (DoR) secondary outcome description DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Time to Response (TTR) secondary outcome description TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Disease Control Rate (DCR) secondary outcome description DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Progression Free Survival (PFS) secondary outcome description PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Overall Survival (OS) secondary outcome description OS is defined as the duration from the start of treatment to death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Adverse Events (AEs) secondary outcome description Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug. secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve secondary outcome description Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS). secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Incidence of anti-drug antibody (ADA) secondary outcome description The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment. secondary outcome time frame Baseline to 30 days after the last dose of study treatment eligibility module eligibility criteria Inclusion Criteria: Willing to sign the ICF and follow the requirements specified in the protocol. Aged 18 to 75 (including 18 and 75), both genders. Expected survival time ≥ 12 weeks. Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology. Failed in the prior one or more line of systemic chemotherapy. HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test. Archival or biopsy tumor specimens should be provided (primary or metastatic). Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ECOG performance score 0 or 1. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities). No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%. Organ function must meet the basic requirements. Coagulation function must meet the basic requirements. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab. Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose MRG002 treatment. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage. Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis. Any severe or uncontrolled systemic diseases. Patients with poorly controlled heart diseases. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection. History of other primary malignancies. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc. Peripheral neuropathy greater than Grade 1. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C). Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials. Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator. healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Program Director central contact role Contact central contact phone 86-21-61637960 central contact e mail clinicaltrials@miracogen.com.cn overall official list overall official overall official name Aiping Zhou, MD overall official affiliation Cancer Institute and Hospital, Chinese Academy of Medical Sciences overall official role Principal Investigator location list location location facility Anhui provincial Cancer Hospital location status Recruiting location city Hefei location state Anhui location zip 230031 location country China location contact list location contact location contact name Changlu Hu location contact role Contact location contact phone 15555426636 location contact e mail 13955116061@139.com location facility The Second Hospital of Anhui Medical University location status Recruiting location city Hefei location state Anhui location zip 230601 location country China location contact list location contact location contact name Dexin Yu location contact role Contact location contact phone 13705690883 location contact e mail yudx_urology@126.com location facility Cancer Hospital Chinese Academy of Medical Sciences location status Recruiting location city Beijing location state Beijing location zip 100000 location country China location contact list location contact location contact name Aipingv Zhou, MD location contact role Contact location contact phone 86-10-87788800 location contact e mail zhouap1825@126.com location facility Beijing hospital location status Not yet recruiting location city Beijing location state Beijing location zip 100005 location country China location contact list location contact location contact name Ben Wan location contact role Contact location contact phone 13701257342 location contact e mail Wanben2000@sina.com location facility Beijing Chao-Yang Hospital，Capital Medical University location status Recruiting location city Beijing location state Beijing location zip 100020 location country China location contact list location contact location contact name Yinong Niu location contact role Contact location contact phone 18601020160 location contact e mail 18601020160@163.com location facility The Fifth Medical Center of the PLA location status Recruiting location city Beijing location state Beijing location zip 100039 location country China location contact list location contact location contact name Lijun Chen location contact role Contact location contact phone 13910777307 location contact e mail chenlj829@163.com location facility Chongqing University Cancer Hospital location status Recruiting location city Chongqing location state Chongqing location zip 400030 location country China location contact list location contact location contact name Hong Luo location contact role Contact location contact phone 13883029913 location contact e mail luodashu@sohu.com location facility Army Medical Center of PLA location status Terminated location city Chongqing location state Chongqing location zip 400042 location country China location facility Fujian Cancer Hospital location status Not yet recruiting location city Fuzhou location state Fujian location zip 350014 location country China location contact list location contact location contact name Yu Chen location contact role Contact location contact phone 13859089836 location contact e mail 833392476@qq.com location facility SUN Yat-sen university Cancer center location status Recruiting location city Guangzhou location state Guangdong location zip 510060 location country China location contact list location contact location contact name Fangjian Zhou location contact role Contact location contact phone 13922735659 location contact e mail zhoufj@sysucc.org.cn location facility The First Affiliated Hospital of Guangzhou Medical University location status Recruiting location city Guangzhou location state Guangdong location zip 510120 location country China location contact list location contact location contact name Yongda Liu location contact role Contact location contact phone 18922347906 location contact e mail 13719007083@163.com location facility ShenZhen Luohu People's Hospital location status Terminated location city ShenZhen location state Guangdong location zip 518005 location country China location facility The Fifth Affiliated Hospital of Sun Yat-sen University location status Not yet recruiting location city Zhuhai location state Guangdong location zip 519000 location country China location contact list location contact location contact name Hongyu Zhang location contact role Contact location contact phone 13928075391 location contact e mail zdwyzhy@163.com location facility Liuzhou People's Hospital location status Recruiting location city Liuzhou location state Guangxi location zip 545026 location country China location contact list location contact location contact name Pei Lu location contact role Contact location contact phone 18037132111 location contact e mail lylpnh@126.com location facility Haerbin medical university cancer hospital location status Recruiting location city Haerbin location state Heilongjiang location zip 150081 location country China location contact list location contact location contact name Hui Chen location contact role Contact location contact phone 13603612355 location contact e mail erchenhui@hotmail.com location facility Henan Cancer Hospital location status Recruiting location city Zhengzhou location state Henan location zip 450003 location country China location contact list location contact location contact name Shujun Yang location contact role Contact location contact phone 13803869419 location contact e mail nykang@126.com location facility Union hospital tongji medical college huazhong univerity ofscience and technology location status Recruiting location city Wuhan location state Hubei location zip 430022 location country China location contact list location contact location contact name Guiling Li location contact role Contact location contact phone 13307187507 location contact e mail Lgl6714@163.com location facility Tongji Hospital location status Terminated location city Wuhan location state Hubei location zip 430030 location country China location facility Xiangya hospital central south university location status Recruiting location city Changsha location state Hunan location zip 410008 location country China location contact list location contact location contact name Minfeng Chen location contact role Contact location contact phone 13517319380 location contact e mail chenminfeng1999@163.com location facility The Affiliated Cancer Hospital of Xiangya School of Medicine(Hunan Cancer Hospital ) location status Recruiting location city Changsha location state Hunan location zip 410031 location country China location contact list location contact location contact name Weiqing Han location contact role Contact location contact phone 13875825253 location contact e mail md70210@sina.com location facility Nantong Tumor Hospital location status Terminated location city Nantong location state Jiangsu location zip 226006 location country China location facility The First Hospital of Jilin University location status Recruiting location city Changchun location state Jilin location zip 130061 location country China location contact list location contact location contact name Ziling Liu location contact role Contact location contact phone 13943001600 location contact e mail drzilingliu@163.com location facility JiLinGuoWen Hospital location status Recruiting location city Siping location state Jilin location zip 136199 location country China location contact list location contact location contact name Jizhong Quan location contact role Contact location contact phone 15774496522 location contact e mail quanjizhong@jlguowen.com location facility Liaoning Cancer hospital location status Recruiting location city Shenyang location state Liaoning location zip 110042 location country China location contact list location contact location contact name Cheng Fu location contact role Contact location contact phone 18900917622 location contact e mail 13840219900@163.com location facility Qinghai University Affiliated Hospital location status Recruiting location city Xining location state Qinghai location zip 810012 location country China location contact list location contact location contact name Guojun Chen location contact role Contact location contact phone 13897283691 location contact e mail chenguojun68@126.com location facility Qilu Hospital of Shandong University location status Recruiting location city Jinan location state Shandong location zip 250012 location country China location contact list location contact location contact name Benkang Shi location contact role Contact location contact phone 13969006388 location contact e mail bkshi68@163.com location facility Rui jin hospital location status Recruiting location city Shanghai location state Shanghai location zip 200025 location country China location contact list location contact location contact name Danfeng Xu location contact role Contact location contact phone 13901734568 location contact e mail xu-danfeng@hotmail.com location facility Zhongshan Hospital Affiliated to Fudan University location status Terminated location city Shanghai location state Shanghai location zip 200125 location country China location facility Changhai Hospital location status Not yet recruiting location city Shanghai location state Shanghai location zip 200433 location country China location contact list location contact location contact name Chuanliang Xu location contact role Contact location contact phone 13816323268 location contact e mail chuanliang_xu@126.com location facility First Affiliated Hospital of Xi'an Jiaotong University location status Recruiting location city Xian location state Shanxi location zip 710061 location country China location contact list location contact location contact name Lei Li location contact role Contact location contact phone 15991752560 location contact e mail Lilydr@163.com location facility Sichuan provincial people's hospital location status Recruiting location city Chengdu location state Sichuan location zip 610072 location country China location contact list location contact location contact name Yong Liao location contact role Contact location contact phone 18981838513 location contact e mail liaoyong616@sina.com location facility Tianjin Medical University Cancer Institute and Hospital location status Recruiting location city Tianjin location state Tianjin location zip 300181 location country China location contact list location contact location contact name Xin Yao location contact role Contact location contact phone 13803000688 location contact e mail yaoxin@tjmuch.com location facility The Second Hospital of Tianjin Medical University location status Recruiting location city Tianjin location state Tianjin location zip 300211 location country China location contact list location contact location contact name Hailong Hu location contact role Contact location contact phone 13662096232 location contact e mail Hhllove2004@163.com location facility The second Affiliated Hospital Zhejiang University School of Medical location status Recruiting location city Hangzhou location state Zhejiang location zip 310003 location country China location contact list location contact location contact name Jimin Chen location contact role Contact location contact phone 13575731457 location contact e mail cjm6300@126.com location facility Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) location status Recruiting location city Hangzhou location state Zhejiang location zip 310005 location country China location contact list location contact location contact name Shaoxing Zhu location contact role Contact location contact phone 18758872716 location contact e mail zsxing2005@126.com location facility The 1'Affiliated Hospital of Wenzhou Medical University location status Recruiting location city Wenzhou location state Zhejiang location zip 325015 location country China location contact list location contact location contact name Zhiliang Weng location contact role Contact location contact phone 13806889501 location contact e mail wengzL2001@163.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002295 condition mesh term Carcinoma, Transitional Cell condition ancestor list condition ancestor condition ancestor id D000002277 condition ancestor term Carcinoma condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf relevance low condition browse leaf id M4703 condition browse leaf name Carcinoma, Transitional Cell condition browse leaf as found Urothelial Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id T5693 condition browse leaf name Transitional Cell Carcinoma condition browse leaf as found Urothelial Carcinoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04839510

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full study rank 61564 study protocol section identification module n c t id NCT04834830 org study id info org study id Version 1.1 26.01.2021 organization org full name University of Vienna org class OTHER brief title Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study official title Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date April 1, 2022 primary completion date type Anticipated completion date struct completion date April 1, 2022 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Daniela Gompelmann responsible party investigator title Prof. Dr. med. responsible party investigator affiliation University of Vienna lead sponsor lead sponsor name University of Vienna lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate the concentrations of interleukin-2, interleukin-10, interferon-gamma, PD1+ lymphocytes, and the interleukin-10 receptor expression in malignant and benign effusions. detailed description In this prospective trial, 80 patients with pleural effusions and indication for thoracocentesis, drainage, indwelling pleural catheter (IPC) management and/or video-assisted thoracoscopic surgery are enrolled. The pleural effusion will be examined for different cytokines, cytokine-receptors, PD1-lymphocytes and CD4+/CD25+/Foxp3+ regulatory T cell. conditions module condition list condition Pleural Effusion design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with pleural effusion arm group description In patients with pleural effusion and indication for diagnostic and/or therapeutic procedures (thoracocentesis, drainage of fluid, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery), pleural fluid will be examined for various cytokines and PD1-lymphoctyes. arm group intervention list arm group intervention name Diagnostic Test: Pleural effusion will be examined for various cytokines and PD1-lymphocytes. intervention list intervention intervention type Diagnostic Test intervention name Pleural effusion will be examined for various cytokines and PD1-lymphocytes. intervention description Examination of pleural effusion intervention arm group label list intervention arm group label Patients with pleural effusion outcomes module primary outcome list primary outcome primary outcome measure To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions primary outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: age >18 years radiologically confirmed pleural effusion with an indication for puncture, pleural drain insertion, or video-assisted thoracoscopy for diagnostic and/or therapeutic reasons Signed declaration of consent Exclusion Criteria: Withdrawal or cessation of participation gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients with malignant or benign pleural effusions requiring diagnostic and/or therapeutic procedures including thoracocentesis, drainage insertion, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery sampling method Non-Probability Sample contacts locations module location list location location facility Medical University of Vienna location status Recruiting location city Vienna location country Austria location contact list location contact location contact name Daniela Gompelmann location contact role Contact location contact phone 0043 1 40400 47730 location contact e mail daniela.gompelmann@meduniwien.ac.at i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010996 condition mesh term Pleural Effusion condition ancestor list condition ancestor condition ancestor id D000010995 condition ancestor term Pleural Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M13038 condition browse leaf name Pleural Effusion condition browse leaf as found Pleural Effusion condition browse leaf relevance high condition browse leaf id M13037 condition browse leaf name Pleural Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04834830

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full study rank 61358 study protocol section identification module n c t id NCT04837508 org study id info org study id MRG002-002 organization org full name Shanghai Miracogen Inc. org class INDUSTRY brief title A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer official title An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date June 7, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date August 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 8, 2021 last update post date struct last update post date December 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Shanghai Miracogen Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior stand therapy. detailed description The study consists of two stages. In Phase IIa, 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002. conditions module condition list condition Advanced or Metastatic Biliary Tract Cancer keyword list keyword MRG002 Antibody Drug Conjugate (ADC) HER2 Biliary Tract Cancer design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 86 enrollment type Anticipated arms interventions module arm group list arm group arm group label MRG002 arm group type Experimental arm group description MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle). arm group intervention list arm group intervention name Drug: MRG002 intervention list intervention intervention type Drug intervention name MRG002 intervention description Administrated intravenously intervention arm group label list intervention arm group label MRG002 outcomes module primary outcome list primary outcome primary outcome measure Objective Response Rate (ORR) by Independent Review Committee (IRC) primary outcome description ORR is defined as the percentage of patients with a complete response (CR) and partial response (PR) as assessed by Independent Review Committee (IRC) according to RECIST v1.1. primary outcome time frame Baseline to study completion, up to 12 months secondary outcome list secondary outcome secondary outcome measure ORR by Investigator secondary outcome description ORR is defined as the percentage of patients with a CR and PR as assessed by Investigator according to RECIST v1.1. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Duration of Response (DoR) secondary outcome description DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Time to Response (TTR) secondary outcome description TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Disease Control Rate (DCR) secondary outcome description DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Progression Free Survival (PFS) secondary outcome description PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Overall Survival (OS) secondary outcome description OS is defined as the duration from the start of treatment to death of any cause. secondary outcome time frame Baseline to study completion, up to 12 months secondary outcome measure Adverse Events (AEs) secondary outcome description Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug. secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve secondary outcome description Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS). secondary outcome time frame Baseline to 30 days after the last dose of study treatment secondary outcome measure Incidence of anti-drug antibody (ADA) secondary outcome description The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment. secondary outcome time frame Baseline to 30 days after the last dose of study treatment eligibility module eligibility criteria Inclusion Criteria: Willing to sign the ICF and follow the requirements specified in the protocol. Aged 18 to 75 (including 18 and 75), both genders. Expected survival time ≥ 12 weeks. Patients with unresectable locally advanced or metastatic biliary tract cancer confirmed by histopathology. Failed in the prior one or more standard therapies. HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test. Archival or biopsy tumor specimens should be provided (primary or metastatic). Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ECOG performance score 0 or 1. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities). No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%. Organ function must meet the basic requirements. Coagulation function must meet the basic requirements. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab. Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment. Presence of clinical manifestation of biliary obstruction. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage. Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis. Any severe or uncontrolled systemic diseases. Patients with poorly controlled heart diseases. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection. History of other primary malignancies. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc. Peripheral neuropathy greater than Grade 1. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C). Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials. Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator. healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Program Director central contact role Contact central contact phone 86-21-61637960 central contact e mail clinicaltrials@miracogen.com.cn overall official list overall official overall official name Aiping Zhou, MD overall official affiliation Cancer Institute and Hospital, Chinese Academy of Medical Sciences overall official role Principal Investigator location list location location facility The first affiliated hospital of bengbu medical college location status Recruiting location city Bengbu location state Anhui location zip 233004 location country China location contact list location contact location contact name Mingxi Wang location contact role Contact location contact phone 0552-3086943 location contact e mail drwmx@126.com location facility Cancer Hospital Chinese Academy of Medical Sciences location status Recruiting location city Beijing location state Beijing location zip 100000 location country China location contact list location contact location contact name Aiping Zhou, MD location contact role Contact location contact phone 86-10-87788800 location contact e mail zhouap1825@126.com location facility Peking Union Medical College Hospital location status Recruiting location city Beijing location state Beijing location zip 100730 location country China location contact list location contact location contact name Mei Guan location contact role Contact location contact phone 010-69158353 location contact e mail guanmei71@126.com location facility ZhuJiang Hospital of Southern Medical University location status Recruiting location city Guangzhou location state Guangdong location zip 510280 location country China location contact list location contact location contact name Weimin Ding location contact role Contact location contact phone 020-62783372 location contact e mail DWM-2001@163.com location facility Harbin Medical University Cancer Hospital location status Recruiting location city Harbin location state Heilongjiang location zip 150081 location country China location contact list location contact location contact name Yanqiao Zhang location contact role Contact location contact phone 0451-86298192 location contact e mail yanqiaozhang@126.com location facility Henan Cancer Hospital location status Recruiting location city Zhengzhou location state Henan location zip 450003 location country China location contact list location contact location contact name Ying Liu location contact role Contact location contact phone 0371-65588007 location contact e mail yaya7207@126.com location facility Liaoning Cancer Hospital&Institute location status Recruiting location city Shenyang location state Liaoning location zip 110801 location country China location contact list location contact location contact name Jingdong Zhang location contact role Contact location contact phone 024-31916651 location contact e mail 13804027878@163.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001661 condition mesh term Biliary Tract Neoplasms condition ancestor list condition ancestor condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001660 condition ancestor term Biliary Tract Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M4099 condition browse leaf name Biliary Tract Neoplasms condition browse leaf as found Biliary Tract Cancer condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M4098 condition browse leaf name Biliary Tract Diseases condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id T761 condition browse leaf name Biliary Tract Cancer condition browse leaf as found Biliary Tract Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04837508

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full study rank 61402 study protocol section identification module n c t id NCT04836936 org study id info org study id STUDY20120027 organization org full name University of Pittsburgh org class OTHER brief title Auriculotherapy in the Treatment of Pre-Operative Anxiety official title Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 13, 2021 start date type Actual primary completion date struct primary completion date January 31, 2023 primary completion date type Anticipated completion date struct completion date January 31, 2023 completion date type Anticipated study first submit date March 9, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date February 14, 2022 last update post date struct last update post date February 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Jacques E. Chelly responsible party investigator title Professor of Anesthesiology (with Tenure) and Orthopedic Surgery responsible party investigator affiliation University of Pittsburgh lead sponsor lead sponsor name Jacques E. Chelly lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary The goal of this clinical trial is to use the validated PROMIS Emotional Distress - Anxiety - Short Form 8a and PROMIS Emotional Distress-Depression-Short Form pre-and post-intervention to establish a superior correlation between the auriculotherapy treatment and the reduction of perioperative anxiety. Subject population will include those having a partial or total nephrectomy for cancer. Drawing the role that auriculotherapy may play in reducing perioperative anxiety related requirement after surgery may also help in reducing the risk of opioid use disorders (OUD) since anxiety has been found to be a major risk factor for OUD in surgical patients. Therefore, this trial will also examine the effect of the auriculotherapy intervention in reducing opioid requirement after surgery. detailed description Sixty subjects undergoing total or partial nephrectomies will be asked to participate in this IRB approved placebo-controlled randomized study. Potential subjects will be recruited out of the surgeon's office or at a preoperative clinical visit prior to surgery. The clinical care team will introduce the study and request permission for the research team to speak with the patient. If the subject agrees to be approached by a member of the research team, then the research team will approach the subject. During the Informed Consent, a PI or Co-I will be available to answer final questions and facilitate the process. After signing an informed consent, the subjects will be equally randomized to either active auriculotherapy treatment (with nitrogen gas) or placebo auriculotherapy treatment (without nitrogen gas). Each subject will be asked to complete the PROMIS Emotional Distress - Anxiety - Short Form 8a, the PROMIS Emotional Distress-Depression-Short Form and Pain Catastrophizing Scale (PCS) in the pre-operative setting. Those whose anxiety scores are ≥19 and ≤29 will be included in the study and randomly distributed to either treatment allocation. Randomization will occur by assigning the participant a subject ID number, and this ID number will correspond to a treatment allocation based on a pre-designed randomization schema. This treatment allocation (intervention/control) will be contained in a sealed, opaque, envelope with the subject ID number that is designated on envelope. The master randomization list will be created and held by an independent data monitor who will both create and hold the master randomization list. A data manager research associate will confidentially reveal the randomization to the PI or Amy Monroe so that the study coordinators, Co-Is and subjects will be blinded. PI or Amy Monroe, and the data managing associate will be the only individuals who are unblinded. Study assessments will be conducted on the day of surgery, in the pre-operative setting. This will include the PROMIS Emotional Distress - Anxiety - Short Form 8a as this is the first assessment conducted after obtaining Informed Consent. It is used to assess eligibility for the study. This assessment will take roughly 5 minutes. Auriculotherapy treatment will also occur in the pre-operative setting, within one hour of surgery and after the patient has received a peripheral nerve block. For the active treatment group, a nitrogen gas canister will be applied to a cryopuncture device (manual attached), and the tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of gas for 2 seconds on each point (7 points total). For the sham device, an empty canister will be applied to the cryopuncture device, and in exactly the same fashion as the treatment group, the tip of the cryopuncture will be sanitized and placed on each treatment point of the ear. Instead of releasing a spurt of nitrogen gas, the empty canister will make the same noise as a full canister, but without the expulsion of gas. We are not expecting any adverse events from performing this technique. The only "adverse event" that is expected is a mild local blistering/scab, which may occur within 24 hours after the treatment. In our experience in our ongoing auriculotherapy study (24 subjects enrolled), we did not observe this adverse event. In the experience of Dr. Chelly(11 years) and Dr. Alimi (30 years), any local blistering or ulceration is extremely mild, and resolves in days without any intervention. No potential adverse effect would require immediate treatment or delay the surgery. After surgery, the subject will be assessed for pain medication requirement and pain scores in the post-anesthesia care unit (PACU) and then assessed daily until discharge. Upon discharge, subjects will repeat the PROMIS Emotional Distress questionnaires and the PCS. Additionally, subjects will be asked to complete an overall satisfaction questionnaire measured on a scale to 0-10. The subjects will take home a diary where they will record daily NRS pain scores (scale 0-10), daily anxiety level (scale 0-10) and daily analgesic/opioid requirement for one-week post-op. The subject will be contacted daily after discharge until completion of the pain diary at Day 7 post-op, and will also be contacted once at 30-day and 90-day post-op to report the PROMIS Emotional Distress -Anxiety- Short Form 8a, the PROMIS Emotional Distress-Depression-Short Form, and Pain Catastrophizing Scale (PCS) verbally over the telephone. The subject will be contacted via phone daily to gather their responses post op to the surveys, a maximum of three times. If we are unable to reach the subject after 3 days they will be considered lost to follow up. If In addition to this, the subject will be asked to assess their functional recovery using the SF-12 questionnaire, and to report their VAS pain score/opioid consumption for the previous week. conditions module condition list condition Anxiety Preoperative keyword list keyword Nephrectomy Auriculotherapy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A Randomized, Double-Blind, Placebo-Controlled trial involving patients undergoing partial or total nephrectomy. design primary purpose Treatment design masking info design masking Triple design masking description The only person unblinded to treatment allocation will be the Principal investigator or individual who will perform the auriculotherapy treatment. design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Auriculotherapy cryopuncture device without nitrogen gas arm group type Placebo Comparator arm group description Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using an empty cryopuncture device without nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management. arm group intervention list arm group intervention name Device: Auriculotherapy cryopuncture device without nitrogen gas arm group label Auriculotherapy cryopuncture device with nitrogen gas arm group type Active Comparator arm group description Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using a cryopuncture device with nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management. arm group intervention list arm group intervention name Device: Auriculotherapy cryopuncture device with nitrogen gas intervention list intervention intervention type Device intervention name Auriculotherapy cryopuncture device without nitrogen gas intervention description Auriculotherapy cryopuncture device without nitrogen gas will be administered. Application of this placebo device will be performed in the same manner as the treatment, but without the expulsion of nitrogen gas. intervention arm group label list intervention arm group label Auriculotherapy cryopuncture device without nitrogen gas intervention type Device intervention name Auriculotherapy cryopuncture device with nitrogen gas intervention description Auriculotherapy cryopuncture device with nitrogen gas will be administered. The tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of nitrogen gas for 2 seconds on each point (6 points total). intervention arm group label list intervention arm group label Auriculotherapy cryopuncture device with nitrogen gas outcomes module primary outcome list primary outcome primary outcome measure Opioid Consumption primary outcome description Demonstrate how auriculotherapy using the cryopuncture device changes participant's total opioid consumption following nephrectomy surgery. primary outcome time frame Day of surgery through discharge or post-operative day 30, whichever came first secondary outcome list secondary outcome secondary outcome measure Pre-operative emotional distress related to anxiety secondary outcome description Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Screening visit secondary outcome measure Post-operative emotional distress related to anxiety secondary outcome description Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Pre-operative emotional distress related to depression secondary outcome description Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant many have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Screening visit secondary outcome measure Post-operative emotional distress related to depression secondary outcome description Post-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire. There are 8 questions about how the participant many have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Pre-operative pain rating using the Pain Catastrophizing Scale secondary outcome description Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome. secondary outcome time frame Screening visit secondary outcome measure Post-operative pain rating using the Visual Analog Scale (VAS) secondary outcome description Post-operative pain ratings will be measured by the assessment of the participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Post-operative pain rating using the Pain Catastrophizing Scale secondary outcome description Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Post-operative analgesic utilization secondary outcome description Post-operative analgesic utilization will be measured using electronic medical records and patient-recorded diaries of daily analgesic/opioid requirements. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Functional Recovery secondary outcome description Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1).These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and well-being). Overall score can range from 12 to 53. Higher scores present a better outcome. secondary outcome time frame Day of surgery through 3 months post-operative secondary outcome measure Overall patient satisfaction secondary outcome description Participants will be asked to assess their overall satisfaction upon discharge on a scale of 0 (least satisfaction) to 10 (highest satisfaction) at the time of discharge secondary outcome time frame Day of surgery through discharge or post-operative day 30, whichever came first eligibility module eligibility criteria Inclusion Criteria: Greater than 18 years of age Scheduled to undergo partial or full elective nephrectomy Subject is willing and able to provide informed consent Anxiety score ≥ 19 and ≤ 29 on the PROMIS Emotional Distress-Anxiety-Short Form 8a. Exclusion Criteria: Opioid dependence, based on the DSM definition of Opioid Use Disorder (OUD) Chronic pain condition where daily opioid use is needed History of fibromyalgia Anatomical malformation of ear (genetic or trauma-induced) Vasculopathy of ear Raynaud's disease Patient Refusal healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Amy Monroe central contact role Contact central contact phone 412-623-6382 central contact e mail monroeal@upmc.edu central contact name Brittany Norton central contact role Contact central contact e mail nortonbe@upmc.edu overall official list overall official overall official name Jacques E Chelly, MD overall official affiliation University of Pittsburgh overall official role Principal Investigator location list location location facility UPMC Shadyside Hospital location status Recruiting location city Pittsburgh location state Pennsylvania location zip 15232 location country United States location contact list location contact location contact name Jacque E Chelly, MD location contact role Contact location contact phone 412-623-6904 location contact e mail chelje@anes.upmc.edu location contact name Amy Monroe location contact role Contact location contact phone 412-623-6382 location contact e mail monroeal@upmc.edu location contact name Jacques E Chelly, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf as found Anxiety condition browse leaf relevance high condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions

NCT04836936

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full study rank 61173 study protocol section identification module n c t id NCT04839913 org study id info org study id COVID-SER organization org full name University of Cagliari org class OTHER brief title Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study official title Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Update From an Unicentric, Regional Study acronym COVID-19 status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 1, 2020 start date type Actual primary completion date struct primary completion date December 10, 2020 primary completion date type Actual completion date struct completion date January 10, 2021 completion date type Actual study first submit date April 7, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Fabio Medas responsible party investigator title Surgical researcher responsible party investigator affiliation University of Cagliari lead sponsor lead sponsor name University of Cagliari lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of seroprevalence between Spring and Fall seasons in a cohort of patients undergoing surgery. conditions module condition list condition SARS-CoV Infection Seroprevalence Covid19 design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 121 enrollment type Actual arms interventions module intervention list intervention intervention type Diagnostic Test intervention name Antibodies testing intervention description Serologic test for both SARS-COV-2 IgG and IgM outcomes module primary outcome list primary outcome primary outcome measure SARS-COV-2 seroprevalence primary outcome description SARS-COV-2 IgG and IgM seroprevalence between spring and fall period primary outcome time frame 1St September - 10Th December 2020 eligibility module eligibility criteria Inclusion Criteria: Patient admitted to our unit who had performed SARS-COV-2 serologic test Exclusion Criteria: age < 18 healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population This is a cohort of elective surgical patients admitted to our unit in the 2020 fall period sampling method Non-Probability Sample contacts locations module location list location location facility University of Cagliari location city Cagliari location country Italy i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000045169 condition mesh term Severe Acute Respiratory Syndrome condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M24598 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found SARS-CoV Infection condition browse leaf relevance high condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T5186 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found SARS-CoV Infection condition browse leaf relevance high condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000000906 intervention mesh term Antibodies intervention ancestor list intervention ancestor intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf as found Period intervention browse leaf relevance high intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04839913

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full study rank 61781 study protocol section identification module n c t id NCT04832009 org study id info org study id 00147066 organization org full name University of Kansas Medical Center org class OTHER brief title Reversing Glucose and Lipid-mediated Vascular Dysfunction official title Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL) acronym REGAL status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 9, 2022 start date type Actual primary completion date struct primary completion date May 9, 2023 primary completion date type Anticipated completion date struct completion date January 1, 2024 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 9, 2022 last update post date struct last update post date May 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Seth Holwerda PhD responsible party investigator title Principal Investigator responsible party investigator affiliation University of Kansas Medical Center lead sponsor lead sponsor name University of Kansas Medical Center lead sponsor class OTHER oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of our study is to understand the extent to which the blood vessels are affected by glucose and fat (lipids) in lean healthy adults and if these changes in the blood vessels contribute to the development of high blood pressure. detailed description Hypertension, obesity, and insulin resistance are associated with elevated muscle sympathetic nerve activity (MSNA), which is important for blood pressure regulation. The measurement of MSNA is safely performed in humans using the microneurographic technique that involves recording sympathetic nerve activity projecting to skeletal muscle using a small microelectrode at the peroneal nerve near the knee. The health of your blood vessels will be tested in this study, in addition to the activity of the nerves that control the blood vessels. The function of the nerves and blood vessels can be diminished by high blood glucose and lipids, and we will test the ability of a well-known antioxidant, ascorbic acid (vitamin C), to restore the function of the nerves and blood vessels. conditions module condition list condition Blood Pressure Hypertension design module study type Interventional phase list phase Early Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Comparisons of outcome variables will be made using a mixed model ANOVA. design primary purpose Other design masking info design masking Triple design masking description Randomized, double-blinded, parallel-design approach study. design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 46 enrollment type Anticipated arms interventions module arm group list arm group arm group label Glucose Infusion arm group type Experimental arm group description Hyperglycemia (glucose infusion) will receive an I.V. Glucose infusion with a co-infusion of ascorbic acid or placebo at your visit 2 and the alternative treatment of ascorbic acid or placebo will be given on the subsequent study visit 3. arm group intervention list arm group intervention name Drug: Dextrose 20 % in 500 ML Injection Drug: Saline Drug: Ascorbic acid arm group label Lipid Infusion arm group type Experimental arm group description Hyperlipidemia (lipid infusion) will receive an I.V. Lipid infusion with a co-infusion of ascorbic acid or placebo at your visit 2 and the alternative treatment of ascorbic acid or placebo will be given on the subsequent study visit 3. arm group intervention list arm group intervention name Drug: Intralipid Drug: Saline Drug: Ascorbic acid intervention list intervention intervention type Drug intervention name Dextrose 20 % in 500 ML Injection intervention description Dextrose (20% intravenous solution) will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, dextrose will be administered via antecubital vein at a standard rate of 4 mg/kg/min for 2 hours. intervention arm group label list intervention arm group label Glucose Infusion intervention other name list intervention other name Glucose intervention type Drug intervention name Intralipid intervention description Intralipid ® 20% will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, Intralipid ® 20% will be administered via antecubital vein at 0.75 mL/min for 2 hours Increases in circulating markers of oxidative stress peak within 2 hours of Intralipid ® 20% infusion in healthy adults (42). An initial heparin bolus of 1000 UL followed by 200 U/hr infusion will be included to activate endothelial lipoprotein lipase and accelerate hydrolysis of fatty acids. intervention arm group label list intervention arm group label Lipid Infusion intervention other name list intervention other name Lipid intervention type Drug intervention name Saline intervention description Saline will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. Will be administered via antecubital vein at 75 to 150 mL/hour for 2 hours. intervention arm group label list intervention arm group label Glucose Infusion Lipid Infusion intervention other name list intervention other name Placebo intervention type Drug intervention name Ascorbic acid intervention description (ASCOR) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min. The KU Investigational Pharmacy will randomize ascorbic acid or placebo (saline) for each participant. intervention arm group label list intervention arm group label Glucose Infusion Lipid Infusion outcomes module primary outcome list primary outcome primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame Baseline primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 30 minutes primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 60 minutes primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 90 minutes primary outcome measure Efficacy of Infusion of Ascorbic Acid primary outcome description The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress. primary outcome time frame 120 minutes eligibility module eligibility criteria Inclusion Criteria: Lean: BMI < 25 kg/m Normal insulin sensitivity: (calculation based on fasting glucose and insulin concentrations in blood) Middle-aged: 18-79 years Blood pressure: < 140 (systolic) and < 90 mmHg (diastolic Weight stable (+/- 5 lbs) for the previous 3 months Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior. Able and willing to provide written informed consent Exclusion Criteria: Diabetes mellitus Type I or Type II: fasting glucose < 126 mg/dL and/or HbA1c < 6.5% Current smoker or History of smoking in the past 3 months. Hyperlipidemia: Fasting triglycerides < 250 mg/dL Hypertension: >130/80 mmHg History of heart disease (e.g., myocardial infarction, stent, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy) History of vascular disease (e.g., bypass, stroke) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 79 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Seth W Holwerda, PhD central contact role Contact central contact phone 9729223230 central contact e mail sholwerda@kumc.edu central contact name Davina A Clonch central contact role Contact central contact phone 9132266009 central contact e mail shoggirl@gmail.com overall official list overall official overall official name Seth W. W Holwerda, PhD overall official affiliation University of Kansas Medical Center overall official role Principal Investigator location list location location facility University of Kansas Medical Center location status Recruiting location city Kansas City location state Kansas location zip 66103 location country United States location contact list location contact location contact name Seth W. W Holwerda location contact role Contact location contact phone 972-922-3230 location contact e mail sholwerda@kumc.edu i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006973 condition mesh term Hypertension condition ancestor list condition ancestor condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf as found Hypertension condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000001205 intervention mesh term Ascorbic Acid intervention mesh id C000545823 intervention mesh term Soybean oil, phospholipid emulsion intervention ancestor list intervention ancestor intervention ancestor id D000000975 intervention ancestor term Antioxidants intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000014815 intervention ancestor term Vitamins intervention ancestor id D000018977 intervention ancestor term Micronutrients intervention ancestor id D000005217 intervention ancestor term Fat Emulsions, Intravenous intervention ancestor id D000057947 intervention ancestor term Parenteral Nutrition Solutions intervention ancestor id D000019999 intervention ancestor term Pharmaceutical Solutions intervention browse leaf list intervention browse leaf intervention browse leaf id M8731 intervention browse leaf name Heparin intervention browse leaf relevance low intervention browse leaf id M45326 intervention browse leaf name Calcium heparin intervention browse leaf relevance low intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse leaf id M3665 intervention browse leaf name Ascorbic Acid intervention browse leaf as found Mesh intervention browse leaf relevance high intervention browse leaf id M223851 intervention browse leaf name Soybean oil, phospholipid emulsion intervention browse leaf as found H1N1 intervention browse leaf relevance high intervention browse leaf id M3444 intervention browse leaf name Antioxidants intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse leaf id M16710 intervention browse leaf name Vitamins intervention browse leaf relevance low intervention browse leaf id M20162 intervention browse leaf name Micronutrients intervention browse leaf relevance low intervention browse leaf id M16037 intervention browse leaf name Trace Elements intervention browse leaf relevance low intervention browse leaf id M7512 intervention browse leaf name Fat Emulsions, Intravenous intervention browse leaf relevance low intervention browse leaf id M28087 intervention browse leaf name Parenteral Nutrition Solutions intervention browse leaf relevance low intervention browse leaf id T477 intervention browse leaf name Vitamin C intervention browse leaf as found Mesh intervention browse leaf relevance high intervention browse leaf id T437 intervention browse leaf name Ascorbic Acid intervention browse leaf as found Mesh intervention browse leaf relevance high intervention browse leaf id T294 intervention browse leaf name Soy Bean intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev FiAg intervention browse branch name Fibrinolytic Agents intervention browse branch abbrev AnCoag intervention browse branch name Anticoagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev Vi intervention browse branch name Vitamins intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical

NCT04832009

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full study rank 61615 study protocol section identification module n c t id NCT04834167 org study id info org study id UTAR-45-2021 organization org full name Universiti Tunku Abdul Rahman org class OTHER brief title OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women official title OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 24, 2022 last update post date struct last update post date May 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yang Mooi Lim responsible party investigator title Deputy Director (Institute of Postgraduate Studies and Research), Professor responsible party investigator affiliation Universiti Tunku Abdul Rahman lead sponsor lead sponsor name Universiti Tunku Abdul Rahman lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma. detailed description This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma. conditions module condition list condition Skin Diseases Skin Disorder Melanoma (Skin) keyword list keyword Melasma Skin treatment Picopulse Malaysian women design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 37 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment arm group type Experimental arm group description Eligible patients will receive ten picopulse treatments for bi-monthly. arm group intervention list arm group intervention name Device: OneDoc Picopulse intervention list intervention intervention type Device intervention name OneDoc Picopulse intervention description Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly. intervention arm group label list intervention arm group label Treatment outcomes module primary outcome list primary outcome primary outcome measure Acceptability of the treatment primary outcome description Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied) primary outcome time frame One month secondary outcome list secondary outcome secondary outcome measure Feasibility of the recruitment and measurement tools secondary outcome description Number of patients referred from OneDoc and eligible for screening Number of patients recruited Follow-up response rates (2 weeks and 1 month follow-ups) secondary outcome time frame Pre-treatment, two weeks and one month secondary outcome measure Treatment adherence secondary outcome description Number of treatments attended secondary outcome time frame five months secondary outcome measure Melasma secondary outcome description Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma) secondary outcome time frame Through study completion, an average of 24 weeks secondary outcome measure Quality of life of patients secondary outcome description Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life secondary outcome time frame Pre-treatment, two weeks and one month post-treatment secondary outcome measure Safety evaluation secondary outcome description Incidence and severity of side effects caused by treatments secondary outcome time frame immediately after and before each subsequent treatment eligibility module eligibility criteria Inclusion Criteria: Women presenting dermal melasma with Fritzpatrick skin type III to V Malaysian citizen Agreed to participate Provide informed consent Exclusion Criteria: Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months. Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders Patients who photosensitivity or taking drugs known to induce photosensitivity, Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity Patients who could not attend follow-up treatments healthy volunteers No gender Female minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Yang Mooi Lim, PhD central contact role Contact central contact phone 60390860288 central contact e mail ymlim@utar.edu.my central contact name Chai Nien Foo, PhD central contact role Contact central contact phone 60390860288 central contact e mail foocn@utar.edu.my overall official list overall official overall official name Yang Mooi Lim, PhD overall official affiliation Universiti Tunku Abdul Rahman overall official role Principal Investigator location list location location facility OneDoc location status Recruiting location city Cheras location country Malaysia references module reference list reference reference p m i d 30215845 reference type result reference citation Amini F, Thazin Oo NM, Okechukwu PN, Seghayat MS, Ng ESC. Polymorphisms in P53 and VEGFA genes in different subtypes of periorbital hyperpigmentation in a Malaysian Chinese population. Australas J Dermatol. 2019 May;60(2):e99-e104. doi: 10.1111/ajd.12918. Epub 2018 Sep 14. reference p m i d 29020467 reference type result reference citation Chalermchai T, Rummaneethorn P. Effects of a fractional picosecond 1,064 nm laser for the treatment of dermal and mixed type melasma. J Cosmet Laser Ther. 2018 Jun;20(3):134-139. doi: 10.1080/14764172.2017.1376098. Epub 2017 Dec 4. reference p m i d 30320904 reference type result reference citation Labadie JG, Krunic AL. Long pulsed dye laser with a back-to-back double-pulse technique and compression for the treatment of epidermal pigmented lesions. Lasers Surg Med. 2019 Feb;51(2):136-140. doi: 10.1002/lsm.23009. Epub 2018 Oct 15. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012871 condition mesh term Skin Diseases condition mesh id D000008548 condition mesh term Melanosis condition ancestor list condition ancestor condition ancestor id D000017495 condition ancestor term Hyperpigmentation condition ancestor id D000010859 condition ancestor term Pigmentation Disorders condition browse leaf list condition browse leaf condition browse leaf id M10680 condition browse leaf name Melanoma condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf as found Skin Diseases condition browse leaf relevance high condition browse leaf id M10683 condition browse leaf name Melanosis condition browse leaf as found Melasma condition browse leaf relevance high condition browse leaf id M18912 condition browse leaf name Hyperpigmentation condition browse leaf relevance low condition browse leaf id M12906 condition browse leaf name Pigmentation Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology

NCT04834167

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full study rank 61512 study protocol section identification module n c t id NCT04835506 org study id info org study id 2021P000391 organization org full name Beth Israel Deaconess Medical Center org class OTHER brief title Proactive Infliximab Optimization Using a PK Dashboard Versus SOC in Patients With Crohn's Disease: The OPTIMIZE Trial official title Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Crohn's Disease: The OPTIMIZE Trial status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 4, 2022 last update post date struct last update post date October 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Adam Cheifetz responsible party investigator title Professor of Medicine responsible party investigator affiliation Beth Israel Deaconess Medical Center lead sponsor lead sponsor name Beth Israel Deaconess Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name The Leona M. and Harry B. Helmsley Charitable Trust collaborator class OTHER collaborator name Icahn School of Medicine at Mount Sinai collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in moderately to severely active CD. detailed description Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) characterized by transmural inflammation of the intestine. CD is a global disease in the 21st century with increasing incidence in newly industrialized countries. One of the most effective therapies to treat patients with moderate to severe CD is the antitumor necrosis factor (TNF) agent infliximab (IFX) either as monotherapy or as a combination therapy with an immunomodulator (IMM), such as azathioprine or methotrexate (MTX). Although more effective, combination therapy is associated with more serious adverse events, such as serious opportunistic infections and cancers, as well as potential treatment adherence issues. Consequently, many patients and physicians choose to use IFX alone as safety is often prioritized over efficacy. Unfortunately, up to 30% of patients do not respond to induction therapy, and up to 50% of initial responders lose response over time. It is only if patients lose response that physicians check blood IFX concentrations (i.e., reactive therapeutic drug monitoring [TDM]), or empirically increase IFX dose. Reactive TDM helps to explain and better manage these patients with lack or loss of response to IFX. In many cases, the lack or LOR is due to low drug concentrations with or without development of antibodies to IFX (ATI). Unfortunately, reactive TDM or empiric dose escalation is often too late for patients who do not either respond to IFX induction therapy or lose response during maintenance. This reactive approach results in many patients losing IFX as a therapeutic option. Preliminary data show that proactive IFX optimization to achieve a threshold drug concentration during maintenance therapy (even if the patient is asymptomatic) compared to empiric dose escalation and/or reactive TDM is associated with better long-term outcomes including longer drug persistence, reduced risk of relapse, and fewer hospitalizations and surgeries. IFX dosing by weight only (i.e., mg/kg) may not be adequate for many patients as interindividual variability in drug clearance and other factors affecting IFX concentrations and PK are often not accounted for. Dosing calculators take into account all of these individual factors and improve the precision of dosing towards better personalized medicine. These systems have already been validated, and personalized dosing has shown clinical benefit in patients with IBD. This is a randomized, controlled, multicenter, open-label study that plans to enroll 196 participants with moderately to severely active CD. All eligible participants will be randomly assigned in a 1:1 ratio to receive either IFX monotherapy with proactive TDM or SOC IFX therapy, with or without concomitant IMM therapy, and empiric dose optimization or reactive TDM, at the discretion of the investigator. conditions module condition list condition Crohn Disease design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 196 enrollment type Anticipated arms interventions module arm group list arm group arm group label proactive infliximab optimization arm group type Experimental arm group description proactive infliximab optimization using a pharmacokinetic dashboard arm group intervention list arm group intervention name Drug: Infliximab arm group label standard of care infliximab dosing arm group type Experimental arm group description standard of care infliximab dosing arm group intervention list arm group intervention name Drug: Infliximab intervention list intervention intervention type Drug intervention name Infliximab intervention description infliximab intervention arm group label list intervention arm group label proactive infliximab optimization standard of care infliximab dosing outcomes module primary outcome list primary outcome primary outcome measure clinical remission primary outcome description Proportion of subjects with sustained corticosteroid-free (no corticosteroid (CS) use from Week 14 through 52) ) clinical remission (on the CDAI at Weeks 14, 26, 52) and no need for rescue therapy. primary outcome time frame 52 weeks secondary outcome list secondary outcome secondary outcome measure clinical remission secondary outcome description Proportion of subjects in CS-free clinical remission (CDAI <150 and no use of CS within previous 6 months) secondary outcome time frame 52 weeks secondary outcome measure deep remission secondary outcome description Proportion of subjects in deep remission (CDAI < 150 and SES-CD ≤ 4, with no individual subscore > 1) secondary outcome time frame 52 weeks secondary outcome measure composite biological and endoscopic remission secondary outcome description Proportion of subjects with a composite biological (hs-CRP<10 mg/L) and endoscopic remission (SES-CD ≤ 4) secondary outcome time frame 52 weeks secondary outcome measure sustained CS-free clinical remission secondary outcome description 4. Proportion of subjects with sustained CS-free clinical remission (CDAI <150 and no CS use from Week 14 through Week 52) secondary outcome time frame 52 weeks secondary outcome measure primary non-responders secondary outcome description Proportion of subjects who are primary nonresponders (≤ 70-point decrease in CDAI score and at least one of: hs-CRP ≥10 mg/L, FC > 250 μg/g, or SES-CD > 4; or need for rescue therapy prior to Week 14) secondary outcome time frame 14 weeks secondary outcome measure biological remission secondary outcome description Proportion of subjects with sustained biological remission (hs-CRP <10 mg/L) secondary outcome time frame 52 weeks secondary outcome measure endoscopic remission secondary outcome description Proportion of subjects with endoscopic remission (SES-CD ≤ 4, with no individual subscore > 1) secondary outcome time frame 52 weeks secondary outcome measure hs-CRP normalization secondary outcome description Proportion of subjects with normalization of hs-CRP (decrease from ≥ 10 at baseline to < 10 mg/L) secondary outcome time frame 52 weeks secondary outcome measure hs-CRP change from baseline secondary outcome description Hs-CRP change from baseline secondary outcome time frame week 14, week 26, and week 52 secondary outcome measure endoscopic response secondary outcome description Proportion of subjects with an endoscopic response (≥ 50% decrease from baseline SES-CD score) secondary outcome time frame 52 weeks secondary outcome measure fecal calprotectin secondary outcome description Proportion of subjects with normalization of fecal calprotectin (decrease from >250 µg/g at baseline to ≤ 250 µg/g) secondary outcome time frame 52 weeks secondary outcome measure fecal calprotectin change secondary outcome description fecal calprotectin change from baseline secondary outcome time frame 52 weeks eligibility module eligibility criteria Inclusion Criteria: Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive. Diagnosis of CD prior to screening using standard endoscopic, histologic, or radiologic criteria. Subjects with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD. Moderately to severely active CD, defined by a total Crohn's Disease Activity Index (CDAI) score between 220 and 450 points, and at least 1 of the following: Elevated CRP > upper limit of normal ) Elevated fecal calprotectin (FC) (> 250 μg/g) SES-CD > 6, or SES-CD > 3 for isolated ileal disease Physician intends to prescribe IFX as part of the usual care of the subject. No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol Able to participate fully in all aspects of this clinical trial. Written informed consent must be obtained and documented. Exclusion Criteria: Subjects with any of the following CD-related complications: Abdominal or pelvic abscess, including perianal Presence of stoma or ostomy Isolated perianal disease Obstructive disease, such as obstructive stricture Short gut syndrome Toxic megacolon or any other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of disease activity (CDAI or SES-CD) Total colectomy. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption. Current bacterial or parasitic pathogenic enteric infection, according to SOC assessments, including: Clostridioides difficile; tuberculosis; known infection with hepatitis B or C virus; known infection with HIV; sepsis; abscesses. History of the following: opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; more than 1 episode of herpes zoster or any episode of disseminated zoster; any other infection requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening. Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence within the last 5 years. Known primary or secondary immunodeficiency. PNR to adalimumab, defined as no objective evidence of clinical benefit after 14 weeks of therapy. Subjects with failure to a prior biologic, defined as PNR or SLR, will be excluded when a maximum of 40% of the planned enrollment (approximately 78 subjects) have failure to prior biologic exposure. Concomitant use of oral corticosteroid therapy exceeding prednisone 40 mg/day, budesonide 9 mg/day, or equivalent, unless a tapering schedule is initiated with a plan to be off CS by Week 14 Presence of any medical condition or use of any medication that is a contraindication for IFX use, as outlined on the product label. A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study. Pregnant or lactating women, to be excluded based on the physician's usual practice for determining pregnancy or lactation status. Known intolerance or hypersensitivity to IFX or other murine proteins. healthy volunteers No gender All minimum age 16 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Vivian Cheng central contact role Contact central contact phone 6176670682 central contact e mail OPTIMIZE@bidmc.harvard.edu location list location location facility University of Miami location status Enrolling by invitation location city Miami location state Florida location zip 33136 location country United States location facility University of Chicago Medicine location status Enrolling by invitation location city Chicago location state Illinois location zip 60637 location country United States location facility Northwestern University location status Enrolling by invitation location city Evanston location state Illinois location zip 60208 location country United States location facility Rockford GI location status Enrolling by invitation location city Rockford location state Illinois location zip 61107 location country United States location facility Beth Israel Deaconess Medical Center location status Recruiting location city Boston location state Massachusetts location zip 02215 location country United States location contact list location contact location contact name Vivian Cheng location contact role Contact location contact phone 617-667-0682 location contact e mail OPTIMIZE@bidmc.harvard.edu location contact name Adam Cheifetz, MD location contact role Principal Investigator location facility University of Minnesota location status Enrolling by invitation location city Minneapolis location state Minnesota location zip 55455 location country United States location facility Dartmouth-Hitchcock Medical Center location status Enrolling by invitation location city Lebanon location state New Hampshire location zip 03766 location country United States location facility NYU Langone Health location status Enrolling by invitation location city New York location state New York location zip 10016 location country United States location facility Icahn School of Medicine at Mount Sinai location status Enrolling by invitation location city New York location state New York location zip 10029 location country United States location facility Weill Cornell Medical College location status Enrolling by invitation location city New York location state New York location zip 10065 location country United States location facility Atrium Health Center for Digestive Health location status Enrolling by invitation location city Charlotte location state North Carolina location zip 28204 location country United States location facility Cleveland Clinic location status Enrolling by invitation location city Cleveland location state Ohio location zip 44195 location country United States location facility Children's Hospital of Philadelphia location status Enrolling by invitation location city Philadelphia location state Pennsylvania location zip 19104 location country United States location facility University of Texas Southwestern Medical Center location status Enrolling by invitation location city Dallas location state Texas location zip 75390 location country United States location facility University of Utah location status Enrolling by invitation location city Salt Lake City location state Utah location zip 84132 location country United States location facility Medical College of Wisconsin location status Enrolling by invitation location city Milwaukee location state Wisconsin location zip 53226 location country United States references module reference list reference reference p m i d 35365535 reference type derived reference citation Papamichael K, Jairath V, Zou G, Cohen B, Ritter T, Sands B, Siegel C, Valentine J, Smith M, Vande Casteele N, Dubinsky M, Cheifetz A. Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial). BMJ Open. 2022 Apr 1;12(4):e057656. doi: 10.1136/bmjopen-2021-057656. i p d sharing statement module i p d sharing Yes i p d sharing description De-identified participant data and trial-level data will be available on reasonable request. This data will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement i p d sharing time frame After completion and publication of primary study. i p d sharing access criteria This data will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003424 condition mesh term Crohn Disease condition ancestor list condition ancestor condition ancestor id D000015212 condition ancestor term Inflammatory Bowel Diseases condition ancestor id D000005759 condition ancestor term Gastroenteritis condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition browse leaf list condition browse leaf condition browse leaf id M5790 condition browse leaf name Crohn Disease condition browse leaf as found Crohn's Disease condition browse leaf relevance high condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M17069 condition browse leaf name Inflammatory Bowel Diseases condition browse leaf relevance low condition browse leaf id M8027 condition browse leaf name Gastroenteritis condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000069285 intervention mesh term Infliximab intervention ancestor list intervention ancestor intervention ancestor id D000003879 intervention ancestor term Dermatologic Agents intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M375 intervention browse leaf name Infliximab intervention browse leaf as found SARS-CoV-2 intervention browse leaf relevance high intervention browse leaf id M6226 intervention browse leaf name Dermatologic Agents intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev Derm intervention browse branch name Dermatologic Agents intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04835506

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full study rank 61211 study protocol section identification module n c t id NCT04839419 org study id info org study id 2019-A02866-51 organization org full name SOS Oxygene Mediterranee org class INDUSTRY brief title Obesity-hypoventilation in Metabolic Syndrom Patients official title PREVALENCE OF OBESITY-HYPOVENTILATION SYNDROME IN PATIENTS WITH METABOLIC SYNDROME status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date August 1, 2020 start date type Actual primary completion date struct primary completion date August 1, 2023 primary completion date type Anticipated completion date struct completion date August 1, 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name SOS Oxygene Mediterranee lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom. detailed description After being informed about the study and potential risks, patient agreed to participate and undergo : a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night. conditions module condition list condition Metabolic Syndrome Obesity Hypoventilation Syndrome Capnography design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 400 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Capnia primary outcome description Arterial pression in CO2 and transcutaneous pression in CO2 primary outcome time frame Up to one mont after inclusion primary outcome measure Arterial pression in CO2 primary outcome description PaCO2 primary outcome time frame At the inclusion secondary outcome list secondary outcome secondary outcome measure BMI secondary outcome description body mass index secondary outcome time frame At the inclusion secondary outcome measure Arterial pression in oxygen secondary outcome description PaO2 secondary outcome time frame At the inclusion secondary outcome measure somnolence secondary outcome description EPWORTH questionnaire secondary outcome time frame At the inclusion secondary outcome measure Physical activity level secondary outcome description Ricci&Gagnon questionnaire secondary outcome time frame At the inclusion secondary outcome measure Arterial blood bicarbonates secondary outcome description HCO3- secondary outcome time frame At the inclusion secondary outcome measure Arterial blood gases secondary outcome description pH secondary outcome time frame At the inclusion secondary outcome measure Hemoglobin secondary outcome description Hb secondary outcome time frame At the inclusion secondary outcome measure obstructive sleep apnea items secondary outcome description Apnea-hypopnea index secondary outcome time frame Up to one mont after inclusion secondary outcome measure Night Oxygen saturation secondary outcome description SpO2 secondary outcome time frame Up to one mont after inclusion eligibility module eligibility criteria Inclusion Criteria: BMI>30 kg/m2 no treatment with CPAP nor NIV Exclusion Criteria: obstructive respiratory disease non-treated cardiac dysfunction healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients will be selected as part of their usual care, during a consultation for their respiratory and metabolic monitoring. sampling method Probability Sample contacts locations module central contact list central contact central contact name Delphine Delample, PhD central contact role Contact central contact phone 0612155648 central contact phone ext +33 central contact e mail d.delample@sosoxygene.com overall official list overall official overall official name Mathieu Despeaux, MD overall official affiliation Clinique du Chateau de Vernhes overall official role Principal Investigator location list location location facility Clinique du Château de Vernhes location status Recruiting location city Bondigoux location zip 31340 location country France location contact list location contact location contact name Mathieu Despeaux, MD location contact role Contact location contact phone 0561372727 location contact phone ext +33 location contact e mail m.despeaux@cliniquevernhes.fr derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007040 condition mesh term Hypoventilation condition mesh id D000010845 condition mesh term Obesity Hypoventilation Syndrome condition mesh id D000009765 condition mesh term Obesity condition mesh id D000024821 condition mesh term Metabolic Syndrome condition mesh id D000013577 condition mesh term Syndrome condition ancestor list condition ancestor condition ancestor id D000004194 condition ancestor term Disease condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000007333 condition ancestor term Insulin Resistance condition ancestor id D000006946 condition ancestor term Hyperinsulinism condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000012131 condition ancestor term Respiratory Insufficiency condition ancestor id D000012120 condition ancestor term Respiration Disorders condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000012818 condition ancestor term Signs and Symptoms, Respiratory condition ancestor id D000020181 condition ancestor term Sleep Apnea, Obstructive condition ancestor id D000012891 condition ancestor term Sleep Apnea Syndromes condition ancestor id D000001049 condition ancestor term Apnea condition ancestor id D000020919 condition ancestor term Sleep Disorders, Intrinsic condition ancestor id D000020920 condition ancestor term Dyssomnias condition ancestor id D000012893 condition ancestor term Sleep Wake Disorders condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf as found Syndrome condition browse leaf relevance high condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf as found Obesity condition browse leaf relevance high condition browse leaf id M22158 condition browse leaf name Metabolic Syndrome condition browse leaf as found Metabolic Syndrome condition browse leaf relevance high condition browse leaf id M9242 condition browse leaf name Hypoventilation condition browse leaf as found Hypoventilation condition browse leaf relevance high condition browse leaf id M12892 condition browse leaf name Obesity Hypoventilation Syndrome condition browse leaf as found Obesity Hypoventilation Syndrome condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M9522 condition browse leaf name Insulin Resistance condition browse leaf relevance low condition browse leaf id M9149 condition browse leaf name Hyperinsulinism condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M14120 condition browse leaf name Respiratory Insufficiency condition browse leaf relevance low condition browse leaf id M14109 condition browse leaf name Respiration Disorders condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M14775 condition browse leaf name Signs and Symptoms, Respiratory condition browse leaf relevance low condition browse leaf id M3513 condition browse leaf name Apnea condition browse leaf relevance low condition browse leaf id M14846 condition browse leaf name Sleep Apnea Syndromes condition browse leaf relevance low condition browse leaf id M21163 condition browse leaf name Sleep Apnea, Obstructive condition browse leaf relevance low condition browse leaf id M21395 condition browse leaf name Parasomnias condition browse leaf relevance low condition browse leaf id M21807 condition browse leaf name Sleep Disorders, Intrinsic condition browse leaf relevance low condition browse leaf id M21808 condition browse leaf name Dyssomnias condition browse leaf relevance low condition browse leaf id M14848 condition browse leaf name Sleep Wake Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders

NCT04839419

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full study rank 61172 study protocol section identification module n c t id NCT04839926 org study id info org study id NH101-11 organization org full name Jiangsu Nhwa Pharmaceutical Co., Ltd. org class INDUSTRY brief title A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects official title A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 2, 2021 start date type Actual primary completion date struct primary completion date August 1, 2021 primary completion date type Anticipated completion date struct completion date August 1, 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Jiangsu Nhwa Pharmaceutical Co., Ltd. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects. detailed description Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg). This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ). conditions module condition list condition Schizophrenia keyword list keyword Safety, Tolerability,Pharmacokinetics CY150112 Single Ascending Dose design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Sequential Assignment design primary purpose Basic Science design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label 0.5mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 0.5mg CY150112 arm group label 1.5mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 1.5mg CY150112 arm group label 4.5mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 4.5mg CY150112 arm group label 10mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 10mg CY150112 arm group label 18mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 18mg CY150112 arm group label 24mg CY150112 arm group type Experimental arm group description single oral CY150112 while fasting on day 1. arm group intervention list arm group intervention name Drug: 24mg CY150112 intervention list intervention intervention type Drug intervention name 0.5mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 0.5mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 1.5mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 1.5mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 4.5mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 4.5mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 10mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 10mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 18mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 18mg CY150112 intervention other name list intervention other name placebo intervention type Drug intervention name 24mg CY150112 intervention description single oral CY150112 while fasting on day 1. intervention arm group label list intervention arm group label 24mg CY150112 intervention other name list intervention other name placebo outcomes module primary outcome list primary outcome primary outcome measure Incidence of AEs primary outcome description Incidence of Adverse Events primary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome list secondary outcome secondary outcome measure Cmax secondary outcome description Maximum (peak) observed drug serum concentration secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure AUC0-t secondary outcome description Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure AUC0-∞ secondary outcome description Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure %AUCex secondary outcome description Extrapolation percentage of AUC0-∞ secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure Tmax secondary outcome description Time of occurrence of Cmax secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure T1/2 secondary outcome description Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure Vd secondary outcome description Apparent volume of distribution secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure CL secondary outcome description Clearance secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose secondary outcome measure λz secondary outcome description Elimination rate constant secondary outcome time frame pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose eligibility module eligibility criteria Inclusion Criteria: Male/female subjects are 18<age ≤45 years of age when signing the informed consent. Male Subjects with body weight of ≥50.0kg ，and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination. After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily. Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study. Exclusion Criteria: The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc. There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc. Subjects with past history of allergy to drugs or allergic disease. Subjects with currently or past history of mental disorders and brain functional disorders. According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior. Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior. Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior. Average amount of daily smoking>5 cigarettes at screening 3 months prior. Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing. Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study. Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ). Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg. Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative. Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit. Subjects who participated in any clinical trial within 3 months before medication. Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products. Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period. Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment. Subjects who directly related to this clinical trial. Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 45 Years std age list std age Adult contacts locations module central contact list central contact central contact name Hua Fang li, MD central contact role Contact central contact phone 021-34773107 central contact e mail lhlh_5@163.com central contact name Li Yan, Research Doctor central contact role Contact central contact phone 021-34773107 central contact e mail lhlh_5@163.com overall official list overall official overall official name Hua Fang li, MD overall official affiliation Shanghai Mental Health Center overall official role Principal Investigator location list location location facility Shanghai Mental Health Center location status Recruiting location city Shanghai location state Shanghai location zip 200030 location country China location contact list location contact location contact name Hua Fang li, MD location contact role Contact location contact phone 021-34773107 location contact e mail lhlh_5@163.com location contact name Li Yan, Research Doctor location contact role Contact location contact phone 021-34773107 location contact e mail lhlh_5@163.com location contact name Hua Fang Li, MD location contact role Principal Investigator location contact name Li Yan, Research Doctor location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012559 condition mesh term Schizophrenia condition ancestor list condition ancestor condition ancestor id D000019967 condition ancestor term Schizophrenia Spectrum and Other Psychotic Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M14528 condition browse leaf name Schizophrenia condition browse leaf as found Schizophrenia condition browse leaf relevance high condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M20991 condition browse leaf name Schizophrenia Spectrum and Other Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions

NCT04839926

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full study rank 61415 study protocol section identification module n c t id NCT04836767 org study id info org study id GO21-178 organization org full name Hacettepe University org class OTHER brief title Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term official title Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term status module status verified date August 2022 overall status Completed expanded access info has expanded access No start date struct start date February 16, 2021 start date type Actual primary completion date struct primary completion date February 3, 2022 primary completion date type Actual completion date struct completion date February 3, 2022 completion date type Actual study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 6, 2022 last update post date struct last update post date August 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ebru Calik Kutukcu responsible party investigator title Associate Professor responsible party investigator affiliation Hacettepe University lead sponsor lead sponsor name Hacettepe University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, consciousness, work productivity, pain, fear of movement, and quality of life in patients with Covid-19 and to compare them with healthy individuals who have not had COVID-19. detailed description In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term exercise capacity, pain, kinesiophobia, peripheral muscle strength, balance, anxiety and depression level, cognitive status and quality of life in individuals with COVID-19. It will also be examined whether these parameters change according to the post-COVID functional restriction level. 3. Materials and Methods of the Research: 3.1. The place of the study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation and Hacettepe University Faculty of Medicine Department of General Internal Medicine 3.2. Time of the study: It is planned to collect data and write the study between February 2021 and February 2022. 3.3. Research population, sample, research group: The population of the study is individuals who have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19. The sample of the study is individuals in the long-term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study, and healthy individuals who have not had COVID-19. Study Design: Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65, whose education level is at least primary school, and whose local language is Turkish. A total of 40 participants, 20 healthy without COVID-19, and 20 with at least 12 weeks past the diagnosis of COVID-19, will be included in the study. The guidance of the participants will be provided by the relevant physicians of the General Internal Medicine Unit of Hacettepe University Internal Diseases Department. In accordance with the COVID-19 pandemic precautions, social distance rules will be followed in the tests to be carried out with individuals, care will be taken to use masks, and the materials to be used in tests and measurements will be disinfected before and after use. COVID-19 Group Inclusion Criteria Having been diagnosed with COVID-19 at least 12 weeks ago, Being literate, Being in the age range of 18-65, Volunteering to participate in research, To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19, Recent myocardial infarction and pulmonary embolism. Having accompanying chronic diseases, Those who have any orthopedic or neurological disorders that will prevent walking, Another COVID-19 PCR Test positivity in the last 12 weeks, Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, Healthy Group Inclusion Criteria Not having COVID-19, Being literate, Being in the age range of 18-65, Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study Those who have any orthopedic or neuromuscular disorders that will prevent walking, Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. Individuals participating in the study will be informed verbally and in writing about the study protocol and informed consent form will be obtained. conditions module condition list condition Corona Virus Infection Covid19 keyword list keyword COVID-19 SARS-CoV2 pandemic post-COVID-19 exercise capacity design module study type Observational patient registry Yes target duration 12 Weeks design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label people with a history of COVID-19 arm group description COVID-19 Group Inclusion Criteria Having been diagnosed with COVID-19 at least 12 weeks ago, Being literate, Being in the age range of 18-65, Volunteering to participate in research, To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19, Recent myocardial infarction and pulmonary embolism. Having accompanying chronic diseases, Those who have any orthopedic or neurological disorders that will prevent walking, Another COVID-19 PCR Test positivity in the last 12 weeks, Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, arm group label healthy people arm group description Healthy Group Inclusion Criteria Not having COVID-19, Being literate, Being in the age range of 18-65, Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study Those who have any orthopedic or neuromuscular disorders that will prevent walking, Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. outcomes module primary outcome list primary outcome primary outcome measure Incremental shuttle walking test primary outcome description It assesses maximal exercise capacity. primary outcome time frame January,2021 - December,2021 secondary outcome list secondary outcome secondary outcome measure Time up and Go Test secondary outcome description Functional balance and walking capacity secondary outcome time frame January,2021 - December,2021 secondary outcome measure Short form McGill-Melzack Pain Questionnaire secondary outcome description The pain rating index has 2 subscales: Sensory subscale with 11 words, and Affective subscale with 4 words. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10 cm visual analogue scale (VAS) for average pain. The higher the total score on the MPQ, the more the pain experience for the patient increases secondary outcome time frame January,2021 - December,2021 secondary outcome measure Tampa Kinesophobia Questionnaire secondary outcome description Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia secondary outcome time frame January,2021 - December,2021 secondary outcome measure Hospital Anxiety and Depression Scale secondary outcome description Assessment of anxiety and depression. Scores range from 0 to 21 for each of the two subscales. Higher scores indicate higher level of anxiety and depression secondary outcome time frame January,2021 - December,2021 secondary outcome measure SF-36 Quality of Life Scale secondary outcome description Assessment of life quality. The scores of each domain ranges from zero to 100 which higher scores indicating higher levels of functioning or well-being secondary outcome time frame January,2021 - December,2021 secondary outcome measure Fatigue Severity Scale secondary outcome description Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception. secondary outcome time frame January,2021 - December,2021 secondary outcome measure Cognitive Status Scale secondary outcome description Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure. secondary outcome time frame January,2021 - December,2021 secondary outcome measure Body Mass Index secondary outcome description Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. secondary outcome time frame January,2021 - December,2021 secondary outcome measure Body composition analysis with bioelectrical impedance analysis system secondary outcome description FM and FFM ratio secondary outcome time frame January,2021 - December,2021 eligibility module eligibility criteria COVID-19 Group Inclusion Criteria Having been diagnosed with COVID-19 at least 12 weeks ago, Being literate, Being in the age range of 18-65, Volunteering to participate in research, To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19, Recent myocardial infarction and pulmonary embolism. Having accompanying chronic diseases, Those who have any orthopedic or neurological disorders that will prevent walking, Another COVID-19 PCR Test positivity in the last 12 weeks, Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, Healthy Group Inclusion Criteria Not having COVID-19, Being literate, Being in the age range of 18-65, Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study Those who have any orthopedic or neuromuscular disorders that will prevent walking, Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult study population The population of the study is individuals who live in Ankara and have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19. The sample of the study is healthy individuals in the long term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 and healthy individuals who have not had COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study. sampling method Probability Sample contacts locations module overall official list overall official overall official name Gülay Sain-Guven, Professor overall official affiliation Hacettepe University, Faculty of Medicine overall official role Study Director location list location location facility Hacettepe University location city Ankara location country Turkey references module reference list reference reference p m i d 32475821 reference type result reference citation Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31. reference p m i d 32085846 reference type result reference citation Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available. Erratum In: Lancet Respir Med. 2020 Feb 25;: reference p m i d 32246917 reference type result reference citation Zhao H, Shen D, Zhou H, Liu J, Chen S. Guillain-Barre syndrome associated with SARS-CoV-2 infection: causality or coincidence? Lancet Neurol. 2020 May;19(5):383-384. doi: 10.1016/S1474-4422(20)30109-5. Epub 2020 Apr 1. No abstract available. reference p m i d 32064853 reference type result reference citation Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese. reference p m i d 32764112 reference type result reference citation Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4). pii: 2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000018352 condition mesh term Coronavirus Infections condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf as found Corona Virus Infection condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders

NCT04836767

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full study rank 61738 study protocol section identification module n c t id NCT04832568 org study id info org study id TJMZK202101 organization org full name Huazhong University of Science and Technology org class OTHER brief title Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery official title Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery: a Prospective Observational Study status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 17, 2021 start date type Actual primary completion date struct primary completion date May 2023 primary completion date type Anticipated completion date struct completion date December 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date September 30, 2022 last update post date struct last update post date October 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hua Zheng responsible party investigator title Principal Investigator responsible party investigator affiliation Huazhong University of Science and Technology lead sponsor lead sponsor name Huazhong University of Science and Technology lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram. conditions module condition list condition Delirium design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Delirium is determined by CAM or CAM-ICU score arm group label No delirium is determined by CAM or CAM-ICU score outcomes module primary outcome list primary outcome primary outcome measure Incidence of postoperative delirium primary outcome description The incidence of postoperative delirium was determined according to the Confusion Assessment Method (CAM) diagnostic algorithm. The algorithm consists of four clinical criteria: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. To define a patient as having delirium, both the first and the second criteria have to be present, as well as either the third or the fourth criteria. The CAM-ICU will be used for patients who are intubated in the postoperative period. primary outcome time frame After surgery through to postoperative day 7 secondary outcome list secondary outcome secondary outcome measure Relative power of each brain waves secondary outcome description Electroencephalogram data were acquired using a 32-channel electroencephalogram recording system (Brain Products, Germany). A 5 min, baseline, eyes-closed recording was conducted at the preoperative holding room when the patient was at rest. Recording of electroencephalogram was commenced before the start of anesthetic induction and was stopped before discharge of the patient from the operating room. We defied delta (1 to 3 Hz), theta (4 to 7 Hz), alpha (8 to 12 Hz), and beta (13 to 40 Hz) frequency bands. And then, the relative power of each frequency bands to the total power of the sum is calculated. secondary outcome time frame During the stay of the patient in the operating room, after surgery through to postoperative day 7 secondary outcome measure Duration of delirium secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Severity of delirium secondary outcome description Delirium severity is evaluated both as the peak (highest) and sum Confusion Assessment Method - Severity (CAM-S) score over all hospital days. The CAM-S includes two forms: a Short Form (CAM-S Short Form, based on the 4-item algorithm, the sum of score ranging from 0 to 7, with 7 being the most severe) and a Long Form (CAM-S Long Form, based on the 10-item CAM instrument, the sum of score ranging from 0 to 19, with 19 being the most severe). secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Worst daily pain scores at rest secondary outcome description Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain). secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Worst daily pain scores with exertion (deep breathing and cough) secondary outcome description Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain). secondary outcome time frame After surgery through to postoperative day 7 secondary outcome measure Length of stay in the Intensive Care Unit (ICU) secondary outcome description Measured in days admitted in the ICU secondary outcome time frame through study completion, an average of 5 days secondary outcome measure Length of hospital stay secondary outcome description Measured in days admitted in the hospital secondary outcome time frame through study completion, an average of 10 days other outcome list other outcome other outcome measure Biomarkers other outcome description Identify biomarkers (such as Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), brain-derived neurotrophic factor (BDNF), and metalloproteases-9 (MMP-9) )of delirium and neural damage through changes in circulating plasma proteins and molecules other outcome time frame before and after surgery in operating room, after surgery through to postoperative day 7 eligibility module eligibility criteria Inclusion Criteria: age of at least 18 years normal cognitive function at the time of enrollment evidenced by a Mini-Mental State Examination (MMSE) score of more than 24 of 30 Chinese Mandarin as the native language providing informed consent Exclusion Criteria: pre-existing delirium assessed according to the Confusion Assessment Method (CAM) history of neurological or psychiatric disease impaired vision or auditory function which may effect the assessments unwillingness to participate in the study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients undergoing cardiovascular surgery sampling method Probability Sample contacts locations module central contact list central contact central contact name Hua Zheng, Dr. central contact role Contact central contact phone 0086-27-83663173 central contact e mail hzheng@hust.edu.cn location list location location facility Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology location status Recruiting location city Wuhan location state Hubei location zip 430030 location country China location contact list location contact location contact name Hua Zheng, Dr. location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003693 condition mesh term Delirium condition ancestor list condition ancestor condition ancestor id D000003221 condition ancestor term Confusion condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6046 condition browse leaf name Delirium condition browse leaf as found Delirium condition browse leaf relevance high condition browse leaf id M5598 condition browse leaf name Confusion condition browse leaf relevance low condition browse leaf id M20979 condition browse leaf name Neurobehavioral Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions

NCT04832568

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full study rank 61577 study protocol section identification module n c t id NCT04834661 org study id info org study id multi-sites practice surgery organization org full name Shanghai Minimally Invasive Surgery Center org class OTHER brief title Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution official title Safety and Feasibility of Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution Under Multi-sites Practice (MSP) Policy, a Retrospective Comparative Study status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date October 20, 2021 start date type Actual primary completion date struct primary completion date October 31, 2021 primary completion date type Actual completion date struct completion date December 31, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 15, 2022 last update post date struct last update post date April 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Cai Zhenghao responsible party investigator title Attending surgeon of gastrointestinal surgery，Ruijin Hospital, Shanghai Jiaotong University School of Medicine responsible party investigator affiliation Shanghai Minimally Invasive Surgery Center lead sponsor lead sponsor name Shanghai Minimally Invasive Surgery Center lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy. This is a single practitioner, retrospective comparative study. The endpoints are peri-operative outcomes, pathological results, and medical costs. conditions module condition list condition Colorectal Cancer Gastric Cancer design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 1130 enrollment type Actual arms interventions module arm group list arm group arm group label inside group arm group description laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution arm group intervention list arm group intervention name Other: surgery inside the primary institution arm group label outside group arm group description laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution arm group intervention list arm group intervention name Other: surgery outside the primary institution intervention list intervention intervention type Other intervention name surgery inside the primary institution intervention description to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution intervention arm group label list intervention arm group label inside group intervention type Other intervention name surgery outside the primary institution intervention description to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution intervention arm group label list intervention arm group label outside group outcomes module primary outcome list primary outcome primary outcome measure overall postoperative complication rate primary outcome description postoperative complications evaluated according to Clavin-Dindo classification primary outcome time frame 30 days after surgery eligibility module eligibility criteria Inclusion Criteria: Age between 18 and 100 years diagnosed as colorectal cancer or gastric cancer undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng Exclusion Criteria: Emergency procedure without histopathological result of malignancy conventional open surgery healthy volunteers No gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult study population colorectal cancer and gastric cancer sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Zhenghao Cai, MD overall official affiliation Ruijin Hospital overall official role Principal Investigator location list location location facility Ruijin Hospital location city Shanghai location state Shanghai location zip 200020 location country China derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013274 condition mesh term Stomach Neoplasms condition ancestor list condition ancestor condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000013272 condition ancestor term Stomach Diseases condition browse leaf list condition browse leaf condition browse leaf id M15216 condition browse leaf name Stomach Neoplasms condition browse leaf as found Gastric Cancer condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M15214 condition browse leaf name Stomach Diseases condition browse leaf relevance low condition browse leaf id T5486 condition browse leaf name Stomach Cancer condition browse leaf as found Gastric Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04834661

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full study rank 61838 study protocol section identification module n c t id NCT04831268 org study id info org study id HRBD 24 04/04/2019 organization org full name Agricultural University of Athens org class OTHER brief title Effects of Traditional Greek Meals on Glycemic Responses official title Effects of Traditional Greek Meals: Lentils With Lupino, Trahanas With Tomato Sauce and Halva With Currants on Glycemic Responses: Randomized Clinical Trial in Healthy Humans status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 1, 2019 start date type Actual primary completion date struct primary completion date September 30, 2019 primary completion date type Actual completion date struct completion date September 30, 2019 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Aimilia Papakonstantinou responsible party investigator title Assistant Professor responsible party investigator affiliation Agricultural University of Athens lead sponsor lead sponsor name Agricultural University of Athens lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This study investigated the effects of Greek traditional meals in dehydrated form consumed after reconstitution with water on glycemic responses detailed description This study aimed at 1. to determined the glycemic index and glycemic load of three mixed meals and 2. to investigate the effects of these mixed meals on postprandial glycemic response in healthy subjects conditions module condition list condition Potential Abnormality of Glucose Tolerance Appetitive Behavior keyword list keyword blood glucose lentils trahanas halva glycemic index design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design intervention model description Crossover Assignment design primary purpose Other design masking info design masking Single design masking description Single (Investigator) design who masked list design who masked Investigator enrollment info enrollment count 12 enrollment type Actual arms interventions module arm group list arm group arm group label Glucose as reference food arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal arm group label Lentils and lupins mixed meal arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal arm group label Trahanas with tomato sauce mixed meal arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal arm group label Halva with currants mixed meal arm group type Experimental arm group description Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. arm group intervention list arm group intervention name Other: Glucose as reference food Other: Lentils and lupins mixed meal Other: Trahanas with tomato sauce mixed meal Other: Halva with currants mixed meal intervention list intervention intervention type Other intervention name Glucose as reference food intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal intervention type Other intervention name Lentils and lupins mixed meal intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal intervention type Other intervention name Trahanas with tomato sauce mixed meal intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal intervention type Other intervention name Halva with currants mixed meal intervention description Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min. intervention arm group label list intervention arm group label Glucose as reference food Halva with currants mixed meal Lentils and lupins mixed meal Trahanas with tomato sauce mixed meal outcomes module primary outcome list primary outcome primary outcome measure Capillary blood glucose responses primary outcome description Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test primary outcome time frame 2 hours secondary outcome list secondary outcome secondary outcome measure Subjective appetite ratings secondary outcome description Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120 min. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g hunger, satiety, desire to eat etc. secondary outcome time frame 2 hours secondary outcome measure Blood pressure secondary outcome description Useful change in systolic and diastolic blood pressure before and 2hr after consumption of three mixed meals secondary outcome time frame 2 hours eligibility module eligibility criteria Inclusion Criteria: healthy non-smoking non-diabetic men and women normal body mass index (BMI; between 18.5 and 25 kg/m2) Exclusion Criteria: severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions) gastrointestinal disorders pregnancy lactation competitive sports alcohol drug dependency healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Aimilia Papakonstantinou, PhD overall official affiliation Agricultural University of Athens overall official role Principal Investigator location list location location facility Agricultural University of Athens location city Athens location state Attica location zip 11855 location country Greece derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000013 condition mesh term Congenital Abnormalities condition browse leaf list condition browse leaf condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf as found Abnormalities condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T316 intervention browse leaf name Tomato intervention browse leaf as found STAT intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04831268

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full study rank 61510 study protocol section identification module n c t id NCT04835532 org study id info org study id 2021-0050 organization org full name Second Affiliated Hospital, School of Medicine, Zhejiang University org class OTHER brief title Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation official title Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial status module status verified date February 2021 overall status Recruiting expanded access info has expanded access No start date struct start date August 10, 2021 start date type Actual primary completion date struct primary completion date October 1, 2022 primary completion date type Anticipated completion date struct completion date March 1, 2024 completion date type Anticipated study first submit date March 16, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 27, 2021 last update post date struct last update post date September 29, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Second Affiliated Hospital, School of Medicine, Zhejiang University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF. detailed description Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF. conditions module condition list condition Bone Loss, Alveolar keyword list keyword tenting screws advanced platelet rich fibrin injectable platelet rich fibrin guided bone regeneration design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 69 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control group arm group type Experimental arm group description Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane arm group intervention list arm group intervention name Procedure: guided bone gereration arm group label Treatment group 1 arm group type Experimental arm group description Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws arm group intervention list arm group intervention name Procedure: guided bone gereration arm group label Treatment group 2 arm group type Experimental arm group description Vertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF arm group intervention list arm group intervention name Procedure: guided bone gereration intervention list intervention intervention type Procedure intervention name guided bone gereration intervention description guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation. intervention arm group label list intervention arm group label Control group Treatment group 1 Treatment group 2 intervention other name list intervention other name tenting screws, A-PRF, I-PRF outcomes module primary outcome list primary outcome primary outcome measure Buccal bone augmentation, BBA(bone height changes between T0 and T2) primary outcome description The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter. primary outcome time frame T0(before surgery), T2(6 months after GBR) secondary outcome list secondary outcome secondary outcome measure Lingual bone augmentation, LBA(bone height changes between T0 and T2) secondary outcome description The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter. secondary outcome time frame T0(before surgery), T2(6 months after GBR) other outcome list other outcome other outcome measure Bone density, BD other outcome description in the area of bone regeneration, ranging 2mm × 2mm other outcome time frame T2(6 months after GBR) eligibility module eligibility criteria Inclusion Criteria: 18-80 years old; single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect ≥ 3mm; 4 weeks after extraction or missing teeth within 3-5 weeks; adjacent teeth exist and loosening is less than Ⅰ degree; periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%; thick gingival biological type. CBCT shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height ≥ 3mm and bone mineral density is sufficient); the patients and their families have informed consent and signed the informed consent form. Exclusion Criteria: pregnant and lactating women; smoking (> 10 cigarettes per day) and alcoholism; taking anticoagulants within 3 months before operation; suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases; patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection; patients who have been treated with bisphosphate / steroids for a long time; have received alveolar ridge bone augmentation surgery; previous history of radiotherapy in the head and neck; acute inflammation in edentulous sites; inability to maintain good oral hygiene or follow-up visits as required. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name 陈莉丽, Master central contact role Contact central contact phone +86 13606507966 central contact e mail chenlili_1030@163.com location list location location facility 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China location status Recruiting location city Hangzhou location state Zhejiang location zip 310000 location country China location contact list location contact location contact name 陈莉丽, Master location contact role Contact location contact phone +86 13606507966 location contact e mail chenlili_1030@163.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000016301 condition mesh term Alveolar Bone Loss condition ancestor list condition ancestor condition ancestor id D000001862 condition ancestor term Bone Resorption condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000055093 condition ancestor term Periodontal Atrophy condition ancestor id D000010510 condition ancestor term Periodontal Diseases condition ancestor id D000009059 condition ancestor term Mouth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition browse leaf list condition browse leaf condition browse leaf id M17899 condition browse leaf name Alveolar Bone Loss condition browse leaf as found Bone Loss, Alveolar condition browse leaf relevance high condition browse leaf id M4293 condition browse leaf name Bone Resorption condition browse leaf relevance low condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M3741 condition browse leaf name Atrophy condition browse leaf relevance low condition browse leaf id M27178 condition browse leaf name Periodontal Atrophy condition browse leaf relevance low condition browse leaf id M12571 condition browse leaf name Periodontal Diseases condition browse leaf relevance low condition browse leaf id M11171 condition browse leaf name Mouth Diseases condition browse leaf relevance low condition browse leaf id M11169 condition browse leaf name Stomatognathic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology

NCT04835532

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full study rank 61283 study protocol section identification module n c t id NCT04838483 org study id info org study id 2/25 organization org full name Okan University org class OTHER brief title Clinical Performance of Posterior Indirect Adhesive Restorations official title Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date September 1, 2021 primary completion date type Anticipated completion date struct completion date September 15, 2021 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Gulsah YENIER responsible party investigator title Assist.Prof. responsible party investigator affiliation Okan University lead sponsor lead sponsor name Okan University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated. detailed description Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent. This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study. Restorations will be evaluated clinically according to FDI World Dental Federation criteria. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p <0.05). conditions module condition list condition Dental Caries Endodontically Treated Teeth Dental Restoration Failure of Marginal Integrity Wear, Occlusal keyword list keyword Indirect restoration Adhesive restoration Cementation Composite resin design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 83 enrollment type Anticipated arms interventions module arm group list arm group arm group label Indirect restorations luted with light-cured composite resin. arm group type Experimental arm group description Subjects for the study will be identified from patients who had treated with indirect adhesive restorations onlay or overlay during the period 2016 to 2017 was performed at Istanbul Okan University Faculty of Dentistry by an experienced clinician. Local anesthesia was applied if necessary. After caries and/or failed restorations were removed, the preparations were performed according to defined principles for adhesive onlays/overlays. At least one cuspal coverage was required for each restoration. All undercuts were eliminated using composite resin. Following the cavity preparation, immediate dentin sealing was applied and polymerized prior to impression taking. Indirect restorations were designed and fabricated with CEREC system. Surface treatments and clinical protocols were performed under manufacturer's instructions. Adhesive cementation with composite resin procedure was carried out with the rubber-dam isolation. arm group intervention list arm group intervention name Device: Indirect adhesive restoration of posterior teeth intervention list intervention intervention type Device intervention name Indirect adhesive restoration of posterior teeth intervention description Indirect restoration of significant loss of dental hard tissue intervention arm group label list intervention arm group label Indirect restorations luted with light-cured composite resin. intervention other name list intervention other name Ceramic onlay or overlay outcomes module primary outcome list primary outcome primary outcome measure Survival rate primary outcome description FDI World Dental Federation criteria functional properties primary outcome time frame at 5 years secondary outcome list secondary outcome secondary outcome measure Esthetic properties secondary outcome description FDI World Dental Federation criteria secondary outcome time frame at 5 years eligibility module eligibility criteria Inclusion Criteria: Significant loss of dental hard tissue Endodontically treated teeth in posterior region Replacement of large compromised existing restoration Large Class II restoration Age of 18-60 years Good oral hygiene Presence of interproximal contact to at least one neighboring teeth • In occlusion with antagonist teeth Cavity preparation with at least one cuspal coverage Exclusion Criteria: Serious medical problems or allergies to substances and/or products to be used Severe periodontal problems Poor oral hygiene Direct pulp capping Presence of parafunctional behaviors Pregnant or breast feeding healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 60 Years std age list std age Adult contacts locations module central contact list central contact central contact name Gülşah Yenier, DDS, PhD central contact role Contact central contact phone +905547810176 central contact e mail gulsahyenier@gmail.com central contact name Elif Ciftcioglu, DDS, PhD central contact role Contact central contact phone +902166771630 central contact e mail elifcif@yahoo.com overall official list overall official overall official name Gülşah Yenier, DDS, PhD overall official affiliation Istanbul Okan University Faculty of Dentistry overall official role Principal Investigator location list location location facility Istanbul Okan University Faculty of Dentistry location status Recruiting location city Istanbul location state Tuzla location zip 34959 location country Turkey location contact list location contact location contact name Gulsah YENIER, DDS, PhD location contact role Contact location contact phone +905547810176 location contact e mail gulsahyenier@gmail.com location contact name Gulsah YENIER, DDS,PhD location contact role Principal Investigator references module reference list reference reference p m i d 23695612 reference type background reference citation D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22. reference p m i d 28653051 reference type background reference citation Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230. reference p m i d 20628774 reference type background reference citation Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. reference p m i d 30073216 reference type background reference citation Magne P, Razaghy M, Carvalho MA, Soares LM. Luting of inlays, onlays, and overlays with preheated restorative composite resin does not prevent seating accuracy. Int J Esthet Dent. 2018;13(3):318-332. reference p m i d 26355440 reference type background reference citation D'Arcangelo C, Vanini L, Casinelli M, Frascaria M, De Angelis F, Vadini M, D'Amario M. Adhesive Cementation of Indirect Composite Inlays and Onlays: A Literature Review. Compend Contin Educ Dent. 2015 Sep;36(8):570-7; quiz 578. Review. reference p m i d 18350945 reference type background reference citation Naeselius K, Arnelund CF, Molin MK. Clinical evaluation of all-ceramic onlays: a 4-year retrospective study. Int J Prosthodont. 2008 Jan-Feb;21(1):40-4. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003731 condition mesh term Dental Caries condition mesh id D000019553 condition mesh term Tooth, Nonvital condition mesh id D000019217 condition mesh term Tooth Attrition condition mesh id D000057085 condition mesh term Tooth Wear condition ancestor list condition ancestor condition ancestor id D000017001 condition ancestor term Tooth Demineralization condition ancestor id D000014076 condition ancestor term Tooth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000003788 condition ancestor term Dental Pulp Diseases condition browse leaf list condition browse leaf condition browse leaf id M6080 condition browse leaf name Dental Caries condition browse leaf as found Dental Caries condition browse leaf relevance high condition browse leaf id M20643 condition browse leaf name Tooth, Nonvital condition browse leaf as found Endodontically Treated Teeth condition browse leaf relevance high condition browse leaf id M27858 condition browse leaf name Tooth Wear condition browse leaf as found Wear, Occlusal condition browse leaf relevance high condition browse leaf id M20358 condition browse leaf name Tooth Attrition condition browse leaf as found Wear, Occlusal condition browse leaf relevance high condition browse leaf id M18491 condition browse leaf name Tooth Demineralization condition browse leaf relevance low condition browse leaf id M15983 condition browse leaf name Tooth Diseases condition browse leaf relevance low condition browse leaf id M11169 condition browse leaf name Stomatognathic Diseases condition browse leaf relevance low condition browse leaf id M6136 condition browse leaf name Dental Pulp Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04838483

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full study rank 61735 study protocol section identification module n c t id NCT04832607 org study id info org study id TRACE secondary id info list secondary id info secondary id 2018-000853-29 secondary id type EudraCT Number secondary id DRKS00018985 secondary id type Other Identifier secondary id domain Deutsches Register Klinischer Studien organization org full name LMU Klinikum org class OTHER brief title Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections official title Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial acronym TRACE status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 27, 2019 start date type Actual primary completion date struct primary completion date June 2024 primary completion date type Anticipated completion date struct completion date December 2024 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 21, 2022 last update post date struct last update post date November 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Prof. Tobias Feuchtinger responsible party investigator title Prof. Dr. med Tobias Feuchtinger responsible party investigator affiliation LMU Klinikum lead sponsor lead sponsor name Prof. Tobias Feuchtinger lead sponsor class OTHER collaborator list collaborator collaborator name European Commission collaborator class OTHER collaborator name Simbec-Orion Group collaborator class INDUSTRY collaborator name Miltenyi Biotec B.V. & Co. KG collaborator class INDUSTRY collaborator name Leiden University Medical Center collaborator class OTHER collaborator name Central Hospital, Nancy, France collaborator class OTHER collaborator name University Hospital, Ghent collaborator class OTHER collaborator name Bambino Gesù Hospital and Research Institute collaborator class OTHER collaborator name University of Newcastle Upon-Tyne collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults. detailed description For a growing number of patients suffering from various conditions as, e.g., haematological malignancies or diverse genetic disorders, haematopoietic stem cell transplantation (HSCT) or bone marrow transplantation offer the only possible curative options. However, HSCT is associated with three major risks: graft rejection, graft-versus-host disease (GvHD) and opportunistic, mostly viral, infections or reactivations resulting from delayed immune reconstitution. Delayed immune reconstitution, however, often is the direct result of the severe pre-transplantation conditioning treatment and T-cell depletion of the transplant necessary to fight the risks of graft rejection and GvHD. Therefore, the risk for life-threatening opportunistic, mostly viral, infections is increased in post-transplantation patients. The most common infections after HSCT are Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Adenovirus (AdV). The standard treatment approach for viral infections/reactivations is chemotherapy which shows limited efficacy and does not restore immunity. Therefore, effective new treatment options are required for this condition. Previous investigations have shown that sufficient T-cell immunity is essential for the control and prevention of viral reactivations and newly occurring infections after HSCT. The infusion of T-cells is therefore a promising new approach to treat immune-comprised patients. However, infusion with unselected T cells is associated with an increased risk for GvHD due to the high content of alloreactive T cells. A very promising approach to minimize this problem is to remove alloreactive T cells and enrich, isolate and purify virus-specific T cells. This approach has been studied for nearly two decades and the data published up to date indicate that virus-specific T-cell responses after adoptive T-cell transfer protect against virus-related complications post HSCT and restore T-cell immunity, in particular for AdV-, CMV- and EBV-infections. Despite these promising results, virus-specific T-cell transfer is not yet translated into daily clinical practice due to the lack of prospective clinical trials confirming the efficacy of this treatment approach. The overall goal of this Phase III, double-blind placebo-controlled study is to test efficacy of multivirus-specific T cells to bring this treatment method in clinical routine. Multivirus-specific T cells generated in this study will be directed against all three most common post-HSCT viral infections: AdV, CMV and EBV. Thus, T-cell immunity will be restored to fight and prevent new viral infections. After an initial screening visit, patients eligible to participate in the study will be treated within 28 days after screening. Patients will be randomized in a 2:1 (treatment: placebo) ratio and receive a single infusion with either multivirus-specific T cells or placebo. Patients will be followed up on the day of treatment, 1 day after and 1, 2, 4, 8 and 15 weeks after treatment. Treatment success will be measured by assessing different parameters including symptoms, quality of life, viral load and T-cell immunity in blood samples. Patients eligible to participate in this study are adult and paediatric patients who have received allogeneic stem cell transplantation and suffer from new or reactivated EBV, AdV or CMV infection refractory to standard antiviral treatment for two weeks. Patients from the six European countries Germany, Belgium, Netherlands, UK, France and Italy will be enrolled. In total 130 patients plus 19 screening failures are expected to participate in the study. conditions module condition list condition AdV Infection EBV Infection CMV Infection Stem Cell Transplant Complications design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 2 (verum): 1 (Placebo) randomization design primary purpose Treatment design masking info design masking Quadruple design masking description Randomization will be stratified with respect to three age groups: Children up to 6 years, children >6 and up to 18 years, and adults >18 years. Accordingly, for each stratum, a separate randomization list will be provided. Randomization will be performed by a representative of the Simbec-Orion Group who will be independent in the sense that he / she will otherwise not be involved in the TRACE trial. design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 149 enrollment type Anticipated arms interventions module arm group list arm group arm group label Multivirus (CMV, EBV, AdV)-specific T cells arm group type Experimental arm group description Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of Cytomegalovirus, Adenovirus and Epstein-Barr Virus Max dose: HLA-matched (8/8) donors: 1.0 x 10e5 T cells/kg recipient BW HLA-mismatched donors: 2.5 x 10e4 T cells/kg recipient BW Min. dose: - 10 T cells/kg recipient BW arm group intervention list arm group intervention name Other: Multivirus (CMV, EBV, AdV)-specific T cells arm group label Sodium chloride arm group type Placebo Comparator arm group description Suspension of multivirus-specific T cells in 20 mL of 0.9% NaCl + 0.5% HSA arm group intervention list arm group intervention name Other: Multivirus (CMV, EBV, AdV)-specific T cells intervention list intervention intervention type Other intervention name Multivirus (CMV, EBV, AdV)-specific T cells intervention description Cell therapy product which is individually produced for each patient and administered via IV bolus injection. intervention arm group label list intervention arm group label Multivirus (CMV, EBV, AdV)-specific T cells Sodium chloride outcomes module primary outcome list primary outcome primary outcome measure Viral clearance primary outcome description Percentage of patients with viral clearance (defined as two consecutive negative PCRs) to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation primary outcome time frame 8 weeks after treatment primary outcome measure Disease Progression primary outcome description Percentage of patients with progression between Day 7 and Week 8 after T-cell Transfer to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation primary outcome time frame day 7 until week 8 after treatment secondary outcome list secondary outcome secondary outcome measure Incidence of acute GvHD secondary outcome description Incidence of newly occurring acute GvHD grade I from Day 0 to Week 8 and Week 15. secondary outcome time frame 15 weeks after treatment secondary outcome measure Incidence of chronic GvHD secondary outcome description Incidence of chronic GvHD from Day 7 to Week 8 and to Week 15 after treatment. secondary outcome time frame 15 weeks after treatment secondary outcome measure Time to newly occuring GvHD secondary outcome description Time to newly occurring acute and chronic GvHD. secondary outcome time frame 15 weeks after treatment secondary outcome measure Severity of GvHD secondary outcome description Severity of acute GvHD ≥ grade II until Week 8 and Week 15. secondary outcome time frame week 8 and 15 week after treatment secondary outcome measure Incidence of acute toxicity secondary outcome description Acute maximum toxicity on the day of T-cell transfer evaluated by measuring vital signs prior to and at different times after the T-cell transfer from 1 hour prior to T-cell transfer to 4 hours post infusion. secondary outcome time frame 15 minutes, 30 minutes, 2 hours and 4 hours post T-cell/placebo transfer secondary outcome measure Severity of acute toxicity secondary outcome description Monitoring of adverse events infusion. secondary outcome time frame 15 minutes, 30 minutes, 2 hours and 4 hours post T-cell/placebo transfer secondary outcome measure Change in viral load of underlying viral infection secondary outcome description Change in viral load of underlying viral infection as assessed by quantitative PCR analysis of peripheral blood; samples taken weekly from Day 7 to Week 8 after IMP transfer as compared to samples taken at Day 0. secondary outcome time frame 8 weeks after treatment secondary outcome measure Time to viral load change of underlying viral infection secondary outcome description Time to 1 log change in viral load. secondary outcome time frame 15 weeks after treatment secondary outcome measure Percentage of viral decrease secondary outcome description Percentage of patients with ≥1 log decrease in CMV, EBV or AdV viral load at Week 8. secondary outcome time frame 8 weeks after treatment secondary outcome measure Viral reactivations secondary outcome description Number of reactivations of the underlying viral infection following initial viral clearance until end of follow-up. secondary outcome time frame 15 weeks after treatment secondary outcome measure Clinical response/resolution of symptoms of underlying viral infection secondary outcome description Number of patients with reduction or clearance of clinical symptoms of underlyingviral infection from Day 7 to Week 8 after IMP transfer as compared to Day 0. secondary outcome time frame 8 weeks after treatment secondary outcome measure Overall survival secondary outcome description Overall survival rate (OS): From Day 0 to end of follow-up. secondary outcome time frame 15 weeks after treatment secondary outcome measure Necessity of antiviral chemotherapy secondary outcome description Number of days requiring antiviral chemotherapy after T-cell transfer from Day 7 to Week 8 after T-cell transfer. secondary outcome time frame Day 7 until Week 8 secondary outcome measure Duration of antiviral chemotherapy secondary outcome description Time to last administration of defined antiviral medication or switch to prophylactic treatment from Day 0 to Week 8 after IMP transfer. secondary outcome time frame 8 weeks after treatment secondary outcome measure Incidence of viral infections other than underlying viral infection secondary outcome description Number of new viral reactivations (CMV, AdV or EBV) other than the underlying viral infection per patient as assessed by PCR analysis and clinical symptoms throughout the study to evaluate the putative prophylactic effect of the treatment. secondary outcome time frame 15 weeks secondary outcome measure Days of hospitalization secondary outcome description Number of days hospitalized after IMP transfer from Day 7 to Week 8. secondary outcome time frame 8 weeks secondary outcome measure Life quality in adults secondary outcome description EQ-5D for adult patients (≥18 years) at Screening and Week 8 to evaluate life quality in adults. A scale from 0 to 100 is used with 100 being best value and 0 the worst. secondary outcome time frame Screening and Week 8. secondary outcome measure Life quality in adults secondary outcome description FACT-BMT for adult patients (≥18 years) at Screening and Week 8 to evaluate life quality in adults. The patients have to answer questions about their physicial, social, emotional and functional wellbeing. A scale from 0 to 4 is used with 0= not at all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much. secondary outcome time frame Screening and Week 8 secondary outcome measure Life quality in children secondary outcome description PEDS-QL for paediatric patients (<18 years) at Screening and Week 8 to evaluate life quality in children. The patients and /or their parents have to answer questions about pain and hurt, fatigue and sleep, nausea, worry, Nutrition, thinking and communication. A scale from 0 to 4 is used with 0=never a Problem, 1=almost never a problem, 2= sometimes a problem, 3=often a problem, 4= almost always a problem. secondary outcome time frame Screening and Week 8 secondary outcome measure Effect on the patient's T-cell phenotype in vivo secondary outcome description T-cell phenotyping, samples taken at Screening, Day 0 and each visit from Day 7 to Week 15 after treatment. secondary outcome time frame Screening until Week 15 secondary outcome measure Effect on the patient's number of expanded T cells secondary outcome description Analysis of virus-specific T cells: frequencies of in vivo expanded virus-specific T cells in peripheral blood samples taken at Screening, Day 0, Day 7 to Week 15 after treatment. secondary outcome time frame Screening until Week 15 secondary outcome measure Quality of the IMP and performance of the CliniMACS® Prodigy secondary outcome description Assessment of the cellular composition, in particular the percentage of IFN-gamma+ cells, in the IMP. secondary outcome time frame Before IMP release (between Screening and Day 0) secondary outcome measure Evaluation of the drop-out rate secondary outcome description Drop-out rate at Day 0 and reasons for drop-out. secondary outcome time frame at Day 0 (planned treatment day) secondary outcome measure Time from inclusion to administration of the IMP secondary outcome description Number of days from Screening to Day 0 (day of IMP transfer) to evaluate the required time frame. secondary outcome time frame Screening until Day 0 (treatment day) secondary outcome measure Adverse events secondary outcome description Documentation of incidence, severity and type of adverse events from Day 0 to Week 8 and serious adverse events throughout the study to evaluate safety. secondary outcome time frame 15 weeks secondary outcome measure Physical examination secondary outcome description Physical examinations will be conducted to identify possible clinically significant pathologies. These findings will be recorded at each visit. The Karnofsky/Lansky index will be included in the physical examination at Screening and at Week 8 only. secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Sign - blood pressure secondary outcome description supine systolic and diastolic blood preasure in mm Hg secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - heart rate secondary outcome description The resting heart rate in beats/min secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - body temperature secondary outcome description Body temperature in °C (aural) secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - body weight secondary outcome description body weight in kg secondary outcome time frame Screening to Week 8 secondary outcome measure Vital Signs - respiratory rate secondary outcome description respiratory rate in breaths/min. secondary outcome time frame Screening to Week 8 secondary outcome measure Incidence of abnormal laboratory values secondary outcome description haemoglobin, leukocytes, thrombocytes, dirfferential blood count (neutrophil granulocytes, lymphocytes, monocytes and easinophil granulocytes), total and conjugated Bilirubin, C reactive Protein (CRP), creatinine, Alanin aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyl Transferase (GGT), Lactate Dehydrase (LDH), Urea. A list of normal ranges will be provided from each site. secondary outcome time frame Screening to Week 8 secondary outcome measure Concomitant medication until Week 8 secondary outcome description All concomitant medication will be recorded from Screening until Week 8. The generic name, indication, route of administration, dose/ unit, start and stop date or ongoing, way of application will be documented. secondary outcome time frame 8 weeks after treatment secondary outcome measure Concomitant medication until Week 15 secondary outcome description During follow-up Week 15, only antiviral therapy, immunosuppression and SAE-related concomitant medication as well as chemotherapy will be documented. The generic name, indication, route of administration, dose/ unit, start and stop date or ongoing, way of application will be documented. Cellular treatment also has to be documented as concomitant medication. secondary outcome time frame 15 weeks after treatment eligibility module eligibility criteria Inclusion Criteria: Adult or paediatric patients (> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection. Written informed consent given (patient or legal representative) prior to any study-related procedures. Exclusion Criteria: Patient with acute GvHD > grade II or extensive chronic GvHD at the time of IMP transfer Patient receiving steroids (>1 mg/kg BW Prednisone equivalent) at Screening. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells/kg BW in case of T-cell depleted HSCT is not considered an exclusion criterion. Patient with organ dysfunction or failure as determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrolment in another clinical trial interfering with the endpoints of this study Any medical condition which could compromise participation in the study according to the investigator's assessment Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab until 8 weeks after IMP Infusion or prophylactic Treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test. Female patient who is pregnant or breast-feeding. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8). Note: Women of childbearing potential must have a negative serum pregnancy test at study entry ≤7 days before IMP administration on Day 0. Acceptable birth control methods are hormonal oral contraceptive ('pill'), contraceptive injection or patch, intrauterine pessar or the combination of two barrier methods. The combination of female and male condomes is NOT acceptable. If the male partner is sterilized, no further contraceptive is required. Women of post-menopausal status (no menses for 12 months without an alternative medical cause) are also not required to use contraceptives during the study. Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent. healthy volunteers No gender All minimum age 2 Months std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Tobias Feuchtinger, Prof central contact role Contact central contact phone 0049 (0)89 4400 central contact phone ext 57945 central contact e mail onkostudien.hauner@med.uni-muenchen.de central contact name Theresa Käuferle, Dr central contact role Contact central contact phone 0049 (0)89 4400 central contact phone ext 52338 central contact e mail info@trace-study.de overall official list overall official overall official name Tobias Feuchtinger, Prof overall official affiliation Klinikum der Universität München overall official role Principal Investigator location list location location facility Jules Bordet Institut (JBI) location status Recruiting location city Brussels location zip 1000 location country Belgium location contact list location contact location contact name Philippe Lewalle, Prof location contact role Contact location contact phone 0032 25417208 location contact e mail philippe.lewalle@bordet.be location contact name Sabrina Constantini location contact role Contact location contact e mail sabrina.costantini@bordet.be location facility UZ Brussel location status Recruiting location city Brussels location zip 1090 location country Belgium location contact list location contact location contact name Ann De Becker, Dr. location contact role Contact location contact e mail ann.debecker@uzbrussel.be location facility Ghent Universal Hospital (UZG) location status Recruiting location city Ghent location zip 9000 location country Belgium location contact list location contact location contact name Tessa Kerre, Prof location contact role Contact location contact phone 0032 93326654 location contact e mail tessa.kerre@ugent.be location contact name Jonas Saegert location contact role Contact location contact phone 0032 93324912 location contact e mail jonas.segaert@uzgent.be location contact name Tessa Kerre, Prof location contact role Principal Investigator location facility Ghent Universal Hospital (UZG) location status Recruiting location city Ghent location zip 9000 location country Belgium location contact list location contact location contact name Tessa Kerre, Prof. location contact role Contact location contact phone 0032 93326654 location contact e mail tessa.kerre@ugent.be location facility UZ Leuven location status Recruiting location city Leuven location zip 3000 location country Belgium location contact list location contact location contact name Johann Maertens, Prof. Dr. location contact role Contact location contact e mail johan.maertens@uzleuven.be location facility Center Hospitalier Universitaire de Liège (CHU) location status Recruiting location city Liège location zip 4000 location country Belgium location contact list location contact location contact name Yves Beguin, Prof location contact role Contact location contact phone 0032 43668855 location contact e mail yves.beguin@chu.ulg.ac.be location contact name Yves Beguin, Prof location contact role Principal Investigator location facility Université de Liège location status Recruiting location city Liège location zip 4000 location country Belgium location contact list location contact location contact name Yves Beguin, Prof. Dr. location contact role Contact location contact e mail yves.beguin@chu.ulg.ac.be location facility Hospital Jeanne de Flandres, CHU de Lille location status Recruiting location city Lille location zip 59037 location country France location contact list location contact location contact name Bénédicte Bruno, Dr. location contact role Contact location contact e mail benedicte.bruno@chru-lille.fr location facility Hôpital Necker Enfantes Malades location status Recruiting location city Lyon location zip 69003 location country France location contact list location contact location contact name Yves Bertrand, Prof. Dr. location contact role Contact location contact e mail Yves.Betrand@ihope.fr location facility Centre Hospitalier Régional Universitaire de Nancy (CHRU) location status Recruiting location city Nancy location zip 54035 location country France location contact list location contact location contact name Daniele Bensoussan, Dr location contact role Contact location contact e mail d.bensoussan@chru-nancy.fr location contact name Maud d'Aveni-Piney, Dr location contact role Contact location contact e mail m.daveni-piney@chru-nancy.fr location facility Hôpital de la Pitie-Salpêtrière location status Recruiting location city Paris location zip 75013 location country France location contact list location contact location contact name Stéphanie Nguyen Quoc, Prof. Dr. location contact role Contact location contact e mail stephanie.nguyen-quoc@aphp.fr location facility Hôpital Robert Debré location status Recruiting location city Paris location zip 75019 location country France location contact list location contact location contact name Jean Hugues Dalle, Prof. Dr. location contact role Contact location contact e mail jean-hugues.dalle@aphp.fr location facility Universitätsklinikum Freiburg location status Not yet recruiting location city Freiburg location state Baden-Württemberg location zip 79106 location country Germany location contact list location contact location contact name Brigitte Strahm, PD Dr. med. location contact role Contact location contact phone 00490761270 location contact phone ext 46280 location contact e mail brigitte-strahm@uniklinik-freiburg.de location facility Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS) location status Recruiting location city Tübingen location state Baden-Württemberg location zip 72076 location country Germany location contact list location contact location contact name Peter Lang, Prof location contact role Contact location contact phone 07071 29 location contact phone ext 81386 location contact e mail peter.lang@med.uni-tuebingen.de location contact name Sabine Edele-Fiedler location contact role Contact location contact e mail Sabine.Edele-Fiedler@med.uni-tuebingen.de location contact name Peter Lang, Prof location contact role Principal Investigator location facility Universitätsklinikum Regensburg location status Not yet recruiting location city Regensburg location state Bavaria location zip 93053 location country Germany location contact list location contact location contact name Jürgen Foll, Prof location contact role Contact location contact e mail juergen.foell@klinik.uni-regensburg.de location contact name Jürgen Föll, Prof location contact role Principal Investigator location facility Universitätsklinikum Würzburg, Pädiatrische Hämatologie/ Onkologie location status Not yet recruiting location city Würzburg location state Bavaria location zip 97080 location country Germany location contact list location contact location contact name Matthias Wölfl, Prof location contact role Contact location contact phone 0049931201 location contact phone ext 27114 location contact e mail Woelfl_M@kw.de location contact name Matthias Wölfl, Prof location contact role Principal Investigator location facility Klinikum der Universität München - Medizinische Klinik und Poliklinik III location status Recruiting location city München location state Bayern location zip 81377 location country Germany location contact list location contact location contact name Johanna Tischer, Prof location contact role Contact location contact phone 089 4400 location contact phone ext 74240 location contact e mail johanna.tischer@med.uni-muenchen.de location contact name Johanna Tischer location contact role Principal Investigator location facility Klinikum rechts der Isar der Technischen Universität location status Recruiting location city München location state Bayern location country Germany location contact list location contact location contact name Mareike Verbeek, Prof location contact role Contact location contact phone 089 4140 location contact phone ext 4879 location contact e mail Mareike.Verbeek@tum.de location contact name Mareike Verbeek location contact role Principal Investigator location facility Universitätsklinikum Würzburg location status Recruiting location city Würzburg location state Bayern location zip 97080 location country Germany location contact list location contact location contact name Hermann Einsele, Prof location contact role Contact location contact phone 09131 201 location contact phone ext 40001 location contact e mail einsele_h@klinik.uni-wuerzburg.de location contact name Sabrina Kraus, Dr location contact role Contact location contact phone 09131201 location contact phone ext 40967 location contact e mail Kraus_s3@ukw.de location contact name Hermann Einsele, Prof location contact role Principal Investigator location contact name Sabrina Kraus, Dr location contact role Sub-Investigator location facility Medizinische Hochschule Hannover location status Recruiting location city Hannover location state Niedersachsen location zip 30625 location country Germany location contact list location contact location contact name Britta Maecker-Kolhoff, Prof location contact role Contact location contact phone 0 511 532 location contact phone ext 9120 location contact e mail Maecker.Britta@MH-Hannover.de location contact name Britta Maecker-Kolhoff, Prof location contact role Principal Investigator location facility Universitätsklinikum Berlin location status Recruiting location city Berlin location zip 13353 location country Germany location contact list location contact location contact name Johannes Schulte, Prof location contact role Contact location contact phone 0049 30450666658 location contact e mail johannes.schulte@charite.de location contact name Johannes Schulte, Prof location contact role Principal Investigator location facility Universitätsklinikum Dresden location status Recruiting location city Dresden location zip 01307 location country Germany location contact list location contact location contact name Friedrich Stölzel, PD Dr. med. habil. location contact role Contact location contact e mail Friedrich.Stoelzel@uniklinikum-dresden.de location contact name Martin Bornhäuser, Prof. Dr. med. location contact role Contact location contact e mail Martin.Bornhaeuser@uniklinikum-dresden.de location facility Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie location status Recruiting location city Düsseldorf location zip 40225 location country Germany location contact list location contact location contact name Roland Meisel, Prof location contact role Contact location contact e mail meisel@med.uni-duesseldorf.de location contact name Roland Meisel, Prof location contact role Principal Investigator location facility Universitätsklinikum Essen location status Recruiting location city Essen location zip 85147 location country Germany location contact list location contact location contact name Stefan Schönberger, Dr. med. location contact role Contact location contact e mail Stefan.Schoenberger@uk-essen.de location contact name Michaela Höfs, Dr. med. location contact role Contact location contact e mail Michaela.Hoefs@uk-essen.de location facility Universitäsklinikum Leipzig location status Recruiting location city Leipzig location zip 04103 location country Germany location contact list location contact location contact name Vladan Vucinic, Dr. med. location contact role Contact location contact e mail Vladan.Vucinic@medizin.uni-leipzig.de location contact name Georg-Nikolaus Franke, Dr. med. location contact role Contact location contact e mail Georg-Nikolaus.Franke@medizin.uni-leipzig.de location facility Klinikum der Universität München - Dr. v. Haunersches Kinderspital location status Recruiting location city Munich location zip 80337 location country Germany location contact list location contact location contact name Tobias Feuchtinger, Prof location contact role Contact location contact phone 0049894400 location contact phone ext 57945 location contact e mail info@trace-study.de location contact name Tobias Feuchtinger, Prof location contact role Principal Investigator location facility Klinikum für Kinder- und Jugenndmedizin location status Recruiting location city Munich location zip 80804 location country Germany location contact list location contact location contact name Irende Teichert-von Lüttichau, PD Dr. med. location contact role Contact location contact e mail Irene.Teichert-vonluettichau@mri.tum.de location contact name Angela Wawer, Dr. med. location contact role Contact location facility Ospedale Pediatrico Bambino Gesù location status Recruiting location city Rom location zip 00165 location country Italy location contact list location contact location contact name Giuseppina Li Pira, Dr. location contact role Contact location contact e mail giuseppina.lipira@opbg.net location facility Leiden University Medical Centre (LUMC) location status Recruiting location city Leiden location state ZA location zip 2333 location country Netherlands location contact list location contact location contact name Peter van Balen, Dr location contact role Contact location contact phone 003171526 location contact phone ext 2267 location contact e mail P.van_Balen@lumc.nl location contact name Peter van Balen, Dr location contact role Principal Investigator location facility Hospital Clínic Barcelona location status Not yet recruiting location city Barcelona location zip 08036 location country Spain location contact list location contact location contact name Maria Suarez-Liedo Grande, Dr location contact role Contact location contact e mail MSUAREZL@clinic.cat location facility Vall d'Hebron Institute of Oncology location status Not yet recruiting location city Barcelona location zip 119-129 location country Spain location contact list location contact location contact name Laura Segura Martinez location contact role Contact location contact e mail lsegura@vhio.net location contact name Pere Barba, Dr location contact role Contact location contact e mail pbarba@vhio.net location contact name Pere Barba, Dr location contact role Principal Investigator location facility Hospital General Universitario Gregorio Marañón location status Not yet recruiting location city Madrid location zip 28007 location country Spain location contact list location contact location contact name Mi Kwon, Dr location contact role Contact location contact e mail mi.kwon@salud.madrid.org location facility Hospital Universitario La Paz location status Not yet recruiting location city Madrid location zip 28046 location country Spain location contact list location contact location contact name Antonio Perez-Martinez, Dr location contact role Contact location contact e mail aperezmartinez@salud.madrid.org location facility Hospital Virgen del Rocío location status Recruiting location city Sevilla location zip 41013 location country Spain location contact list location contact location contact name Jose Antonio Perez Simon, Dr location contact role Contact location contact e mail josea.perez.simon.sspa@juntadeandalucia.es location facility Hospital Universitario Politécnico La Fe location status Not yet recruiting location city Valencia location zip 46026 location country Spain location contact list location contact location contact name Juan Montoro Gomez, Dr location contact role Contact location facility Newcastle University location status Not yet recruiting location city Newcastle location zip NE14LP location country United Kingdom location contact list location contact location contact name Andrew Gennery, Dr. location contact role Contact location contact e mail 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NCT04832607

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full study rank 61891 study protocol section identification module n c t id NCT04830566 org study id info org study id 2021-3572 organization org full name Université de Sherbrooke org class OTHER brief title Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults official title Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Paraspinal Muscle and Thoracolumbar Fascia in Chronic Low Back Pain Adults Assessed by Elastography, Ultrasonography and Myometry status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date March 19, 2021 start date type Actual primary completion date struct primary completion date July 8, 2022 primary completion date type Actual completion date struct completion date July 15, 2022 completion date type Actual study first submit date March 19, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 31, 2022 last update post date struct last update post date November 2, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mélanie Morin responsible party investigator title Research director responsible party investigator affiliation Université de Sherbrooke lead sponsor lead sponsor name Université de Sherbrooke lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties. The main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity. conditions module condition list condition Chronic Low Back Pain keyword list keyword Low back pain Fascia properties Thoracolumbar fascia Myofascial release Manual therapy Osteopathy Ultrasound imaging Sonoelastography design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 49 enrollment type Actual arms interventions module arm group list arm group arm group label Myofascial release technique group arm group type Experimental arm group intervention list arm group intervention name Other: Myofascial release technique arm group label Simulated myofascial release technique group arm group type Sham Comparator arm group intervention list arm group intervention name Other: Simulated Myofascial Release technique intervention list intervention intervention type Other intervention name Myofascial release technique intervention description Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles intervention arm group label list intervention arm group label Myofascial release technique group intervention type Other intervention name Simulated Myofascial Release technique intervention description Superficial hands contact on the lumbar area intervention arm group label list intervention arm group label Simulated myofascial release technique group outcomes module primary outcome list primary outcome primary outcome measure Changes in elastography features of the myofascial unit primary outcome description Evaluated with a shear wave sonoelastography device. primary outcome time frame Baseline (before treatment), post-treatment (immediately after treatment) secondary outcome list secondary outcome secondary outcome measure Changes in ultrasonography features of the myofascial unit secondary outcome description Evaluated with a B-mode ultrasound imaging device secondary outcome time frame Baseline (before treatment) post-treatment (immediately after treatment) secondary outcome measure Changes in myometry features of the myofascial unit secondary outcome description Evaluated with a myotonometer secondary outcome time frame Baseline (before treatment) post-treatment (immediately after treatment) secondary outcome measure Changes in pain intensity secondary outcome description Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome) secondary outcome time frame Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention eligibility module eligibility criteria Inclusion Criteria: adults over 18 years of age, lumbar pain and/or referred pain above or below the gluteal fold , with intensity > 3/10, persisting for > 6 months and presenting during the day > 50% of the time. Exclusion Criteria: history of serious spinal or lower extremity injury or surgery in the last year identifiable back pain or known pathology known rheumatological condition oral or injectable corticosteroids in the lumbar spine within the last 3 months psychiatric disorder pregnancy manual treatment of the lumbo-sacral region 1 month prior to the experimentation and during the week of the study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Nathaly Gaudreault, PhD overall official affiliation Université de Sherbrooke overall official role Study Director overall official name Mélanie Morin, PhD overall official affiliation Université de Sherbrooke overall official role Study Director location list location location facility Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke location city Sherbrooke location state Quebec location zip J1H 5N4 location country Canada i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001416 condition mesh term Back Pain condition mesh id D000017116 condition mesh term Low Back Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M18585 condition browse leaf name Low Back Pain condition browse leaf as found Low Back Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M3866 condition browse leaf name Back Pain condition browse leaf as found Back Pain condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04830566

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full study rank 61566 study protocol section identification module n c t id NCT04834804 org study id info org study id 23032015 organization org full name University of Bologna org class OTHER brief title Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men official title Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 2, 2019 start date type Actual primary completion date struct primary completion date December 2, 2019 primary completion date type Actual completion date struct completion date December 2, 2019 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Francesco Campa responsible party investigator title Principal investigator responsible party investigator affiliation University of Bologna lead sponsor lead sponsor name University of Bologna lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The present investigation lasted a total of 16 weeks, of which 4 were employed for assessment and measurements and 12 weeks were used for the exercise treatment. The participants underwent two different training programs carried out in three weekly 75-min sessions, on alternate days (Mondays, Wednesdays and Fridays, in the morning). Each session of both training programs consisted of a warm-up at the beginning and general stretching at the end. The exercises used in the suspension training program were: squat, rear deltoid row, biceps curl, chest press, low row, rotational ward, split squat whit Y deltoid fly, triceps pushdown. The exercises used in the free weight training program were: squat with support, unilateral squat, hip adduction and abduction, calves, hip flexor, alternating curl, French triceps press, and high row. Eleven participants were included in the control group. conditions module condition list condition Effect of Different Exercise Programs on Body Composition design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 36 enrollment type Actual arms interventions module arm group list arm group arm group label Suspension training group arm group type Experimental arm group intervention list arm group intervention name Other: Physical activity arm group label Free weight training group arm group type Experimental arm group intervention list arm group intervention name Other: Physical activity arm group label Control group arm group type No Intervention intervention list intervention intervention type Other intervention name Physical activity intervention description 12 weeks of exercise training intervention arm group label list intervention arm group label Free weight training group Suspension training group outcomes module primary outcome list primary outcome primary outcome measure Body composition primary outcome description Fat mass primary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria: not having chronic disabling diseases not being bedridden institutionalized or hospitalized have their own mobility, without assistance from people, even if they have the aid of devices -without amputations. Exclusion Criteria: the use of pacemakers and the presence of chronic and uncontrolled metabolic diseases healthy volunteers Accepts Healthy Volunteers gender Male minimum age 65 Years std age list std age Older Adult contacts locations module location list location location facility Francesco Campa location city Bologna location zip 40126 location country Italy i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions

NCT04834804

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full study rank 61915 study protocol section identification module n c t id NCT04830254 org study id info org study id TENS21 organization org full name Cairo University org class OTHER brief title Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients official title Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date January 20, 2021 start date type Actual primary completion date struct primary completion date May 12, 2021 primary completion date type Actual completion date struct completion date May 20, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 26, 2021 last update post date struct last update post date July 27, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Heba Ahmed Ali Abdeen responsible party investigator title Assistant professor responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Cairo University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist. detailed description The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation. conditions module condition list condition Peripheral Arterial Disease design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label study group(A) arm group type Active Comparator arm group description Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks. arm group intervention list arm group intervention name Device: Transcutaneous Electrical Nerve Stimulation(TENS) device arm group label Control group(B) arm group type Sham Comparator arm group description The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation arm group intervention list arm group intervention name Device: Transcutaneous Electrical Nerve Stimulation(TENS) device intervention list intervention intervention type Device intervention name Transcutaneous Electrical Nerve Stimulation(TENS) device intervention description The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks. intervention arm group label list intervention arm group label Control group(B) study group(A) intervention other name list intervention other name TENS outcomes module primary outcome list primary outcome primary outcome measure Red cell distribution width (RDW) primary outcome description Peripheral venous blood samples were obtained from each patient. primary outcome time frame change from baseline to after 12 weeks primary outcome measure Mean platelet volume(MPV) primary outcome description Peripheral venous blood samples were obtained from each patient. primary outcome time frame change from baseline to after 12 weeks primary outcome measure Ankle peak systolic velocity (APSV) primary outcome description is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography primary outcome time frame change from baseline to after 12 weeks primary outcome measure Arterial diameter primary outcome description Diameter of lower limb arteries measured by doppler ultrasonography primary outcome time frame change from baseline to after 12 weeks secondary outcome list secondary outcome secondary outcome measure Actual claudication distance secondary outcome description Claudication pain distance was measured after running on a treadmill constant walking speed of 2 mile/hour at 0% grade, with gradual increases in grade of 2.0% every 2 minutes. secondary outcome time frame change from baseline to after 12 weeks eligibility module eligibility criteria Inclusion Criteria: Unilateral Leriche-Fontaine stage-II PAD Both sexes Aged 50 to 60 years Outpatients Clinically stable Sedentary Not participating in any physical activity last 3 months Exclusion Criteria: Walking disorders related to orthopedic or neuromuscular disease Renal insufficiency requiring dialysis (Renal diseases) Known and documented myopathy Progressive cancer Associated progressive disease causing a deterioration in general health Participation in another research protocol Skin disorder making it impossible to use TENS Absolute contraindication to physical activity Presence of a pacemaker/defibrillator healthy volunteers No gender All minimum age 50 Years maximum age 60 Years std age list std age Adult contacts locations module location list location location facility Faculty of Physical Therapy location city Cairo location zip 12316 location country Egypt i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000058729 condition mesh term Peripheral Arterial Disease condition mesh id D000016491 condition mesh term Peripheral Vascular Diseases condition ancestor list condition ancestor condition ancestor id D000050197 condition ancestor term Atherosclerosis condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M28366 condition browse leaf name Peripheral Arterial Disease condition browse leaf as found Peripheral Arterial Disease condition browse leaf relevance high condition browse leaf id M18046 condition browse leaf name Peripheral Vascular Diseases condition browse leaf as found Peripheral Arterial Disease condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04830254

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full study rank 61932 study protocol section identification module n c t id NCT04830033 org study id info org study id SHIELD COVID - ENO sub-study 2 organization org full name Imperial College London org class OTHER brief title ENO Breathe vs Usual Care in COVID-19 Recovery official title A Randomised Controlled Trial of the English National Opera Breathe Programme Compared With Usual Care in People Recovering From COVID-19 acronym SHIELD ENO status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date April 28, 2021 start date type Actual primary completion date struct primary completion date September 23, 2021 primary completion date type Actual completion date struct completion date September 23, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date November 22, 2021 last update post date struct last update post date December 3, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Imperial College London lead sponsor class OTHER collaborator list collaborator collaborator name Imperial College Healthcare NHS Trust collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A randomised clinical trial to assess the impact of an online singing, breathing and wellbeing programme (ENO Breathe) developed specifically for people recovering from COVID-19. detailed description BACKGROUND: ENO Breathe is a breathing and wellbeing programme developed specifically for people recovering from COVID-19, who are still suffering from breathlessness and associated anxiety. Delivered by ENO in collaboration with Imperial College Healthcare teams entirely online, the programme focuses on breathing re-training through singing. Initial evaluation of the project suggested health improvements related to participation, however, a properly conducted efficacy study is needed. DESIGN: An assessor blind, parallel group, randomised controlled trial, to assess the effects of ENO Breathe compared to usual care on health status. The study will also evaluate the impact on respiratory symptoms, anxiety, depression, and breathlessness perception to investigate the mechanisms involved. RESEARCH QUESION AND OUTCOME MEASURES: The primary outcome will be change in health status, assessed using the RAND-36 tool (RAND SF-36), comparing ENO Breathe and Usual Care arms. Additional endpoints will be: the COPD assessment test score (CAT), 0-100 Visual Analogue Scales (VAS) for breathlessness (at rest, walking around the house, climbing stairs, and running), Dyspnoea-12, anxiety (GAD-7), and depression (PHQ-9). Assessments: The outcomes outlined above will be recorded at baseline prior to randomisation, and then repeated after 6 weeks. POPULATION: Adult patients recovering from COVID-19 will be recruited from specialist COVID-19 clinics, where participants will have been fully assessed and investigated by referring healthcare professionals. Participants in the active arm will attend once weekly ENO online workshop sessions for 6 weeks, and have access to bespoke online digital resources, designed to support participants between sessions. The comparison arm will receive usual care. Randomization will be 1:1. SAMPLE SIZE Sample size: Based on pilot data in people with COPD, where the standard deviation (SD) for change in SF-36 was 15 points, to identify a clinically relevant 10 point difference in SF-36 responses at a 0.05 level of significance with a 90% power would require 48 patients in each treatment arm. Allowing for 20% dropout, we will therefore recruit 120 patients. Primary analysis will be on an intention to treat basis. Change in parameters will be assessed comparing ENO Breathe and Usual Care, using Generalised Linear Models to estimate treatment effects. In order to better understand changes in the RAND-36 "anchor measure", the investigator will relate this to changes in measures of anxiety, depression, breathlessness, and other respiratory symptoms. An additional responder analysis will compare the proportion in each treatment arm achieving a clinically important (10%) improvement in RAND-36 scores. Update 21 JUNE 2021 To calculate the sample size, pilot data from a singing-based intervention in COPD, (considered the most relevant data available at study inception) was used, as outlined above, where the researchers aimed to recruit 120 patients. Data subsequently became available from ENO Breathe participants that rook part in the program prior to the research study, in which the SD was 8 for change in SF-36 scores. We have also decided using an MCID of 5 for the SF-36 is more appropriate, as this is not specific to a particular medical condition. As such, a total sample of 108 participants is required, using 1 to 1 study arm allocation. Allowing for 30% dropout, which is more appropriate, 158 participants will be recruited. Additionally, as a higher than expected number of participants were considered, study withdrawals due to be unable to attend the session times they were allocated, or despite meeting inclusion criteria, 1-to-1 meeting with the session leaders highlighted issues related excessive fatigue precipitated by exertion, so were not deemed appropriate at that point in time. As such, the researchers will also conduct a modified intention to treat analysis including all participants who were randomised and were deemed appropriate to participate following their 1-to-1. This consideration had not been included in the original exclusion criteria, due to limited awareness of its relevance at that time. These changes have been made, and here documented, before any baseline data has been sent to the analysis team, and before any follow up data has been collected. conditions module condition list condition COVID-19 Recovery design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design masking description Masking of participants not possible due to the nature of the intervention. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 153 enrollment type Actual arms interventions module arm group list arm group arm group label ENO Breathe group arm group type Experimental arm group description Participation in the online ENO Breathe programme for 6 weeks. arm group intervention list arm group intervention name Other: ENO Breathe group arm group label Usual Care Group arm group type No Intervention arm group description Participants continue with usual care. intervention list intervention intervention type Other intervention name ENO Breathe group intervention description Six weekly group online workshop sessions, led by an ENO vocal specialist. Workshops will encourage participants to take part in exercises and activities especially designed to support breathing control, providing tools for self-management of breath and anxiety. They will also have access to bespoke online digital resources, designed to support participants between sessions. These will include exercises, song sheets and audio and video materials, especially recorded by the ENO for participants on the programme. intervention arm group label list intervention arm group label ENO Breathe group outcomes module primary outcome list primary outcome primary outcome measure Change from baseline in RAND-36 (RAND SF-36) primary outcome description A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability. primary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome list secondary outcome secondary outcome measure Changes in COPD assessment test (CAT) secondary outcome description A respiratory disease health status measure that has been validated in people recovering from COVID-19. This includes 8 items, scored 0-5 with a possible score from 0 (best) to 40 (worst). secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Generalised Anxiety Disorder Assessment (GAD-7) secondary outcome description Self-administered questionnaire to assess for symptoms, and severity, of anxiety. Includes seven questions scored from 0 to 3, giving a total score out of 21. Lower scores indicate less symptoms of anxiety. secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Patient Health Questionnaire 9 (PHQ-9) secondary outcome description Self-administered questionnaire to assess for symptoms, and severity, of depression. Includes nine questions scored from 0 to 3, giving a total score out of 27. Lower scores indicate less symptoms of depression. secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Dyspnoea-12 questionnaire secondary outcome description Assessment of dyspnoea. Includes 12 descriptors scored from 0 to 3, giving a total score of 36. Lower scores indicate less severe dyspnoea. secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in Visual Analogue Scale ratings of breathlessness secondary outcome description Four Visual Analogue Scales, scored from 0 to 100, for participants to rate their breathlessness while i) at rest, ii) walking around the house, iii) climbing stairs, iv) running. Higher scores indicate more severe dyspnoea (breathlessness). secondary outcome time frame At baseline, then repeated after 6 weeks. secondary outcome measure Changes in SF-6D (Short-Form Six-Dimension) scores secondary outcome description The SF-6D uses data from the RAND SF-36 to generate a continuous index for health that can be used to create a quality-of-life score for cost utility analysis. secondary outcome time frame At baseline, then repeated after 6 weeks. eligibility module eligibility criteria Inclusion Criteria: Adults recovering from COVID-19 with ongoing breathlessness and/or anxiety. Referred from a specialist COVID-19 clinics aligned with the project, after appropriate clinical evaluation and investigation Internet access with appropriate device (e.g. computer or tablet) Exclusion Criteria: - Unable to participate due to comorbidity (e.g. life limiting illness, cognitive impairment) healthy volunteers No gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Nicholas S Hopkinson overall official affiliation Imperial College London overall official role Principal Investigator location list location location facility National Heart and Lung Institute, Imperial College London location city London location zip SW3 6NP location country United Kingdom references module reference list reference reference p m i d 35489367 reference type derived reference citation Philip KEJ, Owles H, McVey S, Pagnuco T, Bruce K, Brunjes H, Banya W, Mollica J, Lound A, Zumpe S, Abrahams AM, Padmanaban V, Hardy TH, Lewis A, Lalvani A, Elkin S, Hopkinson NS. An online breathing and wellbeing programme (ENO Breathe) for people with persistent symptoms following COVID-19: a parallel-group, single-blind, randomised controlled trial. Lancet Respir Med. 2022 Sep;10(9):851-862. doi: 10.1016/S2213-2600(22)00125-4. Epub 2022 Apr 27. i p d sharing statement module i p d sharing Yes i p d sharing description Data will be shared on reasonable request. i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame The data will be available from the date of publication of the main study, and will remain available for at least 2 years. i p d sharing access criteria Data will be shared on reasonable request. derived section misc info module version holder December 02, 2022 submission tracking submission info list submission info submission release date September 27, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology

NCT04830033

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full study rank 61309 study protocol section identification module n c t id NCT04838145 org study id info org study id 2015-003350-41 organization org full name Oslo University Hospital org class OTHER brief title The Diabetes Virus Detection and Intervention Trial official title The Diabetes Virus Detection and Intervention Trial acronym DiViDInt status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date August 30, 2018 start date type Actual primary completion date struct primary completion date October 25, 2020 primary completion date type Actual completion date struct completion date October 25, 2020 completion date type Actual study first submit date January 4, 2019 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lars Krogvold responsible party investigator title Consultant responsible party investigator affiliation Oslo University Hospital lead sponsor lead sponsor name Oslo University Hospital lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary A randomized, double-blind, placebo-controlled study in 96 children and adolescents age 6-15 newly diagnosed with type 1 diabetes to describe the influence of antiviral treatment (Pleconaril and Ribavirin) on progression of disease and residual insulin secretion. detailed description If antiviral treatment is efficient in halting the disease progression, it will be to great benefit for the participating patients. Maintenance or even an increase in beta cell mass due to regeneration will lead to improved endogenous insulin production and give a milder course of the disease with improved glycemic control. This will in a substantial way improve the long-term prognosis with less severe long term vascular complications.Some patients may have close to complete remission and be able to stop insulin treatment. If antiviral treatment is effective, it would add proof to the concept that type 1 diabetes in its origin is a viral disease. This would be an important milestone in medical research and a breakthrough in the understanding of the etiopathogenesis of autoimmune diseases. It may promote the development of vaccines to prevent the disease. T1D seems more aggressive in children than in adults, and the beta cell function decline rapidly compared to adults. As a consequence, the effect of antiviral treatment will potentially be more significant in children than in adults. Children have higher HbA1c which increases the risk of complications. Thus, T1D is a more aggressive disease in children than in adults and hence it's important to do this study in children. Pharmaceuticals are usually studied in different age intervals, commonly 1-6 years, 6-12 years and 12-15 years. For safety reasons and simplicity, the investigators want to start with the two older groups. The investigators will treat the participants with two antiviral medications (Pleconaril and ribavirin) or placebo in a double blind, randomized, placebo controlled, parallel group study. Pleconaril has previously been given in doses of 5-10mg/kg x 2-3 in clinical trials in children, thus achieving serum levels high enough for killing the majority of the viruses. The investigators have, due to the long treatment period, reduced the doses to 5 mg/kg x 2. Ribavirin will be given in dosages according to Summariy of product characteristics (SmPC). The investigators have chosen to administer Investigational Medicinal Product (IMPs) as an oral solution as this will make it easier to give the medication according to weight. conditions module condition list condition Type1 Diabetes Mellitus Enterovirus keyword list keyword Type 1 diabetes Children Enterovirus Recent onset design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A double-blind, placebo controlled, prospective, randomized trial examining the effect of antiviral treatment given for 6months on residual insulin secretion design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 96 enrollment type Actual arms interventions module arm group list arm group arm group label Active treatment arm group type Active Comparator arm group description Pleconaril: 5 mg/kg x2 times a day for 26 weeks up to 40 kg. Max dose 300mg x2. Ribavirin:15 (7.5) mg/kg/day divided in two doses daily for 26 weeks: Max dose 1000mg/24h if body weight<75kg and 1200mg if body weight>75kg. arm group intervention list arm group intervention name Drug: Ribavirin + Pleconaril arm group label Placebo arm group type Placebo Comparator arm group description Receives placebo, on a double blind basis arm group intervention list arm group intervention name Drug: Placebos intervention list intervention intervention type Drug intervention name Ribavirin + Pleconaril intervention description Randomized to treatment with study drugs (ribavirin and pleconaril) intervention arm group label list intervention arm group label Active treatment intervention type Drug intervention name Placebos intervention description Randomized to treatment with placebo intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Insulin secretion primary outcome description Change in mean residual insulin secretion in the Insulin tolerance test (ITT)-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to12 months after initiation of study treatment. primary outcome time frame 12 months secondary outcome list secondary outcome secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 3 months after initiation of study treatment. secondary outcome time frame 3 months secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 6 months after initiation of study treatment. secondary outcome time frame 6 months secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 24 months after initiation of study treatment. secondary outcome time frame 24 months secondary outcome measure Insulin secretion secondary outcome description Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 36 months after initiation of study treatment. secondary outcome time frame 36 months secondary outcome measure Stimulated c-peptide secondary outcome description Proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide >0.2 pmol/L secondary outcome time frame 36 months secondary outcome measure C-peptide filter paper secondary outcome description Fasting and meal stimulated C-peptide from blood sampled on filter paper at home at 4 weekly intervals throughout the study period secondary outcome time frame 36 months secondary outcome measure Insulin dose secondary outcome description Mean Insulin dosage per kilo bodyweight per 24 hours secondary outcome time frame 36 months secondary outcome measure HbA1c secondary outcome description HbA1c at every control secondary outcome time frame 36 months secondary outcome measure Hypoglycemic events secondary outcome description Number of severe hypoglycaemic events and less severe events requiring assistance from others with blood glucose values ≤ 3.9 mmol/L will be registered at each control secondary outcome time frame 36 months secondary outcome measure Insulin-dose-adjusted HbA1c (IDAA1c) secondary outcome description HbA1c adjusted to insulin dose secondary outcome time frame 36 months secondary outcome measure Proinsulin/c-peptide ratio in serum secondary outcome description Proinsulin/c-peptide ratio in serum as a measure of beta cell stress secondary outcome time frame 36 months secondary outcome measure Presence of enterovirus secondary outcome description Presence of enterovirus and rhinovirus and/or neutralizing antibodies against those viruses in nose, blood, saliva and stool secondary outcome time frame 36 months eligibility module eligibility criteria Inclusion Criteria: Diagnosed type 1 Diabetes (E10.9). First injection of insulin maximum three weeks prior to inclusion. Must be willing and capable of taking the study drugs and meet for tests and follow up as described. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice (ICH GCP), and national/local regulations. Aged 6.00-15.99 years at inclusion Exclusion Criteria: Treatment with any oral or injected anti-diabetic medications other than insulin. A history of haemolytic anaemia or significantly abnormal haematology results at screening. History of severe cardiac disease previous six months. Impaired renal function Patients taking ethinyl estradiol Participation in other clinical trials with a new chemical entity within the previous 3 months. Inability or unwillingness to comply with the provisions of this protocol Females who are lactating or pregnant. Males or females (after menarche) not willing to use highly effective contraception (progesterone-only hormonal anticonception with inhibition of ovulation or sexual abstinence) and barrier contraception (condoms), if sexually active during the treatment period and in the following 7 months Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study. healthy volunteers No gender All minimum age 6 Years maximum age 15 Years std age list std age Child contacts locations module overall official list overall official overall official name Knut Dahl-Jørgensen, MD, PhD overall official affiliation Professor overall official role Principal Investigator location list location location facility Pediatric department, Oslo University Hospital location city Oslo location zip 0514 location country Norway i p d sharing statement module i p d sharing No i p d sharing description The data and material collected from the placebo-group will be shared with the "Innodia" consortium derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004769 condition mesh term Enterovirus Infections condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003922 condition mesh term Diabetes Mellitus, Type 1 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000010850 condition ancestor term Picornaviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007239 condition ancestor term Infections condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M6269 condition browse leaf name Diabetes Mellitus, Type 1 condition browse leaf as found Type 1 Diabetes condition browse leaf relevance high condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M7082 condition browse leaf name Enterovirus Infections condition browse leaf as found Enterovirus condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M12897 condition browse leaf name Picornaviridae Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000012254 intervention mesh term Ribavirin intervention mesh id C000115201 intervention mesh term Pleconaril intervention ancestor list intervention ancestor intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M14235 intervention browse leaf name Ribavirin intervention browse leaf as found Type 2 intervention browse leaf relevance high intervention browse leaf id M340095 intervention browse leaf name Pleconaril intervention browse leaf as found Tourniquet cuff intervention browse leaf relevance high intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04838145

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full study rank 61776 study protocol section identification module n c t id NCT04832074 org study id info org study id CamiloJcU21 organization org full name Camilo Jose Cela University org class OTHER brief title Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling official title Immediate Stiffness Changes in Upper Trapezius Active Myofascial Trigger Points After Dry Needling in Patients With Neck Pain: A Randomized, Double-Blinded, Placebo-Controlled Trial acronym ELECTROP status module status verified date May 2021 overall status Completed expanded access info has expanded access No start date struct start date May 5, 2021 start date type Actual primary completion date struct primary completion date May 18, 2021 primary completion date type Actual completion date struct completion date May 19, 2021 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date February 20, 2022 last update post date struct last update post date February 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Camilo Jose Cela University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Shear-wave elastography (SWE) is considered as a useful tool for quantifying muscle stiffness. Considering that Myofascial Trigger Points (MTrP) are defined as "hyperirritable zones in contracted bands of muscle, thought to be caused by muscle overload or stress" and the effectiveness of dry needling applied to active MTrP for reducing pain and disability, the aim of this study is to assess the effects of sham and real dry needling, applied to active MTrP in the upper trapezius muscle in patients with chronic neck pain, on the muscle stiffness in two areas: 1) the most symptomatic area and 2) a control point. conditions module condition list condition Myofascial Pain Syndrome Neck Pain Trigger Point Pain, Myofascial design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized, Double-Blinded, Placebo-Controlled Trial design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Dry Needling arm group type Experimental arm group description Dry needling will be performed with 'solid filiform needles'. The procedure is as follows: The participant will lie in the prone position. The overlying skin will be cleaned with antiseptic spray. The taut band and MTrP, will be localized manually. After measuring the Pain Pressure Thresholds in this location and the control (located 3 cm lateral to the MTrP), the needle within its plastic guide tube will be placed over the MTrP. After a tapping movement to insert the needle, the needle will be moved to the muscle around the bundle and moved forward and backward to the tissue to elicit a small muscle twitch. After eliciting LTR, needling will be stopped. If no twitch were elicited, needling will stopped after two or three stellate movements arm group intervention list arm group intervention name Other: Dry Needling arm group label Sham Dry Needling arm group type Sham Comparator arm group description The same approach will be used with the exception of piercing the skin. The guide tube will press against the tissue and the sham needle will be allowed to drop against the skin. The handle will be tapped briskly but not breaking the skin. The sham needle will stay within the guide tube and will be pressed against the skin twice so as to mimic the quick "in and out" technique. arm group intervention list arm group intervention name Other: Sham Dry Needling intervention list intervention intervention type Other intervention name Dry Needling intervention description Real Dry Needling in the most active Myofascial Trigger Point intervention arm group label list intervention arm group label Dry Needling intervention type Other intervention name Sham Dry Needling intervention description Sham Dry Needling in the same location, but not piercing the skin intervention arm group label list intervention arm group label Sham Dry Needling outcomes module primary outcome list primary outcome primary outcome measure SWE - Young modulus primary outcome description KPa primary outcome time frame Baseline primary outcome measure SWE - Young modulus primary outcome description KPa primary outcome time frame 10 minutes primary outcome measure SWE - Local shear wave speed primary outcome description m/s primary outcome time frame Baseline primary outcome measure SWE - Local shear wave speed primary outcome description m/s primary outcome time frame 10 minutes primary outcome measure Pain Pressure Thresholds primary outcome description kg/cm2 primary outcome time frame Baseline primary outcome measure Pain Pressure Thresholds primary outcome description kg/cm2 primary outcome time frame 10 minutes secondary outcome list secondary outcome secondary outcome measure Visual Analogue Scale secondary outcome description 0-10 secondary outcome time frame Baseline secondary outcome measure Neck Disability Index secondary outcome description 0-100 secondary outcome time frame Baseline eligibility module eligibility criteria Inclusion Criteria: Patients between 18 and 65 and Presence of mechanical neck pain for at least three months duration Presence of at least one active MTrP in the Upper Trapezius muscle Exclusion Criteria: Neck pain of traumatic origin (such as whiplash-associated disorder) Current use of any kind of analgesic therapy Presenting any condition usually considered a perpetuating factor of MTrPs, such as fibromyalgia, hypothyroidism, or iron deficiencies Presenting any contraindication for Dry Needling application Neuropathies (e.g., radiculopathy) Bilateral Pain healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Juan Antonio Valera-Calero, PhD overall official affiliation Camilo José Cela University overall official role Principal Investigator location list location location facility Francisco de Vitoria University location city Pozuelo De Alarcón location state Madrid location zip 28223 location country Spain references module reference list reference reference p m i d 35765779 reference type derived reference citation Valera-Calero JA, Sanchez-Jorge S, Buffet-Garcia J, Varol U, Fernandez-de-Las-Penas C, Alvarez-Gonzalez J. Changes in stiffness at active myofascial trigger points of the upper trapezius after dry needling in patients with chronic neck pain: a randomized controlled trial. Acupunct Med. 2022 Jun 28:9645284221104831. doi: 10.1177/09645284221104831. Online ahead of print. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009209 condition mesh term Myofascial Pain Syndromes condition mesh id D000005356 condition mesh term Fibromyalgia condition mesh id D000019547 condition mesh term Neck Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M7638 condition browse leaf name Fibromyalgia condition browse leaf as found Myofascial Pain Syndrome condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M20638 condition browse leaf name Neck Pain condition browse leaf as found Neck Pain condition browse leaf relevance high condition browse leaf id M11313 condition browse leaf name Myofascial Pain Syndromes condition browse leaf as found Myofascial Pain Syndrome condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3367 intervention browse leaf name Anti-Infective Agents, Local intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04832074

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full study rank 61300 study protocol section identification module n c t id NCT04838262 org study id info org study id MH123928 organization org full name The University of Texas at Arlington org class OTHER brief title Stress and the Sympathetic Nervous System in Adults With Depression official title Daily Stress Processes and Sympathetic Reactivity in Depression status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Actual primary completion date struct primary completion date March 2023 primary completion date type Anticipated completion date struct completion date March 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 26, 2022 last update post date struct last update post date May 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name The University of Texas at Arlington lead sponsor class OTHER collaborator list collaborator collaborator name Penn State University collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To test our hypotheses, we will enroll healthy adults having no history of mood disorders and adults with major depressive disorder (MDD) having a broad range of depressive symptom severity. After screening, subjects will meet with the research coordinator or an investigator for a discussion, with opportunity for questions, before applicable consent forms are obtained. Daily stress processes will be assessed using an ecological momentary assessment approach for 8 consecutive days. On the last day of the daily stress assessment, we will directly measure muscle sympathetic nerve activity, blood pressure, and heart rate during acute laboratory-based cognitive, emotional, and physiological interventions to induce a stress response. A venous blood sample will be taken for measurements of metabolic and renal health and systemic inflammation. Aim 1: To examine the effect of daily psychosocial stressor exposure on acute sympathetic stress reactivity in MDD. Two stressor exposure indicators will be calculated: stressor frequency (i.e., percentage of interview days during which at least one stressor occurred) and total stress (i.e., total number of stressors reported across all interview days) and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults. Aim 2: To determine the relation between negative affective reactivity to daily psychosocial stressor exposure and acute sympathetic stress reactivity in MDD. Negative affective reactivity will be calculated as the change in affect on days when stressors occurred compared to one's typical affect on non-stressor days and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults. conditions module condition list condition Major Depressive Disorder design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Assessment of Daily Stress Processes arm group type Experimental arm group description Subjects will report cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. arm group intervention list arm group intervention name Other: Acute Stressors intervention list intervention intervention type Other intervention name Acute Stressors intervention description Sympathetic nervous system activity and blood pressure will be measured before, during, and after several acute laboratory-based cognitive (Stroop Color Word Test), emotional (International Affective Picture System), and physiological (Cold Pressor Test) stressors. intervention arm group label list intervention arm group label Assessment of Daily Stress Processes outcomes module primary outcome list primary outcome primary outcome measure total number of daily stressors primary outcome description measured each day via self-report using ecological momentary assessment primary outcome time frame 8 days before intervention primary outcome measure change in negative affect in response to daily stressors primary outcome description measured each day via self-report using ecological momentary assessment primary outcome time frame 8 days before intervention primary outcome measure change in muscle sympathetic nerve activity in response to acute stress (compared to resting baseline activity) primary outcome description measured using microneurography primary outcome time frame during laboratory-based intervention (3 minutes) eligibility module eligibility criteria Inclusion Criteria: All participants will be 18-30 yrs. Healthy non-depressed men and women will have no history or evidence of psychiatric illness and will not have a family history of MDD or major psychiatric illness. Men and women with MDD will have symptomatic depression that meets diagnostic criteria and will be non-medicated. The capacity and willingness to provide written informed consent, to attend all study related visits, and to comply with the study protocol. Exclusion Criteria: Subjects will be excluded at the discretion of the PI/collaborating clinician or for any of the following reasons: psychiatric illness aside from MDD (including current or past psychotic disorders, bipolar disorder, schizophrenia or schizoaffective disorder, panic disorder, post-traumatic stress disorder, obsessive compulsive disorder) subthreshold depression current use of psychotropic medications (including major classes of antidepressants, anxiolytics, antipsychotics, mood stabilizers) active suicidal or homicidal ideation active substance dependence or eating disorders current use of any medications that could alter sympathetic reactivity diagnosed or suspected cardiovascular, renal, or metabolic disease (hypertension, heart disease, diabetes, hyperlipidemia) autonomic disorders tobacco use (including electronic cigarettes) obesity (body mass index > 30 kg/m2) breastfeeding or pregnancy <18 or >30 yrs healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module central contact list central contact central contact name Jody Greaney, PhD central contact role Contact central contact phone 817-272-7891 central contact e mail jody.greaney@uta.edu location list location location facility The University of Texas at Arlington location status Recruiting location city Arlington location state Texas location zip 76010 location country United States location contact list location contact location contact name Jody Greaney, PhD location contact role Contact location contact phone 817-272-7891 location contact e mail jody.greaney@uta.edu location contact name Jody Greaney, PhD location contact role Principal Investigator i p d sharing statement module i p d sharing Yes i p d sharing description Per the data sharing policy of the National Institute of Mental Health (NIMH), we will deposit all phenotypic, psychosocial stress, and sympathetic reactivity data from this study to the NIMH Data Archive. We will use standard data dictionaries (NIH Toolbox Cognition Battery, NIH Toolbox Emotion Battery, PHQ-9) and will collect the data necessary to generate global unique identifiers for each study subject. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000003865 condition mesh term Depressive Disorder, Major condition ancestor list condition ancestor condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf relevance low condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depressive Disorder condition browse leaf relevance high condition browse leaf id M6212 condition browse leaf name Depressive Disorder, Major condition browse leaf as found Major Depressive Disorder condition browse leaf relevance high condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions

NCT04838262

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full study rank 61799 study protocol section identification module n c t id NCT04831775 org study id info org study id 00000464 organization org full name University of Texas at Austin org class OTHER brief title Cognitive Training for Diabetes Self-Management official title Cognitive Training for Diabetes Self-Management status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Actual primary completion date struct primary completion date March 28, 2023 primary completion date type Anticipated completion date struct completion date March 28, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 16, 2022 last update post date struct last update post date May 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Texas at Austin lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes. detailed description Aim 1: Test the efficacy of the MAPSS-DM intervention for improving cognitive function, A1C, and DM-SM. Based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved DM-SM immediately post-intervention and at three and six-months post-intervention. Aim 2: To explore changes in glycemic variability and their association with changes in cognitive function. The working hypothesis here is that MAPSS-DM participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance. conditions module condition list condition Diabetes Mellitus, Type 2 keyword list keyword cognitive function glucose variability design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design masking description The intervention will be delivered by a research assistant and outcome data collection will be done by two other research assistants design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Memory, Attention, and Problem Solving Skills for Diabetes arm group type Experimental arm group description The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice over 8 weeks. Classes 1 & 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. The computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on. The intervention group will be asked to practice 20 minutes, 7 days a week. arm group intervention list arm group intervention name Behavioral: Memory, Attention, and Problem Solving Skills for Diabetes arm group label Brain Games Only arm group type Active Comparator arm group description An active control group will be used. The differing variable between the two groups is the class sessions. Those randomized to the control group will only receive a link to the BrainHQ games site. A specific amount of practice will not be prescribed, but the frequency and duration of participant's practice will be obtained from BrainHQ. Participants will receive a weekly phone call to maintain connection to the study. Data collection will be on the same schedule as the intervention group. arm group intervention list arm group intervention name Behavioral: Brain Games intervention list intervention intervention type Behavioral intervention name Memory, Attention, and Problem Solving Skills for Diabetes intervention description The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice and will be held over 8 weeks. The classes will be taught by a GRA. Classes 1 & 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. Each online class will follow the same format: (1) introduction/revisiting content from the previous class; (2) review of progress on computer exercises; (3) practicing cognitive strategies in class; and (4) a weekly topic. The GRA will also prescribe exercises for the following weeks. intervention arm group label list intervention arm group label Memory, Attention, and Problem Solving Skills for Diabetes intervention type Behavioral intervention name Brain Games intervention description The computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Participants will only need a computer, smart phone, or tablet with Internet access to securely log onto the website. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on. intervention arm group label list intervention arm group label Brain Games Only intervention other name list intervention other name BrainHQ outcomes module primary outcome list primary outcome primary outcome measure Change in A1C at week 22 primary outcome description Measure of average glucose over 3 months primary outcome time frame Baseline, and week 22 primary outcome measure Change in diabetes self-management adherence at week 22 primary outcome description Summary of Diabetes Self-Care Activities: 8 items; Brief assessment of diabetes related psychosocial self-efficacy. Responses are made on a 5-point scale (1 = strongly disagree to 4 = strongly agree) to items such as "I believe that I am able to turn my diabetes goals into a workable plan." Cronbach's alphas range from 0.81 to 0.96. Higher scores indicate higher levels of self-management adherence. primary outcome time frame Baseline, week 8, and week 22 primary outcome measure Change in glucose variability at week 22 primary outcome description Continuous Glucose Monitor (CGM): To be worn for 2 weeks at baseline and week 22; The following glucose composites will be calculated: (1) the overall mean, (2) the proportion of readings indicating hypoglycemia (%<70mg/dL), (3) the proportion of readings indicating hyperglycemia (% >160mg/dL), (4) the proportion of out of range readings (% either <70mg/dL or >160mg/dL) and (5) the SD of CGM glucose readings. primary outcome time frame Baseline, week 8, and week 22 primary outcome measure Change in attention, visual scanning and motor speed at week 22 primary outcome description Symbol Digit Modalities Test: Participants are given a series of symbols and digits and instructed to verbalize the digit associated with each symbol. The number of correct responses in 90 sec constitutes the score, and higher scores reflect better cognitive function. primary outcome time frame Baseline, week 8, and week 22 secondary outcome list secondary outcome secondary outcome measure Change in perceived cognitive function at week 22 secondary outcome description PROMIS v2.0 - Cognitive Function: 32 items; assess patient-perceived cognitive deficits including the areas of mental acuity, concentration, verbal and nonverbal memory, and verbal fluency. Reliability has been measured at 0.94 and test-retest correlation at 0.83. Higher scores indicate more perceived difficulty with cognitive function. secondary outcome time frame Baseline, week 8, and week 22 eligibility module eligibility criteria Inclusion Criteria: age 50 years old or greater T2DM diagnosis for 2 years access to phone and Internet Score of ≥10 on the Perceived Deficits Questionnaire (PDQ) A1C of >7%. Exclusion Criteria: a diagnosis of dementia/head injury score of >5 on the Mini-Cog inability to speak English, and T1DM diagnosis healthy volunteers Accepts Healthy Volunteers gender All minimum age 50 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Heather E Cuevas, PhD central contact role Contact central contact phone 15124226059 central contact e mail hcuevas@mail.nur.utexas.edu overall official list overall official overall official name Heather E Cuevas, PhD overall official affiliation The University of Texas at Austin overall official role Principal Investigator location list location location facility The University of Texas at Austin location status Recruiting location city Austin location state Texas location zip 78712 location country United States location contact list location contact location contact name Heather E Cuevas, PhD location contact role Contact location contact phone 512-422-6059 location contact e mail hcuevas@mail.nur.utexas.edu i p d sharing statement module i p d sharing No i p d sharing description Only de-identified quantitative and qualitative data will be available to other qualified researchers upon request from the PI two years after completion of the study. After review of the purpose of the data request to make sure it is consistent with the original project goals and verification that the request meets IRB approval, de-identified data may be shared with researchers two years after completion of the study. It is recognized that the government reserves the right to identify repositories for submission of data for archive as stated in the grant instructions. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003924 condition mesh term Diabetes Mellitus, Type 2 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf as found Diabetes Mellitus, Type 2 condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse leaf id T433 intervention browse leaf name Tannic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements

NCT04831775

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full study rank 61783 study protocol section identification module n c t id NCT04831983 org study id info org study id ABRUPT organization org full name University of Milano Bicocca org class OTHER brief title ABlative Radiotherapy (for) Unfavorable Prostate Tumors official title Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer acronym ABRUPT status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date April 1, 2029 primary completion date type Anticipated completion date struct completion date April 1, 2029 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 21, 2022 last update post date struct last update post date July 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Stefano Arcangeli responsible party investigator title Associate Professor responsible party investigator affiliation University of Milano Bicocca lead sponsor lead sponsor name University of Milano Bicocca lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. detailed description Patients enrolled in this observational prospective trial will be offered image-guided, volumetric modulated radiotherapy (IGRT-VMAT) in a single session (SDRT) of 21 Gy to the whole gland with a simultaneous boost of 24 Gy to the macroscopic PI-RADS driven (4-5) tumour(s). ADT will be prescribed concomitantly, as per standard of care. A real time non-ionizing prostate monitoring will be used to account for intra-fractional errors. If the dose constraints to the normal tissues are at risk, these will be prioritised over the aimed boost dose. The primary endpoint of the trial is the treatment related toxicity measured by the CTCAE v5.0. Secondary endpoints are quality of life in different domains (sexual, rectal , urinary) and biochemical outcome. Patients will be followed at one month, then every 3 months for the first 12 months and every 6 months thereafter. Quality of Life will be prospectively evaluated through validated tools (ECOG, EPIC, IIEF-5, IPSS, ICIQ-SF) at various timepoints. Percentage or total mean score will be reported according the questionnaires, whether they grade values in a scale or use descriptive statistics. Kaplan-Meier curve analysis of biochemical relapse free survival (b-RFS) at 2 and 5-year bRFS for all patients will be estimated. conditions module condition list condition Prostate Cancer keyword list keyword Unfavorable Prostate Tumors Stereotactic Body Radiotherapy (SBRT) Volumetric Modulated Arc Therapy (VMAT) Prostate Imaging Reporting and Data System (PI-RADS) Toxicity Quality of Life design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 30 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 primary outcome description To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SD RT with focal boost on dominant lesion(s) for intermediate unfavorable and selected high risk organ-confined prostate cancer. primary outcome time frame 60 months secondary outcome list secondary outcome secondary outcome measure QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL secondary outcome description To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-26 Questionnaire secondary outcome time frame 60 months secondary outcome measure Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best) secondary outcome description To assess erectile function after SDRT using IIEF 5 secondary outcome time frame 60 months secondary outcome measure Number of participants with voiding symptoms assessed by International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst) secondary outcome description To assess voiding symptoms after SDRT using IPSS secondary outcome time frame 60 months secondary outcome measure Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst) secondary outcome description To assess urinary continence after SDRT using ICIQ-SF secondary outcome time frame 60 months secondary outcome measure Number of participants with biochemical relapse assessed by PSA (Phoenix definition) secondary outcome description To assess biochemical outcome after SDRT using serum PSA levels secondary outcome time frame 60 months eligibility module eligibility criteria INCLUSION CRITERIA Histologically proven prostate adenocarcinoma; Intermediate and High risk disease, as per the NCCN definition; N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) Choline or PSMA PET-CT; ECOG performance status between 0 and 2; Life expectancy of > 5 years, in the opinion of the investigator; IPSS score must be ≤ 19 (alpha blockers allowed); EXCLUSION CRITERIA: ≥T3b disease according to the 8th AJCC classification; PSA>20 ng/ml at any time point; Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy); Previous radiotherapy to the pelvis; Previous invasive malignancy unless disease free for a minimum of 5 years; Active Crohn's Disease or Ulcerative Colitis; healthy volunteers No gender Male minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult study population Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA > 20 ng/mL allowed), as per NCCN definition sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name STEFANO ARCANGELI, MD central contact role Contact central contact phone +39 039-2333663 central contact e mail stefano.arcangeli@unimib.it location list location location facility Radiation Oncology, ASST Monza (University of Milan Bicocca) location status Recruiting location city Monza location state MB location zip 20900 location country Italy location contact list location contact location contact name Stefano Arcangeli, MD location contact role Contact location contact phone +39 0 39 2333663 location contact e mail stefano.arcangeli@unimib.it references module reference list reference reference p m i d 30480549 reference type result reference citation Bodo S, Campagne C, Thin TH, Higginson DS, Vargas HA, Hua G, Fuller JD, Ackerstaff E, Russell J, Zhang Z, Klingler S, Cho H, Kaag MG, Mazaheri Y, Rimner A, Manova-Todorova K, Epel B, Zatcky J, Cleary CR, Rao SS, Yamada Y, Zelefsky MJ, Halpern HJ, Koutcher JA, Cordon-Cardo C, Greco C, Haimovitz-Friedman A, Sala E, Powell SN, Kolesnick R, Fuks Z. 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full study rank 61653 study protocol section identification module n c t id NCT04833673 org study id info org study id 333 organization org full name Hacettepe University org class OTHER brief title The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial official title The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial status module status verified date June 2020 overall status Completed expanded access info has expanded access No start date struct start date June 22, 2020 start date type Actual primary completion date struct primary completion date December 30, 2020 primary completion date type Actual completion date struct completion date March 15, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Gülşah Kesik responsible party investigator title res.ass. responsible party investigator affiliation Hacettepe University lead sponsor lead sponsor name Hacettepe University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Even though, current treatments including IVIG, corticosteroids, biological agents can provide positive effects on MS symptoms, MS cannot be cured completely today. Therefore, in addition to the available medical treatment options, patients may tend towards complementary and integrative therapies. Relaxation techniques are one of the non-pharmacological and side-effect-free therapy options that are currently used to alleviate the symptoms of many different chronic diseases. Progressive muscle relaxation exercise (PMR) and Benson relaxation technique (BRT) are two common types of relaxation techniques recommended for symptom management in chronic diseases owing to simple to learn and apply compared to other complementary and integrative methods for patients. PMR is uncomplicated and low-cost method, originally designed by Jacobson (1938), which helps individuals to feel calmer through consecutive muscle tension and relaxation of a muscle group. This method can relieve muscle tension, facilitate sleep, and reduce severity of pain and fatigue. There are studies in the literature reporting the positive effects of PMR on fatigue, sleep quality, quality of life, anxiety and stress in MS patients. One of these techniques which is well tolerated is BRT, designed by Herbert Benson in the 1970s as a nonpharmacologic and behavioral method. This technique led to relaxation using mental imagery and mediation. BRT creates a relaxation influence in the body by decreasing the sympathetic nervous system activity and increasing the parasympathetic nervous system activity. There are few studies in the literature reporting that BRT is beneficial on pain and fatigue in MS patients.To the best of our knowledge, there is no study on the impact of relaxation techniques on pain, fatigue and kinesophobia in MS patients. The aim of this study was to examine and compare the effects of PMR and BRT on abovementioned symptoms in MS patients. conditions module condition list condition Multiple Sclerosis, Relapsing-Remitting Pain, Chronic Fatigue Syndrome, Chronic Kinesiophobia keyword list keyword multiple sclerosis pain fatigue kinesiophobia relaxation techniques muscle relaxation design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A Three Arms Randomized Trial design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 80 enrollment type Actual arms interventions module arm group list arm group arm group label PMR arm group type Experimental arm group description The PMR intervention involving tensing and relaxing the body muscles accompanied with deep breathing. The researchers told each participant to sit in a soundless and breathable room and in a comfortable position before each session at their home. The participants performed tensing and relaxing for each body part in order, starting with the facial muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet; all muscle tension and relaxation procedures were performed with deep breathing. The participants were instructed to tense a specified group of muscles for 5 s and relax it for 10 s while breathing out. Moreover, throughout this exercise, the participants imagined a wave of relaxation flowing over their body. arm group intervention list arm group intervention name Behavioral: PMR: Progressive Muscle Relaxation arm group label BRT arm group type Experimental arm group description Within the scope of this technique, first of all, the participants were asked to focus on a word that relieves them such as love, health or well-being. And so, the participants were asked to be in comfortable position in a silent and breathable room with the closed eyes, relax their muscles from the sole of their feet and progressing up to their face gradually, keep them relaxed, accompanied with deep breathing, be aware of their breathing, exhale gently. They continue these practices for 20 minutes and try to relax their muscles. After finishing the duration, they sit quietly for several minutes with eyes closed and later with eye opened. arm group intervention list arm group intervention name Behavioral: BRT:Benson Relaxation Technique arm group label CG arm group type No Intervention arm group description Regarding CG, the participants were invited to the same room and received only a single time attention-matched education on "Living with MS"; including definition of MS, dietary advices for MS patients. The attention-matched education was performed face to face and lasted for 10 min. All participants in the three study groups also received usual treatment and care. intervention list intervention intervention type Behavioral intervention name PMR: Progressive Muscle Relaxation intervention description tensing and relaxing the body muscles accompanied with deep breathing intervention arm group label list intervention arm group label PMR intervention type Behavioral intervention name BRT:Benson Relaxation Technique intervention description relaxation using mental imagery and mediation intervention arm group label list intervention arm group label BRT outcomes module primary outcome list primary outcome primary outcome measure Fatigue primary outcome description Fatigue Severity Scale primary outcome time frame 12 weeks secondary outcome list secondary outcome secondary outcome measure Chronic Pain secondary outcome description VAS secondary outcome time frame 12 weeks secondary outcome measure Kinesiophobia secondary outcome description Tampa Scale for Kinesophobia secondary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria: over the age of 18 having relapsing-remitting MS type and not had an attack during the study not receiving any other complementary and integrative therapy during the research, with an Expanded Disability Status Scale score of 5.5 and below, volunteer to participate in study Exclusion Criteria: having physical or mental health problems that can interfere with communication having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis, rheumatoid arthritis, deep anemia (hmg <8 mg / dl) or oncological diagnoses not having undergone any surgical operation in the last 3 months healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name gulsah kesik, MSc overall official affiliation research assisstant overall official role Principal Investigator location list location location facility Hacettepe University location city Ankara location state None Selected location zip 06100 location country Turkey references module reference list reference reference p m i d 35149625 reference type derived reference citation Kesik G, Ozdemir L, Mungan Ozturk S. The Effects of Relaxation Techniques on Pain, Fatigue, and Kinesiophobia in Multiple Sclerosis Patients: A 3-Arm Randomized Trial. J Neurosci Nurs. 2022 Apr 1;54(2):86-91. doi: 10.1097/JNN.0000000000000620. i p d sharing statement module i p d sharing No i p d sharing description Private and personal information of the participants is not open to sharing. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015673 condition mesh term Fatigue Syndrome, Chronic condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000020529 condition mesh term Multiple Sclerosis, Relapsing-Remitting condition mesh id D000012598 condition mesh term Sclerosis condition mesh id D000005221 condition mesh term Fatigue condition mesh id D000059350 condition mesh term Chronic Pain condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003711 condition ancestor term Demyelinating Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000004679 condition ancestor term Encephalomyelitis condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf as found Sclerosis condition browse leaf relevance high condition browse leaf id M17412 condition browse leaf name Fatigue Syndrome, Chronic condition browse leaf as found Fatigue Syndrome, Chronic condition browse leaf relevance high condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf as found Fatigue condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M21467 condition browse leaf name Multiple Sclerosis, Relapsing-Remitting condition browse leaf as found Multiple Sclerosis, Relapsing-Remitting condition browse leaf relevance high condition browse leaf id M28595 condition browse leaf name Chronic Pain condition browse leaf as found Pain, Chronic condition browse leaf relevance high condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M6994 condition browse leaf name Encephalomyelitis condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04833673

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full study rank 61855 study protocol section identification module n c t id NCT04831047 org study id info org study id 20210199 organization org full name University of Miami org class OTHER brief title The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance official title The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance status module status verified date May 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date June 8, 2021 start date type Actual primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date April 1, 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 11, 2022 last update post date struct last update post date May 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Wendy Lee responsible party investigator title Associate Professor of Ophthalmology and Dermatology responsible party investigator affiliation University of Miami lead sponsor lead sponsor name University of Miami lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes. conditions module condition list condition Ptosis, Eyelid Conjunctiva Inflamed Eye Manifestations design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 114 enrollment type Actual arms interventions module arm group list arm group arm group label Upneeq Group arm group type Experimental arm group description Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) arm group intervention list arm group intervention name Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution arm group label Control Group arm group type Sham Comparator arm group description Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Oxymetazoline hydrochloride 0.1% ophthalmic solution intervention description One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. intervention arm group label list intervention arm group label Upneeq Group intervention other name list intervention other name Upneeq intervention type Drug intervention name Placebo intervention description One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. intervention arm group label list intervention arm group label Control Group intervention other name list intervention other name Balanced saline solution outcomes module primary outcome list primary outcome primary outcome measure Change in palpebral fissure height primary outcome description Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation. primary outcome time frame Baseline, Day 1 secondary outcome list secondary outcome secondary outcome measure Change in eye redness secondary outcome description Scoring of ocular redness from clinical photographs will be performed by investigators on a 0 - 4 unit scale as compared to standardized reference photographs (0 = no redness, 4 = very red) before and after drop instillation. secondary outcome time frame Baseline, Day 1 secondary outcome measure Patient-reported eye appearance secondary outcome description Patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey, which includes scales assessing eye appearance and upper eyelid apperarance, each with a sum score of 7 (worst) to 28 (best). Additionally, patients will be queried regarding their perception of the drop effects including changes in eye appearance after drop instillation. secondary outcome time frame Day 1 eligibility module eligibility criteria Inclusion Criteria: Adults age 18 and above able to provide informed consent to participate Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention Exclusion Criteria: Adults unable to consent Individuals less than 18 years of age Prisoners Pregnant women. Known contradictions or sensitivities to study medication (oxymetazoline) Ocular surgery within the past 3 months or refractive surgery within the past six months Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm) Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters Presence of an active ocular infection Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents Inability to sit comfortably for 15 - 30 minutes healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Wendy W. Lee, MD overall official affiliation University of Miami Bascom Palmer Eye Institute overall official role Principal Investigator location list location location facility University of Miami Bascom Palmer Eye Institute location city Miami location state Florida location zip 33136 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001763 condition mesh term Blepharoptosis condition mesh id D000005132 condition mesh term Eye Manifestations condition mesh id D000003231 condition mesh term Conjunctivitis condition ancestor list condition ancestor condition ancestor id D000005141 condition ancestor term Eyelid Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000003229 condition ancestor term Conjunctival Diseases condition browse leaf list condition browse leaf condition browse leaf id M13413 condition browse leaf name Prolapse condition browse leaf relevance low condition browse leaf id M7196 condition browse leaf name Erythema condition browse leaf relevance low condition browse leaf id M5607 condition browse leaf name Conjunctivitis condition browse leaf as found Conjunctiva Inflamed condition browse leaf relevance high condition browse leaf id M7427 condition browse leaf name Eye Manifestations condition browse leaf as found Eye Manifestations condition browse leaf relevance high condition browse leaf id M4196 condition browse leaf name Blepharoptosis condition browse leaf as found Ptosis, Eyelid condition browse leaf relevance high condition browse leaf id M7436 condition browse leaf name Eyelid Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id M5605 condition browse leaf name Conjunctival Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC11 condition browse branch name Eye Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000010656 intervention mesh term Phenylephrine intervention mesh id D000010109 intervention mesh term Oxymetazoline intervention mesh id D000019999 intervention mesh term Pharmaceutical Solutions intervention mesh id D000009883 intervention mesh term Ophthalmic Solutions intervention ancestor list intervention ancestor intervention ancestor id D000000316 intervention ancestor term Adrenergic alpha-Agonists intervention ancestor id D000000322 intervention ancestor term 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NCT04831047

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full study rank 61694 study protocol section identification module n c t id NCT04833140 org study id info org study id 2021P001506 organization org full name Massachusetts General Hospital org class OTHER brief title Estrogen Administration for the Treatment of NASH in Postmenopausal Women official title Estrogen Administration for the Treatment of NASH in Postmenopausal Women status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date December 2, 2021 start date type Actual primary completion date struct primary completion date March 31, 2027 primary completion date type Anticipated completion date struct completion date March 31, 2027 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 8, 2022 last update post date struct last update post date April 15, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Karen Klahr Miller, MD responsible party investigator title Chief, Neuroendocrine Unit, Massachusetts General Hospital responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH. conditions module condition list condition NASH - Nonalcoholic Steatohepatitis design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Estradiol arm group type Active Comparator arm group description Estradiol in the form of a transdermal patch 100 mcg daily (Vivelle-Dot generic). Women with an intact uterus will also receive progesterone (100 mg) in the form of a vaginal tablet (Endometrin, Ferring Pharmaceuticals, Inc.) inserted daily for endometrial protection arm group intervention list arm group intervention name Drug: Estradiol patch arm group label Placebo arm group type Placebo Comparator arm group description Placebo patch (containing no estradiol) Women with an intact uterus will also receive vaginal placebo capsules (containing no progesterone) arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Estradiol patch intervention description The patch will provide 100mcg of estradiol daily. intervention arm group label list intervention arm group label Estradiol intervention type Drug intervention name Placebo intervention description Placebo patch will contain no estradiol. intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Liver fibrosis primary outcome description Reduction in degree of liver fibrosis primary outcome time frame 12 months primary outcome measure Liver fat primary outcome description Reduction in amount of fat in the liver primary outcome time frame 12 months eligibility module eligibility criteria Inclusion criteria: Postmenopausal women 45-70 years old NASH by biopsy or NAFLD by imaging within 6 months of screen Hepatitis C antibody and hepatitis B surface antigen negative Negative mammogram within 1 year Exclusion criteria: Heavy alcohol use Use of NASH pharmacotherapies within 12 months of study entry Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam Participation in NASH clinical trial within 6 months of study entry Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry Known diagnosis of chronic liver disease other than NAFLD or found on biopsy Contraindication to liver biopsy including INR > 1.5, platelets < 50,000/mL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes Hgb < 10.0 g/dL or glomerular filtration rate < 60 mL/min Contraindications to estrogen therapy Any vaginal bleeding, including spotting, within the last year Active malignancy Severe chronic illness Use of estrogen or progesterone within a year of baseline visit Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip healthy volunteers No gender Female minimum age 45 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Anu Gerweck, NP central contact role Contact central contact phone 617-724-1837 central contact e mail avgerweck@mgh.harvard.edu overall official list overall official overall official name Karen K. Miller, MD overall official affiliation Massachsuetts General Hospital overall official role Principal Investigator location list location location facility Massachusetts General Hospital location status Recruiting location city Boston location state Massachusetts location zip 02114 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005234 condition mesh term Fatty Liver condition mesh id D000065626 condition mesh term Non-alcoholic Fatty Liver Disease condition ancestor list condition ancestor condition ancestor id D000008107 condition ancestor term Liver Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M7527 condition browse leaf name Fatty Liver condition browse leaf as found Steatohepatitis condition browse leaf relevance high condition browse leaf id M10259 condition browse leaf name Liver Diseases condition browse leaf relevance low condition browse leaf id M29693 condition browse leaf name Non-alcoholic Fatty Liver Disease condition browse leaf as found Nonalcoholic Steatohepatitis condition browse leaf relevance high condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id T5868 condition browse leaf name Visceral Steatosis condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000004958 intervention mesh term Estradiol intervention ancestor list intervention ancestor intervention ancestor id D000004967 intervention ancestor term Estrogens intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M7260 intervention browse leaf name Estradiol intervention browse leaf as found Resection intervention browse leaf relevance high intervention browse leaf id M7268 intervention browse leaf name Estrogens intervention browse leaf relevance low intervention browse leaf id M13397 intervention browse leaf name Progesterone intervention browse leaf relevance low intervention browse leaf id M266205 intervention browse leaf name Estradiol 17 beta-cypionate intervention browse leaf relevance low intervention browse leaf id M266206 intervention browse leaf name Estradiol 3-benzoate intervention browse leaf relevance low intervention browse leaf id M234941 intervention browse leaf name Polyestradiol phosphate intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Repr intervention browse branch name Reproductive Control Agents

NCT04833140

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full study rank 61821 study protocol section identification module n c t id NCT04831489 org study id info org study id Microaspiration in ERCP organization org full name Theodor Bilharz Research Institute org class OTHER brief title Microaspiration in ERCP official title Risk of Pulmonary Micro-aspiration in Intubated vs Sedated Patients Undergoing ERCP status module status verified date April 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date December 2021 primary completion date type Anticipated completion date struct completion date February 2022 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Moshira sayed mohamed responsible party investigator title Lecturer of Anasthesia and intensive care responsible party investigator affiliation Theodor Bilharz Research Institute lead sponsor lead sponsor name Theodor Bilharz Research Institute lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. apparent aspiration is noticeable however microaspiration is hard to detect clinically. our study aims at determining whether general anesthesia with endotracheal intubation or deep sedation is safer in ERCP patients. detailed description Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. In fact, with the wide use of ERCP, many critical patients in whom conventional surgery was a high-risk procedure could be managed by endoscopic treatment. Compared to other endoscopic procedures, ERCP is considered a relatively longer and more complex one, with a substantially higher complication rate. Anesthetic techniques must facilitate the success of this procedure without adding to morbidity. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. Many anesthetic techniques are used, ranging from conscious sedation to general anesthesia. The worldwide accepted method is deep sedation in the presence of an anesthetist without endotracheal intubation. Intubation is recommended in very exceptional cases, for example is morbidly obese patients. According to some authors, general anesthesia is less used as an anesthetic technique in ERCP; drawbacks of GA include: the lengthier time required for induction of and recovery from anesthesia which affects patients' turnover, the risk of residual neuromuscular blockade, the higher cost as well as ERCP is usually a day case procedure favoring the sedation technique. On the other hand, monitored anesthesia care or deep sedation in remote locations can avoid these drawbacks. For ERCP cases, which can be very challenging, few studies have addressed what is the best anesthetic choice, i.e. deep sedation or general anesthesia with intubation. Significant complications such as aspiration, hypoxemia, and hypotension are potential risks in patients undergoing ERCP procedures, and important factors that can modify these events' severity include patients' ASA status, patients' hydration and oxygenation status, and monitoring techniques used during the procedure. Perioperative pulmonary aspiration (POPA) may lead to clinically significant morbidities and/or mortality. The risk factors for pulmonary aspiration are usually overlooked unless the patient has a history of gastrointestinal diseases (for example gastroesophageal reflux disease, upper gastrointestinal bleeding, or intestinal obstruction). However, aspiration pneumonia is seldom observed in healthy patients undergoing regular endoscopy. On the other hand, prolonged or difficult procedures may be associated with increased risks of regurgitation and aspiration. Apparent aspiration is a notable adverse event during gastrointestinal endoscopy, on the other hand, microaspiration is an underreported complication, and data about it is scarce. Since hypoxemia is a common manifestation of pulmonary aspiration and pulse oximetry monitoring is a routine practice, therefore, postoperative hypoxemia (POH) can be used as a potential signal for POPA. There is no conclusive data to support or refuse the need for endotracheal intubation to avoid microaspiration during ERCP; therefore, the participants in the study decided to prospectively compare both techniques as regards the risk of microaspiration. conditions module condition list condition Pulmonary Microaspiration design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Retrospective enrollment info enrollment count 50 enrollment type Anticipated arms interventions module arm group list arm group arm group label deep sedation arm group description Anesthesia will be induced using titrated doses of propofol (0.5-1.5 mg/kg) and fentanyl (25-50 μg) initially to carefully maintain spontaneous breathing yet maintaining airway patency. Once adequate jaw relaxation is achieved, the endoscopy probe will be inserted. Maintenance of sedation will be carried out using propofol infusion between 80-120 mcg/kg/min. Additional dose 25-50 mg propofol will be given to the patient if spontaneous movement occurs arm group intervention list arm group intervention name Radiation: Imaging arm group label Genral anesthesia arm group description After mask pre-oxygenation, anesthesia will be induced with (2 mg/kg) propofol and (1 μg /kg) fentanyl. The neuromuscular blockade will be achieved with (0.5 mg/kg) atracurium followed by tracheal intubation. Anesthesia will be maintained to keep the end-tidal anesthetic concentrations within 1 MAC for sevoflurane. The neuromuscular blockade will be maintained with intermittent doses of atracurium (0.1mg/kg). Mechanical ventilation is adjusted with fresh gas flow oxygen in air 30-40% at a rate of 2 L/min to maintain end-tidal carbon dioxide of 35-40 mm Hg. Reversal of neuromuscular blockade will be achieved by intravenous administration of neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. arm group intervention list arm group intervention name Radiation: Imaging intervention list intervention intervention type Radiation intervention name Imaging intervention description pre and postoperative CT scan of lung intervention arm group label list intervention arm group label Genral anesthesia deep sedation outcomes module primary outcome list primary outcome primary outcome measure POPA primary outcome description Perioperative Pulmonary Aspiration (POPA), which will be defined as the presence of an acute pulmonary infiltrate on chest CT within the 24 hours period following ERCP. primary outcome time frame 24 hours postoperatively secondary outcome list secondary outcome secondary outcome measure Number of intraoperative hypoxic episodes. secondary outcome description Number of intraoperative hypoxic episodes in postoperative period secondary outcome time frame 24 hours postoperative. eligibility module eligibility criteria Inclusion Criteria: ASA 1-3. Age above 18 years old. Preoperative pulmonary stability criteria (defined as a respiratory rate 12-24 breaths per minute, SpO2 ≥ 94% on room air) - Exclusion Criteria: Age < 18 years. Morbid obesity BMI ≥ 40 Kg/ m2. Pregnancy. Fasting ≤ 6 hours for solid food and ≤ 2 hours for clear liquids. 4 A pre-existing lung condition in patients requiring supplemental oxygen, inhalational bronchodilator, or systemic bronchodilator or steroid. Patients in the intensive care unit and/or requiring mechanical ventilation prior to the procedure. Previously intubated patients during the same hospitalization. Tracheostomized patients. Patients with swallowing disorders. Bowel obstruction. Anticipated difficult intubation. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population the population of the study will be randomly selected from the daily scheduled cases undergoing ERCP in the Gastroenterology department of Theodor Bilhrarz research institute. sampling method Probability Sample contacts locations module location list location location facility Theodor Bilharz research institute location city Cairo location country Egypt references module reference list reference reference p m i d 11778129 reference type background reference citation Shah SK, Mutignani M, Costamagna G. Therapeutic biliary endoscopy. Endoscopy. 2002 Jan;34(1):43-53. doi: 10.1055/s-2002-19395. reference p m i d 27708522 reference type background reference citation Motiaa Y, Bensghir M, Jaafari A, Meziane M, Ahtil R, Kamili ND. Anesthesia for endoscopic retrograde cholangiopancreatography: target-controlled infusion versus standard volatile anesthesia. Ann Gastroenterol. 2016 Oct-Dec;29(4):530-535. doi: 10.20524/aog.2016.0071. Epub 2016 Jul 14. reference p m i d 23635608 reference type background reference citation Garewal D, Vele L, Waikar P. Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures. Curr Opin Anaesthesiol. 2013 Aug;26(4):475-80. doi: 10.1097/ACO.0b013e3283620139. reference p m i d 21295639 reference type background reference citation Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005. reference p m i d 24202650 reference type background reference citation Sorser SA, Fan DS, Tommolino EE, Gamara RM, Cox K, Chortkoff B, Adler DG. Complications of ERCP in patients undergoing general anesthesia versus MAC. Dig Dis Sci. 2014 Mar;59(3):696-7. doi: 10.1007/s10620-013-2932-2. Epub 2013 Nov 8. No abstract available. reference p m i d 23877477 reference type background reference citation Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M17459 intervention browse leaf name Propofol intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M7570 intervention browse leaf name Fentanyl intervention browse leaf relevance low intervention browse leaf id M1673 intervention browse leaf name Sevoflurane intervention browse leaf relevance low intervention browse leaf id M3742 intervention browse leaf name Atropine intervention browse leaf relevance low intervention browse leaf id M11485 intervention browse leaf name Neostigmine intervention browse leaf relevance low intervention browse leaf id M3736 intervention browse leaf name Atracurium intervention browse leaf relevance low intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse leaf id T433 intervention browse leaf name Tannic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AdjAn intervention browse branch name Adjuvants, Anesthesia intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev PlAggInh intervention browse branch name Platelet Aggregation Inhibitors intervention browse branch abbrev AnArAg intervention browse branch name Anti-Arrhythmia Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements

NCT04831489

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full study rank 61322 study protocol section identification module n c t id NCT04837976 org study id info org study id F.20.09.02 organization org full name Oxford Brookes University org class OTHER brief title Lifestyle and Non-motor Symptom Management in Parkinson's Disease official title Views and Priorities of Lifestyle Factors in the Management of Non-motor Symptoms in Parkinson's Disease: Qualitative Interviews and Consensus Workshops With Patients, Caregivers, and Healthcare Professionals status module status verified date February 2022 overall status Terminated why stopped Recruitment for the first stage has been completed. However the research team no longer has the staff or resources to complete stage 2 of the research. expanded access info has expanded access No start date struct start date May 14, 2021 start date type Actual primary completion date struct primary completion date October 7, 2021 primary completion date type Actual completion date struct completion date October 7, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date February 23, 2022 last update post date struct last update post date March 11, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Sophie Lawrie responsible party investigator title PhD Candidate responsible party investigator affiliation Oxford Brookes University lead sponsor lead sponsor name Oxford Brookes University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Parkinson's Disease (PD) has generally been thought of as a movement disorder however other health-related symptoms, known as non-motor symptoms, are also very common. Non-motor symptoms can be very broad and present in numerous conditions, making identifying the symptoms of early-stage Parkinson's disease very difficult. Non-motor symptoms, including fatigue, and problems with sleep and mood, can happen decades before motor symptoms and have a greater impact on quality of life and psychological wellbeing. Despite this treatment options for non-motor symptoms are limited and therefore the development and testing of new treatments is a main priority. Due to the limited treatments options available, self-management of symptoms through positive lifestyle changes is a warranted area of research. The perspectives amongst patients, caregivers, and HCP's regarding lifestyle behavior change and its impact on fatigue and related non-motor symptoms has yet to be investigated in detail. This study includes two stages: telephone interviews and online consensus workshops. Patients with PD whom have experience of fatigue, partners/caregivers and Healthcare professionals will be able to participate in interviews only, workshops only or both. The interviews will investigate patients, partners/caregivers and Healthcare Professionals views and priorities of lifestyle factors in the management of non-motor symptoms in Parkinson's disease as well as identifying factors that influence lifestyle changes amongst PD patients. Stage 2 will involve small consensus workshops to generate ideas and feedback related to the design and content of the soon-to be developed lifestyle program. Results from both stages of this study will be used to help develop and design a lifestyle management program for fatigue and associated non-motor symptoms in Parkinson's Disease. detailed description Global aim: To assess stakeholders (patients, supportive individuals, and HCP's) views and priorities of lifestyle factors in the management of fatigue and related non-motor symptoms in Parkinson's disease, in addition to identifying facilitators and barriers to lifestyle-related behavior change, in order to inform the development of a subsequent lifestyle intervention. The study consists of two stages: Semi-structured interviews (lasting around 60 minutes) Online consensus workshops using a nominal group technique (2x 60 minute sessions) Setting: Both stages will be conducted remotely. For Stage 1 interviews will be conducted over the telephone (with or without videoconferencing). Stage 2 will use an online brainstorming platform to run the consensus workshop with concurrent videoconferencing. Participants: For both stages' participants will include individuals with Parkinson's Disease, supportive individual's (partners/caregivers/family members/significant others) and healthcare professionals. Analysis: Stage 1- Interviews will be analyzed using thematic analysis and framework mapping onto the COM-B model. Themes will be deductively mapped onto the categories and its associated constructs of the Capability, Opportunity and Motivation to Behaviour (COM-B) model to identify specific targetable aspects of behavior that may need to be addressed in the subsequent lifestyle intervention. A secondary categorical form narrative analysis of the interviews will also be conducted to supplement the main group analysis by providing a detailed insight into the experiences and stories of participants in relation to lifestyle changes on an individual level. Stage 2- Responses during the consensus workshop will be analyzed using frequency counts and descriptive. Data will include a complete list of ideas, scores allocated to each idea, the overall rank of each idea and any additional comments made by participants. conditions module condition list condition Parkinson Disease Fatigue keyword list keyword Qualitative Semi-structured interviews Thematic analysis Framework Nominal Group Technique Consensus methods design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 41 enrollment type Actual arms interventions module arm group list arm group arm group label Individuals with Parkinson's Disease arm group intervention list arm group intervention name Other: Semi-structured interviews and a consensus workshops using nominal group techniques. arm group label Supportive individuals arm group description For example carers, family members or any other individual providing regular support or care to the person with Parkinson's. arm group intervention list arm group intervention name Other: Semi-structured interviews and a consensus workshops using nominal group techniques. arm group label Healthcare Professionals arm group intervention list arm group intervention name Other: Semi-structured interviews and a consensus workshops using nominal group techniques. intervention list intervention intervention type Other intervention name Semi-structured interviews and a consensus workshops using nominal group techniques. intervention description Stage 1 of the study includes individual remote semi-structured interviews (one per participant). Stage 2 involves taking part in a consensus workshop with around 7 other Parkinson's experts, consisting of patients, supportive individuals and healthcare professionals. intervention arm group label list intervention arm group label Healthcare Professionals Individuals with Parkinson's Disease Supportive individuals outcomes module primary outcome list primary outcome primary outcome measure Themes related to the views and priorities of lifestyle factors in relation to fatigue and non-motor symptom management in Parkinson's Disease. primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure Facilitators to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease. primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure Barriers to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease. primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure Identified behavioral targets for the intervention as indicated by the mapping of themes onto the COM-B model (capability, opportunity or motivation) primary outcome time frame Assessed during the interview (60 minutes) after enrollment primary outcome measure A list of potential methods of intervention delivery, structure and content, ranked in order of preference created during consensus workshops. primary outcome time frame From participation in the first consensus session after enrollment until session 2 (around 1-2 weeks later) other outcome list other outcome other outcome measure Parkinson's Fatigue Scale (PFS-16) other outcome description A patient-rated scale that measures fatigue in Parkinson's disease ranging from 0 to 80.. A Score of 8 or above indicates the presence of significant fatigue. Higher scores correspond to worse fatigue. other outcome time frame Once prior to the interview and/or consensus workshop. other outcome measure Becks Depression Inventory (BDI-II) other outcome description A 21-item self-reported questionnaire with scores for each item ranging from 0 (absence of symptoms) to 3 (severe symptoms). Total scores range between 0 and 63 with higher scores indicating greater severity of depressive symptoms. other outcome time frame Once after enrollment, prior to the interview- patients only other outcome measure Geriatric Anxiety Scale (GAS) other outcome description Self-reported assessment of anxiety symptoms amongst older adults. Scores range from 0 to 20, with scores of 0-8 indicating an absence of clinically significant anxiety and scores of 9 and above indicating the presence of clinically significant anxiety. other outcome time frame Once after enrollment, prior to the interview- patients only other outcome measure Apathy Evaluation Scale (AES) other outcome description Self-reported assessment of apathy symptoms. The total AES score ranges between 18 to 72 with a lower score indicating greater apathy. other outcome time frame Once after enrollment, prior to the interview- patients only other outcome measure Parkinson's Disease Sleep Scale (PDSS-2) other outcome description Self-rated assessment to quantify the level of sleep disruption in Parkinson's Disease. Scores range from 0 to 60, with higher scores representing more severe nocturnal disturbance. other outcome time frame Once after enrollment, prior to the interview- patients only. eligibility module eligibility criteria Inclusion criteria A) Patients A diagnosis of idiopathic Parkinson's Disease Age of 18 years or above Current or previous experience of persistent fatigue Able to communicate clearly in English over the telephone/online for over an hour Have access to a working computer and internet connection (required for stage 2 only). B) Supportive person (partner/family member/caregiver) Age of 18 years or above A supportive person of an individual with Parkinson's Disease whom has already consented to take part in the research. Supportive individuals cannot take part without an associated individual with Parkinson's Disease having already consented. Has regular contact with and is involved in the care and/or support of an individual diagnosed with Idiopathic Parkinson's Disease. Able to communicate clearly in English over the telephone/online for over an hour Have access to a working computer and internet connection (required for stage 2 only). C) Healthcare Professionals Healthcare Professional with at least 2 years experience of Parkinson's disease treatment/management/clinical care and/or an academic currently working in the area of Parkinson's Disease treatment. Have access to a working computer and internet connection (required for stage 2 only). Exclusion criteria A) Patients Reduced cognition that would preclude active involvement and capacity to consent to participate Unable to communicate clearly in English over the telephone/online for over an hour. B) Partners/Caregivers Reduced cognition that would preclude active involvement and capacity to consent to participate Unable to communicate clearly in English over the telephone/online for over an hour. C) Health Care Professional Less than 2 years' experience in the treatment/management/clinical care of individuals with Parkinson's disease as determined by self-report They have worked in this field but have stopped for two years or more. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients and Supportive Individuals will be recruited from a Neurology clinic at Oxford University Hospitals NHS Foundation Trust (OUHFT) and from the Parkinson's UK website. Healthcare proffesionals will be recruited via the Parkinson's UK Excellence Network. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Sophie Lawrie overall official affiliation Oxford Brookes University overall official role Principal Investigator location list location location facility Oxford Brookes University location city Oxford location state Oxfordshire location zip OX3 0BP location country United Kingdom i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010300 condition mesh term Parkinson Disease condition ancestor list condition ancestor condition ancestor id D000020734 condition ancestor term Parkinsonian Disorders condition ancestor id D000001480 condition ancestor term Basal Ganglia Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000009069 condition ancestor term Movement Disorders condition ancestor id D000080874 condition ancestor term Synucleinopathies condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition browse leaf list condition browse leaf condition browse leaf id M12365 condition browse leaf name Parkinson Disease condition browse leaf as found Parkinson's Disease condition browse leaf relevance high condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf relevance low condition browse leaf id M21647 condition browse leaf name Parkinsonian Disorders condition browse leaf relevance low condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M3926 condition browse leaf name Basal Ganglia Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11181 condition browse leaf name Movement Disorders condition browse leaf relevance low condition browse leaf id M2217 condition browse leaf name Synucleinopathies condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases

NCT04837976

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full study rank 61337 study protocol section identification module n c t id NCT04837781 org study id info org study id 178420 organization org full name University of Baghdad org class OTHER brief title The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement official title The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement (Conventional and Accelerated): Clinical Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 23, 2019 start date type Actual primary completion date struct primary completion date February 2, 2021 primary completion date type Actual completion date struct completion date March 8, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 12, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mushriq F. Abid responsible party investigator title Assistant Professor responsible party investigator affiliation University of Baghdad lead sponsor lead sponsor name University of Baghdad lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both lower anterior teeth alignment and the rate of maxillary canine retraction. detailed description To evaluate the effect of vitamin D deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic, additionally find the effect of vitamin D deficiency on molar anchorage loss, canine rotation, lower incisor crowding alignment time, pain experienced by the patient during OTM and rate of orthodontically induce apical root resorption. conditions module condition list condition Tooth Position Anomalies keyword list keyword Orthodontic, tooth movement, acceleration design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design masking description Blinding to treatment allocation was possible only for the investigator and data analyst because the clinicians could know the intervention as osteo-perforation can be obviously seen clearly. Masking the intervention for the participants were not possible because micro-osteoperforation is a surgical procedure. All the trial documents were labeled with the study ID number, which was used for participant identification and data collection without unmasking the allocation group. This allowed the investigator to complete data collection and measurements blindly. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 45 enrollment type Actual arms interventions module arm group list arm group arm group label Normal vitamin D arm group type Experimental arm group description Include patients with normal vitamin D level (above 30ng/ml). Vitamin D level will be measured at the beginning of treatment if there is deficiency then the patient refer to specialized physician to be supplied with vitamin D supplement to optimized the level to normal then start orthodontic treatment arm group intervention list arm group intervention name Procedure: Micro-osteoperforation arm group label Vitamin D deficiency arm group type Experimental arm group description Include patients with unknown vitamin D level until time of canine retraction where we measure level if deficiency exist (below 30ng/ml) then the patient will be referred to specialized physician to be supplied with vitamin D supplement. arm group intervention list arm group intervention name Procedure: Micro-osteoperforation arm group label Control arm group type Experimental arm group description includes patients with unknown vitamin D level until the completion of canine retraction where we measure level. If deficiency exists (below 30ng/ml) then we will refer the patient to specialized physician to be supplied with vitamin D supplement arm group intervention list arm group intervention name Procedure: Micro-osteoperforation intervention list intervention intervention type Procedure intervention name Micro-osteoperforation intervention description Micro-osteoperforation Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental side before canine retraction. Three MOPs were placed distal to canine on experimental sides in all group. intervention arm group label list intervention arm group label Control Normal vitamin D Vitamin D deficiency intervention other name list intervention other name MOP outcomes module primary outcome list primary outcome primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 4 weeks primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 8 weeks primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 12 weeks primary outcome measure Canine retraction rate primary outcome description Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side primary outcome time frame 16 weeks secondary outcome list secondary outcome secondary outcome measure Alignment efficiency secondary outcome description 3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished. secondary outcome time frame 4 weeks secondary outcome measure Alignment efficiency secondary outcome description 3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished. secondary outcome time frame 8 weeks secondary outcome measure Alignment efficiency secondary outcome description 3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished. secondary outcome time frame 12 weeks secondary outcome measure Root resorption secondary outcome description The amount of root resorption was measured at the start of treatment and after 12 weeks, the length of the root was recoded at these time intervals. Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds. secondary outcome time frame 12 weeks secondary outcome measure pain perception secondary outcome description Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10- point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment secondary outcome time frame 7 days eligibility module eligibility criteria Inclusion Criteria: Age ranged from 18 to 30 years, from both sex. Healthy general medical condition, healthy periodontal condition. Malocclusion that requires extraction of the maxillary first premolars, followed by canine retraction, with moderate lower incisor crowding (Little's irregularity index 3-6mm). Normal shape and structure of maxillary canine, with no history of filling or root canal treatment and normal shape and structure of maxillary first molar. Exclusion Criteria: Pregnant women. Patient with renal or liver disease. Patient taking corticosteroid or anticonvulsant drugs. Patient with thyroid or parathyroid problems. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module overall official list overall official overall official name Mushriq Abid, MSc, PhD overall official affiliation University of Baghdad overall official role Principal Investigator location list location location facility College of Dentisry-University of Baghdad location city Baghdad location state Al-Rusafa location country Iraq references module reference list reference reference p m i d 35198025 reference type derived reference citation Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022. derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16702 intervention browse leaf name Vitamin D intervention browse leaf relevance low intervention browse leaf id M5155 intervention browse leaf name Cholecalciferol intervention browse leaf relevance low intervention browse leaf id M16710 intervention browse leaf name Vitamins intervention browse leaf relevance low intervention browse leaf id T442 intervention browse leaf name Cholecalciferol intervention browse leaf relevance low intervention browse leaf id T440 intervention browse leaf name Calciferol intervention browse leaf relevance low intervention browse leaf id T479 intervention browse leaf name Vitamin D3 intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev BDCA intervention browse branch name Bone Density Conservation Agents intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Vi intervention browse branch name Vitamins

NCT04837781

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full study rank 61484 study protocol section identification module n c t id NCT04835870 org study id info org study id ZR-CHOP organization org full name The First Affiliated Hospital of Soochow University org class OTHER brief title Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL official title Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date October 1, 2025 primary completion date type Anticipated completion date struct completion date October 1, 2025 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 14, 2022 last update post date struct last update post date September 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name The First Affiliated Hospital of Soochow University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients detailed description Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients. conditions module condition list condition Non-GCB/ABC Diffuse Large B-Cell Lymphoma keyword list keyword Zanubrutinib, R-CHOP, Newly diagnosed Non-GCB DLBCL design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 78 enrollment type Anticipated arms interventions module arm group list arm group arm group label R-CHOP + Zanubrutinib arm group type Experimental arm group description Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) arm group intervention list arm group intervention name Drug: Zanubrutinib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone intervention list intervention intervention type Drug intervention name Zanubrutinib intervention description Zanubrutinib-160mg bid PO d0-d20(1-21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name BTK inhibitors intervention type Drug intervention name Rituximab intervention description Rituximab-375 mg/m2 i.v d0 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name MabThera intervention type Drug intervention name Cyclophosphamide intervention description Cyclophosphamide-750 mg/m2 i.v d1 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name CTX intervention type Drug intervention name Doxorubicin intervention description Doxorubicin-50 mg/m2 i.v d1 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name ADM intervention type Drug intervention name Vincristine intervention description Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name VCR intervention type Drug intervention name Prednisone intervention description Prednisone-100 mg p.o d1-d5 (/21d) intervention arm group label list intervention arm group label R-CHOP + Zanubrutinib intervention other name list intervention other name Prednisonum outcomes module primary outcome list primary outcome primary outcome measure Progression-free Survival(PFS) primary outcome description To measure the duration of response to ZR-CHOP over a follow-up period of 18 months primary outcome time frame up to 18 months secondary outcome list secondary outcome secondary outcome measure Overall Response Rate (ORR) secondary outcome description To measure the duration of response to ZR-CHOP over a follow-up period of 18 months secondary outcome time frame up to 18 months secondary outcome measure Complete Response Rate secondary outcome description Number of patients who achieved complete response after treatment by ZR-CHOP secondary outcome time frame up to 18 months secondary outcome measure Duration of Response secondary outcome description Duration of overall response will be assessed from the first ZR-CHOP given to progression,death or last follow-up. secondary outcome time frame up to 18 months secondary outcome measure Overall Survival secondary outcome description OS will be assessed from the first ZR-CHOP given to death or last follow-up. secondary outcome time frame up to 18 months secondary outcome measure Adverse events profile secondary outcome description Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated secondary outcome time frame Measured from start of treatment until 28 days after last dose eligibility module eligibility criteria Inclusion Criteria: Histologically confirmed Non-GCB DLBCL with extrinsic involvement Age ≥ 18 years Measurable disease of at least 15mm(node)/10mm（extranodal） ECOG performance status 0-2 Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L) Estimated survival time ≥3 months Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study Exclusion Criteria: Accepted major surgery within 4 weeks before treatment; Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma; Previous history of indolent lymphoma; Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ; History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists; Requires treatment with a strong/medium CYP3A inducer; The previous use of anthracycline-based drugs > 150 mg/m2; Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease; HIV infection and/or active hepatitis B or active hepatitis C; Uncontrolled systemic infection; Pregnant or breasting-feeding women; According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Caixia Li, M.D central contact role Contact central contact phone +86 512 67781856 central contact e mail licaixia@suda.edu.cn central contact name Jia Chen, M.D central contact role Contact central contact phone +86 512 67781856 central contact e mail chenjiasuzhou@gmail.com overall official list overall official overall official name Depei Wu, M.D overall official affiliation The First Affiliated Hospital of Soochow University overall official role Study Chair location list location location facility The First Affiliated Hospital of USTC Anhui Provincial Hospital location status Recruiting location city Hefei location state Anhui location country China location contact list location contact location contact name Xingbing Wang location contact role Contact location contact phone +86-0551-62283160 location contact e mail wangxingbing@ustc.edu.cn location facility Fujian Medical University Union Hospital location status Recruiting location city Fuzhou location state Fujian location country China location contact list location contact location contact name Jianda Hu location contact role Contact location contact phone +86-0591-83357896 location contact e mail drjiandahu@163.com location facility The First Affiliated Hospital of Xiamen University location status Recruiting location city Xiamen location state Fujian location country China location contact list location contact location contact name Bing Xu location contact role Contact location contact phone 0592-2137275 location contact e mail xubingzhangjian@126.com location facility The First People's Hospital of Changzhou location status Recruiting location city Changzhou location state Jiangsu location country China location contact list location contact location contact name Weiying Gu location contact role Contact location contact phone 0519-68870000 location contact e mail guweiying2001@163.com location facility Jiangsu Cancer Hospital location status Recruiting location city Nanjing location state Jiangsu location country China location contact list location contact location contact name Jianqiu Wu location contact role Contact location contact phone +86-025-83283597 location contact e mail wujq211@163.com location facility Nanjing Drum Tower Hospital location status Recruiting location city Nanjing location state Jiangsu location country China location contact list location contact location contact name Jingyan Xu location contact role Contact location contact phone +86-025-83106666 location contact e mail xjy1967@sina.com location facility Zhongda Hospital Southeast University location status Recruiting location city Nanjing location state Jiangsu location country China location contact list location contact location contact name Zheng Ge location contact role Contact location contact phone +86-025-8372111 location contact e mail gezheng2008@163.com location facility Nantong Tumor Hospital location status Recruiting location city Nantong location state Jiangsu location country China location contact list location contact location contact name Xiaohong Xu location contact role Contact location contact phone +86-0513-86712105 location contact e mail xhx107@163.com location facility The First Affiliated Hospital of Soochow University location status Recruiting location city Suzhou location state Jiangsu location zip 215000 location country China location contact list location contact location contact name Caixia Li location contact role Contact location facility Changshu No.1 People's Hospital location status Recruiting location city Suzhou location state Jiangsu location country China location contact list location contact location contact name Guifang Zhang location contact role Contact location contact phone +86-0512-52773259 location contact e mail 1194366857@qq.com location facility Suzhou Hongci Hematology Hospital location status Recruiting location city Suzhou location state Jiangsu location country China location contact list location contact location contact name Ting Xu location contact role Contact location contact phone +86-0512-83837999 location contact e mail 21132075@qq.com location contact name Xiaochen Chen location contact role Contact location contact phone +86-0512-83837999 location contact e mail chenxiabcd100@163.com location facility Zhangjiagang First Peoples Hospital location status Recruiting location city Suzhou location state Jiangsu location country China location contact list location contact location contact name Qiurong Zhang location contact role Contact location contact phone +86-0512-56919999 location contact e mail zhangqr1982@163.com location facility Affiliated Hospital Of Jiangnan University location status Recruiting location city Wuxi location state Jiangsu location country China location contact list location contact location contact name Haiying Hua location contact role Contact location contact phone +86-0510-68088900 location contact e mail huahy007@163.com location facility Wuxi People's Hospital location status Recruiting location city Wuxi location state Jiangsu location country China location contact list location contact location contact name Xin Zhou location contact role Contact location contact phone +86-0510-82700775 location contact e mail 13358111962@189.com location facility Xuzhou Central Hospital location status Recruiting location city Xuzhou location state Jiangsu location country China location contact list location contact location contact name Yan Xue location contact role Contact location contact phone +86-0516-85790126 location contact e mail xueyanxz@163.com location facility Shandong Provincial Hospital Affiliated to Shandong First Medical University location status Recruiting location city Jinan location state Shandong location country China location contact list location contact location contact name Xin Wang location contact role Contact location contact phone +86-0531-82169114 location contact e mail xinw007@126.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000016403 condition mesh term Lymphoma, Large B-Cell, Diffuse condition ancestor list condition ancestor condition ancestor id D000016393 condition ancestor term Lymphoma, B-Cell condition ancestor id D000008228 condition ancestor term Lymphoma, Non-Hodgkin condition ancestor id D000008223 condition ancestor term Lymphoma condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf relevance low condition browse leaf id M17980 condition browse leaf name Lymphoma, B-Cell condition browse leaf relevance low condition browse leaf id M17983 condition browse leaf name Lymphoma, Large B-Cell, Diffuse condition browse leaf as found Diffuse Large B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id M10374 condition browse leaf name Lymphoma, Non-Hodgkin condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf relevance low condition browse leaf id T640 condition browse leaf name B-cell Lymphoma condition browse leaf as found B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id T1866 condition browse leaf name Diffuse Large B-Cell Lymphoma condition browse leaf as found Diffuse Large B-Cell Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000011241 intervention mesh term Prednisone intervention mesh id D000003520 intervention mesh term Cyclophosphamide intervention mesh id D000069283 intervention mesh term Rituximab intervention mesh id D000004317 intervention mesh term Doxorubicin intervention mesh id D000014750 intervention mesh term Vincristine intervention mesh id C000629551 intervention mesh term Zanubrutinib intervention ancestor list intervention ancestor intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000018906 intervention ancestor term Antineoplastic Agents, Alkylating intervention ancestor id D000000477 intervention ancestor term Alkylating Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000019653 intervention ancestor term Myeloablative Agonists intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000903 intervention ancestor term Antibiotics, Antineoplastic intervention ancestor id D000059005 intervention ancestor term Topoisomerase II Inhibitors intervention ancestor id D000059003 intervention ancestor term Topoisomerase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000018931 intervention ancestor term Antineoplastic Agents, Hormonal intervention ancestor id D000000972 intervention ancestor term Antineoplastic Agents, Phytogenic intervention ancestor id D000050257 intervention ancestor term Tubulin Modulators intervention ancestor id D000050256 intervention ancestor term Antimitotic Agents intervention ancestor id D000050258 intervention ancestor term Mitosis Modulators intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M373 intervention browse leaf name Rituximab intervention browse leaf as found Test intervention browse leaf relevance high intervention browse leaf id M236470 intervention browse leaf name Zanubrutinib intervention browse leaf as found Muscle relaxation intervention browse leaf relevance high intervention browse leaf id M5879 intervention browse leaf name Cyclophosphamide intervention browse leaf as found Based intervention browse leaf relevance high intervention browse leaf id M6644 intervention browse leaf name Doxorubicin intervention browse leaf as found Biological intervention browse leaf relevance high intervention browse leaf id M13273 intervention browse leaf name Prednisone intervention browse leaf as found Until intervention browse leaf relevance high intervention browse leaf id M227311 intervention browse leaf name Liposomal doxorubicin intervention browse leaf relevance low intervention browse leaf id M16647 intervention browse leaf name Vincristine intervention browse leaf as found Undergoing intervention browse leaf relevance high intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M20095 intervention browse leaf name Antineoplastic Agents, Alkylating intervention browse leaf relevance low intervention browse leaf id M2972 intervention browse leaf name Alkylating Agents intervention browse leaf relevance low intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf relevance low intervention browse leaf id M3376 intervention browse leaf name Antibiotics, Antitubercular intervention browse leaf relevance low intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M20119 intervention browse leaf name Antineoplastic Agents, Hormonal intervention browse leaf relevance low intervention browse leaf id M25350 intervention browse leaf name Tubulin Modulators intervention browse leaf relevance low intervention browse leaf id M25349 intervention browse leaf name Antimitotic Agents intervention browse leaf relevance low intervention browse leaf id M24973 intervention browse leaf name Protein Kinase Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents

NCT04835870

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full study rank 61701 study protocol section identification module n c t id NCT04833049 org study id info org study id TAK-994-1004 organization org full name Takeda org class INDUSTRY brief title Study to Evaluate Absorption, Metabolism, and Excretion, of TAK-994 in 6 Healthy Male Adults official title A Phase 1 Study to Assess Absolute Bioavailability of TAK-994 and to Characterize Mass Balance, Pharmacokinetics, Absorption, Metabolism, and Excretion of [14C]TAK-994 in Male Healthy Subjects status module status verified date June 2021 overall status Completed expanded access info has expanded access No start date struct start date April 14, 2021 start date type Actual primary completion date struct primary completion date June 20, 2021 primary completion date type Actual completion date struct completion date June 20, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 28, 2021 last update post date struct last update post date June 29, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Takeda lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994. detailed description The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy male participants. This study will characterize how TAK -994 is absorbed, metabolize, excreted by the body, after single oral administration by collecting plasma, urine, and feces samples for testing. The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and Part B. In Part A, all participants will receive TAK-994 as tablet and [14C]TAK-994 as intravenous infusion. In Part B, all participants will receive a single dose of [14C]TAK-994 as an oral suspension. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 67 days, including a 28-day screening period plus approximately 30 days for follow up. conditions module condition list condition Healthy Volunteers keyword list keyword Drug Therapy design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Sequential Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 6 enrollment type Actual arms interventions module arm group list arm group arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 arm group type Experimental arm group description TAK-994 Dose 1, tablet, orally, on Day 1, followed by [14C]TAK-994 Dose 2, infusion, intravenously, on Day 1 of Part A, followed by a washout period of at least 8 days, further followed by [14C]TAK-994 Dose 3, suspension, orally, on Day 1 of Part B. arm group intervention list arm group intervention name Drug: TAK-994 Oral Tablet Drug: [14C]TAK-994 Intravenous Infusion Drug: [14C]TAK-994 Oral Suspension intervention list intervention intervention type Drug intervention name TAK-994 Oral Tablet intervention description TAK-994 tablet. intervention arm group label list intervention arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 intervention type Drug intervention name [14C]TAK-994 Intravenous Infusion intervention description [14C]TAK-994 intravenous infusion. intervention arm group label list intervention arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 intervention type Drug intervention name [14C]TAK-994 Oral Suspension intervention description [14C]TAK-994 oral suspension. intervention arm group label list intervention arm group label TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 outcomes module primary outcome list primary outcome primary outcome measure Part A: Percent Absolute Bioavailability (%F) for TAK-994 primary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose primary outcome measure Part B: Percentage of Total Radioactivity (TRA) in Urine (Cum Percent [%] Dose [UR]) Relative to the Administered Radioactive Dose primary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose primary outcome measure Part B: Percentage of TRA in Feces (Cum%Dose[FE]) Relative to the Administered Radioactive Dose primary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose primary outcome measure Part B: Percentage of TRA Recovered in in the Urine and Feces Combined (Combined Cum%Dose) Relative to the Administered Radioactive Dose primary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome list secondary outcome secondary outcome measure Part A, Ceoi: Plasma Concentration at the end of Infusion for [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, CL: Total Clearance for [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, Vss: Volume of Distribution at Steady State After Intravenous Administration for [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 and [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994 and [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, t(1/2z): Terminal Disposition Half-life for TAK-994 and [14C]TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, Cmax: Maximum Observed Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part A, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose secondary outcome measure Part B, Cmax: Maximum Observed Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, t(1/2z): Terminal Disposition Half-life for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUClast: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUC∞: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Infinity for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, AUCt: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Time t for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose secondary outcome measure Part B, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood TRA Concentration for TAK-994 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose eligibility module eligibility criteria Inclusion Criteria: Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 32.0 kilogram per square meter (kg/m^2) at the screening. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing and throughout the study, based on participant self-reporting. Agrees to comply with any applicable contraceptive requirements of the protocol. Agree not to donate sperm from the first dosing until 95 days after the last dosing. Agree and able to remain in the clinical research unit (CRU) for the duration of the study. Understands the study procedures in the ICF, and be willing and able to comply with the protocol. Able to swallow oral suspensions. Exclusion Criteria: Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee. History or presence of gastritis, gastrointestinal tract, hepatic disorder, cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease, or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug. History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing per the Diagnostic and Statistical Manual of Mental Disorders-V criteria. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. Current or past history of epilepsy, seizure, convulsion, tremor, or related symptoms. Positive urine drug or alcohol results at screening or check-in. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening. Seated heart rate is lower than 45 beats per minute (bpm) or higher than 100 bpm at screening. Orthostatic vital sign results with a decrease in systolic greater than (>) 20 mmHg or decrease in diastolic >10 mmHg, and increase in pulse of >20 bpm. QT interval corrected for heart rate using Frederica's equation (QTcF) is >450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening. Liver function tests including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5*upper limit of normal (ULN) at screening or check-in. Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening. Tattoo(s) or scarring at or near the site of IV infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator of designee; Infrequent bowel movements (less than approximately once per day) within 30 days prior to dosing. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of dosing. Lactose intolerance. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of last dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is, weighted annual limit recommended by the International Commission on Radiological Protection [ICRP] of 3000 millirem [mrem]). Unable to refrain from or anticipates the use of: Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After first dosing and throughout the study, ibuprofen (up to 1.2 gram [g] per 24 hours) may be administered at the discretion of the Investigator or designee. Milk of Magnesia (that is, magnesium hydroxide) (less than or equal to [<=] 60 milliliter [mL] per day) may be administered from Day 3 of each study part, at discretion of the Investigator, to ensure defecation. Any drugs known to be significant inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study, including the follow-up period. Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of pharmacokinetics (PK)/pharmacodynamics interaction with study drug. Participation in another clinical study treated with the radiolabeled drug within 6 months prior to the first dosing. Participants has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer [354 mL/12 Ounce [oz]], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day). Participant consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study. Donation of blood or significant blood loss within 56 days prior to the first dosing. Plasma donation within 7 days prior to the first dosing. Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Part A of the current study. healthy volunteers Accepts Healthy Volunteers gender Male minimum age 19 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name Study Director overall official affiliation Takeda overall official role Study Director location list location location facility Celerion location city Lincoln location state Nebraska location zip 68502 location country United States references module see also link list see also link see also link label To obtain more information on the study, click here/on this link see also link u r l https://clinicaltrials.takeda.com/study-detail/606d6838620b3b001e9dbb5c i p d sharing statement module i p d sharing Yes i p d sharing description Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing access criteria IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. i p d sharing u r l https://vivli.org/ourmember/takeda/ derived section misc info module version holder December 02, 2022

NCT04833049

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full study rank 61642 study protocol section identification module n c t id NCT04833816 org study id info org study id 2019-48 secondary id info list secondary id info secondary id 2020-004812-81 secondary id type EudraCT Number organization org full name Assistance Publique Hopitaux De Marseille org class OTHER brief title Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient official title Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient acronym KLOE status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 5, 2022 start date type Actual primary completion date struct primary completion date May 5, 2024 primary completion date type Anticipated completion date struct completion date August 4, 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 6, 2022 last update post date struct last update post date August 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Assistance Publique Hopitaux De Marseille lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group. conditions module condition list condition Traumatic Injury keyword list keyword ketamine analgesia ISS trauma design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 140 enrollment type Anticipated arms interventions module arm group list arm group arm group label Ketamin arm group type Experimental arm group description Patient will get a bolus of ketamine at 0.1 mg / kg followed by a continuous infusion of ketamine at a dose of 0.15 mg / kg / hour arm group intervention list arm group intervention name Drug: Administration of drug arm group label Placebo arm group type Placebo Comparator arm group description Patient will get a bolus of NaCL at 0.1 mg / kg followed by a continuous infusion of NaCl at a dose of 0.15 mg / kg / hour arm group intervention list arm group intervention name Drug: Administration of drug intervention list intervention intervention type Drug intervention name Administration of drug intervention description Administration of ketamin during the 48h after trauma intervention arm group label list intervention arm group label Ketamin Placebo outcomes module primary outcome list primary outcome primary outcome measure Total dose of sufentanil primary outcome description All doses of sufentanil and opiods administration primary outcome time frame 48 hours secondary outcome list secondary outcome secondary outcome measure Total amount of opiods secondary outcome time frame 5 days secondary outcome measure Pain assessment secondary outcome time frame 5 days secondary outcome measure Delirium secondary outcome description Scale CAM-ICU (confusion assesment method) secondary outcome time frame 5 days secondary outcome measure Global Quality of life secondary outcome description SF-36 score secondary outcome time frame 3 months secondary outcome measure Chronical pain secondary outcome description SF-MPQ-2 secondary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: Male or female adult Trauma patient presenting at least 2 lesions in two different regions as defined by the ISS (injury severity score) (Head or neck, Face, Thorax, Abdomen and pelvic contents, Upper limbs or pelvic girdle, Lower limbs, External (any skin surface). Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)> 1. Patient having signed an informed consent Exclusion Criteria: Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome). Patient in whom the infusion could not be started within the first 6 hours of initial treatment. Patient whose state of consciousness is incompatible with understanding the protocol. Patient with chronic unbalanced arterial hypertension. Patient with severe heart failure. Patient with a BMI> 35 kg / m² or a weight of more than 120 kg. Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness. Presence of a history of chronic pain. Presence of a history of epilepsy. Presence of a history of psychosis or drug addiction. Presence of a history of stroke. Patients with an allergy to the molecule or excipients composing ketamine Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol. Pregnant or breastfeeding woman. Patient not understanding French. Protected adult patient (under guardianship, curatorship or legal protection). healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Gary Duclos, MD central contact role Contact central contact phone 0491965531 central contact phone ext 33 central contact e mail gary.duclos@ap-hm.fr overall official list overall official overall official name Jean Olivier ARNAUD overall official affiliation AP-HM overall official role Study Director location list location location facility Service Anesthésie Réanimation - Hôpital nord location status Recruiting location city Marseille location zip 13015 location country France location contact list location contact location contact name Gary Duclos location contact role Contact location contact phone 0491965531 location contact e mail gary.duclos@ap-hm.fr i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014947 condition mesh term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Traumatic Injury condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11134 intervention browse leaf name Morphine intervention browse leaf relevance low intervention browse leaf id M9826 intervention browse leaf name Ketamine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04833816

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full study rank 61814 study protocol section identification module n c t id NCT04831580 org study id info org study id GOG-3043 organization org full name GOG Foundation org class NETWORK brief title A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer official title A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC) acronym ROCC status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 22, 2022 start date type Actual primary completion date struct primary completion date August 2028 primary completion date type Anticipated completion date struct completion date August 2029 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 13, 2022 last update post date struct last update post date April 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name GOG Foundation lead sponsor class NETWORK collaborator list collaborator collaborator name Intuitive Foundation collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary This is a randomized controlled trial to compare survival for patients who undergi robotic assisted laparoscopy versus open radical hysterectomy and lymph node assessment for the treatment of early stage cervical cancer. detailed description This is a multi-center, open-label, randomized, non-inferiority clinical trial with the hypothesis that robotically assisted radical hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal radical hysterectomy with respect to disease free survival. A t the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the radical hysterectomy is abandoned will be deemed non-evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted. Standard arm: Radical hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device). Study arm: Radical hysterectomy is performed as per standard robotic technique (Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10) conditions module condition list condition Cervical Cancer design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 840 enrollment type Anticipated arms interventions module arm group list arm group arm group label Open radical hysterectomy arm group type Active Comparator arm group intervention list arm group intervention name Other: open surgery arm group label Robotic radical hysterectomy arm group type Experimental arm group intervention list arm group intervention name Device: da Vinci intervention list intervention intervention type Device intervention name da Vinci intervention description Minimally invasive robotic-assisted surgical device intervention arm group label list intervention arm group label Robotic radical hysterectomy intervention type Other intervention name open surgery intervention description open radical hysterectomy intervention arm group label list intervention arm group label Open radical hysterectomy outcomes module primary outcome list primary outcome primary outcome measure Survival primary outcome description 3 year disease-free survival primary outcome time frame 36 months eligibility module eligibility criteria Inclusion Criteria: Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell) Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator. Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard. Patient must be age 18 years or older. Patient must have ECOG performance status 0-1. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women. Patient must have signed an approved informed consent and authorization permitting the release of personal health information. Exclusion Criteria: Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation) Patients with FIGO stage 1A1, IB3, II-IV (2018 staging). Patient with inability to receive an MRI. Patients with a tumor size ≥4cm or with definite evidence of vaginal/parametrial involvement on MRI (if MRI findings are not definitive, then clinical examination must also reveal parametrial or vaginal extension). Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes). Patients with a history of prior pelvic or abdominal radiotherapy. Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg. Patient compliance and geographic proximity that do not allow adequate follow-up. Patients with poorly controlled HIV with CD4 counts <500. healthy volunteers No gender Female gender based Yes minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jennifer Klein, MEd central contact role Contact central contact phone 215-854-0770 central contact e mail jklein@gog.org overall official list overall official overall official name Kristin Bixel, MD overall official affiliation The Ohio State Unversity overall official role Study Chair location list location location facility Mount Sinai Comprehensive Cancer Center location status Recruiting location city Miami location state Florida location zip 33140 location country United States location contact list location contact location contact name Irina Bakura Caso location contact role Contact location contact e mail irina.bakuracaso@msmc.com location contact name Brian Slomovitz, MD location contact role Principal Investigator location facility St. Vincent Hospital and Health Care Center Inc location status Recruiting location city Indianapolis location state Indiana location zip 46260 location country United States location contact list location contact location contact name Cynthia Cruz Rivera location contact role Contact location contact e mail cynthia.cruzrivera@ascension.org location contact name Sarah Goodrich, MD location contact role Principal Investigator location facility Willis-Knighton Physician Network Gynecologic Oncology Associates location status Recruiting location city Shreveport location state Louisiana location zip 71118 location country United States location contact list location contact location contact name Carrie Key, RN location contact role Contact location contact e mail ckay@wkhs.com location contact name Destin Black, MD location contact role Principal Investigator location facility Baystate Medical Center location status Recruiting location city Springfield location state Massachusetts location zip 01199 location country United States location contact list location contact location contact name Laura Sorci location contact role Contact location contact e mail Laura.Sorci@baystatehealth.org location contact name Tashanna Myers, MD location contact role Principal Investigator location facility FirstHealth Outpatient Cancer Center location status Recruiting location city Pinehurst location state North Carolina location zip 28374 location country United States location contact list location contact location contact name Tina Thompson location contact role Contact location contact e mail tpthompson@firsthealth.org location contact name Michael Sundborg, MD location contact role Principal Investigator location facility Kettering Health Cancer Center location status Recruiting location city Kettering location state Ohio location zip 45429 location country United States location contact list location contact location contact name Julie Carstens location contact role Contact location contact e mail julie.carstens@ketteringhealth.org location contact name Thomas Reid, MD location contact role Principal Investigator location facility Chattanooga's Program in Women's Oncology location status Recruiting location city Chattanooga location state Tennessee location zip 37403 location country United States location contact list location contact location contact name Kimberly Donelson location contact role Contact location contact e mail Kimberly.Donelson@erlanger.org location contact name Stephen Depasquale, MD location contact role Principal Investigator i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002583 condition mesh term Uterine Cervical Neoplasms condition ancestor list condition ancestor condition ancestor id D000014594 condition ancestor term Uterine Neoplasms condition ancestor id D000005833 condition ancestor term Genital Neoplasms, Female condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000002577 condition ancestor term Uterine Cervical Diseases condition ancestor id D000014591 condition ancestor term Uterine Diseases condition browse leaf list condition browse leaf condition browse leaf id M4982 condition browse leaf name Uterine Cervical Neoplasms condition browse leaf as found Cervical Cancer condition browse leaf relevance high condition browse leaf id M16494 condition browse leaf name Uterine Neoplasms condition browse leaf relevance low condition browse leaf id M8097 condition browse leaf name Genital Neoplasms, Female condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M4977 condition browse leaf name Uterine Cervical Diseases condition browse leaf relevance low condition browse leaf id M16491 condition browse leaf name Uterine Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions

NCT04831580

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full study rank 61878 study protocol section identification module n c t id NCT04830748 org study id info org study id MT & TE & 1ry KOA organization org full name Cairo University org class OTHER brief title Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis official title Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis status module status verified date June 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 1, 2022 start date type Actual primary completion date struct primary completion date January 1, 2023 primary completion date type Anticipated completion date struct completion date May 1, 2023 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 3, 2022 last update post date struct last update post date June 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name moaaz ragab riyad amin responsible party investigator title Teaching assistant at faculty of physical therapy responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Cairo University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to compare between therapeutic exercises and therapeutic exercises preceded by mechanical traction in treatment of patients with primary knee osteoarthritis attributed to the outcomes of pain, muscle strength, functional disability and functional performance. Hypotheses There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of knee pain severity in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of functional disability in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric quadriceps muscle strength in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric hamstring muscle strength in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing walking time in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing ascending and descending stairs time in patients with primary knee osteoarthritis. detailed description Knee osteoarthritis is the most common cause of musculoskeletal pain and disability, resulting in major disability and pain in affected individuals. It is a chronic degenerative disorder of multifactorial aetiology, including acute and/or chronic insults from normal wear and tear, age, obesity and joint injury. It nearly affects about one in each eight adults worldwide, its prevalence rates vary from 7.8 to 9.3% in Egyptian population. Current clinical guidelines recommend non pharmacological conservative strategies including physical therapy given their ease of application and relatively low cost with minimal adverse effects (e.g.: strengthening exercises, aerobic exercises, stretching exercises, hydrotherapy, manual therapy, massage therapy, thermotherapy, electrotherapy, ultrasound therapy, external support braces and taping). It was reported that therapeutic exercise is beneficial for patients with knee osteoarthritis in terms of outcomes of pain, function, performance and quality of life. In addition, it was reported that strengthening, flexibility and neuromotor skill exercises have a large efficacy over aerobic and mind body exercise. Unloading strategies should be proposed as a first line of therapy for the patient with knee osteoarthritis before any attempts are made at tissue regeneration, repair or replacement. Manual or mechanical knee joint distraction is a conservative technique that provides transient joint separation and unloading that aids in improving clinical symptoms of patients. Addition of mechanical knee distraction to therapeutic exercises helps in gaining the positive effects of both exercise and unloading techniques. Although this approach has not been used extensively or applied pragmatically, several studies were found showing promising results in terms of reducing pain at both rest and movement, improving knee flexion and extension range of motion, reducing disability, increasing functional abilities and improving the quality of life of patients. Forty male and female patients with the diagnosis of primary knee osteoarthritis will be recruited in this study. All patients will be assessed and treated in the outpatient clinic of the faculty of physical therapy, Cairo University. Patients will be randomly distributed into 2 equal experimental groups: the first experimental group will receive therapeutic exercises (stretching and strengthening exercise) while the second experimental group will receive mechanical traction of the knee followed by therapeutic exercises. All patients will be treated for 12 sessions, 3 times per week each other day for 4 weeks. Clinical assessments will include assessment of pain severity, functional disability, isometric muscle strength, and functional performance. conditions module condition list condition Knee Osteoarthritis keyword list keyword Traction Distraction Therapeutic exercises design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 2 groups The first group will include 20 patients and will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. The second group will include 20 patients and will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee. design primary purpose Treatment design masking info design masking Single design masking description Patients will be blinded to study hypotheses and informed only about comparing different programs of treatment of knee osteoarthritis. After randomization, participants will only be provided with details of the program they will be undertaking. design who masked list design who masked Participant enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Therapeutic exercises group arm group type Active Comparator arm group description The first group will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. arm group intervention list arm group intervention name Other: Therapeutic exercises arm group label Therapeutic exercises and mechanical traction group arm group type Experimental arm group description The experimental group will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee. arm group intervention list arm group intervention name Other: Mechanical knee traction Other: Therapeutic exercises intervention list intervention intervention type Other intervention name Mechanical knee traction intervention description Continuous knee joint mechanical traction will be applied to the patients positioned in supine lying position with the affected knee flexed at 25-30 degrees by a wedge placed under the affected knee. The thigh will be secured with a strap for stabilization and the leg will be held by the specially designed greave with the weight of traction hanging throughout a pulley system. The amount of traction will be set to about 10% of body weight. The treatment will be applied for 20 minutes continuously, once a day, 3 times per week for 4 weeks. The traction force will be progressed gradually during the program ( e.g.: weekly increase force by 1% of body weight if the patient can tolerate the duration of 20 min with the preset force). intervention arm group label list intervention arm group label Therapeutic exercises and mechanical traction group intervention type Other intervention name Therapeutic exercises intervention description Therapeutic exercises will be divided into stretching and strengthening exercises: Stretching will be done passively for the hamstring, rectus femoris and calf muscles. Each exercise will be done for 3 reps each with a hold period of 30-60 secs with a 30-60 rest period between reps. Strengthening exercises will be done for the quadriceps and hamstring muscles ( inner range knee extension- knee extension in sitting- straight leg raise in flexion- prone hamstring curl- standing hamstring curl- straight leg raise in extension). Exercise will be done for 3 sets each will consist of 10 reps with a rest period of 2-3 minutes between sets. The starting weight should be 50% of the patient's 1 RM. The end position will be held for 5 seconds. Progression will be achieved by increasing the exercise rep and intensity gradually throughout the program. E.g.: weekly increase force by 5% if patient can tolerate an increased repetition of 20 rep with the preset force. intervention arm group label list intervention arm group label Therapeutic exercises and mechanical traction group Therapeutic exercises group outcomes module primary outcome list primary outcome primary outcome measure Measurement of knee pain severity change after 4 weeks of intervention primary outcome description Knee pain severity will be measured on an 11-point numerical pain rating scale, where 0= no pain and 10= worst possible pain. primary outcome time frame baseline, 4 weeks secondary outcome list secondary outcome secondary outcome measure Measurement of Functional Disability change after 4 weeks of intervention secondary outcome description The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered patient reported measure that is both valid and disease-specific.It has been translated and validated into Arabic language. It is a 24-item questionnaire, grouped into three subscales including pain; stiffness; and physical function. Total score ranges from 0 (best) to 96 (worst) points. secondary outcome time frame baseline, 4 weeks secondary outcome measure Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention secondary outcome description Isometric muscle strength (Nm/kg) will be recorded for quadriceps and hamstring muscle groups. Using a hand held dynamo-meter the torque generated by the muscle is measured in newton-metre (Nm) which is later normalised to body mass in kilograms (kg). muscle strength = Torque (Nm) / body mass (kg). secondary outcome time frame baseline, 4 weeks secondary outcome measure Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test secondary outcome description The 40 meter fast paced walk test is a performance-based test that measures short distance walking activity. Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests. secondary outcome time frame baseline, 4 weeks secondary outcome measure Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test secondary outcome description The 12 step stair climb test is a performance-based test that measures the time required to go up and down 12 stairs (step height, 17 cm; step depth, 30 cm). Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests. secondary outcome time frame baseline, 4 weeks eligibility module eligibility criteria Inclusion Criteria: Patients will have grade II of primary knee osteoarthritis. Patients with bilateral primary knee osteoarthritis, the more painful knee will be selected as the affected knee in this study. Age of patients will range from 45 years to 65 years old. Duration of illness will range from 3- 12 months. Exclusion Criteria: Malignancy presence of skin lesions or infections at the treatment sites healthy volunteers No gender All minimum age 45 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Moaaz Ragab Amin, T.A. central contact role Contact central contact phone 01007210132 central contact e mail moaaz.elsakka@gmail.com central contact name Karima Hassan, lecturer central contact role Contact central contact phone 01223359644 central contact e mail Karima_hassan2008@yahoo.com overall official list overall official overall official name Karima Abdelaty Hassan, lecturer overall official affiliation Cairo University overall official role Study Director overall official name Ibrahim Magdy Elnaggar, Prof overall official affiliation Cairo University overall official role Study Director location list location location facility Faculty of physical therapy Cairo university location status Recruiting location city Cairo location state Giza location zip 12613 location country Egypt location contact list location contact location contact name Karima Hassan, Phd location contact role Contact location contact phone 012-233-59644 location contact e mail Karima_hassan2008@yahoo.com references module reference list reference reference p m i d 22960239 reference type background reference citation Alpayci M, Ozkan Y, Yazmalar L, Hiz O, Ediz L. A randomized controlled trial on the efficacy of intermittent and continuous traction for patients with knee osteoarthritis. Clin Rehabil. 2013 Apr;27(4):347-54. doi: 10.1177/0269215512459062. Epub 2012 Sep 7. reference p m i d 9415651 reference type background reference citation Bellamy N, Campbell J, Stevens J, Pilch L, Stewart C, Mahmood Z. Validation study of a computerized version of the Western Ontario and McMaster Universities VA3.0 Osteoarthritis Index. J Rheumatol. 1997 Dec;24(12):2413-5. reference p m i d 11138949 reference type background reference citation Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004. reference p m i d 28183213 reference type background reference citation Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part two: strengthening exercise programs. Clin Rehabil. 2017 May;31(5):596-611. doi: 10.1177/0269215517691084. Epub 2017 Feb 1. reference p m i d 18783739 reference type background reference citation Chopra A, Abdel-Nasser A. Epidemiology of rheumatic musculoskeletal disorders in the developing world. Best Pract Res Clin Rheumatol. 2008 Aug;22(4):583-604. doi: 10.1016/j.berh.2008.07.001. reference p m i d 26405113 reference type background reference citation Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24. Review. reference p m i d 19182026 reference type background reference citation Guermazi A, Hunter DJ, Roemer FW. Plain radiography and magnetic resonance imaging diagnostics in osteoarthritis: validated staging and scoring. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:54-62. doi: 10.2106/JBJS.H.01385. reference p m i d 15135142 reference type background reference citation Guermazi M, Poiraudeau S, Yahia M, Mezganni M, Fermanian J, Habib Elleuch M, Revel M. Translation, adaptation and validation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for an Arab population: the Sfax modified WOMAC. Osteoarthritis Cartilage. 2004 Jun;12(6):459-68. doi: 10.1016/j.joca.2004.02.006. reference p m i d 15679884 reference type background reference citation Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. reference p m i d 25440203 reference type background reference citation Khademi-Kalantari K, Mahmoodi Aghdam S, Akbarzadeh Baghban A, Rezayi M, Rahimi A, Naimee S. Effects of non-surgical joint distraction in the treatment of severe knee osteoarthritis. J Bodyw Mov Ther. 2014 Oct;18(4):533-9. doi: 10.1016/j.jbmt.2013.12.001. Epub 2013 Dec 11. reference p m i d 29950778 reference type background reference citation Lee DK, Lee NY. Case study of continuous knee joint traction treatment on the pain and quality of life of patients with degenerative gonarthritis. J Phys Ther Sci. 2018 Jun;30(6):848-849. doi: 10.1589/jpts.30.852. Epub 2018 Jun 12. reference p m i d 21655421 reference type background reference citation Maher S, Creighton D, Kondratek M, Krauss J, Qu X. The effect of tibio-femoral traction mobilization on passive knee flexion motion impairment and pain: a case series. J Man Manip Ther. 2010 Mar;18(1):29-36. doi: 10.1179/106698110X12595770849560. reference p m i d 24462672 reference type background reference citation McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. reference p m i d 19350249 reference type background reference citation Palhais NS, Guntern D, Kagel A, Wettstein M, Mouhsine E, Theumann N. Direct magnetic resonance arthrography of the knee: utility of axial traction. Eur Radiol. 2009 Sep;19(9):2225-31. doi: 10.1007/s00330-009-1389-3. Epub 2009 Apr 7. reference p m i d 29997112 reference type background reference citation Rausch Osthoff AK, Niedermann K, Braun J, Adams J, Brodin N, Dagfinrud H, Duruoz T, Esbensen BA, Gunther KP, Hurkmans E, Juhl CB, Kennedy N, Kiltz U, Knittle K, Nurmohamed M, Pais S, Severijns G, Swinnen TW, Pitsillidou IA, Warburton L, Yankov Z, Vliet Vlieland TPM. 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis. Ann Rheum Dis. 2018 Sep;77(9):1251-1260. doi: 10.1136/annrheumdis-2018-213585. Epub 2018 Jul 11. reference p m i d 25200270 reference type background reference citation Sato T, Sato N, Masui K, Hirano Y. Immediate effects of manual traction on radiographically determined joint space width in the hip joint. J Manipulative Physiol Ther. 2014 Oct;37(8):580-5. doi: 10.1016/j.jmpt.2014.08.002. Epub 2014 Sep 4. reference p m i d 21298256 reference type background reference citation Waller C, Hayes D, Block JE, London NJ. Unload it: the key to the treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1823-9. doi: 10.1007/s00167-011-1403-6. Epub 2011 Feb 5. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010003 condition mesh term Osteoarthritis condition mesh id D000020370 condition mesh term Osteoarthritis, Knee condition ancestor list condition ancestor condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf as found Osteoarthritis condition browse leaf relevance high condition browse leaf id M21321 condition browse leaf name Osteoarthritis, Knee condition browse leaf as found Knee Osteoarthritis condition browse leaf relevance high condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases

NCT04830748

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full study rank 61232 study protocol section identification module n c t id NCT04839146 org study id info org study id NL76192.000.20 organization org full name Radboud University Medical Center org class OTHER brief title Safety and Tolerability of COVID-19 Vaccine (ABNCoV2) official title First-in-human Trial of the Coronavirus Virus-like Particle Subunit Vaccine ABNCoV2 in SARS-CoV-2-naïve Adult Volunteers in Good Health acronym COUGH-1 status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date March 11, 2021 start date type Actual primary completion date struct primary completion date December 30, 2021 primary completion date type Actual completion date struct completion date February 25, 2022 completion date type Actual study first submit date March 11, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 16, 2022 last update post date struct last update post date March 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Radboud University Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name European Union collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the immunogenicity-tolerability ratio 14 days following first vaccination with ABNCoV2. detailed description This first-in-human phase 1 trial of ABNCoV2 is a single center, sequential dose-escalation, open labelled trial to establish the safety and tolerability of two doses of ABNCoV2, formulated with and without MF59 in healthy, adult, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-naïve volunteers. The immunological objective of this trial is to identify a dosage that optimizes the immunogenicity-tolerability ratio 14 days following first vaccination with ABNCoV2. The trial will be carried out by the Radboud University Medical Center (Radboudumc). The trial involves first-in-human administration, dose escalation of ABNCoV2 and adjuvant selection. Volunteers will be screened for eligibility and receive two vaccinations by intramuscular injection. While we cannot predict with certainty the safety in human subjects, we have adopted a safety-orientated staggered trial design with ascending doses of ABNCoV2. Seven groups of volunteers (n=6) will receive a given dose of ABNCoV2, either with or without MF59, followed by a booster with the same dose and formulation four weeks after the first vaccination. All vaccinations will be given as intramuscular injection. The pre-defined escalation schedule will start with 6 μg ABNCoV2, with a maximum dose of 70 μg. Dose-escalation will proceed only in absence of protocol-defined safety signals. MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel at the first three escalation steps (Group 1-3) to detect superiority or futility of the MF59-adjuvanted against the non-adjuvanted formulation. Up to forty-two (n=42) subjects will be enrolled, as well as one reserve subject per group. Safety follow-up will be done at following timepoints: baseline, day 1, day 2, day 7, day 14, day 25, day 29, day 30, day 35, day 42, day 70, day 119 and day 196 after first ABNCoV2 administration. conditions module condition list condition Covid19 Severe Acute Respiratory Syndrome SARS-CoV-2 Infection design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description ABNCoV2 is a virus-like particle vaccine. It will be administered as two intramuscular injections in groups of up to 9 volunteers. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. The pre-defined escalation schedule will start with 6 μg ABNCoV2, followed by 12, 25 and 50 μg with a maximum dose of 70 μg. MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel to detect superiority or futility of the MF59-adjuvanted against the non-adjuvanted formulation at the 6, 12 and 25 μg dosage. Approval for further dose escalation and choice of adjuvant use will be provided by a safety monitoring committee (SMC), supported by pre-defined analyses of safety, tolerability and immunogenicity data at day 14 post-first-vaccination. Recruitment for the two best (safe, tolerable and most immunogenic) regimens will continue until 12 volunteers per regimen have been immunized. design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 45 enrollment type Actual arms interventions module arm group list arm group arm group label Group 1: 6 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 2: 12 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 3: 25 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 4: 50 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted or MF59-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 5: 70 microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted or MF59-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 6: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description The subjects in Group 6 (n=6) will receive the next lower dosage of the highest non-adjuvanted or MF59-adjuvanted ABNCoV2 dose achieved intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine arm group label Group 7: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant arm group type Experimental arm group description The subjects in Group 7 (n=6) will receive the highest non-adjuvanted or MF59-adjuvanted ABNCoV2 dose achieved intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. arm group intervention list arm group intervention name Biological: ABNCoV2 Vaccine intervention list intervention intervention type Biological intervention name ABNCoV2 Vaccine intervention description SARS-CoV-2 vaccine intervention arm group label list intervention arm group label Group 1: 6 microgram ABNCoV2 with/without MF59 adjuvant Group 2: 12 microgram ABNCoV2 with/without MF59 adjuvant Group 3: 25 microgram ABNCoV2 with/without MF59 adjuvant Group 4: 50 microgram ABNCoV2 with/without MF59 adjuvant Group 5: 70 microgram ABNCoV2 with/without MF59 adjuvant Group 6: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant Group 7: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant intervention other name list intervention other name cVLP-RBD RBDn-CLP ABNCoV2 outcomes module primary outcome list primary outcome primary outcome measure Primary safety endpoint: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE) primary outcome description Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE) primary outcome time frame up to 28 weeks primary outcome measure Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies primary outcome description Concentration of ABNCoV2-specific antibodies primary outcome time frame 14 days following first vaccination. secondary outcome list secondary outcome secondary outcome measure Secondary study endpoint: Number and severity of at least possibly related solicited AEs secondary outcome description Number and severity of at least possibly related solicited AEs secondary outcome time frame within one week following administration of ABNCoV2. other outcome list other outcome other outcome measure Concentration of ABNCoV2-specific antibodies at baseline and during immunization and follow up. other outcome description ABNCoV2-specific antibody concentrations will be measured by ELISA during immunisation and follow-up. other outcome time frame up to 28 weeks other outcome measure Inhibitory titre in invasion inhibition assay at baseline and during immunization and follow up. other outcome description Inhibitory titres will be measured in an in vitro SARS-CoV-2 invasion inhibition assay. other outcome time frame up to 28 weeks other outcome measure Cellular immune responses (T and B cell) at baseline and during immunization and follow up. other outcome description Cellular responses will be analysed by cytometry and enzyme-linked absorbent spot (ELISpot) assay. other outcome time frame up to 28 weeks other outcome measure Correlation of response vaccine to habitual sleep using the Pittsburgh Sleep Quality Index (PSQI) other outcome description The PSQI will be used to investigate if sleep quality is associated with immune responses to the vaccine. other outcome time frame one month prior first ABNCoV2 immunization eligibility module eligibility criteria Inclusion Criteria: Subject must sign written informed consent to participate in the trial. Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of the study by passing a quiz (assessment of understanding). Subjects must score at least 80% correct on a multiple-choice quiz. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them, and they will have the opportunity to retest. In the opinion of the investigator, the subject can and will comply with the requirements of the protocol. Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -1 until 24 weeks following last vaccination (end of study). Subject is a male or non-pregnant and non-lactating female age ≥ 18 and ≤ 55 years and in good health at time of ABNCoV2 administration. Subject agrees to their general practitioner (GP) being informed about participation in the study and agrees to sign a form to request the release by their GP, and medical specialist when necessary, of any relevant medical information concerning possible contra-indications for participation in the study to the investigator(s). The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period according to current Sanquin guidelines. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. All other female subjects must agree to use continuous adequate contraception2 for the duration of the study. Female subjects must have a negative pregnancy test at the inclusion visit. Exclusion Criteria: Any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the US Food and Drug Administration (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials [30]. 2. History of COVID-19 infection. 3. Chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 4. Positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion. 5. Screening tests positive for SARS-CoV-2, SARS-CoV-2 antibodies, Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV). 6. Receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period. 7. Participation in any other clinical study in the 30 days prior to the start of the study or during the study period. 8. Immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed SARS-CoV-2 vaccine, given within the framework of the national SARS-CoV-2 vaccination campaign. The time between last vaccination with ABNCoV2 and a SARS-CoV-2 vaccine provided by the campaign shall be at least 4 weeks. 9. Known hypersensitivity to any of the vaccine components (adjuvant or protein). 10. Administration of immunoglobulins and/or any blood products within the three months prior to the first dose of ABNCoV2 or planned administration during the study period. 11. Previous participation in a COVID-19 vaccine study. 12. Body Mass Index (BMI) >35 kg/m2. 13. Pregnancy, lactation or intention to become pregnant during the study period. 14. History of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment. 15. Being an employee or student of the department of Medical Microbiology of the Radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only. 16. Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name Benjamin Mordmüller, Prof overall official affiliation Stichting Radboud university medical center overall official role Principal Investigator location list location location facility Radboud univserity medical center location city Nijmegen location state Gelderland location zip 6525GA location country Netherlands derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000045169 condition mesh term Severe Acute Respiratory Syndrome condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M24598 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T5186 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse leaf id M35114 intervention browse leaf name MF59 oil emulsion intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04839146

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full study rank 61371 study protocol section identification module n c t id NCT04837339 org study id info org study id 2019_0015 organization org full name Hopital Foch org class OTHER brief title Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation official title Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation acronym DATACOL status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 17, 2022 start date type Actual primary completion date struct primary completion date March 2037 primary completion date type Anticipated completion date struct completion date March 2037 completion date type Anticipated study first submit date November 2, 2020 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 2, 2022 last update post date struct last update post date August 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hopital Foch lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation. Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample. conditions module condition list condition Lung Transplant Rejection Lung Transplant Failure Lung Transplant; Complications Lung Transplant Failure and Rejection keyword list keyword DATACOL design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 900 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with lung disease requiring transplantation or who have undergone lung transplantation arm group type Other arm group description There is no intervention to be administered. arm group intervention list arm group intervention name Other: Collection of biological samples intervention list intervention intervention type Other intervention name Collection of biological samples intervention description Blood sample, biopsies sample, hair sample. intervention arm group label list intervention arm group label Patients with lung disease requiring transplantation or who have undergone lung transplantation outcomes module primary outcome list primary outcome primary outcome measure Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers). primary outcome description Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection. primary outcome time frame 15 years secondary outcome list secondary outcome secondary outcome measure Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression). secondary outcome description Correlation of biomarkers (graft) with the functionality of the allograft secondary outcome time frame 15 years secondary outcome measure Stratify lung transplant recipients using non-invasive biomarkers and a gene expression profile for risk of allograft loss based on first year post-transplant data secondary outcome description Assessment of the risk of graft loss based on biomarker variations in repeated measurements. secondary outcome time frame 15 years secondary outcome measure Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection secondary outcome description Correlation between gene expression in lung transplants and response to treatment of rejection secondary outcome time frame 15 years secondary outcome measure Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection. secondary outcome description Costs incurred to define the risk of allograft rejection secondary outcome time frame 15 years secondary outcome measure Assessing patient acceptability and well-being using invasive and non-invasive biomarkers secondary outcome description Variation in patient well-being with the use of a non-invasive strategy to define the risk of allograft rejection secondary outcome time frame 15 years eligibility module eligibility criteria Inclusion Criteria: Men or women over 15 years of age Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent. Be affiliated with a Health Insurance plan. Exclusion Criteria: Pregnant, parturient and/or lactating woman Hemoglobin level less than or equal to 8g/dl Persons of full age who are subject to a legal protection measure or who are unable to express their consent Persons under the protection of justice Not being able to follow the study requirements for geographical, social or psychological reasons Patient refusal. healthy volunteers No gender All minimum age 15 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Antoine ROUX, Dr central contact role Contact central contact phone 0146252635 central contact phone ext +33 central contact e mail a.roux@hopital-foch.com central contact name Elisabeth HULLIER-AMMAR, Dr central contact role Contact central contact phone 0146251175 central contact e mail drci-promotion@hopital-foch.com location list location location facility Roux location status Recruiting location city Suresnes location country France location contact list location contact location contact name Antoine Roux location contact role Contact i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022

NCT04837339

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full study rank 61198 study protocol section identification module n c t id NCT04839588 org study id info org study id Telerehab CH Usability secondary id info list secondary id info secondary id R43CA232936 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R43CA232936 organization org full name Bright Cloud International Corp org class INDUSTRY brief title Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study official title Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments acronym TCIFCU status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date June 7, 2021 start date type Actual primary completion date struct primary completion date December 31, 2021 primary completion date type Actual completion date struct completion date December 31, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 27, 2022 last update post date struct last update post date April 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Bright Cloud International Corp lead sponsor class INDUSTRY collaborator list collaborator collaborator name National Cancer Institute (NCI) collaborator class NIH collaborator name Rutgers, The State University of New Jersey collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations. Perform usability study on 2 elderly healthy volunteers and 2 breast cancer survivors with lasting cognitive impairments following chemotherapy, so to improve the product design. The usability evaluation will be done at NJ Bioscience Center (North Brunswick, NJ). detailed description The study will generate data on ease of use of a system for subjects with stage II or stage III breast cancer survivors with lasting cognitive impairments subsequent to their first chemotherapy regimen. The usability component will uncover technical issues in its usability, as well as its rating on perceived usefulness. Data will also be collected on the ease of remote monitoring of the subjects by clinicians. This portion of the study is intended to provide information pertaining to the usability of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting chemotherapy related cognitive impairment (CRCI) subsequent to first chemotherapy regimen, living in the community. Specific aims are: testing of a added biosensors, new technology acceptance and ease of use at home by these individuals; a caregiver console and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review. Participants will each perform 4 usability evaluation sessions. At the end of each session participants will fill a custom evaluation form, using 5-point Likert scale scoring. At the end of the last session participants will also fill a USE standardized usability evaluation form. conditions module condition list condition Chemotherapy-Related Cognitive Impairment Healthy keyword list keyword chemotherapy cognitive impairments breast cancer design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Other enrollment info enrollment count 4 enrollment type Actual arms interventions module arm group list arm group arm group label Usability study, healthy volunteers and those with cognitive impairments following chemotherapy arm group description 2 elderly healthy volunteers and 2 participants with lasting cognitive impairments following chemotherapy for breast cancer. All will perform evaluation of a computer-based experimental system. Participants will be Female Either healthy or breast cancer survivor; Age 20 to 65 years; Have st least 12 years of formal education; Be English speakers; arm group intervention list arm group intervention name Other: Usability study intervention list intervention intervention type Other intervention name Usability study intervention description Participants will first be screened for propensity to simulation sickness and for cognitive state using the MoCA evaluation test. Those who passed the screening will perform 4 usability sessions rating the ease of use and perceived benefit of the experimental system and of a caregiver interface laptop. The 2 healthy volunteers will evaluate first, such that issues may be resolved before testing is done on the impaired participants. Each session will be compensated with a $35 payment. During each session participants will play a series of increasing difficulty simulated tasks, aimed to train primarily the executive functions domain. At the end of each session participants will rate their experience using custom subjective evaluation forms with multiple items. Each item will be scored using a 5-point Likert scale. At the end of the 4th session, participants will also fill the USE standardized usability form. This usability evaluation will be conducted at the NJ Bioscience Center. intervention arm group label list intervention arm group label Usability study, healthy volunteers and those with cognitive impairments following chemotherapy outcomes module primary outcome list primary outcome primary outcome measure USE questionnaire to assess the usability of a computerized system primary outcome description A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the experimental system [Lund, 2001] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max). Participants will also be able to comment in free form on aspects they liked most and least about the device. primary outcome time frame At the end of the 4th evaluation session (about 1 month from enrollment) secondary outcome list secondary outcome secondary outcome measure Subjective rating questionnaire of the device and therapy secondary outcome description Participants rate the usefulness, satisfaction issues, and ease of use of the experimental system and its therapeutic games, as well as ease of use of the Caregiver laptop. The Subjective Evaluation Form consists of questions, each rated on a 5-point Likert scale (1 worst to 5 best outcome). secondary outcome time frame At each of 4 evaluation sessions over 1 month from enrollment other outcome list other outcome other outcome measure Simulation Sickness Questionnaire for participant other outcome description Form used at screening post-consent to determine a participant's propensity for simulation sickness [Kennedy et al.,1993]. The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 48 (worst outcome - certainty that the participant will experience severe simulation sickness). other outcome time frame Screening at consent (one time) other outcome measure Cyber-sickness Susceptibility Questionnaire for participant other outcome description Form used at screening post-consent to determine a participant's propensity for simulation sickness [Freiwald et al., 2020]. The questionnaire asks participants 26 questions The first 13 questions ascertain the general heath and fitness of the subject, and have Yes/No answers The remaining 13 questions are score on a on a 5 point Likert scale, with five point Likert scales, referring to the frequency of each complaint's occurrence. These scales range from 0 to 4 with the labels "very rarely", "rarely", "occasionally", "frequently" and "very often". other outcome time frame Screening at consent (one time) other outcome measure Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment other outcome description Used at screening post-consent to determine level of cognitive impairment [Nasreddine et al 2005] for participants. The form has a score range from 0 (worst) to 30 (best) - no cognitive impairments. For the participants with early Alzheimer's Disease the form will confirm the participant is in the score range of 19-25. other outcome time frame Screening at consent (one time) other outcome measure Biosensor readings other outcome description Custom biosensors will provide additional data which will be used to gauge levels of cognitive engagement with the tasks performed during the evaluation. other outcome time frame At each of 4 evaluation sessions over 1 month from enrollment other outcome measure Game difficulty level other outcome description Game difficulty level when performing a simulated game task using the experimental system. Levels are 1 (easiest) to 16 (hardest) other outcome time frame At each of 4 evaluation sessions over 1 month from enrollment other outcome measure Heart rate other outcome description Heart rate (Pulse) measured with a medical meter at start and end of each usability evaluation session other outcome time frame Before and after each of 4 evaluation sessions over 1 month from enrollment other outcome measure Blood pressure (systolic and diastolic) other outcome description Blood pressure (Systolic and diastolic) measured with a medical meter before and after each Usability evaluation session. other outcome time frame Before and after each of 4 evaluation sessions over 1 month from enrollment eligibility module eligibility criteria At NJ Bioscience Center Healthy Volunteers Female Age 20 to 65; Good or corrected hearing; Good or corrected vision; No motor or cognitive impairments; English speakers; Those with low propensity for simulation sickness (as determined by the Simulation Sickness Questionnaire [Kennedy et al, 1993]). Either healthy or having had stage II or stage III breast cancer; Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment [Chapman 2016] or 26-30 indicating normal cognition; EXCLUSION CRITERIA Male; Female participants younger than 20 or older than 65; High propensity for simulation sickness (as determined by Simulation Sickness Questionnaire screening); Those with severe visual neglect or legally blind; Those with severe hearing loss or deafness; Those with uncontrolled hypertension (>190/100 mmHg); Those with severe cognitive impairment (MoCA score<10); Current diagnosis of moderate-severe depression (Beck Depression Inventory II score of 17-63); a history of psychiatric illness, defined as serious psychiatric illness such as bipolar mood disorder and schizophrenia, or requiring psychiatric hospitalization. a history of or current substance abuse; a previous head injury resulting in loss of consciousness; a prior diagnosis of neurological illness; a current or prior diagnosis of brain cancer; non-English speakers; Those unable to reliable participate in pre-study assessment due to any reason; Those with co-morbidities limiting arm and neck motor function (ex. lymphedema, chronic pain, severe arthritis); Less than 1 month post first chemotherapy regimen or starting chemotherapy during 16 weeks post screening (as chemotherapy during study participation is a confounding factor); Those with Stage IV (metastatic) breast cancer will be excluded; Those presenting with multiple cancers, such as breast and arm bone cancer, or breast and brain cancer; Those who are unwilling to allow a home inspection to ascertain Internet quality, determine best placement for the experimental or sham systems, for installation and removal of the systems and necessary repairs. healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description Since the study targets breast cancer survivors, participants will all be female. Breast cancer prevalence is overwhelmingly in women. minimum age 20 Years maximum age 65 Years std age list std age Adult Older Adult study population The targeted subjects will be either breast cancer survivors, living in the community, without requiring transfers, or healthy, age-matched volunteers. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Grigore C Burdea, PhD overall official affiliation Bright Cloud Int'l Corp overall official role Principal Investigator location list location location facility Bright Cloud Int'l Corp location city North Brunswick location state New Jersey location zip 08902 location country United States location facility New Jersey Bioscience Center location city North Brunswick location state New Jersey location zip 08902 location country United States references module see also link list see also link see also link label Description: BCI's corporate site showing therapeutic games used with the device see also link u r l http://www.BrightBrainer.com i p d sharing statement module i p d sharing No i p d sharing description We will not disclose data on individual participants. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000084202 condition mesh term Chemotherapy-Related Cognitive Impairment condition mesh id D000060825 condition mesh term Cognitive Dysfunction condition ancestor list condition ancestor condition ancestor id D000003072 condition ancestor term Cognition Disorders condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000064420 condition ancestor term Drug-Related Side Effects and Adverse Reactions condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf relevance low condition browse leaf id M28858 condition browse leaf name Cognitive Dysfunction condition browse leaf as found Cognitive Impairment condition browse leaf relevance high condition browse leaf id M2441 condition browse leaf name Chemotherapy-Related Cognitive Impairment condition browse leaf as found Chemotherapy-Related Cognitive Impairment condition browse leaf relevance high condition browse leaf id M5453 condition browse leaf name Cognition Disorders condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M29456 condition browse leaf name Drug-Related Side Effects and Adverse Reactions condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders

NCT04839588

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full study rank 61870 study protocol section identification module n c t id NCT04830852 org study id info org study id Pro00015510 secondary id info list secondary id info secondary id 21X125F1 secondary id type Other Identifier secondary id domain Leidos organization org full name Children's National Research Institute org class OTHER brief title Pediatric COVID Outcomes Study (PECOS) official title Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date July 23, 2021 start date type Actual primary completion date struct primary completion date July 1, 2027 primary completion date type Anticipated completion date struct completion date July 1, 2027 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date December 28, 2021 last update post date struct last update post date January 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Roberta DeBiasi responsible party investigator title MD, MS, Division Chief, Infectious Diseases, Co-Director of the Congenital Zika Program responsible party investigator affiliation Children's National Research Institute lead sponsor lead sponsor name Children's National Research Institute lead sponsor class OTHER collaborator list collaborator collaborator name National Institute of Allergy and Infectious Diseases (NIAID) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations. Participants aged 21 years and younger with laboratory confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection will visit the study sites for clinical and research evaluations and sample collection at schedules dependent on time since infection. Participants enrolled within 12 weeks after acute infection or positive test will be part of the "recovery group" and will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. Participants enrolled more than 12 weeks after acute infection or positive test will be in the "convalescent group" and will attend study visits at baseline and subsequently every 6 months for a total of 3 years. Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. This protocol will establish a cohort of pediatric patients recovered from SARS CoV-2 infection and a biorepository for evaluation of the potential roles of host genetics, immune response, and other possible factors influencing long-term outcomes. Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2. detailed description This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics of the immune response to SARS-CoV-2, genetic factors associated with long-term outcomes, and the extent and duration of protective immunity. The study procedures include: Non-contrast chest computed tomography (CT) or chest X-ray: All participants will undergo 2 chest imaging procedures, one at baseline and one at the final study visit (year 3). Non-contrast cardiac magnetic resonance imaging (MRI): All participants will undergo 2 to 3 non-contrast cardiac MRI procedures during this study. Echocardiogram Electrocardiography (EKG) Pulmonary Function Test (PFT) Questionnaires: To complete the questionnaires will take approximately 25 to 64 minutes. Collection of blood (including for optional genetic testing), nasopharyngeal (NP) swab, urine, and stool. Genetic testing (optional): This protocol involves genetic testing using whole genome sequencing (WGS) approaches for all participants. Clinical photography (optional): Participants may decline photographs or place any restrictions on their use. conditions module condition list condition Covid19 MIS-C Associated With COVID-19 MIS-C Multisystem Inflammatory Syndrome in Children SARS-CoV2 Infection keyword list keyword SARS-CoV-2 COVID-19 MIS-C Post-COVID Long-term effects Pediatric Children design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Blood, nasopharyngeal swab, stool and urine. enrollment info enrollment count 5000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Recovery Group arm group description Participants aged 21 years and younger and enrolled within 12 weeks after acute infection or positive test. These participants will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. arm group label Convalescent Group arm group description Participants aged 21 years and younger and enrolled more than 12 weeks after acute infection or positive test. These participants will attend study visits at baseline and subsequently every 6 months for a total of 3 years. arm group label Healthy contacts arm group description Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. arm group label Parents/guardians of participants arm group description Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2. outcomes module primary outcome list primary outcome primary outcome measure Incidence and prevalence of medical sequelae, study procedures analysis primary outcome description Incidence and prevalence of medical sequelae among symptomatic SARS-CoV-2 infection survivors, asymptomatic SARS CoV 2 infection survivors, and MIS-C survivors. primary outcome time frame 6 years primary outcome measure Risk factors for medical sequelae, study procedures analysis primary outcome description Risk factors for medical sequelae among symptomatic SARS CoV 2 infection survivors, asymptomatic SARS-CoV-2 infection survivors, and MIS-C survivors. primary outcome time frame 6 years secondary outcome list secondary outcome secondary outcome measure Quality of life and social impact, study procedures analysis secondary outcome description Health-related quality of life and social impact in children and adolescents recovered from SARS-CoV-2 infection including parent/guardian and child assessments. secondary outcome time frame 6 years secondary outcome measure Incidence and prevalence of reinfection, study procedures analysis secondary outcome description Incidence and prevalence of reinfection in previously infected and recovered SARS-CoV-2 and MIS-C survivors with and without vaccination. secondary outcome time frame 6 years secondary outcome measure Biorepository, study procedures analysis secondary outcome description Establishment of a biorepository for additional biomarker analysis. secondary outcome time frame 6 years eligibility module eligibility criteria Inclusion Criteria: Survivors and control cohorts: In order to be eligible to participate in this study as a survivor or as a control, an individual must meet all of the following criteria: Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years). Willing to allow storage of samples and data for future research. At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation. In addition, an individual must meet all criteria for one of the following cohorts. Symptomatic survivor cohort (including MIS-C): Documented prior COVID-19 or MIS-C as evidenced by one of the following: detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with Emergency Use Authorization (EUA)/approval from the US Food and Drug Administration (FDA) and a history of clinical manifestation compatible with COVID-19*; or positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of clinical manifestation compatible with COVID-19*; or meeting CDC case definition for MIS-C (see Appendix 1). Onset of COVID-19/MIS-C symptoms is at least 4 weeks before baseline visit. *one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea. Asymptomatic survivor cohort: Documented prior SARS-CoV-2 infection as evidenced by one of the following: detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with EUA/approval from the FDA without history of clinical manifestation compatible with COVID-19; or positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA without history of clinical manifestation compatible with COVID-19*. Positive SARS-CoV-2 RNA or antigen test is at least 4 weeks before baseline visit. one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea. Healthy contact (control) cohort: 1. No diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 and meets one of the following criteria: Lived in the same household as a participant with SARS-CoV-2 infection during the time of illness, or was within approximately 6 feet (2 meters) of the participant for a prolonged period of time, or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on). Lives in an area affected by SARS-CoV-2 infection Parents and guardians: In order to participate in this study as a parent or guardian, an individual must meet all of the following criteria: Is a parent or guardian of a participant enrolled as a survivor or as a control. Stated willingness to comply with all study procedures and availability for the duration of the study. Willing to allow storage of data for future research. Exclusion Criteria: Survivors and controls: An individual who meets any of the following criteria will be excluded from participation in this study: Any symptoms suggestive of an ongoing infection within 15 days of baseline visit, including but not limited to fever > 38.2 °C, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain). Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study. Pregnancy. Parents and guardians: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study. Co-enrollment: Participants may be co-enrolled in other clinical studies, including observational studies and therapeutic trials. However, the study staff should be informed of co-enrollment. healthy volunteers Accepts Healthy Volunteers gender All minimum age 0 Years maximum age 21 Years std age list std age Child Adult study population Patients aged 0 to 21 years with confirmed history of symptomatic SARS CoV-2 infection (including COVID-19), MIS C, or asymptomatic SARS CoV-2 infection (n = up to 1000), as well as healthy contacts (aged ≤21 years; n = up to 1000). Additionally, a parent or guardian of each participant will be enrolled to complete targeted questionnaires (n = up to 2000). Accrual ceiling is 5000 patients. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Roberta DeBiasi, MD, MS central contact role Contact central contact phone 2024761708 central contact e mail CN-NIAID-pedsCOVIDstudy@childrensnational.org central contact name Gina A. Montealegre Sanchez, MD, MS central contact role Contact overall official list overall official overall official name Roberta DeBiasi, MD, MS overall official affiliation Children's National Research Institute overall official role Principal Investigator overall official name Gina A. Montealegre Sanchez, MD, MS overall official affiliation National Institute of Allergy and Infectious Diseases (NIAID) overall official role Principal Investigator location list location location facility Children's National Hospital location status Recruiting location city Washington location state District of Columbia location zip 20010 location country United States location contact list location contact location contact name Roberta DeBiasi, MD, MS location contact role Contact location facility National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID) location status Recruiting location city Bethesda location state Maryland location zip 20852 location country United States location contact list location contact location contact name Gina A. Montealegre Sanchez, MD, MS location contact role Contact location contact e mail niaidpedscovid@niaid.nih.gov references module see also link list see also link see also link label If you are interested in participating in this study, please complete this form. A study team member will contact you with additional information. see also link u r l https://childrensnational.formstack.com/forms/covid_misc_study derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3665 intervention browse leaf name Ascorbic Acid intervention browse leaf relevance low intervention browse leaf id T477 intervention browse leaf name Vitamin C intervention browse leaf relevance low intervention browse leaf id T437 intervention browse leaf name Ascorbic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Vi intervention browse branch name Vitamins

NCT04830852

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full study rank 61500 study protocol section identification module n c t id NCT04835662 org study id info org study id 20575 organization org full name RTI International org class OTHER brief title Engaging Fathers for Improving Dietary Diversity in Kaduna State official title Engaging Fathers for Improving Dietary Diversity in Kaduna State status module status verified date February 2021 overall status Completed expanded access info has expanded access No start date struct start date May 31, 2019 start date type Actual primary completion date struct primary completion date September 25, 2020 primary completion date type Actual completion date struct completion date September 25, 2020 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name RTI International lead sponsor class OTHER collaborator list collaborator collaborator name FHI 360 collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children. detailed description This was pre-post study designed to measure changes in complementary feeding practices and document the feasibility and acceptability of an intervention to engage fathers in supporting dietary diversity in Kaduna State, Nigeria. This study was conducted as part of the Alive & Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design and implementation of the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study was carried out in 6 wards (2 urban, 4 rural) of Igabi local government area in Kaduna State. We collected survey data cross-sectionally from 495 cohabiting mothers and fathers of children 6-23 months at baseline and endline. Participants were randomly sampled within 99 clusters selected proportional to population size. The purpose of the surveys was to obtain data on children's complementary feeding, changes in fathers' and mothers' knowledge and attitudes related to complementary feeding, and fathers' support for complementary feeding, and to measure participants' exposure to the intervention components. To measure feasibility and acceptability of the intervention, we conducted 24 in-depth interviews at the end of the intervention with community and religious leaders and Community Health Extension Workers who were involved in implementing the intervention. In addition, we conducted separate focus group discussions with mothers and fathers (8 groups each) at the end of the intervention to learn about changes in social norms related to fathers' engagement in complementary feeding and their experiences with participating in the intervention. conditions module condition list condition Complementary Feeding keyword list keyword Minimum dietary diversity Minimum meal frequency design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 2168 enrollment type Actual arms interventions module arm group list arm group arm group label Complementary feeding promotion arm group type Other arm group description Intervention arm group intervention list arm group intervention name Behavioral: Complementary feeding promotion intervention list intervention intervention type Behavioral intervention name Complementary feeding promotion intervention description The intervention engaged fathers through community meetings, religious services, and mobile phone text and voice messages. Mothers received home visits from community health extension workers (CHEWs), which fathers also could attend. Social behavior change communication materials included TV and radio messages, sermon guides, counseling cards, pamphlets, posters, and feeding bowls. intervention arm group label list intervention arm group label Complementary feeding promotion outcomes module primary outcome list primary outcome primary outcome measure Minimum dietary diversity primary outcome description The proportion of children 6-23 months who consumed at least 4 food groups on the previous day (World Health Organization indicator definition) primary outcome time frame 24 hours secondary outcome list secondary outcome secondary outcome measure Minimum feeding frequency secondary outcome description The proportion of children 6-23 months who consumed minimum number of meals by age group and breastfeeding status (WHO indicator definition) secondary outcome time frame 24 hours secondary outcome measure Minimum acceptable diet secondary outcome description Proportion of children 6-23 months with both minimum dietary diversity and minimum meal frequency (WHO indicator definition) secondary outcome time frame 24 hours secondary outcome measure Consumption of specific food group secondary outcome description Proportion of children 6-23 months who consumed each of the 7 food groups that make up the dietary diversity indicator secondary outcome time frame 24 hours eligibility module eligibility criteria Inclusion Criteria: For the surveys, men were eligible to participate in the surveys if they were 18 years of age or older, had a child aged 6 to 23 months, and were living in the same household as the child's mother. Women were eligible to participate if they were aged 18 to 49 years or aged 15 to 17 years and married, had a child aged 6 to 23 months, and were living in the same household as the child's father. For the qualitative component, mothers, fathers, community and religious leaders, and community health extension workers who participated in the intervention were eligible. - Exclusion Criteria: Refusal to participate or provide consent. - healthy volunteers Accepts Healthy Volunteers gender All gender based Yes gender description Men were eligible to participate in the surveys if they were 18 years of age or older, had a child aged 6 to 23 months, and were living in the same household as the child's mother. Women were eligible to participate if they were aged 18 to 49 years or aged 15 to 17 years and married, had a child aged 6 to 23 months, and were living in the same household as the child's father minimum age 15 Years maximum age 49 Years std age list std age Child Adult contacts locations module overall official list overall official overall official name Valerie Flax overall official affiliation RTI International overall official role Principal Investigator location list location location facility Alive and Thrive location city Kaduna location country Nigeria references module reference list reference reference p m i d 35854939 reference type derived reference citation Allotey D, Flax VL, Ipadeola AF, Kwasu S, Adair LS, Valle CG, Bose S, Martin SL. Fathers' Complementary Feeding Support Strengthens the Association Between Mothers' Decision-Making Autonomy and Optimal Complementary Feeding in Nigeria. Curr Dev Nutr. 2022 Jun 2;6(7):nzac098. doi: 10.1093/cdn/nzac098. eCollection 2022 Jul. reference p m i d 35669047 reference type derived reference citation Flax VL, Ipadeola A, Schnefke CH, Kwasu S, Mikail AA, Bose S, Brower AO, Edwards S. Complementary Feeding Social and Behavior Change Communication for Fathers and Mothers Improves Children's Consumption of Fish and Eggs and Minimum Meal Frequency in Kaduna State, Nigeria. Curr Dev Nutr. 2022 Apr 8;6(5):nzac075. doi: 10.1093/cdn/nzac075. eCollection 2022 May. i p d sharing statement module i p d sharing Yes i p d sharing description The data will be open i p d sharing time frame January 31, 2022 derived section misc info module version holder December 02, 2022

NCT04835662

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full study rank 61249 study protocol section identification module n c t id NCT04838925 org study id info org study id Pro00106634 secondary id info list secondary id info secondary id 1R41DA053011-01 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/1R41DA053011-01 organization org full name CrossComm, Inc. org class INDUSTRY brief title Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain official title Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 22, 2022 start date type Actual primary completion date struct primary completion date April 2023 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 18, 2022 last update post date struct last update post date July 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name CrossComm, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Duke University collaborator class OTHER collaborator name National Institute on Drug Abuse (NIDA) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes is u s export No description module brief summary The purpose of this study is to develop and test the feasibility of a commercially-ready mobile neurofeedback app for individuals with chronic pain. Thirty (30) participants who are prescribed opioids for chronic pain will use the new mobile neurofeedback app and an EEG headset for 10 minutes at a time, 4 times a week for 12 weeks and provide feedback about using the app. detailed description In this STTR Phase I project, CrossComm will collaborate with Duke University to develop a commercial-ready mobile neurofeedback technology and test its feasibility among patients using opioids to treat chronic pain. Specific Aim 1 is to develop a commercial-ready mobile neurofeedback app and will be built according to commercial standards of robustness and maintainability. Specific Aim 2 is to test feasibility of the commercially available mobile app in N=30 patients with chronic pain prescribed opioids. Participants will be recruited for a baseline interview with the Duke Behavioral Health & Technology Lab after passing a preliminary telephone screen. After providing informed consent, participants will provide data on demographics, pain symptoms, and opioid consumption. Each participant will download the mobile neurofeedback app to their smartphone and be instructed to use the intervention for 10 minutes a day, 4 times a week for 12 weeks. Study coordinators will conduct four teleconference sessions (weeks 1, 3, 6 and 9) to reinforce training, troubleshoot difficulties, and support intervention utilization. After the 12-week mobile neurofeedback intervention, the investigators will collect follow-up data, including pain measures, mobile app (usage, satisfaction, & usability), and user feedback on the human-computer interface. Data from these will inform further app refinement preparing for STTR Phase II. conditions module condition list condition Chronic Pain Opioid Use keyword list keyword Chronic Pain Opioids Prescription Opioids Pain Musculoskeletal Pain Mobile Apps Mobile Health Neurofeedback EEG Feedback Biofeedback Alternative Therapy design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Device Feasibility design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Mobile Neurofeedback arm group type Experimental arm group description Participants engage in the use of a mobile neurofeedback intervention, which involves using a mobile app paired with an EEG headset, to achieve a calm, relaxed state. Participants will be instructed to use the intervention at a minimum of 10 minutes a day, 4 times a week for a total of 12 weeks. arm group intervention list arm group intervention name Device: Mobile Neurofeedback App intervention list intervention intervention type Device intervention name Mobile Neurofeedback App intervention description Neurofeedback intervention delivered via mobile app. Participants wear an EEG headset which is connected to a mobile app that delivers feedback about brainwave data indicating whether they are in a calm, relaxed state. Participants hear a lower/simple sound when they are below a target level and higher/richer sound when they approach or achieve their target. intervention arm group label list intervention arm group label Mobile Neurofeedback outcomes module primary outcome list primary outcome primary outcome measure Mobile App Usage primary outcome description Objective data on number of mobile neurofeedback sessions completed by participants. Intervention adherence data will inform the feasibility of real-world use of the commercial-ready mobile app. primary outcome time frame 12 weeks secondary outcome list secondary outcome secondary outcome measure Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) secondary outcome description Rating on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) of how satisfied participants were with the mobile neurofeedback app. secondary outcome time frame At 3 month follow-up (end of intervention) secondary outcome measure Mobile App Usability assessed by the System Usability Scale secondary outcome description The participant indicates level of agreement with 10 statements (1: strongly disagree - 5 strongly agree). Scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. (From: https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html) Higher scores indicate better usability. secondary outcome time frame At 3 month follow-up (end of intervention) eligibility module eligibility criteria Inclusion Criteria: Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months) Prescribed opioids for pain management Exclusion Criteria: History of seizures Plans to have pain-related surgery in the next 3 months Has an implanted medical device that could experience interference during EEG, such as a spinal cord stimulator or pacemaker healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Eric B Elbogen, PhD central contact role Contact central contact phone 919-684-9983 central contact e mail eric.elbogen@duke.edu central contact name Alex Thompson central contact role Contact central contact phone 919-681-1613 central contact e mail DBHTL@duke.edu overall official list overall official overall official name Eric B Elbogen, PhD overall official affiliation Duke University overall official role Principal Investigator overall official name Donald K Shin overall official affiliation CrossComm, Inc. overall official role Principal Investigator location list location location facility Duke University School of Medicine Department of Psychiatry location status Recruiting location city Durham location state North Carolina location zip 27705 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000059350 condition mesh term Chronic Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M28595 condition browse leaf name Chronic Pain condition browse leaf as found Chronic Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M28597 condition browse leaf name Musculoskeletal Pain condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04838925

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full study rank 61848 study protocol section identification module n c t id NCT04831138 org study id info org study id STU 032018-078 organization org full name University of Texas Southwestern Medical Center org class OTHER brief title Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma official title A Prospective Study to Evaluate Quantitative Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 24, 2021 start date type Actual primary completion date struct primary completion date March 24, 2026 primary completion date type Anticipated completion date struct completion date March 24, 2027 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 1, 2022 last update post date struct last update post date April 11, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ananth Madhuranthakam responsible party investigator title Director of MR Research and Associate Professor responsible party investigator affiliation University of Texas Southwestern Medical Center lead sponsor lead sponsor name University of Texas Southwestern Medical Center lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Magnetic Resonance Imaging (MRI) including Arterial Spin Labeling (ASL) will be performed before, during, and after the treatment, in a total of up to 6 MRI sessions until 7 months after the first session, or when progression is clinically indicated. Thereafter, patients will be followed through standard clinical examinations for the next 3 years or until demise, whichever occurs first. Clinically, metastatic renal cell carcinoma (RCC) patients are imaged every 2-3 months after the initiation of anti-angiogenic therapy, since morphological (i.e. size) changes are not anticipated earlier. However, our preliminary experience has shown functional changes including perfusion as early as 2-weeks after the initiation of the treatment. T0, T1, and T2 sessions will be performed for this proposal, while T3, T4, and T5 will be performed along with the clinical imaging sessions. All MR imaging sessions will be scheduled within ±1 or ±2 weeks of the target time period. The research MR imaging may take approximately an additional 15 minutes per each imaging session, when done in conjunction with the clinical imaging. The T0, T1, and T2 research MR imaging sessions will be performed additionally for the purpose of this study, with each taking approximately one hour. detailed description The incidence of kidney cancer has steadily increased over the past three to four decades and is among the 10 most frequently diagnosed cancers in the US. Approximately 63,990 new cases of kidney cancer are estimated in 2017 and the prognosis has been historically poor. The current 5-year survival rates are estimated at 74% overall, decreasing to 53% among patients with locally advanced diseases. The most common form of kidney cancer, renal cell carcinoma (RCC), occurs in 90% of all kidney cancers. Among patients with localized RCC who are treated with nephrectomy, approximately one quarter have relapses in distant sites. Among patients with metastatic RCC, the 5-year survival rates are approximately 8%. With better understanding of the pathogenesis of the most common type of RCC, clear-cell renal cell carcinoma (ccRCC), newer treatment options with new agents are being developed to increase survival rates. The high cost and potential risks associated with human trials for the newly developed experimental therapies have emphasized the need for sensitive monitoring of tumor response. Imaging approaches can play an important role in the evaluation and selection of potential new therapies with non-invasive longitudinal monitoring of treatment response. Currently, the radiological assessment of treatment outcomes predominantly relies on morphological (i.e. size) changes using the Response Evaluation Criteria in Solid Tumors (RECIST) and other similar scores. This is a major limiting factor as the effects of many therapeutic agents at the microscopic level precede the eventual changes in tumor size. One such tumor property that has gained increased attention is angiogenesis, which has been shown to support tumor proliferation and infiltration. Increasing numbers of clinical trials have begun targeting tumor vascular supplies by directly inhibiting angiogenesis (e.g. antiangiogenic therapy). Such clinical trials and the eventual clinical use of these therapies would be greatly assisted by the availability of robust imaging indicators of angiogenesis (i.e. tissue perfusion). Positron Emission Tomography (PET) using 15O-labeled water (15O-PET) is considered the gold standard for non-invasive measurement of tissue perfusion. However, the use of 15O-PET requires a cyclotron in close proximity to PET to produce short lived 15O-water (half life 2.4 min), limiting its applicability in clinical settings. Alternative imaging techniques include ultrasound using microbubbles, perfusion computed tomography (CT) using iodinated contrast agent and perfusion MRI using gadolinium based contrast agents. All of these techniques require exogenous agents, restricting their use in longitudinal monitoring of treatment response. ASL-MRI has recently emerged as a quantitative imaging (QI) method to measure perfusion (or capillary blood flow) without the administration of exogenous contrast agents. ASL magnetically "labels" the highly permeable water in the blood as a tracer and measures their accumulation in the tissue of interest, without injecting any exogeneous contrast. Various versions of ASL have been validated in animals using microspheres, and in humans using 15O-PET in the brain. ASL also has a number of advantages compared to dynamic contrast enhanced (DCE) and dynamic susceptibility contrast (DSC) based MR perfusion measurements. Specifically, ASL does not require exogenous agent alleviating the concerns of gadolinium accumulation or nephrogenic systemic fibrosis (NSF) in patients with impaired renal function and, unlike DCE/DSC, the contribution of vascular permeability to ASL measured perfusion is negligible enabling absolute perfusion quantification in physiological units. conditions module condition list condition Renal Cell Carcinoma keyword list keyword magnetic resonance imaging arterial spin labeling design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label RCC Patients arm group type Experimental arm group description Patients with locally advanced or metastatic renal cell carcinoma arm group intervention list arm group intervention name Procedure: MRI with ASL intervention list intervention intervention type Procedure intervention name MRI with ASL intervention description T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement. T1 (Day 7+-2): contrast-enhanced research MRI with ASL T2 (Day 14+-2): contrast-enhanced research MRI with ASL T3: MRI with ASL will be performed along with patient's standard of care imaging session. T4: MRI with ASL will be performed along with patient's standard of care imaging session. T5: MRI with ASL will be performed along with patient's standard of care imaging session. intervention arm group label list intervention arm group label RCC Patients outcomes module primary outcome list primary outcome primary outcome measure Change in perfusion in the tumor primary outcome description Will determine if changes in ASL measured tumor perfusion is associated with treatment response, measured as time to progression. One-sample correlation test will be used to determine the correlation between change in ASL measured tumor perfusion (baseline to 7+-2 days and 14+-2 days) and time to progression. The correlations will be measured and compared using Pearson's correlation coefficient along with 95% confidence interval. primary outcome time frame Baseline to 7 and 14 days primary outcome measure Progression Free Survival (PFS) primary outcome description Will determine if changes in ASL measured perfusion is associated with PFS. PFS will be correlated with baseline perfusion and post-treatment changes at 7-, and 14-days compared to baseline using univariable and multivariable Cox regression models. Will determine whether changes in ASL measured tumor perfusion as a continuous variable in the tumor from baseline to 7-, and 14-days after initiation of therapy is associated with PFS. The hazard ratio and its 95% confidence interval will be presented. primary outcome time frame Up to 3 years secondary outcome list secondary outcome secondary outcome measure ASL measured perfusion within enhancing tumor secondary outcome description Will determine if ASL measured tumor perfusion at baseline is associated with treatment response, measured as time to progression. One-sample correlation test will be used to determine the correlation between baseline ASL measured tumor perfusion and time to progression. The correlations will be measured and compared using Pearson's correlation coefficient along with 95% confidence interval. secondary outcome time frame Baseline secondary outcome measure Overall Survival (OS) secondary outcome description Will determine if changes in ASL measured perfusion is associated with OS. OS will be correlated with baseline perfusion and post-treatment changes at 7- and 14-days compared to baseline using univariable and multivariable Cox regression models. Will determine whether changes in ASL measured tumor perfusion as a continuous variable within the tumor from baseline to 7-, and 14-days after initiation of therapy is associated with OS. The hazard ratio and its 95% confidence interval will be presented. secondary outcome time frame Up to 3 years eligibility module eligibility criteria Inclusion Criteria: Patients with locally advanced or metastatic renal cell carcinoma. Patients scheduled to undergo anti-angiogenic treatment or immunotherapy Eastern Cooperative Oncology Group (ECOG) Status 0, 1 and 2. Women of child-bearing potential must agree to undergo a urine pregnancy screening per standard Radiology departmental protocol, in place to prevent imaging of pregnant patients. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Subjects may not be receiving any other anti-angiogenic agents, at the time of enrollment. Subjects must not be pregnant since pregnancy is a contraindication to administration of gadolinium-based contrast agents. Any contraindication to MRI per Radiology Department's routine protocol, e.g. MRI-incompatible objects, including but not limited to medical devices (e.g. pacemakers, automated implantable cardioverter defibrillators, etc.) and other foreign bodies. Known severe allergic reaction to Gadolinium-based contrast agents. Patients with sickle cell disease and patients with other hemolytic anemias (low red blood count in body). Patients with uncontrollable claustrophobia, severe lower back pain, and uncontrollable tremors, to the point that it would render them unable to tolerate an MRI study. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Kelli Key, PhD central contact role Contact central contact phone 214-648-8152 central contact e mail Kelli.Key@UTSouthwestern.edu central contact name Ananth Madhuranthakam, PhD central contact role Contact central contact phone 214-648-7737 central contact e mail Ananth.Madhuranthakam@UTSouthwestern.edu location list location location facility UT Southwestern Medical Center location status Recruiting location city Dallas location state Texas location zip 75390 location country United States location contact list location contact location contact name Kelli Key, PhD location contact role Contact location contact phone 214-648-8152 location contact e mail Kelli.Key@UTSouthwestern.edu derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002292 condition mesh term Carcinoma, Renal Cell condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000000230 condition ancestor term Adenocarcinoma condition ancestor id D000007680 condition ancestor term Kidney Neoplasms condition ancestor id D000014571 condition ancestor term Urologic Neoplasms condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000007674 condition ancestor term Kidney Diseases condition ancestor id D000014570 condition ancestor term Urologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4700 condition browse leaf name Carcinoma, Renal Cell condition browse leaf as found Renal Cell Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M2737 condition browse leaf name Adenocarcinoma condition browse leaf relevance low condition browse leaf id M9855 condition browse leaf name Kidney Neoplasms condition browse leaf relevance low condition browse leaf id M16472 condition browse leaf name Urologic Neoplasms condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse leaf id T4906 condition browse leaf name Renal Cell Carcinoma condition browse leaf as found Renal Cell Carcinoma condition browse leaf relevance high condition browse leaf id T1341 condition browse leaf name Clear Cell Renal Cell Carcinoma condition browse leaf as found Renal Cell Carcinoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04831138

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full study rank 61525 study protocol section identification module n c t id NCT04835337 org study id info org study id 202032 organization org full name Centers for Disease Control and Prevention, China org class OTHER_GOV brief title The Health Benefits of Indoor Air Filtration Among Children official title Investigating the Health Benefits of Indoor Air Filtration Among Children: a Randomized Crossover Trial in Jiaozuo, China status module status verified date July 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 10, 2021 start date type Actual primary completion date struct primary completion date November 15, 2021 primary completion date type Anticipated completion date struct completion date April 15, 2022 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 27, 2021 last update post date struct last update post date July 28, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Tiantian Li responsible party investigator title professor responsible party investigator affiliation Centers for Disease Control and Prevention, China lead sponsor lead sponsor name Tiantian Li lead sponsor class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study aims to explore the health benefits of air purifier on the impact of air pollutants on children's health. detailed description From April 2021 to November 2021, researchers conduct a randomized double-blind crossover trial on 110 healthy children in Jiaozuo City, Henan Province. The children are divided into two groups according to their classes and alternated the use of true or sham purifiers devices, including air purifiers and fresh air system. Air purifiers are installed in the classroom and bedrooms of the children. Fresh air system are installed in the classroom. A total of 6 epidemiological surveys are conducted on the subjects, with an interval of 60 days or more. All participants and research staffs were blinded to the group assignment. In addition, air pollutant exposure monitoring, questionnaire surveys, physical examinations, and biological sample collection are conducted on the research subjects each time. The biological samples are further tested for the concentration levels of related biomarkers such as the respiratory system, cardiovascular system, metabolic system, and nervous system. Furthermore, comprehensive evaluation of children's behavioral ability is also carried out. conditions module condition list condition Protective Effect of Air Purifier on Children's Health design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Prevention design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 110 enrollment type Anticipated arms interventions module arm group list arm group arm group label Air purifier arm group type Experimental arm group description Participants in this group receive an intervention of real air purifiers placed in the indoor environment. arm group intervention list arm group intervention name Behavioral: Air Purifiers arm group label Control arm group type Sham Comparator arm group description Participants in this group receive an intervention of sham air purifiers, we just remove the filter in the purifiers, and the other treatments are the same as the real purification group. arm group intervention list arm group intervention name Behavioral: Sham Air Purifiers intervention list intervention intervention type Behavioral intervention name Air Purifiers intervention description Students are divided into two groups: intervention group and control group. The intervention team places an air purifier in the indoor environment to intervene. All the indoor environment of the group use the same qualified air purifier, and all participants and research staffs are blinded to the group assignment. intervention arm group label list intervention arm group label Air purifier intervention type Behavioral intervention name Sham Air Purifiers intervention description The control group is also intervened. The intervention is to place a sham air purifier (remove the filter screen) in the indoor environment, and all the indoor environment use the same air purifier as the intervention group. All participants and research staffs are blinded to the group assignment. intervention arm group label list intervention arm group label Control outcomes module primary outcome list primary outcome primary outcome measure Changes of Forced Vital Capacity of Lung Function primary outcome description The pulmonary function measures are performed by the professional medical staff. Before the pulmonary function test, subjects practice several times by themselves. During the examination, each subject stand and clamp the nose clip, and repeat the test, with the best result as the criterion. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of FeNO primary outcome description Use NIOX VERO Sensor to measure fractional exhaled nitric oxide (FeNO) as a biomarker for formaldehyde inhalation exposure. After deep breathing, the subjects gently inhaled into the device. The instrument showed FeNO level of the subjects. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of FeCO primary outcome description Use Pico Smokerlyzer to measure fractional exhaled carbon monoxide (FeCO). After deep breathing, the subjects held their breath for 15 seconds and then gently inhaled into the device. The instrument showed FeCO level and the estimated value of carboxyhemoglobin in blood. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of Systolic Blood Pressure primary outcome description Systolic blood pressure for each subject is conducted by the same trained staff using the same instrument. Average levels are calculated by the treatments of intervention or control. primary outcome time frame Baseline and at the end of each 60 days intervention period primary outcome measure Changes of LF/HF of HRV primary outcome description Use Nihon Kohden Electrocardiograph to measure heart rate variability and examine the ratio between low frequency and high frequency (LF/HF). To eliminate possible error, subjects are conducted by the same trained staff using the same instrument. primary outcome time frame Baseline and at the end of each 60 days intervention period secondary outcome list secondary outcome secondary outcome measure Changes of CRP secondary outcome description Detect the concentration of C-reactive protein in blood sample to examine the different level of inflammation between the group of intervention and control. secondary outcome time frame Baseline and at the end of each 60 days intervention period secondary outcome measure Changes of 8-OHdG secondary outcome description Detect the concentration of 8-hydroxydeoxyguanosine (8-OHdG) in urine sample as a marker of generalized, cellular oxidative stress to DNA. secondary outcome time frame Baseline and at the end of each 60 days intervention period secondary outcome measure Changes of PR secondary outcome description Examine persistent response (PR) as the index to test the focus ability of children. The test is performed by the Wsiconsin card sorting test through computer, and the index reflects the ability of cognitive transfer. The normal value is less than or equal to 27. secondary outcome time frame Baseline and at the end of each 60 days intervention period eligibility module eligibility criteria Inclusion Criteria: 8 ≤ 12 years old Volunteer to participate in this study Exclusion Criteria: Current and past medical history, including asthma, childhood diabetes, childhood hypertension, behavior-related diseases Students who plan to transfer or move within six months Unable to cooperate with follow-up healthy volunteers Accepts Healthy Volunteers gender All minimum age 8 Years maximum age 12 Years std age list std age Child contacts locations module central contact list central contact central contact name Tiantian Li central contact role Contact central contact phone 010-50930213 central contact e mail litiantian@nieh.chinacdc.cn overall official list overall official overall official name Tiantian Li overall official affiliation National Institute of Environmental Health, Chinese Center for Disease Control and Prevention overall official role Study Director location list location location facility National Institute of Environmental Health, Chinese Center for Disease Control and Prevention location status Recruiting location city Beijing location zip 100021 location country China location contact list location contact location contact name tiantian Li location contact role Contact location contact phone 010-50930213 location contact e mail litiantian@nieh.chinacdc.cn derived section misc info module version holder December 02, 2022

NCT04835337

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full study rank 61587 study protocol section identification module n c t id NCT04834531 org study id info org study id ZLJN-V2.0 organization org full name China Academy of Chinese Medical Sciences org class OTHER brief title Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) official title Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis status module status verified date June 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date July 2021 start date type Anticipated primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date October 2023 completion date type Anticipated study first submit date September 21, 2020 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 13, 2021 last update post date struct last update post date June 15, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Zhong Wang responsible party investigator title Institute of Clinical Basic Medicine of Traditional Chinese Medicine responsible party investigator affiliation China Academy of Chinese Medical Sciences lead sponsor lead sponsor name Zhong Wang lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis. conditions module condition list condition Chronic Obstructive Pulmonary Disease Chronic Bronchitis design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 324 enrollment type Anticipated arms interventions module arm group list arm group arm group label Zhuli capsule arm group type Experimental arm group description Base on the standard medical treatment, the patients in this group will be used Zhuli capsule, 2 capsules (1.2 g) once, three time a day for 7 days. arm group intervention list arm group intervention name Drug: Zhuli capsule Other: Standard medical treatment arm group label Placebo arm group type Placebo Comparator arm group description Base on the standard medical treatment, the patients in this group will be used placebo capsule, 2 capsules (1.2 g) once, three time a day for 7 days. arm group intervention list arm group intervention name Drug: Placebo Other: Standard medical treatment intervention list intervention intervention type Drug intervention name Zhuli capsule intervention description This capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days. intervention arm group label list intervention arm group label Zhuli capsule intervention type Drug intervention name Placebo intervention description The placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days. intervention arm group label list intervention arm group label Placebo intervention type Other intervention name Standard medical treatment intervention description Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include: if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs; if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks. intervention arm group label list intervention arm group label Placebo Zhuli capsule outcomes module primary outcome list primary outcome primary outcome measure The clinical control rate of sputum primary outcome description Defined as the proportion of patients with the expectoration rate ≥90%. primary outcome time frame Day 7 secondary outcome list secondary outcome secondary outcome measure Time to sputum turn white secondary outcome time frame up to Day 7 secondary outcome measure Cough Symptom Score Scale secondary outcome description Cough Symptom Score Scale include Day Cough Symptom Score and Night cough symptom score. In Day Cough Symptom Score, zero means no cough,one means occasionally short cough,two means frequent cough, slightly affecting daily activities,three means frequent coughing seriously affects daily activities;In Night cough symptom score,zero means no cough,one means short-term cough when falling asleep or occasional night cough,two means cough slightly affects night sleep,three means cough seriously affects night sleep. secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure Use of Antibiotic secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure Chronic obstructive pulmonary disease Assessment Test secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure The Phlegm-heat Syndrome (Tan-re Zheng) scale secondary outcome description The Phlegm-heat Syndrome (Tan-re Zheng) scale include measures of the main symptoms and the secondary symptoms. The main symptom is about the color ，the characteristics and the amount of sputum.Each one includes four levels,0 represents normal，3 represents mild symptom,6 represents moderate symptom,9 represents Severe symptom.The secondary symptoms include Day cough，Night cough，Dry throat thirst，fever，blush，Dry stool，Yellow urine ，Red tongue and pulse.Each one includes different levels.The higher score represents the more meeting The Phlegm-heat Syndrome (Tan-re Zheng) ，the lower score means the opposite. secondary outcome time frame 0,Day 3, Day 7 secondary outcome measure The change value about the volume of sputum after treatment secondary outcome description Monitor the sputum volume everyday and compare changes in sputum volume in the treatment. secondary outcome time frame 0,Day 3, Day 7 eligibility module eligibility criteria Inclusion Criteria: Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis; Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM Age from 18 to 75 years old, regardless of gender; The score of each dimension of the sputum assement scale is ≥1; Those who have not participated in other drug clinical research in the past one month; Sign the informed consent letter. Exclusion Criteria: Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases. Loose stools due to Spleen deficiency and stomachache caused by cold. Diabetes or severe cardiovascular, liver (ALT>1.5×ULN), kidney (Cr>1.5×ULN) and other primary diseases. Pregnant and lactating women. Patients with acute and chronic respiratory failure. Those who cannot give full informed consent due to mental disorders. People with disabilities recognized by law. People with allergies, or allergic to the ingredients of the drug used in this test. Those who have used drugs with expectorant effects within the day. Patients who are participating in clinical trials of other drugs. - healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Zhong Wang, M.D. central contact role Contact central contact phone 86-10-64093207 central contact e mail zhonw@vip.sina.com central contact name Jun Liu, Ph.D. central contact role Contact central contact phone 86-10-64093207 central contact e mail franlj1104@aliyun.com location list location location facility China-Japan Friendship Hospital location city Beijing location state Beijing location zip 100029 location country China location contact list location contact location contact name Hongchun Zhang, Prof. location contact role Contact location contact phone 86-10-84205298 location contact e mail 13701226664@139.com location facility Guangdong Provincial Hospital of Traditional Chinese Medicine location city Guangzhou location state Guangdong location zip 510120 location country China location contact list location contact location contact name Lin Lin, Prof location contact role Contact location contact phone 86-20-81887233-34430 location contact e mail drlinlin620@163.com location facility Sichuan Provincial Hospital of Traditional Chinese Medicine location city Chengdu location state Sichuan location zip 610075 location country China location contact list location contact location contact name Qing-Song Huang, Prof location contact role Contact location contact phone 86-28-87783481 location contact e mail 252465965@qq.com location facility Zhejiang Provincial Hospital of Chinese Medicine location city Hangzhou location state Zhejiang location zip 310006 location country China location contact list location contact location contact name Zhen Wang, Prof. location contact role Contact location contact phone 86-571-86620303 location contact e mail wangzhen610@sina.cn derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001991 condition mesh term Bronchitis condition mesh id D000029481 condition mesh term Bronchitis, Chronic condition mesh id D000008171 condition mesh term Lung Diseases condition mesh id D000008173 condition mesh term Lung Diseases, Obstructive condition mesh id D000029424 condition mesh term Pulmonary Disease, Chronic Obstructive condition ancestor list condition ancestor condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000001982 condition ancestor term Bronchial Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M22602 condition browse leaf name Pulmonary Disease, Chronic Obstructive condition browse leaf as found Chronic Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf as found Pulmonary Disease condition browse leaf relevance high condition browse leaf id M10322 condition browse leaf name Lung Diseases, Obstructive condition browse leaf as found Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M4419 condition browse leaf name Bronchitis condition browse leaf as found Bronchitis condition browse leaf relevance high condition browse leaf id M22605 condition browse leaf name Bronchitis, Chronic condition browse leaf as found Chronic Bronchitis condition browse leaf relevance high condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M4410 condition browse leaf name Bronchial Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M4421 intervention browse leaf name Bronchodilator Agents intervention browse leaf relevance low intervention browse leaf id M7395 intervention browse leaf name Expectorants intervention browse leaf relevance low intervention browse leaf id M20116 intervention browse leaf name Anti-Asthmatic Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents

NCT04834531

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full study rank 61424 study protocol section identification module n c t id NCT04836650 org study id info org study id FOSSIL organization org full name Universidad de Extremadura org class OTHER brief title Effect of Postural Insoles on Stability and Leg Muscular Activity official title Effect of Postural Metatarsal Bar Orthotic Element on Stability and Leg Muscular Activity. A Randomized Clinical Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date April 6, 2021 start date type Actual primary completion date struct primary completion date April 15, 2021 primary completion date type Actual completion date struct completion date April 22, 2021 completion date type Actual study first submit date February 26, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 23, 2021 last update post date struct last update post date April 26, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Alfonso Martínez Nova responsible party investigator title Clinical Professor responsible party investigator affiliation Universidad de Extremadura lead sponsor lead sponsor name Universidad de Extremadura lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Posturology allows to treat postural problems by using postural insoles, which will have an effect at the neurophysiological level. Pieces of 1 to 3 millimeters are inserted to stimulate specific receptors located on the sole of the foot, which will affect the muscular proprioception and modify the activation of the ascending muscle chains. The hypothesis of this work is based on the fact that the use of postural insoles with a 2 millimeters metatarsal bar will influence the displacement of the center of pressure and the muscle activity of the leg when compared with a placebo insoles. Participants will be healthy subjects and will be divided into two groups, control and experimental. Subjects in the control group will be given a pair of flat insoles (placebo insoles) with 1.2 millimeters polyester resin. Those of the experimental group will be made the same insoles but they will include by thermal fusion a metatarsal bar of 2 millimeters polyester resin in the metatarsal zone corresponding to the 1st, 2nd, 3rd and 4th metatarsal head. Postural stability analysis will be performed with the force platform of the Biomechanics Institute of Valencia (IBV-Spain) and at the same time an electromyographic analysis in the dominant leg with a surface electromyograph system. Subjects will be assessed with their eyes open and closed under two situations, with footwear and with footwear and insoles. conditions module condition list condition Postural Stability Muscular Activity keyword list keyword Metatarsal Bar Insoles Postural stability Electromyograph Activity design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label Flat Insole (no metatarsal bar) arm group type Placebo Comparator arm group description Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles. arm group intervention list arm group intervention name Diagnostic Test: Postural stability assessment with a force platform. Diagnostic Test: Muscular assessment with a electromyograph arm group label Flat Insole (with 2 millimeters metatarsal bar) arm group type Experimental arm group description Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles with a 2 millimeters polyester resin metatarsal bar. arm group intervention list arm group intervention name Diagnostic Test: Postural stability assessment with a force platform. Diagnostic Test: Muscular assessment with a electromyograph intervention list intervention intervention type Diagnostic Test intervention name Postural stability assessment with a force platform. intervention description The postural stability will be assessed in static by means of the antero-posterior and medio-lateral displacements of the center of pressure in Romberg open and closed eyes test measured with a force platform (NED/SVE-IBV-Spain). Three 30-second measurements will be made in each condition. intervention arm group label list intervention arm group label Flat Insole (no metatarsal bar) Flat Insole (with 2 millimeters metatarsal bar) intervention type Diagnostic Test intervention name Muscular assessment with a electromyograph intervention description The activity of the medial and lateral gastrocnemius, soleus and anterior tibial muscles of the dominant leg will be assessed with the mDurance surface electromiograph at the same time as postural stability analysis is performed.Three 30-second measurements will be made in each condition. intervention arm group label list intervention arm group label Flat Insole (no metatarsal bar) Flat Insole (with 2 millimeters metatarsal bar) outcomes module primary outcome list primary outcome primary outcome measure Change of postural balance primary outcome description The mediolateral and anteroposterior excursion of centre of pressures will be measured in millimeters with a force platform with and without the insoles primary outcome time frame From baseline to 10 minutes primary outcome measure Change of muscular activity primary outcome description The muscular activity in gastrocnemius, soleus and tibialis anterioris will be measured as a percentage (%) with a surface electromyograph in one leg with and without the insoles primary outcome time frame From baseline to 10 minutes eligibility module eligibility criteria Inclusion Criteria: Healthy subjects with no discomfort in gait Subjects with not muscle and skeletal diseases Exclusion Criteria: Subjects with balance disorders, pain at legs Subjects with loss of balance healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module location list location location facility Alfonso Martínez Nova location city Plasencia location state Cáceres location zip 10600 location country Spain i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022

NCT04836650

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full study rank 61634 study protocol section identification module n c t id NCT04833920 org study id info org study id 539 organization org full name Assiut University org class OTHER brief title Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy official title Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date January 2022 primary completion date type Anticipated completion date struct completion date June 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Shereen Mamdouh responsible party investigator title Associate professor responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) detailed description Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy. conditions module condition list condition Chemotherapy-induced Peripheral Neuropathy keyword list keyword brain stimulation chemotherapy induced peripheral neuropathy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 26 enrollment type Anticipated arms interventions module arm group list arm group arm group label active tDCS arm group type Active Comparator arm group description tDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days arm group intervention list arm group intervention name Device: transcranial dirrect current brain stimuation arm group label sham tDCS arm group type Sham Comparator arm group description tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds arm group intervention list arm group intervention name Device: transcranial dirrect current brain stimuation intervention list intervention intervention type Device intervention name transcranial dirrect current brain stimuation intervention description tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day), intervention arm group label list intervention arm group label active tDCS sham tDCS outcomes module primary outcome list primary outcome primary outcome measure changes in the visual analogue scale primary outcome description patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable primary outcome time frame 0 (prestimulation), on the 5th day, 15th days and one month after the last session secondary outcome list secondary outcome secondary outcome measure changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS) secondary outcome description the patients will be asked to describe his pain by answering questions in yes or no; score ≥ 12 suggests neuropathic pain is likely to be involved and score < 12 suggests that neuropathic pain is unlikely to be involved secondary outcome time frame 0 (prestimulation),on the 5th day, 15th days and one month after the last session eligibility module eligibility criteria Inclusion Criteria: any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment Exclusion Criteria: patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia, higher brain dysfunction, migraine headache, brain cancer or metastasis and those known to have epilepsy healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Shereen M Kamal, Associate professor central contact role Contact central contact phone 01006279209 central contact e mail sheridouh79@yahoo.com overall official list overall official overall official name Shereen M Kamal, Associate Professor overall official affiliation Assiut University overall official role Principal Investigator location list location location facility South Egypt Cancer Institute location status Recruiting location city Assiut location zip 11715 location country Egypt location contact list location contact location contact name Shereen M Kamal, Lecturer location contact role Contact location contact phone 01006279209 location contact e mail sheridouh79@yahoo.com i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010523 condition mesh term Peripheral Nervous System Diseases condition ancestor list condition ancestor condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M12584 condition browse leaf name Peripheral Nervous System Diseases condition browse leaf as found Peripheral Neuropathy condition browse leaf relevance high condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04833920

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full study rank 61795 study protocol section identification module n c t id NCT04831827 org study id info org study id 20-012010 organization org full name Mayo Clinic org class OTHER brief title Promoting Equity for Cancer Screening and Follow-up official title Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS) status module status verified date October 2021 overall status Withdrawn why stopped Insufficient study resources and change in practice. expanded access info has expanded access No start date struct start date September 1, 2021 start date type Anticipated primary completion date struct primary completion date May 2023 primary completion date type Anticipated completion date struct completion date May 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 19, 2021 last update post date struct last update post date October 27, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Chyke A. Doubeni responsible party investigator title Principal Investigator responsible party investigator affiliation Mayo Clinic lead sponsor lead sponsor name Mayo Clinic lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a randomized trial to assess the efficacy of reminder mechanisms on colorectal cancer (CRC) screening uptake among a cohort of patients who were previously mailed a multitarget stool DNA (mt-sDNA) test and did not complete the screening. Patients will be identified as being due for CRC screening and will be mailed a mt-sDNA kit to their home. Patients who do not complete screening with mt-sDNA within 30 days will be identified and randomized into one of three study arms to receive reminders to complete the mt-sDNA screening. The primary outcome is the rate of completion of screening for colorectal cancer with mt-sDNA test. detailed description Colorectal cancer (CRC) is the third leading cause of cancer-related death in the United States, and screening has been shown to reduce mortality from CRC. Screening is underutilized in the United States, particularly in some communities such as Blacks/African Americans, American Indians/Alaskan Natives, and rural populations, contributing to disparities in mortality. For CRC screening, mt-sDNA testing is one of several tests that are recommended by the United States Preventive Services Task Force (USPSTF). As part of a quality improvement program at our institution, those who are due for CRC screening are identified using a validated electronic algorithm and a kit is mailed directly to each patient. Our intervention is initiated on non-respondents to the mailed mt-sDNA outreach by testing the use of a technology-enabled reminder system. Thirty days after being mailed a mt-sDNA kit, patients who have not completed the screening will be randomized to receive a reminder to complete the mt-sDNA screening by one of three mechanisms (time 0): Automated reminder using the EHR patient portal messaging system. Automated reminder using a customized interactive voice response (IVR) system Personalized reminder phone calls from the clinical team This will allow for an empirical test of processes that can be employed to improve delivery of CRC screening and reduce preventable deaths in populations that are underserved with evidence-based interventions. conditions module condition list condition Colorectal (Colon or Rectal) Cancer design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking Single design masking description Investigators will be blinded to study arm; research coordinators will not be blinded because it is not practical to do so, but steps will be taken to minimize their awareness about study hypotheses. design who masked list design who masked Investigator enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label IVR Reminder arm group type Experimental arm group description Participants will receive an interactive voice reminder arm group intervention list arm group intervention name Other: IVR Reminder arm group label Personalized Phone Call Reminder arm group type Active Comparator arm group description Participants will receive a personalized phone call arm group intervention list arm group intervention name Other: Phone call from research team arm group label Portal Message Only arm group type Active Comparator arm group description Participants will receive a online patient portal message reminder arm group intervention list arm group intervention name Other: EHR Portal message intervention list intervention intervention type Other intervention name IVR Reminder intervention description Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21. intervention arm group label list intervention arm group label IVR Reminder intervention type Other intervention name Phone call from research team intervention description Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21. intervention arm group label list intervention arm group label Personalized Phone Call Reminder intervention type Other intervention name EHR Portal message intervention description Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21. intervention arm group label list intervention arm group label Portal Message Only outcomes module primary outcome list primary outcome primary outcome measure Primary Endpoint (intention-to-treat) primary outcome description The completion rate of mt-sDNA among eligible patients. The primary comparison will be the return rate compared across intervention arms. primary outcome time frame Completion by 6 months post randomization secondary outcome list secondary outcome secondary outcome measure Secondary Outcome (per protocol analysis) secondary outcome description The completion rate of mt-sDNA among eligible patients. The comparison will be the return rate compared across intervention arms, excluding participants who received an alternative intervention due to not having appropriate portal access. secondary outcome time frame Completion by 6 months post randomization eligibility module eligibility criteria Inclusion Criteria: Adults, between 50 to 75 years old. Due for colorectal cancer screening based on not having a record of a colonoscopy within 10 years, sigmoidoscopy, or CT colonography within 5 years, mt-sDNA within 3 years, or FIT within 1 year. Asymptomatic for colorectal cancer such as rectal bleeding or reported abdominal mass. Exclusion Criteria: For the intervention study, patients will be restricted to those aged 50 to 75 years and are due for colorectal cancer screening. We will exclude any patient who has: Had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, mt-sDNA within 3 years, CT colonography within 5 years, and FOBT/FIT within twelve months of inclusion into the study; A diagnosis of CRC or other GI cancer; History of confirmed Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis) or other colitis; Had a colectomy, partial or total; A diagnosis of Lynch Syndrome; A diagnosis of Familial Adenomatous Polyposis (FAP); Iron deficiency anemia; Lower GI bleeding; A metastatic (Stage IV) blood or solid tumor cancer; End stage renal disease; A first degree relative with CRC prior to age 50 or 2+ first degree relatives diagnosed at any age. healthy volunteers Accepts Healthy Volunteers gender All minimum age 50 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Chyke Doubeni, MBBS, MPH overall official affiliation Mayo Clinic overall official role Principal Investigator location list location location facility Mayo Clinic in Rochester location city Rochester location state Minnesota location zip 55905 location country United States references module see also link list see also link see also link label Mayo Clinic Clinical Trials see also link u r l https://www.mayo.edu/research/clinical-trials i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition ancestor list condition ancestor condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal (Colon or Rectal) Cancer condition browse leaf relevance high condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M13996 condition browse leaf name Rectal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04831827

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full study rank 61509 study protocol section identification module n c t id NCT04835545 org study id info org study id DP-2021-Nemec organization org full name Czech Technical University in Prague org class OTHER brief title Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency official title Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency status module status verified date July 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date April 1, 2024 primary completion date type Anticipated completion date struct completion date April 1, 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 20, 2022 last update post date struct last update post date July 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Czech Technical University in Prague lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of the study is to investigate Work of Breathing of a person in simulated avalanche snow and consequent use of the measured data for judging which one of three simulated scenarios are alike while increasing hypercapnia in the simulated avalanche snow. detailed description The study is a part of a university diploma thesis aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. The Investigator is measuring Work of Breathing in three scenarios: a) 2L air pocket, b) 2L air pocket with resistance compensation and c) no air pocket. The investigator hypothesize that the Work of Breathing during compensation of air pocket will be alike with no air pocket scenario, thus proving significance of the resistance reduction for survival. The aim of the study is to investigate the effect of Work of Breathing on gas exchange in subjects breathing into the simulated avalanche snow scenarios. conditions module condition list condition Accident Caused by Snow Avalanche keyword list keyword snow avalanche hypercapnia work of breathing design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Basic Science design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 13 enrollment type Actual arms interventions module arm group list arm group arm group label Wet Perlite, 2L air pocket arm group type Experimental arm group description Breathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket arm group intervention list arm group intervention name Other: extreme hypercapnia induced by ventilation insufficiency arm group label Wet Perlite 2L air pocket with resistance compensation arm group type Experimental arm group description Breathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation arm group intervention list arm group intervention name Other: extreme hypercapnia induced by ventilation insufficiency arm group label Wet Perlite, no air pocket arm group type Experimental arm group description Breathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket arm group intervention list arm group intervention name Other: extreme hypercapnia induced by ventilation insufficiency intervention list intervention intervention type Other intervention name extreme hypercapnia induced by ventilation insufficiency intervention description extreme hypercapnia intervention arm group label list intervention arm group label Wet Perlite 2L air pocket with resistance compensation Wet Perlite, 2L air pocket Wet Perlite, no air pocket outcomes module primary outcome list primary outcome primary outcome measure The length of breathing primary outcome description Time to termination of the breathing experiment due to the decision of the tested subject, or determined by high end-tidal carbon dioxide value or by the order by the clinician assessing the health status of the subjects. primary outcome time frame Continuously within up to 7 minute interval from the beginning of the breathing experiment eligibility module eligibility criteria Inclusion Criteria: healthy and fit volunteers, classified as The American Society of Anesthesiologists class I without a smoking history Exclusion Criteria: Tiffeneau Index less than 0.70 any cardiovascular or respiratory condition healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 30 Years std age list std age Adult contacts locations module overall official list overall official overall official name Karel Roubík, PhD overall official affiliation Czech Technical University in Prague, FBMI overall official role Study Director location list location location facility Czech Technical University, Faculty of Biomedical Engineering location city Kladno location zip 272 01 location country Czechia references module reference list reference reference p m i d 26666523 reference type background reference citation Roubik K, Sieger L, Sykora K. Work of Breathing into Snow in the Presence versus Absence of an Artificial Air Pocket Affects Hypoxia and Hypercapnia of a Victim Covered with Avalanche Snow: A Randomized Double Blind Crossover Study. PLoS One. 2015 Dec 14;10(12):e0144332. doi: 10.1371/journal.pone.0144332. eCollection 2015. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000053120 condition mesh term Respiratory Aspiration condition mesh id D000006935 condition mesh term Hypercapnia condition ancestor list condition ancestor condition ancestor id D000012120 condition ancestor term Respiration Disorders condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000012818 condition ancestor term Signs and Symptoms, Respiratory condition browse leaf list condition browse leaf condition browse leaf id M26290 condition browse leaf name Respiratory Aspiration condition browse leaf as found Breathing condition browse leaf relevance high condition browse leaf id M9138 condition browse leaf name Hypercapnia condition browse leaf as found Hypercapnia condition browse leaf relevance high condition browse leaf id M14109 condition browse leaf name Respiration Disorders condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M14775 condition browse leaf name Signs and Symptoms, Respiratory condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M5423 intervention browse leaf name Cocaine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev VaCoAg intervention browse branch name Vasoconstrictor Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04835545

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full study rank 61363 study protocol section identification module n c t id NCT04837443 org study id info org study id 217 organization org full name Gazi University org class OTHER brief title The Effect of the Rubber Hand Illusion on Sensory Thresholds official title The Effect of the Rubber Hand Illusion on Sensory Thresholds status module status verified date July 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 28, 2021 start date type Actual primary completion date struct primary completion date September 1, 2021 primary completion date type Anticipated completion date struct completion date October 1, 2021 completion date type Anticipated study first submit date March 18, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 26, 2021 last update post date struct last update post date July 27, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Zafer Günendi responsible party investigator title professor doctor responsible party investigator affiliation Gazi University lead sponsor lead sponsor name Gazi University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The rubber hand illusion (RHI) causes a change in body perception and awareness as a result of the integration of simultaneously perceived visual and tactile stimulation. In the rubber hand illusion (RHI), which was first described in 1998, a realistic hand model is perceived as a part of the body and body awareness is impaired. In the RHI, the participant's real hand is positioned behind a screen so that it is out of sight; The rubber model hand is placed in the field of vision and in the appropriate position with the real hand. Brush is applied simultaneously to the same parts of the real and rubber hands. He/she perceives the rubber hand as his own and the brush starts to feel as if it is being rubbed into his own hand. This method, which causes the illusion of body belonging, has been defined as the rubber hand illusion. During the rubber hand illusion, increased activity was observed in the ventral premotor cortex, infraparietal cortex and cerebellum in functional MRI. It is suggested that this phenomenon occurs with the integration of interrelated visual, tactile and proprioceptive senses reaching the premotor cortex. Quantitative sensory tests are standardized subjective clinical sensitivity tests that require the collaboration of the person to be examined. In the tests, calibrated stimuli are applied to capture perception and pain thresholds, thus providing information about sensory thresholds. The impairment of body perception caused by RHI contributes to the multi-faceted understanding of sensory perception, higher-level cognitive processes, brain mapping and functions. In the studies; It has been suggested that the conflict between visual and proprioceptive sensory information created during the rubber hand illusion is resolved by the attenuation of somatosensory input at the cortical level. As far as we know, tactile sensory threshold from quantitative sensory tests, two-point discrimination from cortical senses, pressure pain threshold measured by the algometer, and vibration threshold variation during and after rubber hand burning, which causes changes in body perception, have not been studied before. In this study, the relationship between the RHI phenomenon and sensory thresholds will be evaluated. conditions module condition list condition Healthy keyword list keyword sensory threshold rubber hand illusion design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Basic Science design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Synchronous working group arm group type Experimental arm group intervention list arm group intervention name Behavioral: Rubber hand illusion arm group label Asynchronous working group arm group type Sham Comparator arm group intervention list arm group intervention name Behavioral: Rubber hand illusion intervention list intervention intervention type Behavioral intervention name Rubber hand illusion intervention description Tactile sensory threshold from quantitative sensory tests, two point discrimination from cortical senses, pressure pain threshold measured by algometer will be examined during and after the rubber hand burning, which causes changes in body perception. intervention arm group label list intervention arm group label Asynchronous working group Synchronous working group outcomes module primary outcome list primary outcome primary outcome measure tactile sensation threshold primary outcome description Semmes-Weinstein monofilaments (SWM) are widely used for reproducible testing and measurement of tactile sensory threshold. The sizes of Semmes-Weinstein monofilaments increase on a logarithmic scale. It is made with nylon (line) monofilaments of approximately the same length. To apply, monofilaments are kept perpendicular to the skin and brought into contact. When the pressure is increased and the end point of the filament reaches the forcing threshold, the filament bends. Even if pressure is continued after the filaments are bent, there is no increase in the pressure felt on the skin. For this reason, when the monofilaments are inclined, since no more pressure can be applied with that filament, it is questioned whether the patient is felt or not. Three applications should be made to the patient with the same filament. primary outcome time frame one hour primary outcome measure two point discrimination primary outcome description Two point discrimination (TPD) is the ability to distinguish between two points that are brought into contact with the skin at the same time and with the same pressure, that they are actually two separate points, not one. It was described by Ernest Heinrich Weber (1846). Blunt tip static and mobile TPD is usually tested using Disk-Criminator. Two points are brought into contact with the skin with a compass-like instrument or a compass. It can randomly switch between touching and touching a point or two points in the area being tested. The person being tested is asked to say how many points he felt. The smallest distance resulting in the perception of two different stimuli is recorded as the patient's two point discrimination threshold. primary outcome time frame one hour primary outcome measure pressure pain threshold primary outcome description Pain pressure threshold is defined as the minimum pressure value that creates a perception of pain. The test determines the amount of pressure in a particular area as soon as an ever-increasing painless pressure stimulus turns into a painful feeling of pressure. The pressure algometer (dolorimeter) used for this test is a device used to evaluate sensitivity to pain. The mechanical method using the pressure sensor provides ease of use, is harmless to the patient, and has acceptable reliability and repeatability. Light pressure is applied to the body area to be tested with the algometer. The intensity of the pressure is increased gradually. The participant is asked to say the moment he feels the sensation of pain instead of pressure during the algometric measurement. The amount of pressure that causes pain is recorded as the pressure pain threshold (PPT) in kg / cm2. It has been shown that 3 measurements are required to maximize measurement properties. primary outcome time frame one hour eligibility module eligibility criteria Inclusion Criteria: Healthy 18-65 years old age Exclusion Criteria: Neuropathy Presence of any known neurological or psychiatric disease Inability to cooperate with the tests to be performed Amputation and nerve damage in the upper extremities Upper extremities dysfunction due to nerve damage healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name zafer günendi, MD central contact role Contact central contact phone +903122025219 central contact e mail zafergunendi@yahoo.com location list location location facility Gazi University Faculty of Medicine Department of PMR location status Recruiting location city Ankara location zip 06500 location country Turkey location contact list location contact location contact name hatice ceylan, MD location contact role Contact location contact phone +903122025219 references module reference list reference reference p m i d 16343947 reference type background reference citation Tsakiris M, Prabhu G, Haggard P. Having a body versus moving your body: How agency structures body-ownership. Conscious Cogn. 2006 Jun;15(2):423-32. doi: 10.1016/j.concog.2005.09.004. Epub 2005 Dec 15. reference p m i d 9486643 reference type background reference citation Botvinick M, Cohen J. Rubber hands 'feel' touch that eyes see. Nature. 1998 Feb 19;391(6669):756. doi: 10.1038/35784. No abstract available. reference p m i d 22000838 reference type background reference citation Ramakonar H, Franz EA, Lind CR. The rubber hand illusion and its application to clinical neuroscience. J Clin Neurosci. 2011 Dec;18(12):1596-601. doi: 10.1016/j.jocn.2011.05.008. Epub 2011 Oct 13. reference p m i d 23285026 reference type background reference citation Mohan R, Jensen KB, Petkova VI, Dey A, Barnsley N, Ingvar M, McAuley JH, Moseley GL, Ehrsson HH. No pain relief with the rubber hand illusion. PLoS One. 2012;7(12):e52400. doi: 10.1371/journal.pone.0052400. Epub 2012 Dec 20. reference p m i d 30967758 reference type background reference citation Fang W, Zhang R, Zhao Y, Wang L, Zhou YD. Attenuation of Pain Perception Induced by the Rubber Hand Illusion. Front Neurosci. 2019 Mar 22;13:261. doi: 10.3389/fnins.2019.00261. eCollection 2019. reference p m i d 3614975 reference type background reference citation Fischer AA. Pressure algometry over normal muscles. Standard values, validity and reproducibility of pressure threshold. Pain. 1987 Jul;30(1):115-126. doi: 10.1016/0304-3959(87)90089-3. reference p m i d 28877282 reference type background reference citation Won SY, Kim HK, Kim ME, Kim KS. Two-point discrimination values vary depending on test site, sex and test modality in the orofacial region: a preliminary study. J Appl Oral Sci. 2017 Jul-Aug;25(4):427-435. doi: 10.1590/1678-7757-2016-0462. reference p m i d 21712138 reference type background reference citation Haloua MH, Sierevelt I, Theuvenet WJ. Semmes-weinstein monofilaments: influence of temperature, humidity, and age. J Hand Surg Am. 2011 Jul;36(7):1191-6. doi: 10.1016/j.jhsa.2011.04.009. i p d sharing statement module i p d sharing No i p d sharing description Since the study is planned as a specialist thesis, the details of the study can be shared by the faculty administration. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007088 condition mesh term Illusions condition ancestor list condition ancestor condition ancestor id D000010468 condition ancestor term Perceptual Disorders condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M9288 condition browse leaf name Illusions condition browse leaf as found Illusion condition browse leaf relevance high condition browse leaf id M12531 condition browse leaf name Perceptual Disorders condition browse leaf relevance low condition browse leaf id M20979 condition browse leaf name Neurobehavioral Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions

NCT04837443

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full study rank 61349 study protocol section identification module n c t id NCT04837625 org study id info org study id MC2020883 organization org full name Huashan Hospital org class OTHER brief title A Multicenter Prospective Registration Study of Myasthenic Crisis in China official title A Multicenter Prospective Registration Study of Myasthenic Crisis in China status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date October 1, 2020 start date type Actual primary completion date struct primary completion date September 30, 2026 primary completion date type Anticipated completion date struct completion date September 30, 2026 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Chongbo Zhao responsible party investigator title Professor responsible party investigator affiliation Huashan Hospital lead sponsor lead sponsor name Huashan Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study is a multicenter, prospective, observational research. It will register the basic demographic information, medical history characteristics, clinical features, auxiliary examinations, treatment, outcomes of tracheal intubation/ventilator related events, and clinical outcomes of Myasthenic Crisis patients. The objectives including: Obtain epidemiological data of MC in China; Establish a standardized registration system for MC patients in China; Explore the epidemiology, clinical characteristics, serological characteristics, clinical characteristics of MC, predisposing and predictive factors, extubation process/time, weaning/extubation outcome and predictors of clinical outcome in Chinese MC patients. conditions module condition list condition Myasthenia Gravis Myasthenic Crisis design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Myasthenic Crisis Cohort arm group intervention list arm group intervention name Other: no interventions intervention list intervention intervention type Other intervention name no interventions intervention description no interventions intervention arm group label list intervention arm group label Myasthenic Crisis Cohort outcomes module primary outcome list primary outcome primary outcome measure MG-ADL of 3 years after off-mechanical ventilation primary outcome time frame Sep,2026 eligibility module eligibility criteria Inclusion Criteria: (1)clinical history and signs of fluctuating weakness and fatigability; (2)seropositivityforAChR/MuSKantibodies; (3)If negative or the tested antibodies, positive repetitive nerve stimulation(RNS) at low frequency(2-5Hz) is required; (4)A serious, life-threatening, rapid worsening of MG and potential airway compromise from ventilatory or bulbar dysfunction. Exclusion Criteria: the RNS had over 100% increase after high frequency stimulation or R2 repeats,to differentiate from lambert-Eaton syndrome and congenital MG. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population The study population will be recruited from multiple centers across China. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Xiao Huan, MD central contact role Contact central contact phone +8618351973910 central contact e mail hx941223@163.com central contact name Susan Luo, MD;PHD central contact role Contact central contact e mail SusanRo_36@hotmail.com location list location location facility Huashan Hospital Fudan University location status Recruiting location city Shanghai location state Shanghai location zip 200040 location country China location contact list location contact location contact name Xiao Huan, MD location contact role Contact location contact e mail hx941223@163.com location contact name Susan Luo, MD；PHD location contact role Contact location contact e mail SusanRo_36@hotmail.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009157 condition mesh term Myasthenia Gravis condition ancestor list condition ancestor condition ancestor id D000020361 condition ancestor term Paraneoplastic Syndromes, Nervous System condition ancestor id D000009423 condition ancestor term Nervous System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000010257 condition ancestor term Paraneoplastic Syndromes condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000020511 condition ancestor term Neuromuscular Junction Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11264 condition browse leaf name Myasthenia Gravis condition browse leaf as found Myasthenia Gravis condition browse leaf relevance high condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M12322 condition browse leaf name Paraneoplastic Syndromes condition browse leaf relevance low condition browse leaf id M21313 condition browse leaf name Paraneoplastic Syndromes, Nervous System condition browse leaf relevance low condition browse leaf id M11519 condition browse leaf name Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M21450 condition browse leaf name Neuromuscular Junction Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3973 condition browse leaf name Myasthenia Gravis condition browse leaf as found Myasthenia Gravis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04837625

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full study rank 61719 study protocol section identification module n c t id NCT04832815 org study id info org study id IRB_00125426 organization org full name VA Salt Lake City Health Care System org class FED brief title Equine Human Interaction With Veterans official title Equine Human Interaction With Veterans status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date December 19, 2019 start date type Actual primary completion date struct primary completion date December 19, 2023 primary completion date type Anticipated completion date struct completion date December 19, 2023 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 2, 2022 last update post date struct last update post date June 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name VA Salt Lake City Health Care System lead sponsor class FED collaborator list collaborator collaborator name Utah State University collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research purposes. conditions module condition list condition PTSD keyword list keyword Equine PTSD design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Equine Therapy arm group type Experimental arm group intervention list arm group intervention name Behavioral: Equine Therapy arm group label Treatment as Usual (TAU) arm group type No Intervention arm group label Therapeutic Horsemanship Program arm group type Experimental arm group intervention list arm group intervention name Behavioral: Therapeutic Horsemanship Program intervention list intervention intervention type Behavioral intervention name Equine Therapy intervention description Aim 1: Six session equine interventions. Intervention will be provided one day per week for four weeks. During the first two weeks, each intervention day with consist of two sessions with a lunch break in between. Weeks four and five consist of one trail riding session per intervention day followed by lunch. Each session will be approximately 1.5 hours in length. Sessions 1-4 will occur at the USU Equine Education Center, and session 5-6 will occur on local trails. Optional transportation for participants will be provided from the VA to the intervention site. intervention arm group label list intervention arm group label Equine Therapy intervention type Behavioral intervention name Therapeutic Horsemanship Program intervention description Aim 2: Therapeutic Horsemanship program utilizes the USU Pathways to Horsemanship model and covers levels of equestrian training from basic groundwork to more advanced riding techniques. Training occurs in a three or six-session format with once weekly sessions over three or six weeks. Mindfulness and mindful self-compassion training may be included. intervention arm group label list intervention arm group label Therapeutic Horsemanship Program outcomes module primary outcome list primary outcome primary outcome measure Mean Difference in Acceptance and Action Questionnaire-II (AAQII) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program primary outcome description AAQII measures psychological flexibility. The total AAQII score can range from 7 to 49, with higher values indicating greater psychological inflexibility. Mixed Effect Modeling will be used for the analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome at multiple time points: pre-intervention, post-intervention for selected or all sessions, and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Heart Rate (HR) Indices primary outcome description To determine correlations between physiological responses of the rider and horse, the following heart rate (HR) indices will be computed: Mean HR, standard deviation of the beat-to-beat intervals (SDRR) and the root mean square of successive beat-to-beat differences (rMSSD). Both SDRR and rMSSD are measures of HR variability and reflect shifts between sympathetic (e.g., decrease in HR variability) or parasympathetic (e.g., increase in HR variability) drive. These measures will be taken during each equine intervention session. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Positive and Negative Affect Scale (PANAS) among the Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program primary outcome description PANAS measures short-term positive and negative emotions. The total PANAS-C score can range from 12 to 60 for the positive affect (PA) scale, with higher values indicating greater PA. Similarly, the score range from 15 to 75 for the negative affect (NA) scale, with higher values indicating greater NA. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the primary outcome at multiple time points: pre-intervention, post-intervention sessions, and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Physical Activity Enjoyment Scale (PACES) for Equine Therapy + TAU cohort compared to the TAU only cohort and for Horsemanship Skills Training Program primary outcome description PACES measures enjoyment of activity. The total PACES score can range from 18 to 126, with higher values indicating greater enjoyment. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate the outcome after the intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Posttraumatic Stress Disorder Checklist (PCL) for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description PCL measures PTSD symptoms. The total PCL score can range from 17 to 85, with higher values indicating greater PTSD symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Beck Depression Inventory (BDI) for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description BDI measures depressive symptoms. The total BDI score can range from 0 to 63, with higher values indicating greater depressive symptoms. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description Q-LES-Q-SF measures quality of, and satisfaction with, life. The total Q-LES-Q-SF score can range from 14 to 70, with higher values indicating greater satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean and Standard Deviation of Personal Satisfaction Program Survey for Horsemanship Skills Training Program and for Equine Therapy + TAU cohort compared to the TAU only cohort primary outcome description Personal Satisfaction Program Survey measures satisfaction with the program. The total Personal Satisfaction Program Survey score can range from 0 to 210, with higher values indicating greater program satisfaction. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention sessions and post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Toronto Mindfulness Scale (TMS) for Equine Therapy + TAU cohort primary outcome description TMS measures state mindfulness. The total TMS score can range from 0 to 52, with higher values indicating greater state mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome pre-intervention, post-intervention sessions, post-intervention. primary outcome time frame through study completion, an average of 2 years primary outcome measure Mean Difference in Five Facet Mindfulness Questionnaire (FFMQ) for Horsemanship Skills Training Program. primary outcome description The total FFMQ score can range from 8 to 40 for each of the facets (observe, describe, act aware, nonjudge, nonreact), with higher values indicating greater levels of mindfulness. Mixed Effect Modeling will be used for the primary analyses. Within and between group analyses of pre- to post-intervention psychological instrument and service utilization data will be conducted to determine whether outcomes are associated with program participation. We'll estimate outcome post-intervention. primary outcome time frame through study completion, an average of 2 years secondary outcome list secondary outcome secondary outcome measure Mean and Standard Deviation of Demographic information including medical and psychiatric diagnoses secondary outcome description Demographic information as well as medical and psychiatric diagnoses of the participants will be extracted from the electronic medical record. Demographic information includes age, race, ethnicity, and service connection. Numbers of psychiatric hospitalizations and emergency department visits for 6 months pre- and 6 months post-intervention will be extracted from the electronic medical record. secondary outcome time frame through study completion, an average of 2 years eligibility module eligibility criteria Inclusion Criteria: For Aim 1: Currently enrolled for services at the VA Salt Lake City Health Care System At least one mental health service encounter within the preceding 12 months Diagnosed with PTSD by a clinician within the preceding 24 months Have a doctor release to participate in equine activities For Aim 2: Currently enrolled for services at the VA Salt Lake City Health Care System Have a doctor release to participate in equine activities Exclusion Criteria: Pregnancy Diagnoses of a psychotic spectrum illness and/or cognitive impairment Physical disability that would prevent horseback riding Weight >= 250 lbs. Potentially the severity of and psychological and/or behavioral symptoms will be considered healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name William R Marchand, MD overall official affiliation Salt Lake City Veterans' Administration Medical Center overall official role Principal Investigator location list location location facility VA Salt Lake City Health Care System location city Salt Lake City location state Utah location zip 84148 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022

NCT04832815

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full study rank 61829 study protocol section identification module n c t id NCT04831385 org study id info org study id CREC 2021.266 organization org full name Chinese University of Hong Kong org class OTHER brief title The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia official title The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia status module status verified date March 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2022 start date type Anticipated primary completion date struct primary completion date August 31, 2024 primary completion date type Anticipated completion date struct completion date August 31, 2025 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 18, 2022 last update post date struct last update post date March 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Alice Pik Shan KONG responsible party investigator title Professor responsible party investigator affiliation Chinese University of Hong Kong lead sponsor lead sponsor name Chinese University of Hong Kong lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is a RCT aiming to use CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D comorbid with insomnia. detailed description Insomnia is the most common sleep disorders affecting 10% to 30% of the population, imposing a huge burden on healthcare systems. While the amount of deep sleep (slow wave and rapid eye movement) declines with age, older people are known to be at escalated risk of sleep disturbances with 20-50% adults aged more than 65 years suffering from insomnia. Cognitive behavioral therapy (CBT-I) is the recommended first line treatment of chronic insomnia. However, only 40% Hong Kong Chinese adults seek help for insomnia and most of them have treatment from Complementary Alternative Medicine (CAM) or western doctors for hypnotics and none for CBT-I. Furthermore, there are increasing concerns regarding the potential negative effects of hypnotics on glycemic control. From a meta-analysis including 17 studies involving 36,938,981 individuals with insomnia followed up for a mean period of 11.6 years, there was a tendency of increased risk of mortality associated with hypnotic use. CBT-I is well recognized as an efficacious treatment modality in people with chronic insomnia. From the results of a systemic review and meta-analysis including 20 randomized controlled trials (RCT) involving 1,162 participants with insomnia, intervention with CBT-I, incorporated at least 3 of the following elements: cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation, CBT-I is demonstrated to improve sleep outcomes namely sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE). From another meta-analysis including 37 studies aiming to examine the effect of CBT-I for insomnia comorbid with psychiatric and/or medical conditions including alcohol dependence, depression, post-traumatic stress disorders, chronic pain, cancer, Parkinson disease, coronary artery disease, pulmonary and renal diseases, CBT-I is also shown to improve sleep parameters with beneficial effects greater in those comorbid with psychiatric than in medical conditions. Although CBT-I is considered the first line treatment for chronic insomnia, the effect of CBT-I on the functional outcomes of the comorbid medical conditions is unclear. To date, there was one RCT in United States including 109 older adults (mean age 64.8 ±6.0 years) randomized to 2-hours group sessions (7-10 subjects per group) weekly over 4 months of CBT-I (n=47), Tai Chi Chih (n=39) and sleep seminar (n=23), which found that participants randomized to CBT-I had a lower risk of having increased biological risk (defined as having ≥4 biomarkers out of a total of 8) at 16-months ie 12 months post-intervention when compared to those in sleep seminar only (odd ratio, OR=0.06, 95% confidence interval, CI 0.005-0.67, p<0.01). However, the effect of CBT-I on changes of glycemia had not been reported in this study. There is another pilot RCT (ClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996), enrolled 28 type 2 diabetes (T2D) with insomnia symptoms and recruitment was completed by 1 June 2019 (for 6-weeks intervention including six 1-hour sessions of CBT-I versus health education), in which insomnia severity was the primary outcome and random glucose by glucometer and glycated haemoglobin (HbA1c) were the other outcomes measures; but the results of this pilot RCT are still pending. Taken together, the effect of CBT-I on glycemic control and other outcomes in people with T2D comorbid with insomnia are under-explored. Diabetes is one of the most prevalent non-communicable diseases affecting up to 463 million people worldwide and this figure is estimated to rise to 700 million by 2045, accounting for 10.9% of world population. From the United Kingdom Prospective Diabetes Study (UKPDS), the landmark trial of T2D, 0.9% difference in HbA1c between intensive treatment and conventional treatment arms (HbA1c 7% versus 7.9%), resulted in 12% reduction of any diabetes related endpoints (p=0.029). Although diabetes is prevalent and there is a wealth of evidence supporting that good glycemic control can prevent diabetes related complications, many people with diabetes across the globe do not reach glycemic goals. Our group has reported that <50% T2D reached glycemic goal of HbA1c <7% in Hong Kong. Behavioral changes, along with lifestyle modifications, are the cornerstones of diabetes management. Healthy diet and regular exercise not only have beneficial effects on glycemic control in T2D, but also improves sleep in T2D with insomnia. Sleep plays a pivotal role in regulating energy metabolism and updated guidelines have included adequate sleep, on average 7 hours per night, as one of the key elements of lifestyle therapy in diabetes management. Apart from quantity, quality of sleep is also essential for well-being of an individual. Optimal treatment of insomnia in diabetes may potentially help to improve glycemia although the importance of management of insomnia has not received adequate clinical attention. Of note, there are higher percentage of people with chronic insomnia suffering from diabetes than those without insomnia (13.1% versus 5%). Our team has reported that, among 3,753 Hong Kong Chinese with T2D, around one out of ten T2D had insomnia and insomnia is more commonly found in women than in men (11.4% versus 8.2%, p=0.01). Interestingly, we found that T2D men with comorbid insomnia have worse glycemic control, in terms of higher fasting plasma glucose (FPG) and HbA1c, than their counterpart without insomnia whereas such difference was not observed in women. Although insomnia is more common in women, men with insomnia is at higher risk for insomnia related glycemic problems. Other researchers have reported that people with T2D and insomnia symptoms have worse self-care than their counterparts without insomnia symptoms and the suboptimal self-care behavior in people with T2D comorbid insomnia is potentially the hurdle to achieve glycemic goals. Not only insomnia may worsen glycemic control of T2D, insomnia may also increase the risk of development of cognitive impairment. From 981 Hong Kong Chinese T2D aged ≥60 years, without cognitive impairment at baseline (58.1% men, mean age: 62.5±2.5 years, mean HbA1c 7.4±2.2%), 3.1% developed cognitive impairment after a median follow-up of 6.8 years (interquartile range: 1.7 years), and T2D comorbid with insomnia has a 4-fold risk of development of cognitive impairment compared to their counterpart without insomnia [unpublished data, presented as poster in European Association for the Study of Diabetes (EASD) in Barcelona in 2019, https://www.easd.org/annual-meeting/easd-2019.html]. While CBT-I improves sleep in people suffering from chronic insomnia, there is a lack of evidence regarding the impact of CBT-I on cognitive function. Against this background and based on a multidisciplinary team experienced in CBT-I, including endocrinologist, geriatrician, psychiatrist, clinical psychologist, behavioural therapist and statistician, we propose to conduct a RCT with CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D men comorbid with insomnia. conditions module condition list condition Diabetes Mellitus, Type 2 Insomnia design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 214 enrollment type Anticipated arms interventions module arm group list arm group arm group label CBT-i arm group type Experimental arm group intervention list arm group intervention name Behavioral: Cognitive Behavioural Therapy arm group label Control (Usual Care) arm group type No Intervention arm group description Control intervention list intervention intervention type Behavioral intervention name Cognitive Behavioural Therapy intervention description CBT is a first line therapy for insomnia intervention arm group label list intervention arm group label CBT-i outcomes module primary outcome list primary outcome primary outcome measure The primary outcome measure will be changes in glycemic control, as measured by HbA1c, from baseline. primary outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: Aged ≥60 years; T2D with suboptimal glycemic control defined as HbA1c 7.5-10%; Chinese ethnicity; Comorbid with insomnia having ISI score >14; Able and willing to give informed written consen Exclusion criteria: Cognitive impairment (HK-MoCA score of ≤22); Depression (GDS-15 score >8) and other psychiatric disorders e.g. generalized anxiety disorder, restless leg syndrome, schizophrenia to be elucidated by history from research nurse and questionnaires; OSA as defined as apnoea-hypopnoea index (AHI) ≥15 events per night; Benign prostatic hypertrophy by history and/or elevated PSA and any other chronic medical condition that is likely to affect sleep e.g. chronic pain; Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep; Cerebrovascular accidents, vascular dementia, or any condition that are known to affect cognitive function; Shift workers; Haemoglobinopathies, renal failure, need of regular blood transfusion or any other conditions which will affect the validity of HbA1c in measurement of glycemia; Any condition, as judged by the investigators, as ineligible to participate in this study. healthy volunteers No gender All minimum age 60 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Alice Kong, MD central contact role Contact central contact phone 3505 2648 central contact e mail alicekong@cuhk.edu.hk i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007319 condition mesh term Sleep Initiation and Maintenance Disorders condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003924 condition mesh term Diabetes Mellitus, Type 2 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000020919 condition ancestor term Sleep Disorders, Intrinsic condition ancestor id D000020920 condition ancestor term Dyssomnias condition ancestor id D000012893 condition ancestor term Sleep Wake Disorders condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf as found Diabetes Mellitus, Type 2 condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M9508 condition browse leaf name Sleep Initiation and Maintenance Disorders condition browse leaf as found Insomnia condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M21395 condition browse leaf name Parasomnias condition browse leaf relevance low condition browse leaf id M21807 condition browse leaf name Sleep Disorders, Intrinsic condition browse leaf relevance low condition browse leaf id M21808 condition browse leaf name Dyssomnias condition browse leaf relevance low condition browse leaf id M14848 condition browse leaf name Sleep Wake Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology

NCT04831385

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full study rank 61683 study protocol section identification module n c t id NCT04833283 org study id info org study id 101499310010796 organization org full name I.M. Sechenov First Moscow State Medical University org class OTHER brief title The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass. official title The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass and Its Impact on Postoperative Complications. status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date January 25, 2021 start date type Actual primary completion date struct primary completion date September 2, 2022 primary completion date type Anticipated completion date struct completion date February 28, 2023 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date May 31, 2022 last update post date struct last update post date June 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name I.M. Sechenov First Moscow State Medical University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The aim of the study is to evaluate the effects of intermittent hypoxic-hyperoxic training (IHHT) to protect myocardium against perioperative myocardial injury during cardiac surgery using cardiopulmonary bypass. detailed description This is a prospective, single-center, randomized controlled clinical trial, which will involve patients over 18 years old who would be recruited consecutively during pre-admission consultation at the I.M Sechenov First Moscow State Medical University Cardiac Surgery Department. All patients with a diagnosis of valvular heart disease, or aortic arch disease and indications for cardiac surgery, according to the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines. Five days before the operation, patients will be randomly assigned into two groups using a computer-generated randomization table: intermittent hypoxic-hyperoxic training and an intermittent hypoxic-hyperoxic training control group. For both groups laboratory testing (specific biomarkers - C-reactive protein, troponin I, fatty acid-binding protein (FABPs) and lactate) will be performed before training and after the surgery, and the hypoxic-inducible factor (HIF 1 alpha) would be implemented before and after the trainings. Patients in the intermittent hypoxic-hyperoxic training group will undergo four daily procedures of interval hypoxic-hyperoxic training before cardiac surgery, using a normobaric device to obtain hypoxic and hyperoxic gas mixtures (ReOxy Cardio; Aimediq S.A., Luxemburg, Registration certificate in RU P3H 2014/1486). Before the start of the training, each patient would undergo a hypoxic test to assess the individual response to hypoxia, and to determine the rate of reduction of blood oxygen saturation (SpO2) with a finger pulse oximeter (Masimo SET, measurement accuracy ±2%). During 5 minutes the patient will receive air with reduced oxygen content (12%), through a mask under constant monitoring of the heart rate (HR) and SpO2. As a safety measure, minimal SpO2 would be set at 82% and maximal accepted increase of heart rate would be set to +50% of the initial heart rate. When these values would be reached, the supply of oxygen automatically would be switched to a hyperoxic gas mixture (35%-40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 was lower before the procedure), therefore depending on the rate of saturation reduction, will be taken 1 to 3 minutes (mean 1 min and 50 seconds). The intention is to create hyperoxic arterial oxygen tension and not to simply reduce the time required to recover from hypoxia. Intermittent hypoxic hyperoxic training would be considered successful if there were no significant side effects during the procedure such as angina pain, loss of consciousness, severe dizziness or other variants of significant subjective deterioration of the patient's condition. In the case of successfully passing the test, patients will proceed to the basic intermittent hypoxic hyperemic training. During the training, the hypoxic gas mixture will be given to the patient again in intermittent mode, based on the individual test parameters and alternating with the supply of a hyperoxic gas mixture. One cycle of the procedure consists of hypoxic and hyperoxygenated intervals, the duration of which will be regulated automatically according to the biofeedback principle, based on monitoring of individual values of SpO2 and heart rate. The duration of the hypoxic period ranges from 3 to 5 minutes, and the duration of the hyperoxic period ranges from 1 to 3 minutes, depending on the SpO2 recovery rate. The total time of the hypoxic gas mixture inhaled during one procedure will be 20-30 min. A final training would be conducted in the evening before the surgery. Patients in the intermittent hypoxic-hyperoxic training - control group also will undergo four daily procedures before surgery, using 40 min training periods with simulation of intermittent hypoxic-hyperoxic training by using the same equipment, the patient receives moistened air through a placebo mask under constant monitoring of heart rate and SpO2. Only the person who will conduct the training would know about the patient's allocation to a particular intervention group, the anesthesiologists and cardiac surgeons will not have access to this information. Episodes of cardiac arrhythmias, hypotension with a need for inotropic drug prescription, changes in electrocardiogram, pulse values and blood pressure levels will be recorded during surgery and the postoperative period. Patients will be monitored for 7 days in the hospital, and 30 days after discharge to evaluate the complications. Differences between groups will be assessed using the unpaired Student's t-test or the one-tailed Anova test followed by the Bonferroni post-test. Baseline corrected logistic regression models will be used to estimate the training effect in relation to primary and secondary endpoints. Statistical significance will be set at 0.05 to test hypotheses. conditions module condition list condition Valvular Heart Disease Aortic Arch Aneurysm Surgery keyword list keyword cardiac pulmonary bypass reperfusion interval hypoxic-hyperoxic training preconditioning valvular heart disease, aortic arch aneurysm design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label the intervention group intermittent hypoxic-hyperoxic training arm group type Experimental arm group description the intervention group is patients performing intermittent hypoxic-hyperoxic training before operation. ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) Intervention Description: Perform 4 trainings daily of intermittent hypoxic hyperoxic trainings before surgery, using 40 min trainings periods, the patient will receive air with reduced oxygen content (12 %) through a mask under constant monitoring of heart rate (HR) and SpO2. As a safety measure, minimal SpO2 was set at 82 % and maximal accepted increase of heart rate was set to + 50 % of the initial HR. When these values would be reached, the supply of oxygen automatically switched to a hyperoxic gas mixture (35% - 40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 would be lower before the procedure), which, depending on the rate of saturation reduction, will takes 1 to 3 min (mean 1 min and 50 s). arm group intervention list arm group intervention name Device: ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) arm group label the control group arm group type Placebo Comparator arm group description intermittent hypoxic-hyperoxic training control group will be identical to the main group, also underwent four daily procedures before surgery using 40 min training periods with simulation of intermittent hypoxic-hyperoxic trainings by using the same equipment, whereas moistened air will be delivered through a placebo mask arm group intervention list arm group intervention name Device: ReOxy Cardio device intervention list intervention intervention type Device intervention name ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) intervention description Perform 4 trainings daily of intermittent hypoxic hyperoxic trainings before surgery, using 40 min trainings periods, the patient will receive air with reduced oxygen content (12 %) through a mask under constant monitoring of heart rate (HR) and SpO2. As a safety measure, minimal SpO2 was set at 82 % and maximal accepted increase of heart rate was set to + 50 % of the initial HR. When these values would be reached, the supply of oxygen automatically switched to a hyperoxic gas mixture (35% - 40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 would be lower before the procedure), which, depending on the rate of saturation reduction, will takes 1 to 3 min (mean 1 min and 50 s). intervention arm group label list intervention arm group label the intervention group intermittent hypoxic-hyperoxic training intervention type Device intervention name ReOxy Cardio device intervention description Perform 4 trainings daily of intermittent hypoxic-hyperoxic trainings before surgery, using 40 min trainings periods, whereas moistened air will be delivered through a mask under constant monitoring of heart rate (HR) and SpO2. intervention arm group label list intervention arm group label the control group outcomes module primary outcome list primary outcome primary outcome measure Death from a cardiac cause primary outcome description Death from cardiac causes during the current hospitalization or 30 days after discharge primary outcome time frame The first 30 days from the date of discharge primary outcome measure Myocardial infarction primary outcome description Myocardial infarction after current surgery and one month after discharge primary outcome time frame through study completion, an average of 1 month after discharge primary outcome measure Stroke primary outcome description Stroke in postoperative period until the date of the discharge primary outcome time frame through study completion, an average of 1 month after discharge secondary outcome list secondary outcome secondary outcome measure Electrocardiogram deterioration caused by myocardial ischemia; secondary outcome description Electrocardiogram deterioration caused by myocardial ischemia (ST segment elevation or depression, Q wave, negative T wave ) during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Angina pectoris - typical chest pain III - IV functional class (Canadian Cardiovascular Society classification) secondary outcome description Having an angina pectoris during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Documented episodes of atrial fibrillation/ atrial flutter. secondary outcome description Documented episodes of atrial fibrillation or atrial flutter during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Ventricular proarrhythmia requiring additional therapy secondary outcome description Detection of ventricular proarrhythmia during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Atrioventricular block 2-3 degrees secondary outcome description Atrioventricular block 2-3 degree during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Episodes of hypotension requiring additional therapy secondary outcome description Episodes of hypotension (systolic blood pressure of less than 90 mmHg/ diastolic of less than 60 mmHg) requiring additional therapy during hospitalization or 30 days after discharge secondary outcome time frame through study completion, an average of 1 month after discharge secondary outcome measure Length of stay in the intensive care unit secondary outcome time frame through study completion, an average of 1month eligibility module eligibility criteria Inclusion Criteria: 1. Written consent to participate in the study 2. Male or female patients over 18 years 3. Indications for planned replacement of the aortic or mitral valves or operations on the aortic arch. Exclusion Criteria: 1. Individual intolerance to the intermittent hypoxic-hyperoxic training 2. Acute coronary syndrome after hospitalization and before the surgery 3. The presence of an acute infectious process after hospitalization and before the surgery (fever, leukocytosis with a shift leukocyte formula to the left, increased erythrocyte sedimentation rate (ESR), increased C-reactive protein) 4. Uncompensated hypertension at the time of the procedure (systolic blood pres-sure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg) 5. Loss of consciousness, severe dizziness Non-inclusion criteria: Occlusive atherosclerotic disease of lower limbs, Acute coronary syndrome within 4 weeks before entry Preoperative renal insufficiency (serum creatinine higher than 200 mmol/L), Acute infectious diseases Partial and secondary generalized forms of epilepsy, Uncompensated hypertension (Blood pressure at the time of the procedure: systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg) Severe bronchial asthma with the development of respiratory failure of the II-III degree and individual intolerance to oxygen deficiency. 9. Severe hepatic impairment (class C child-Pugh) Intervention type 10. Mental illness (if patients are not capable of understanding the nature, significance and implications of the clinical trial) 11. Myocardial insufficiency as a component of multiple organ failure in decompensation of liver and kidney diseases healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Philipp Kopylov, Professor central contact role Contact central contact phone +7-903-687-72-64 central contact e mail fjk@inbox.ru central contact name Ines Dhif, MD central contact role Contact central contact phone +7-929-020-55-98 central contact e mail ines.dhif@hotmail.fr location list location location facility University Clinical Hospital №1 location status Recruiting location city Moscow location zip 119991 location country Russian Federation location contact list location contact location contact name Ines Dhif, MD location contact role Contact location contact phone +79290205598 location contact e mail ines.dhif@hotmail.fr i p d sharing statement module i p d sharing No i p d sharing description Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006331 condition mesh term Heart Diseases condition mesh id D000000783 condition mesh term Aneurysm condition mesh id D000006349 condition mesh term Heart Valve Diseases condition ancestor list condition ancestor condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M3337 condition browse leaf name Hypoxia condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf as found Heart Disease condition browse leaf relevance high condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M3265 condition browse leaf name Aneurysm condition browse leaf as found Aneurysm condition browse leaf relevance high condition browse leaf id M8589 condition browse leaf name Heart Valve Diseases condition browse leaf as found Valvular Heart Disease condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases

NCT04833283

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2346, 1477, 1105, 1762, 2603, 119, 1109, 9355, 1104, 1103, 177, 1183, 26466, 1596, 1669, 9123, 1121, 124, 1106, 126, 1904, 117, 1105, 1103, 9355, 1104, 1103, 177, 24312, 10649, 1596, 1669, 9123, 1121, 122, 1106, 124, 1904, 117, 5763, 1113, 1103, 156, 1643, 2346, 1477, 7593, 2603, 119, 1109, 1703, 1159, 1104, 1103, 177, 1183, 26466, 1596, 3245, 7759, 16957, 1219, 1141, 7791, 1209, 1129, 1406, 118, 1476, 11241, 119, 138, 1509, 2013, 1156, 1129, 3303, 1107, 1103, 3440, 1196, 1103, 6059, 119, 7195, 24767, 1107, 1103, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 118, 1654, 1372, 1145, 1209, 13971, 1300, 3828, 8826, 1196, 6059, 117, 1606, 1969, 11241, 2013, 6461, 1114, 14314, 1104, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1118, 1606, 1103, 1269, 3204, 117, 1103, 5351, 7881, 11758, 4772, 1586, 1194, 170, 1282, 4043, 7739, 1223, 4836, 9437, 1104, 1762, 2603, 1105, 156, 1643, 2346, 1477, 119, 2809, 1103, 1825, 1150, 1209, 5880, 1103, 2013, 1156, 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1596, 118, 177, 24312, 10649, 1596, 2013, 1981, 1372, 2076, 17635, 1981, 1372, 6136, 1103, 9108, 1372, 1110, 4420, 4072, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1196, 2805, 119, 11336, 2346, 16844, 10103, 2660, 4442, 117, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 113, 146, 3048, 18784, 114, 11300, 21987, 14177, 27530, 131, 14286, 13199, 125, 2013, 1116, 3828, 1104, 27946, 177, 1183, 26466, 1596, 177, 24312, 10649, 1596, 2013, 1116, 1196, 6059, 117, 1606, 1969, 11241, 2013, 1116, 6461, 117, 1103, 5351, 1209, 3531, 1586, 1114, 3549, 7621, 3438, 113, 1367, 110, 114, 1194, 170, 7739, 1223, 4836, 9437, 1104, 1762, 2603, 113, 145, 2069, 114, 1105, 156, 1643, 2346, 1477, 119, 1249, 170, 3429, 4929, 117, 10298, 156, 1643, 2346, 1477, 1108, 1383, 1120, 5787, 110, 1105, 12477, 23984, 3134, 2773, 1104, 1762, 2603, 1108, 1383, 1106, 116, 1851, 110, 1104, 1103, 3288, 145, 2069, 119, 1332, 1292, 4718, 1156, 1129, 1680, 117, 1103, 3880, 1104, 7621, 7743, 6759, 1106, 170, 177, 24312, 10649, 1596, 3245, 7759, 113, 2588, 110, 118, 1969, 110, 152, 1477, 114, 117, 1107, 16036, 1104, 1134, 1156, 1129, 1598, 1235, 156, 1643, 2346, 1477, 1680, 1620, 110, 113, 1256, 1191, 156, 1643, 2346, 1477, 1156, 1129, 2211, 1196, 1103, 7791, 114, 117, 1134, 117, 5763, 1113, 1103, 2603, 1104, 2068, 23022, 7234, 117, 1209, 2274, 122, 1106, 124, 11241, 113, 1928, 122, 11241, 1105, 1851, 188, 114, 119, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 15545, 2093, 131, 11336, 2346, 16844, 10103, 2660, 4442, 117, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 113, 146, 3048, 18784, 114, 1981, 1372, 3107, 1103, 1654, 1372, 1981, 1372, 2076, 5033, 4043, 3291, 8223, 4626, 2772, 1981, 1372, 6136, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1654, 1372, 1209, 1129, 6742, 1106, 1103, 1514, 1372, 117, 1145, 9315, 1300, 3828, 8826, 1196, 6059, 1606, 1969, 11241, 2013, 6461, 1114, 14314, 1104, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 1116, 1118, 1606, 1103, 1269, 3204, 117, 6142, 11758, 4772, 1586, 1209, 1129, 4653, 1194, 170, 1282, 4043, 7739, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 15545, 2093, 131, 11336, 2346, 16844, 10103, 2660, 4442, 9108, 2190, 9108, 9108, 2076, 15545, 2093, 9108, 1271, 11336, 2346, 16844, 10103, 2660, 4442, 117, 27946, 177, 1183, 26466, 1596, 118, 177, 24312, 10649, 1596, 2013, 113, 146, 3048, 18784, 114, 9108, 6136, 14286, 13199, 125, 2013, 1116, 3828, 1104, 27946, 177, 1183, 26466, 1596, 177, 24312, 10649, 1596, 2013, 1116, 1196, 6059, 117, 1606, 1969, 11241, 2013, 1116, 6461, 117, 1103, 5351, 1209, 3531, 1586, 1114, 3549, 7621, 3438, 113, 1367, 110, 114, 1194, 170, 7739, 1223, 4836, 9437, 1104, 1762, 2603, 113, 145, 2069, 114, 1105, 156, 1643, 2346, 1477, 119, 1249, 170, 3429, 4929, 117, 10298, 156, 1643, 2346, 1477, 1108, 1383, 1120, 5787, 110, 1105, 12477, 23984, 3134, 2773, 1104, 1762, 2603, 1108, 1383, 1106, 116, 1851, 110, 1104, 1103, 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full study rank 61236 study protocol section identification module n c t id NCT04839094 org study id info org study id Q2059 organization org full name Centre Hospitalier Universitaire Vaudois org class OTHER brief title Dry Versus Wet Nasopharyngeal Rapid Test for the Detection of COVID-19. official title Dry Nasopharyngeal Swab Versus Transported in Viral Transport Media Rapid Antigen Test Comparison for the Detection of SARS-CoV-2: a Comparative Trial (RESTART). acronym RESTART status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date December 10, 2020 start date type Actual primary completion date struct primary completion date February 1, 2021 primary completion date type Actual completion date struct completion date February 1, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Antonios Kritikos responsible party investigator title Principal Investigator responsible party investigator affiliation Centre Hospitalier Universitaire Vaudois lead sponsor lead sponsor name Centre Hospitalier Universitaire Vaudois lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Saliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen testing (RAT) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Thus, in the RESTART study the investigators compare antigen and RT-PCR testing methods on nasopharyngeal (NP) swabs and salivary samples. The investigators conducted a prospective observational study among COVID-19 hospitalized patients between 10th December 2020 and 1st February 2021. Paired saliva and NP samples were investigated by RT-PCR (Cobas 6800, Roche-Switzerland) and by two rapid antigen tests: One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland). detailed description In response to the growing SARS-CoV-2 pandemic and shortages of laboratory based rapid molecular testing capacity and reagents on a worldwide scale, multiple manufacturers have developed rapid testing kits to use out of laboratory settings. These simple kits are based either on detection of proteins from the SARS-CoV-2 virus on respiratory samples (e.g. nasopharyngeal or throat swabs), or detection, in blood or serum, of human antibodies generated in response to infection. On 28 October 2020 the Swiss Federal Council decided that as of 2 November 2020, in addition to polymerase chain reaction (PCR) tests, which are considered the "Gold standard" for SARS-CoV-2 diagnosis, it would be possible to conduct nasopharyngeal rapid antigen tests all over Switzerland, also outside licensed laboratories. In a hospital care setting rapid tests are intended to help physicians on prompt clinical management of cases with COVID-19 compatible symptoms upon admission and facilitate patient triage and flow, notably in a period marked of transition to higher incidence rates and enormous pressure on health system. This strategy was subsequently adopted by the University Hospital of Lausanne as well. Roche's SARS-CoV-2 Rapid Antigen Test (which is the actual test employed by our institution) is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. This test is performed using a nasopharyngeal swab collected from a patient with a result available after 10-15 minutes. While the manufacturer reports very good diagnostic performances of the test, literature shows high variability of sensitivity and specificity.Rapid antigen test's diagnostic performances can be high enough to detect cases with high viral load (i.e. pre-symptomatic and early symptomatic cases up to five days from symptom onset. Because of the intense but short-lived nature of SARS-CoV-2 shedding form the upper respiratory tract, the clinical use of rapid antigen testing requires great attention to the timing of infection because testing late in the course of infection will cause an apparently low clinical sensitivity. There is a significant decline of the viral load after 5-7 days of symptoms. In order to account for this possible drawback and compensate the loss of rapid antigen test's diagnostic performance on late infection, a confirmatory RT-PCR is systematically performed by the microbiology laboratory of Lausanne University Hospital. So as to avoid multiple sampling of the same patient and accelerate time-to-final-results, a single nasopharyngeal swab is performed on each patient and soaked on a viral transport medium. From this transport medium both tests are performed (rapid antigen test and RT-PCR). This procedure, introduces a pre-dilution step (in contrast to the usual rapid antigen testing procedure using a dry nasopharyngeal swab) but is in accordance to the specifications of the manufacturers' instructions. While current literature advocates against a significant decrease of tests' analytical performances due to this strategy, there is no strong consensus regarding the influence of transport medium on viral load stability and on test's analytical and clinical sensitivity conditions module condition list condition SARS-CoV-2 keyword list keyword SARS-CoV-2 diagnosis RT-PCR rapid antigen testing saliva viral transport medium design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 58 enrollment type Actual arms interventions module intervention list intervention intervention type Diagnostic Test intervention name rapid antigen testing versus RT-PCR intervention description Sensitivity of rapid antigen testing and RT-PCR performed on nasopharyngeal swabs versus saliva samples in COVID-19 hospitalized patients. outcomes module primary outcome list primary outcome primary outcome measure Diagnostic assessment primary outcome description Comparison of diagnostic performances (sensitivity, specificity, positive and negative predictive value) of the different strategies on patients hospitalised with a SARS-CoV-2 infection. primary outcome time frame On the day of inclusion secondary outcome list secondary outcome secondary outcome measure Limit of detection determination. secondary outcome description - Define the limit of detection viral load and lowest dilution with the highest positivity rate of both strategies. secondary outcome time frame On the day of inclusion eligibility module eligibility criteria Inclusion Criteria: Hospitalized patients aged above 18 years with confirmed SARS-CoV-2 infection by RT-PCR assay. Provide informed consent. Exclusion Criteria: Patient's refusal to participate in the study. Patients with negative RT-PCR if already performed for patient's follow up as part of standard care. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population All hospitalized patients with a confirmed SARS-CoV-2 infection will be screened for inclusion criteria. sampling method Non-Probability Sample contacts locations module location list location location facility Centre Hospitalier Universitaire Vaudois location city Lausanne location state Vaud location country Switzerland i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04839094

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full study rank 61274 study protocol section identification module n c t id NCT04838600 org study id info org study id PN-00025 organization org full name RLS Global org class INDUSTRY brief title A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv® official title A Multicenter, Prospective, Observational, Post-Market Clinical Follow-up Investigation to Confirm Clinical Performance and Safety of ChloraSolv® When Used on Chronic Leg Ulcers and Chronic Diabetic Foot Ulcers in Need of Debridement acronym ChloraSolv02 status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 7, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 12, 2022 last update post date struct last update post date July 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name RLS Global lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users. Approximately 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound. detailed description As above conditions module condition list condition Chronic Leg Ulcer Chronic Diabetic Foot Ulcer keyword list keyword Leg ulcer DFU ChloraSolv Debridement design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 65 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name ChloraSolv intervention description Debridement with ChloraSolv until the wound is visually assessed as clean. outcomes module primary outcome list primary outcome primary outcome measure Incidence of clean wound bed at End of Treatment, as assessed by investigator primary outcome description When the investigator judges that the wound is clean primary endpoint is reached and confirmed by planimetry. primary outcome time frame 1 - 24 weeks secondary outcome list secondary outcome secondary outcome measure Relative change in devitalized tissue and wound size at End of Treatment, compared to Baseline, assessed by planimetry secondary outcome description Assessed by planimetry secondary outcome time frame 1 - 24 weeks eligibility module eligibility criteria Inclusion Criteria: Chronic leg ulcers and chronic diabetic foot ulcers in need of debridement Male or female, 18 years of age and above Able to read and understand the Patient Informed Consent and to provide meaningful written informed consent Exclusion Criteria: Known allergy/hypersensitivity to any of the components of ChloraSolv Renal insufficiency defined as serum creatinine >200 μmol/L Macroangiopathy expected to demand vascular intervention or percutaneous angioplasty performed less than 3 months after start of treatment; toe pressure <30mm Hg Kidney or pancreas transplanted Patient under cortisone treatment >60mg/day Patient treated with chemotherapy or any other immune-inhibiting drugs 12 months before start of treatment Other identified on-going pathologies in the area of wound, such as cancer Pregnancy or breastfeeding Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator Subjects not suitable for the investigation according to the investigator's judgment or other significant medical conditions that the investigator determines could interfere with compliance or investigation assessments. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population The investigation population will comprise of 65 subjects fulfilling the eligibility criteria of the PMCF investigation. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Caroline Gröndahl, MSc central contact role Contact central contact phone +46764194910 central contact e mail caroline.grondahl@rlsglobal.se overall official list overall official overall official name Anders Jönsson, MD overall official affiliation Orthopedic Clinic Mölndal Hospital Sweden overall official role Principal Investigator location list location location facility Vårdcentralen Tunafors location status Recruiting location city Eskilstuna location country Sweden location contact list location contact location contact name Carina Hartin location contact role Contact location contact e mail carina.hartin@regionsormland.se location contact name Ban Paulus, MD location contact role Principal Investigator location facility Carlanderska Hospital location status Active, not recruiting location city Göteborg location country Sweden location facility Wästerläkarna location status Recruiting location city Göteborg location country Sweden location contact list location contact location contact name Henrik von Sydow, MD location contact role Contact location contact e mail henrik.von.sydow@wasterlakarna.se location contact name Henrik von Sydow, MD location contact role Principal Investigator location facility Wetterhälsan Munksjöstaden location status Recruiting location city Jönköping location country Sweden location contact list location contact location contact name Marina Ivanova location contact role Contact location contact e mail marina.ivanova@rjl.se location contact name Patrik Andersson, MD location contact role Principal Investigator location facility Orthopedic Clinic Mölndal Hospital location status Recruiting location city Mölndal location country Sweden location contact list location contact location contact name Anders Jönsson, MD location contact role Contact location contact e mail anders.k.jonsson@vgregion.se location contact name Anders Jönsson, MD location contact role Principal Investigator location facility Framtidens vårdavdelning location status Recruiting location city Trelleborg location country Sweden location contact list location contact location contact name Veronica Himanen location contact role Contact location contact e mail veronica.himanen@skane.se location contact name Nadine Fadhel Dhaher, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No i p d sharing description This is an observational study required by the notified body to confirm clinical performance and safety. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000017719 condition mesh term Diabetic Foot condition mesh id D000016523 condition mesh term Foot Ulcer condition mesh id D000007871 condition mesh term Leg Ulcer condition mesh id D000014456 condition mesh term Ulcer condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000003925 condition ancestor term Diabetic Angiopathies condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000012883 condition ancestor term Skin Ulcer condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000048909 condition ancestor term Diabetes Complications condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000003929 condition ancestor term Diabetic Neuropathies condition ancestor id D000005534 condition ancestor term Foot Diseases condition browse leaf list condition browse leaf condition browse leaf id M16358 condition browse leaf name Ulcer condition browse leaf as found Ulcer condition browse leaf relevance high condition browse leaf id M19085 condition browse leaf name Diabetic Foot condition browse leaf as found Diabetic Foot condition browse leaf relevance high condition browse leaf id M18071 condition browse leaf name Foot Ulcer condition browse leaf as found Foot Ulcers condition browse leaf relevance high condition browse leaf id M10035 condition browse leaf name Leg Ulcer condition browse leaf as found Leg Ulcers condition browse leaf relevance high condition browse leaf id M6272 condition browse leaf name Diabetic Angiopathies condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M14838 condition browse leaf name Skin Ulcer condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M25157 condition browse leaf name Diabetes Complications condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M6276 condition browse leaf name Diabetic Neuropathies condition browse leaf relevance low condition browse leaf id M7810 condition browse leaf name Foot Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04838600

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full study rank 61641 study protocol section identification module n c t id NCT04833829 org study id info org study id STUDY00000560 secondary id info list secondary id info secondary id R34MH124638 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R34MH124638 organization org full name Emory University org class OTHER brief title Cross-disciplinary HIV Integrated Mental Health Support Intervention official title Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) Intervention acronym CHIMES status module status verified date June 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date November 1, 2020 start date type Actual primary completion date struct primary completion date January 1, 2023 primary completion date type Anticipated completion date struct completion date January 1, 2023 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 7, 2022 last update post date struct last update post date June 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Sophia Hussen responsible party investigator title Associate Professor responsible party investigator affiliation Emory University lead sponsor lead sponsor name Emory University lead sponsor class OTHER collaborator list collaborator collaborator name National Institute of Mental Health (NIMH) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The proposed project seeks to develop and test an intervention to improve engagement in HIV and mental health care for young Black gay, bisexual and other men who have sex with men (YB-GBMSM) in Ryan White clinics. detailed description Young Black gay, bisexual and other men who have sex with men (YB-GBMSM) are disproportionately impacted by HIV, with suboptimal rates of engagement across the HIV Continuum of Care (HIV-CoC). Mental health (MH) comorbidities contribute to poor HIV care engagement for many YB-GBMSM; however, effective treatment for these conditions is hindered by barriers including logistical challenges, medical mistrust, and MH stigma. The Ryan White Care act supports integration of HIV and MH services; however, preliminary studies demonstrate low rates of MH referrals and MH care engagement among YB-GBMSM living with HIV, even in these ostensibly integrated care settings. The objective of this study is to develop and implement CHIMES (Cross-disciplinary HIV Integrated with Mental Health Support), a clinic- and provider-level intervention to improve HIV-MH care integration and MH care engagement among YB-GBMSM attending Ryan White clinics. The rationale for this study is that efforts to improve integration of services, particularly if they are culturally tailored, are likely to increase MH and HIV care engagement for YB-GBMSM. The proposed study will pursue two specific aims: (1) to develop the CHIMES intervention; and (2) to conduct a hybrid type 2 implementation-effectiveness pilot trial of CHIMES in two Health Resources and Services Administration (HRSA)/Ryan White-funded clinics in Atlanta, Georgia - a city in the heart of the Southern HIV epidemic. For the first aim, the researchers will work collaboratively with provider and patient stakeholders, adapt existing evidence-based interventions, and build on formative data to refine intervention content, informed by the Capability- Opportunity-Motivation-Behavior (COM-B) Model. For the second aim, the researchers will implement CHIMES in the two clinic settings and conduct a mixed-methods assessment in which continuous data collection informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework will be used to evaluate effectiveness and implementation processes. The effectiveness of the CHIMES intervention will be measured by change in HIV and MH care engagement before, during, and after CHIMES implementation. The researchers will abstract clinic-level aggregate data to characterize change in HIV-CoC and MH care engagement outcomes for YB-GBMSM. conditions module condition list condition Human Immunodeficiency Virus HIV Infections keyword list keyword Mental health design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 850 enrollment type Anticipated arms interventions module arm group list arm group arm group label Clinic Patients During the Pre-implementation Period arm group type Active Comparator arm group description Patients visiting one of the study clinics prior to implementation of the CHIMES intervention. The Baseline time period consists of study Months 1 - 12. Data are retroactively abstracted from medical records of patients who had clinic visits that occurred between January 1, 2019 and December 31, 2019. arm group intervention list arm group intervention name Behavioral: Standard of Care arm group label Clinic Patients During the Implementation Period arm group type Experimental arm group description Patients visiting one of the study clinics during the Implementation period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 13 - 27. arm group intervention list arm group intervention name Behavioral: CHIMES Intervention arm group label Clinic Patients During the Maintenance Period arm group type Experimental arm group description Patients visiting one of the study clinics during the Maintenance period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 28 - 33. arm group intervention list arm group intervention name Behavioral: CHIMES Intervention intervention list intervention intervention type Behavioral intervention name CHIMES Intervention intervention description There are six components to the intervention: Posters and other print materials to prompt providers and patients to discuss MH care engagement. Brief verbal scripts to help HIV providers facilitate patient MH engagement and discuss barriers to MH utilization. Expanded MH screening procedures, including at initial intake. Case management, emphasizing MH care engagement. Interactive trainings for all HIV providers on MH needs, screening/treatment, and barriers to MH service utilization specific to YB-GBMSM. Regular case review meetings. intervention arm group label list intervention arm group label Clinic Patients During the Implementation Period Clinic Patients During the Maintenance Period intervention type Behavioral intervention name Standard of Care intervention description The standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study. intervention arm group label list intervention arm group label Clinic Patients During the Pre-implementation Period outcomes module primary outcome list primary outcome primary outcome measure Number of Mental Health Visits primary outcome description The number of mental health visits by clinic patients during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Percentage of Mental Health Visits by YB-GBMSM primary outcome description The percentage of mental health visits by YB-GBMSM clinic patients during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Number of Patients Attending Two HIV Care Visits primary outcome description The number of patients who come to two HIV Care visits in a 12 month period, during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Number of Patients with HIV RNA Viral Suppression primary outcome description The number of patients with HIV RNA less than 200 Copies, during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Number of Mental Health Care Referrals primary outcome description The number of referrals to mental health care during a 12 month period, during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 primary outcome measure Percentage of Mental Health Referrals for YB-GBMSM primary outcome description The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period. primary outcome time frame Baseline (Months 1-12) up to Month 33 eligibility module eligibility criteria Inclusion Criteria: young Black gay, bisexual and other men who have sex with men (YB-GBMSM) living with HIV patient at Grady Health System Infectious Disease Program or Emory University Hospital Midtown Infectious Disease Clinic Exclusion Criteria: none healthy volunteers No gender Male minimum age 18 Years maximum age 29 Years std age list std age Adult contacts locations module overall official list overall official overall official name Sophia Hussen, MD, MPH overall official affiliation Emory University overall official role Principal Investigator location list location location facility Grady Infectious Diseases Clinic (Ponce Clinic) location city Atlanta location state Georgia location zip 30308 location country United States location facility Emory Midtown Hospital Infectious Disease Outpatient Clinic location city Atlanta location state Georgia location zip 30322 location country United States i p d sharing statement module i p d sharing Yes i p d sharing description De-identified participant data will be made available to other researchers, using established public repositories. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame Participant data will be made available for sharing after publication of this study. i p d sharing access criteria Data will be available to other researchers using established public repositories. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015658 condition mesh term HIV Infections condition mesh id D000000163 condition mesh term Acquired Immunodeficiency Syndrome condition ancestor list condition ancestor condition ancestor id D000086982 condition ancestor term Blood-Borne Infections condition ancestor id D000003141 condition ancestor term Communicable Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000015229 condition ancestor term Sexually Transmitted Diseases, Viral condition ancestor id D000012749 condition ancestor term Sexually Transmitted Diseases condition ancestor id D000016180 condition ancestor term Lentivirus Infections condition ancestor id D000012192 condition ancestor term Retroviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007153 condition ancestor term Immunologic Deficiency Syndromes condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000012897 condition ancestor term Slow Virus Diseases condition browse leaf list condition browse leaf condition browse leaf id M17402 condition browse leaf name HIV Infections condition browse leaf as found Human Immunodeficiency Virus condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M9351 condition browse leaf name Immunologic Deficiency Syndromes condition browse leaf relevance low condition browse leaf id M2674 condition browse leaf name Acquired Immunodeficiency Syndrome condition browse leaf as found Human Immunodeficiency Virus condition browse leaf relevance high condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2595 condition browse leaf name Blood-Borne Infections condition browse leaf relevance low condition browse leaf id M14710 condition browse leaf name Sexually Transmitted Diseases condition browse leaf relevance low condition browse leaf id M17085 condition browse leaf name Sexually Transmitted Diseases, Viral condition browse leaf relevance low condition browse leaf id M17792 condition browse leaf name Lentivirus Infections condition browse leaf relevance low condition browse leaf id M14178 condition browse leaf name Retroviridae Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M14852 condition browse leaf name Slow Virus Diseases condition browse leaf relevance low condition browse leaf id T4202 condition browse leaf name Oculocerebral Syndrome With Hypopigmentation condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04833829

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full study rank 61826 study protocol section identification module n c t id NCT04831424 org study id info org study id NYSPI 7424 organization org full name Columbia University org class OTHER brief title Mitochondrial Stress, Brain Imaging, and Epigenetics official title The Mitochondrial Stress, Brain Imaging, and Epigenetics Study acronym MiSBIE status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 12, 2018 start date type Actual primary completion date struct primary completion date December 31, 2024 primary completion date type Anticipated completion date struct completion date April 30, 2025 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 18, 2022 last update post date struct last update post date July 19, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Martin Picard responsible party investigator title Associate Professor of Behavioral Medicine (in Psychiatry and Neurology) responsible party investigator affiliation Columbia University lead sponsor lead sponsor name Columbia University lead sponsor class OTHER collaborator list collaborator collaborator name Dartmouth College collaborator class OTHER collaborator name Centre National de la Recherche Scientifique, France collaborator class OTHER collaborator name Massachusetts General Hospital collaborator class OTHER collaborator name Technische Universität Dresden collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The MiSBIE study collects biological, behavioral, psychosocial, neuropsychological, and brain imaging data in participants with either: normal mitochondrial function, individuals with the m.3243A>G mitochondrial DNA (mtDNA) mutation, and individuals a single large-scale mtDNA deletion. These defects induce mitochondrial allostatic load (MAL). The 2-day protocol, plus home-based data collection, will provide a comprehensive assessment of the multi-systemic dysregulation associated with MAL or mitochondrial dysfunction, and the link to physical and mental health-related symptoms. Aim 1: Determine the influence of MAL on systemic AL biomarkers. Aim 2: Establish the influence of MAL on stress reactivity profiles. Aim 3. Examine the association between MAL and psychological functioning. detailed description Age-related physical and cognitive decline, as well as the risk of neurological diseases, are increased by the effects of psychosocial stress. Psychosocial stress triggers neuroendocrine, metabolic, cardiovascular, and inflammatory changes in the body. These changes vary in nature and magnitude between individuals, and are associated with long-term disease risk. However, the biological determinants of the stress response are not well understood. This project aims to translate the preclinical findings (how mitochondria regulate the different organ systems and major stress response axes are activated during psychological stress) by studying a population of individuals with varying degree of mitochondrial dysfunction, and to test potential neural mechanism, and why some individuals respond more strongly than others to the same stressor. Each participant will be studied over two consecutive days. Participants will be housed on campus to standardize study conditions. On Day 1, participants will donate blood and saliva, undergo a neuropsychological assessment, and complete questionnaires to assess psychosocial functioning and psychiatric symptoms. After lunch, the investigator will monitor dynamic changes in mental health-related biological outcomes (positive and negative affect, circulating levels of the inflammatory cytokine IL-6, and salivary cortisol) in response to a standardized laboratory challenge. On Day 2, participants will undergo a medical evaluation to assess clinical symptoms and undergo a whole brain neuroimaging session where both resting and stress elicited activity will be measured. A variant of the same stressor as on Day 1 will be used in the neuroimaging session. Participants will then be debriefed, concluding the individuals participation in the study. Participants also complete a home-based saliva and stool collection to examine diurnal variation in salivary hormones, and to examine microbiome composition. This translational project will generate a unique combination of complimentary molecular, cellular, and neuroimaging data that will advance our understanding of the links between mitochondria, the brain, and mental health-related outcomes. conditions module condition list condition Mitochondrial Diseases keyword list keyword Mitochondria Brain Imaging Psychophysiology Epigenetics Stress Metabolic rate Mitochondrial function design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description All participants will undergo TSST and have samples With DNA collected (blood plasma and serum, purified leukocytes, saliva, urine, buccal epithelial cells, hair are stored). design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label Healthy controls arm group type Experimental arm group description No diagnosis of mitochondrial disease arm group intervention list arm group intervention name Behavioral: Trier social stress test arm group label Mutation arm group type Experimental arm group description Participants carrying the m.3243A>G point mutation, without a diagnosis of MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) arm group intervention list arm group intervention name Behavioral: Trier social stress test arm group label Mutation with MELAS arm group type Experimental arm group description Participants carrying the m.3243A>G point mutation, with a diagnosis of MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) arm group intervention list arm group intervention name Behavioral: Trier social stress test arm group label Deletion arm group type Experimental arm group description Participants carrying a single, large-scale mtDNA deletion arm group intervention list arm group intervention name Behavioral: Trier social stress test intervention list intervention intervention type Behavioral intervention name Trier social stress test intervention description The Trier social stress test (TSST) is a tool for investigating psychobiological stress responses in a laboratory setting. It is a laboratory procedure used to reliably induce stress in human research participants. The study is not examining or validating the test itself but rather using it as a tool to measure the response/focus of study. intervention arm group label list intervention arm group label Deletion Healthy controls Mutation Mutation with MELAS intervention other name list intervention other name TSST outcomes module primary outcome list primary outcome primary outcome measure Average TSST-induced elevation in cortisol primary outcome description This is designed to measure cortisol reactivity to the trier social stress test (TSST), quantified from salivary cortisol (LC-MS) over an 8-timepoints timecourse. The elevation will be measured as the area under the curve (AUC) for the cortisol time course. primary outcome time frame Day 1 post challenge (approximately 2 hours) primary outcome measure Average allostatic load index primary outcome description Groups will be compared on a quantitative allostatic load (AL) index integrating baseline fasting measures of neuroendocrine, immune and metabolic systems, urinary catecholamines, hematological measures, and hair/diurnal cortisol levels. primary outcome time frame Blood collected on Day 1 secondary outcome list secondary outcome secondary outcome measure Average TSST-induced elevation in heart rate secondary outcome description Groups will be compared on heart rate (HR) as a measure of cardiovascular reactivity to stress, monitored using a continuous 3-lead ECG. The elevation will be computed from the baseline HR to the peak HR reached during the TSST. secondary outcome time frame Day 1 post challenge (approximately 2 hours) secondary outcome measure Correlation between anxiety and mitochondrial respiration secondary outcome description The association between mitochondrial respiration using extracellular flux analysis (Seahorse) on blood lymphocytes, and anxiety symptoms measured using the state and trait anxiety inventory (STAI), will be quantified by a linear regression across all study participants. secondary outcome time frame Day 1 secondary outcome measure Average neuropsychological function secondary outcome description Groups will be compared on the fluency/initiation domain of executive functioning assessed using the Delis-Kaplan Executive Function System (D-KEFS) test. secondary outcome time frame Day 2 neuropsychological session eligibility module eligibility criteria Inclusion Criteria: Men and women patients between 18 and 55 years of age Willing to provide saliva samples and have venous catheter installed for blood collection during the hospital visit Willing to provide informed consent and capacity to consent Use of effective method of birth control for women of childbearing capacity English Speaking Exclusion Criteria: Individuals with cognitive deficit incapable of providing informed consent will not be included Symptoms of flu or other seasonal infection four weeks preceding hospital visit Raynaud's syndrome (Raynaud phenomenon) Involvement in any therapeutic trials listed on clinicaltrials.gov, including exercise Metal inside or outside the body or claustrophobia prohibitive to MRI testing Diagnosed with mitochondrial disease m.3243A>G, or large scale mtDNA deletion (for healthy controls) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module central contact list central contact central contact name Martin Picard, PhD central contact role Contact central contact phone 6467748967 central contact e mail mp3484@columbia.edu overall official list overall official overall official name Martin Picard, PhD overall official affiliation Columbia University overall official role Principal Investigator location list location location facility Columbia University Irving Medical Center location status Recruiting location city New York location state New York location zip 10032 location country United States location contact list location contact location contact name Martin Picard, PhD location contact role Contact location contact phone 646-774-8967 location contact e mail mp3484@columbia.edu location contact name Martin Picard, PhD location contact role Principal Investigator location contact name Michio Hirano, MD location contact role Sub-Investigator location contact name Richard Sloan, PhD location contact role Sub-Investigator location contact name Caroline Trumpff, PhD location contact role Sub-Investigator references module see also link list see also link see also link label Study Brochure see also link u r l http://www.picardlab.org/uploads/7/7/8/4/77845210/1_misbie_brochure_2018-06-26.pdf i p d sharing statement module i p d sharing Yes i p d sharing description All data will be deposited to the NIMH Data Archive. i p d sharing info type list i p d sharing info type Study Protocol Informed Consent Form (ICF) i p d sharing time frame Data will be made available at the end of the study, without a expiry date. i p d sharing access criteria Access will be handled through the NIMH Data Archive (NDA) i p d sharing u r l https://nda.nih.gov derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000028361 condition mesh term Mitochondrial Diseases condition ancestor list condition ancestor condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition browse leaf list condition browse leaf condition browse leaf id M22494 condition browse leaf name Mitochondrial Diseases condition browse leaf as found Mitochondrial Disease condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04831424

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full study rank 61399 study protocol section identification module n c t id NCT04836975 org study id info org study id D4191R00036 organization org full name AstraZeneca org class INDUSTRY brief title Reveal the Patterns of Presentation, Management and Outcome of Patients With SCLC and Stage III NSCLC in Saudi Arabia: official title A Multicenter Retrospective Observational Study to Reveal the Patterns of Presentation, Management and Outcome of Patients With Small Cell Lung Cancer (SCLC) and Stage III Non-Small Cell Lung Cancer (NSCLC) in Saudi Arabia acronym REVEAL status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 9, 2022 start date type Actual primary completion date struct primary completion date November 30, 2022 primary completion date type Anticipated completion date struct completion date November 30, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 25, 2022 last update post date struct last update post date August 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name AstraZeneca lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A retrospective, multi-centre, observational study to describe the treatment patterns, the demographic, clinical outcomes, treatment effectiveness, and healthcare resource utilization (HCRU) for patients diagnosed with primary Small Cell Lung Cancer SCLC (Extensive stage & Limited Stage)and stage III NSCLC in a real-world setting. detailed description A retrospective, multi-centre, observational study to describe the treatment patterns, the demographic, clinical outcomes, treatment effectiveness, and healthcare resource utilization (HCRU) for patients diagnosed with primary Small Cell Lung Cancer SCLC (Extensive stage & Limited Stage)and stage III NSCLC in a real-world setting Cohort of patients diagnosed with primary SCLC (limited or extensive stage) or stage III NSCLC, aims to characterize the treatment patterns from the index date (defined as the date of initial diagnosis of locally advanced stage III NSCLC and SCLC) to the end of follow-up (defined as the earliest of death, last available medical record or end of the observation period "defined as the date of data abstraction") including the type of treatment received, duration of each treatment regimen, and reasons for stopping treatment regimen. The study population will be identified by participating physicians involved in the diagnosis, treatment and management of these patients through the review of established patient medical records. Eligible patients (both alive and deceased) will have their data anonymously abstracted from their medical records into a centrally designed electronic case report form (eCRF). conditions module condition list condition Lung Cancer keyword list keyword Small Cell Lung Cancer (SCLC) Stage III Non-Small Cell Lung Cancer (NSCLC) design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 150 enrollment type Anticipated arms interventions module arm group list arm group arm group label SCLC arm group description Patient Diagnosed with Small Cell Lung Cancer- (extensive or limited) arm group label NSCLC arm group description Patient diagnosed with primary stage III Non-Small cell lung Cancer outcomes module primary outcome list primary outcome primary outcome measure Treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" primary outcome description To characterize the treatment patterns of patients diagnosed with primary Small Cell Lung Cancer "SCLC" (Extensive stage & Limited Stage) through recoding type of treatment received primary outcome time frame 9 Month primary outcome measure To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". primary outcome description To characterize the treatment patterns of patients diagnosed with primary stage III Non-Small Cell Lung Cancer "NSCLC". through recoding type of treatment received primary outcome time frame 9 Month secondary outcome list secondary outcome secondary outcome measure Patient demographic for the patients diagnosed with primary SCLC secondary outcome description Recording Patient demographic for the patients diagnosed with primary SCLC (Age, gender, etc..) secondary outcome time frame 9 Months secondary outcome measure Clinical characteristics for the patients diagnosed with primary SCLC secondary outcome description Recording Clinical characteristics for the patients diagnosed with primary SCLC(Diagnosis, extent of the disease, etc...) secondary outcome time frame 9 Months secondary outcome measure Patient demographic for patients diagnosed with primary stage III NSCLC secondary outcome description Recording Patient demographic for patients diagnosed with primary stage III NSCLC(Age, gender, etc..) secondary outcome time frame 9 Months secondary outcome measure Clinical characteristics for the patients diagnosed with primary stage III NSCLC secondary outcome description Recording Clinical characteristics for the patients diagnosed with primary stage III NSCLC(Diagnosis, extent of the disease, etc...) secondary outcome time frame 9 Months other outcome list other outcome other outcome measure Determining treatment effectiveness outcomes other outcome description Determining treatment effectiveness outcomes: - Objective response rate [ORR]: is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease other outcome time frame 9 Months other outcome measure Healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC other outcome description Recording healthcare resource utilization (HCRU) associated with primary SCLC (Extensive stage & Limited Stage) / stage III NSCLC treatment. HCRU will be assessed by describing the following: Hospitalizations, Outpatient visits, Emergency department visits, Number of medical and surgical treatments received, Use of imaging studies and other procedures other outcome time frame 9 Months other outcome measure Determining treatment effectiveness outcomes other outcome description Determining treatment effectiveness outcomes: - Disease control rate [DCR]: is a composite of ORR and stable disease other outcome time frame 9 Months eligibility module eligibility criteria Inclusion Criteria: 1. Adult male or female (≥18 years old or according to the age of majority as defined by local regulations). 2. First-ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including SCLC and NSCLC) in the patient's medical records. 3. Patients either diagnosed with a primary diagnosis of SCLC (extensive or limited) or stage III NSCLC, confirmed by pathology, between 1st of January 2015 and 31st of December 2019. 4. Medical records available at the participating site reflect at least nine months of follow-up from the index date (unless the patient died within the first nine months of diagnosis) Exclusion Criteria: 1. Patients with concomitant cancer at the time of diagnosis other than SCLC or stage III NSCLC, except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms. Cancer will be considered concomitant if it occurs within five years of NSCLC or SCLC diagnosis 2. Patients initially diagnosed with stage I to II NSCLC who have progressed to stage III 3. Current or prior use of "Durvalumab" treatment healthy volunteers No gender All std age list std age Child Adult Older Adult study population patients who were diagnosed with primary Small Cell Lung Cancer (Extensive stage & Limited Stage) or stage III Non-Small Cell Lung Cancer sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name AstraZeneca Clinical Study Information Center central contact role Contact central contact phone 1-877-240-9479 central contact e mail information.center@astrazeneca.com location list location location facility Research Site location status Not yet recruiting location city Dammam location country Saudi Arabia location facility Research Site location status Recruiting location city Riyadh location country Saudi Arabia location facility Research Site location status Not yet recruiting location city Riyadh location country Saudi Arabia i p d sharing statement module i p d sharing Yes i p d sharing description Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. i p d sharing time frame AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. i p d sharing access criteria When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. i p d sharing u r l https://astrazenecagroup-dt.pharmacm.com/DT/Home derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008175 condition mesh term Lung Neoplasms condition ancestor list condition ancestor condition ancestor id D000012142 condition ancestor term Respiratory Tract Neoplasms condition ancestor id D000013899 condition ancestor term Thoracic Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M10324 condition browse leaf name Lung Neoplasms condition browse leaf as found Lung Cancer condition browse leaf relevance high condition browse leaf id M4698 condition browse leaf name Carcinoma, Non-Small-Cell Lung condition browse leaf relevance low condition browse leaf id M27476 condition browse leaf name Small Cell Lung Carcinoma condition browse leaf relevance low condition browse leaf id M14131 condition browse leaf name Respiratory Tract Neoplasms condition browse leaf relevance low condition browse leaf id M15810 condition browse leaf name Thoracic Neoplasms condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T5271 condition browse leaf name Small Cell Lung Cancer condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04836975

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full study rank 61310 study protocol section identification module n c t id NCT04838132 org study id info org study id K-2021-009-01 organization org full name Guangzhou First People's Hospital org class OTHER brief title Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery official title Application of Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery : Study Protocol of a Randomized Double-blind Controlled Trial status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 16, 2021 start date type Actual primary completion date struct primary completion date October 31, 2021 primary completion date type Anticipated completion date struct completion date November 30, 2021 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Guangzhou First People's Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Bilateral transverse thoracic muscle plane( TTP) block is expected to be a new analgesic mode in perioperative of cardiac surgery via sternotomy. detailed description This is a single-center, randomized, double-blind, parallel controlled clinical trial. Eighty patients planning to undergo coronary artery bypass grafting or heart valve surgery via median sternotomy were randomly assigned 1:1 to the experimental group or control group. After general anesthesia, all subjects were injected with 0.3% ropivacaine (experimental group) or 0.9% normal saline (control group) 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound by anesthesiologist. The main outcome indicators were the threshold of incision pain and the total amount of analgesics used during the operation and 48h after the operation. Secondary outcome measures were as follows: postoperative VAS score, duration of mechanical ventilation, days in ICU, total days of hospitalization, and hospitalization cost. This study will provide evidence-based medical evidence and clinical data support for the application of TTP block in cardiac surgery. conditions module condition list condition Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Transversus thoracis muscle plane and rectus sheath block with ropivacaine arm group type Experimental arm group description Using the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.3% ropivacaine respectively. arm group intervention list arm group intervention name Procedure: Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine arm group label Transversus thoracis muscle plane and rectus sheath puncture with saline arm group type Experimental arm group description Using the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.9% saline respectively. arm group intervention list arm group intervention name Procedure: Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline intervention list intervention intervention type Procedure intervention name Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine intervention description A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.3% ropivacaine 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound. intervention arm group label list intervention arm group label Transversus thoracis muscle plane and rectus sheath block with ropivacaine intervention type Procedure intervention name Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline intervention description A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.9% saline 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound. intervention arm group label list intervention arm group label Transversus thoracis muscle plane and rectus sheath puncture with saline outcomes module primary outcome list primary outcome primary outcome measure Incidence of hyperalgesia primary outcome description a 180mN von-Frey wire (Touch Test™ Sensory Evaluator, USA) was used to test the pain sensitivity of the area around the wound primary outcome time frame Surgery to 48 hours after primary outcome measure The total amount of analgesics used in the perioperative period. primary outcome description During the perioperation, the amount of analgesics during the operation, the total amount of analgesic pump drugs used and the frequency of pressing the additional bolus trigger in the patient's analgesia system at 48 hours after the operation, and the amount of remedial analgesics primary outcome time frame Surgery to 48 hours after secondary outcome list secondary outcome secondary outcome measure Visual Analogue Scale secondary outcome description A scale with a length of about 10cm is used. One side is marked with 10 scales, and the two ends are marked with "0" and "10" points respectively. 0 points mean painless, and 10 points mean the most intense pain that is unbearable secondary outcome time frame Extubation to 24 hours after secondary outcome measure Length of stay in hospital secondary outcome description record how many days doses the patient spends in hospital secondary outcome time frame the day before hospital discharge secondary outcome measure Postoperative complications secondary outcome description such as nausea and vomiting, pulmonary infection, wound infection, delayed healing, renal insufficiency, etc. secondary outcome time frame the day before hospital discharge secondary outcome measure incidence of postoperative delirium secondary outcome description Changes in postoperative state of consciousness were assessed secondary outcome time frame Day 7 after operation eligibility module eligibility criteria Inclusion Criteria: Patients voluntarily cooperate with the study and sign an informed consent form; Ages between 18 and 65; American Society of Anesthesiologists (ASA) classification: I-III; Undergo coronary artery bypass grafting (CABG) or heart valve surgery with midsternal incision. Exclusion Criteria: Refuse to participate in the trial; Allergic to the anesthetics or analgesics; Suffering with serious systemic diseases (kidney, liver, lungs and endocrine system); American Association of Anesthesiologists (ASA) classification: IV-V; Unstable hemodynamics; History of drug abuse or chronic pain; Mental disorders or communication difficulties; Died during or immediately after the operation. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jierong Luo, master central contact role Contact central contact phone +8615802031110 central contact e mail jierongluo@outlook.com central contact name Bin Zheng, doctor central contact role Contact overall official list overall official overall official name Bin Zheng, doctor overall official affiliation Guangzhou First People's Hospital overall official role Study Chair location list location location facility Guangzhou First People's Hospital location status Recruiting location city Guangzhou location state Guangdong location zip 510180 location country China location contact list location contact location contact name Jierong Luo, MD location contact role Contact location contact phone 86-20-81048306 location contact e mail jierongluo@outlook.com location contact name Jierong Luo, MD location contact role Sub-Investigator location contact name Bin Zheng, MD location contact role Principal Investigator location contact name Guokun Ou, MD location contact role Sub-Investigator location contact name Haitao Zhou, MD location contact role Sub-Investigator location contact name Xiaoqing Xie, MD, Msc location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000077212 intervention mesh term Ropivacaine intervention ancestor list intervention ancestor intervention ancestor id D000000779 intervention ancestor term Anesthetics, Local intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M1700 intervention browse leaf name Ropivacaine intervention browse leaf as found Intensity intervention browse leaf relevance high intervention browse leaf id M3261 intervention browse leaf name Anesthetics, Local intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04838132

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full study rank 61693 study protocol section identification module n c t id NCT04833153 org study id info org study id mjpakk73645 organization org full name University of Turku org class OTHER brief title Continuing Education Intervention Named "Person First - Please" official title Continuing Education Intervention "Person First - Please" of Person-Centred Care Targeted to Nurses in Older People Long-term Care acronym PFP status module status verified date November 2022 overall status Completed expanded access info has expanded access No start date struct start date August 30, 2021 start date type Actual primary completion date struct primary completion date January 2, 2022 primary completion date type Actual completion date struct completion date March 31, 2022 completion date type Actual study first submit date March 13, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 5, 2022 last update post date struct last update post date November 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Mari Pakkonen responsible party investigator title PhD-candidate responsible party investigator affiliation University of Turku lead sponsor lead sponsor name Mari Pakkonen lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC. Research question 1: What is the effectiveness of the PFP intervention on the PCC collective competency of nurses in older people LTC? Hypothesis for research question 1 are: 1. Nurses in intervention group will have higher level of competence of PCC than control. Research question 2: How PCC climate has been maintained in older people LTC from the point of view of the nurses, next of kin and older people? Hypothesis for research question 2 are: PCC climate will be better in intervention group than control from point of view of the nurses, next of kin and older people. The higher competence of nurses the higher level of PCC climate from point of view of the next of kin and older people. The higher collective competence of the nurses the higher level of the PCC climate from point of view of the next of kin and older people. detailed description The study takes place in older people long-term care on two cities in western part of Finland. The long-term care units are similar as stuff structure, nurse/resident ration, working ideology and quality management. The research design is quasi-experimental research with pre- and post- test measurements in the intervention and control groups. The intervention group will follow the protocol and the control group participants will follow the usually care. Data are being collected at baseline, immediately after 10 weeks intervention and at follow-up 6 weeks after intervention. Continuing education named "Person First - Please" (PFP) based on Person-Centered Care (PCC) Practice Framework and Theory of Collective Competence and it consist of four modules: Information, Person, Autonomy and Dignity. Information module will take one hour in the first intervention week, and it will include information about the study; informed consent; short clarification about concept PCC and prerequisites for PCC. Tree other modules takes 4 hours contact with researcher in every three weeks. Power analyses for the sample size showed that for 0.8 effect size, power of 0.8 and statistical significance of 0.05 with three main hypotheses, for intervention group n=64 and for control group n=128. ICC of 0.1 was used based on previous sample of the primary outcome measurement. The sampling based on cluster sampling. Two cities will be constituting the clusters in western part of Finland. From these cities will be selected first all public long-term care units for the older people. To avoid contamination, one of the cities will be selected to participate in the intervention and the other in the control. Participants in the study consist of nurses (Registered Nurses, Licensed Practice Nurses, Caregiver Assistants) who work in older people LTC and older people from the same units participate alone or with their next of kin. Nurses background questions are age, education, working experience. Older people and next of kin background questions are age, length of the living in LTC, relationship, number of visits per week in LTC. The effectiveness of an intervention is measured by validated measurements that have been properly licensed. The data will be analysed by latest version of the Software Platform for Statistical Analysis (SPSS). Descriptive statistic will be calculated for the numerical and categorical data. The normal distribution of the data and 95% confidence intervals will be calculated for the numerical and categorical data. Intervention and control group will be statistically compared, and differences will be measured at each time point. At the baseline will be ensure the similarity of intervention and control group for background variables. Cross-tabulations will be done for categorical and numerical variables. The sum variable of the measurements during the three different measurement time will be analysed using hierarchical linear mixed models will compare the changes over time between the groups. Each participant will be informed before about the purpose of the study, issues related to research ethics, reporting of the findings and they will sign informed consent. Since the study involves research participants who are vulnerable due to cognitive impairment, researcher have clear protocol and special attention will be paid to ethical issues during the study. conditions module condition list condition Nurse-Patient Relations keyword list keyword Person-centred care Continuing education Long-term care Older people design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 250 enrollment type Actual arms interventions module arm group list arm group arm group label PFP intervention arm group type Experimental arm group description PFP 10 week continuing education intervention arm group intervention list arm group intervention name Behavioral: Person-First - Please (PFP) arm group label Control arm arm group type No Intervention arm group description Usual care intervention list intervention intervention type Behavioral intervention name Person-First - Please (PFP) intervention description PFP takes 10 weeks and consist of four modules: Information, Person, Autonomy and Dignity. Information module takes 1 hour contact on first week. The other modules will follow every third weeks, starting from week 2. So that on week 2, 5 and 8 researcher meet nurses in 4 hours education session. Between the modules, nurses can take contact online to the researcher. intervention arm group label list intervention arm group label PFP intervention outcomes module primary outcome list primary outcome primary outcome measure Changes in nurses PCC competency primary outcome description The competence data will be collected by the Patient-centred Care Competency (PCC) scale as primary outcome. The PCC scale consists of 17 items with 5-point Likert scale (1 = minimal, 2 = below average, 3 = average, 4 = good, 5 = excellent), divided subscales: respecting patients' perspectives, promoting patient involvement in care processes, providing for patient comfort, and advocating for patients. primary outcome time frame baseline - after the intervention - 6 week follow up secondary outcome list secondary outcome secondary outcome measure Changes in PCC climate in lens of nurses, older people and next of kin secondary outcome description The PCC climate data will be collected by Person-centred questionnaire (PCQ-S) staff version and (PCQ-P) patient version (6- point Likert scale: 0 = No, I disagree completely; 1 = No, I disagree; 2 = No, I partly disagree, 3 = Yes, I partly agree; 4 = Yes, I agree; 5 = Yes, I agree completely). Scales are divided subscales: hospitality, safety and everydayness. Data will be collect from nurses, older people and their next of kin. secondary outcome time frame baseline - after the intervention - 6 week follow up secondary outcome measure Evaluation of the continuing education named PFP in lens of the nurses secondary outcome description A feasibility tool has been developed for this intervention. Data will be collected from the nurses in end of the every PFP-modules, excluded information module. Tool consist of the subscales: content of the PFP; evaluation about the pedagogical methods; utilization of the PFP; evaluation of the PFP dosage; evaluation of the trainer. There is 5-point Likert scale: 1 = disagree; 2 = partly disagree; 3 = no disagree/no agree; 4 = agree; 5 = agree completely. secondary outcome time frame during the intervention eligibility module eligibility criteria Inclusion Criteria: Nurses (RNs, Licensed Practice Nurses, Caregiver Assistants) who works in older people LTC. The inclusion criteria for nurses are that they work permanently or on a long-term deputy (at least 6 months) in units. The criteria for older people participating alone are that older people have enough cognitive capacity assessed by managers of the units. The criteria for next of kin participating is they will visit at least weekly in LTC. Exclusion Criteria: short- time deputy nurses older people in terminal care healthy volunteers No gender All maximum age 110 Years std age list std age Child Adult Older Adult contacts locations module overall official list overall official overall official name Suhonen, Professor overall official affiliation University of Turku overall official role Study Director location list location location facility Social services and health care location city Rauma location state Satakunta location zip 26100 location country Finland i p d sharing statement module i p d sharing No i p d sharing description small sample size and vulnerable participants derived section misc info module version holder December 02, 2022

NCT04833153

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full study rank 61679 study protocol section identification module n c t id NCT04833335 org study id info org study id APHP190736 organization org full name Assistance Publique - Hôpitaux de Paris org class OTHER brief title ASL in Brain Metastasis MRI Following Gamma Knife Treatment official title ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment. acronym GK-ASL status module status verified date October 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date December 1, 2022 start date type Anticipated primary completion date struct primary completion date July 1, 2023 primary completion date type Anticipated completion date struct completion date July 1, 2024 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date October 28, 2022 last update post date struct last update post date October 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Assistance Publique - Hôpitaux de Paris lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment. The primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment detailed description The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion. conditions module condition list condition Brain Metastases keyword list keyword ASL MRI Metastasis Gamma knife Radionecrosis design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus arm group type Experimental arm group description Inclusion visit, 1 month later, 6 month later arm group intervention list arm group intervention name Other: MRI perfusion sequence intervention list intervention intervention type Other intervention name MRI perfusion sequence intervention description Quantitative analysis intervention arm group label list intervention arm group label Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus intervention other name list intervention other name Arterial Spin Labeling (ASL) outcomes module primary outcome list primary outcome primary outcome measure Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence primary outcome description Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after. primary outcome time frame Evolution between Baseline MRI, 1 and 6 month follow up MRI secondary outcome list secondary outcome secondary outcome measure ASL Perfusion: Cerebral blood flow measurements secondary outcome time frame Baseline MRI, 1 and 6 month follow up MRI secondary outcome measure Interreader correlation secondary outcome description Two neuroradiologists secondary outcome time frame Baseline MRI, 1 and 6 month follow-up MRI secondary outcome measure Morphological analysis of the lesions secondary outcome description Lesion size, oedema secondary outcome time frame Baseline MRI, 1 and 6 month follow-up MRI eligibility module eligibility criteria Inclusion Criteria: Brain metastasis from histologically proven tumor GK treatment within 4 month prior to the inclusion Lesions suspected of progression/ radionecrosis : i.e.≥ 25% of the size progression Lesion size: gadolinium enhanced part of the tumour ≥1 cm Exclusion Criteria: Pregnancy Medical history of primitive brain tumour MRI incompatibility/ medical history of contrast agent allergy Claustrophobia Patient unable to consent Epilepsia/recent stroke Patients participating in other studies Patients without health care insurance healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Natalia SHOR, MD central contact role Contact central contact phone +330661884335 central contact e mail shor.natalia@icloud.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009362 condition mesh term Neoplasm Metastasis condition mesh id D000001932 condition mesh term Brain Neoplasms condition ancestor list condition ancestor condition ancestor id D000009385 condition ancestor term Neoplastic Processes condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000016543 condition ancestor term Central Nervous System Neoplasms condition ancestor id D000009423 condition ancestor term Nervous System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M19712 condition browse leaf name Disease Progression condition browse leaf relevance low condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf as found Metastases condition browse leaf relevance high condition browse leaf id M4361 condition browse leaf name Brain Neoplasms condition browse leaf as found Brain Metastases condition browse leaf relevance high condition browse leaf id M11482 condition browse leaf name Neoplastic Processes condition browse leaf relevance low condition browse leaf id M11519 condition browse leaf name Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M18089 condition browse leaf name Central Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases

NCT04833335

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full study rank 61459 study protocol section identification module n c t id NCT04836195 org study id info org study id PCLX-001-01 organization org full name Pacylex Pharmaceuticals org class INDUSTRY brief title Phase I Trial of PCLX-001 in B-cell Non-Hodgkin Lymphoma and Advanced Solid Malignancies official title Phase I Trial of PCLX-001 in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma and Advanced Solid Malignancies status module status verified date September 2021 overall status Recruiting expanded access info has expanded access No start date struct start date September 14, 2021 start date type Actual primary completion date struct primary completion date February 28, 2023 primary completion date type Anticipated completion date struct completion date July 31, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 26, 2022 last update post date struct last update post date September 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Pacylex Pharmaceuticals lead sponsor class INDUSTRY collaborator list collaborator collaborator name Ozmosis Research Inc. collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a phase I dose-escalation study of oral PCLX-001, conducted in a multicenter, non-randomized, open-label, non-controlled design. The study is comprised of two parts: Part A (single-agent dose escalation) and Part B (single-agent expansion cohorts). detailed description This is a phase I dose-escalation study of oral PCLX-001, conducted in a multicenter, non-randomized, open-label, non-controlled design. The study is comprised of two parts: Part A (single-agent dose escalation) and Part B (single-agent expansion cohorts). For Part A dose-escalation, patients will be accrued in cohorts of 3 to 6 patients to each dose level. A new dose level cannot open to accrual until toxicity has been determined in the preceding dose level (i.e. all patients have completed their first cycle of therapy and data for all patients in that dose level have been reviewed at a safety cohort review meeting). Six patients will be treated at the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). If required, the MTD cohort may be expanded by an additional 10 patients for further toxicity and response assessment. The MTD cohort expansion may be restricted to B-cell lymphoma or advanced solid tumours to ensure there is proper distribution during dose escalation. For Part B (single agent expansion cohorts), two expansion cohorts (N=20 each) will be opened to determine the preliminary clinical activity of PCLX-001 at the RP2D: Expansion Cohort A: Participants with advanced solid malignancies showing preclinical sensitivity or molecular markers of sensitivity to PCLX-001. This includes breast, nonsmall cell lung (NSCLC), small-cell lung (SCLC), colorectal (CRC), and bladder cancers Expansion Cohort B: Participants with relapsed/refractory (R/R) B-cell lymphoma: diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and Burkitt lymphoma. Transformed large B-cell lymphoma will also be included. conditions module condition list condition B-cell Non Hodgkin Lymphoma Advanced Solid Tumor design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Sequential Assignment design intervention model description For Part A dose-escalation, patients will be accrued in cohorts of 3 to 6 patients to each dose level. A new dose level cannot open to accrual until toxicity has been determined in the preceding dose level (i.e. all patients have completed their first cycle of therapy and data for all patients in that dose level have been reviewed at a safety cohort review meeting). Six patients will be treated at the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label PCLX-001 intervention arm group type Experimental arm group description The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level. Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle. The starting dose of PCLX-001 will be 20 mg daily Expansion Cohort Once the MTD has been defined, preliminary activity will be further evaluated in the expansion part of the study. The RP2D may be the MTD but not necessarily as not only safety data will be taken into account prior to its determination. arm group intervention list arm group intervention name Drug: PCLX-001 treated intervention list intervention intervention type Drug intervention name PCLX-001 treated intervention description To ensure maximal safety in this first-in-human trial, the starting dose level was chosen to be 20 mg daily. PCLX-001 will be provided as an oral flat daily dose on a 28-day cycle. Missed doses for any reason will not be administered at a later time. The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. If DLT attributable to the treatment is experienced in 1/3 patients, three more patients (for a total of six patients) will be treated at that dose level. If no additional DLT is observed at the expanded dose level (i.e. 1/6 with DLT), the dose will be escalated. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level. DLT and determination of MTD will be based on cycle 1 toxicities. intervention arm group label list intervention arm group label PCLX-001 intervention outcomes module primary outcome list primary outcome primary outcome measure To determine, during the dose escalation phase, the recommended dose of PCLX-001 for the dose expansion phase of the trial. primary outcome description The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT. primary outcome time frame Cycle length is 28 days primary outcome measure To determine the time to maximum plasma level (Tmax) of PCLX-001 primary outcome description Tmax is the time at which the maximum plasma concentration of PCLX-001 is achieved. primary outcome time frame Measured on Cycle 1: Pre-dose on Days 1,2,8(±2), 15 (±2), 22 (±2), Day 1 and Day 15 will also measure at 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours; Cycle 2 pre-dose on Day 1 & 15; Cycle 3 pre-dose on Day 1 (Each cycle is 28 days) primary outcome measure To determine the maximum plasma level (Cmax) of PCLX-001 primary outcome description Cmax is the maximum plasma concentration of PCLX-001. primary outcome time frame Measured on Cycle 1: Pre-dose on Days 1,2,8(±2), 15 (±2), 22 (±2), Day 1 and Day 15 will also measure at 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours; Cycle 2 pre-dose on Day 1 & 15; Cycle 3 pre-dose on Day 1 (Each cycle is 28 days) secondary outcome list secondary outcome secondary outcome measure To evaluate the clinical response rate in patients treated with PCLX-001 with advanced solid malignancies secondary outcome description Tumor response and progression of solid tumors and NHL will be evaluated by the investigator at each study center consistent with RECIST 1.1 criteria. secondary outcome time frame Tumor measurements for efficacy evaluation will be made at initiation and at the end of every 2nd cycle (each cycle is 28 days) secondary outcome measure To evaluate the clinical response rate in patients treated with PCLX-001 with relapsed/refractory (R/R) B-cell lymphoma secondary outcome description Tumor response and progression of solid tumors and NHL will be evaluated by the investigator at each study center consistent with Lugano Classification of Lymphoma response. secondary outcome time frame Tumour assessment will be done at the end of every second cycle (each cycle is 28 days). other outcome list other outcome other outcome measure Assess the pharmacodynamic (PD) effects of PCLX-001 in patients with B-cell lymphomas other outcome description Collection of blood samples for exploratory biomarker research is also a part of this trial. Specimens will be stored and may be used for research purposes to identify biomarkers useful for predicting and monitoring PCLX-001. other outcome time frame Cycle 1 Days 1, 2, 8, 15, 22; Cycle 2 Days 1 & 15, Cycle ≥ 3 Day 1 (Cycle is 28 days) other outcome measure Assess the pharmacodynamic (PD) effects of PCLX-001 in patients with advanced solid tumours other outcome description Archived tissue samples will be requested from all patients and pre-treatment biopsies will be optional for patients enrolled in whom an archival biopsy is older than 6 months. These will be collected for response prediction analyses and exploratory research. Archived tumour blocks will be returned to the clinical investigator at the end of the study or, if requested, once sections have been obtained for biomarker analysis. other outcome time frame Access either archived biopsies or at patient screening eligibility module eligibility criteria Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained before any study-specific procedures are performed. Male or female patients aged ≥ 18 years Dose Escalation Participants with histologically-confirmed advanced solid tumor who have failed at least one prior therapy and/or are not eligible for therapies expected to provide clinical benefit. Histologically-confirmed B-cell lymphomas that are expected to express CD20 including DLBCL, HGBL, FL (grades 1 to 3b), MCL, and Burkitt lymphoma who have failed at least two prior therapies and/or are not eligible for therapies expected to provide clinical benefit (including autologous stem cell transplantation). Transformed large B-cell lymphoma patients are eligible. FL patients should meet criteria for requiring treatment. Dose Expansion Cohort A: Participants with histologically-confirmed advanced breast, NSCLC, SCLC, colorectal, and bladder cancers who have failed at least one prior therapy and/or are not eligible for therapies expected to provide clinical benefit. Cohort B: Participants with histologically-confirmed R/R B-cell lymphomas that are expected to express CD20 including DLBCL, HGBL, FL (grades 1-3a), FL (grade 3b), MCL, and Burkitt lymphoma who have failed at least two prior therapies and/or are not eligible for therapies expected to provide clinical benefit. Transformed large B-cell lymphoma patients are eligible. FL patients should meet criteria for requiring treatment. Patients must have evaluable or measurable disease (as per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1], or the Lugano lymphoma classification. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (Appendix A). Life expectancy of at least 12 weeks Patients must have adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 (±3) days before the first dose of study drug: Hemoglobin ≥ 85 g/L Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L for Dose Escalation and ≥ 75 x 109/L for Dose Expansion NOTE: For Dose Expansion, patient who do not meet the above hematological criteria, because of bone marrow suppression from prior therapies and/or extensive tumour involvement in the marrow, may be considered for enrollment in the trial after consultation with the Medical Monitor. Patients must have adequate liver function as assessed by the following laboratory tests to be conducted within 7 (±3) days before the first dose of study drug: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times ULN or ≤ 5 times ULN for patients with malignant liver involvement Patients must have adequate kidney function, as assessed by the estimated glomerular filtration rate (eGFR) >50 mL/min within 7 (±3) days before the first dose of study drug (eGFR to be calculated by the Cockcroft-Gault formula) or creatinine ≤ 1.5 times the ULN Patients must have adequate coagulation, as assessed by the following laboratory tests to be conducted within 7 (±3) days before the first dose of study drug: Prothrombin time/International normalized ratio (PT/INR) ≤ 1.5 for patients not on anticoagulation Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN for patients not on anticoagulation Note: Patients on anticoagulation with an agent such as heparin (eg. enoxaparin, dalteparin, etc.) will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Adequate cardiac function per institutional normal measured by echocardiography or multigated acquisition (MUGA) scan (LVEF ≥ 50%) Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 (±3) days before the start of administration of study drug. Note: A woman is of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active from signing of the informed consent form for the full study until at least 6 months after the last study drug administration. Patients must agree to utilize 2 reliable and acceptable methods of contraception simultaneously. A man is considered fertile after puberty unless permanently sterile by bilateral orchiectomy. Men being treated with PCLX-001 are advised not to father a child during and up to 6 months after treatment; prior to treatment, advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with PCLX-001. Female partners of childbearing potential from male study participants have to use adequate contraception / birth control between signing of the informed consent and 6 months after the last administration of the study drug if the male study participant is not sterilized. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control. Highly effective (failure rate of less than 1% per year) contraception methods, when used consistently and correctly, include: Combined (estrogen and progestin containing: oral, intravaginal transdermal and progestin-only (oral, injectable, implantable) hormonal contraception associated with inhibition of ovulation. Intra-uterine device (IUD) or intrauterine hormone-releasing system (IUS). Bilateral tubal occlusion or vasectomized partner (provided that partner is the sole sexual partner and has received medical assessment of the surgical success). Sexual abstinence (reliability to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient). Male patients with a female partner of reproductive potential must use a condom and ensure that an additional form of contraception is also used during treatment and until 6 months after last study drug administration. Patients must agree to utilize reliable and acceptable methods of contraception simultaneously Exclusion Criteria: Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class > II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry, or uncontrolled cardiac arrhythmias Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion) Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C Patients with known human immunodeficiency virus (HIV) infection Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Patients with chronic HBV or HCV infection are eligible at the investigator's discretion provided that the disease is stable and sufficiently controlled under treatment. Infections of CTCAE Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade > 2 Symptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a stable imaging study within 4 weeks prior to the first dose of study drug and is clinically stable with respect to the tumor at the time of study entry. Patients with asymptomatic brain metastases must not be on steroid therapy. Patients with neurological symptoms should undergo a CT / MRI scan of the brain to exclude new or progressive brain metastases. Current or past history of central nervous system (CNS) lymphoma Uncontrolled seizure disorder requiring therapy (e.g. strong CYP3A4 inducers such as carbamazepine and phenytoin) History of organ allograft transplantation or autologous stem cell transplantation ≤ 3 months prior to the first dose of study drug. Patients who received prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to study drug administration Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE Grade > 2 within 4 weeks before the first dose of study drug Serious, non-healing wound, ulcer, or bone fracture Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, with the exception of the following previous or concurrent cancer types: Curative treatment for localized cancer completed without signs of recurrence and treatment-related toxicity and low risk of recurrence as assessed by the investigator, In-situ prostate cancer, Gleason Score <7, prostate-specific antigen <10 ng/mL (very low risk and low risk, according to therapy guidelines, e.g. the National Comprehensive Cancer Network guideline; active surveillance / observation is a recommended option). Any clinical condition that is considered unstable or might jeopardize the safety of the patient and his / her compliance in the study Inability to swallow oral medications Any malabsorption condition Breastfeeding. Female patients must not breastfeed during treatment and until 4 months after last study drug administration. Treatment with anticancer chemotherapy or immunotherapy during the study or within 3 weeks before the first dose of study drug. For small-molecule drugs, a period of at least 3 half-lives before the first dose of study drug is acceptable. Mitomycin C or nitrosoureas should not be given within 6 weeks before the first dose of study drug. Treatment with systemic steroids (prednisone dose ≥10 mg/day or equivalent dose). Acute toxic effects (CTCAE Grade ≥2) of previous anticancer chemotherapy or immunotherapy that have not yet stabilized or if significant post-treatment toxicities have been observed. (Note however that toxic effects of previous anticancer therapy considered as chronic, such as chemotherapy-induced neuropathy, fatigue, alopecia, or anorexia of CTCAE Grade <2, for which further resolution is not expected, do not prevent participation in this study.) Radiotherapy for target lesions during study or within 3 weeks before the first dose of study drug. Palliative radiotherapy is allowed for non-target lesions. Major surgery or significant trauma within 4 weeks before the first dose of study drug Previous assignment to treatment during this study Concomitant participation in another clinical study with investigational medicinal product(s) Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site) Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug. Strong CYP3A4 inhibitors and inducers are prohibited during the study and until the active FU visit. Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex > 120 ms (except for bundle branch block pattern), or prolongation of the of the QTc interval (Fridericia) over 450 ms unless agreed otherwise between the investigator and the sponsor's medically responsible person healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Pacylex central contact role Contact central contact phone 1 (888) 580-4483 central contact e mail info@pacylex.com overall official list overall official overall official name Randeep Sangha overall official affiliation Cross Cancer Institute overall official role Principal Investigator location list location location facility Cross Cancer Institute location status Recruiting location city Edmonton location state Alberta location zip T6G 1Z2 location country Canada location contact list location contact location contact name Randeep Sangha location contact role Contact location contact e mail info@pacylex.com location contact name Randeep Sangha, MD location contact role Principal Investigator location facility Princess Margaret Hospital location status Recruiting location city Toronto location state Ontario location zip M5G 2M9 location country Canada location contact list location contact location contact name Swati Singla, M Sc location contact role Contact location contact phone 416-946-4501 location contact phone ext 5742 location contact e mail CCRUkitsquad@uhn.ca location contact name John Kuruvilla, MD location contact role Principal Investigator location facility Centre Hospitalier de l'Université de Montréal - CHUM location status Recruiting location city Montréal location state Quebec location zip H2X 0C1 location country Canada location contact list location contact location contact name Adeline Hamon location contact role Contact location contact phone 514-890-8000 location contact phone ext 30737 location contact e mail uit.eligibilite.chum@ssss.gouv.qc.ca references module reference list reference reference p m i d 33093447 reference type background reference citation Beauchamp E, Yap MC, Iyer A, Perinpanayagam MA, Gamma JM, Vincent KM, Lakshmanan M, Raju A, Tergaonkar V, Tan SY, Lim ST, Dong WF, Postovit LM, Read KD, Gray DW, Wyatt PG, Mackey JR, Berthiaume LG. Targeting N-myristoylation for therapy of B-cell lymphomas. Nat Commun. 2020 Oct 22;11(1):5348. doi: 10.1038/s41467-020-18998-1. avail i p d list avail i p d avail i p d type Study Protocol avail i p d u r l https://drive.google.com/file/d/19vOgkQi8xSyNo1PcQqGaMbt_x3pLUcLs/view?usp=sharing avail i p d type Informed Consent Form avail i p d u r l https://drive.google.com/file/d/1t_PLSn7mFnndj1Ha9X2wVp9oitY3kgSu/view?usp=sharing i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008223 condition mesh term Lymphoma condition mesh id D000008228 condition mesh term Lymphoma, Non-Hodgkin condition mesh id D000016393 condition mesh term Lymphoma, B-Cell condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id M17980 condition browse leaf name Lymphoma, B-Cell condition browse leaf as found B-Cell Non-Hodgkin Lymphoma condition browse leaf relevance high condition browse leaf id M10374 condition browse leaf name Lymphoma, Non-Hodgkin condition browse leaf as found Non-Hodgkin's Lymphoma condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id T640 condition browse leaf name B-cell Lymphoma condition browse leaf as found B-Cell Non-Hodgkin Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases

NCT04836195

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full study rank 61654 study protocol section identification module n c t id NCT04833660 org study id info org study id YUMC 2021-03-043 organization org full name Yeungnam University College of Medicine org class OTHER brief title rTMS on Diabetic Peripheral Neuropathic Pain official title The Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain: A Randomized Controlled Trial status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 30, 2021 start date type Anticipated primary completion date struct primary completion date May 25, 2021 primary completion date type Anticipated completion date struct completion date June 15, 2021 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 21, 2021 last update post date struct last update post date April 22, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Min Cheol Chang responsible party investigator title Associate Professor responsible party investigator affiliation Yeungnam University College of Medicine lead sponsor lead sponsor name Min Cheol Chang lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Background: Approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (DPN). Pain from DPN deteriorates the quality of life and hinders daily life activities. Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN. Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores [PCSs and MCSs]), at 1-week post-treatment. conditions module condition list condition Diabetic Peripheral Neuropathic Pain keyword list keyword diabetic peripheral neuropathy diabetes repetitive transcranial magnetic stimulation pain quality of life design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 22 enrollment type Anticipated arms interventions module arm group list arm group arm group label rTMS group arm group type Experimental arm group description Each patient will receive five consecutive sessions (Monday to Friday for 1 week). Patients in the rTMS group will administer rTMS over the optimal scalp site at 10 Hz, with an intensity of 90% of the MT and a duration of 5 seconds, for a total of 20 trains separated by 55-second intertrain pauses (a total of 1,000 pulses). The coil will be placed tangentially to the scalp at an approximate angle of 45° tilted backward and laterally. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods. arm group intervention list arm group intervention name Device: repetitive transcranial magnetic stimulation arm group label sham group arm group type Sham Comparator arm group description Patients in the sham group will administer sham stimulation using the same protocol, except that the angle of the coil is 90° (i.e., perpendicular, rather than tangential) to the skull. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods. arm group intervention list arm group intervention name Device: repetitive transcranial magnetic stimulation intervention list intervention intervention type Device intervention name repetitive transcranial magnetic stimulation intervention description Repetitive transcranial magnetic stimulation (rTMS) is a safe, noninvasive, and effective therapeutic intervention that uses an electromagnetic coil applied to the scalp to produce a magnetic field. rTMS induces changes in cortical excitability at the stimulation site and transsynaptically at distant areas. Cortical excitability is increased by high-frequency (≥5 Hz) stimulation and is decreased by low-frequency (1 Hz) stimulation. The application of high-frequency unilateral rTMS to the motor cortex in patients is reported to have a potential to control various types of pain, such as neuropathic pain, fibromyalgia, and musculoskeletal origin pain (myofascial pain syndrome, shoulder pain, and lower back pain). intervention arm group label list intervention arm group label rTMS group sham group outcomes module primary outcome list primary outcome primary outcome measure Pain before intervention to be assessed with Numeric Rating Scale primary outcome description We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain). primary outcome time frame The NRS score will be assessed the day before starting the stimulation sessions (pre-treatment). primary outcome measure Pain after intervention to be assessed with Numeric Rating Scale primary outcome description We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain). primary outcome time frame The NRS score will be assessed 1 day after the completion of the sessions. primary outcome measure Pain after intervention to be assessed with Numeric Rating Scale primary outcome description We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain). primary outcome time frame The NRS score will be assessed 1 week after the completion of the sessions. primary outcome measure Quality of life before intervention to be assessed with Short Form 36-Item Health Survey primary outcome description We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. primary outcome time frame The SF-36 PCS and SF-36 MCS will be measured the day before starting the stimulation sessions. primary outcome measure Quality of life after intervention to be assessed with Short Form 36-Item Health Survey primary outcome description We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. primary outcome time frame The SF-36 PCS and SF-36 MCS will be measured 1 week after the completion of the sessions. eligibility module eligibility criteria Inclusion Criteria: diabetes neuropathic pain (stocking glove distribution) of a numeric rating scale (NRS) score of ≥3 (where 0 indicates no pain and 10 indicates the most intense pain imaginable) in the lower extremities pain duration of ≥3 months age between 21 and 80 years Exclusion Criteria: presence of contraindications for TMS, such as a history of epileptic seizure, presence of metal in the skull, and presence of a cardiac pacemaker. healthy volunteers No gender All minimum age 21 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chang central contact role Contact central contact phone +82-10-9362-1220 central contact e mail wheel633@ynu.ac.kr overall official list overall official overall official name Min Cheol Chang overall official affiliation Yuengnam University overall official role Study Director location list location location facility Yeungnam University Hospital location city Daegu location zip 705-717 location country Korea, Republic of location contact list location contact location contact name Staff location contact role Contact location contact phone +82-053-624-8352 location contact e mail irb@ymc.yu.ac.kr references module reference list reference reference p m i d 17226897 reference type background reference citation Dobretsov M, Romanovsky D, Stimers JR. 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Personal information of individuals is kept strictly confidential and cannot be used for other research without personal consent. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009437 condition mesh term Neuralgia condition mesh id D000003929 condition mesh term Diabetic Neuropathies condition ancestor list condition ancestor condition ancestor id D000010523 condition ancestor term Peripheral Nervous System Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000048909 condition ancestor term Diabetes Complications condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M11533 condition browse leaf name Neuralgia condition browse leaf as found Neuropathic Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M12584 condition browse leaf name Peripheral Nervous System Diseases condition browse leaf relevance low condition browse leaf id M6276 condition browse leaf name Diabetic Neuropathies condition browse leaf as found Diabetic Peripheral Neuropathic Pain condition browse leaf relevance high condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M25157 condition browse leaf name Diabetes Complications condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders

NCT04833660

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full study rank 61911 study protocol section identification module n c t id NCT04830306 org study id info org study id Pro00108027 organization org full name Duke University org class OTHER brief title Step, Walk, Bike: Comparisons of Fitness Assessments official title Comparison of Submaximal Exercise Tests With Maximal Exercise Test status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date April 6, 2022 start date type Actual primary completion date struct primary completion date September 21, 2022 primary completion date type Actual completion date struct completion date September 21, 2022 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 4, 2022 last update post date struct last update post date October 5, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Duke University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To compare cardiorespiratory fitness parameters (oxygen consumption and respiratory ventilation) measured during two sub-maximal exercise tests (six minute step test, 6MST & six minute walk test, 6 MWT) with maximal exercise test (cardiopulmonary exercise test, CPET) detailed description After enrollment, the subjects will complete each of the following CRF assessments: Sub-maximal exercise test Six Minute Step Test (6MST): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. The subject will be given a standardized set of instructions on how to complete the test by raising each knee to 90 degrees of hip flexion. The total number of steps completed during the timed 6-minute period will be recorded. Sub-maximal exercise test Six Minute Walk Test (6MWT): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. A 30-m unobstructed hallway with turning points marked with small cones will be used. The subject will be given a standardized set of instructions on how to complete the test. The total distance walked during the timed 6-minute period will be recorded. Maximal exercise cardiopulmonary exercise test (CPET): The CPET is performed using an electromagnetically-braked cycle ergometer, 12-lead continuous ECG, continuous pulse oximetry, continuous expired gas analysis (oxygen and carbon dioxide) with ventilation [termed 'metabolic cart'] and intermittent non-invasive blood pressure measurement every 2 minutes. Once the subject is seated comfortably on the bike and adjusted for optimum cycling position, the face mask is fitted. The subjects are instructed on how to perform the incremental ramp test, starting with a baseline rest phase (no leg turnover) for 2 mins followed by reference phase of 2 mins of leg turnover with no resistance (0 watts). The incremental rise in work-rate from baseline is pre-determined by using the equation derived by Wasserman and colleagues in which the same work-rate is increased throughout the test to the limit of tolerance. A work-rate is selected by study staff to aim for a test duration of between 8 and 12 minutes. The subjects are instructed to maintain a cycling cadence of 55 - 65 revolutions per minute (rpm) during the exercise phase. One the limit of tolerance (maximal watts) is reached the resistance on the bike is removed () watts) and the subjects are encouraged to continue cycling for a further 2 mins during the recovery phase. The order in which 6MST and 6MWT are performed will be randomized. Between test the subjects will be allowed to rest in a chair until the heart rate is within 5 beats per min of resting values and blood pressure in within 10 mmHg of resting values. The CPET will be conducted once both 6MWT and 6MST have been completed. If the subject expresses fatigue after either 6MWT and 6MST, then the subject may elect to re-attend on a separate day to complete the evaluation. At completion of exercise evaluations the subjects will be discharged from study participation. No further follow up will be performed. Up to 40 subjects aged 18 or older will be enrolled. Inclusion Criteria: Age 18 and older Able to speak English Ambulatory [assistive devices ok] Able to provide informed consent Exclusion Criteria: Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET Inmate of correctional facility (i.e. prisoner) Diagnosed history of dementia Inability to ambulate independently Considered inappropriate to participate by Principal Investigator conditions module condition list condition Cardiorespiratory Fitness keyword list keyword aerobic power CPET CPEX cardiopulmonary exercise testing exercise capacity functional capacity physical activity design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Crossover Assignment design intervention model description All subjects will be asked to complete the three exercise tests design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label 6MST arm group type Active Comparator arm group description Six minute step test arm group intervention list arm group intervention name Behavioral: Exercise arm group label 6MWT arm group type Active Comparator arm group description Six minute walk test arm group intervention list arm group intervention name Behavioral: Exercise arm group label CPET arm group type Active Comparator arm group description Cardiopulmonary exercise test arm group intervention list arm group intervention name Behavioral: Exercise intervention list intervention intervention type Behavioral intervention name Exercise intervention description Completion of exercise in accordance with assigned protocol intervention arm group label list intervention arm group label 6MST 6MWT CPET outcomes module primary outcome list primary outcome primary outcome measure Total amount of oxygen consumed per minute as measured by wearable face mask primary outcome description Oxygen measured in mL/min primary outcome time frame Up to 15 minutes secondary outcome list secondary outcome secondary outcome measure Total amount of respiratory ventilation per minute as measured by wearable face mask secondary outcome description Respiratory ventilation measured in liters per minute secondary outcome time frame Up to 15 minutes eligibility module eligibility criteria Inclusion Criteria: Age 18 and older Able to speak English Ambulatory [assistive devices ok] Able to provide informed consent Exclusion Criteria: Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET Inmate of correctional facility (i.e. prisoner) Diagnosed history of dementia Inability to ambulate independently Considered inappropriate to participate by Principal Investigator healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name David MacLeod, FRCA overall official affiliation Duke University overall official role Principal Investigator location list location location facility Duke University Health System location city Durham location state North Carolina location zip 27710 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11134 intervention browse leaf name Morphine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04830306

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full study rank 61176 study protocol section identification module n c t id NCT04839874 org study id info org study id NHS Grampian organization org full name NHS Grampian org class OTHER_GOV brief title Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes? official title Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes? status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date December 1, 2021 start date type Actual primary completion date struct primary completion date March 31, 2023 primary completion date type Anticipated completion date struct completion date March 31, 2023 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 8, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name NHS Grampian lead sponsor class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study will focus on speaking to women who have been diagnosed with one of the five main gynaecological cancers: ovarian, endometrial (womb), cervical, vulval and vaginal. Too many women are dying from gynaecological cancer in the UK. There are many reasons for this, but the study investigators think that embarrassment might be one of the reasons. It can be embarrassing to talk about gynaecological cancers or the symptoms that they cause. This might lead some women to delay going to their doctor when they have symptoms. This study will speak with women who have been diagnosed with a gynaecological cancer to ask them what they did before they were diagnosed; when did they realise something was wrong; what made them go to their doctor; did having gynaecological symptoms make them think differently about going to the doctor? This information will be used to find ways of making it as easy as possible for women to go to their doctors as early as possible. This will hopefully see fewer women dying from these cancers. detailed description The study will explore the research questions using qualitative semi-structured interviews with women diagnosed with gynaecological cancer. A study information sheet, reply slip and a reply-paid envelope will be sent to eligible patients by their secondary care clinician, with reminders sent after two weeks. Recruitment and interviewing will take place until data saturation occurs (three interviews with no new shared beliefs) on the main themes. Interviews will take place at a mutually convenient time and place, ideally face to face but could be conducted over the telephone if preferred by the interviewee or if social distancing measures are still in place due to Covid-19. Further verbal and written information regarding the study will be provided prior to interview commencement and participants will be given the opportunity to ask questions. Those agreeing to take part in a face to face interview will sign a consent form in duplicate (one for the participant and one copy for the research team). Those participating in a telephone interview will be read each point of the consent form and asked to agree to each one. This will be recorded, transcribed and used as evidence of consent. Interviews will be conducted flexibly allowing for shorter interviews where necessary and participants will be reminded that the interviews can be terminated at any time. The participant can withdraw from the study at any time: data already collected with consent will be retained and used in the study. No further data will be collected, or any other research procedures carried out on or in relation to the participant. All interviews will be digitally audio recorded and transcribed verbatim by the CI or NHSG approved transcription service. The data will be stored and managed using NVivo software. Interviews will follow a semi-structured topic guide based on the COM-B behaviour change model concepts of capability, opportunity and motivation. Changes can be made to the topic guide as interviews are conducted. Data familiarisation will be by reading and rereading transcripts and by listening to the recorded interviews. Data will be analysed using iterative deductive and inductive methods combining Framework analysis and thematic analysis. A contact will be provided for patients should they become distressed because of contact by or participation in the study. Although all data collected will stored and analysed with the strictest of confidence in line with the General Data Protection Regulations (2018), if details of any improper conduct or poor practice are disclosed the research team may be obliged to report this. The participant's GP will not be informed. Study participants will have any travel costs reimbursed. conditions module condition list condition Gynaecological Cancer keyword list keyword Health seeking behaviour Pelvic examination design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 15 enrollment type Anticipated arms interventions module intervention list intervention intervention type Other intervention name No intervention intervention description Semi-structured qualitative interviews outcomes module primary outcome list primary outcome primary outcome measure Description of the facilitators and barriers to health seeking behaviour in women diagnosed with gynaecological cancer using semi-structured qualitative interviews. primary outcome description Semi-structured interviews will be used to explore the facilitators and barriers to health seeking behaviour in women who have been diagnosed with a gynaecological cancer. Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model. primary outcome time frame 2 years secondary outcome list secondary outcome secondary outcome measure Description of the perceptions of pelvic examination in women diagnosed with gynaecological cancer using semi-structured interviews. secondary outcome description Semi-structured interviews will be used to explore the perceptions to pelvic examination in women who have been diagnosed with a gynaecological cancer. Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model. secondary outcome time frame 2 years eligibility module eligibility criteria Inclusion Criteria: Clinical diagnosis of gynaecological cancer Exclusion Criteria: Non-English speaking participants Cognitive impairment Terminal stage of illness Diagnosis through screening programmes gender Female gender based Yes gender description Gynaecological cancers which are female sex dependant minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult study population Women who have been diagnosed with a gynaecological cancer sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Pauline Williams central contact role Contact central contact phone 07528085261 central contact e mail pauline.williams@abdn.ac.uk location list location location facility NHS Grampian location status Recruiting location city Aberdeen location state Aberdeen City location country United Kingdom i p d sharing statement module i p d sharing No i p d sharing description Identifiable patient data will not be shared. Interview data will be shared in a report to funders and to peer reviewed journals derived section misc info module version holder December 02, 2022

NCT04839874

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full study rank 61813 study protocol section identification module n c t id NCT04831593 org study id info org study id 2019-167 organization org full name Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital org class OTHER_GOV brief title The Rate of Full and Empty Stomach in Elective and Emergency Pediatric Patients official title The Rate of Full and Empty Stomach in a Large Cohort of Elective and Emergency Pediatric Patients by Preoperative Ultrasound Examination: a Prospective Observational Study status module status verified date July 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date October 30, 2022 primary completion date type Anticipated completion date struct completion date October 30, 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 19, 2022 last update post date struct last update post date July 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Feyza Sever responsible party investigator title Specialist physician responsible party investigator affiliation Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital lead sponsor lead sponsor name Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital lead sponsor class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Background and Aim: Pulmonary aspiration of gastric content in the perioperative period is rare, but it is an important cause of morbidity and mortality that anesthetists never want to encounter. Due to reasons such as emergency surgical procedures, communication problems with pediatric patients or their parents, impaired cognitive function, obesity, diabetes mellitus, chronic liver and kidney diseases, it is observed that there is sometimes inconsistency between the periods defined in the preoperative fasting guidelines in pediatric patients and the state of gastric content and volume encountered in clinical practice. There is a lack of data on children on this issue. In this study, primary we aimed to evaluate the incidence of empty and full stomach in pediatric patients who underwent elective and emergency surgery in our routine anesthesia practice. Also we want to determine the relationship between fasting time and qualitative assessment of gastric content. Secondary this study sought to examine whether correlation between gastric ultrasound finding and fasting time, and also to determine relationship with the current comorbidities. Design: This is a prospective, single blinded, observational study. The minimum sample size required to determine the prevalence of full stomach, 0.05, within the limits of ± 0.025 with 0.95 confidence, was calculated as 292. When calculating with the proposed equation of n = 100 + 50i to determine the factors affecting by logistic regression (here i is the number of variables in the model), the minimum number of samples required for logistic regression analysis was calculated as 300 in case of 4 independent variables in the model. n=100+50*4= 300 Methods: Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia at our hospital are enrolled in this prospective observational study between April and December 2021. Preoperative ultrasound examination of the gastric antrum are performed by one anesthesiologist who has been instructed and supervised by an experienced pediatric radiologist and who is blind to the patient's history. Ultrasonographic measurement of the gastric antral cross-sectional area (CSA) are performed in supine position and right lateral decubitus position (RLD). The gastric antrum is imaged in a sagittal plane, between the left lobe of the liver and the pancreas, at the level of the aorta, as previously described [1]. This examination allowed qualitative assessment of gastric contents according to the three-point grading scale previously described by Perlas and colleagues[2]. Grade 0 was defined by the absence of appearance of any content in a flat antrum in both the supine and the RLD positions. Grade 1 was defined by the appearance of any gastric content in the RLD position only, and Grade 2 was defined by the appearance of any content in both the RLD and the supine positions. The antral cross-sectional area is also calculated in both position, by measuring the longitudinal diameter (D1) and the anteroposterior diameter (D2) of the antrum, from serosa to serosa using this formula [3] Antral area= (π x D1 X D2) / 4. Patients' characteristic data ( age, gender, weight, height, BMI and ASA physical status classification), fasting duration, type of elective and emergency surgery, chronic disease and complications (regurgitation, pulmonary aspiration, etc.) that may develop during the peroperative period are recorded. conditions module condition list condition Ultrasound Children Surgery keyword list keyword Ultrasound Antrum Children Surgery design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 600 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group Elective arm group description In our clinic, pediatric patients who will undergo elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in elective pediatric patients before general anesthesia. arm group intervention list arm group intervention name Other: Group El arm group label Group Emergency arm group description In our clinic, pediatric patients who will undergo emergency surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in emergency pediatric patients before general anesthesia. arm group intervention list arm group intervention name Other: Group Em intervention list intervention intervention type Other intervention name Group El intervention description Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid. intervention arm group label list intervention arm group label Group Elective intervention other name list intervention other name Gastric ultrasound in elective pediatric patients before general anesthesia. intervention type Other intervention name Group Em intervention description Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid. intervention arm group label list intervention arm group label Group Emergency intervention other name list intervention other name Gastric ultrasound in emergency pediatric patients before general anesthesia. outcomes module primary outcome list primary outcome primary outcome measure Prevalence of full stomach primary outcome description In our clinic, pediatric patients who will undergo emergency and elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach in pediatric patients before general anesthesia. primary outcome time frame 30 minutes primary outcome measure The relationship between fasting time and qualitative assessment of gastric content primary outcome description We would like to determine the relationship (and correlation with preoperative fasting guidelines) between the fasting time that pediatric patients and their parents reported to us and the qualitative assessment of gastric content in our clinical practice primary outcome time frame 30 minutes secondary outcome list secondary outcome secondary outcome measure Demographic data and comorbidities secondary outcome description The secondary objective of this study is to examine correlation between gastric ultrasound finding and the demographic data ( age, gender, weight, height, BMI, ASA physical status classification), and type of elective and emergency surgery ) and current comorbidities of pediatric patients. secondary outcome time frame 30 minutes eligibility module eligibility criteria Inclusion Criteria: Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia are included in the study. Exclusion Criteria: Exclusion criteria will be, having a nasogastric tube inserted and patient refusal. healthy volunteers Accepts Healthy Volunteers gender All maximum age 18 Years std age list std age Child Adult study population Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia sampling method Probability Sample contacts locations module overall official list overall official overall official name Feyza Sever overall official affiliation Ankara City Hospital Childrens' Hospital overall official role Principal Investigator location list location location facility Ankara City Hospital Childrens' Hospital location city Ankara location state Çankaya location zip 06800 location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004630 condition mesh term Emergencies condition ancestor list condition ancestor condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M6948 condition browse leaf name Emergencies condition browse leaf as found Emergency condition browse leaf relevance high condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000000777 intervention mesh term Anesthetics intervention ancestor list intervention ancestor intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf as found Response intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04831593

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full study rank 61188 study protocol section identification module n c t id NCT04839718 org study id info org study id 1421043 organization org full name Kaiser Permanente org class OTHER brief title Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program official title Evaluating the Implementation and Outcomes of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Collaborative Care Program in A Large, Integrated Healthcare System: A Mixed Methods Observational Study Protocol acronym ADAPT status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2019 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 15, 2022 last update post date struct last update post date March 31, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Kaiser Permanente lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Depression and anxiety are increasingly common conditions for which primary care providers (PCPs) serve as the initial healthcare contact for most patients. Comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care. Collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs. ADAPT is a novel collaborative care model. By using technology-driven appointments with providers, ADAPT increases access to mental healthcare, and reduces member wait times. This mixed methods study will assess implementation measures of the ADAPT program and the components of ADAPT related to patient mental health improvement compared to specialty mental health care. The hypothesis is that: ADAPT program will have good program reach and efficacy. We will examine program implementation and maintenance. Further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization. conditions module condition list condition Depression Anxiety keyword list keyword Depression Anxiety design module study type Observational patient registry No design info design observational model list design observational model Ecologic or Community design time perspective list design time perspective Retrospective enrollment info enrollment count 10000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control arm group description Patients receiving referral to specialty mental healthcare arm group label ADAPT arm group description ADAPT arm group intervention list arm group intervention name Behavioral: ADAPT intervention list intervention intervention type Behavioral intervention name ADAPT intervention description The Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program is a novel collaborative psychiatric care model that is designed to unburden PCPs and psychiatrists, increase access to quality specialty mental healthcare for Kaiser Permanente members, and improve patient depression and anxiety treatment outcomes by utilizing technology-driven appointments. This program uses principles of collaborative care, including patient-centered care, population-based care, evidence-based care, measurement-based treatment to target, and accountable care. intervention arm group label list intervention arm group label ADAPT outcomes module primary outcome list primary outcome primary outcome measure Patient reach primary outcome description Examine and compare patients eligible and enrolled in ADAPT versus those eligible but not enrolled in ADAPT primary outcome time frame through study completion, 2 years secondary outcome list secondary outcome secondary outcome measure Member characteristics associated with depression remission secondary outcome description Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience). secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Member characteristics associated with anxiety remission secondary outcome description Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience). secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient therapy engagement secondary outcome description number of therapy contacts (individual, group and combined) secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient medication provider engagement secondary outcome description number of clinical pharmacy contacts secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient medication engagement secondary outcome description medication length of treatment secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient psychiatry engagement secondary outcome description number of contact with psychiatrist secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Patient time to care secondary outcome description average time from ADAPT referral to first appointment with therapist or pharmacist secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Depression outcomes secondary outcome description Examine if patients enrolled in ADAPT demonstrate non-inferior depression outcomes defined by change in the patient health questionnaire (PHQ-9) score compared to treatment as usual. secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Anxiety outcomes secondary outcome description Examine if patients enrolled in ADAPT demonstrate non-inferior anxiety outcomes defined by generalized anxiety disorder (GAD-2) score compared to treatment as usual. secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Efficacy: Time to clinical improvement secondary outcome description Compare time to clinical improvement as defined by change in Adult Outcomes Questionnaire (AOQ score) from baseline to 3, and 6 months for members in ADAPT compared to treatment as usual. secondary outcome time frame baseline, 3 and 6 months secondary outcome measure Implementation: measurement-based care secondary outcome description Examine provider use of measurement-based care secondary outcome time frame through study completion, 2 years secondary outcome measure Implementation: Diagnosis secondary outcome description Examine provider use of a specific depression or anxiety diagnosis secondary outcome time frame through study completion, 2 years secondary outcome measure Maintenance: Measurement-based care secondary outcome description Examine provider use of measurement-based care over time secondary outcome time frame through study completion, 2 years secondary outcome measure Maintenance: Diagnosis secondary outcome description Examine provider use of a specific depression or anxiety diagnosis over time secondary outcome time frame through study completion, 2 years eligibility module eligibility criteria Inclusion Criteria: Adult Outcomes Questionnaire (AOQ) score between 10-30 English-Speaking Exclusion Criteria: High risk for suicide defined by answer to question 9 on PHQ-9 of 1 or more Diagnosis of bipolar disorder Diagnosis of a psychotic disorder Dementia diagnosis Active substance use disorder diagnosis Current hospice Current home-based palliative care Residing in a skilled nursing facility Residing in an assisted living facility Non-Kaiser Permanente Member Established psychiatric care outside of Kaiser Permanente gender All minimum age 18 Years std age list std age Adult Older Adult study population Kaiser Permanente Northern California adult members who screen positive for depression or anxiety in primary care and are referred to treatment. sampling method Probability Sample contacts locations module central contact list central contact central contact name Kathryn K Erickson-Ridout, MD PhD central contact role Contact central contact phone 7075713778 central contact e mail Kathryn.Erickson-Ridout@kp.org overall official list overall official overall official name Kathryn K Erickson-Ridout, MD PhD overall official affiliation Kaiser Permanente overall official role Principal Investigator location list location location facility Kaiser Permanente Northern California Division of Research location status Recruiting location city Oakland location state California location zip 94612 location country United States location contact list location contact location contact name Kathryn K Erickson-Ridout, PhD location contact role Contact location contact phone 707-571-3778 location contact e mail Kathryn.Erickson-ridout@kp.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf as found Anxiety condition browse leaf relevance high condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions

NCT04839718

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full study rank 61758 study protocol section identification module n c t id NCT04832308 org study id info org study id 61023 organization org full name Palo Alto Veterans Institute for Research org class OTHER brief title Mobile Intervention Supervised Exercise Therapy Study 1 official title Mobile Intervention Supervised Exercise Therapy Study 1 acronym MiSET-1 status module status verified date November 2022 overall status Withdrawn why stopped Lack of grant funding expanded access info has expanded access No start date struct start date August 20, 2021 start date type Actual primary completion date struct primary completion date June 1, 2022 primary completion date type Actual completion date struct completion date June 1, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 2, 2022 last update post date struct last update post date November 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Oliver Aalami responsible party investigator title Clinical Associate Professor of Surgery responsible party investigator affiliation Stanford University lead sponsor lead sponsor name Palo Alto Veterans Institute for Research lead sponsor class OTHER collaborator list collaborator collaborator name Society for Vascular Surgery collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life. detailed description This is a national randomized controlled study with approximately 10-15 sites enrolling patients with Rutherford II peripheral artery disease (PAD) in total. Patients will be randomized between the SVS SET Program and "usual care" for each site. The primary outcome will be to study the site-specific effect on utilization of exercise therapy. Secondary outcomes will be the effect on the 6-minute-walk test, passive activity and quality of life. conditions module condition list condition Peripheral Artery Disease Claudication, Intermittent design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Block randomization stratified by site. design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label SVS SET Program arm group type Experimental arm group description Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription. arm group intervention list arm group intervention name Behavioral: Exercise Therapy arm group label Usual Care arm group type No Intervention arm group description This usual care arm will allow sites to direct patients as they usually do. This could include an in-person exercise therapy program or simply exercise instruction during an office visit. intervention list intervention intervention type Behavioral intervention name Exercise Therapy intervention description This is a health coach driven exercise prescription for patients recommending 30 minutes or more of moderate effort walking 3-5 days a week with expected walk-rest-walk-rest intervals. intervention arm group label list intervention arm group label SVS SET Program outcomes module primary outcome list primary outcome primary outcome measure Number of Participants Who Complete a 12-week Exercise Therapy Program primary outcome description Completion of a 12-week program in the treatment group will be completion of the remote SVS SET Program while the "usual care" group may have an in-person 12-week exercise therapy program. primary outcome time frame 12 weeks. secondary outcome list secondary outcome secondary outcome measure Mobile Phone Delivered 6-Minute Walk Test secondary outcome description Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points. secondary outcome time frame Weeks 0, 6 and 12 secondary outcome measure Passive Activity as Measured on Mobile Device secondary outcome description Daily passive step count activity as measured by sensors in mobile phone. secondary outcome time frame 12 weeks. secondary outcome measure Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ) secondary outcome description QoL questionnaires will be asked on the mobile phone at three time points. secondary outcome time frame Weeks 1, 6, and 12 secondary outcome measure Adherence as Measured by Completion of Scheduled Daily Walks secondary outcome description Adherence to the recommended exercise therapy frequency (3 walks per week) and duration (for at least 30 minutes or more) will be measured secondary outcome time frame 12 weeks. secondary outcome measure Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year secondary outcome description Freedom from any surgical intervention will be reported at one year by performing a chart review. secondary outcome time frame 1 year. eligibility module eligibility criteria Inclusion Criteria: 18 years of Age Rutherford Class I-II PAD (claudication) Ambulatory Exercise Therapy Naive (>18 mo) Primary Owner of an Android or iOS device Willingness to participate (text, call, fill out surveys) via a mobile phone Exclusion Criteria: Symptomatic coronary artery disease Oxygen dependent COPD Significant osteoarthritis limiting ambulation healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000058729 condition mesh term Peripheral Arterial Disease condition mesh id D000007383 condition mesh term Intermittent Claudication condition ancestor list condition ancestor condition ancestor id D000050197 condition ancestor term Atherosclerosis condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000016491 condition ancestor term Peripheral Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M28366 condition browse leaf name Peripheral Arterial Disease condition browse leaf as found Peripheral Artery Disease condition browse leaf relevance high condition browse leaf id M9570 condition browse leaf name Intermittent Claudication condition browse leaf as found Claudication, Intermittent condition browse leaf relevance high condition browse leaf id M18046 condition browse leaf name Peripheral Vascular Diseases condition browse leaf relevance low condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology

NCT04832308

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full study rank 61291 study protocol section identification module n c t id NCT04838379 org study id info org study id 01210861577 organization org full name Assiut University org class OTHER brief title Ultrasound Guided Rectus Sheath Block in Pediatric Single Port Laparoscopic Appendectomy official title Ultrasound Guided Rectus Sheath Block by Bupivacaine With or Without Dexmedetomidine in Pediatric Single Port Laparoscopic Appendectomy status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 2021 start date type Anticipated primary completion date struct primary completion date May 2022 primary completion date type Anticipated completion date struct completion date August 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 13, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kirolos Gamal Reda responsible party investigator title Principal Investigator responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The current study aimed to assess the analgesic effect of ultrasound guided RSB with dexmedetomidine in the perioperative period of the surgical site after appendectomy In comparing only the postoperative outcome detailed description laparoscopic appendectomy is one of the most frequently performed pediatric surgeries. Although minimally invasive, this technique is still associated with a significant amount of pain and anxiety in children . Indeed, children who are highly anxious prior to surgery tend to have more postoperative pain, delayed hospital discharge, and higher incidence of emergence delirium, sleep disturbances, and other mal-adaptive behavior changes that can last up to a few weeks following surgery . To improve analgesia and decrease postoperative anxiety in children undergoing laparoscopic appendectomies multimodal approach for pain control can be employee; Over the past years, the concept of pain management has extended from simply decreasing pain intensity to optimizing patient's condition. The goal is to decrease pain scores, stress response that should be avoided in patients, particularly cardiac patients, together with a decrease in analgesics-related adverse effects like nausea, vomiting, retention of urine and over sedation. By achieving these goals, we can certainly facilitate patient recovery and minimize the hospital stay. Improved pain control can be achieved by a combination of different types of regional analgesia with systemic analgesics. The main contributor to pain post abdominal operations is the pain from abdominal wall incision . Many procedures were followed to decrease this intense postoperative pain such as, epidural catheter analgesia, Transverse Abdominis Plane (TAP) block, local wound infiltration, Patient-Controlled Analgesia (PCA), peripheral nerve blocks, in addition to Systemic administration of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or opioids. The Rectus Sheath Block (RSB) is one of these regional techniques that are suitable for operations with a midline incision or laparoscopic surgery with the main incision at the umbilical port. A previous study showed the analgesic efficacy of ultrasound guided rectus sheath block for laparoscopic appendectomy compared to a control group injected with saline instead of a local anesthetic in addition to the usefulness of traditional local anesthetics to provide analgesia during the course of the postoperative period is restricted by their short duration of action. Dexmedetomidine (DEX) has been shown as a valuable additive to local anesthetics in neuraxial blocks and peripheral nerve blocks leading to prolongation of postoperative analgesia and better pain control . . dexmedetomidine (DEX) α-2 adrenergic receptor consists of three α-2 isoacceptors (α-2a, α-2b and α-2c), which regulate the various pharmacodynamic effects of this drug . The α-2a receptor seems to promote sedation and anxiolysis in the locus coeruleus, as well as to generate bradycardia and peripheral vasodilation by stimulation of the cerebral vasomotor center. The α-2b receptor prevents tremor, generates analgesia in the dorsal horns of the spinal cord and determines peripheral vasoconstriction. The α-2c receptor modulates the mental stat. conditions module condition list condition Appendicitis Acute keyword list keyword us guided rectus sheath block laparscopic appendectomy regional anesthesia design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Age: 3-8years. Weight: 10-60 kg. Sex: both males and females. ASA physical status: I-II. design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label group Bupivacaine arm group type Placebo Comparator arm group description will include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision arm group intervention list arm group intervention name Procedure: Ultrasound guided rectus sheath block arm group label group bupivacaine&dex arm group type Active Comparator arm group description 2 will include 30 patients: each one will receive 2.5mg/kg of 0.25% bupivacaine plus 2 µ/kg of dexmedetomidine diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision arm group intervention list arm group intervention name Procedure: Ultrasound guided rectus sheath block intervention list intervention intervention type Procedure intervention name Ultrasound guided rectus sheath block intervention description Sixty patients were randomized to receive ultrasound-guided RSB After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block (BRSB) was performed intervention arm group label list intervention arm group label group Bupivacaine group bupivacaine&dex outcomes module primary outcome list primary outcome primary outcome measure evaluate the first call for rescue analgesia primary outcome description the time of the first call for analgesia is recorded primary outcome time frame 24 hours after recovery from anesthesia eligibility module eligibility criteria Inclusion Criteria: ● Age: 3-8years. Weight: 10-60 kg. Sex: both males and females. ASA physical status: I-II. Exclusion Criteria: • Patient's guardian refusal to participate in the study. Patients having known hypersensitivity to dexametomidine will be excluded. Patients with cardiovascular, liver or renal disease, unsatisfactory preoperative peripheral arterial oxygen saturation, neurological or psychiatric disease and coagulation disturbances. Any perioperative cardiovascular or respiratory event occurred or difficulties in pain perception and assessment which make the study intervention clinically unacceptable. Patients on regular use of analgesic or who received analgesic 24 h before surgery healthy volunteers No gender All minimum age 3 Years maximum age 8 Years std age list std age Child contacts locations module central contact list central contact central contact name Kirolos Gamal central contact role Contact central contact phone 01210861577 central contact e mail kokojemy72@gmail.com central contact name wesam nashat central contact role Contact central contact phone 01002416772 central contact e mail dr.wesamnashat2015@gmail.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001064 condition mesh term Appendicitis condition ancestor list condition ancestor condition ancestor id D000059413 condition ancestor term Intraabdominal Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000005759 condition ancestor term Gastroenteritis condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000002429 condition ancestor term Cecal Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition browse leaf list condition browse leaf condition browse leaf id M3528 condition browse leaf name Appendicitis condition browse leaf as found Appendicitis condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M28618 condition browse leaf name Intraabdominal Infections condition browse leaf relevance low condition browse leaf id M8027 condition browse leaf name Gastroenteritis condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M4831 condition browse leaf name Cecal Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M4467 intervention browse leaf name Bupivacaine intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M21815 intervention browse leaf name Dexmedetomidine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics

NCT04838379

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full study rank 61617 study protocol section identification module n c t id NCT04834141 org study id info org study id 09.2020.897 organization org full name Marmara University org class OTHER brief title Correlation Between Thoracic Kyphosis Posture and Static Balance official title Correlation Between Thoracic Kyphosis Posture and Static Balance status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date October 13, 2020 start date type Actual primary completion date struct primary completion date December 30, 2020 primary completion date type Actual completion date struct completion date February 10, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Marmara University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The effects of balanced posture and postural changes have been evaluated in specific populations with different factors that can affect body postures and balance, such as age, musculoskeletal system, and other metabolic diseases. Studies on postural kyphosis and balance involvement are very few in the literature especially in the health population. Of the few studies that have evaluated kyphosis and balance, most are limited by small sample size and the exclusion of men. Many have focused primarily on the geriatric population. The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance. detailed description Background: Kyphosis is roughly a slight forward curvature of the spine. A slight kyphosis or posterior curvature is normal throughout the human body and is present in every individual. Hyperkyphotic is a kyphotic angle greater than 40° commonly measured on a lateral X-ray measured by the Cobb method between C7 and T12. Postural stability or balance is the ability to keep the center of mass within the boundaries of the support base. Moving the center of mass beyond the boundaries of the support base may cause postural instability and loss of balance. There are studies showing that kyphotic posture affects the center of gravity and affects fall in the elderly, but there are limited studies on the effect of balance in young individuals. The Aim of This Study Is: To study the correlation between the balance and severity of thoracic kyphosis will be investigated conditions module condition list condition Kyphosis Balance; Distorted Postural Kyphosis Spine Disease Balance design module study type Observational patient registry Yes target duration 1 Day design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 46 enrollment type Actual arms interventions module arm group list arm group arm group label Kyphotic Group arm group description Participants with kyphosis angle ≥ 40 degrees joined the kyphosis group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting. Static balance Assessment: Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) arm group intervention list arm group intervention name Other: FlexiCurve ruler method to assess thoracic kyphosis angle arm group label Control Group arm group description Participants with kyphosis angle < 40 degrees for the control group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting. Static balance Assessment: Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) arm group intervention list arm group intervention name Other: FlexiCurve ruler method to assess thoracic kyphosis angle intervention list intervention intervention type Other intervention name FlexiCurve ruler method to assess thoracic kyphosis angle intervention description The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance. intervention arm group label list intervention arm group label Control Group Kyphotic Group intervention other name list intervention other name NeuroCom Balance Manager System ® static posturography device to assess static balance outcomes module primary outcome list primary outcome primary outcome measure Kyphosis Angle primary outcome description Kyphosis angle will be measured by felxicurve ruler, normally kyphosis angle below 40 degrees recognized as normal. For participants with kyphosis angle above 40 degrees recognized as hyperkyphotic posture. FlexiCurve ruler method is valid and reliable to the gold standard. primary outcome time frame 2 Months primary outcome measure Static Balance Measures primary outcome description NeuroCom Balance Manager System ® static posturography device to assess static balance, which is objective evaluating system. The system compare the values reported for participants assessment then compare them to pre-recorded data base. The values of the test is assessed according to the percentage to the normal (average) values matched with the age group and gender. Above 80% determined as normal, and below this value determine balance disturbance. primary outcome time frame 2 Months eligibility module eligibility criteria Inclusion Criteria: Adults aged 18 and over willing to attend the study. For those who join the thoracic kyphosis group, individuals with a kyphosis angle ≥ 40 degrees. Individuals with a kyphosis angle < 40 degrees for the control group. Exclusion Criteria: Spine trauma, surgery, bone pathology, arthritis etc. have a history of illness Kyphotic deformity types are rounded back, Scheuermann's disease, hunched back, flat back and Dowager hump. Any spinal deformity, bone abnormality, postural deformity and disc herniation with / without peripheral symptoms. Body mass index (BMI), which is an indicator of obesity, is more than > 30. Complaining of balance problems, coordination problems, other neurological or vestibular diseases that affect body balance and posture. Having any orthopedic or neurological disease that affects the body joints or the integrity of the musculoskeletal system. Use of any medication that can cause dizziness or drowsiness in the last months. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Fourty-six subjects who joined the study were healthy without any disease might affect balance, body posture, and denied a past history of vestibular disorders, syncope, seizures, or neurological disorders such as stroke or Parkinson's disease. The study take place in Marmara university, Başıbüyük campus, between the period September 2020 to December 2020. Participants were recruited through online poster announcement, they directly contacted the primary investigator for booking an appointment. An appointment were made for the participants in the Faculty of Health Sciences, Physiotherapy and Rehabilitation Department, Biomechanics and Performance Analysis Laboratory, Marmara University. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name AYSEL yildiz, Ass. Prof. overall official affiliation Marmara University overall official role Principal Investigator location list location location facility Marmara University location city Istanbul location zip 34854 location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007738 condition mesh term Kyphosis condition mesh id D000013122 condition mesh term Spinal Diseases condition ancestor list condition ancestor condition ancestor id D000013121 condition ancestor term Spinal Curvatures condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M15071 condition browse leaf name Spinal Diseases condition browse leaf as found Spine Disease condition browse leaf relevance high condition browse leaf id M9910 condition browse leaf name Kyphosis condition browse leaf as found Kyphosis condition browse leaf relevance high condition browse leaf id M15070 condition browse leaf name Spinal Curvatures condition browse leaf relevance low condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions

NCT04834141

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full study rank 61521 study protocol section identification module n c t id NCT04835389 org study id info org study id AT-2021-001 organization org full name VIVEX Biologics, Inc. org class INDUSTRY brief title Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis official title A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis status module status verified date July 2021 overall status Withdrawn why stopped Company decision start date struct start date June 1, 2021 start date type Anticipated primary completion date struct primary completion date March 1, 2022 primary completion date type Anticipated completion date struct completion date June 30, 2022 completion date type Anticipated study first submit date December 11, 2020 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 2, 2021 last update post date struct last update post date July 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name VIVEX Biologics, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name MCRA collaborator class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary A randomized, double-blind, placebo-controlled trial comparing a single intra-articular injection of 2.0 mL AlloGen vs 2.0 mL sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks. detailed description This is a Phase 1, randomized, double-blind, placebo-controlled trial comparing a single intra-articular 2.0 mL injection of either AlloGen or sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks. The patient will remain blinded to his or her treatment throughout the study duration. The investigator/assessor will also remain blinded throughout the treatment period. Only the individual(s) preparing the injection will not be blinded. Black tape over the injection syringe will mask the study treatment. Up to 30 adult patients with osteoarthritis of one knee that has failed to adequately respond to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen, will be enrolled at up to 5 sites in the US. The first 6 subjects will be staggered to evaluate any significant toxicity. Any adverse event data collected will be reviewed by the Data Safety Monitoring Board (DSMB) prior to treating the subsequent subject. Cumulative safety data from these 6 subjects will be reviewed by the DSMB. conditions module condition list condition Osteoarthritis, Knee keyword list keyword osteoarthritis biologic design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized, Placebo-Controlled, Double-Blinded design primary purpose Treatment design masking info design masking Triple design masking description Subjects and investigators (including outcomes assessment) will be blinded to the treatment arm that is assigned. design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label AlloGen Liquid arm group type Experimental arm group description A single-dose, intra-articular (IA) injection of 2.0 mL of AlloGen Liquid administered to the affected knee. arm group intervention list arm group intervention name Biological: AlloGen Liquid arm group label Saline arm group type Placebo Comparator arm group description A single-dose, intra-articular (IA) injection of 2.0 mL of saline administered to the affected knee. arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Biological intervention name AlloGen Liquid intervention description Amniotic fluid intervention arm group label list intervention arm group label AlloGen Liquid intervention type Drug intervention name Placebo intervention description 0.9% normal saline intervention arm group label list intervention arm group label Saline outcomes module primary outcome list primary outcome primary outcome measure Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee primary outcome description The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events primary outcome time frame Baseline to 12 weeks secondary outcome list secondary outcome secondary outcome measure Evaluate preliminary efficacy of the injection by assessing pain subscale scores secondary outcome description Composite change from baseline in WOMAC-A (pain subscale) scores secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing function subscale scores secondary outcome description Composite change from baseline in WOMAC-C (function subscale) score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing pain secondary outcome description Change from baseline in WOMAC-A scores secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing function secondary outcome description Change from baseline in WOMAC-C score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by Visual Analog Scale secondary outcome description Change from baseline in Visual Analog Scale (VAS) secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing total WOMAC secondary outcome description Change from baseline in total WOMAC score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee secondary outcome description Incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 26 weeks secondary outcome time frame 26 Weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing Patient-Reported Outcomes Measurement Information System (PROMIS) secondary outcome description Change from baseline in PROMIS pain interference and physical function scores secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing total SF-12 score secondary outcome description Change from baseline in total SF-12 score secondary outcome time frame Baseline, 6, 12 and 26 weeks secondary outcome measure Evaluate preliminary efficacy of the injection by assessing total KOOS score secondary outcome description Change from baseline in total KOOS score secondary outcome time frame Baseline, 6, 12 and 26 weeks eligibility module eligibility criteria Inclusion Criteria: Subject has both clinical and radiographic findings consistent with osteoarthritis of the knee: Subject has clinical findings including (but not limited to) tenderness to palpation, swelling/effusion, stiffness, chronic limited range of motion. Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 2 to 3 using the Kellgren-Lawrence grading scale. Failed conservative care over the past 3 months of at least 2 conservative treatments including oral pain medication [analgesics, steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs)] and structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of knee osteoarthritis. Subject has a BMI less than 40 kg/m2 Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study. Subject must have a VAS pain score of 4 or greater on a 100-mm scale. All subjects of reproductive age or capacity must use adequate contraception (abstinence, surgically sterilized, postmenopausal, or consistently use an effective contraception method) during the study. Subject agrees not to take additional knee symptom-modifying drugs (e.g., glucosamine, collagen, hyaluronic acid) during the study without reporting the use to the study team. Exclusion Criteria: Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 4 on the Kellgren-Lawrence grading scale. Subject has active infection at the injection site. Subject has symptomatic OA of the contralateral knee or of either hip (VAS≥40) that is not responsive to acetaminophen (Tylenol®) and/or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, e.g. Ibuprofen) and requires other therapy. Subject has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer. Subject has documented history of gout or pseudo-gout. Subject has a known allergy to local anesthetics. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or Human Immunodeficiency Virus (HIV). Subject has diagnosis of hematologic, renal, hepatic, or coagulation abnormalities based on medical history and laboratory results. Subject has received any of the following to the target knee: Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening; Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening; Has had or is planning to have major surgery in the target knee within 26 weeks of treatment; or History of unicondylar or total knee arthroplasty. Subject is currently participating in another clinical trial or has used an investigational drug, device or biologic within 12 weeks prior to treatment. Subject has a history of immunosuppressive use or chemotherapy in the last 12 months. Subject has had prior radiation to the index knee. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin). Subject is breast feeding or pregnant or plans to become pregnant within 12 weeks of treatment. Subject has any significant medical condition that, in the opinion of the Investigator, would increase the chances of an adverse event and/or would interfere with protocol evaluation and participation. Subject is a worker's compensation patient. Subject has taken pain medication <48 hours prior to the injection or has received pain medicine other than acetaminophen and/or NSAIDs for conditions unrelated to OA of the index knee. Subject has a history of alcohol or substance abuse. Physical or IA injection exclusion criteria include: Frank mechanical symptoms such as locking, intermittent block to range of motion, or loose body sensations (meniscal displacement or IA loose body), Knee surgery on index knee within 12 months or on contralateral knee within 6 months, and/or Acute injury to the knee within 3 months. Subject has uncontrolled, unstable diabetes mellitus with HbA1C =/>8%. History within preceding 5 years of solid organ or hematologic transplantation or diagnosis of non-basal cell malignancy. History within the preceding 6 months of septic arthritis in the affected knee or sepsis/bacteremia. History within the preceding 3 months of infection requiring antibiotic treatment . healthy volunteers No gender All minimum age 18 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Brian Cole, MD overall official affiliation Brian Cole MD overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010003 condition mesh term Osteoarthritis condition mesh id D000020370 condition mesh term Osteoarthritis, Knee condition ancestor list condition ancestor condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf as found Osteoarthritis condition browse leaf relevance high condition browse leaf id M21321 condition browse leaf name Osteoarthritis, Knee condition browse leaf as found Osteoarthritis, Knee condition browse leaf relevance high condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases

NCT04835389

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full study rank 61457 study protocol section identification module n c t id NCT04836221 org study id info org study id 00003543 organization org full name Medstar Health Research Institute org class OTHER brief title Comorbidities And Reducing inEquitieS official title Multi-level Interventions to Manage Co-morbidities Among Black Breast and Prostate Cancer Patients acronym CARES status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 5, 2021 start date type Actual primary completion date struct primary completion date November 30, 2022 primary completion date type Anticipated completion date struct completion date November 30, 2022 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 9, 2021 last update post date struct last update post date December 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hannah Arem responsible party investigator title Scientific Director, Implementation Science responsible party investigator affiliation Medstar Health Research Institute lead sponsor lead sponsor name Medstar Health Research Institute lead sponsor class OTHER collaborator list collaborator collaborator name Pfizer collaborator class INDUSTRY collaborator name American Cancer Society, Inc. collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Black cancer patients tend to have worse outcomes than White cancer patients. Some of this disparity may be due to comorbidities. The purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity. Comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. This study will offer additional support and tools to manage cancer patient's health needs. First, the study will use a mobile health application, managed by a company called Welldoc, to monitor patient progress in real time and to provide ongoing guidance. Second, the study will connect patients with a Community Health Worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. Lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed. conditions module condition list condition Cancer, Breast Diabetes Mellitus Hypertension Cancer Prostate keyword list keyword Prostate Cancer Breast Cancer Diabetes Mellitus Hypertension Community Health Workers mHealth design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description Will receive mHealth support for comorbidity and support from a Community Health Worker by phone arm group intervention list arm group intervention name Behavioral: Support intervention list intervention intervention type Behavioral intervention name Support intervention description Community Health Workers will conduct weekly phone calls to monitor blood pressure or blood glucose, to check in on patient need for social, practical or emotional supports, and to encourage healthy lifestyle modification. Participants will also have access to a mobile app to support chronic disease management (Either diabetes or hypertension). intervention arm group label list intervention arm group label Intervention outcomes module primary outcome list primary outcome primary outcome measure Feasibility of study protocol primary outcome description Accrual of >50 patients into the study primary outcome time frame Study recruitment period will be approximately 12 months primary outcome measure Feasibility of an active management strategy for comorbidities primary outcome description >80% recording blood pressure and/or blood glucose 3+ times per week primary outcome time frame Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months) primary outcome measure Feasibility of an active management strategy for comorbidities primary outcome description >80% completion of weekly phone calls with community health workers primary outcome time frame Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months) secondary outcome list secondary outcome secondary outcome measure Provider perspectives on acceptability of active management of comorbidities secondary outcome description >80% reporting agree to completely agree on the scale: Acceptability of Intervention Measure (FIM) measure. secondary outcome time frame Beginning and end of study (approximately 18 months) other outcome list other outcome other outcome measure Preliminary changes in self-efficacy other outcome description PROMIS Self-Efficacy for Managing Chronic Conditions other outcome time frame To be assess at baseline and end of study; approximately 6-7 months per participant other outcome measure Preliminary changes in social support other outcome description PROMIS Social Support other outcome time frame To be assess at baseline and end of study; approximately 6-7 months per participant eligibility module eligibility criteria Inclusion Criteria: Black women with a diagnosis of stage 0-IV breast cancer and within a month of treatment initiation or with 6+ months of treatment left OR Black men with a history of prostate cancer who are on long-term androgen deprivation therapy; Blood pressure >=120/80 OR diagnosis of diabetes Individuals who develop these conditions during treatment such as those scheduled to initiate steroid-containing chemotherapy or targeted PI3K inhibitor therapies Access to a smartphone and/or internet for the duration of the study. Can understand and communicate in English Exclusion Criteria: - Unwilling to participate in a 6-month study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Hannah Arem, PhD central contact role Contact central contact phone 202-893-2430 central contact e mail Hannah.Arem@medstar.net overall official list overall official overall official name Hannah Arem, PhD overall official affiliation Medstar Health Research Institute overall official role Principal Investigator location list location location facility MedStar Washington Hospital Center location status Recruiting location city Washington location state District of Columbia location zip 20010 location country United States location contact list location contact location contact name Andrea Lopez location contact role Contact location contact e mail andrea.j.lopez@medstar.net derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001943 condition mesh term Breast Neoplasms condition mesh id D000006973 condition mesh term Hypertension condition mesh id D000003920 condition mesh term Diabetes Mellitus condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf as found Cancer, Breast condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes Mellitus condition browse leaf relevance high condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf relevance low condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf as found Hypertension condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases

NCT04836221

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full study rank 61411 study protocol section identification module n c t id NCT04836819 org study id info org study id SGPAM-DKL11 organization org full name Ondokuz Mayıs University org class OTHER brief title Analgesia Management in Bariatric Surgery official title Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date April 8, 2021 start date type Actual primary completion date struct primary completion date June 5, 2021 primary completion date type Actual completion date struct completion date July 1, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 1, 2021 last update post date struct last update post date July 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yasemin Burcu Ustun responsible party investigator title Associate Professor responsible party investigator affiliation Ondokuz Mayıs University lead sponsor lead sponsor name Ondokuz Mayıs University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated. detailed description Patients will be divided into three groups. Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation. Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation. Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation. Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively. Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group will be placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group mentioned in the envelope. conditions module condition list condition Morbid Obesity Bariatric Surgery Candidate Pain Postoperative keyword list keyword Dexmedetomidine Ketamine Lidocaine Obesity Morbid Pain Postoperative design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description The patients will be randomly classified into three groups. design primary purpose Supportive Care design masking info design masking Double design masking description Drugs to be used will be prepared 30 minutes before the surgery in the drug preparation room by a nurse who is not involved in the study. Investigators and patients will be blinded to the group assignments. design who masked list design who masked Participant Investigator enrollment info enrollment count 78 enrollment type Actual arms interventions module arm group list arm group arm group label Group L arm group type Active Comparator arm group description IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours. arm group intervention list arm group intervention name Drug: Lidocain arm group label Group K arm group type Active Comparator arm group description IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. arm group intervention list arm group intervention name Drug: Ketamine arm group label Group D arm group type Active Comparator arm group description IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours. arm group intervention list arm group intervention name Drug: Dexmedetomidine intervention list intervention intervention type Drug intervention name Lidocain intervention description IV lidocaine infusion (2 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 1 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. intervention arm group label list intervention arm group label Group L intervention type Drug intervention name Ketamine intervention description IV ketamine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. intervention arm group label list intervention arm group label Group K intervention type Drug intervention name Dexmedetomidine intervention description IV dexmedetomidine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4. intervention arm group label list intervention arm group label Group D outcomes module primary outcome list primary outcome primary outcome measure Postoperative pain: VAS scores at rest and movement primary outcome description Pain status at rest and movement will be assessed by VAS scores. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain imaginable). primary outcome time frame Up to 15 days after the surgery. secondary outcome list secondary outcome secondary outcome measure Postoperative Rescue Analgesic Requirement secondary outcome description After the end of surgery 25-50 mg meperidine (maximum dose 200 mg) will be administered i.m. as rescue analgesia when requested by the patient and if VAS>4. the Rescue analgesic dosage will be recorded. secondary outcome time frame Up to three days after surgery secondary outcome measure Postoperative nausea, retching and vomiting secondary outcome description The number of patients who has complained of nausea, retching and vomiting will be recorded. secondary outcome time frame Up to 3 days after surgery. secondary outcome measure Time to first mobilization secondary outcome description The patients first mobilization time after the operation will be recorded. secondary outcome time frame Up to 24 hours after surgery. secondary outcome measure Time to discharge secondary outcome description The length of hospital stay will be recorded. secondary outcome time frame Trough hospital stay, an average of 1 week. eligibility module eligibility criteria Inclusion Criteria: Body mass index>35 kg/m2 The American Society of Anaesthesiologists (ASA) physical status class II III Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG) Exclusion Criteria: refusal to participate allergy to the study drugs chronic kidney disease (creatinine>150 μmol/L) mental illness liver, respiratory or oncological disease, cardiac dysfunction (ejection fraction <40%), uncontrolled hypertension, preoperative analgesic use, chronic pain, history of alcohol or drug addiction healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Ersin Koksal overall official affiliation Ondokuz Mayıs University overall official role Principal Investigator location list location location facility Ondokuz Mayis University location city Samsun location state Atakum location zip 55270 location country Turkey references module reference list reference reference p m i d 31256367 reference type background reference citation Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3. Review. reference p m i d 16517328 reference type background reference citation Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009. reference p m i d 21773855 reference type background reference citation Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20. Review. reference p m i d 30474791 reference type background reference citation Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1. reference p m i d 28120147 reference type background reference citation Bamgbade OA, Oluwole O, Khaw RR. Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. Obes Surg. 2017 Jul;27(7):1828-1834. doi: 10.1007/s11695-017-2562-4. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009767 condition mesh term Obesity, Morbid condition ancestor list condition ancestor condition ancestor id D000009765 condition ancestor term Obesity condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M11854 condition browse 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Lidocaine intervention mesh id D000020927 intervention mesh term Dexmedetomidine intervention mesh id D000007649 intervention mesh term Ketamine intervention ancestor list intervention ancestor intervention ancestor id D000000779 intervention ancestor term Anesthetics, Local intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000000889 intervention ancestor term Anti-Arrhythmia Agents intervention ancestor id D000061567 intervention ancestor term Voltage-Gated Sodium Channel Blockers intervention ancestor id D000026941 intervention ancestor term Sodium Channel Blockers 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intervention browse leaf as found Hospital intervention browse leaf relevance high intervention browse leaf id M10166 intervention browse leaf name Lidocaine intervention browse leaf as found Advanced intervention browse leaf relevance high intervention browse leaf id M16053 intervention browse leaf name Tramadol intervention browse leaf relevance low intervention browse leaf id M235540 intervention browse leaf name Dexamethasone acetate intervention browse leaf relevance low intervention browse leaf id M9837 intervention browse leaf name Ketoprofen intervention browse leaf relevance low intervention browse leaf id M10747 intervention browse leaf name Meperidine intervention browse leaf relevance low intervention browse leaf id M3261 intervention browse leaf name Anesthetics, Local intervention browse leaf relevance low intervention browse leaf id M3365 intervention browse leaf name Anti-Arrhythmia Agents intervention browse leaf relevance low intervention browse leaf id M22330 intervention browse leaf name Sodium Channel Blockers intervention browse leaf relevance low intervention browse leaf id M29178 intervention browse leaf name Diuretics, Potassium Sparing intervention browse leaf relevance low intervention browse leaf id M9195 intervention browse leaf name Hypnotics and Sedatives intervention browse leaf relevance low intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M19939 intervention browse leaf name Analgesics, Non-Narcotic intervention browse leaf relevance low intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M2820 intervention browse leaf name Adrenergic alpha-Agonists intervention browse leaf relevance low intervention browse leaf id M2825 intervention browse leaf name Adrenergic Agonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M3260 intervention browse leaf name Anesthetics, Dissociative intervention browse leaf relevance low intervention browse leaf id M19919 intervention browse leaf name Anesthetics, Intravenous intervention browse leaf relevance low intervention browse leaf id M19914 intervention browse leaf name Anesthetics, General intervention browse leaf relevance low intervention browse leaf id M19924 intervention browse leaf name Excitatory Amino Acid Antagonists intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev AnEm intervention browse branch name Antiemetics intervention browse branch abbrev Gast 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NCT04836819

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full study rank 61596 study protocol section identification module n c t id NCT04834414 org study id info org study id CHIPS secondary id info list secondary id info secondary id W81XWH2090021 secondary id type Other Grant/Funding Number secondary id domain DoD organization org full name University of Pittsburgh org class OTHER brief title CHIlled Platelet Study "CHIPS" official title CHIlled Platelet Study acronym CHIPS status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date October 21, 2021 start date type Actual primary completion date struct primary completion date March 1, 2024 primary completion date type Anticipated completion date struct completion date March 31, 2024 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 22, 2022 last update post date struct last update post date November 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Philip Spinella responsible party investigator title Professor- Surgery and Critical Care Medicine, Co- Director- Trauma and Transfusion Medicine Research Center, Associate Medical Director- Center for Military Medicine Research responsible party investigator affiliation University of Pittsburgh lead sponsor lead sponsor name Philip Spinella lead sponsor class OTHER collaborator list collaborator collaborator name University of Utah collaborator class OTHER collaborator name University of Minnesota collaborator class OTHER collaborator name Washington University School of Medicine collaborator class OTHER collaborator name United States Department of Defense collaborator class FED oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets. conditions module condition list condition Acute Blood Loss keyword list keyword platelets cold-stored platelets bleeding hemostasis complex cardiac surgery design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Sequential Assignment design intervention model description Adaptive Design design primary purpose Treatment design masking info design masking Triple design masking description Partial Blind design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Room Temperature Platelets arm group type Active Comparator arm group description Platelets stored at 20-24 degrees Celsius arm group intervention list arm group intervention name Biological: Room Temperature Platelets arm group label Cold Stored Platelets arm group type Experimental arm group description Platelets stored at 1-6 degree Celsius arm group intervention list arm group intervention name Biological: Cold Stored Platelets intervention list intervention intervention type Biological intervention name Cold Stored Platelets intervention description Platelets stored at 1-6 degree Celsius intervention arm group label list intervention arm group label Cold Stored Platelets intervention type Biological intervention name Room Temperature Platelets intervention description Platelets stored at 20-24 degrees Celsius intervention arm group label list intervention arm group label Room Temperature Platelets outcomes module primary outcome list primary outcome primary outcome measure Hemostatic efficacy primary outcome description Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome. primary outcome time frame 24 hours after first study platelet transfusion secondary outcome list secondary outcome secondary outcome measure Chest tube output secondary outcome description Assessed by volume secondary outcome time frame 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) other outcome list other outcome other outcome measure Blood product administration other outcome description The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood other outcome time frame 24 and 72 hours from start time of first study platelet transfusion other outcome measure Total Dose of individual hemostatic adjuncts other outcome description Antifibrinolytic and coagulation factor concentrates other outcome time frame 24 and 72 hours from start time of first study platelet transfusion other outcome measure Mechanical ventilation other outcome description Duration of mechanical ventilation days other outcome time frame up to 28 days after first study platelet transfusion other outcome measure Length of stay other outcome description ICU and hospital length of stay other outcome time frame up to 28 days other outcome measure Relative change in hemostatic parameters other outcome description CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG other outcome time frame 6 and 24 hours after first study platelet transfusion other outcome measure Unplanned sternal closure delay other outcome description Sternum left open after cardiac surgery other outcome time frame prior to ICU admission other outcome measure Re-exploration for bleeding other outcome description Return to OR after ICU admission other outcome time frame 24 hours first study platelet transfusion other outcome measure Unplanned extracorporeal support post operatively other outcome description Placed on ECMO other outcome time frame within 48 hours of first study platelet transfusion other outcome measure Morbidities after ICU admission other outcome description Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock other outcome time frame within 7 days of first study platelet transfusion other outcome measure Measures of end organ injury other outcome description If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically. other outcome time frame within 48 hours of first study platelet transfusion other outcome measure Transfusion associated adverse events other outcome description As per CDC guidelines other outcome time frame within 7 days of first study platelet transfusion other outcome measure Arterial thrombotic event other outcome description Stroke, MI other outcome time frame within 7 days of first study platelet transfusion other outcome measure Venous thrombotic event other outcome description Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram other outcome time frame within 7 days of first study platelet transfusion other outcome measure All cause mortality other outcome description Death for any reason other outcome time frame up to 28 days eligibility module eligibility criteria Inclusion Criteria: Age greater than 28 days and less than 85 years Planned complex cardiac surgery with planned use of cardiopulmonary bypass Exclusion Criteria: Expected order for washed or volume reduced platelets Patient with known anti-platelet antibodies Platelet transfusion refractoriness due to anti-HLA antibodies Known or suspected pregnancy Previously randomized in this study Conscious objection or unwillingness to receive blood products Known IgA deficiency Known congenital platelet disorder Known congenital bleeding disorder Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis Patients intended to receive whole blood either intra-operative or post-operative for bleeding Platelet transfusion (of any type) within 24 hours prior to the date of surgery Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery. healthy volunteers No gender All minimum age 29 Days maximum age 84 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Meghan Huff, BSN central contact role Contact central contact phone 314-362-1319 central contact e mail meghanhuff@wustl.edu central contact name Christina Daniel, BSN central contact role Contact central contact e mail christina.daniel@wustl.edu overall official list overall official overall official name Philip C Spinella, MD overall official affiliation University of Pittsburgh overall official role Principal Investigator overall official name Marie E Steiner, MD overall official affiliation University of Minnesota overall official role Principal Investigator overall official name Nicole D Zantek, MD overall official affiliation University of Minnesota overall official role Principal Investigator location list location location facility Ronald Reagan UCLA Medical Center location status Recruiting location city Los Angeles location state California location zip 90095 location country United States location contact list location contact location contact name Jennifer Scovotti location contact role Contact location facility University of Florida location status Recruiting location city Gainesville location state Florida location zip 32608 location country United States location contact list location contact location contact name Jessica Cobb location contact role Contact location facility Northwestern Memorial Hospital location status Recruiting location city Chicago location state Illinois location zip 60611 location country United States location contact list location contact location contact name Nora Ibrahim location contact role Contact location facility University of Kansas Medical Center location status Recruiting location city Kansas City location state Kansas location zip 66103 location country United States location contact list location contact location contact name Rachel Henning location contact role Contact location facility John Hopkins location status Recruiting location city Baltimore location state Maryland location zip 21287 location country United States location contact list location contact location contact name Colleen Mennie location contact role Contact location facility University of Michigan location status Recruiting location city Ann Arbor location state Michigan location zip 48109 location country United States location contact list location contact location contact name Wajid Kahn location contact role Contact location facility Mayo Clnic location status Recruiting location city Rochester location state Minnesota location zip 55905 location country United States location contact list location contact location contact name Beth Montonye location contact role Contact location facility Wake Forest location status Recruiting location city Winston-Salem location state North Carolina location zip 27157 location country United States location contact list location contact location contact name Lynn Harris location contact role Contact location facility Cincinnati Children's Hospital location status Recruiting location city Cincinnati location state Ohio location zip 45229 location country United States location contact list location contact location contact name Paula Casson location contact role Contact location facility Children's Hospital of Philadelphia location status Recruiting location city Philadelphia location state Pennsylvania location zip 19104 location country United States location contact list location contact location contact name Paula Hu location contact role Contact location facility University of Pittsburgh Pennsylvania location status Recruiting location city Pitts location state Pennsylvania location zip 15232 location country United States location contact list location contact location contact name Kristin Konopka location contact role Contact location facility Rhode Island Hospital location status Recruiting location city Providence location state Rhode Island location zip 02910 location country United States location contact list location contact location contact name Tracey Cheves location contact role Contact location facility University of Texas Children's Medical Center location status Recruiting location city Dallas location state Texas location zip 75235 location country United States location contact list location contact location contact name Delaney Evans location contact role Contact location facility University of Texas Medical Center Clements location status Recruiting location city Dallas location state Texas location zip 75235 location country United States location contact list location contact location contact name Kenni Landgraf location contact role Contact location facility Baylor Texas Children's location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Menard Elizabeth location contact role Contact location facility University of Wisconsin- Madison location status Recruiting location city Madison location state Wisconsin location zip 53792 location country United States location contact list location contact location contact name Daniel Griese location contact role Contact location facility Children's Hosptial of Wisconsin location status Recruiting location city Milwaukee location state Wisconsin location zip 53226 location country United States location contact list location contact location contact name Regina Cole location contact role Contact references module reference list reference reference p m i d 29521797 reference type background reference citation Krachey E, Viele K, Spinella PC, Steiner ME, Zantek ND, Lewis RJ. The design of an adaptive clinical trial to evaluate the efficacy of platelets stored at low temperature in surgical patients. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S41-S46. doi: 10.1097/TA.0000000000001876. reference p m i d 32902572 reference type background reference citation Strandenes G, Sivertsen J, Bjerkvig CK, Fosse TK, Cap AP, Del Junco DJ, Kristoffersen EK, Haaverstad R, Kvalheim V, Braathen H, Lunde THF, Hervig T, Hufthammer KO, Spinella PC, Apelseth TO. A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery. Anesthesiology. 2020 Dec 1;133(6):1173-1183. doi: 10.1097/ALN.0000000000003550. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006470 condition mesh term Hemorrhage condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M8708 condition browse leaf name Hemorrhage condition browse leaf as found Blood Loss condition browse leaf relevance high condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M8728 intervention browse leaf name Hemostatics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Coag intervention browse branch name Coagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04834414

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full study rank 61772 study protocol section identification module n c t id NCT04832126 org study id info org study id PRJ1801 organization org full name D'Or Institute for Research and Education org class OTHER brief title Genetic Analysis of Heart Channelopathies in Brazilian Patients and Their Relatives official title Genetic Analysis of Heart Channelopathies in Brazilian Patients and Their Relatives status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2018 start date type Actual primary completion date struct primary completion date August 1, 2021 primary completion date type Anticipated completion date struct completion date July 31, 2024 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Nilson Araújo de Oliveira Junior responsible party investigator title Dr. responsible party investigator affiliation D'Or Institute for Research and Education lead sponsor lead sponsor name D'Or Institute for Research and Education lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary several genes have been associated with ion channel diseases, but a large number of families do not yet have an identified genetic cause. There is a lack of information on the genetic characteristics of channelopathies in Brazilians affected by these diseases. This study aims to carry out a comprehensive genetic analysis of cardiac channelopathies in Brazilian patients and their families. The study will involve 20 patients and 80 family members (a total of 100 individuals) accompanied by the Rede D'Or arrhythmia group in Rio de Janeiro. Individuals will be recruited and subjected to DNA sequencing and phenotypic evaluation, including clinical evaluation, echocardiography, 24-hour Holter or longer electrocardiographic monitoring. An integrated analysis of phenotype-genotype will be made in all individuals included in the study. Patients and their families will be followed up annually for 2 to 5 years through clinical evaluations and the same complementary methods described. The DNA sequencing of patients and their families may contribute to improve the diagnosis of channelopathies and allow the determination of the pattern of occurrence of the disease in the cases involved. Besides, this study may lead to the discovery of new genetic variants associated with channelopathies that will serve as a basis for designing and carrying out broader molecular epidemiological studies. The study of the molecular genetics of channelopathies is important mainly so that patients can avoid sudden death, but also for the medical community, researchers, laboratories, companies involved in the production of medical devices, and public health authorities detailed description Inherited arrhythmias are characterized by variable expressiveness and incomplete penetrance. Extensive genotype-phenotype studies are needed to elucidate the genetic basis of these diseases. There are several reasons for studying the molecular genetics of channelopathies, such as determining the molecular epidemiology of these diseases, offering evidence for a better understanding of the molecular basis of diseases, determining the genetic patterns of occurrence (inherited or again), and improving the diagnosis and genetic counseling. Besides, the genetic study of these diseases can lead to the discovery of new genetic variants associated with these diseases and to the creation of experimental models. Genetic testing is recommended (Class I) for any patient with a strong clinical suspicion of genetically inherited channelopathies including long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome, and short QT syndrome. Specific genetic testing for the mutation identified in the index case is also recommended (Class I) for family members. The molecular genetics of cardiac channelopathies has been extensively studied in populations in developed countries. In the past, the most frequently used methods were the sequencing of a single or a few suspect genes. More recently, wider panels or even the sequencing of the complete exome have been increasingly used. This procedure has allowed the discovery of an increasing number of genetic variants. Although the genetic basis for many cases of these diseases is known, many families do not yet have a definite genetic cause. Besides, it is difficult to predict the pathogenicity and clinical evolution of individual mutations. Recent advances in the generation of induced pluripotent stem cells (iPS) may allow considerable progress in the translational research of arrhythmias. Since the discovery of the first channelopathy in 1995 , the use of genetic tests for diagnostic and prognostic purposes has evolved considerably and is now being used in clinical practice and not just for research purposes. Despite all these advances, the use of DNA sequencing to determine the presence or absence of some diseases is a challenge, since all these clinical syndromes can be associated with different mutations, many of which have not yet been described. The genetic sequencing of patients with genetically inherited arrhythmias is essential not only to provide clinical information related to well-characterized mutations but also to contribute to the discovery of new genetic alterations. In Brugada syndrome, for example, although 12 genotypes have been described so far, genetic changes have been identified in only 30% of cases. The reason for these discrepancies is related to still incomplete knowledge of all the pathways involved in the function and regulation of cardiac ion channels. Brief descriptions of the most studied channelopathies are presented below. Long QT syndrome (LQTS) This disease has been identified in different areas of the world, in different ethnic groups. Although at least 13 forms of the disease have been described so far, the cause in approximately 20% of cases is not yet defined. The disease is characterized by a prolongation of the QT interval and arrhythmic events. The arrhythmias usually found in these patients are episodes of polymorphic ventricular tachycardia (torsades de pointes) that causes dizziness and syncope and may progress to ventricular fibrillation and sudden death. Individuals affected by LQTS are more susceptible to atrial fibrillation than the general population This being the most studied channelopathy, the correlation between genetic variants and clinical evolution is very high. Currently, it is known that exercise and emotional stress trigger arrhythmias in patients with LQT1 and that patients with LQT3 usually have episodes of arrhythmia during sleep. It is also known that LQT8 is extremely aggressive with symptoms appearing early and a poor response to treatment. At least 20% of genetically proven LQTS cases have normal ECG. For all these reasons, LQTS is an example of how genetic characterization can help in understanding the pathophysiology of a clinical condition and improve treatment. Brugada Syndrome (BRS) This clinical syndrome is characterized by spontaneous episodes of polymorphic ventricular tachycardia that can degenerate into ventricular fibrillation and a typical electrocardiographic pattern of elevation of the ST segment from V1 to V3. The prevalence of this disease is higher in Asia where, in some locations, it is considered the most common cause of natural death among men under 50 years old. The syndrome usually begins in adulthood, being rare in children. Several genotypes have already been described, typically involving a decrease in the currents of sodium (Na) or an increase in the currents of potassium (K). The pattern of inheritance is autosomal dominant, so half of the family members are expected to be affected. As mentioned earlier for LQTS, the molecular genetics of several cases with clinical criteria for Brugada syndrome has not yet been elucidated. The treatment of choice is the implantation of a defibrillator. No pharmacological treatment is safe, although isoproterenol or quinidine can be used in cases of electrical storms. Ablation is being investigated to control some of these patients. The diagnosis is made from the electrocardiogram (ECG) with a typical pattern associated with the clinical evidence of the disease. Occasionally a provocative drug test may be necessary, as the typical pattern may be transient. Blockers of Na channels such as ajmaline can help to identify these patients. Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) This disease is characterized by arrhythmic events of bidirectional or polymorphic ventricular tachycardia triggered by an adrenergic stimulus. Baseline ECG and imaging tests are nonspecific. Ventricular arrhythmias are observed exclusively during efforts so that the stress test and the Holter are important diagnostic methods. Two types of mutations have been described so far. One at the ryanodine receptor and the other at the gene encoding calsequestrin. Only 60% of diagnosed individuals carry one of these mutations and, therefore, other genes must be involved. Other conditions Several other arrhythmic genetic syndromes have been described, such as short QT syndrome, sudden unexplained death syndrome, idiopathic ventricular fibrillation, early repolarization, and some genetic forms of atrial fibrillation. Many patients are diagnosed after an episode of sudden aborted death. Better genetic categorization of these cases could help to better understand the mechanisms involved in these diseases and improve treatment. Family screening and adequate genetic counseling are essential. OBJECTIVES PRIMARY OBJECTIVE This study aims to carry out a comprehensive genetic analysis of cardiac channelopathies in Brazilian patients and their families. SECONDARY OBJECTIVES Discover new genetic variants that are causal or associated with arrhythmias. Determine the molecular epidemiology of these diseases. Find evidence for a better understanding of the molecular basis of these diseases. Allow the creation of experimental models. Determine the genetic patterns of occurrence (inherited or new, among others). Allow an improvement in the diagnosis. Enable an improvement in genetic counseling. HYPOTHESES Genetic analysis will improve the diagnosis and genetic counseling of patients and their families. Early diagnosis can prevent sudden death in some cases. There is a possibility to detect new genetic variants associated with channelopathies. METHODS STUDY DESIGN AND POPULATION 20 patients and 80 family members (a total of 100 individuals) accompanied by the arrhythmia group of Rede D'Or will be recruited. The total number of individuals to include in the study refers to a convenience sample based on patients currently followed by the group of specialists from Rede D'Or who are part of the study and their families. The choice of up to 4 family members per proband is justified by the fact that this number of related individuals is, in most cases, sufficient to determine the pattern of occurrence and segregation of phenotypes. The specification of the family members of each proband that will be included will be made on a case-by-case basis depending on the pattern of genetic inheritance, the family composition, and the availability of samples from other family members. The inheritance pattern of causal genetic variants or those associated with phenotypes jointly defined as cardiac channelopathies is, more commonly, autosomal dominant. In this context, the genetic testing of both parents and, whenever possible, of first-degree relatives affected or not by the phenotype is sufficient for the establishment or exclusion of causality. Although less common, sporadic cases can also be seen. In such cases, the pathogenic genetic variant should not be detected in the parents but testing them is necessary to confirm the sporadic pattern. In these cases, siblings and/or first-degree relatives should only be tested in the absence of the parents. This is a pilot study that will provide information on the population affected by these diseases in our country. All eligible patients, affected by channelopathies and followed up in hospitals and clinics belonging to Rede D'Or São Luiz in Rio de Janeiro and selected family members, will be invited to participate in the study. DNA sequencing will be performed 3 ± 2 months after inclusion. The phenotypic analysis will be performed 2 ± 1 months after inclusion and will consist of a clinical evaluation, echocardiography, 24-hour Holter, or prolonged electrocardiographic monitoring (data collection form - Appendix B). A complete and integrated genotype-phenotype analysis of the cases included will be performed. Patients and their families will be followed for a minimum of 2 years and a maximum of 5 years and they will be evaluated annually with clinical consultations and with the same complementary methods described above. PROCEDURES Collection and purification of DNA samples Genomic DNA will be purified from peripheral blood or mouth swabs. Whole blood will be collected by peripheral phlebotomy in tubes containing K2EDTA as an anticoagulant. Blood samples will be stored at 4-8 oC for up to a week before DNA purification. Mouth swabs will be collected using the ORAcollect • DNA kit (OCR-100) (DNA Genotek Inc., Canada). Genomic DNA from whole blood or mouth swab samples will be purified using DNeasy Blood & Tissue Kit (QIAGEN). The analysis of germline genetic variants (inherited or de novo) through DNA sequencing, either by the Sanger method or by new generation sequencing, is not influenced by the tissue or body fluid from which the DNA is purified. Therefore, peripheral blood or oral smears/saliva can be used as a source of DNA without any technical compromise or introduction of bias. Thus, the choice of blood or oral swab will be determined essentially by the comfort and convenience for the research participant and aiming at the rational use of the available resources. DNA quantification and quality control The purified genomic DNA will be quantified by ultraviolet spectrophotometry using the NanoDrop microvolume spectrophotometer (ThermoFisher Scientific). DNA integrity will be measured by agarose gel electrophoresis and using the Agilent 4200 TapeStation system. Genetic analysis strategy In the initial discovery phase, 20 probands will be selected for analysis of sequence and copy number variants within a panel of selected candidate genes. The suspicious causal variables identified in this initial phase will later be analyzed in up to 4 family members or first-degree relatives for each proband. Genetic panel and gene selection criteria Candidate genes included in the panel were selected from searches in the Online Mendelian Inheritance in Man (OMIM) database, by reviewing the literature and consensus, recommendations, and guidelines issued by panels and specialist societies. The final list of candidate genes was established to include clinically informative genes, i.e., which assist in diagnostic or therapeutic decisions, and experimental evidence indicative of genetic involvement in the pathophysiology of arrhythmias. New generation sequencing Candidate genes will be analyzed for the detection of sequence and copy number variants using new generation sequencing. The entire coding region and intron-exon boundaries will be sequenced using Ampliseq ™ technology. The oligonucleotides for the amplification of the regions of interest will be designed using the online tool Ion AmpliSeq Designer. The sequencing libraries will be generated using the Ion AmpliSeq ™ Library Kit on the Ion OneTouch 2 System (ThermoFisher Scientific). The sequencing will be performed on an Ion Personal Genome Machine (PGM) sequencer using the Ion 318 ™ Chip v2 BC and the Ion PGM ™ Hi-Q ™ View Sequencing reagents (ThermoFisher Scientific). Sequencing analysis will be performed using the Ion Reporter ™ software (ThermoFisher Scientific). Interpretation and reporting of sequence variants. The interpretation and registration of sequence variants will be performed according to the consensual recommendation of the American College of Medical Genetics and Genomics, the Association for Molecular Pathology, and the College of American Pathologists. Briefly, to describe variants identified in genes that cause Mendelian disorders, this consensus recommends the use of standard terms: pathogenic, probably pathogenic, uncertain meaning, likely benign and benign. According to this recommendation, the process of classifying variants in these five categories is based on a series of different types of evidence, such as population data, computer simulations, functional data, and genetic segregation data. The evaluation of the pathogenicity of the genetic variants that are detected will be done independently, i.e., "blind", by the specialists. The clinical evaluation of the patients and determination of the phenotype will be carried out by the arrhythmia specialists in the group under the supervision of Dr. Nilson Araújo. The genetic evaluation will be done in a 'blind' way by Dr. Marcelo Reis. In case of divergence between the variant found and the phenotype, the findings will be reviewed by Dr. Luciana Sacilotto (specialist in arrhythmia with experience in clinical genetics) and by Dr. Carolina Bustamante (specialist in molecular genetics). Computational prediction of the functional effect of genetic variants To estimate the functional effects of the sequence variants, a series of publicly available tools will be used. These algorithms consider the evolutionary conservation of amino acid residues and conserved protein domains, protein structure and function, Hiden Markov models, and position-dependent logic. Whenever available, functional experimental data in vitro on the effect of specific sequence variants will also be considered for interpretation. conditions module condition list condition Channelopathies keyword list keyword channelopathies arrhythmia genetic analysis Sudden cardiac death design module study type Observational patient registry No design info design observational model list design observational model Family-Based design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Genomic DNA is purified from peripheral blood or mouth swabs enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patient arm group description patients with channelopathies arm group intervention list arm group intervention name Genetic: Genetic analysis arm group label Family arm group description relatives of patients with channelopathies arm group intervention list arm group intervention name Genetic: Genetic analysis intervention list intervention intervention type Genetic intervention name Genetic analysis intervention description Genomic DNA will be purified from peripheral blood or mouth swabs. Whole blood will be collected by peripheral phlebotomy in tubes containing K2EDTA as an anticoagulant. Blood samples will be stored at 4-8 oC for up to a week before DNA purification. Mouth swabs will be collected using the ORAcollect • DNA kit (OCR-100) (DNA Genotek Inc., Canada). Genomic DNA from whole blood or mouth swab samples will be purified using DNeasy Blood & Tissue Kit (QIAGEN). intervention arm group label list intervention arm group label Family Patient outcomes module primary outcome list primary outcome primary outcome measure phenotypic analysis primary outcome description by genomic DNA purified from peripheral blood or mouth swabs. primary outcome time frame Patients and their families will be followed up to 5 years eligibility module eligibility criteria Inclusion Criteria: Patients from Rede D'or São Luiz and their relatives Patients whit arrhythmia and their relatives Presence of inheritance pattern of causal genetic variants or those associated with phenotypes jointly defined as cardiac channelopathies and their relatives Exclusion Criteria: None healthy volunteers No gender All std age list std age Child Adult Older Adult study population patients and family members accompanied by the arrhythmia group of Rede D'Or, Rio de Janeiro, Brazil. The number of individuals we intend to include in the study refers to a convenience sample based on patients currently followed by the group of specialists from Rede D'Or who are part of the study and their families. The choice of up to 4 family members per proband is justified by the fact that this number of related individuals is, in most cases, sufficient to determine the pattern of occurrence and segregation of phenotypes. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Nilson O Araujo, Dr. central contact role Contact central contact phone + 55 21 3883-6000 central contact e mail nilson.ojunior@rededor.com.br central contact name Renata J Moll, Dr. central contact role Contact central contact phone +55 21 3883-6000 central contact e mail renata.moll@idor.org overall official list overall official overall official name Nilson O Araujo, Dr overall official affiliation D'Or Institute for Research and Education (IDOR) overall official role Principal Investigator location list location location facility D'Or Institute for Research and Education (IDOR) location status Recruiting location city Rio De Janeiro location zip 22281-100 location country Brazil location contact list location contact location contact name Nilson O Araujo, Dr. location contact role Contact location contact e mail nilson.oaraujo@rededor.com.br location contact name Renata J Moll, Dr. location contact role Contact location contact e mail renata.moll@idor.org references module reference list reference reference p m i d 23266818 reference type result reference citation Abriel H, Zaklyazminskaya EV. 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Epub 2008 Oct 27. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000053447 condition mesh term Channelopathies condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M3605 condition browse leaf name Arrhythmias, Cardiac condition browse leaf relevance low condition browse leaf id M5997 condition browse leaf name Death condition browse leaf relevance low condition browse leaf id M18270 condition browse leaf name Death, Sudden, Cardiac condition browse leaf relevance low condition browse leaf id M26404 condition browse leaf name Channelopathies condition browse leaf as found Channelopathies condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3396 intervention browse leaf name Anticoagulants intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AnCoag intervention browse branch name Anticoagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04832126

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full study rank 61933 study protocol section identification module n c t id NCT04830020 org study id info org study id CampusBioMedico secondary id info list secondary id info secondary id 1ZIDES102465 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/1ZIDES102465 organization org full name Campus Bio-Medico University org class OTHER brief title Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes official title Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes acronym HA-COVID status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date February 26, 2021 start date type Actual primary completion date struct primary completion date June 30, 2021 primary completion date type Actual completion date struct completion date September 30, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date March 1, 2022 last update post date struct last update post date March 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Campus Bio-Medico University lead sponsor class OTHER collaborator list collaborator collaborator name National Institute of Environmental Health Sciences (NIEHS) collaborator class NIH oversight module is f d a regulated drug No is f d a regulated device No description module brief summary To determine whether inhaled Yabro protects against progression of COVID19-induced respiratory failure preventing the passage to non-invasive ventilation (NIV) and promotes recovery from COVID19 lung disease in hospitalized patients. detailed description All patients will be treated with state of the art COVID19 treatment as per the treating clinician (Remdesivir, systemic corticosteroids, monoclonal antibodies, convalescent plasma, biologic cytokine inhibitors and other interventions as per the latest guidelines). Patients randomized to the active intervention group will also receive HMW-HA (Yabro®, 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer, while patients randomized in the control group will receive a matching placebo two times daily. Due to increased risk for SARS-CoV-2 transmission via the usual mask nebulization procedure, patients will receive the nebulized treatment via high-flow oxygen tubing as described in the literature 36-38. Patients will be treated until there is a qualitative change in oxygen requirement, i.e. either progression to assisted ventilation (non-invasive or invasive), or weaning from oxygen supplementation. Because COVID19 may result in long-term O2 dependency, the study and treatment period will be limited to a maximum of 10 days. Moreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment. conditions module condition list condition Covid19 design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 180 enrollment type Actual arms interventions module arm group list arm group arm group label HMW-HA arm group type Active Comparator arm group description HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) arm group intervention list arm group intervention name Drug: HMW-HA arm group label placebo arm group type Placebo Comparator arm group description 5 ml of saline via nebulizer b.i.d. arm group intervention list arm group intervention name Drug: HMW-HA intervention list intervention intervention type Drug intervention name HMW-HA intervention description Aerolized administration b.i.d. intervention arm group label list intervention arm group label HMW-HA placebo intervention other name list intervention other name Yabro outcomes module primary outcome list primary outcome primary outcome measure Cumulative time on oxygen primary outcome description cumulative duration of oxygen treatment primary outcome time frame 10 days secondary outcome list secondary outcome secondary outcome measure Need for advanced airway intervention or death due to COVID19; secondary outcome description need of intubation or death due to COVID19 secondary outcome time frame 10 days secondary outcome measure Rate of change of respiratory rate; secondary outcome description rapidity of decrease of respiratory rate secondary outcome time frame 10 days secondary outcome measure Change in PaO2 /FiO2 ratio during treatment secondary outcome description improvement of PaO2/FiO2 ratio after 10 days of treatment secondary outcome time frame 10 days secondary outcome measure Time to discharge from hospital secondary outcome description decrease of cumulative days of hospitalization secondary outcome time frame 10 days eligibility module eligibility criteria Inclusion Criteria: Age ≥ 18 Diagnosis of COVID19 by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) and no alternative explanation for current clinical condition. Respiratory failure requiring oxygen therapy Has symptoms consistent with COVID-19, and is in non-fibroproliferative stage of disease, as determined by investigator. Exclusion Criteria: Respiratory arrest or the need for immediate intubation; Upper airway obstruction; Facial trauma; Inability to cooperate (e.g. agitation or dementia) Inability to give informed consent Participation in another study for COVID19 treatments Deterioration due to other reasons than progressive COVID19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc. Palliative care or expectation that patient will not survive > 72 hours post randomization per clinical judgment of the investigator. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Raffaele Antonelli Incalzi, MD overall official affiliation Università Campus-Biomedico di Roma overall official role Principal Investigator location list location location facility Università Campus Biomedico di Roma location city Roma location zip 00128 location country Italy i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M26290 condition browse leaf name Respiratory Aspiration condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9030 intervention browse leaf name Hyaluronic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04830020

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full study rank 61565 study protocol section identification module n c t id NCT04834817 org study id info org study id 20216401 organization org full name University of California, Irvine org class OTHER brief title Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment official title The Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment status module status verified date November 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date October 2023 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 2, 2022 last update post date struct last update post date November 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kristen Kelly responsible party investigator title Professor responsible party investigator affiliation University of California, Irvine lead sponsor lead sponsor name University of California, Irvine lead sponsor class OTHER collaborator list collaborator collaborator name BioPhotas collaborator class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment. detailed description This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application. conditions module condition list condition Wound Heal design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label LED treatment arm group type Experimental arm group description LED treatment with Celluma POD device after laser test area arm group intervention list arm group intervention name Device: Celluma POD arm group label Control arm group type No Intervention arm group description No treatment after laser test area intervention list intervention intervention type Device intervention name Celluma POD intervention description A blue and near infrared handheld LED device intervention arm group label list intervention arm group label LED treatment outcomes module primary outcome list primary outcome primary outcome measure Days to healing primary outcome description The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment. primary outcome time frame 56 days secondary outcome list secondary outcome secondary outcome measure Pain level secondary outcome description A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome. secondary outcome time frame 56 days eligibility module eligibility criteria Inclusion Criteria: Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla. Subjects shall have given written informed consent for both the LED therapy and for clinical photography. Exclusion Criteria: Patients will be excluded if any of the exclusion criteria applies Subjects refuse to give informed consent for either the phototherapy or the clinical photography. Subjects have previous photosensitivity problems (solar urticaria, etc.). Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties. Subjects taking any systemic drug with known immunosuppressant properties. Subjects applying any medications to the research site (inner biceps, close to the axilla). Subjects have medical or psychosocial conditions associated with a risk of poor protocol compliance. Subjects are smokers or have smoked within the last 30 days prior to the trial. Subjects have epilepsy or a history of seizures Subjects currently taking cortisone injections or any other kind of steroid injections(s) Subjects with known cancer tumor in the treatment area or metastasis healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Kristen Kelly, MD overall official affiliation University of California, Irvine overall official role Principal Investigator location list location location facility UCI Beckman Laser Institute and Medical Clinic location city Irvine location state California location zip 92697 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions

NCT04834817

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full study rank 61404 study protocol section identification module n c t id NCT04836910 org study id info org study id 8032-20-SMC organization org full name Sheba Medical Center org class OTHER_GOV brief title Microbiome and Polycystic Ovaries official title The Change in Microbiome Following Treatment of Women With Polycystic Ovaries status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 1, 2023 start date type Anticipated primary completion date struct primary completion date March 30, 2026 primary completion date type Anticipated completion date struct completion date March 30, 2026 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2022 last update post date struct last update post date April 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dr. Aya Mohr-Sasson responsible party investigator title Principal Investigator responsible party investigator affiliation Sheba Medical Center lead sponsor lead sponsor name Sheba Medical Center lead sponsor class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome. detailed description Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. It seems there are both genetic, epigenetic and environmental contributors (almost 100 susceptible genes were identified). The quality of life (QQL) of women suffering from PCOS is significantly reduced in all domains (functional ability, physical and emotional) and major health problems is correlated to PCOS. Women with PCOS demonstrate hyperinsulinemia and insulin resistance. They have an increased risk for type 2 diabetes and impaired glucose tolerance. Studies have shown that adipocyte function is considerably aberrant in women with PCOS including: lower lipase activity, defective glucose transport and dyslipidemia. Obesity is more prevalent in women with PCOS. They are also exposed to long term risk for additional disorders like cardiovascular diseases (atherosclerosis) or even cancer (endometrial or ovarian) . PCOS is the primary cause of anovulatory subfertility. Furthermore, women with PCOS are at risk for pregnancy and obstetrical complications including preterm birth, pre- eclampsia and meconium aspiration syndrome of neonates after birth. PCOS is diagnosed according the Rotterdam criteria . It requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen)- clinical and/ or biochemical (presence of hirsutism, acne or alopecia). 2. Oligo or anovulation (including menstrual dysfunction). 3. PCO-M polycystic ovaries morphology (over 12 follicles, 2-9 mm or increased ovarian volume). The term microbiome describes the genetic material of all the microbes (bacteria, fungi, protozoa and viruses) that live onside and inside the human body. It is important for development of the body, immunity and nutrition. The microbiome may influence the susceptibility to different infectious diseases and contribute to chronic illnesses. The gut microbiota contains 100 trillion microbes. When discussing gut bacteria, it is primarily referred to the large intestine (colon). Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Preliminary studies have shown that different bacterial species colonize the gut of PCOS induced animals compared to controls. A novel theory was developed concerning the development of PCOS. A diet high of sugars sets as a convenient platform for gram negative bacteria ("bad" bacteria) while reducing "good" bacteria. The cell wall of the gram negative bacteria is comprised of lipopolysaccharide (LPS) which stimulates the immune system. The high sugar diet increases the permeability of the gut ("leaky gut") leading to chronic inflammation which produces impaired insulin receptor function. The insulin facilitates an increase in the production of androgens by the ovaries which leads to PCOS . The dysbiosis was correlated with sex hormone levels and ovarian changes. In addition, treating PCOS using lactobacillus ("good" bacteria) transplantation showed improved ovarian functions. Even though, several studies established the connection between the dysbiosis of the gut and PCOS, only a few studies were conducted on the association between the vaginal microbiome and the development of PCOS. To detail, the vaginal microbiome in PCOS is more diverse and heterogeneous, with the relative abundance of certain species (such as Mycoplasma) and lower level of others (such as Lactobacillus which keeps the vagina acidic) . Moreover, should this association be strengthen between the microbiome of the gut and vagina to PCOS, it could serve as grounds to new horizons for treatment. There are several therapies for PCOS treatment (Life style interventions, improving metabolic dysfunction and medical treatment ), however, currently, there is no ideal therapy that fully treats all the clinical features. Due to all the aforementioned, we aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome. Study design A prospective longitudinal case control study that will be conducted at Sheba Medical Center (tertiary medical center). Study group will include 20 women in fertility age (age 18-42) diagnosed with PCOS according to the Rotterdam Criteria who haven't started any kind of treatment. The control group would be healthy women matched by age. Women in both groups will be recruited at the Endocrine outpatient's clinics. All women will sign informed consent form after receiving information on the study from one of the research team members. Vaginal and rectal samples will be collected during the regular clinic visits that will be set by the medical interventions requirements (including: dietary recommendations, physical activity, hormonal contraception, insulin resistance treatment, fertility treatment, pregnancy follow-up): at first visit after recruitment 1 month following first intervention 3 month following first intervention conditions module condition list condition Polycystic Ovary Syndrome Microbial Colonization keyword list keyword polycystic ovaries, microbiome design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description Stool samples for microbiome analysis, vaginal swab enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Study Group: Women with Polycystic Ovary Syndrome arm group description Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment arm group intervention list arm group intervention name Other: Dietary recommendations Drug: Oral contraceptive pills Drug: Metformin arm group label Cohort Group: Women without Polycystic Ovary Syndrome intervention list intervention intervention type Other intervention name Dietary recommendations intervention description Fruit, vegetables, legumes (e.g. lentils and beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat and brown rice). At least 400 g (i.e. five portions) of fruit and vegetables per day excluding potatoes, sweet potatoes, cassava and other starchy roots. Less than 10% of total energy intake from free sugars Less than 30% of total energy intake from fats. Unsaturated fats (found in fish, avocado and nuts, and in sunflower, soybean, canola and olive oils) are preferable to saturated fats. Less than 5 g of salt (equivalent to about one teaspoon) per day. intervention arm group label list intervention arm group label Study Group: Women with Polycystic Ovary Syndrome intervention other name list intervention other name World Health Organisation (WHO) recommendations intervention type Drug intervention name Oral contraceptive pills intervention description Hormonal treatment intervention arm group label list intervention arm group label Study Group: Women with Polycystic Ovary Syndrome intervention type Drug intervention name Metformin intervention description Insulin resistance treatment intervention arm group label list intervention arm group label Study Group: Women with Polycystic Ovary Syndrome outcomes module primary outcome list primary outcome primary outcome measure Vaginal and gut microbiota composition before and after intervention recommended and in comparison to women without PCOS. primary outcome description Evaluated by PCR ( ng/microl) primary outcome time frame Through study completion, an estimated period of 1 year secondary outcome list secondary outcome secondary outcome measure Hirsutism secondary outcome description Change in hirsutism - subjectively reported by the women during clinic visits, on scale 0-4 (0-no change, 4-substantial improvement), and additionally evaluated before and after treatment by the Modified Ferriman-Gallwey Scoring (evaluating 9 body areas to assess hair growth (on 0-4 scale: 0-no hair growth to 4- extensive hair growth) secondary outcome time frame Through study completion, an estimated period of 1 year secondary outcome measure Acne secondary outcome description Change in Acne sevirity - subjectively reported by the women during clinic visits - Mild/ Moderate /Severe secondary outcome time frame Through study completion, an estimated period of 1 year secondary outcome measure Fertility secondary outcome description Sucess achieving pregnancy secondary outcome time frame Through study completion, an estimated period of 1 year eligibility module eligibility criteria Inclusion Criteria: Study group: Untreated women diagnosed with PCOS that are planned for intervention. Control group: Women without PCOS visiting the gynecologic outpatient's clinics. Exclusion Criteria: Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor). Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week). 4. Vaginitis/ Pelvic Inflammatory Disease (PID) gender Female minimum age 18 Years maximum age 42 Years std age list std age Adult study population Study group will include 20 women in fertility age (age 18-42) diagnosed with PCOS according to the Rotterdam Criteria who haven't started any treatment. The control group would include healthy women matched by age. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Aya Mohr-Sasson, M.D central contact role Contact central contact phone 0523692906 central contact e mail mohraya@gmail.com location list location location facility Sheba Medical Center location status Recruiting location city Ramat-Gan location zip 52621 location country Israel location contact list location contact location contact name Aya Sasson location contact role Contact location contact phone 0523692906 location contact e mail mohraya@gmail.com references module reference list reference reference p m i d 29794677 reference type background reference citation American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 194: Polycystic Ovary Syndrome. Obstet Gynecol. 2018 Jun;131(6):e157-e171. doi: 10.1097/AOG.0000000000002656. Erratum in: Obstet Gynecol. 2020 Sep;136(3):638. reference p m i d 28646699 reference type background reference citation Macut D, Bjekić-Macut J, Rahelić D, Doknić M. Insulin and the polycystic ovary syndrome. Diabetes Res Clin Pract. 2017 Aug;130:163-170. doi: 10.1016/j.diabres.2017.06.011. Epub 2017 Jun 12. Review. reference p m i d 27233760 reference type background reference citation Lizneva D, Suturina L, Walker W, Brakta S, Gavrilova-Jordan L, Azziz R. Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):6-15. doi: 10.1016/j.fertnstert.2016.05.003. Epub 2016 May 24. reference p m i d 27406348 reference type background reference citation McCartney CR, Marshall JC. CLINICAL PRACTICE. Polycystic Ovary Syndrome. N Engl J Med. 2016 Jul 7;375(1):54-64. doi: 10.1056/NEJMcp1514916. Review. reference p m i d 29995717 reference type background reference citation Azziz R. Polycystic Ovary Syndrome. Obstet Gynecol. 2018 Aug;132(2):321-336. doi: 10.1097/AOG.0000000000002698. Review. reference p m i d 27510637 reference type background reference citation Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57. Review. reference p m i d 28045919 reference type background reference citation Lindheim L, Bashir M, Munzker J, Trummer C, Zachhuber V, Leber B, Horvath A, Pieber TR, Gorkiewicz G, Stadlbauer V, Obermayer-Pietsch B. Alterations in Gut Microbiome Composition and Barrier Function Are Associated with Reproductive and Metabolic Defects in Women with Polycystic Ovary Syndrome (PCOS): A Pilot Study. PLoS One. 2017 Jan 3;12(1):e0168390. doi: 10.1371/journal.pone.0168390. eCollection 2017. reference p m i d 32311120 reference type background reference citation Hong X, Qin P, Huang K, Ding X, Ma J, Xuan Y, Zhu X, Peng D, Wang B. Association between polycystic ovary syndrome and the vaginal microbiome: A case-control study. Clin Endocrinol (Oxf). 2020 Jul;93(1):52-60. doi: 10.1111/cen.14198. 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browse leaf relevance high intervention browse leaf id M9206 intervention browse leaf name Hypoglycemic Agents intervention browse leaf relevance low intervention browse leaf id T242 intervention browse leaf name Olive intervention browse leaf relevance low intervention browse leaf id T305 intervention browse leaf name Sunflower intervention browse leaf relevance low intervention browse leaf id T294 intervention browse leaf name Soy Bean intervention browse leaf relevance low intervention browse leaf id T93 intervention browse leaf name Cassava intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Hypo intervention browse branch name Hypoglycemic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Repr intervention browse branch name Reproductive Control Agents intervention browse branch abbrev HB intervention browse branch 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NCT04836910

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full study rank 61202 study protocol section identification module n c t id NCT04839536 org study id info org study id MREC: 2021116-9722 organization org full name University of Malaya org class OTHER brief title Comparing Sevoflurane With Propofol Sedation in ESRF Patients official title A Comparative Study of Sevoflurane Sedation With TCI Propofol Sedation in Dialysis Dependent End Stage Renal Failure Patients for Transposition of Brachiocephalic Fistula Repair status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date March 31, 2022 primary completion date type Anticipated completion date struct completion date April 30, 2022 completion date type Anticipated study first submit date March 28, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Malaya lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary End-stage renal failure (ESRF) cohorts undergo brachiocephalic fistula(BCF) transposition with supraclavicular block. However, this is inadequate because the incision may extend to the axillary region which requires intercostobrachial (T2) dermatome blockage. Sedation is commonly indicated to allay anxiety whilst allowing intraprocedural lignocaine infiltration. It is challenging to administer safe sedation to ESRF patients due to multiple comorbidities, polypharmacy, altered pharmacokinetic drug handling. Intraoperative hypotension can be common and evident from the residual effect of antihypertensive and intravascular hypovolemia from regular hemodialysis. Midazolam is metabolized to an active metabolite which can accumulate causes apnea and delayed recovery. TCI propofol needs higher induction doses to achieve hypnosis causes exaggerated hypotension which may jeopardize organ perfusion. The investigators are exploring the potential benefit of sevoflurane sedation which are independent of renal clearance, rapid onset and offset, and ischemic preconditioning property in ESRF cohorts. detailed description Regional anesthesia has been shown to be superior to general anesthesia in end-stage renal disease (ESRF) patients undergoing brachiocephalic transposition by ensuring graft patency, reducing pharmacokinetic (pK) and pharmacodynamic (pD) unpredictability, and minimize hemodynamic instability. However, a supraclavicular nerve block is inadequate in BCF transposition where surgical incision may extend to the axillary region which requires intercostobrachial nerve (T2) dermatome to be blocked. Intraprocedural lignocaine infiltration or pectoralis minor (PEC 2) block may be required to anaesthetize this region. Hence, sedation is commonly indicated to allay anxiety and to blunt sympathetic stress response to surgery. ESRF patient is a challenging cohort to administer safe sedation due to multiple comorbidities, polypharmacy, altered pK handling of drug with a high proportion of total body water, the altered volume of distribution, protein binding, drug metabolism and excretion[3]. Commonly used intravenous midazolam causes delayed recovery and apnoea due to loss of renal ability to clear active metabolite α1-hydroxymidazolam. Target controlled infusion (TCI) propofol needs a higher induction dose to achieve clinical end-point of hypnosis in ESRF patient and causes hemodynamic disturbances. Dialysis dependent ESRF patients are commonly hypertensive and adapted to a higher baseline blood pressure. Intraoperative hypotension is exaggerated from residual effect of antihypertensive, relative intravascular hypovolemia from pre-op haemodialysis and pre-operative fasting with no replacement fluid. Blood pressure determine perfusion, and existing evidence suggests intraoperative hypotension is associated with stroke, myocardial injury and delirium. Major hypertension guidelines have recommended target blood pressure level of 140/90 mm Hg for patients with renal disease. Volatile sedation with sevoflurane in intensive care has been widely appraised for significant shorten and superior awakening time and reduced incidence of delirium compared with conventional midazolam/ propofol intravenous sedation. Sevoflurane has rapid onset of action with no significant concern of tolerance and tachyphylaxis. Drug clearance is via pulmonary exhalation which is independent of hepatic and renal function. Volatile agent is a mild analgesia with opioid sparing effect via N methyl-D-aspartate receptor blockade, thus provide a more stable sedation profile.ESRF patients are prone to develop ischemic heart disease due to calcification of intima. Sevoflurane also possess ischemic preconditioning and end organ cytoprotective properties along with anti-inflammatory mechanism. conditions module condition list condition Sevoflurane Kidney Diseases Procedural Hypotension keyword list keyword Sevoflurane Sedation, ESRF design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 36 enrollment type Anticipated arms interventions module arm group list arm group arm group label Target controlled infusion (TCI) propofol arm group type Active Comparator arm group description For TCI propofol group, all patients will receive nasal CPAP mask and nasal breathing with oxygen of 3 litre/min. We will utilize the Schneider model to target effect-site (Cet) starting from 0.5 mcg/ml and with a gradual 0.5mcg/ml increment every 30s until OAAS score of 3 is achieved. For any patients with OAAS score < 3, Cet will be decreased by a decremental 0.5 mcg/ml. The deepest level of sedation will be recorded. arm group intervention list arm group intervention name Drug: Sevoflurane inhalant product arm group label Sevoflurane sedation arm group type Experimental arm group description Patients randomised to this arm will be given time to familiarise with the nasal continuous positive airway pressure (CPAP) mask and nasal breathing with oxygen 3 litre/min via a Bain anaesthetic circuit before the introduction of sevoflurane. Once the patient starts to adapt to nasal CPAP mask, sevoflurane will be delivered, starting with a concentration of 0.2% and increase stepwise by 0.2% every 30s until sedation score of OAAS of 3 is achieved. Anaesthetist in charge will assess and maintain sedation endpoint to OAAS 3. If patient is over sedated, sevoflurane concentration will be reduced by 0.2% until OAAS 3. The deepest level of sedation will be recorded. arm group intervention list arm group intervention name Drug: Sevoflurane inhalant product intervention list intervention intervention type Drug intervention name Sevoflurane inhalant product intervention description Sevoflurane will be delivered in an incremental dose to throughout procedure to achieve clinical sedation endpoint OAAS 3. intervention arm group label list intervention arm group label Sevoflurane sedation Target controlled infusion (TCI) propofol intervention other name list intervention other name Ultane, 74412392 outcomes module primary outcome list primary outcome primary outcome measure Change in mean arterial pressure from baseline following sedation primary outcome description Hemodynamic instability is defined as event below: Hypotension- Drop in mean arterial pressure (MAP) from baseline by more than 20% Hypotension - Drop in systolic blood pressure (sBP < 140 mmHg) and diastolic blood pressure (dBP < 90 mmHg) primary outcome time frame At baseline, pre-, and immediately after intervention secondary outcome list secondary outcome secondary outcome measure Number of hemodynamic interventions required during sedation secondary outcome description administration of vasoactive drugs to maintain hemodynamic within target (sBP> 140 mmHg, dBP > 80 mmHg, MAP within 20% baseline) secondary outcome time frame At baseline, pre-, and immediately after intervention secondary outcome measure Duration of hemodynamic instability secondary outcome description Time course of drop in mean arterial pressure more than 20% secondary outcome time frame At baseline, pre-, and immediately after intervention and surgery secondary outcome measure Onset time and recovery time secondary outcome description Onset time: time from starting sedation to Observer Assessment of Alertness/ Sedation (OAAS) score 3 (maintain at 3 for a consecutive 15 mins) Recovery time: Time from cessation of sedation to return to OAAS score 5 secondary outcome time frame At baseline, pre-, and immediately after intervention and surgery eligibility module eligibility criteria Inclusion Criteria: Patient with end stage renal failure, dialysis dependent undergoing transposition of brachiocephalic fistula repair American Society of Anesthesiology Physical Status Classification System (ASA) II or III Exclusion Criteria: Patient refusal History or family history of malignant hyperthermia Known allergy to propofol or local anaesthetic agent Patients who have taken neuroleptics, benzodiazepine over 2 weeks within 1 month Chronic use of alcohols/ opioid Active lungs disease (eg. acute exacerbation of chronic obstructive pulmonary disease) Active and significant cardiac disease (eg. decompensated congestive cardiac failure, recent myocardial infarction) End-stage heart failure with left ventricular ejection fraction < 30% Recent (< 3 months) cerebrovascular accident healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chao Chia Cheong, MMed Master central contact role Contact central contact phone +60163113597 central contact e mail chaochia@um.edu.my central contact name Chew Yin Y Wang, FRCA central contact role Contact central contact phone +60192340232 central contact e mail wangcy1836@gmail.com overall official list overall official overall official name Chao Chia Cheong, MMed Master overall official affiliation University Malaya overall official role Principal Investigator references module reference list reference reference p m i d 29359313 reference type background reference citation Quek KH, Low EY, Tan YR, Ong ASC, Tang TY, Kam JW, Kiew ASC. Adding a PECS II block for proximal arm arteriovenous access - a randomised study. Acta Anaesthesiol Scand. 2018 May;62(5):677-686. doi: 10.1111/aas.13073. Epub 2018 Jan 22. reference p m i d 19550340 reference type background reference citation Rutkowska K, Knapik P, Misiolek H. The effect of dexmedetomidine sedation on brachial plexus block in patients with end-stage renal disease. Eur J Anaesthesiol. 2009 Oct;26(10):851-5. doi: 10.1097/EJA.0b013e32832a2244. reference p m i d 29782787 reference type background reference citation Virmani S, Onuchic A, El-Ali IM, Trivedi RD. Propofol Induced Hyperkalemia and Its Management in End Stage Renal Disease Patients. Conn Med. 2016 Sep;80(8):491-493. reference p m i d 29247451 reference type background reference citation Zhong W, Zhang Y, Zhang MZ, Huang XH, Li Y, Li R, Liu QW. Pharmacokinetics of dexmedetomidine administered to patients with end-stage renal failure and secondary hyperparathyroidism undergoing general anaesthesia. J Clin Pharm Ther. 2018 Jun;43(3):414-421. doi: 10.1111/jcpt.12652. Epub 2017 Dec 16. reference p m i d 26559744 reference type background reference citation Xie X, Atkins E, Lv J, Bennett A, Neal B, Ninomiya T, Woodward M, MacMahon S, Turnbull F, Hillis GS, Chalmers J, Mant J, Salam A, Rahimi K, Perkovic V, Rodgers A. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet. 2016 Jan 30;387(10017):435-43. doi: 10.1016/S0140-6736(15)00805-3. Epub 2015 Nov 7. reference p m i d 31725024 reference type background reference citation Maheshwari K, Ahuja S, Khanna AK, Mao G, Perez-Protto S, Farag E, Turan A, Kurz A, Sessler DI. Association Between Perioperative Hypotension and Delirium in Postoperative Critically Ill Patients: A Retrospective Cohort Analysis. Anesth Analg. 2020 Mar;130(3):636-643. doi: 10.1213/ANE.0000000000004517. reference p m i d 24352797 reference type background reference citation James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427. Erratum in: JAMA. 2014 May 7;311(17):1809. reference p m i d 29245269 reference type background reference citation Kim HY, Lee JE, Kim HY, Kim J. Volatile sedation in the intensive care unit: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Dec;96(49):e8976. doi: 10.1097/MD.0000000000008976. Review. i p d sharing statement module i p d sharing Yes i p d sharing description All collected individual participant data (IPD) and all IPD that underlie results in a publication i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing time frame Starting 6 months after publication i p d sharing access criteria Personal enquiry via email derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007674 condition mesh term Kidney Diseases condition mesh id D000007022 condition mesh term Hypotension condition ancestor list condition ancestor condition ancestor id D000014570 condition ancestor term Urologic Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf as found Kidney Disease condition browse leaf relevance high condition browse leaf id M25871 condition browse leaf name Renal Insufficiency condition browse leaf relevance low condition browse leaf id M9851 condition browse leaf name Kidney Failure, Chronic condition browse leaf relevance low condition browse leaf id M9224 condition browse leaf name Hypotension condition browse leaf as found Hypotension condition browse leaf relevance high condition browse leaf id M7684 condition browse leaf name Fistula condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000077149 intervention mesh term Sevoflurane intervention ancestor list intervention ancestor intervention ancestor id D000010975 intervention ancestor term Platelet Aggregation Inhibitors intervention ancestor id D000018685 intervention ancestor term Anesthetics, Inhalation intervention ancestor id D000018681 intervention ancestor term Anesthetics, General intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M17459 intervention browse leaf name Propofol intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M1673 intervention browse leaf name Sevoflurane intervention browse leaf as found Vaginal intervention browse leaf relevance high intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse leaf id M13017 intervention browse leaf name Platelet Aggregation Inhibitors intervention browse leaf relevance low intervention browse leaf id M19918 intervention browse leaf name Anesthetics, Inhalation intervention browse leaf relevance low intervention browse leaf id M19914 intervention browse leaf name Anesthetics, General intervention browse leaf relevance low intervention browse leaf id T433 intervention browse leaf name Tannic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev PlAggInh intervention browse branch name Platelet Aggregation Inhibitors intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements

NCT04839536

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full study rank 61518 study protocol section identification module n c t id NCT04835428 org study id info org study id AGN-CIP-201 secondary id info list secondary id info secondary id STAND secondary id type Other Identifier secondary id domain AgNovos organization org full name AgNovos Healthcare, LLC org class INDUSTRY brief title STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures official title A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment status module status verified date November 2022 overall status Recruiting start date struct start date May 31, 2022 start date type Actual primary completion date struct primary completion date December 31, 2024 primary completion date type Anticipated completion date struct completion date December 31, 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 28, 2022 last update post date struct last update post date November 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name AgNovos Healthcare, LLC lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes description module brief summary This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement. conditions module condition list condition Vertebral Compression Fracture Compression Fracture Vertebral Compression keyword list keyword LOEP AGN1 design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Four hundred eight (408) eligible subjects at up to twenty (20) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group). design primary purpose Treatment design masking info design masking Single design masking description Study subjects will not be informed of their treatment group assignment at the time of randomization or at any time before the subject's last office visit. The blind will be broken only if it is necessary to protect the safety or welfare of the subject as determined by the Investigator. design who masked list design who masked Participant enrollment info enrollment count 408 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment with AGN1 LOEP SV Kit arm group type Experimental arm group description The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone. arm group intervention list arm group intervention name Device: Treatment Group: AGN1 LOEP SV Kit arm group label Treatment with PMMA bone cement arm group type Active Comparator arm group description High viscosity PMMA bone cement will be used for vertebral augmentation. arm group intervention list arm group intervention name Device: Control Group: PMMA bone cement intervention list intervention intervention type Device intervention name Treatment Group: AGN1 LOEP SV Kit intervention description The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone. intervention arm group label list intervention arm group label Treatment with AGN1 LOEP SV Kit intervention type Device intervention name Control Group: PMMA bone cement intervention description High viscosity PMMA bone cement will be used for vertebral augmentation. intervention arm group label list intervention arm group label Treatment with PMMA bone cement outcomes module primary outcome list primary outcome primary outcome measure Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS) primary outcome description Change in VCF-related pain by > 20 mm from baseline as measured by a 100 mm Visual Analogue Scale (VAS) where 0mm is no pain, and 100mm is worst pain possible. primary outcome time frame 24 months primary outcome measure Change in function primary outcome description change of function from baseline as measured by the Oswestry Disability Index (ODI) primary outcome time frame 24 months primary outcome measure Radiographic evidence of implant resorption (Intervention Group only) primary outcome description change in resorption from procedure as assessed by independent radiographer primary outcome time frame 24 months primary outcome measure Radiographic evidence of bone formation (Intervention Group only) primary outcome description change in bone formation from procedure as assessed by independent radiographer primary outcome time frame 24 months primary outcome measure Adverse events primary outcome description Occurrence of device-related serious adverse events, device-related adverse events or serious adverse events categorized as failure or surgical intervention at the target level occurring post-treatment primary outcome time frame 24 months eligibility module eligibility criteria Inclusion Criteria: Subject is a male or female aged 55 and 85 years, inclusive, of age at time of study treatment. Subject has only one (1) acute VCF. Note that subjects are eligible if they have an asymptomatic, chronic VCF(s) at any non-target, non-adjacent vertebral level. The acute VCF meets all of the following criteria: Due to diagnosed or presumed underlying osteoporosis T1 to L5 inclusively Target VCF-related pain ≤ 6 months at time of study treatment Target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline. Target VCF is acute or persistent (not healed), as demonstrated on imaging, including T2 weighted STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or other serial imaging demonstrating acuity. Focal tenderness to palpation of the spinal process of the target VCF on the physical exam correlates with imaging. Subject has failed conservative medical therapy (bed rest, observation, chiropractic care, orthotics, opioid and non-opioid analgesics, and/or physical therapy), defined as either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after more than 6 weeks of conservative care. Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline. Subject is capable of giving written informed consent to participate in the study. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented. Exclusion Criteria: Target VCF is unstable, including split or burst fracture. Subject has a bleeding disorder. Subject has an active infection of the spine or has an infection being actively treated with antibiotics. Target VCF is due to underlying or suspected tumor. Target VCF is due to high-energy trauma. Target VCF is due to osteonecrosis. Target VCF has a local kyphotic angle of > 30 degrees, measured as the angle between the superior endplate and inferior endplate at the target VCF. Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels. The pedicle(s) in the target vertebral body appear unable to safely accommodate transpedicular access instrumentation. Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF. Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated. Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis. Subject has spondylolisthesis > Grade 1 at target vertebral body. Subject requires daily opioid medication for pain not related to the target VCF. Subject has severe cardiopulmonary deficiencies. Subject has a Body Mass Index (BMI) > 35. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia). Subject has a history of tuberculous spondylitis. Subject has a history of invasive malignancy within the last five (5) years, other than non-melanoma skin cancer. Subject is not excluded if they have a history of malignancy over 5 years ago treated with curative intent and without clinical signs or symptoms since then. Subject is on oral or parenteral immune-suppressive drugs. Subject has uncontrolled diabetes mellitus. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min. Subject has a diagnosed calcium metabolism disorder. Subject has known allergies to calcium-based bone void fillers. Subject is pregnant or planning to become pregnant during participation in the study. In the judgment of the Investigator, the subject is not a good study candidate. (e.g. substance abuse or chemical dependency, inability to adhere to follow-up schedule, progression of the fracture between screening and the procedure visit). Subject is currently enrolled in another interventional clinical study. healthy volunteers No gender All minimum age 55 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Allison Gorman central contact role Contact central contact phone 2407536424 central contact e mail agorman@agnovos.com overall official list overall official overall official name Kern Singh overall official affiliation Midwest Orthopedics at Rush overall official role Principal Investigator location list location location facility Alabama Clinical Therapeutics location status Recruiting location city Birmingham location state Alabama location zip 35235 location country United States location contact list location contact location contact name Brittany Fry location contact role Contact location contact phone 205-833-2228 location contact e mail brittany.fry@actstudy.net location contact name Jill Andringa location contact role Contact location contact e mail jill.andringa@actstudy.net location contact name Bradley Goodman, MD location contact role Principal Investigator location contact name Srinivas Mallempati, MD location contact role Sub-Investigator location facility Mayo Clinic location status Not yet recruiting location city Phoenix location state Arizona location zip 85054 location country United States location contact list location contact location contact name Allyson Jensen location contact role Contact location contact phone 480-342-6922 location contact e mail jensen.allyson1@mayo.edu location contact name Chandan Krishna, MD location contact role Principal Investigator location contact name Brian Chong, MD location contact role Sub-Investigator location facility GW Medical Faculty Associates location status Not yet recruiting location city Washington location state District of Columbia location zip 20037 location country United States location contact list location contact location contact name Alejandro Jaco location contact role Contact location contact phone 202-741-3519 location contact e mail aljaco@mfa.gwu.edu location contact name Wayne Olan, MD location contact role Principal Investigator location facility Cleveland Clinic Florida location status Recruiting location city Stuart location state Florida location zip 34994 location country United States location contact list location contact location contact name Irene Ball location contact role Contact location contact phone 772-419-2146 location contact e mail BallI@ccf.org location contact name Angelic Gamez location contact role Contact location contact phone 772-223-5945 location contact e mail gameza3@ccf.org location contact name Jeffrey Miller, MD location contact role Principal Investigator location contact name Oszkar Szentirmai, MD location contact role Sub-Investigator location facility Rush University Medical Center location status Not yet recruiting location city Chicago location state Illinois location zip 60612 location country United States location contact list location contact location contact name Kavita Ahuja location contact role Contact location contact phone 224-229-2988 location contact e mail kavita.ahuja@rushortho.com location contact name Mukesh Ahuja location contact role Contact location contact phone 312-805-8456 location contact e mail mukesh.ahuja@rushortho.com location contact name Kern Singh, MD location contact role Principal Investigator location facility NorthShore University HealthSystem location status Recruiting location city Evanston location state Illinois location zip 60201 location country United States location contact list location contact location contact name Boris Jancan location contact role Contact location contact phone 847-570-3674 location contact e mail bjancan@northshore.org location contact name Robert Frech location contact role Contact location contact phone 847-570-4046 location contact e mail rfrech@northshore.org location contact name Michael Musacchio, MD location contact role Principal Investigator location contact name Shakeel Chowdhry, MD location contact role Sub-Investigator location contact name William Ares, MD location contact role Sub-Investigator location facility University of Kansas Medical Center Research Institute, Inc. location status Recruiting location city Kansas City location state Kansas location zip 66160 location country United States location contact list location contact location contact name Rachel Henning location contact role Contact location contact phone 913-945-8072 location contact e mail rhenning2@kumc.edu location contact name Daewood Sayed, MD location contact role Principal Investigator location contact name Chris Lam, MD location contact role Sub-Investigator location contact name Andrew Sack, MD location contact role Sub-Investigator location contact name Timothy Sowder, MD location contact role Sub-Investigator location facility Louisiana Spine Institute location status Recruiting location city Shreveport location state Louisiana location zip 71101 location country United States location contact list location contact location contact name Heather Bowman location contact role Contact location contact phone 318-629-6337 location contact e mail HBowman@louisianaspine.org location contact name Marcus Stone, PhD location contact role Contact location contact phone 318-629-5585 location contact e mail MStone@louisianaspine.org location contact name Pierce Nunley, MD location contact role Principal Investigator location facility Anne Arundel Medical Center (AAMC) location status Recruiting location city Annapolis location state Maryland location zip 21401 location country United States location contact list location contact location contact name Brook Fowler location contact role Contact location contact phone 443-481-5757 location contact e mail mfowler3@luminishealth.org location contact name Chad Patton, MD location contact role Principal Investigator location facility Lahey Medical Center location status Not yet recruiting location city Burlington location state Massachusetts location zip 01805 location country United States location contact list location contact location contact name Patricia Bruff location contact role Contact location contact phone 781-744-8011 location contact e mail patricia.m.bruff@lahey.org location contact name Neil Patel, MD location contact role Principal Investigator location facility Washington University St. Louis location status Recruiting location city Saint Louis location state Missouri location zip 63130 location country United States location contact list location contact location contact name Robin Haverman location contact role Contact location contact phone 314-747-1624 location contact e mail rlhaverman@wustl.edu location contact name Theo VanderVelde, MD location contact role Principal Investigator location contact name Jack Jennings, MD location contact role Sub-Investigator location facility Montefiore location status Recruiting location city Bronx location state New York location zip 10467 location country United States location contact list location contact location contact name Aureliana Toma, MD location contact role Contact location contact phone 973-934-0042 location contact e mail atoma@montefiore.org location contact name Seon Kyu Lee, MD location contact role Principal Investigator location contact name Allen Brook, MD location contact role Sub-Investigator location facility Mt. Sinai location status Not yet recruiting location city New York location state New York location zip 10029 location country United States location contact list location contact location contact name Serina Deeba location contact role Contact location contact phone 212-241-1297 location contact e mail srina.deeba@mountsinai.org location contact name Sukaina Davdani location contact role Contact location contact phone 212-241-1297 location contact e mail sukaina.davdani@mountsinai.org location contact name Reade De Leacy, MD location contact role Principal Investigator location contact name Amish Doshi, MD location contact role Sub-Investigator location facility Neuroradiology and Pain Solutions of Oklahoma location status Not yet recruiting location city Oklahoma City location state Oklahoma location zip 73134 location country United States location contact list location contact location contact name Michelle Bovee location contact role Contact location contact phone 405-286-2060 location contact e mail mbovee@npsdoc.com location contact name Dan Nguyen, MD location contact role Principal Investigator location facility Texas Back Institute location status Recruiting location city Plano location state Texas location zip 75093 location country United States location contact list location contact location contact name Shannon Rusch location contact role Contact location contact phone 972-608-5000 location contact e mail srusch@texasback.com location contact name David Enenebeaku location contact role Contact location contact phone 972-608-5000 location contact e mail denebeaku@texasback.com location contact name Mark Kayanja, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000050723 condition mesh term Fractures, Bone condition mesh id D000050815 condition mesh term Fractures, Compression condition ancestor list condition ancestor condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M25523 condition browse leaf name Fractures, Bone condition browse leaf as found Fracture condition browse leaf relevance high condition browse leaf id M25588 condition browse leaf name Fractures, Compression condition browse leaf as found Compression Fracture condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions

NCT04835428

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full study rank 61830 study protocol section identification module n c t id NCT04831372 org study id info org study id IRB-20-1004 organization org full name Carilion Clinic org class OTHER brief title On-Table Versus Off-Table Total Hip Arthroplasty official title Comparing On-Table vs Off-Table Total Hip Arthroplasty Via the Direct Anterior Approach: A Prospective Randomized Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 7, 2021 start date type Actual primary completion date struct primary completion date April 10, 2023 primary completion date type Anticipated completion date struct completion date April 10, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 27, 2021 last update post date struct last update post date April 28, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Carilion Clinic lead sponsor class OTHER collaborator list collaborator collaborator name Virginia Tech Carilion School of Medicine and Research Institute collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The first method is the "on-table" method, which uses a specialized surgical table, called a traction table. This table involves placing both feet in specialized boots that are then hooked up to the table, and allows for positioning of the operative leg with aid of the table. The major limitations associated with the traction table are the need for two additional staff members and the purchase of said table. The second method is the "off-table" method. In this method the patient is placed on a standard operating room table and the operative leg is manually positioned by the surgeon during the procedure . This obviates the need for the additional staff members or purchase of a specialized table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method. detailed description BACKGROUND: The Direct Anterior Approach (DAA) for total hip arthroplasty (THA) has become increasingly popular in the US over the last decade (Berry & Bozic, 2010). Major limitations of the DAA with traction table include the need for an additional surgeon's assistant, a traction table operator, and the purchase of said table. To counter these limitations, some surgeons advocate for the performing the DAA with a conventional operating room table {Cohen, 2017;Molenaers, 2017}. However to date, there are no studies directly comparing the efficiency and efficacy of these two techniques for DAA. OBJECTIVE: Currently, it is unclear which surgical technique is more efficient and effective for total hip arthroplasties (THA). We hypothesize that there will be an increase in efficiency as measured by time when performing a standard operating table (Off-Table) DAA THA when compared to a purpose built traction table (On-Table) DAA THA. In addition, there will be less pain and faster functional recovery in the early post-operative period for patients who underwent an "Off-Table" DAA THA when compared to an "On-Table" DAA THA. SPECIFIC AIMS: 1) Determine whether there is a difference in operating room efficiency between surgeries after a THA via DAA with a standard OR table versus a purpose-built traction table; 2) examine whether there is a difference in early post-operative pain and clinical outcomes when comparing patients who underwent a THA via the DAA with a standard OR table versus a purpose built traction table. 3) report differences in complication rates between those two. METHODS: This is a prospective randomized clinical trial that will evaluate adult patients admitted to Carilion Clinic undergoing primary unilateral total hip arthroplasty. Off and on table DAA procedures will be performed by a single surgeon with multiple years of training and experience in both. Cluster randomization will be performed where patients will be randomized through scheduling. Demographic data will be collected. Operative records will be used to record operative times for each approach. Radiographs to assess implant positioning on postoperative day 0. The primary outcome variables are intra-operative data such as time the patient enters the operating room, time of incision, time of dressing application, exit room time, implants used, operative report. For secondary outcome variables, we will assess at 2 and 6 week follow ups routine Patient-Reported Outcome Measures including narcotic utilization based on pill count and MEq, and the PROMIS and HOOS, JR. measures. EXPECTED OUTCOMES: We expect that the Off-table DAA technique will be associated with faster set up, surgical time, and overall room time when compared to the On-table approach. Additionally, we expect less early post-operative pain in the groin, knee and ankle. We expect that the patient report outcome measures at 2 and 6 weeks post-op for the off-table DAA group will be equivalent or better than the on-table DAA group. Finally we expect no difference in complication rate. conditions module condition list condition Arthroplasty, Replacement, Hip Osteoarthritis, Hip keyword list keyword Direct anterior approach Hip arthroplasty On table Off table design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Primary Objectives- Determine whether there is a difference in operating room efficiency when preparing for, positioning, performing and turning over an operating room after a total hip arthroplasty (THA) via the direct anterior approach (DAA) when using a purpose built traction table ("On-Table") vs a standard operating table ("Off-Table")? Secondary Objective- Examine whether there is a difference in early post-operative pain, mobilization, complication rates and clinical outcomes when comparing patients who underwent a THA via the DAA when using an "On-Table" vs "Off-Table" technique. design primary purpose Treatment design masking info design masking None (Open Label) design masking description BLINDING: none It is impossible to blind the surgeon to the arm as the techniques and instruments required for on-table vs off-table are substantially different. All subjects will be patients of Dr. Owen and he is the only operating surgeon for this study. The patient will see the beds when they are rolled into the operating room and are positioned. Thorough informed consent will make it apparent which table they are using. enrollment info enrollment count 130 enrollment type Anticipated arms interventions module arm group list arm group arm group label On Table Group arm group type Active Comparator arm group description The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The control group will be using the first method, which is the "on-table" method, which uses a specialized surgical table, called a traction table. This table involves placing both feet in specialized boots that are then hooked up to the table, and allows for positioning of the operative leg with aid of the table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method. arm group intervention list arm group intervention name Procedure: On Table Group arm group label Off Table Group arm group type Experimental arm group description The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The experimental group will be using the second method, which is the "off-table" method. In this method the patient is placed on a standard operating room table and the operative leg is manually positioned by the surgeon during the procedure . This obviates the need for the additional staff members or purchase of a specialized table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method. arm group intervention list arm group intervention name Procedure: Off Table Group intervention list intervention intervention type Procedure intervention name Off Table Group intervention description Total Hip arthroplasty being performed via the Direct Anterior Approach using a standard operating room table intervention arm group label list intervention arm group label Off Table Group intervention type Procedure intervention name On Table Group intervention description Total Hip arthroplasty being performed via the Direct Anterior Approach using a traction table intervention arm group label list intervention arm group label On Table Group outcomes module primary outcome list primary outcome primary outcome measure Set Up Time primary outcome description Time point that patient enters room to time point of first incision primary outcome time frame Time point that patient enters room to time point of first incision primary outcome measure Surgery Time primary outcome description Time point of first incision to time point of dress application primary outcome time frame Time point of first incision to time point of dress application primary outcome measure Takedown Time primary outcome description Time point of Dress application to Time point of exiting operating room primary outcome time frame Time point of Dress application to Time point of exiting operating room primary outcome measure Total Room Time primary outcome description Time point that patient enters room to time point of exiting operating room primary outcome time frame Time point that patient enters room to time point of exiting operating room secondary outcome list secondary outcome secondary outcome measure Patient Reported Outcomes Measurement Information System/Hip Disability and Osteoarthritis Outcome Score, Joint Replacement scores secondary outcome description Hip pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = extreme pain secondary outcome time frame pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op secondary outcome measure Visual Analog Scale scores secondary outcome description Hip, knee, ankle pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = worst pain secondary outcome time frame pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op secondary outcome measure Narcotic Utillization secondary outcome description Measured by pill count usage and converted into MME secondary outcome time frame 2 weeks post op pill count eligibility module eligibility criteria Inclusion Criteria: All patients undergoing primary unilateral THA Patient 18 years of age and older Patients who are able to provide consent Exclusion Criteria: Bilateral procedure Non-Primary arthroplasty Prior non-arthroplasty operation requiring removal of hardware Inability to have spinal anesthesia (blood thinners) BMI > 40 Active Smoking HbA1c > 8.0 Failure to meet medical clearance Pregnant women per standard of care healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Trevor M Owen, MD central contact role Contact central contact phone (540) 510-6200 central contact e mail tmowen@carilionclinic.org overall official list overall official overall official name Trevor M Owen, MD overall official affiliation Carilion Clinic overall official role Principal Investigator location list location location facility Carilion Institute for Orthopaedics & Neurosciences location status Recruiting location city Roanoke location state Virginia location zip 24014 location country United States location contact list location contact location contact name Trevor Owen, MD location contact role Contact location contact phone 540-510-6200 location contact e mail tmowen@carilionclinic.org references module reference list reference reference p m i d 30852068 reference type background reference citation Abdel MP, Berry DJ. Current Practice Trends in Primary Hip and Knee Arthroplasties Among Members of the American Association of Hip and Knee Surgeons: A Long-Term Update. J Arthroplasty. 2019 Jul;34(7S):S24-S27. doi: 10.1016/j.arth.2019.02.006. Epub 2019 Feb 12. reference p m i d 19576399 reference type background reference citation Bender B, Nogler M, Hozack WJ. Direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009 Jul;40(3):321-8. doi: 10.1016/j.ocl.2009.01.003. reference p m i d 15062700 reference type background reference citation Berger RA. Mini-incision total hip replacement using an anterolateral approach: technique and results. Orthop Clin North Am. 2004 Apr;35(2):143-51. reference p m i d 20580196 reference type background reference citation Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2010 Sep;25(6 Suppl):2-4. doi: 10.1016/j.arth.2010.04.033. Epub 2010 Jul 1. reference p m i d 28511947 reference type background reference citation Cohen EM, Vaughn JJ, Ritterman SA, Eisenson DL, Rubin LE. Intraoperative Femur Fracture Risk During Primary Direct Anterior Approach Cementless Total Hip Arthroplasty With and Without a Fracture Table. J Arthroplasty. 2017 Sep;32(9):2847-2851. doi: 10.1016/j.arth.2017.04.020. Epub 2017 Apr 21. reference p m i d 16330993 reference type background reference citation Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb. reference p m i d 28087159 reference type background reference citation Molenaers B, Driesen R, Molenaers G, Corten K. The Direct Anterior Approach for Complex Primary Total Hip Arthroplasty: The Extensile Acetabular Approach on a Regular Operating Room Table. J Arthroplasty. 2017 May;32(5):1553-1559. doi: 10.1016/j.arth.2016.12.016. Epub 2016 Dec 22. reference p m i d 18555653 reference type background reference citation Nakata K, Nishikawa M, Yamamoto K, Hirota S, Yoshikawa H. A clinical comparative study of the direct anterior with mini-posterior approach: two consecutive series. J Arthroplasty. 2009 Aug;24(5):698-704. doi: 10.1016/j.arth.2008.04.012. Epub 2008 Jun 13. reference p m i d 25157041 reference type background reference citation Post ZD, Orozco F, Diaz-Ledezma C, Hozack WJ, Ong A. Direct anterior approach for total hip arthroplasty: indications, technique, and results. J Am Acad Orthop Surg. 2014 Sep;22(9):595-603. doi: 10.5435/JAAOS-22-09-595. reference p m i d 20378307 reference type background reference citation Restrepo C, Parvizi J, Pour AE, Hozack WJ. Prospective randomized study of two surgical approaches for total hip arthroplasty. J Arthroplasty. 2010 Aug;25(5):671-9.e1. doi: 10.1016/j.arth.2010.02.002. Epub 2010 Apr 8. reference p m i d 30448326 reference type background reference citation Tian S, Goswami K, Manrique J, Blevins K, Azboy I, Hozack WJ. Direct Anterior Approach Total Hip Arthroplasty Using a Morphometrically Optimized Femoral Stem, a Conventional Operating Table, Without Fluoroscopy. J Arthroplasty. 2019 Feb;34(2):327-332. doi: 10.1016/j.arth.2018.10.023. Epub 2018 Oct 26. i p d sharing statement module i p d sharing No i p d sharing description No current plan to do so. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015207 condition mesh term Osteoarthritis, Hip condition ancestor list condition ancestor condition ancestor id D000010003 condition ancestor term Osteoarthritis condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf relevance low condition browse leaf id M17064 condition browse leaf name Osteoarthritis, Hip condition browse leaf as found Osteoarthritis, Hip condition browse leaf relevance high condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases

NCT04831372

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full study rank 61269 study protocol section identification module n c t id NCT04838665 org study id info org study id OVS 2010-08-10-109 organization org full name University of the Philippines org class OTHER brief title Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study official title Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 30, 2011 start date type Actual primary completion date struct primary completion date September 30, 2011 primary completion date type Actual completion date struct completion date September 30, 2011 completion date type Actual study first submit date February 18, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of the Philippines lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Retinopathy of prematurity (ROP) is one of the common anatomic causes of blindness among Filipinos, accounting for 47.7% of the cases. With this retinopathy being preventable and treatable, ROP screening has been proven to be effective in preventing blindness, which is achieved with the usage of mydriatics. Even if the regimen of multiple alternate instillations of 0.5% tropicamide and 2.5% phenylephrine is the one recommended by international guidelines for ROP screening, the mydriatic regimen used by many of the country's institutions is the single instillation of 0.5% tropicamide + 0.5% phenylephrine applied via a cotton wick placed in the inferior fornix (SIW). There have been no studies yet on the safety and efficacy in premature infants of this mydriatic preparation and method, although it is hypothesized that the usage of a cotton wick promotes the possible systemic effects of the mydriatic combination used. This study then aims to determine the safety and efficacy of different mydriatic regimens in premature infants referred for screening of ROP using (1) multiple alternate instillations of 0.5% cyclopentolate hydrochloride and 2.5% phenylephrine (MAI), (2) single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI), and (3) single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick placed in the inferior fornix (SIW) in a tertiary Philippine hospital. This study was designed as a randomized, double blind, clinical study which enrolled sixty preterm infants referred for ROP Screening from January to July 2011. With instillations via MAI, SI, and SIW, systolic blood pressure (SBP), diastolic pressure (DBP), mean arterial pressure (MAP), heart rate, and oxygen saturation were monitored from ten minutes prior to instillation up to forty-five minutes after instillation. Pupil dilations were also measured at the forty-fifth minute. detailed description I. Introduction Retinopathy of prematurity (ROP) is one of the common anatomic causes of blindness among Filipinos, accounting for 47.7% of the cases. With this retinopathy being preventable and treatable, ROP screening has been proven to be effective in preventing blindness, which is achieved with the usage of mydriatics. Even if the regimen of multiple alternate instillations of 0.5% tropicamide and 2.5% phenylephrine is the one recommended by international guidelines for ROP screening, the mydriatic regimen usually used by many of the country's institutions is the regimen of 0.5% tropicamide + 0.5% phenylephrine applied via a cotton wick placed in the inferior fornix. There have been no studies yet on the safety and efficacy in premature infants of this mydriatic preparation and method, although it is hypothesized that the usage of a cotton wick promotes the possible systemic effects of the mydriatic combination used. II. Significance It is the aim of this study to evaluate the safety and efficacy of the mydriatic regimens we use in our institution and compare it to the recommendation by the UK ROP Guidelines. In doing so, this study aims to (1) document vital sign changes in the infant during dilation, (2) identify adverse systemic changes due to the mydriatic regimen and (3) provide appropriate interventions and recommendations to address these adverse effects. These will greatly improve the ROP screening process in our institution. III. Objectives The general objective is to determine vital sign changes related to Pupil Dilation among preterm infants referred for ROP Screening from Neonatal Intensive Care Unit, Pediatric Wards and Eye Instrumentation Center of the Philippine General Hospital (PGH). Specifically, its objective is to compare the vital sign changes and mydriasis in (1) multiple alternate instillations of 0.5% Cyclopentolate Hydrochloride + 2.5% Phenylephrine (MAI) (2) single instillation of 0.5%/0.5% Phenylephrine + Tropicamide (SI) and (3) single instillation of 0.5%/0.5% Phenylephrine + Tropicamide with a cotton wick placed in the inferior fornix (SIW). IV. Methodology This study was designed as a randomized, double blind, clinical study which enrolled sixty preterm infants referred for ROP Screening from January to July 2011. Each subject was randomly distributed into the standard, instillation, and packing group. To avoid observer bias, two investigators were involved per monitoring during dilation. The first investigator was assigned only to place the monitoring devices and to administer the mydriatics contained in unmarked 1 mL syringe which content was unknown to him. The vital signs monitored during dilation were blood pressures (systolic, diastolic and mean arterial pressure (MAP)), heart rates and oxygen saturations using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors. A digital camera and a millimeter rule were used to approximate size of pupil dilatation. Measurement of all the vital signs and pupil dilation from a subject was derived from a single dilation session only. Prior to data collection up to the end of monitoring, other factors that may affect the vital signs of the preterm infants were addressed. This included hunger, cold temperature, and soiled diapers. Baseline vital signs determination was then performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is a significant difference in the vital signs between 10 and 5 minutes prior to the initial drop. For the MAI, multiple alternate drops of 0.5% cyclopentolate then 2.5% phenylephrine every 5 minutes in two doses were instilled (total of 0.2 milliliter of 0.5% cyclopentolate and 0.2 millimeter of 2.5% Phenylephrine). Vital signs were continuously recorded at time 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45. At the 45th minute, a lid retractor was placed in the eyes of the subject after a drop of topical anesthesia. Pictures of the eyes were taken with a millimeter rule to serve as measurement reference. For the SI, only a drop of 0.5%/0.5% tropicamide + phenylephrine was properly instilled at time 0 (total of 0.1 milliliter). Vital signs were continuously recorded at time 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45. At the 45th minute, a lid retractor was placed in the eyes of the subject after a drop of topical anesthesia. Pictures of the eyes were taken with a millimeter rule to serve as measurement reference. For the SIW, a cotton wisp soaked with a drop of 0.5%/0.5% tropicamide + phenylephrine was placed on the lower fornix in each eye of the infant (total of 0.1 milliliter). The weight of the cotton wisp was standardized at 0.02 milligram using a digital weighing scale. Vital signs were continuously recorded at time 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45. At the 45th minute, a lid retractor is placed in the eyes of the subject after a drop of topical anesthesia. Pictures of the eyes were taken with a millimeter rule to serve as measurement reference. Pictures were uploaded into the computer monitor for the actual measurement. Vital sign changes were monitored using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors. In the presence of significant vital sign changes, immediate intervention will be done. In the presence of a significant increase in BP or heart rate, the infant will be observed. Both changes are expected from undergoing a stressful procedure such as placing a lid retractor in measuring the pupil dilation. The infant will be referred to the NICU ROD for further work up should tachycardia persist even after the examination. The blood pressure, heart rate and sensorium will be continuously monitored so as to avoid any ensuing bradycardia. In the presence of a significant drop in BP, the infant will be referred to the NICU ROD for further work up to determine the possible source. Fluid challenge will be done to check if the cause of hypotension is just attributable to hypovolemia. The investigator will determine body temperature to check for hypothermia. If hypothermic, slow rewarming will be done by placing back the infant inside a close incubator or beside a radiant warmer. Blood glucose will be checked for hypoglycemia. Should hyperglycemia be detected, the infant can be started on 2cc/kg D5water. Infant will be worked up for infection as well. During events of hypoxia or oxygen desaturation of less than 85%, the infant will be given supportive ventilation as required. Oxygen saturation will be monitored using the pulse oximeter. In the event of an apnea happening, supportive ventilation will be provided immediately, together with significant stimulation. The infant will be referred to the NICU ROD for possible intubation. In the event of bradycardia, significant stimulation will be started on the infant. The infant will be referred to the NICU ROD for further work-up to determine the cause. The investigator is also to determine body temperature to check for hypothermia. If hypothermic, slow rewarming will be done by placing back the infant inside a close incubator or beside a radiant warmer. Blood glucose will be determined to check for hypoglycemia. Should hyperglycemia be detected, the infant can be started on 2cc/kg D5water. Infant can be worked up for infection as well. In the event that a subject suffers from any of the abovementioned adverse effects, the appropriate interventions cited will be administered free of charge. Should the adverse effects believed by the investigators to be secondary to the ROP screening only and additional expenses are needed to procure medicines or equipment, the investigators will shoulder the expenses. If the medicine or equipment is immediately needed, the relative may spend first for them and have the expenses reimbursed with the investigators later. Should the amount to procure the said medicine or equipment cannot be produced by the relative, the investigators can be immediately contacted to assist the relatives immediately. All other expenses will be shouldered by the investigators through reimbursements. Expenses amounting to P500 for the medicine and P1000 for the equipment will be shouldered by the investigators. Should it exceed these limits, the infant will be referred to any charitable institution for further assistance. The blood pressure (systole, diastole and MAP), HR and oxygen saturation obtained during dilatation were analyzed. They were graphed to determine patterns from baseline up to 45 minutes. Wilcoxon signed rank test was used to assess statistical significance for oxygen saturation, being a non-parametric variable. Poor dilatation among ROP patients with the advanced disease will be noted. A subgroup analysis was also done to determine the any relationship between the amounts of mydriatic used to the weight of the infant. An interim analysis was done within the study to assess if the two mydriatic regimens were particularly beneficial or harmful compared to the concurrent standard group. Either the Pocock or the Flemming method will be used to decide if this study needed to terminate earlier than planned. Unblinding can be done should it be made necessary during the interim analysis or during course of the study. This protocol was submitted to the PGH ERB for ethics review and approval. It was conducted only upon approval from the ERB. All patient information were anonymized and are confidential. There is no funding received by the investigators for the conduct of this research. conditions module condition list condition Retinopathy of Prematurity design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Diagnostic design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) arm group type Active Comparator arm group description 20 infants were enrolled in Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) arm group intervention list arm group intervention name Drug: 0.5% cyclopentolate and 2.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick arm group label Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) arm group type Experimental arm group description Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) arm group intervention list arm group intervention name Drug: 0.5% cyclopentolate and 2.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix arm group type Experimental arm group description Single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick placed in the inferior fornix (SIW) arm group intervention list arm group intervention name Drug: 0.5% cyclopentolate and 2.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine Drug: 0.5% tropicamide + 0.5% phenylephrine with a cotton wick intervention list intervention intervention type Drug intervention name 0.5% cyclopentolate and 2.5% phenylephrine intervention description Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) dropped every 5 minutes for two doses intervention arm group label list intervention arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) intervention other name list intervention other name Multiple Alternate Instillation of Cyclopentolate Hydrochloride Dilate® Micro Labs Limited Bangalore and Phenylephrine Hydrochloride Mydfrin™ 25mg/mL (2.5%) Alcon Fort Worth Texas intervention type Drug intervention name 0.5% tropicamide + 0.5% phenylephrine intervention description Single instillation of 0.5% tropicamide + 0.5% phenylephrine intervention arm group label list intervention arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) intervention other name list intervention other name Single instillation of Tropicamide + Phenylephrine Hydrochloride Sanmyd-P 0.5%/0.5% Santen Osaka Japan intervention type Drug intervention name 0.5% tropicamide + 0.5% phenylephrine with a cotton wick intervention description Single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick weighing 0.02 milligrams placed in the inferior fornix for the entire 45 minutes intervention arm group label list intervention arm group label 1 instillation of 0.5% tropicamide +0.5% phenylephrine w/a cotton wick placed in the inferior fornix Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) Single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI) intervention other name list intervention other name Single instillation of Tropicamide + Phenylephrine Hydrochloride Sanmyd-P 0.5%/0.5% Santen Osaka Japan with a cotton wick placed in the inferior fornix weighing 0.02 milligrams outcomes module primary outcome list primary outcome primary outcome measure Systolic blood pressure and systolic blood pressure changes primary outcome description Measured in mmHg using a well-fitted neonatal cuff placed in the arm connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline systolic blood pressure determination was performed 10 and 5 minute prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the v/s between 10 and 5 minutes primary outcome measure Diastolic blood pressure and diastolic blood pressure changes primary outcome description Measured in mmHg using a well-fitted neonatal cuff placed in the arm connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline diastolic blood pressure determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 primary outcome measure Mean arterial blood pressure and mean arterial blood pressure changes primary outcome description Measured in mmHg using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline mean arterial blood pressure determination was performed 10 and 5 mins. prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 an primary outcome measure Heart rate primary outcome description Measured in beats per minute using the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline heart rate determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 minutes prior primary outcome measure Oxygen saturation primary outcome description Measured in percent saturation using a pulse oximeter connected to the newly calibrated Phillips Digital IntelliVue MP20 junior Cardiac monitors primary outcome time frame A baseline heart rate determination was performed 10 and 5 minutes prior to the first drop of mydriatic or proparacaine prior to packing. Additional reading will be done if there is significant difference in the vital signs between 10 and 5 minutes prior primary outcome measure Pupil diameter primary outcome description Measuring using a digital camera and a millimeter ruler primary outcome time frame Measured at the 45th minute post-instillation of the specified intervention secondary outcome list secondary outcome secondary outcome measure Successful retinopathy of prematurity screening secondary outcome description Whether or not a successful ROP screening was carried out secondary outcome time frame After the 45th minute measurement of pupil diameter eligibility module eligibility criteria Inclusion criteria: birth weight of less than 1500 g gestational age of 32 weeks or less an unstable clinical course who are believed to be at high risk for Retinopathy of Prematurity, as assessed by their individual attendings Exclusion criteria cited that infants with cardiac abnormalities directly affecting the heart rate and oxygen saturation infants with inotropic medications infants with ventilatory support healthy volunteers Accepts Healthy Volunteers gender All minimum age 1 Week maximum age 32 Weeks std age list std age Child contacts locations module overall official list overall official overall official name Roland Joseph D Tan, MD overall official affiliation University of the Philippines Manila overall official role Principal Investigator i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012178 condition mesh term Retinopathy of Prematurity condition mesh id D000015878 condition mesh term Mydriasis condition ancestor list condition ancestor condition ancestor id D000012164 condition ancestor term Retinal Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000007235 condition ancestor term Infant, Premature, Diseases condition ancestor id D000007232 condition ancestor term Infant, Newborn, Diseases condition ancestor id D000011681 condition ancestor term Pupil Disorders condition browse leaf list condition browse leaf condition browse leaf id M25022 condition browse leaf name Premature Birth condition browse leaf relevance low condition browse leaf id M14151 condition browse leaf name Retinal Diseases condition browse leaf relevance low condition browse leaf id M14165 condition browse leaf name Retinopathy of Prematurity condition browse leaf as found Retinopathy of Prematurity condition browse leaf relevance high condition browse leaf id M17572 condition browse leaf name Mydriasis condition browse leaf as found Mydriasis condition browse leaf relevance high condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id M9431 condition browse leaf name Infant, Premature, Diseases condition browse leaf relevance low condition browse leaf id M9428 condition browse leaf name Infant, Newborn, Diseases condition browse leaf relevance low condition browse leaf id M13687 condition browse leaf name Pupil Disorders condition browse leaf relevance low condition browse leaf id T4981 condition browse leaf name Retinopathy of Prematurity condition browse leaf as found Retinopathy of Prematurity condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000010656 intervention mesh term Phenylephrine intervention mesh id D000010109 intervention mesh term Oxymetazoline intervention mesh id D000014331 intervention mesh term Tropicamide intervention mesh id D000003519 intervention mesh term Cyclopentolate intervention ancestor list intervention ancestor intervention ancestor id D000002316 intervention ancestor term Cardiotonic Agents intervention ancestor id D000009184 intervention ancestor term Mydriatics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000013566 intervention ancestor term Sympathomimetics intervention ancestor id D000014662 intervention ancestor term Vasoconstrictor Agents intervention ancestor id D000014663 intervention ancestor term Nasal Decongestants intervention ancestor id D000019141 intervention ancestor term Respiratory System Agents intervention ancestor id D000058646 intervention ancestor term Adrenergic alpha-1 Receptor Agonists intervention ancestor id D000000316 intervention ancestor term Adrenergic alpha-Agonists intervention ancestor id D000000322 intervention ancestor term Adrenergic Agonists intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000018727 intervention ancestor term Muscarinic Antagonists intervention ancestor id D000018680 intervention ancestor term Cholinergic Antagonists intervention ancestor id D000018678 intervention ancestor term Cholinergic Agents intervention ancestor id D000010276 intervention ancestor term Parasympatholytics intervention browse leaf list intervention browse leaf intervention browse leaf id M5878 intervention browse leaf name Cyclopentolate intervention browse leaf as found Hepatic vein intervention browse leaf relevance high intervention browse leaf id M16235 intervention browse leaf name Tropicamide intervention browse leaf as found Natural History Study intervention browse leaf relevance high intervention browse leaf id M12183 intervention browse leaf name Oxymetazoline intervention browse leaf as found Chantix intervention browse leaf relevance high intervention browse leaf id M12713 intervention browse leaf name Phenylephrine intervention browse leaf as found Migraine intervention browse leaf relevance high intervention browse leaf id M252669 intervention browse leaf name Dipivefrin intervention browse leaf relevance low intervention browse leaf id M4724 intervention browse leaf name Cardiotonic Agents intervention browse leaf relevance low intervention browse leaf id M11291 intervention browse leaf name Mydriatics intervention browse leaf relevance low intervention browse leaf id M15497 intervention browse leaf name Sympathomimetics intervention browse leaf relevance low intervention browse leaf id M16561 intervention browse leaf name Vasoconstrictor Agents intervention browse leaf relevance low intervention browse leaf id M7118 intervention browse leaf name Ephedrine intervention browse leaf relevance low intervention browse leaf id M26739 intervention browse leaf name Pseudoephedrine intervention browse leaf relevance low intervention browse leaf id M16562 intervention browse leaf name Nasal Decongestants intervention browse leaf relevance low intervention browse leaf id M20290 intervention browse leaf name Respiratory System Agents intervention browse leaf relevance low intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M2820 intervention browse leaf name Adrenergic alpha-Agonists intervention browse leaf relevance low intervention browse leaf id M2825 intervention browse leaf name Adrenergic Agonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse leaf id M19954 intervention browse leaf name Muscarinic Antagonists intervention browse leaf relevance low intervention browse leaf id M19913 intervention browse leaf name Cholinergic Antagonists intervention browse leaf relevance low intervention browse leaf id M19911 intervention browse leaf name Cholinergic Agents intervention browse leaf relevance low intervention browse leaf id M12341 intervention browse leaf name Parasympatholytics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev VaCoAg intervention browse branch name Vasoconstrictor Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention browse branch abbrev CaAg intervention browse branch name Cardiotonic Agents intervention browse branch abbrev CNSSti intervention browse branch name Central Nervous System Stimulants

NCT04838665

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full study rank 61480 study protocol section identification module n c t id NCT04835922 org study id info org study id 615-2020 secondary id info list secondary id info secondary id REF/2021/01/000059 secondary id type Registry Identifier secondary id domain NHRC trial registry number organization org full name Tribhuvan University Teaching Hospital, Institute Of Medicine. org class OTHER brief title Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in PCNL official title Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in Percutaneous Nephrolithotomy: A Prospective Randomized Clinical Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date November 9, 2020 start date type Actual primary completion date struct primary completion date November 9, 2021 primary completion date type Anticipated completion date struct completion date November 12, 2021 completion date type Anticipated study first submit date February 20, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dr Sushil Gyawali responsible party investigator title MS Resident responsible party investigator affiliation Tribhuvan University Teaching Hospital, Institute Of Medicine. lead sponsor lead sponsor name Tribhuvan University Teaching Hospital, Institute Of Medicine. lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Percutaneous nephrolithotomy (PCNL) is the preferred treatment for renal stones >2 cm or resistant to ESWL. Postoperative pain following this invasive surgery adds to the morbidity of patient which requires additional analgesia and can affect the quality of care. To lower the morbidity of PCNL, proper and adequate management of postoperative pain remains an integral component of PCNL. There are many ways to reduce the postoperative pain following PCNL including mini PCNL, tubeless PCNL, use of regional analgesia etc. However the modality of analgesic technique is still a matter of debate. The aim of this study is to evaluate the efficacy of intercostal nerve block compared with peritract infiltration in patient undergoing PCNL. Specifically, the study will look on to the demography of patients undergoing PCNL and their indications. The study will also compare the intensity of pain in two groups using visual analogue scale (VAS). The study will be a prospective double blinded randomized clinical trial done at Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching hospital (TUTH). The time frame of this study will be of 1 year or when sample size is fulfilled including all the patients who visit the hospital for PCNL and fulfils the inclusion criteria. At the end of our study we expect to conclude that the use of intercostal nerve block is superior or inferior than or equal to peritract infiltration in alleviating the postoperative pain following PCNL. detailed description Introduction: The incidence and prevalence of renal calculi have increased globally across all ages, sex, and race, probably due to change in dietary habits and global warming. PCNL is considered 'gold standard' for the management of large renal calculi because it is less invasive and morbid than the open surgery. Currently, the indications for PCNL include large size renal calculi (>1.5-2 cm), staghorn calculi, upper tract calculi not responding to other modalities of treatment, lower pole stones, cystine nephrolithiasis, and stones in anatomically abnormal kidneys. However, the procedure causes postoperative pain, mostly due to dilatation of the renal capsule, the parenchyma and pain along the tract of the nephrostomy tube. So the postoperative pain remains an integral part of management. Postoperative pain management not only reduces patient suffering but also improve patient satisfaction, reduces morbidity and in parallel enhances recovery, improves rehabilitation, reduces hospital stay and thereby overall hospital cost. The postoperative pain due to the procedure may vary with individual pain perception, use of percutaneous nephrostomy (PCN) tubes, comorbid conditions, choice of analgesic route, anesthetic agents and postoperative course. Small calibers of tubes, even mini PCNL or tubeless PCNL and regional analgesia such as intercostal nerve block, peritract infiltration, paravertebral block etc. could further decrease postoperative pain and analgesic requirement and hence improving postoperative patient comfort. However, studies on these techniques have produced conflicting results due to the use of different local anesthetics, various regional techniques, and different study designs. So this study aims to compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in alleviating postoperative pain following the procedure with the subjective assessment of pain Rational/justification : • The optimal method of pain control after percutaneous nephrolithotomy remains controversial till now. We need better technique of analgesia to decrease the pain following PCNL. Intercostal nerve block and peritract infiltration are common regional analgesic methods used by most of the investigators that had shown to be adequate for postoperative pain control. This study may be helpful in providing evidence for a clinical guideline to manage postoperative pain that will eventually help to decrease the morbidity and bring better outcome. General Objective : To compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy. Specific Objective : To analyse the demography of the patient [age, sex, BMI, stone size and laterality, renal function test, stone burden (size, Guy's Stone score etc.)] undergoing PCNL. To compare the intensity of pain using visual analogue score, resting and dynamic VAS scores, following PCNL between two groups (ICNB and PTI). To compare the time to first rescue analgesia and total analgesic requirement between both groups. To document the complications of both groups. Research Hypothesis Is Intercostal nerve block more efficacious than peritract infiltration following PCNL in alleviating pain? Study Variables Independent Variables: Age, Sex, BMI, stone location, laterality and size, Guys Stone score (burden), ASA grade, comorbidity, Group I (ICBN), Group P (PTI) nephrostomy tract size (mini vs standard), no of Tracts (single vs multiple), use to tube (tube vs tubeless), length of hospital stay, stone clearance, complications Dependent Variables R-VAS score, D-VAS score, Time to first analgesic demand, Total analgesic requirement conditions module condition list condition Kidney Stone keyword list keyword PCNL Intercostal nerve block Peritract Infiltration Bupivacaine Kidney stone design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description the study will be prospective double blind randomized trial using 0.25% bupivacaine in patients undergoing PCNL under one of the two arms: Intercostal Nerve block or Peritract Infiltration. design primary purpose Treatment design masking info design masking Double design masking description Double blinded study : participants and investigator will be blinded using sealed enveloped method. design who masked list design who masked Participant Investigator enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intercostal Nerve Block arm group type Experimental arm group description • In Group I (ICBN group): Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine at the termination of PCNL under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each). arm group intervention list arm group intervention name Procedure: Intercostal Nerve Block arm group label Peritract infiltration arm group type Active Comparator arm group description In Group P (PTI): Single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given on completion of PCNL by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). Then the surgical wound and intervention site will be covered with an occlusive dressing. arm group intervention list arm group intervention name Procedure: Peritract Infiltration intervention list intervention intervention type Procedure intervention name Intercostal Nerve Block intervention description : Following PCNL Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each) intervention arm group label list intervention arm group label Intercostal Nerve Block intervention other name list intervention other name Regional anesthesia intervention type Procedure intervention name Peritract Infiltration intervention description At the end of PCNL a single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). intervention arm group label list intervention arm group label Peritract infiltration intervention other name list intervention other name Regional anesthesia outcomes module primary outcome list primary outcome primary outcome measure Postoperative Pain Score (VAS score) primary outcome description Patients undergoing PCNL who fulfil the inclusion criteria will be identified at the time of admission. • Patients will be randomized in two groups using sealed envelope method into ICNB (group I) and PTI (group P) prior to surgery. After the procedure (intervention) the intensity of pain will be evaluated by an independent observer (the researcher or an independent ward nurse) blinded to the allocated groups at postoperative 2, 8, 12 and 24 hours. The pain score will be assessed separately by Visual Analogue Scale (VAS), a 10-point scale ranging from 0, minimum or no pain, to 10, the maximum pain score perceived or imagined by the patient, at rest (RVAS) and on deep breathing or coughing known as dynamic VAS (DVAS). • primary outcome time frame up to 24 hours secondary outcome list secondary outcome secondary outcome measure Time to First Rescue analgesia secondary outcome description Pain score will be recorded after the intervention as described earlier. Patients who will have VAS score of > 4 or intractable pain will be given rescue analgesia, that is injection ketorolac intravenously. The usual dose is 30 mg 4-6 hourly by the intravenous route. The time after procedure that patient needs first dose of rescue analgesia i.e Inj Ketorolac will be recorded. Dosage will be adjusted according to pain severity and response. secondary outcome time frame up to 24 hours secondary outcome measure Total Analgesic Requiremennt secondary outcome description Total Analgesia requirement of Inj Ketorolac required by the patient for the first 24 hours up to the discharge will be added up and recorded along with the time given. secondary outcome time frame up to 24-48 hours eligibility module eligibility criteria Inclusion Criteria: All patients above 16 yrs of age undergoing PCNL in Tribhuvan University Teaching Hospital. Exclusion Criteria: Patient ≤16 years of age, known history of hypersensitivity/anaphylaxis/ contraindications to bupivacaine, Systemic Diseases (CKD, active UTI, untreated sepsis), Relook surgery, high ASA grade ( >2) unfit for anesthesia/PCNL , Contraindications for PCNL (pregnancy, coagulopathy) , Patients who decline to participate healthy volunteers No gender All minimum age 17 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Sushil Gyawali, MS Resident central contact role Contact central contact phone +9779849742715 central contact e mail drsushilgyawali@gmail.com central contact name Bhojraj Luitel, MCh Urology central contact role Contact central contact phone +9779851222344 central contact e mail drbhojraj@gmail.com overall official list overall official overall official name Uttam Sharma, MS Surgery overall official affiliation HOD, Department of Urology and Kidney Transplant Surgery, TUTH overall official role Study Chair location list location location facility Tribhvan University Teaching Hospital location status Recruiting location city Kathmandu location state Bagmati location zip 00977 location country Nepal location contact list location contact location contact name Sushil Gyawali, MS Resident location contact role Contact location contact phone +9779849742715 location contact e mail drsushilgyawali@gmail.com location contact name Bhojraj Luitel, MCh Urology location contact role Contact location contact phone +9779851222344 location contact e mail drbhojraj@gmail.com location contact name Bhojraj Luitel, MCh Urology location contact role Sub-Investigator location contact name Sushil Gyawali, MS Resident location contact role Principal Investigator location contact name Amit Sharma Bhattarai, MD Anesthesia location contact role Sub-Investigator location contact name Uttam Sharma, MS Surgery location contact role Sub-Investigator references module reference list reference reference p m i d 28890561 reference type background reference citation Jonnavithula N, Chirra RR, Pasupuleti SL, Devraj R, Sriramoju V, Pisapati MV. A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study. Indian J Anaesth. 2017 Aug;61(8):655-660. doi: 10.4103/ija.IJA_88_17. reference p m i d 31649454 reference type background reference citation Singh I, Yadav OK, Gupta S. Efficacy of intercostal nerve block with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Urol Ann. 2019 Oct-Dec;11(4):363-368. doi: 10.4103/UA.UA_141_18. reference p m i d 29288788 reference type result reference citation Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27. see also link list see also link see also link label choi et al , Pubmed article, PCNL see also link u r l https://pubmed.ncbi.nlm.nih.gov/29288788/ i p d sharing statement module i p d sharing No i p d sharing description After the research is completed, results will be published as Original Article in Journal. Relevant Individual data will be published in Journal itself as a part of the article. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007669 condition mesh term Kidney Calculi condition mesh id D000053040 condition mesh term Nephrolithiasis condition ancestor list condition ancestor condition ancestor id D000007674 condition ancestor term Kidney Diseases condition ancestor id D000014570 condition ancestor term Urologic Diseases condition ancestor id D000052878 condition ancestor term Urolithiasis condition ancestor id D000014545 condition ancestor term Urinary Calculi condition ancestor id D000002137 condition ancestor term Calculi condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition browse leaf list condition browse leaf condition browse leaf id M9845 condition browse leaf name Kidney Calculi condition browse leaf as found Kidney Stone condition browse leaf relevance high condition browse leaf id M26279 condition browse leaf name Nephrolithiasis condition browse leaf as found Kidney Stone condition browse leaf relevance high condition browse leaf id M4551 condition browse leaf name Calculi condition browse leaf relevance low condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse leaf id M16447 condition browse leaf name Urinary Calculi condition browse leaf relevance low condition browse leaf id M26256 condition browse leaf name Urolithiasis condition browse leaf relevance low condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000000777 intervention mesh term Anesthetics intervention ancestor list intervention ancestor intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M4467 intervention browse leaf name Bupivacaine intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf as found Response intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals

NCT04835922

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