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## Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery - NCT ID: NCT06300346 - Study ID: Soh-Med-23-12-02MS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-18 - Lead Sponsor: Sohag University ### Study Description Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia ### Conditions - Emetic Attacks During Caesarean Delivery With Spinal Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Propofol ### Outcomes Primary Outcomes - Incidence of nausea and vomiting with spinal anesthesia Secondary Outcomes - Measurement of hemodynamics postoperative ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Treatment of Ectopic Pregnancy by Low Dose of Methotrexate - NCT ID: NCT06300333 - Study ID: Ectopic tubal pregnancy - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Assiut University ### Study Description Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy ### Conditions - Ectopic Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Methotrexate ### Outcomes Primary Outcomes - descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease - NCT ID: NCT06300320 - Study ID: TQ05105-II-06 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease ### Conditions - Chronic Graft Versus Host Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TQ05105 tablets ### Outcomes Primary Outcomes - Objective response rate (ORR) at 24 weeks Secondary Outcomes - Best objective response rate (BOR) - Duration of response (DOR) - Failure-free survival (FFS) - Incidence rate of malignancy relapse or recurrence - Non relapse mortality - Overall Survival (OS) - Adverse event rate - Severity of adverse events (AEs) ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, 230001, China @@
## Study of ATX-01 in Participants With DM1 - NCT ID: NCT06300307 - Study ID: CT-ATX-01-DM1-1.1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: ARTHEx Biotech S.L. ### Study Description The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo.There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo.ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b. ### Conditions - Myotonic Dystrophy 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ATX-01 - Placebo ### Outcomes Primary Outcomes - Incidence of adverse events Secondary Outcomes - Incidence of clinically significant changes in laboratory assessments, electrocardiograms (ECGs), vital signs, suicidal ideation and behavior - Maximum observed plasma concentration (Cmax) of ATX-01 - Area under the plasma concentration-time curve (AUC) of ATX-01 - Video hand opening time - Change from baseline in ankle dorsiflexion strength by quantitative myometry - Change from baseline in Impact on Activities of Daily Living questionnaire item scores ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Acute Coronary Syndrome and Acupressure - NCT ID: NCT06300294 - Study ID: AIBU-SBF-AYN-3 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-01-31 - Lead Sponsor: Abant Izzet Baysal University ### Study Description This study aims to examine the effect of acupressure on physiological parameters and anxiety levels in individuals diagnosed with Acute Coronary Syndrome (ACS).H1-1: Acupressure applied to individuals diagnosed with ACS has an effect on the level of anxiety.H1-2: Acupressure applied to individuals diagnosed with ACS has an effect on blood pressure.H1-3: Acupressure applied to individuals diagnosed with ACS has an effect on heart rate.H1-4: Acupressure applied to individuals diagnosed with ACS has an effect on respiratory rate.H1-5: Acupressure applied to individuals diagnosed with ACS has an effect on the pain level.H1-6: Acupressure applied to individuals diagnosed with ACS has an effect on cortisol levels. ### Conditions - Acute Coronary Syndrome - Nursing ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - acupressure ### Outcomes Primary Outcomes - means of blood pressure - means of hear rate - means of respiratory rate - means of cortisol. Secondary Outcomes - means of subjective anxiety scores. - means of subjective pain scores. - electrocardiography evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Neuromuscular and Aquatic Exercise Programs on Fall Risk and Physical Function in Geriatrics - NCT ID: NCT06300281 - Study ID: NEAEGeriatircs - Status: NOT_YET_RECRUITING - Start Date: 2024-05-04 - Completion Date: 2024-10-30 - Lead Sponsor: Alanya Alaaddin Keykubat University ### Study Description Objective: The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics.Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (NE Group) and Group 2 (AE Group) (Randomizer.org). NE (Neuromuscular Exercise) group will participate in a 12-week exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns.AE (Aqıuatic Exercise) Group will participate in an aquatic exercise program, which includes warm-up, mobility and strength, stretching, and cooling exercises in a 140 cm deep pool with a water temperature of 32 °. Data will be collected using the International Physical Activity Survey Short Form (IPAQ-SF), Montreal Cognitive Assessment Scale (MoCA), Geriatric Pain Measure, Optojump-next (Microgate, Bolzano, Italy), 6-minute Walk Test, 30-second-Sit-to-Stand Test, Four Step Square Test, Berg Balance Scale, Fear of Falling Avoidance Behavior Questionnaire.Practice Implications: This current study will contribute to the understanding of how neuromuscular exercises affect falls and physical function in geriatrics. ### Conditions - Geriatrics - Exercise Therapy - Fall - Physical Functional Performance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Neuromuscular Exercise - Aquatic Exercise ### Outcomes Primary Outcomes - Change in Pain - Change in walking and reaction time - Change in aerobic capacity - Change in muscular fitness - Change in s balance - Change in dynamic balance - Change in fear of falling Secondary Outcomes - Physical activity level - Level of cognition ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Advapro Coronary Stent System in Coronary Artery Diseased Patients. - NCT ID: NCT06300268 - Study ID: CSPL/PL/2023/004 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: Advanced MedTech Solutions Pvt. Ltd. ### Study Description A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population.To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit.A QCA Analysis will be performed on minimum 48 patients in Indian population only.Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14. ### Conditions - Coronary Artery Disease - De Novo Stenosis Lesion - Coronary Stent Implantation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - AdvaPro Sirolimus Eluting Coronary Stent System ### Outcomes Primary Outcomes - Composite Endpoint Secondary Outcomes - Incidence of DOCE - Incidence of POCE - Incidence of MACE - Target vessel failure (TVF) - Non-Target Vessel related Myocardial Infarction - Stent thrombosis - Device success - Procedural Success - Acute Device Success ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the H.O.O.V.E.S. Healing Intensives Program - NCT ID: NCT06300255 - Study ID: IRB 00166616 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2029-02-01 - Lead Sponsor: VA Salt Lake City Health Care System ### Study Description The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention. ### Conditions - Anxiety - PTSD - Depression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - H.O.O.V.E.S. Healing Intensives ### Outcomes Primary Outcomes - Mean Difference in AAQII pre- to post-session and pre- to post-intervention - Mean Difference in PANAS pre- to post-session and pre- to post-intervention - Mean Difference in STAI pre- to post-session and pre- to post-intervention - Mean Difference in PCL pre- to post-session and pre- to post-intervention - Mean Difference in BDI pre- to post-session and pre- to post-intervention - Mean Difference in PTGI pre- to post-session and pre- to post-intervention - Mean Difference in B-SCS pre- to post-session and pre- to post-intervention Secondary Outcomes - Mean Difference in AAQII pre- to post-session - Mean Difference in PANAS pre- to post-session - Mean Difference in STAI pre- to post-session ### Location - Facility: George E. Wahlen Department of Veterans Affairs Medical Center, Salt Lake City, Utah, 84148, United States @@
## Incentives for Influenza Vaccination - NCT ID: NCT06300242 - Study ID: UP-23-00859 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-17 - Completion Date: 2024-02-29 - Lead Sponsor: University of Southern California ### Study Description In this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. Our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/"treatment as usual" group. We further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm. ### Conditions - Influenza Vaccination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Reminders - Financial Incentive - Placebo ### Outcomes Primary Outcomes - Vaccination status at 1 week Secondary Outcomes - Vaccination status at 2 weeks - Vaccination status at 1 month ### Location - Facility: Contra Costa Health Services, Martinez, California, 94553, United States @@
## NAPO - Novel Approach for Oligospermia - NCT ID: NCT06300229 - Study ID: 2023-508325-27-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: Martin Blomberg Jensen ### Study Description This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL). ### Conditions - Infertility, Male ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Denosumab - sodium chloride ### Outcomes Primary Outcomes - The difference in sperm concentration (million pr. mL) on day 80 Secondary Outcomes - The difference in semen quality (total sperm count, motile sperm, progressive motile sperm and morphologically normal sperm) between baseline and two semen samples delivered at day 80 and day 83 after inclusion - The change/differences in number of pregnancies achieved before day 180 - The difference in the number of miscarriages throughout the trial before day 180 - The change/difference in serum levels of follicle stimulating hormone (FSH) on day 80 - The change/difference in serum levels of reproductive hormone luteinizing hormone (LH) on day 80 - The change/difference in serum levels of reproductive hormone AMH on day 80 - The change/difference in serum levels of reproductive hormone Inhibin B on day 80 ### Location - Facility: Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen, N/A, N/A, Denmark @@
## A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors - NCT ID: NCT06300216 - Study ID: KYLL-202401-034-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2028-05-26 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients. ### Conditions - Neuroendocrine Tumors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Octreotide microspheres ### Outcomes Primary Outcomes - Treatment Emergent Adverse Events Secondary Outcomes ### Location - Facility: Qilu hospital of Shandong University, Jinan, Shandong, 250012, China @@
## Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis - NCT ID: NCT06300203 - Study ID: CM310_IIS_SAR07 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2025-05-30 - Lead Sponsor: Beijing Tongren Hospital ### Study Description Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease. ### Conditions - Seasonal Allergic Rhinitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Interleukin-4 receptor responders - Placebo ### Outcomes Primary Outcomes - Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2. Secondary Outcomes ### Location - Facility: Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, 100000, China @@
## Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV - NCT ID: NCT06300190 - Study ID: Treatment SLAP type IV lesion - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-07 - Lead Sponsor: Assiut University ### Study Description Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV ### Conditions - SLAP Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biceps tenodesis alone - Biceps tenodesis and labrum repair ### Outcomes Primary Outcomes - Clinical outcome by American shoulder elbow score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure - NCT ID: NCT06300177 - Study ID: D1553-III-01 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2027-12 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint. ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - D-1553 Tablet - Docetaxel injection ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective mitigation rate (ORR) - Duration of Response (DOR) - Disease control rate (DCR) - Time to response (TTR) - Patient-reported outcome (PRO) - Abnormal laboratory test indicators - Adverse event rate - Time to Maximum Plasma Concentration (Tmax) - Half life (t1/2) ### Location - Facility: Anhui Province Hospital, Hefei, Anhui, 230002, China @@
## The Effect of Unripe Carob Fruit in Celiac Patients - NCT ID: NCT06300164 - Study ID: Unripecarobinceliac - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Toros University ### Study Description The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction. ### Conditions - Celiac Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Unripre Carob ### Outcomes Primary Outcomes - Examination of between group differences regarding serum Total Antioxidant Capacity (TAC) - Examination of between group differences regarding serum Malondialdehyde (MDA) - Examination of between group differences regarding serum zonulin Secondary Outcomes - Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC) - Comparison of between group differences regarding serum Malondialdehyde (MDA) - Comparison of between group differences regarding serum zonulin ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia - NCT ID: NCT06300151 - Study ID: Ultrasound Real-time Guidance - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Zongxun Lin ### Study Description Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers. ### Conditions - Labor Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia - Dural Puncture Epidural Labor Analgesia ### Outcomes Primary Outcomes - Analgesic effect（onset time） - Analgesic effect（block level） - Analgesic effect（block effect） - Analgesic effect（Visual Analogue Scale） - Analgesic effect（number of Patient controlled analgesia） - Analgesic effect（time of Patient controlled analgesia） - Uterine contraction indicators（Frequency） - Uterine contraction indicators（duration） - Uterine contraction indicators（Number of pregnant women with Tachysystole） - Uterine contraction indicators（Number of pregnant women with hypertonus） - Fetal heart indicators（Fetal heart rate） - Fetal heart indicators（NICHD classification） - Fetal heart indicators（Fetal Heart Rate decelerations） - Fetal heart indicators（Fetal Heart Rate Variability） - Apgar score - Sacral sensory block of pregnant women - modified bromage score Secondary Outcomes - Operation evaluation（Time） - Operation evaluation（number of times） - Operation evaluation（side effects and Complications） - Delivery mode - Concentration of Interleukin 6 - Concentration of hypersensitive C-reactive protein - Concentration of cortisol - Maternal rehabilitation indicators（Postpartum hospital stay） - Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale） - Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40）） - Number of pregnant women with adjust the treatment plan and adjustment method - Drug consumption - Effect of stages of labor（time） - body temperature changes - Number of pregnant women with Infection during labor - Side effects and complications of labor analgesia - The reasons and number of pregnant women with conversion of natural labor to Caesarean section - Self-Rating Anxiety Scale - Delivery fear score（numerical rating scale） - Delivery satisfaction survey ### Location - Facility: Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China @@
## Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis - NCT ID: NCT06300138 - Study ID: 2023-631-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: First Hospital of China Medical University ### Study Description Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals. ### Conditions - Sporotrichosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Itraconazole - Infrared thermotherapy apparatus - Itraconazole and Infrared thermotherapy apparatus ### Outcomes Primary Outcomes - the overall clinical clearance rate of skin lesions Secondary Outcomes - Overall clinical clearance rate and recurrence rate - adverse reactions and incidence - the clearance rate of target skin lesions - overall lesion clearance rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Percutaneous Cryoablation of Low-risk Early Breast Cancer - NCT ID: NCT06300125 - Study ID: R1881/23 - L2-015 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2031-03-01 - Lead Sponsor: European Institute of Oncology ### Study Description Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cryoablation ### Outcomes Primary Outcomes - Procedure failure rate Secondary Outcomes - Assessment of subject's quality of life in terms of evaluation of sources of distress - Assessment of subject's satisfaction - Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable) - Ipsilateral breast tumor recurrence - Distant metastasis ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level - NCT ID: NCT06300112 - Study ID: Amasya Univ_emine.akca - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06-30 - Lead Sponsor: Amasya University ### Study Description The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns. ### Conditions - Stress - Sexuality - Sleep ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - YOGA ### Outcomes Primary Outcomes - Perceived stress level - Sexual Quality of Life Secondary Outcomes ### Location - Facility: Amasya University, Amasya, N/A, 05100, Turkey @@
## Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block - NCT ID: NCT06300099 - Study ID: AZAST/Research/52/20-Jan-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Al-Azhar University ### Study Description Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dexamethasone - Dexmedetomidine ### Outcomes Primary Outcomes - postoperative visual assessment scale for pain. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease - NCT ID: NCT06300086 - Study ID: NUDGE-CKD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2034-10-01 - Lead Sponsor: Tor Biering-Sørensen ### Study Description Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters. ### Conditions - Chronic Kidney Diseases - Behavior and Behavior Mechanisms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: OTHER ### Interventions - Electronically delivered nudging letters to patients with CKD - Electronically delivered nudging letter to associated GPs of patients with CKD ### Outcomes Primary Outcomes - Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors Secondary Outcomes - Number of participants with any prescription of renin-angiotensin system inhibition - Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors - Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors - Number of participants with a new prescription of renin-angiotensin system inhibition - Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors - Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors - Time from intervention delivery to a new prescription of renin-angiotensin system inhibition - Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors ### Location - Facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, Hovedstaden, 2900, Denmark @@
## Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children - NCT ID: NCT06300073 - Study ID: AB-360-001-2022 - Status: COMPLETED - Start Date: 2023-02-14 - Completion Date: 2023-02-17 - Lead Sponsor: Lander Enterprises, LLC ### Study Description The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush. ### Conditions - Dental Plaque ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Experimental: U-shaped Power Toothbrush - Placebo Comparator: Soft Manual Toothbrush ### Outcomes Primary Outcomes - Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all tooth surfaces of the whole mouth. Secondary Outcomes ### Location - Facility: Salus Research, Inc, Fort Wayne, Indiana, 46825, United States @@
## Synbiotic Supplementation in Cyclists - NCT ID: NCT06300060 - Study ID: REB23-1161 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-02-01 - Lead Sponsor: University of Calgary ### Study Description The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health. ### Conditions - Exercise Endurance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Synbiotic - Placebo ### Outcomes Primary Outcomes - Change in endurance exercise performance measured during a 20km cycling distance trial Secondary Outcomes - Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test - Change in peak power output (PPO) measured during a Step-Ramp-Step Test - Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP) - Change in time to exhaustion measured during a cycling session at 85% of the peak power output - Change in fat and carbohydrate oxidation measured during exercise sessions - Change in blood lactate concentration measured via pinprick capillary blood test - Change in body composition measured by dual energy X-ray absorptiometry (DXA) - Change in intestinal permeability markers measured in serum - Change in cytokines - Change in gastrointestinal symptoms measured by self-report - Change in fecal SCFA concentration measured by gas chromatography - Synbiotic strains quantification measured by qPCR in fecal matter - Change in fecal microbiota composition - Incidence of adverse events ### Location - Facility: University of Calgary, Calgary, Alberta, T2N 1N4, Canada @@
## Diabetes Transition Coordinator Study - NCT ID: NCT06300047 - Study ID: REB23-0679 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-01 - Completion Date: 2028-12-31 - Lead Sponsor: University of Calgary ### Study Description The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.The 3 main aims are:1. To assess the effects of our transition intervention on clinical and patient-reported outcomes.2. To implement the transition intervention and evaluate the implementation outcomes.3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention. ### Conditions - Type 1 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Non-Medical Transition Coordinator ### Outcomes Primary Outcomes - Lost to Followup Secondary Outcomes - Patient Reported Outcome Survey 1 - Patient Reported Outcome Survey 2 - Patient Reported Outcome Survey 3 - Clinical Outcome 1 - Clinical Outcome 2 - Clinical outcome 3 - Clinical outcome 4 - Clinical Outcome 5 - Clinical Outcome 6 ### Location - Facility: Alberta Children's Hospital, Calgary, Alberta, N/A, Canada @@
## Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy - NCT ID: NCT06300034 - Study ID: bagattoni2 - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2022-03-01 - Lead Sponsor: University of Bologna ### Study Description Parental perceptions on staining due to Silver Diamine Fluoride (SDF) could affect its implementation in pediatric dentistry. This study represents the second part of a wider project focused on SDF aesthetic acceptability among Italian parents. ### Conditions - Perceptions - Acceptability - SDF ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Parental overall acceptance of SDF staining on anterior and posterior teeth Secondary Outcomes - Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior - Parental overall acceptability of SDF staining according to demographic background ### Location - Facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile, Bologna, N/A, N/A, Italy @@
## Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices - NCT ID: NCT06300021 - Study ID: PEC19242 - Status: COMPLETED - Start Date: 2021-09-14 - Completion Date: 2022-05-20 - Lead Sponsor: Givaudan France Naturals ### Study Description The goal of this clinical trial is to learn about the extent to which turmeric compounds in different food matrices becomes available to the body in healthy volunteers. The main question it aims to answer is:* Is the availability to the body of a turmeric dietary supplement altered when consumed in fruit nectar, oat milk, yogurt drink, or gummies in comparison to a dietary supplement capsule?Participants will ingest a turmeric dietary supplement as a capsule or in different food matrices on six testing days (separated by at least one week). The day before testing day, a standardized dinner will be provided to the participants in the evening and participants will be instructed to not consume any foods or beverages (except water) and to arrive fasted (12 hours) at the investigation site. Participants will ingest turmeric dietary supplement formulations one by one in random order in the morning of testing days. Regular blood and urine samples will be collected before and up to 24 hours after the turmeric dietary supplement ingestion. Standardized meals will be provided during the entire testing day (lunch, mid-afternoon snack, dinner). ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - TPG capsule - TPG ready to drink - TPG dairy analog - TPG probiotic drink - TPG gummies - TPG sport bar ### Outcomes Primary Outcomes - Dose-normalized AUC0-24h of total curcuminoids Secondary Outcomes - Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites - Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites - Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites - AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites - AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites - AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites - Relative bioavailability for normalized AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites - Relative bioavailability for normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites - Relative bioavailability for normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites - Cmax of total curcuminoids, curcuminoid compounds and of their metabolites - Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites - Half-life of total curcuminoids, curcuminoid compounds and of their metabolites - Tmax of total curcuminoids, curcuminoid compounds and of their metabolites ### Location - Facility: Biofortis, Saint-Herblain, N/A, 44800, France @@
## Cetylated Fatty Acid for Reducing Pain After TKA - NCT ID: NCT06300008 - Study ID: OrthoTU13 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-12 - Lead Sponsor: Thammasat University ### Study Description To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA. ### Conditions - Postoperative Pain - Postoperative Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - cetylated fatty acid - Placebo ### Outcomes Primary Outcomes - Visual analog scale - Visual analog scale - Visual analog scale - Visual analog scale - inflammatory marker - inflammatory marker - inflammatory marker - inflammatory marker - Knee skin temperature - Knee skin temperature - Knee skin temperature - Knee skin temperature Secondary Outcomes - Knee circumference (cm) - Knee circumference (cm) - Knee circumference (cm) - Knee circumference (cm) - Knee Range of Motion - Knee Range of Motion - Knee Range of Motion - Knee Range of Motion - Modified WOMAC - Modified WOMAC - Modified WOMAC - Thai forgotten joint score - Thai forgotten joint score - Thai forgotten joint score ### Location - Facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university, Khlong Luang, Pathumthani, 066, Thailand @@
## Phenotype and Burden of a Midfacial Segment Pain - NCT ID: NCT06299995 - Study ID: MFSP - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-24 - Completion Date: 2025-03-31 - Lead Sponsor: Swiat Zdrowia ### Study Description The purpose of this study is to describe midfacial segment pain phenotype, burden and comorbidities in a multicentre and multidisciplinary setting. The ultimate goal is a comprehensive description of this type of pain allowing for its implementation in future classifications.This cross-sectional study is designed to describe midfacial segment pain in a clinical setting. Patients from rhinologic, headache and facial pain or oral medicine/dentistry secondary care centres will be recruited during a one year period. Individuals with other facial pain according to current classification such as sinonasal disorders, neoplasms, local infections, history of significant trauma associated with pain onset will be excluded. Data will be collected through a structured questionnaire covering pain characteristics, coexisting diagnoses, pain-related burden and consequences, physical examination and paranasal sinuses imaging. ### Conditions - Facial Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pain characteristics Secondary Outcomes - Coexisting diagnoses - Pain-related burden and consequences ### Location - Facility: Department of Otolaryngology, University of Malta, Imsida, N/A, N/A, Malta @@
## An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO - NCT ID: NCT06299982 - Study ID: SSGJ-608-PsO-III-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-03-20 - Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ### Study Description The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis. ### Conditions - Plaque Psoriasis Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 608 Q2W - 608 Q4W ### Outcomes Primary Outcomes - Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) - Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement Secondary Outcomes - Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) - Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100) - Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) - Adverse events (AE) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest - NCT ID: NCT06299969 - Study ID: StBernwardH - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: St.Bernward Hospital ### Study Description The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA). ### Conditions - Out-Of-Hospital Cardiac Arrest ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - In-hospital mortality Secondary Outcomes - CPC score - MRS ### Location - Facility: St Bernward Hospital, Hildesheim, Niedersachsen, 31134, Germany @@
## Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark - NCT ID: NCT06299956 - Study ID: 2023-SFHHB-IC-001 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2029-01 - Lead Sponsor: Slagelse Hospital ### Study Description The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.The objective of this project is to describe:1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.3. Outcomes available for assessment of benefits and harms from the SET intervention.Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking. ### Conditions - Intermittent Claudication ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Supervised exercise therapy ### Outcomes Primary Outcomes - Maximal Walking Distance Secondary Outcomes - Pain-free walking distance - Vascular Quality of Life Questionnaire-6 (VASCUQoL-6) ### Location - Facility: PROgrez, Slagelse, N/A, 4700, Denmark @@
## Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke - NCT ID: NCT06299943 - Study ID: BiofeedbackTargetGaitTraining - Status: RECRUITING - Start Date: 2022-01-24 - Completion Date: 2025-12-30 - Lead Sponsor: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health ### Study Description Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults. ### Conditions - Stroke - Biofeedback - Gait, Hemiplegic - Gait Training - Hemiparesis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biofeedback gait training by biomechanical target parameter ### Outcomes Primary Outcomes - Gait cycle - Foot clearance - Speed of walking - Stance phase - Single support phase - Hip joint amplitude - Knee joint amplitude - Ankle joint amplitude - EMG amplitude of tibialis anterior muscle - EMG amplitude of gastrocnemus muscle - EMG amplitude of quadriceps femoris muscle - EMG amplitude of Hamstring muscle Secondary Outcomes - Muscle strength - Activities of Daily Living - Modified Rankin Scale for Neurologic Disability - The Timed Up and Go Test - The Medical Research Council Weakness Scale ### Location - Facility: FCCerebroPathStroke, Moscow, N/A, 117997, Russian Federation @@
## Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy - NCT ID: NCT06299930 - Study ID: LRR after NACT vs ACT - Status: COMPLETED - Start Date: 2022-04-22 - Completion Date: 2023-09-12 - Lead Sponsor: Seoul National University Hospital ### Study Description Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neoadjuvant chemotherapy - Adjuvant chemotherapy ### Outcomes Primary Outcomes - Locoregional recurrence-free survival (LRR) Secondary Outcomes - Distant metastasis-free survival ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## WORK-ON Vocational Rehabilitation for People With Inflammatory Arthritis - NCT ID: NCT06299917 - Study ID: CeViG - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-09-01 - Lead Sponsor: The Danish Center for Expertise in Rheumatology ### Study Description People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues.Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline. ### Conditions - Rheumatoid Arthritis - Psoriatic Arthritis - Axial Spondyloarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - WORK-ON ### Outcomes Primary Outcomes - Work Ability Index (WAI) single item Secondary Outcomes - Job loss - Work hours per week - Work Productivity and Activity Impairment questionnaire, general health (WPAI:GH) - Sickness absenteeism - Work ability in relation to demands - Job insecurity - Physical activity while at work - Occupational balance - Health related quality of life - VAS Pain - Fatigue - Physical activity - Mental well-being - Sleep - Work Ability Index (WAI) single item ### Location - Facility: Danish Hospital for Rheumatic Diseases, Sønderborg, N/A, 6400, Denmark @@
## Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke - NCT ID: NCT06299904 - Study ID: stroke - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-12-01 - Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University ### Study Description To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Modified Air-pulse Stimulation - Conventional air-pulse stimulation ### Outcomes Primary Outcomes - the score of Fiberoptic endoscopic examination of swallowing (FEES) - the score of Murray's secretion scale (MSS) - the score of penetration-aspiration scale (PAS) Secondary Outcomes - the score of Clinical Pulmonary Infection Score (CPIS) ### Location - Facility: the Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116024, China @@
## Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity - NCT ID: NCT06299891 - Study ID: PhT_HypOb_Protocol_Clean_07-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-31 - Lead Sponsor: Seattle Children's Hospital ### Study Description Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness.Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 12-28-year-old individuals with HO. ### Conditions - Hypothalamic Obesity - Hypothalamic Tumor - Craniopharyngioma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] - Placebo ### Outcomes Primary Outcomes - Treatment-emergent adverse events Secondary Outcomes - Maximum tolerated dose - % change in BMI - Proportion of individuals who experience 5% decrease in BMI - Proportion of individuals who experience 2.5% decrease in BMI - Change in body fat mass - Change in visceral fat mass - Change in hunger - Change in energy intake ### Location - Facility: The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States @@
## MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns] - NCT ID: NCT06299878 - Study ID: MelPRO-0322 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-07-01 - Lead Sponsor: Russian Academy of Medical Sciences ### Study Description The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:* radiological and pathological response rate to three doses of antiPD1 agents;* do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years. ### Conditions - Melanoma, Skin - Melanoma Stage Iii ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gut microbiota analysis ### Outcomes Primary Outcomes - 2-year disease-free survival Secondary Outcomes - pathological response rate ### Location - Facility: N.N. Blokhin Russian Cancer Research Center, skin tumor department, Moscow, N/A, 115478, Russian Federation @@
## Comparison of Detection Rates Between Two Commonly Used Bone Density Measurement Methods - NCT ID: NCT06299865 - Study ID: YXLL-KY-2023（150） - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Xiaoqian Zhang ### Study Description 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.1. Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.).2. Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.3. Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.4. Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P\<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis. ### Conditions - Osteoporosis - Diagnosis - Dual Energy X-ray Absorptiometry - Quantitative Computed Tomography ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ungrouped ### Outcomes Primary Outcomes - Comparison of the difference in detection rates of osteoporosis between dual energy X-ray and quantitative CT Secondary Outcomes ### Location - Facility: Shandong Provincial Qianfoshan Hospital, Jinan, Shandong, N/A, China @@
## Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer - NCT ID: NCT06299852 - Study ID: TK01 - Status: RECRUITING - Start Date: 2022-07-01 - Completion Date: 2025-09-01 - Lead Sponsor: N.N. Petrov National Medical Research Center of Oncology ### Study Description This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT.The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT.The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure. ### Conditions - HER2-positive Metastatic Breast Cancer - Oligometastatic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trastuzumab emtansine ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Progression free survival (PFS) - Toxicity profile - Second co-primary outcome measure is quality of life ### Location - Facility: N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, N/A, N/A, Russian Federation @@
## PAS-004 in Patients With Advanced Solid Tumors - NCT ID: NCT06299839 - Study ID: PAS-004-102 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2027-02 - Lead Sponsor: Pasithea Therapeutics Corp. ### Study Description The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are:* How well participants are able tolerate different doses of PAS-004, and* What side effects PAS-004 might have.Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, or until:* They decide to withdraw from the study, or* They experience unacceptable side effects, or* Their disease progresses, or another illness interferes with taking the study drug, or* The sponsors stops the study. ### Conditions - RAS Mutation - NF1 Mutation - RAF Mutation - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PAS-004 ### Outcomes Primary Outcomes - Evaluation of dose limiting toxicities (DLTs) - Evaluation of adverse events (AEs) - Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004. - Evaluation of hematology laboratory parameters - Evaluation of clinical chemistry laboratory parameters Secondary Outcomes - Apparent terminal elimination half-life (t1/2) in Plasma - Peak Plasma Concentration (Cmax) - Plasma predose or trough concentration (Ctau/Ctrough) - Time of maximum plasma concentration (Tmax) - Area under the concentration versus time curve from time zero to the last sampling time with quantifiable analyte (AUC0-t) - Area under the concentration versus time curve from time zero extrapolated to infinity if possible (AUC0-∞) - Area under the concentration versus time curve for the dosing interval, assuming steady state has been reached and duplicating the predose concentration for the 24 hour postdose concentration (AUC0-tau) - Apparent total plasma clearance if possible (CL/F) - Evaluation of the percentage of extracellular signal-regulated kinase phosphorylation (pERK) inhibition from baseline - Evaluation of the objective response rate (ORR) - Evaluation of progression-free survival (PFS) - Evaluation of overall survival (OS) ### Location - Facility: NEXT Oncology, Austin, Texas, 78758, United States @@
## A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure - NCT ID: NCT06299826 - Study ID: D9090C00008 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-10 - Completion Date: 2025-11-24 - Lead Sponsor: AstraZeneca ### Study Description The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF). ### Conditions - Chronic Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AZD5462 - Placebo ### Outcomes Primary Outcomes - Cohort A and B: Change from Baseline in Ejection Fraction Secondary Outcomes - Cohort A and B: Change from Baseline in Ejection Fraction - Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS) - Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC) - Cohorts A and B: Percentage Change from Baseline in cardiac biomarkers - Cohorts A and B : Plasma Concentration of AZD5462 - Cohorts A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection - NCT ID: NCT06299813 - Study ID: 771.284 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-04-01 - Lead Sponsor: A.O.U. Città della Salute e della Scienza ### Study Description The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation.The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations. ### Conditions - Adenovirus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bentelan - Placebo ### Outcomes Primary Outcomes - Proportion of patients with a sustained fever resolution at 24 hours from randomization Secondary Outcomes - Pharyngeal-tonsillar pain level in patients younger than 36 months - Hospitalization - Duration of hospitalization (among those hospitalized), measured in days - Cumulative incidence of fever resolution - Fever duration - Pharyngeal-tonsillar pain level in patients older than 36 months ### Location - Facility: Ospedale Infantile Regina Margherita, Torino, N/A, 10126, Italy @@
## Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer - NCT ID: NCT06299800 - Study ID: CE385/2023 - Status: RECRUITING - Start Date: 2024-02-04 - Completion Date: 2025-02-04 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice.Primary objective of the study:- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus;Secondary objectives of the study:* description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus;* assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes;* assess the relationship between the characteristics of patients and the time to the onset of cancer. ### Conditions - Diabetes Mellitus, Type 2 - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - phenotyping of patients followed at a third-level diabetes centre with cancer ### Outcomes Primary Outcomes - Smoking assessment at first visit - Alcool consumption at first visit - BMI assessment at first visit - Glycated assessment at first visit Secondary Outcomes - First-line therapy characteristics assessment at first visit - Primary outcomes and recurrence or presence of a secondary tumor - Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data - Tumour characterization in the considered population, detected at the first clinical visit ### Location - Facility: SCDU Endocrinology, AOU Ospedale Maggiore della Carità, Novara, N/A, 28100, Italy @@
## Cognitive Dysfunction in the Addictions Study - Project 4 (P4) - NCT ID: NCT06299787 - Study ID: 058-2021 - Status: RECRUITING - Start Date: 2022-02-07 - Completion Date: 2025-07-01 - Lead Sponsor: Centre for Addiction and Mental Health ### Study Description The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder. ### Conditions - Major Depressive Disorder - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - intermittent theta burst stimulation - Sham stimulation ### Outcomes Primary Outcomes - Executive Function Index - inhibition - Executive Function Index - working memory - Executive Function Index - set shifting Secondary Outcomes - 17-Item Hamilton Depression Rating Scale (HRSD-17) ### Location - Facility: Centre for Addiction and Mental Health, Toronto, Ontario, M6J 1H4, Canada @@
## Emergency Care at Home - NCT ID: NCT06299774 - Study ID: 2023P003383 - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2025-03-02 - Lead Sponsor: Brigham and Women's Hospital ### Study Description This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department. ### Conditions - Emergency Medical Services - Emergency Department Visits ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Emergency care at home - Emergency care at a brick-and-mortar emergency department ### Outcomes Primary Outcomes - Participant with an emergency department presentation, observation, or hospitalization within 9 days Secondary Outcomes - Time to care initiation - Time spent receiving care - Number of days at home within 9 days ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications - NCT ID: NCT06299761 - Study ID: BBI-825-101 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2027-02 - Lead Sponsor: Boundless Bio ### Study Description BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BBI-825 ### Outcomes Primary Outcomes - Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825 - Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825 Secondary Outcomes - Maximum observed plasma concentration (Cmax) of BBI-825 - Trough observed plasma concentration (Ctrough) of BBI-825 - Time to Cmax (Tmax) of BBI-825 - Area under the concentration time curve (AUC) of BBI-825 - Anti-tumor activity of BBI-825 as determined by RECISTv1.1 ### Location - Facility: Sarcoma Oncology Research Center, Santa Monica, California, 90403, United States @@
## A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding. - NCT ID: NCT06299748 - Study ID: ARGX-113-PAC-2206 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2033-12 - Lead Sponsor: argenx ### Study Description This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported. ### Conditions - Myasthenia Gravis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Efgartigimod ### Outcomes Primary Outcomes - Pregnancy outcomes Secondary Outcomes - Congenital malformations - The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness) - Maternal complications of pregnancy - Maternal infections - The number of observed fetal growth deficiency ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation - NCT ID: NCT06299735 - Study ID: AsenaIremYildiz1 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-09-30 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques. ### Conditions - Heart Valvular Disease - Coronary Arteriosclerosis - One-lung Ventilation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Minimally Invasive Cardiac Surgery (airway management with double-lumen tube) - Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker) ### Outcomes Primary Outcomes - Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker Secondary Outcomes - Duration of insertion of the double-lumen tube / bronchial blocker - Incidence of postoperative sore throat - Incidence of postoperative hoarseness - Impact of the success of lung collapse - Satisfactory lung collapse time ### Location - Facility: Ankara bilkent city hospital, Ankara, Çankaya, 06530, Turkey @@
## Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents - NCT ID: NCT06299722 - Study ID: N-20230055 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-07 - Lead Sponsor: Aalborg University ### Study Description We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis). ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - STEEL - Circuit training ### Outcomes Primary Outcomes - Isometric strength Secondary Outcomes - Health-related quality of life - Step counts - Caloric expenditure - Maximal dynamic strength - Bone mineral density of the lumbar spine and body composition - Grip strength and rate of force development - Muscular strength, endurance, and rate of force development - Cardiorespiratory fitness and endurance - Exercise compliance and fidelity - Adverse events - Movement-evoked pain - Satisfaction with the intervention - Blood glucose - Glycated hemoglobin (Hba1c) - Insulin - Proinsulin c-peptide - Total cholesterol - High-density lipoprotein cholesterol - Low-density lipoprotein cholesterol - Very low-density lipoprotein cholesterol - Triglycerides - Glucagon - Homeostatic Model assessment for Insulin resistance score - Body Mass Index (BMI) - Lean body mass - Fat mass - Android/gynoid fat distribution - Abdominal circumference - Self-reported Tanner staging - Blood pressure ### Location - Facility: Rigshospitalet, Copenhagen, N/A, N/A, Denmark @@
## A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA) - NCT ID: NCT06299709 - Study ID: VX23-121-012 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-06 - Lead Sponsor: Vertex Pharmaceuticals Incorporated ### Study Description The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA. ### Conditions - Cystic Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - VNZ/TEZ/D-IVA - VNZ/TEZ/D-IVA ### Outcomes Primary Outcomes - Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA - Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA - Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA - Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA Secondary Outcomes - Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) ### Location - Facility: Celerion, Inc., Tempe, Arizona, 85283, United States @@
## A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists - NCT ID: NCT06299696 - Study ID: VX23-121-011 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-26 - Completion Date: 2024-05 - Lead Sponsor: Vertex Pharmaceuticals Incorporated ### Study Description The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules. ### Conditions - Cystic Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - VNZ/TEZ/D-IVA ### Outcomes Primary Outcomes - Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method Secondary Outcomes ### Location - Facility: Site 001, Woburn, Massachusetts, 01801, United States @@
## Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment - NCT ID: NCT06299683 - Study ID: 230487 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-08-04 - Lead Sponsor: Vanderbilt University Medical Center ### Study Description Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. ### Conditions - Chronic Interstitial Cystitis - Bladder Pain Syndrome - Painful Bladder Syndrome - Cystitis, Interstitial - Cystitis, Chronic Interstitial - Interstitial Cystitis - Interstitial Cystitis, Chronic - Interstitial Cystitis (Chronic) With Hematuria - Interstitial Cystitis (Chronic) Without Hematuria - Chronic Prostatitis - Chronic Prostatitis With Chronic Pelvic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Psychosocial Treatment - Pelvic Floor Physical Therapy ### Outcomes Primary Outcomes - Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale. Secondary Outcomes - Chronic Overlapping Pain Condition-Screener (COPCS) - Quantitative Sensory Testing - Tolerance Average (QST-TOL) - Quantitative Sensory Testing - Threshold Average (QST-THR) - Quantitative Sensory Testing - Temporal Summation (QST-TS) - Urinary Nerve Growth Factor (NGF) - Urinary Interleukin-6 (IL6) - Interleukin-6, whole blood stimulated (IL6-LPS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial - NCT ID: NCT06299670 - Study ID: 939 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-12-31 - Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh ### Study Description Transfusion Dependent Thalassemia (TDT) is an emerging global public health concern. Hemopoietic stem cell transplantation (HSCT) is the only curative treatment. But its adoption is limited due to lack of HLA matched donor, experienced centers and high initial cost. So, researches are going on in search of an effective, safe, easily available treatment option. Use of fetal haemoglobin inducing agents shows promising effects in treatment of TDT patients. Thalidomide an immunomodulating and anti-angiogenic drug has been shown to induce γ-globin gene expression and increase the proliferation of erythroid cells. Furthermore Hydroxyurea (HU) is known to increase haemoglobin (Hb) by HbF induction and reduction of inflammation and hypercoagulability.Recent studies with combination of HU and Thalidomide have shown promising results in treatment of Thalassemia patients. However, most of those studies are retrospective or single arm nonrandomized trials \& The study population includes both adult and children age group . So the effectiveness of combination therapy of Thalidomide and HU needs to be established through randomized trials.This single centered non blinded quasi randomized clinical trial will be conducted at the Department of Pediatric Hematology and Oncology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh for one year of period. Thirty transfusion dependent thalassemia children of 3-18 years old will be included in each group. The objective of this study is to assess the effectiveness of combination of Thalidomide and Hydroxyurea in TDT children. It will play an important role in planning a cost effective and affordable treatment option for TDT children.This study will involve minimum physical risk to the patient. Written informed consent will be taken from parents or study subjects after brief explanation of the purpose and procedure. They will also be informed about the freedom to participate or not to participate at any time. Privacy and confidentiality will be safe guarded. History regarding age, sex, height, weight of these patients will be taken. Thorough physical examinations and laboratory investigations including CBC, Hb electrophoresis, serum Ferritin, serum creatinine, SGPT will be done. Data will be collected in a predesigned questionnaire and will be kept confidential. Statistical analysis will be done using the statistical software SPSS. ### Conditions - Transfusion-dependent Thalassemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thalidomide - Hydroxy Urea - Combinations ### Outcomes Primary Outcomes - Change in Hb Level - Change in Blood transfusion frequency - Change in HbF Secondary Outcomes - Change in Biochemicals - Adverse effect ### Location - Facility: Bangabandhu Sheikh Mujib Medical University, Dhaka, N/A, 1000, Bangladesh @@
## Intervention for Managing Physical Reactions to Overwhelming Emotions - NCT ID: NCT06299657 - Study ID: 2023H0286 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Ohio State University ### Study Description The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP.This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET).Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for \~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention. ### Conditions - Anxiety - Substance Use Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - IMPROVE - PHET ### Outcomes Primary Outcomes - Intolerance of Uncertainty-12 Scale - Anxiety Sensitivity-3 Scale - PROMIS Anxiety Short Form - Timeline Followback - Desire for Drug Questionnaire - Penn Alcohol Craving Scale - Hyperkatifeia Interference Scale - Alcohol Version. - Clinical Institute Withdrawal Assessment Alcohol Scale Revised. - Hyperkatifeia Interference Scale - Opioid Version. - Subjective Opiate Withdrawal Scale - NPU Threat Task - Straw Breathing Avoidance Task - Emotion Picture Paradigm Task Secondary Outcomes ### Location - Facility: Ohio State University Department of Psychiatry and Behavioral Health, Columbus, Ohio, 43062, United States @@
## Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss - NCT ID: NCT06299644 - Study ID: 2023P003282 - Status: NOT_YET_RECRUITING - Start Date: 2025-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss. ### Conditions - Obesity - Obesity, Morbid - Metabolic Disease - Weight, Body ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Endoscopic Sleeve Gastroplasty - Belt and Suspenders - Endoscopic Sleeve Gastroplasty - Belt ### Outcomes Primary Outcomes - Percent TWL (%TWL) - Adverse Events Secondary Outcomes - Gastric Emptying - Number of participants with improvement in fasting glucose - Number of participants with improvement in Hemoglobin A1c (HgA1c %) - Improvement in fasting lipids profile - Number of participants with a change in ghrelin hormone values - Obesity-related comorbidities - hypertension - Obesity-related comorbidities - change in hypertension concomitant medications - Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications - Obesity-related comorbidities - pre-diabetes/diabetes - Obesity-related comorbidities - gastroesophageal reflux (GERD) ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Endoscopic Relapse Risks Evaluation After Ileocolic Resection for Crohn's Disease - NCT ID: NCT06299631 - Study ID: RECHMPL23_0187 - Status: COMPLETED - Start Date: 2015-01 - Completion Date: 2023-12 - Lead Sponsor: University Hospital, Montpellier ### Study Description Aim of the study:To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents.Methods:From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected.Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period.Short and long-term outcomes were compared between the two groups.Primary outcome:Endoscopic recurrence (defined as \> i2 lesions according to Rutgeerts classification) 6 months after surgery ### Conditions - Crohn's Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ileocolic resection ### Outcomes Primary Outcomes - Endoscopic recurrence rate Secondary Outcomes - Resection margins - Length of resected specimen - Duration of surgery - Intra-operative blood loss - Postoperative morbidity rate - Mortality rate - Myenteric plexitis - Number of inflammatory cells in myenteric plexuses ### Location - Facility: Montpellier University Hospital, Montpellier, N/A, 34295, France @@
## Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism - NCT ID: NCT06299618 - Study ID: ENIGMA-I - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: University College Cork ### Study Description The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism. ### Conditions - Autism - Autism Spectrum Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Symptoms of anxiety - Symptoms of anxiety - Symptoms of depression - Symptoms of depression Secondary Outcomes ### Location - Facility: University College Cork, Cork, N/A, N/A, Ireland @@
## Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori - NCT ID: NCT06299605 - Study ID: SHARE2401 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-11 - Lead Sponsor: Shandong University ### Study Description The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated. ### Conditions - Helicobacter Pylori Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days - Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days - Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days ### Outcomes Primary Outcomes - Eradication rate Secondary Outcomes - Rate of adverse reactions - Patient compliance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Microglial Activation in Severe Asthma and Healthy Controls - NCT ID: NCT06299592 - Study ID: 2023-1626 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2028-08 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are:* How airway inflammation in asthma affects the brain; and,* Whether airway inflammation in asthma is related to symptoms of depression and anxietyOver the course of 3 visits, participants will:* Complete questionnaires* Complete computer tasks* Undergo allergy skin test and breathing tests* Give two blood samples* Give a sputum sample* Complete brain imaging scansResearchers will compare results between participants with asthma, and participants who do not have asthma. ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PET/MRI using [18F]FEPPA tracer ### Outcomes Primary Outcomes - Binding of [18F]-FEPPA Secondary Outcomes - How activated microglia correspond to immune biomarkers in lung and blood - Relationship between activated microglia and cognitive function - Relationship between activated microglia and psychological symptoms ### Location - Facility: Center for Healthy Minds, Madison, Wisconsin, 53703, United States @@
## GD-11 for Injection in the Treatment of Acute Ischemic Stroke - NCT ID: NCT06299579 - Study ID: WG-GD11-III-01 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-12-31 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment. ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GD-11 for injection test group - Placebo control group ### Outcomes Primary Outcomes - Proportion of subjects with mRS score ≤1 on 90th day of treatment Secondary Outcomes ### Location - Facility: Beijing Tiantan Hospital Capital Medical University Beijing, Beijing, Beijing, 100000, China @@
## Perceptions of the CF Screening Protocol Incorporating NGS - NCT ID: NCT06299566 - Study ID: CF NGS - Status: COMPLETED - Start Date: 2022-01-19 - Completion Date: 2023-02-28 - Lead Sponsor: King's College London ### Study Description Newborn bloodspot screening (from now on referred to as screening) for cystic fibrosis (CF) became part of the national screening programme in 2007. Screening for CF is also well established internationally. The current process works well but has some disadvantages: carrier reporting - which is not the intention of CF screening in the UK (\~200 pa); need for repeat samples which can be costly and contribute to parental worry (\~300 pa.); mutation panels not fully reflecting the ethnic diversity of the birth population; identification of children designated as CF screen positive, inconclusive diagnosis (CFSPID) which can cause uncertainty (\~20-30 pa).A trial of NGS in one centre in the UK, for one year found that it was technically feasible at reasonable cost and with an acceptable turn around time. In addition, the trial determined that using NGS could mitigate against some of the disadvantages described above.The purpose of this piece of work was to:1. Gather, compare and analyse the views of a range of stakeholders on the proposed CF screening protocol incorporating NGS.2. Use the outcomes to inform discussions and decisions by the fetal, maternal and child health (FMCH) group and UK National Screening Committee (NSC) about the proposed protocol3. Consider what generalisable information on the views of stakeholders on newborn screening could be generated from this exercise to inform other FMCH and UK NSC discussions4. Evaluate and learn from the exercise to inform future stakeholder engagement activities by the UK NSC and screening programmes. ### Conditions - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Focus groups/interviews/questionnaires exploring stakeholder views of the proposed CF screening protocol incorporating NGS. Secondary Outcomes - Focus groups/interviews/questionnaires exploring stakeholder views on equivocal, carrier, false positives/negatives results, late onset/uncertain conditions - Q sorts used to develop data and materials FMCH and UK NSC can use to engage stakeholders - Surveys to explore principles of engagement for stakeholders ### Location - Facility: King's College London, London, N/A, SE5 9RS, United Kingdom @@
## Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) - NCT ID: NCT06299553 - Study ID: INCB88888-040 PRO-MIND - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2027-06-30 - Lead Sponsor: Incyte Biosciences Italy S.r.l ### Study Description The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL. ### Conditions - DLBCL - Diffuse Large B Cell Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Progression free survival (PFS) Secondary Outcomes - Baseline Characteristics - Overall Response Rate (ORR) - Duration of Response (DoR) - Time to next treatment (TTNT) - Time to response - Overall Survival (OS) - Disease Control Rate (DCR) - Event Free Survival (EFS) - Progression-Free-Survival 2 (PFS2) - Information of which treatment the patients will get after tafasitamab discontinuation - Safety of tafasitamab combined with lenalidomide - Safety of tafasitamab in monotherapy - Describe the treatment adherence of lenalidomide and dose reduction. - Health-Related Quality of Life (HRQoL) - Health-Related Quality of Life (HRQoL) - Health economics - Hospitalization - Health economics - DLBCL treatment - Health economics - Concomitant Treatments - Health economics - Monitoring activities - Health economics - monitoring activities performed after patients' discharge - Health economics - Adverse event treatment - Health economics - Unplanned specialist visits - Exploratory objectives - Exploratory objectives ### Location - Facility: Incyte Biosciences Italy S.r.l, Milan, N/A, 20122, Italy @@
## Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia - NCT ID: NCT06299540 - Study ID: 54179060CLL4033 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-09-30 - Lead Sponsor: Janssen Cilag S.A.S. ### Study Description The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G). ### Conditions - Leukemia, Lymphocytic, Chronic, B-Cell ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Individual Physical Activity Intervention (IPAI) - Ibrutinib ### Outcomes Primary Outcomes - Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5 Secondary Outcomes - Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12 - Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5 - Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12 - Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12 - Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5 - Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12 - Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12 - Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5 - Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12 - Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline - Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12 - Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Total Score and Sub Score at Month 4.5, Month 6.5, and Month 12 - Change From Baseline in Total Sleep Time Using Connected Watch - Change From Baseline in Total Sleep Score Using Connected Watch - Change From Baseline in Sleep Stages Using Connected Watch - Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12 - Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12 - Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch - Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch - Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch - Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch - Percentage of Participants with Treatment-related Adverse Events - Time to Treatment Discontinuation (TTD) - Reasons for Treatment Discontinuation - Percentage of Participants Who Still Wear the Connected Watch - Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch) - Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment - For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI - For Group 1: Percentage of Participants Who Follow the Adapted Physical Activity (APA) Sessions, the Walking Objectives and the APA Appointment as Scheduled With the APA Among Those Who Have Started IPAI - For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study - For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study - For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study - For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Telerehabilitation in Patients With Fibromyalgia - NCT ID: NCT06299527 - Study ID: 01032024 - Status: COMPLETED - Start Date: 2023-05-27 - Completion Date: 2024-01-27 - Lead Sponsor: Marmara University ### Study Description Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16). ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise Program ### Outcomes Primary Outcomes - Visual Analog Scale Secondary Outcomes - Revised Fibromyalgia Impact Questionnaire - Pain Catastrophizing Scale - Hospital Anxiety and Depression Scale - 6 Minute Walk Test - Arm Curl Test - Laser Cursor Assisted Angle Repetition Test (LI-RATT) - Short Form - 12 ### Location - Facility: Faculty of Health Sciences, Istanbul, Maltepe, 1464185881, Turkey @@
## RAFT-P&A Randomized Control Trial - NCT ID: NCT06299514 - Study ID: 4754 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2029-12-31 - Lead Sponsor: Lawson Health Research Institute ### Study Description Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy. ### Conditions - Atrial Fibrillation - Heart Failure - Pacemaker - Arrhythmia Atrial ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pace and Ablate - Medication ### Outcomes Primary Outcomes - Winratio Secondary Outcomes - All-cause mortality - Cardiovascular mortality - Number of heart failure events - All-cause hospitalization - Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ) - Exercise - Biochemical marker ### Location - Facility: London Health Sciences Centre - University Hospital, London, Ontario, N6A5A5, Canada @@
## How Can Child Health Services Identify and Respond to Family Violence - NCT ID: NCT06299501 - Study ID: LS 2015-1199 and 2017-24 - Status: COMPLETED - Start Date: 2017-08-23 - Completion Date: 2019-08-31 - Lead Sponsor: Karolinska Institutet ### Study Description Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. This study is a three-armed randomized controlled trial (RCT) conducted to assess the effectiveness of different approaches to identify family violence within CHS. Two different approaches are tested and compared to treatment as usual; 1) information about family violence at home visit when child is newborn, and questions posed to all mothers at the 6-8-week visit; 2) information about family violence at home visit when child is newborn, and questions posed to mothers on evidence based indication. Nurses who are randomized into any of the two intervention arms receive training and supervision. The outcomes of the study are related to knowledge, attitudes, and practices around identification and support in case of family violence and number of identified cases of family violence. ### Conditions - Family Violence - Domestic Violence - Intimate-partner Violence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Routine questions - Questions on evidence based indication - Treatment as usual ### Outcomes Primary Outcomes - Knowledge, attitudes and practices Secondary Outcomes - Number of cases of family violence ### Location - Facility: Central Child Health Care (Centrala barnhälsovården), Stockholm, N/A, N/A, Sweden @@
## Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia - NCT ID: NCT06299488 - Study ID: PS03 - Status: COMPLETED - Start Date: 2023-04-05 - Completion Date: 2023-07-01 - Lead Sponsor: Lakshmi Nutraceuticals LLC ### Study Description Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf extract) on sleep. The purpose of this study is to evaluate the effects of taking this combination product on various aspects of sleep. This study is being conducted by People Science, and is sponsored by Lakshmi Nutraceuticals, LLC. The information we gather will help inform how people may use Sip2Sleep® to affect the quality of sleep.Participants in this study will complete a number of surveys about their difficulties falling asleep and staying asleep (insomnia), their energy level during the day and health status regarding their quality of sleep.There are no major risks associated with this study. ### Conditions - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Sip2Sleep: Montmorency Cherry and Apocynum Venetum ### Outcomes Primary Outcomes - Subjective Sleep Quality Secondary Outcomes - Insomnia Sleep Index - Generalized Anxiety Disorder-7 (GAD-7) - Subjective Alertness ### Location - Facility: People Science Inc., West Hollywood, California, 90069, United States @@
## Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC - NCT ID: NCT06299475 - Study ID: 2023-06755-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-09 - Lead Sponsor: Karolinska Institutet ### Study Description To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP). ### Conditions - Contraception ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Online counseling and invitation ### Outcomes Primary Outcomes - Use of effective contraception Secondary Outcomes - Contraceptive use - Incidence of pregnancy and abortion - Satisfaction with the intervention - Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups - Process evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PTCy and ATG for MSD and MUD Transplants - NCT ID: NCT06299462 - Study ID: PTCy-ATG-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-21 - Completion Date: 2031-06-01 - Lead Sponsor: Instituto Nacional de Cancer, Brazil ### Study Description Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).Since then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.This is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors. ### Conditions - Acute Myeloid Leukemia - Acute Lymphoblastic Leukemia - Myelodysplastic Syndromes - Hodgkin Lymphoma - Non-hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ATG 5.0 - Cyclophosphamide injection - ATG 2.5±1.5 ### Outcomes Primary Outcomes - Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria Secondary Outcomes - Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria - Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949 - Cumulative incidence of chronic GVHD as defined by the NIH criteria - Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria - Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse - Cumulative incidence of relapse, defined as > 5% blasts in bone marrow or 1% blasts in peripheral blood (acute leukemias/myelodysplasia) or biopsy proven relapse or positve PET-CT (lymphoma) - Rate of overall survival - Rate of disease-free survival (death or relapse) - Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment) - Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms) - Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL) - Measuremnt of quality of life using the FACT-BMT scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement - NCT ID: NCT06299449 - Study ID: KFSIRB200-174 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-03-20 - Lead Sponsor: Kafrelsheikh University ### Study Description Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach. ### Conditions - Implant Complication - Dental Implant Failed ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - free-hand socket shield - AI/guided socket shield ### Outcomes Primary Outcomes - Stability Quotient of dental implant - pink esthetic score - Midfacial Mucosal Alterations - facial marginal bone level Secondary Outcomes ### Location - Facility: faculty of dentistry, kafrelsheikh University, Kafr Ash Shaykh, Kafrelsheikh, 214312, Egypt @@
## Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure - NCT ID: NCT06299436 - Study ID: IRB00426760 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-03-31 - Lead Sponsor: Johns Hopkins University ### Study Description Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH. ### Conditions - Heart Failure With Reduced Ejection Fraction - Pulmonary Hypertension - Right Heart Failure Due to Left Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnostic accuracy based on Area Under Curve (AUC) Secondary Outcomes - Percentage improvement in ex vivo right ventricular tissue sample - Predictive capacity (based on likelihood ratio) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients - NCT ID: NCT06299423 - Study ID: 3677 - Status: RECRUITING - Start Date: 2023-11-22 - Completion Date: 2025-11-30 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring. ### Conditions - Inflammatory Bowel Diseases - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - Howdy Senior® device ### Outcomes Primary Outcomes - Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV) Secondary Outcomes - Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI) - Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S) - Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery - 90-day postoperative complications - Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV) - Healthcare costs ### Location - Facility: IRCCS Humanitas Research Hospital, Rozzano, MI, 20089, Italy @@
## PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects - NCT ID: NCT06299410 - Study ID: ITI-1284-008 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Intra-Cellular Therapies, Inc. ### Study Description The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ITI-1284 10 mg - ITI-1284 20 mg ### Outcomes Primary Outcomes - % Receptor occupancy Secondary Outcomes - Pharmacokinetics: AUC0-t - Pharmacokinetics: Cmax - Pharmacokinetics: Tmax - Percentage of subjects with treatment-emergent adverse events - Change from baseline in ECG QT interval - Change from baseline in aspartate aminotransferase - Change from baseline in alanine aminotransferase ### Location - Facility: Clinical Site 1, New Haven, Connecticut, 06520, United States @@
## Breastfeeding Education and Humor-Based Practices on Breastfeeding - NCT ID: NCT06299397 - Study ID: Inonu-SBF-4 - Status: COMPLETED - Start Date: 2023-06-14 - Completion Date: 2024-02-14 - Lead Sponsor: Inonu University ### Study Description The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'. ### Conditions - Humor as Topic - Breast Feeding - Mother-Child Relations - Breastfeeding, Exclusive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - breastfeeding - humor training - Control Group ### Outcomes Primary Outcomes - Breastfeeding Motivation Scale Secondary Outcomes - Maternal Attachment Scale ### Location - Facility: Simge OZTURK, Bartin, N/A, 74100, Turkey @@
## The Use of Voice-Based AI in 988 Crisis Counseling - NCT ID: NCT06299384 - Study ID: R44MH133517 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-08 - Lead Sponsor: Lyssn.io, Inc. ### Study Description Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. Our goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities. ### Conditions - Suicide - Suicide and Self-harm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - LyssnCrisis ### Outcomes Primary Outcomes - Post-Call Survey - Call-taker crisis counseling fidelity - System Usability Scale (SUS) - Acceptability of Intervention Measure; AIM - Intervention Appropriateness Measure; IAM - Feasibility of Intervention Measure; FIM Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations - NCT ID: NCT06299371 - Study ID: MA-NSCLC-II-033 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2029-04-15 - Lead Sponsor: Liaoning Tumor Hospital & Institute ### Study Description This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab - paclitaxel for injection (albumin bound) - Cisplatin or Carboplatin ### Outcomes Primary Outcomes - Pathological complete response rate Secondary Outcomes - Major pathologic response rate - R0 rate - Event Free Survival - Overall Survival - Objective response rate - Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic - NCT ID: NCT06299358 - Study ID: KMU_MPEPE_1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-06 - Completion Date: 2025-01-01 - Lead Sponsor: Karamanoğlu Mehmetbey University ### Study Description Infantile colic is a developmental disorder that reduces comfort levels in infants with intense crying crises and has negative effects on the infant and family. The study is planned to measure the effect of the combination of maternal heart sound simulation, aromatic foot massage and maternal heart sound simulation and aromatic foot massage on the colic and comfort levels of infants with infantile colic. It is aimed to alleviate colic symptoms, increase comfort levels, regulate daily crying and sleep durations (increase in sleep durations, decrease in crying durations) and support the development of infants in this context by using maternal heart sound simulation, aromatic foot massage and their combined application. ### Conditions - Nurse's Role - Infantile Colic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Foot massage - Mother heart sound - Foot massage and maternal heart sound ### Outcomes Primary Outcomes - Changes in colic scale ratings induced by maternal heart sound - Changes in comfort scale ratings as a result of maternal heart sound - Changes in colic scale assessments induced by foot massage - Changes in comfort scale assessments induced by foot massage Secondary Outcomes ### Location - Facility: Karamanoglu Mehmetbey University, Karaman, Center, 70100, Turkey @@
## The Effect of Motor Imagery Dosage on Motor Learning in Healthy Adults - NCT ID: NCT06299345 - Study ID: 1870394-1 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2022-04-28 - Lead Sponsor: Ahmed Mahmoud Kadry ### Study Description The goal of this clinical trial is to compare the effects of different durations of Motor Imagery (MI) practice and physical practice on motor performance enhancement in healthy adults. The main questions it aims to answer are:* Does Motor Imagery (MI) practice improve motor performance?* How do different doses of MI practice (low vs. high) compare to no MI practice in enhancing motor performance?Participants:* Be randomly assigned to one of three groups: no MI practice (control group), low dose MI practice (6 minutes per session), or high dose MI practice (12 minutes per session).* Complete nine sessions over three weeks, practicing a timed mirror tracing task.* Have their performance measured in each session by the time taken to complete the task and the number of errors made.Compared the control group, low dose MI group, and high dose MI group to see if there are significant differences in motor performance enhancement, aiming to determine the effectiveness of MI and the optimal dose for practice. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Motor imagery training - NO motor imagery training ### Outcomes Primary Outcomes - Time - Errors Secondary Outcomes ### Location - Facility: Concordia University Wisconsin, Mequon, Wisconsin, 53097, United States @@
## Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction - NCT ID: NCT06299332 - Study ID: DO611503A - Status: RECRUITING - Start Date: 2023-06-23 - Completion Date: 2025-05 - Lead Sponsor: InMode MD Ltd. ### Study Description The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED). ### Conditions - Erectile Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Device treatment ### Outcomes Primary Outcomes - Change in ED symptoms, following the RF treatment Secondary Outcomes - Change in sexual activity leading to optimal penetration - Evaluate efficacy of the RF treatment for erectile function - Evaluate efficacy of the RF treatment for erectile function - Evaluate efficacy of the RF treatment for erectile function - Evaluate efficacy of the RF treatment for hardness of erection ### Location - Facility: LC Medical 140 W 58th St, Suite A New York, NY 10019, New York, New York, 10019, United States @@
## Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD - NCT ID: NCT06299319 - Study ID: 149-2021 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Centre for Addiction and Mental Health ### Study Description Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD).The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms. ### Conditions - Obsessive-Compulsive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Psilocybin ### Outcomes Primary Outcomes - Feasibility of administering psilocybin (25 mg) in adults with treatment-resistant OCD - Incidence of adverse events (Safety and Tolerability) - Change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score from baseline Secondary Outcomes - Proportion of participants who respond to treatment - Changes in Patient Health Questionnaire (PHQ-9) from Baseline to Week 3 - Change in the Clinical Global Impression (CGI) scale from Baseline to Week 3 - Change in the World Health Organization Quality of Life Short Version (WHOQOL-BREF) score from Baseline to Week 3 - Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) from Baseline to Week 3 - Change in Generalized Anxiety Disorder (GAD-7) scores from Baseline to Week 3 - Changes in behavioural assessments for well-being (Warwick-Edinburgh Mental Wellbeing Scale; WEMWBS) from Baseline to Week 3 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma - NCT ID: NCT06299306 - Study ID: D3250R00116 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-01-31 - Lead Sponsor: AstraZeneca ### Study Description This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany. ### Conditions - Asthma, Bronchial ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment. Secondary Outcomes - Changes in the AIRQ® total score - Bi-weekly changes in the AIRQ® total score over time - Changes in the AIRQ® impairment domain score - Changes in the AIRQ® risk domain score - Proportion of patients with prescribed use of oral corticosteroids (OCS) - Proportion of patients with self-reported OCS use - Proportion of patients with a change in other asthma therapies - Treatment switches (change in prescribed therapies) over time and time on treatment. - Assessment of the patient satisfaction with digital and analog healthcare - Assessment of the patient-reported 1-year prior healthcare utilization - Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare - Assessment of the provider preferences in digital versus analog healthcare monitoring. - Assessment of the patient preferences towards remote monitoring and healthcare delivery. - Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS - Changes in laboratory parameter - IgE level - Changes in lung function parameters - Tiffenau-Index - Correlations between environmental factors and patients' asthma exacerbations - Correlation between environmental factors and changes in AIRQ® score - Changes in laboratory parameter - blood eosinophil - Changes in laboratory parameter - blood neutrophil - Changes in laboratory parameter - FeNO - Changes in laboratory parameter - C-reactive protein (CRP) level - Changes in lung function parameters - FEV1 % ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Facial Emotion Recognition in Anorexia Nervosa - NCT ID: NCT06299293 - Study ID: 21C306 - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-02-01 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Altered emotional processing is reported in Anorexia Nervosa. However, this capability is generally measured through explicit measures, like self-report questionnaires and facial emotion recognition tasks. Instead, no previous research has investigated implicit emotional processing in this clinical condition. In the implicit facial emotion recognition task grounded on the implicit "redundant target effect", individuals generally respond faster when two identical targets are presented simultaneously rather than when presented alone; moreover, the competitive presence of a distractor (that is another emotion or a neutral expression) affects the correct recognition of the target. The ability to recognize and detect facial expressions is explored about two main emotions, fear and anger, because of their role in the intra- and interindividual psychological processing. ### Conditions - Anorexia Nervosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Facial Emotion Recognition Test ### Outcomes Primary Outcomes - Behavioural measure relative to recognition ability Secondary Outcomes - Behavioural measure relative to the detection ability ### Location - Facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, Piancavallo, VCO, 28824, Italy @@
## The Effect Of Dual-Task Training On Motor And Cognitive Performance In School-Age Children - NCT ID: NCT06299280 - Study ID: Igdir180 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-01 - Lead Sponsor: Igdir University ### Study Description The aim of the study is to investigate the effect of dual task training on performance in school-age children. Although studies on this subject in the world are limited, a comprehensive study on school-age children is needed.MATERIAL AND METHOD:* Evaluation will begin by applying demographic information and the Physical Activity Survey for Children.* The evaluations to be made will primarily evaluate the child's performance on a single cognitive task in a supported sitting position on a chair, without a motor task.* To evaluate single motor performance, a 2-minute walk test and a 30-second sit-stand test will be applied.* Dual task evaluations will be carried out by adding a cognitive task while applying the 2-minute walk and 30-second sit-to-stand test.* Walking speed will be evaluated with the 10m walk test.* Balance parameter will be evaluated with functional reaching test.* Using the Visual Analog Scale (VAS), participating children will be asked to score the difficulty of cognitive and motor performance as a number between 0 and 10.* Walking speeds will be normalized by measuring lower extremity lengths.* The children will be randomly divided into two groups and the study group will be given dual-task training by creating dual-task situations during the activities carried out in physical education classes.* After 4 weeks, appropriate analyzes will be made with the data obtained as a result of the evaluations performed by the same evaluator.As a result of this study, motor and cognitive performance in single-task conditions in typically developing children will be revealed. Additionally, changes in this performance will be detected in dual-task situations. The gains to be obtained as a result of the training will also reveal the importance of implementing dual task training in school-age children. ### Conditions - Healthy - Child, Only ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - dual task training - single task training ### Outcomes Primary Outcomes - Physical Activity Questionnaire for Children (PAQ-C) - Physical Activity Questionnaire for Adolescent (PAQ-A) - Single cognitive task performance - 2-minute walk test - 30-second sit-stand test - 10m walk test. (single-task conditions) - 10m walk test. (dual-task conditions) - functional reaching test. - Visual Analog Scale (VAS) - lower extremity lengths assessment Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Dual Task on Manual Skill Performance in Children and Adolescents - NCT ID: NCT06299267 - Study ID: Igdir181 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-07-15 - Lead Sponsor: Igdir University ### Study Description The aim of the study is to investigate the effect of dual-task conditions on manual dexterity performance in typically developing young people and children between the ages of 7-18.MATERIAL AND METHOD:* Demographic information, dominant extremity will be noted and the evaluation will begin by applying the Physical Activity Questionnaire for Children.* The evaluations will primarily evaluate the child's performance on a single cognitive task* The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or adolescent.* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.* the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the -9-Hole Test and writing a paragraph.* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.As a result of this study, manual dexterity performance and cognitive performance in single-task conditions in typically developing children and adolescents will be revealed. Additionally, changes in this performance will be detected in dual-task situations. ### Conditions - Child, Only - Adolescent Development ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - dual task conditions ### Outcomes Primary Outcomes - single cognitive task - Visual Analogue Scale (VAS) - 9-Hole Peg Test.-Single task - 9-Hole Peg Test and writing a given paragraph.-Dual task - writing a given paragraph.-Single task - writing a given paragraph.-Dual task Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Placebo Effect About Fatigue in Obesity - NCT ID: NCT06299254 - Study ID: 21C305 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels. ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Placebo-Natural History ### Outcomes Primary Outcomes - Behavioural outcome of fatigue Secondary Outcomes - The individual level of perceived fatigue ### Location - Facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, Piancavallo, VCO, 28824, Italy @@
## Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity - NCT ID: NCT06299241 - Study ID: 01C313 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-21 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. The secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient. ### Conditions - Obesity - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Fat free mass - Evaluation of lower limb muscle strength - Senior Fitness Test (SFT) - Physical performance test (PPT) - Fat mass Secondary Outcomes - Questionnaire SF-12 (Short Form Health Survey) - Oswestry Disability Index questionnaire ### Location - Facility: Istituto Auxologico Italiano, Site Piancavallo, Oggebbio, Verbania, 28824, Italy @@
## Is Sensorimotor Training Effective Following a Distal Radius Fracture? - NCT ID: NCT06299228 - Study ID: HSA - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Hand Surgery Associates LLC ### Study Description The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist. ### Conditions - Distal Radius Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental Group - Control Group ### Outcomes Primary Outcomes - Active Joint Position Sense (AJPS) Secondary Outcomes - Patient Rated Wrist and Hand Evaluation ### Location - Facility: Hand Surgery Associates, Olyphant, Pennsylvania, 18447, United States @@
## Factors and Prognosis of Obstructive Pyelonephritis Patients - NCT ID: NCT06299215 - Study ID: APHP240044 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-03-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.Most of the available data on this condition comes from small, retrospective, single-centre series.To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients. ### Conditions - Pyelonephritis - Prognostic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function. Secondary Outcomes - Death - Stage 3 Acute kidney injury (KDIGO classification) - failure to recover renal function - the incidence of acute renal failure defined by KDIGO 1 - the incidence of acute renal failure defined by KDIGO 2 and 3 - the incidence of Renal replacement therapy - the incidence of non-recovery of renal fuction - The number of days alive without Renal replacement therapy - The number of days alive without catecholamines - The number of days alive without antibiotics - The number of days alive without - Death rate ### Location - Facility: Hospital Saint Louis, Paris, N/A, 75010, France @@
## Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy - NCT ID: NCT06299202 - Study ID: 69HCL23_0204 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment).Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria.Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland.A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement.During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out).Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI.Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Diagnostic test ### Outcomes Primary Outcomes - The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM Secondary Outcomes - RTEe according to the 3 categories of RCB score - The type of enhancement (TE) % ### Location - Facility: Hôpital de la Croix Rousse, Lyon, N/A, 69004, France @@
## A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care - NCT ID: NCT06299189 - Study ID: 309264 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-09 - Lead Sponsor: Haukeland University Hospital ### Study Description The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program. ### Conditions - ADHD - ADHD - Combined Type - ADHD Predominantly Inattentive Type - ADHD, Predominantly Hyperactive - Impulsive ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MinADHD ### Outcomes Primary Outcomes - The Adult ADHD Self-Rating Scale - Adult ADHD Quality of Life Measure Secondary Outcomes - The Patient Health Questionnaire - Generalized Anxiety Disorder-7 - Personality Disorder Severity ICD-11 - EuroQoL 5D-5L ### Location - Facility: Bjørgvin DPS, Bergen, N/A, N/A, Norway @@
## Whole Heart Radiotherapy for End-stage Heart Failure - NCT ID: NCT06299176 - Study ID: ESHF-WHRT (2024-10362) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile. ### Conditions - Heart Failure NYHA Class III - Heart Failure NYHA Class IV - End-stage Heart Failure - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Whole Heart Radiation Therapy ### Outcomes Primary Outcomes - Change in mean left ventricle ejection fraction - Acute adverse events definitely or probably related to radiation therapy at 30 days as per CTCAE v 5.0 Secondary Outcomes - Overall survival - Hospital stays - Subacute adverse events - Late adverse events - Medication Changes - dose - Medication Changes - number - Quality of life CHFQOLQ-20 - Quality of life - SF-36 - Troponin changes - Lactate changes - Renal Function - b-natrurietic peptide ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NM32-2668 in Adult Patients With Selected Advanced Solid Tumors - NCT ID: NCT06299163 - Study ID: NB-NM032-2668-101 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2027-12-31 - Lead Sponsor: Numab Therapeutics AG ### Study Description This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors. ### Conditions - Ovarian Carcinoma - Fallopian Tube Carcinoma - Peritoneal Carcinoma - Endometrial Cancer - Adenocarcinoma of Lung - Triple Negative Breast Cancer - Liposarcoma - Leiomyosarcoma - Mesothelioma, Malignant - Adenocarcinoma - Gastroesophageal Junction (GEJ) - Adenocarcinoma of the Stomach - Melanoma, Malignant - Renal Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - NM32-2668 ### Outcomes Primary Outcomes - Incidence of Dose Limiting Toxicities (DLTs) - Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS]) - Frequency of dose interruptions/reductions - Duration of dose interruptions/reductions Secondary Outcomes - Assessment of the maximum observed serum concentration (Cmax) - Assessment of the the minimum observed serum concentration (Cmin) - Time from dosing at which maximum observed serum concentration is apparent (Tmax) - Assessment of the terminal phase (apparent elimination) rate constant (λz) - Assessment of the elimination half-life (t½) - Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]) - Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) - Assessment of clearance (CL) of NM32-2668 in serum - Assessment of the volume of distribution (Vd) of NM32-2668 in serum - Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum - Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum - Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum - Frequency of specific anti-drug antibodies (ADAs) to NM32-2668 - Concentration of specific ADAs to NM32-2668 - Incidence of specific ADAs by category to NM32-2668 - Best Overall Response (BOR) according to RECIST 1.1 - Overall Response Rate (ORR) according to RECIST 1.1 - Disease Control Rate (DCR) according to RECIST 1.1 - Progression-free Survival (PFS) according to RECIST 1.1 - Time to Response (TTR) according to RECIST 1.1 - Duration of Response (DOR) according to RECIST 1.1 - Overall Survival (OS) ### Location - Facility: Lifespan Cancer Institute at Rhode Island Hospital, Providence, Rhode Island, 02903, United States @@
## Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children - NCT ID: NCT06299150 - Study ID: 2023-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: October University for Modern Sciences and Arts ### Study Description Dental trauma (DT) of the incisors and their supporting tissues, which is one of the most challenging dental emergency situations, requires immediate assessment and management due to psychological and physical reasons. (8) This is especially important for young permanent teeth because of continuing development in order to minimize undesired complications. The treatment of dental trauma is sometimes neglected. (9,10) although it might lead to pain, difficulty in articulation and mastication as well as having considerable negative effects on patient's self-esteem. (11) However, aesthetics of the anterior teeth are very important aspects of human appearance and could be affected by many factors including the presence of fillings, tooth color, position, alignment, shape and number. (12)Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. (13) According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19. (14)As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic and time-efficient restoration is frequently demanded.(15) According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment.(16) As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color and function in a minimum amount of time. (17,18) Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. (19) Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies. (20, 21)In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments-has become increasingly popular over the last few years. (22,23) PLVs are thin pieces of glass-matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, as for conventional laminate veneers, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. (24) Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. (25,26) Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies (27,28) and case reports (29, 30, 31), without any clinical information available at present.Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment or partial laminate veneers) that require minimal to no preparation depends on the type of restoration will receive and doesn't require local anesthesia. ### Conditions - Composites Resins ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IPS e.max CAD ### Outcomes Primary Outcomes - Clinical success/ survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures - NCT ID: NCT06299137 - Study ID: RE2022-0000000349 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-10 - Lead Sponsor: Rhode Island Hospital ### Study Description The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:* Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.* Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures. ### Conditions - Rib Fractures - Pain Acute - Regional Anesthesia - Opioid Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Serratus Anterior Plane Block - Ropivacaine injection ### Outcomes Primary Outcomes - PIC Score Secondary Outcomes - Total oral morphine equivalents over the first 24 hours ### Location - Facility: Rhode Island Hospital, Providence, Rhode Island, 02903, United States @@
## A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors - NCT ID: NCT06299124 - Study ID: RGT-419B-102 - Status: RECRUITING - Start Date: 2023-04-17 - Completion Date: 2025-06-30 - Lead Sponsor: Regor Pharmaceuticals Inc. ### Study Description This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors. ### Conditions - Breast Cancer - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RGT-419B ### Outcomes Primary Outcomes - Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level Secondary Outcomes - Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs) - Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax - Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf) - Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2) - Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax) - Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses - Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion - Tumor Response assessed by Investigator according to RECIST v1.1 - QTc Interval - Changes in corrected QT interval ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC) - NCT ID: NCT06299111 - Study ID: R9933-DVT-2308 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2026-06-08 - Lead Sponsor: Regeneron Pharmaceuticals ### Study Description This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'.The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.The study is looking at several other research questions, including:* What side effects may happen from taking the study drug* How much study drug is in your blood at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) ### Conditions - Venous Thromboembolism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - REGN9933 - REGN7508 - Placebo ### Outcomes Primary Outcomes - Incidence of confirmed VTE per central reading center (CRC) review - Incidence of treatment-emergent adverse event (TEAEs) - Severity of TEAEs Secondary Outcomes - Incidence of confirmed PICC associated venous thrombosis per CRC review - Incidence of major bleeding - Incidence of clinically relevant non-major (CRNM) bleeding - Concentrations of REGN9933 in serum - Concentrations of REGN7508 in serum - Change in activated partial thromboplastin time (aPTT) - Change in prothrombin time (PT) - Incidence of anti-drug antibody (ADA) to REGN9933 over time - Titer of ADA to REGN9933 over time - Incidence of ADA to REGN7508 over time - Titer of ADA to REGN7508 over time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss - NCT ID: NCT06299098 - Study ID: R1033-OB-2288 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-13 - Completion Date: 2026-06-24 - Lead Sponsor: Regeneron Pharmaceuticals ### Study Description This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy.Parts A and B of the study are looking at several other research questions, including:* What side effects may happen from taking the study drug* How much study drug is in the blood at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Trevogrumab-Part A - Trevogrumab-Part B - Garetosmab - Semaglutide - Matching Placebo-Part A - Matching Placebo-Trevogrumab - Matching Placebo-Garetosmab ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) - Severity of TEAEs - Percent body weight change - Percent change in total fat mass Secondary Outcomes - Concentrations of trevogrumab in serum over time - Percent body weight change - Percent change in total fat mass - Percent change in total lean mass - Change in waist circumference (cm) - Percent change in body weight - Percent change in total lean mass - Percent change in regional measurements of body composition - Percent change in gynoid fat mass - Change in total lean mass:total fat mass ratio - Proportion of weight loss attributable to fat mass loss - Percent change in android (central) fat mass - Percent change in thigh muscle volume (TMV) - Body weight reduction of ≥5% - Body weight reduction of ≥10% - Body weight reduction of ≥15% - Body weight reduction of ≥20% - Body weight reduction of ≥25% - Percent change in fasting serum triglycerides - Percent change in total cholesterol - Percent change in Apolipoprotein B (Apo B) - Percent change in low-density lipoprotein cholesterol (LDL-C) - Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT) - Change in physical functioning domain score of SF-36 - Concentrations of garetosmab in serum over time - Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time - Titer of ADAs to trevogrumab after repeated doses over time - Incidence of ADAs to garetosmab after repeated doses over time - Titer of ADAs to garetosmab after repeated doses over time - Incidence of TEAEs - Severity of TEAEs ### Location - Facility: ProSciento, Chula Vista, California, 91911, United States @@
## Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover. - NCT ID: NCT06299085 - Study ID: OSTEO-BS (L4191) - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio ### Study Description By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality. ### Conditions - Bariatric Surgery Candidate ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery. ### Outcomes Primary Outcomes - Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery. Secondary Outcomes - Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast - NCT ID: NCT06299072 - Study ID: PEP-2303 - Status: COMPLETED - Start Date: 2023-09-05 - Completion Date: 2023-09-19 - Lead Sponsor: PepsiCo Global R&D ### Study Description In this online survey conducted suing the YouGov consumer insights panel, the primary aims of this study are to provide for the first time an estimate of consumer awareness regarding wholegrains; their definitions and knowledge of potential benefits in the Saudi Arabia adult population and the he estimated consumption amongst Saudi consumers.Secondary Objectives are to assess the breakfast habit, oat consumption \& health concerns amongst Saudi consumers; identify socio-demographic and consumer characteristics associated with breakfast consumption, the types of foods consumed at breakfast, and fill gaps in knowledge regarding breakfast eating habits, commonly consumed breakfast foods. ### Conditions - Diet, Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey ### Outcomes Primary Outcomes - Consumer awareness regarding wholegrains - Consumer definitions of wholegrains - Consumer knowledge of potential benefits of wholegrains - Wholegrain consumption Secondary Outcomes - Breakfast habits - Oat consumption - Health concerns - Socio-demographics associated with breakfast consumption - Consumer characteristics associated with breakfast consumption - Types of foods consumed at breakfast - Fill gaps in knowledge regarding breakfast eating habits - Commonly consumed breakfast foods ### Location - Facility: Remote, no facility visits, Riyadh, N/A, N/A, Saudi Arabia @@
## Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients - NCT ID: NCT06299059 - Study ID: Compliance - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: Zeng Changhao ### Study Description The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube Feeding ### Outcomes Primary Outcomes - Rehabilitation Treatment Compliance Questionnaire Secondary Outcomes - Patient Health Questionnaire-9 - Swallowing Quality of Life questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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