pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease
NCT Number: NCT06555042
Acronym: VAP-PET
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn Disease|Inflammatory Bowel Diseases|Crohn Disease of Small Intestine|Crohn Colitis|Crohn's Ileocolitis|Crohn Disease in Remission
Sponsor: Turku University Hospital
Collaborators: University of Turku
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-06-06
Locations: Turku PET Centre, Turku, Varsinais-Suomi, 20540, Finland

Summary:
This is an observational, single center, imaging study. The CD patients with active disease will be assessed by \[68Ga\]Ga-DOTA-Siglec-9 and \[15O\]H2O PET/MRE. Patients with high clinical suspicion of small intestine's CD in outpatient gastroenterology clinic of Turku University Hospital will be recruited. The patients must fulfil the eligibility criteria and give their signed approvement prior to their enrolment into the study.

20 patients with high suspicion of active small bowels CD will be enrolled to being evaluated for potential participation in this study. In patients with diagnosed small bowels CD, PET-MRE will be repeated 3 months after the initial imaging (and based on clinical diagnostic started medication) to verify disease remission/inadequacy of the treatment.

Assessments for CD clinical disease activity will be performed at screening and \[68Ga\]Ga-DOTA-Siglec-9 and \[15O\]H2O PET/MRE assessments will be performed within a month for each patient.

After PET/MRE all patients can be treated according to patients' needs with immunosuppressive drugs. Follow-up visits are organized at after PET/MRE imaging at gastroenterology outpatient clinic.

Primary Outcome Measures: VAP-1 expression in the small bowel of patients with Crohn's disease, VAP-1 is expressed in the small bowel of patients with Crohn's disease and can be assessed by \[68Ga\]Ga-DOTA-Siglec-9 PET/MRE., 18 months
Secondary Outcome Measures: VAP-1 immunohistochemistry, VAP-1 is expressed in the small bowel of patients with Crohn's disease and can be assessed by immunohistochemical staining of tissue biopsies., 18 months|Tissue perfusion, Intestinal blood flow is increased in inflamed small bowel and decreased in the late fibrosing stages of Crohn's disease., 18 months
DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases
NCT Number: NCT06555003
Acronym: CLEAR-DEBIRI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Liver Neoplasm|Colorectal Cancer Metastatic
Interventions: DRUG: Drug-Eluting Embolic Bead|DRUG: Chemotherapy drug
Sponsor: Tehran University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-11

Summary:
A total of 116 patients who meet the inclusion criteria and are chemotherapy-naïve for their metastatic disease, will be randomly assigned to either the treatment group (DEBIRI plus systemic chemotherapy) or the control group (systemic chemotherapy alone).

After 4 cycles of chemotherapy and 2 cycles of DEBIRI, patient reassessment to evaluate treatment response, based on RECIST criteria, will be performed using MRI or CT scan within 1-3 months of treatment initiation.

The feasibility of secondary tumor resection, as primary endpoint, will be reassessed at a three-month follow-up multidisciplinary team (MDT) meeting, guided by established clinical guidelines.

Primary Outcome Measures: Conversion to resectability: The proportion of patients who were initially deemed unresectable but, after undergoing specific intervention (Based on study arm) are reassessed for tumor shrinkage and found to be candidates for surgical resection., The feasibility of secondary tumor resection after receiving treatment, based on follow up imaging and tumor downsizing, will be discussed in multidisciplinary meeting (including surgeons, radiologists and oncologists)., within 3 months after treatment initiation
Secondary Outcome Measures: Adverse event rate, Unfavorable and unintended signs and symptoms associated with the treatment., Within 1 year of treatment administration
Sensory Perceptual Training on Activities of Daily Living and Hand Functions
NCT Number: NCT06554990
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy, Spastic
Interventions: OTHER: physical therapy excersies|OTHER: sensory perceptual motor exercises
Sponsor: Badr University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-01-15

Summary:
Many risk factors can come to the fore in CP. With the new studies on CP, new risk factors are defined and existing risks are better understood. In the light of current information, general risk factors for CP are defined as premature birth, fetal growth restriction, multiple pregnancies, infections in the fetal or neonatal period, birth asphyxia, perinatal stroke, and congenital developmental disorders In addition, related risk factors are classified as prenatal, perinatal and postnatal

Primary Outcome Measures: quality upper extremity test, It was especially designed to evaluate the hand function's limitation, pre and post treatment for 12 weeks
Secondary Outcome Measures: Jebsen Taylor Hand Function Test, It was especially designed to evaluate Time motor performance, pre and post treatment for 12 weeks|Katz Index, It was especially designed to evaluate activities of daily living, pre and post treatment for 12 weeks
Platelets to Albumin Ratio for Prediction of Acute Kidney Injury in Patients Admitted to the Intensive Care Unit
NCT Number: NCT06554977
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Platelets/Albumin and Aki
Interventions: OTHER: Laboratory
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-09

Summary:
To evaluate the role of platelet to albumin ratio to detect Acute kidney injury in patients admitted to intensive care

Primary Outcome Measures: Detect relation between platelets to albumin ratio for prediction of transient or persistent AKI in ICU patients, T he included patients will be divided into two groups according to the optimal cut-off value of

PAR: high-PAR group (≥ 7.2), low-PAR group (\< 7.2). Number of patients is 140, 2years
Secondary Outcome Measures: Effect of the cause of ICU admission on platelets to albumin ratio and persistent AKI, - Relation between platelets to albumin ratio to hospital stay 2- Relation of platelets to albumin ratio to the need for ranel replacement therapy, 2years
Feasibility, Safety and Effectiveness of Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy
NCT Number: NCT06554964
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ectopic Pregnancy
Interventions: PROCEDURE: performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube
Sponsor: Assaf-Harofeh Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
Ectopic pregnancy prevalence is approximately 1-2% of all pregnancies, majority of which located in the fallopian tube. Among the risk factors for ectopic pregnancy is tubal factor - meaning a mechanical problem within the fallopian tube resulting in the pregnancy remaining in the fallopian tube. The treatment o tubal pregnancy can be expectant, medical via metotrexate or surgicl via laparoscopic salpingectomy of the involved fallopian tube. The purpose of this study is to assess the feasibility of chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy hence assessing the function of the remaining fallopian tube and trying to predict future fertility for the patient.

Primary Outcome Measures: Precentage of successful chromotubation (passing of blue dye through the fallopian tube) during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy., How many cases would demonstrate patent fallopian tube via blue dye injected verses how many occluded ones., 1 year
Secondary Outcome Measures: Percentage of adverse reaction to chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy., How many allergic reactions, 1 year
Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
NCT Number: NCT06554951
Acronym: CARE_24
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: CAR-T Cell Therapy|Extracellular Vesicles
Interventions: OTHER: Patients who are candidates for CAR-T cell therapy for hematologic malignancy
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2026-08-31

Summary:
Patients with refractory/relapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested.

Therefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.

Primary Outcome Measures: Response rate to treatment with CAR-T cells, For lymphoma: complete remission is defined by the absence of signs, symptoms, and PET/CT of the disease as described by Mac Manus MP et al. Cancer Imaging. 2007;7:10-8 For multiple myeloma: complete remission is defined as absence of M protein signs using standard tests, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates (Fernandez de Larrea C et al. Biol Blood Marrow Transplant. 2011 Jul;17:1084-7).

For acute leukemia: complete remission is defined with less than 5% blasts in os-seo marrow and all other blood cell counts have returned to normal levels.Dohner H et al Blood. 2022;140:1345-1377., 18 months
Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients.
NCT Number: NCT06554938
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingival Bleeding|Dental Plaque
Interventions: DEVICE: water pik|DEVICE: Super floss
Sponsor: Ajman University
Sex: ALL
Age: ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-11-10
Completion Date: 2024-02-10
Locations: Ajman University, Ajman, United Arab Emirates

Summary:
Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.

Primary Outcome Measures: Gingival bleeding, Gingival bleeding scores will be evaluted, 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention|Dental plaque, Dental plaque scores will be evaluated, 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
SEx-specific Differences in Cardiac Surgery Patients (SECS).
NCT Number: NCT06554925
Acronym: SECS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Female|Male|Surgery, Cardiac
Interventions: PROCEDURE: Cardiac surgery
Sponsor: Jennifer Breel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-01
Completion Date: 2031-03-01
Locations: Academic Medical Center, Amsterdam, North Holland, 1105AZ, Netherlands

Summary:
The aim of this study is to evaluate the differences between females and males undergoing cardiac surgery. The investigators will look at perioperative factors such as adaption of body weight, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at sort-term (within 30 days) and long-term (90 days and 1 year).

Primary Outcome Measures: Postoperative mortality, Incidence of perioperative mortality, Measured at 20 years postoperatively|Postoperative mortality, Incidence of perioperative mortality, Measured at 30 days postoperatively|Postoperative mortality, Incidence of perioperative mortality, Measured at 1 year postoperatively|Postoperative mortality, Incidence of perioperative mortality, Measured at 5 years postoperatively
Secondary Outcome Measures: Postoperative complications (Morbidity), Incidence of peroperative and post-operative complications, Measured at 30 days|Postoperative complications (Morbidity), Incidence of peroperative and post-operative complications, Measured at 90 days|Postoperative complications (Morbidity), Incidence of peroperative and post-operative complications, Measured at 365 days|Development of a predictive risk score using a composite outcome, Predictive risk score, Up to 30 days postoperatively
A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine
NCT Number: NCT06554886
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Migraine
Interventions: DEVICE: Cryoneurolysis
Sponsor: St. Olavs Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-02

Summary:
The trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine. Chronic migraine is a condition that causes moderate to severe headache.

In this study, the investigators want to evaluate the freezing technique in chronic migraine. The main goal is to see how much headache relief is experienced after receiving the treatment. The investigators will also record other important information about the participants.

The study is looking to recruit 12 adults with chronic migraine to take part in the study. Participants will register their headache burden in a headache diary for at least 4 weeks before receiving treatment with the freezing technique. They will continue to register headache in the headache diary during the follow-up. After this initial treatment, participants with recurring headache can receive treatment as needed for up to two years.

The results of this study will help us decide if the freezing technique may be viable treatment option for chronic migraine and enable us plan for further studies on this treatment.

Primary Outcome Measures: Headache days - severe and moderate, Difference in change in mean monthly headache days with moderate or severe intensity, Weeks 5 - 8 post intervention versus baseline|Safety - AE and SAE, Occurrence of treatment-emergent AE and SAE, 8 weeks post-intervention
Secondary Outcome Measures: Headache days - any intensity, Difference in change in mean monthly headache days with any intensity, Weeks 5 - 8 post intervention versus baseline|Migraine days, Difference in change in mean monthly migraine days, Weeks 5 - 8 post intervention versus baseline|Responders 30%, Number of 30% responders, Weeks 5 - 8 post-intervention|Responders 50%, Number of 50% responders, Weeks 5 - 8 post-intervention|Headache Intensity, Difference in the mean monthly headache intensity with a 11 point VAS scale as registered in headache diary, Weeks 5 - 8 post intervention versus baseline|Medication consumption, Difference in mean monthly days with acute medication consumption as registered in headache diary, Weeks 5 - 8 post intervention versus baseline
Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders
NCT Number: NCT06554873
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Smoking Cessation|Harm Reduction
Interventions: DRUG: Nicoderm|DRUG: Nicorette 4Mg Chewing Gum|DRUG: Nicorette Lozenge Product|OTHER: NJOY e-cigarette|OTHER: on!
Sponsor: Rose Research Center, LLC
Collaborators: Global Action to End Smoking
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-12-31
Locations: Rose Research Center, Charlotte, North Carolina, 28262, United States|Rose Research Center, Raleigh, North Carolina, 27617, United States

Summary:
To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.

Primary Outcome Measures: Smoking abstinence - CO, To determine whether maintained use of nicotine products can help sustain smoking abstinence rates for early responders. An expired air CO reading of ≤ 5 ppm at 24 weeks., Week 12 and Week 24
Secondary Outcome Measures: Smoking abstinence - Self report of no smoking, Percent smoking abstinence at 12 weeks and 24 weeks, defined on an intent-to-treat basis as a self-report of no-smoking for the prior 7 days, Week 12 and Week 24|Reduction in Expired Air CO, Percent of participants achieving a 50% reduction in expired air CO at 12 weeks and 24 weeks relative to baseline., Week 12 and Week 24|Usage of Nicotine Products, Self-reported usage of nicotine products., Week 1 through Week 24, Week 36|Saliva Cotinine Concentrations, Saliva cotinine concentrations reflective of nicotine product usage in smoking-abstinent individuals., Week 12, Week 24, Week 36
Scapular Blackburn Stabilization Versus PNF in Impingement Syndrome
NCT Number: NCT06554860
Acronym: impingment
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Impingement Syndrome
Interventions: OTHER: scapular Blackburn stabilization plus exercise|OTHER: PNF plus Exercise|OTHER: exercise only
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-02-15

Summary:
purpose of study to Aim to investigate effect(s) of scapular Blackburn stabilization exercises compared toscapular proprioceptive neuromuscular facilitation (SPNF) exercise in addition to conventional exercises on shoulder pain, function, shoulder,sacpular ROM, scapular muscle strength and scapular orientation in patients with sub acromial impingement syndrome

Participants will be randomly allocated to three groups as follow:

Group A (n=17): will receive a program of conventional exercise include rotator cuff strengthening ,stretching for posterior capsule and stretching for pectoralis minor for 18 sessions (3 sessions per week for six weeks) Group B (n=17): will receive a scapular PNF exercise program in addition to conventional Exercise with the same frequency. Group C (n=17): will receive a scapular Blackburn stabilization exercises in addition to conventional Exercise with the same frequency

Primary Outcome Measures: shoulder pain and functional disability, Shoulder pain and disability index., minimum number 0=mean No pain and No disabilities and maximum number 10=mean highest pain and maximum disability, Assessment procedure will be performed pre intervention and post third and sixth week of treatment|A-shoulder flexion ROM B- shoulder external rotation C-shoulder internal rotation, Digital Inclinometer., Assessment procedure will be performed pre intervention and post third and sixth week of treatment|selective muscle strength on: A- upper trapezius B- middle trapezius C-lower trapezius. D- serrates anterior, -Lafayette Hand-held dynamometer, Assessment procedure will be performed pre intervention and post third and sixth week of treatment|scapula orientation, lateral scapular slide test, Assessment procedure will be performed pre intervention and post third and sixth week of treatment
Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
NCT Number: NCT06554847
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Dermatitis, Atopic|Eczema, Atopic
Interventions: DRUG: 611|DRUG: Placebo|DRUG: Topical corticosteroid
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-11
Completion Date: 2026-08-16
Locations: Shanghai Dermatology Hospital, Shanghai, Shanghai, 200050, China|Hangzhou First People's Hospital, Hangzhou, Zhejiang, 31003, China|The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, 315010, China

Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Primary Outcome Measures: Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score), Baseline to Week 16|Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16., Baseline to Week 16
Secondary Outcome Measures: Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16, Baseline to Week 16
A Study to Investigate the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin When Given in Healthy Participants
NCT Number: NCT06554821
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: Rosuvastatin|DRUG: Ticagrelor
Sponsor: AstraZeneca
Collaborators: Parexel
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-05
Completion Date: 2024-09-24
Locations: Research Site, Berlin, 14050, Germany

Summary:
The purpose of this study is to measure the effect of ticagrelor on the pharmacokinetics (PK) of rosuvastatin in healthy participants.

Primary Outcome Measures: Area under concentration-time curve from time 0 to infinity (AUCinf), To assess the effect of ticagrelor on plasma PK (AUCinf) of rosuvastatin dose 1 and dose 2 separately, in healthy participants., From Day 1 to Day 11|Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast), To assess the effect of ticagrelor on plasma PK (AUClast) of rosuvastatin dose 1 and dose 2 separately, in healthy participants., From Day 1 to Day 11|Maximum observed drug concentration (Cmax), To assess the effect of ticagrelor on plasma PK (Cmax) of rosuvastatin dose 1 and dose 2 separately, in healthy participants., From Day 1 to Day 11
Secondary Outcome Measures: Number of participants with adverse events (AEs), To examine the safety and tolerability of rosuvastatin alone and in combination with ticagrelor., Approximately 7 weeks|Terminal elimination half-life (t1/2), To assess the effect of ticagrelor on the PK (t1/2) of rosuvastatin in healthy participants., From Day 1 to Day 11|Terminal rate constant (parent only) (λz), To assess the effect of ticagrelor on the PK (λz) of rosuvastatin in healthy participants., From Day 1 to Day 11|Time to reach maximum observed concentration (tmax), To assess the effect of ticagrelor on the PK (tmax) of rosuvastatin in healthy participants., From Day 1 to Day 11|Amount of drug excreted (Ae), To assess the effect of ticagrelor on the urine PK (Ae) of rosuvastatin in healthy participants., From Day 1 to Day 11|Renal clearance (Clrenal), To assess the effect of ticagrelor on the urine PK (Clrenal) of rosuvastatin in healthy participants., From Day 1 to Day 11|Percent of dose excreted, To assess the effect of ticagrelor on the urine PK of rosuvastatin in healthy participants., From Day 1 to Day 11
Socioeconomic Factors and Mortality in the Intensive Care Population
NCT Number: NCT06554808
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Socio-economic Status
Sponsor: Uppsala University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 113848
Study Design: Observational Model: |Time Perspective: p
Start Date: 2005-01-01
Completion Date: 2016-12-31

Summary:
It is important to find out how much of the socioeconomic factors´ impact on mortality on ICU patient´s can be explained by the presence of comorbidity. The aim of this study is to clarify the impact of socioeconomic factors on mortality and how much of this effect are due to comorbidity in the intensive care population.

Primary Outcome Measures: Mortality, Mortality, january 1, 2005 til december 31, 2016
Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Toothbrush
NCT Number: NCT06554782
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Manual Toothbrush
Interventions: DEVICE: manual u-shaped toothbrush
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 47
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12
Completion Date: 2026-01

Summary:
To assess the child's compliance towards manual U-shaped toothbrush versus regular manual toothbrush.

Primary Outcome Measures: compliance of patient, questioning the parents about compliance either yes or no, 1 week
Secondary Outcome Measures: full mouth plaque score, Turesky modified Quigley-Hein plaque index technique index score: total score/number of surfaces examined 0-1= low \>2= high, 1 week
Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study
NCT Number: NCT06554769
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthodontic Appliance Complication
Interventions: PROCEDURE: non rigid indirect anchorage connection|PROCEDURE: rigid indirect anchorage connection
Sponsor: Cairo University
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-02
Completion Date: 2024-06-02
Locations: Cairo University, Cairo, Egypt

Summary:
Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases

Primary Outcome Measures: anchorage loss, amount of anchorage loss of the upper first molar during canine retraction using digital model in mm., 4 month
Secondary Outcome Measures: vertical position of the upper second premolar, The secondary outcome was to assess the change in the vertical position of the upper second premolar following canine retraction using indirect anchorage using digital models in mm., 4 month
Annexin Levels of Periodontal Inflammatory Regulation
NCT Number: NCT06554756
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Diseases|Inflammation
Interventions: OTHER: Saliva, serum and GCF sampling
Sponsor: Medipol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-05-15
Completion Date: 2024-03-12
Locations: Istanbul Medipol University, School of Dentistry, Istanbul, Fatih, Turkey

Summary:
ANXA1, a member of the annexin family, plays a role in the resolution of inflammation and the regulation of anti-inflammatory responses, while ANXA2 is involved in the initiation of the inflammatory responses. The aim of this study was to determine the effects of annexin family (ANXA1 and ANXA2) in periodontal disease.

Primary Outcome Measures: Pocket probing depth, Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe., 6 months|Clinical attachment level, Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ.

To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth.

In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract), 6 months|Bleeding on probing, referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth., 6 months
Secondary Outcome Measures: Saliva, serum and GCF samples processing and analyses, Saliva, GCF and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for ANXA1, ANXA2 and IL-1beta using commercial ELISA kits, 1 month
Plant-Based Defaults
NCT Number: NCT06554743
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Choice Behavior|Dietary Habits
Interventions: BEHAVIORAL: Default Veg|BEHAVIORAL: Default Meat
Sponsor: Arizona State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 365
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-03-01
Completion Date: 2024-02-22
Locations: Arizona State University, Phoenix, Arizona, 85004, United States

Summary:
In this study, participants at six different academic events were randomly assigned to one of two conditions: (1) a default meat group, where the default choice was a meal with meat and participants had the option of opting out and choosing a plant-based meal; and (2) a default veg group, where the default choice was a plant-based meal with the option of opting out and choosing a meal with meat. Based on the success of prior studies that implemented plant-based defaults through preselection, we hypothesized that more participants would choose the plant-based meal when that option was set as the default, and we hypothesized that the default intervention would be equally effective across academic institutions. We also hypothesized that the default intervention would be equally effective across demographic groups, which would help to further demonstrate the generalizability of our plant-based default intervention.

Primary Outcome Measures: Proportion of participants selecting the plant-based meal, The percent (%) of participants selecting the plant-based meal option instead of the meal with meat option on the event RSVP from, Immediately during the completion of the event RSVP form
Merck Belzutifan PAS
NCT Number: NCT06554730
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Von Hippel Lindau Disease|Renal Cell Carcinoma
Interventions: OTHER: Merck Belzutifan PAS in adult patients
Sponsor: M.D. Anderson Cancer Center
Collaborators: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-31
Completion Date: 2029-05-13
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.

Primary Outcome Measures: Patient Ancestry Questionnaire, Primary outcome measure: Proportion of patients who undergo surgery or other tumor reductive procedure. Reason for surgery and tumor characteristics preceding surgery will also be collected., Through study completion, an average of 6 years
Autonomic Nervous System Dysregulation in People With Chronic Neck Pain
NCT Number: NCT06554704
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Neck Pain|Autonomic Nervous System
Interventions: BEHAVIORAL: Isometric hand grip test
Sponsor: National Yang Ming Chiao Tung University
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2025-05-01

Summary:
The goal of this observational study is to investigate heart rate variability in different positions and in response to isometric hand-grip test in people with non-specific chronic neck pain as compared with healthy controls. The main questions it aims to answer are:

* Do the heart rate variability indices differ between people with non-specific chronic neck pain and healthy controls in supine sitting and standing positions?
* Do the heart rate variability indices differ between people with non-specific chronic neck pain and healthy controls when challenged by the isometric hand-grip test?

Primary Outcome Measures: Heart rate variability, Time domain and frequency domain indices, Five-minute
THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: A Clinical Study
NCT Number: NCT06554678
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Early Postoperative Atelectasis
Interventions: PROCEDURE: Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）|PROCEDURE: conventional oxygen mask
Sponsor: Subei People's Hospital of Jiangsu Province
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-18
Completion Date: 2025-03
Locations: Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, 225000, China

Summary:
This study aims to explore the clinical effect of THRIVE in improving early postoperative atelectasis in patients undergoing long-term non-intubated anesthesia gastrointestinal endoscopy.

Primary Outcome Measures: Incidence of atelectasis, 7 days
Selective Neck Dissection Versus Modified Neck Dissection in PTC
NCT Number: NCT06554652
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Thyroid Cancer
Interventions: PROCEDURE: Lymph node tracer navigated selective neck dissection|PROCEDURE: Modified neck dissection
Sponsor: Fudan University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-06-30
Locations: Fudan Univeristy Shanghai Cancer Center, Shanghai, China

Summary:
This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.

Primary Outcome Measures: Local-regional Recurrence Free Survival，LRFS, The time from surgery to the recurrence based on RECIST 1.1,. The definition of local-regional areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes., 5 years
Secondary Outcome Measures: Local-regional Recurrence Rate，LRR, The percentage of patients with local-regional recurrence in the total number of patients., 5 years|Progression Free Survival，PFS, The time from surgery to tumor progression, including local-regional recurrence and distant metastasis., 5 years|Overall Survival，OS, The time from surgery to patient death, 5 years|Adverse Events，AE, The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery., 5 years|Quality of Life as assessed by UW-QOL V4.1, Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Washington University Quality of Life Questionnaire V4.1 (UW-QOL V4.1)., 5 years|Quality of Life as assessed by QoL/Thyroid, Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Thyroid Cancer Quality of Life Scale QoL/Thyroid., 5 years
A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
NCT Number: NCT06554639
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Prostatic Neoplasms
Interventions: DRUG: MK-5684|DRUG: Prednisone|DRUG: Fludrocortisone acetate|DRUG: Diltiazem hydrocholoride
Sponsor: Merck Sharp & Dohme LLC
Sex: MALE
Age: ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2024-08-18
Locations: Celerion ( Site 0001), Tempe, Arizona, 85283, United States

Summary:
Researchers have designed a study medicine called MK-5684 as a new way to treat prostate cancer.

The purpose of this study is to learn what happens to MK-5684 in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to MK-5684 in the body when it is given with and without another medicine called diltiazem.

Primary Outcome Measures: Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma, AUC0-inf of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 120 hours post-dose|Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma, AUC0-last of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 120 hours post-dose|Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma, AUC0-24 of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 24 hours post-dose|Maximum concentration (Cmax) of MK-5684 in plasma, Cmax of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 120 hours post-dose|Time to Maximum concentration (Tmax) of MK-5684 in plasma, Tmax of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 120 hours post-dose|Apparent terminal half-life (t1/2) of MK-5684 in plasma, t1/2 of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 120 hours post-dose|Apparent Clearance (CL/F) of MK-5684 in plasma, CL/F of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 120 hours post-dose|Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma, Vz/F of MK-5684 in plasma will be determined., Predose, and at designated timepoints up to 120 hours post-dose
Secondary Outcome Measures: Number of participants who experience one or more adverse events (AEs), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 39 days|Number of participants who discontinue study intervention due to an AE, An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 39 days
Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL
NCT Number: NCT06554626
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Precursor B-Cell Lymphoblastic Leukemia
Interventions: DRUG: Dexamethasone|DRUG: Blinatumomab|DRUG: Venetoclax|DRUG: Inotuzumab ozogamicin|DRUG: Methotrexate|DRUG: Pegaspargase|DRUG: Cytarabine
Sponsor: First Affiliated Hospital of Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-08-01
Locations: The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China

Summary:
Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Venetoclax sequenced with Inotuzumab Ozogamicin in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

Primary Outcome Measures: Event free survival(EFS), Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;, up to 2 years
Secondary Outcome Measures: Complete remission with or without incomplete PB cell recovery(CR/CRi) rate, Blast rate lower than 5% with or without peripheral blood cell recovery, at the end of Cycle 1（each cycle is 28days）|Overall survival (OS), Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;, up to 5 years|Minimal residual disease (MRD), MRD level detected by flow cytometry which value \<0.1% is defined as negtive, At the end of Cycle 1（each cycle is 28 days）
Other Outcome Measures: Minimal residual disease (MRD), MRD level detected by next generation sequencing, At the end of Cycle 2（each cycle is 28 days）
Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
NCT Number: NCT06554613
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer
Interventions: DRUG: Olanzapine|DRUG: Nivolumab
Sponsor: Second Affiliated Hospital of Nanchang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2028-05-31

Summary:
Clinical Trial

The objective of this clinical trial is to determine whether antidepressant medications, such as olanzapine, in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone. The main questions it aims to answer are:

Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone? What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors?

Participants will:

Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months.

Visit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends.

Keep a record of their symptoms and disease progression.

Primary Outcome Measures: The Overall Survival（OS）, The Overall Survival（OS），From the time of a patient's diagnosis or the commencement of treatment, to the time of the patient's death., 24 months
A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT Number: NCT06554600
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Refractory or Relapsed Diffuse Large B Cell Lymphoma
Interventions: DRUG: Zanubrutinib|DRUG: Polatuzumab Vedotin|DRUG: Bendamustine|DRUG: Rituximab
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2028-08-31
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hanzhou, Zhejiang, 310009, China

Summary:
This is a prospective, multicenter, single-arm, open phase II study to explore the efficacy and safety of Zanubrutinib in combination with Polatuzumab Vedotin, bendamustine, and rituximab (Polo-ZBR) in subjects with relapsed/refractory diffuse large B-cell lymphoma. Subjects with relapsed/refractory DLBCL who met the inclusion/exclusion criteria were screened and treated with 4 courses of Pola-ZBR regimen after signing informed consent. Subjects achieving PR or CR were consolidated with autologous transplantation consolidation or the original regimen for 2 additional courses, and then given Zanubrutinib maintenance therapy for 1 year. The final follow-up was observed until 2 years after enrollment.

Primary Outcome Measures: Objective Response rate（ORR）, The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of induction treatment., Up to 12 weeks
Secondary Outcome Measures: Complete Response rate（CRR）, The proportion of patients who achieved complete response in efficacy evaluation at the end of induction treatment., Up to 12 weeks|Progression-free Survival（PFS）, PFS was defined as the period from date of enrollment until the date of disease progression, relapse, or death from any cause., Up to 2 years after enrollment|Overall Survival(OS), OS was defined as the time from date of randomization until the date of death from any cause., Up to 2 years after enrollment|Percentage of Participants With Adverse Events (AEs), Toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, Up to 12 weeks
A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants
NCT Number: NCT06554574
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: LTG-305
Sponsor: Latigo Biotherapeutics
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2025-03-31
Locations: Clinical Research Unit, Christchurch, New Zealand

Summary:
This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered LTG-001 in healthy male and female participants

Primary Outcome Measures: To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants., Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs), Up to 7 days of dosing