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protocolSection identificationModule nctId: NCT06360159, orgStudyIdInfo id: Massage on Newborns, briefTitle: Massage for Newborns Receiving Nasal CPAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-05-15, completionDateStruct date: 2026-05-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sultan Besiktas, class: OTHER, descriptionModule briefSummary: One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP., conditionsModule conditions: Massage, conditions: Stress, conditions: Newborn, conditions: Comfort, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention group (Massage): Babies in the intervention group will be massaged three times a day for 3 days, each session lasting 15 minutes, in accordance with the field massage technique. Massage application will be applied 1 hour after the babies are fed. For massage application, apply oil, solution and cream etc. to the baby's skin will not be used. During the massage application, the baby will be placed in prone and supine positions. Massage will be applied to the newborns in the intervention group by the assistant researcher.Control group: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Intervention, outcomesModule primaryOutcomes measure: Stress Level, primaryOutcomes measure: Salivary Cortisol Level, primaryOutcomes measure: Comfort Score, primaryOutcomes measure: Bilirubin Level, primaryOutcomes measure: Nutrient ıntake amount, primaryOutcomes measure: Abdominal Circumference Measurement, primaryOutcomes measure: Defecation Frequency, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360146, orgStudyIdInfo id: 120685123, briefTitle: Early Mobilisation of Post Cardiac Surgery in Geriatrics., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ahi Evran University Education and Research Hospital, class: OTHER, descriptionModule briefSummary: Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises., conditionsModule conditions: Cardiac Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Single, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Early mobilisation, outcomesModule primaryOutcomes measure: International Physical Activity Questionnaire, secondaryOutcomes measure: Two Minute Walking Test, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İsmail Ceylan, city: Kırşehir, state: Merkez, zip: 40100, country: Turkey, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False
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protocolSection identificationModule nctId: NCT06360133, orgStudyIdInfo id: VVN001-CCS-301, briefTitle: Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: VivaVision Biotech, Inc, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease., conditionsModule conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: VVN001 Ophthalmic Solution, 5%, interventions name: VVN001 Ophthalmic Solution, Vehicle, outcomesModule primaryOutcomes measure: Corneal Fluorescein Staining, secondaryOutcomes measure: Eye Dryness, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eye & Ent Hospital of Fudan University, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06360120, orgStudyIdInfo id: 00023098816, briefTitle: Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-04-10, completionDateStruct date: 2025-05-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects., conditionsModule conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Atorvastatin 40 Mg Oral Tablet, interventions name: Rosuvastatin 20mg, outcomesModule primaryOutcomes measure: the rate of new stroke at 90 days, secondaryOutcomes measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week, secondaryOutcomes measure: value of Modified Rankin Scale (mRS) at one week, secondaryOutcomes measure: value of Modified Rankin Scale(mRS) at three months, secondaryOutcomes measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events, secondaryOutcomes measure: rate of drug adverse effects, secondaryOutcomes measure: Drug adverse effects: all side effects related to the drugs of our study will be reported, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kafr Elsheikh University Hospital, status: RECRUITING, city: Kafr Ash Shaykh, zip: 33511, country: Egypt, contacts name: mohamed G. Zeinhom, MD, role: CONTACT, phone: 2001009606828, email: [email protected], geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06360107, orgStudyIdInfo id: 76729, briefTitle: RCT of a Brief Video Intervention Targeting Peer Inclusion to Reduce Depression-related Stigma in Adolescents, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: New York State Psychiatric Institute, class: OTHER, collaborators name: Columbia University, descriptionModule briefSummary: The goal of this study is to test the efficacy of a brief video intervention emphasizing peer inclusion on depression-related stigma and stigma outcomes (e.g., help seeking attitudes, secrecy) among adolescents 14-18.Timely identification and treatment of depression in adolescents is a public health priority. However, most youth with depression do not seek treatment, and stigma has been identified as the primary barrier to help-seeking. Experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing depression-related stigma and increasing help-seeking among adolescents. However, given the extreme time constraints of these videos, optimizing the messaging is paramount. Prior research has indicated that concerns about peer social inclusion are fundamental in shaping stigma among adolescents.In this 3-arm RCT, we will recruit adolescents aged 14-18 using an online crowdsourcing platform, to test the efficacy of a) standard BVI that addresses mental health treatment but does not address concerns about peer inclusion/exclusion, b) novel BVI focused on mental health treatment and peer inclusion, and c) control condition that provides information without social contact., conditionsModule conditions: Depression, conditions: Adolescent - Emotional Problem, conditions: Stigma, Social, conditions: Help-Seeking Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 650, type: ESTIMATED, armsInterventionsModule interventions name: brief video, outcomesModule primaryOutcomes measure: Depression Stigma Scale (modified), primaryOutcomes measure: Ultra-brief Self-stigma of Help-Seeking, secondaryOutcomes measure: Adolescent Stigma Scale (modified), eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: New York State Psychiatric Institute, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06360094, orgStudyIdInfo id: 1490-0004, secondaryIdInfos id: 2023-510249-79-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1301-1311, type: REGISTRY, domain: WHO Registry (ICTRP), briefTitle: A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-27, primaryCompletionDateStruct date: 2025-07-21, completionDateStruct date: 2025-08-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, conditions: Progressive Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: BI 1839100, interventions name: Placebo, outcomesModule primaryOutcomes measure: IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h), primaryOutcomes measure: IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h), secondaryOutcomes measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score, secondaryOutcomes measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm), secondaryOutcomes measure: IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h), secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL), secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score, secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm), secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score, secondaryOutcomes measure: IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360081, orgStudyIdInfo id: 1479-0019, secondaryIdInfos id: 2023-510495-31-00, type: OTHER, domain: CTIS, secondaryIdInfos id: U1111-1303-4345, type: OTHER, domain: WHO, briefTitle: A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-24, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Zongertinib, outcomesModule primaryOutcomes measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72h (AUC0-72h), primaryOutcomes measure: Maximum measured concentration of the analyte in plasma (Cmax), secondaryOutcomes measure: Time from dosing to maximum measured concentration of the analyte in plasma (tmax), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360068, orgStudyIdInfo id: SLE-SASP POC, secondaryIdInfos id: 82371767, type: OTHER_GRANT, domain: National Natural Science Foundation of China, briefTitle: A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Qiong Fu, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16?Participants will:Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate.Visit the clinic once every 4 weeks for checkups and tests., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Sulfasalazine Tablets, outcomesModule primaryOutcomes measure: the change of disease activity (SLEDAI score), secondaryOutcomes measure: the number of patients who can reach SRI-4, secondaryOutcomes measure: the change of prednisone dosage, otherOutcomes measure: the change of interferon stimulating genes (ISG) expression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360055, orgStudyIdInfo id: M2024130, briefTitle: Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effects of oral D-mannose tablets for 2 consecutive weeks on the pharmacokinetics of dabigatrun etexilate, a P-glycoprotein probe substrate drug, in healthy adults, conditionsModule conditions: Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Dabigatran Etexilate, interventions name: D-mannose, outcomesModule primaryOutcomes measure: Plasma concentration of dabigatran, primaryOutcomes measure: Serum concentrations of glycoomics such as D-mannose, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Cheng Cui, role: CONTACT, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06360042, orgStudyIdInfo id: MA-HCC-II-021, briefTitle: Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Peking University Cancer Hospital & Institute, class: OTHER, descriptionModule briefSummary: This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC., conditionsModule conditions: Unresectable Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab plus Apatinib, interventions name: Adebrelimab plus Bevacizumab, interventions name: Camrelizumab plus Apatinib, outcomesModule primaryOutcomes measure: 12-month overall survival rate, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: DoR, secondaryOutcomes measure: TTR, secondaryOutcomes measure: TTP, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Jun Zhou, role: CONTACT, phone: 13366152815, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06360029, orgStudyIdInfo id: LvL UP, briefTitle: The LvL UP Pilot Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Singapore ETH Centre, class: OTHER, collaborators name: ETH Zurich, collaborators name: National University of Singapore, collaborators name: Nanyang Technological University, descriptionModule briefSummary: Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs.LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations (Castro et al., 2023). Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less.The goal of this pilot study is to assess the feasibility of a Sequential, Multiple Assignment, Randomized Trial (SMART) aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability. The main questions it aims to answer are:1. What are the intervention's preliminary, short-term effects? What is the intervention's level of engagement? What is the number of dropouts? What is the percentage of missing data? What is the intervention's responder / non-responder rate after week 4? How easy was to recruit the target sample size and which channels worked best?2. Considering the above pilot study results: What is the overall feasibility of the SMART research protocol in its current form? Are there any changes required for the main trial? This includes: recruitment approach, intervention content and delivery (app, provision of human support), and/or trial assessments (online and in-person)., conditionsModule conditions: Health Behavior, conditions: Noncommunicable Diseases, conditions: Mental Health Issue, conditions: Lifestyle Risk Reduction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: LvL UP, interventions name: LvL UP + MI, interventions name: Comparison, outcomesModule primaryOutcomes measure: Mental well-being, secondaryOutcomes measure: Subjective well-being, secondaryOutcomes measure: Mental health (depression), secondaryOutcomes measure: Mental health (stress), secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Health behaviours (physical activity), secondaryOutcomes measure: Health behaviours (steps), secondaryOutcomes measure: Health behaviours (diet 1), secondaryOutcomes measure: Health behaviours (diet 2), secondaryOutcomes measure: Health behaviours (sleep), secondaryOutcomes measure: Health behaviours (smoking and alcohol consumption), secondaryOutcomes measure: Anthropometry (body weight), secondaryOutcomes measure: Anthropometry (body height), secondaryOutcomes measure: Anthropometry (waist circumference), secondaryOutcomes measure: Anthropometry (hip circumference), secondaryOutcomes measure: Anthropometry (self-reported height and weight), secondaryOutcomes measure: Resting blood pressure, secondaryOutcomes measure: Blood metabolic profile, otherOutcomes measure: LvL UP app: Response time, otherOutcomes measure: LvL UP app: Duration of app usage, otherOutcomes measure: LvL UP app: Actual usage of app components, otherOutcomes measure: LvL UP app: Coaching topic / sub-topic use, otherOutcomes measure: LvL UP app: Conversational turns, otherOutcomes measure: LvL UP app: Breeze (slow-paced breathing tool) usage, otherOutcomes measure: LvL UP app: Access to smartphone sensors (location - obfuscated), otherOutcomes measure: LvL UP app: Access to smartphone sensors (location types), otherOutcomes measure: LvL UP app: Access to smartphone sensors (raw gyroscope), otherOutcomes measure: LvL UP app: Access to smartphone sensors (raw accelerometer), otherOutcomes measure: LvL UP app: Access to smartphone sensors (physical activity), otherOutcomes measure: LvL UP app: Access to smartphone sensors (WiFi connection status), otherOutcomes measure: LvL UP app: Access to smartphone sensors (WiFi networks in range), otherOutcomes measure: LvL UP app: Access to smartphone sensors (bluetooth scan), otherOutcomes measure: LvL UP app: Access to smartphone sensors (battery % level and charging status), otherOutcomes measure: LvL UP app: Access to smartphone sensors (screen on/off), otherOutcomes measure: LvL UP app: Access to smartphone sensors (call and SMS metadata), otherOutcomes measure: LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action), otherOutcomes measure: LvL UP app: Access to smartphone sensors (step count), otherOutcomes measure: LvL UP app: Access to smartphone sensors (brightness), otherOutcomes measure: LvL UP app: Access to smartphone sensors (breeze audio), otherOutcomes measure: LvL UP app: Access to Apple Healthkit & Google Fit data, otherOutcomes measure: Process evaluation: Health literacy questionnaire, otherOutcomes measure: Process evaluation: Stages of change questionnaire, otherOutcomes measure: Process evaluation: Unintended consequences, otherOutcomes measure: Process evaluation (intervention group participants only): Net promoter score, otherOutcomes measure: Process evaluation (intervention group participants only): System usability scale, otherOutcomes measure: Process evaluation (intervention group participants only): Session alliance inventory, otherOutcomes measure: Process evaluation (intervention group participants only): Self-report habit index, otherOutcomes measure: Process evaluation (intervention group participants only): MITI-4, otherOutcomes measure: Process evaluation (intervention group participants only): UMars, otherOutcomes measure: Process evaluation (intervention group participants only): Interview, otherOutcomes measure: Process evaluation (Research team): Field Notes, otherOutcomes measure: Exploratory aims: Sociodemographic, otherOutcomes measure: Exploratory aims: Use of digital health technologies, otherOutcomes measure: Exploratory aims: Ecologic Momentary Assessment of mood state, otherOutcomes measure: Exploratory aims: Personality, otherOutcomes measure: Exploratory aims: Work Engagement, otherOutcomes measure: Exploratory aims: Self-reported sickness absence, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Saw Swee Hock School of Public Health, status: RECRUITING, city: Singapore, zip: 117549, country: Singapore, contacts name: Shenglin Zheng, MSc, role: CONTACT, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, locations facility: Singapore ETH Center, status: ACTIVE_NOT_RECRUITING, city: Singapore, zip: 138602, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06360016, orgStudyIdInfo id: Protocol-RAP, briefTitle: Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs, acronym: Protocol-RAP, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-13, primaryCompletionDateStruct date: 2023-05-31, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, collaborators name: University of Malaga, descriptionModule briefSummary: Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants., conditionsModule conditions: Self Regulation, conditions: Impulsive, conditions: Attention Difficulties, conditions: Emotion Regulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pre and post-test with the control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Double (Investigator, Outcomes Assessor), whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: Recreation Activity Program, outcomesModule primaryOutcomes measure: Self-Regulation Assessment, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Selcuk University, city: Konya, zip: 42400, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06360003, orgStudyIdInfo id: SAHoWMU-CR2024-01-109, briefTitle: "Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.Researches will break the method of this investigation into two steps:First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group., conditionsModule conditions: Ventricular Outflow Tract Ventricular Arrhythmias, conditions: Radio Frequency Catheter Ablation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Right Ventricular Outflow Tract Posterior Septum Pacing, interventions name: systemic mapping and ablation, outcomesModule primaryOutcomes measure: Rate of Immediate Ablation Success, primaryOutcomes measure: Rate of Ablation Complication, primaryOutcomes measure: Accuracy of RVOT posterior septal pacing protocol, secondaryOutcomes measure: Incidence of Complications Post-operative, secondaryOutcomes measure: Incidence of Complication, secondaryOutcomes measure: Rate of Recurrence during Follow up, secondaryOutcomes measure: Incidence of Complication, secondaryOutcomes measure: Rate of Recurrence during Follow up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, status: RECRUITING, city: Wenzhou, state: Zhejiang, zip: 325000, country: China, contacts name: Cheng Zheng, PhD, role: CONTACT, phone: 86-0577-85676609, email: [email protected], geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
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protocolSection identificationModule nctId: NCT06359990, orgStudyIdInfo id: RushUMCEmezue, briefTitle: BrotherlyACT: A Culturally Congruent and Technology-Enhanced Youth Violence and Substance Use Intervention for Black Boys and Men, acronym: BrotherlyACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-02-15, completionDateStruct date: 2026-02-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Rush University Medical Center, class: OTHER, descriptionModule briefSummary: This study will adapt and test a culturally tailored, multi-component, and trauma-focused digital intervention to reduce the risk and effects of youth violence and substance use and bridge service access gaps for young Black males (YBM) in pediatric emergency and community-based low-resource settings., conditionsModule conditions: Violence in Adolescence, conditions: Substance Use, conditions: Avoidance of Healthcare, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: BrotherlyACT, interventions name: BrotherlyACT Waitlist Control Group (WCG), outcomesModule primaryOutcomes measure: The Reactive-Proactive Aggression Questionnaire (RPQ), primaryOutcomes measure: Multidimensional Peer Victimization Scale (MPVS), primaryOutcomes measure: The Alcohol Use Disorders Identification Test (AUDIT), primaryOutcomes measure: Drug Use Disorders Identification Test (DUDIT), primaryOutcomes measure: Change in Attitude toward Substance Use, secondaryOutcomes measure: Emotional Avoidance Strategy Inventory for Adolescents (EASI-A), secondaryOutcomes measure: The Kessler Psychological Distress Scale (K-10), secondaryOutcomes measure: The University of Rhode Island Change Assessment Scale (URICA), secondaryOutcomes measure: Intensity-of-Care Measurements, secondaryOutcomes measure: Violent Intentions-Teen Conflict Survey, eligibilityModule sex: MALE, minimumAge: 15 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Rush University Medical Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Chuka N Emezue, PhD, MPH, role: CONTACT, phone: 312-942-6151, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06359977, orgStudyIdInfo id: YB-202442, briefTitle: The Effect of Quantitative EEG Combined With Ultrasound and Sputum Volume on Predicting Weaning Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Qingdao University, class: OTHER, descriptionModule briefSummary: Neurocritical patients often face the need for removal of endotracheal tubes. However, despite following the extubation criteria for general critical ill patients, neurocritical patients still exhibit a higher rate of weaning failure, significantly higher than that of general critical ill patients. The extubation criteria for general critical patients emphasize the assessment of lung conditions. However, neurological critical patients often have less severe lung damage, but factors such as consciousness level and coughing ability may significantly influence extubation. Quantitative EEG serves as an objective tool to reflect consciousness level status, while bedside ultrasound can assess respiratory muscle function. Additionally, sputum volume may reflect the condition of lung condition. Therefore, we believe that combination of these three indicators can better predict the success of extubation for neurocritical patients., conditionsModule conditions: Weaning Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Quantitative EEG monitoring and beside ultrasound evaluation, outcomesModule primaryOutcomes measure: Quantitative EEG indicators, primaryOutcomes measure: Respiratory muscles thickness in centimeter, primaryOutcomes measure: Respiratory muscles thickening fraction (%), primaryOutcomes measure: Sputum volume in milliliter, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359964, orgStudyIdInfo id: CRE2023.195, briefTitle: Infective Complications in TP Biopsy Without Antibiotic Prophylaxis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1900, type: ESTIMATED, armsInterventionsModule interventions name: Transperineal Biopsy without antibiotics prophylaxis, interventions name: Transperineal Biopsy with antibiotics prophylaxis, outcomesModule primaryOutcomes measure: The difference in UTI hospitalization rate between the two groups after biopsy, primaryOutcomes measure: The difference in urosepsis rates between the two groups after biopsy, secondaryOutcomes measure: Post-biopsy UTI rates between the two groups, secondaryOutcomes measure: Assessment of bacteriology and antibiotic resistant profile between the two groups, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359951, orgStudyIdInfo id: 24-0103, briefTitle: Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ann & Robert H Lurie Children's Hospital of Chicago, class: OTHER, collaborators name: American Psychological Association Division 53 Society for Clinical Child & Adolescent Psychology, descriptionModule briefSummary: This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms., conditionsModule conditions: Depression, conditions: Eating Disorders, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Project YES, outcomesModule primaryOutcomes measure: Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995), primaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), primaryOutcomes measure: Generalized Anxiety Disorder -7 (GAD-7), secondaryOutcomes measure: Dietary Restriction Screener - 2 (DRS 2), secondaryOutcomes measure: Adult State Hope Scale, secondaryOutcomes measure: Self-Hate Scale, secondaryOutcomes measure: Beck Hopelessness -4, secondaryOutcomes measure: Program Feedback Scale, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ann & Robert H Lurie Children's Hospital of Chicago, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Anna M Ros, PhD, role: CONTACT, phone: 312-227-5433, email: [email protected], contacts name: Lisa Kuhns, PhD, role: CONTACT, phone: 312-227-6119, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06359938, orgStudyIdInfo id: Cer22/01, briefTitle: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF, acronym: RSA-PACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ceryx Medical Ltd, class: INDUSTRY, collaborators name: Cardiff and Vale University Health Board, descriptionModule briefSummary: The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.The main questions the trial aims to answer are:* Is the new type of pacemaker safe?* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Atrial pacing with respiratory sinus arrhythmia (RSA) variability, interventions name: Monotonic right atrial overdrive pacing, outcomesModule primaryOutcomes measure: Number of arrhythmia episodes per patient during pacing, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardiff & Vale University Health Board, city: Cardiff, zip: CF14 4XW, country: United Kingdom, contacts name: Zaheer Yousef, role: CONTACT, email: [email protected], contacts name: Avraj Virdi, role: CONTACT, geoPoint lat: 51.48, lon: -3.18, hasResults: False
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protocolSection identificationModule nctId: NCT06359925, orgStudyIdInfo id: Suprazygomatic nerve block, briefTitle: Suprazygomatic Nerve Block in Tonsillectomy Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-22, primaryCompletionDateStruct date: 2025-09-20, completionDateStruct date: 2026-02-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids., conditionsModule conditions: Tonsillectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine, interventions name: Suprazygomatic maxillary nerve block using Bupivacaine, outcomesModule primaryOutcomes measure: time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score, secondaryOutcomes measure: time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale, secondaryOutcomes measure: Parents satisfaction score, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359912, orgStudyIdInfo id: CNYX-EPCs-002-1, briefTitle: Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Allife Medical Science and Technology Co., Ltd., class: INDUSTRY, collaborators name: First Affiliated Hospital Xi'an Jiaotong University, descriptionModule briefSummary: The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound., conditionsModule conditions: Critical Limb Ischemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: EPCs, interventions name: Clinical standard treatment (CST), outcomesModule primaryOutcomes measure: adverse events, secondaryOutcomes measure: Painless walking and intermittent claudication distance, secondaryOutcomes measure: Blood flow of the affected limb, secondaryOutcomes measure: Rutherford grade, secondaryOutcomes measure: The area of skin ulcer, secondaryOutcomes measure: Vascular Quality of Life Questionnaire-6 score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hui Shi, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Shaoying Lu, Dr, role: CONTACT, phone: +862985323473, phoneExt: +862985323473, email: [email protected], contacts name: Fanggang Li, role: CONTACT, phone: 86-18911352611, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06359899, orgStudyIdInfo id: AK0901-2001, briefTitle: A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Shanghai Ark Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: AK0901 capsule, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the efficacy of AK0901 compared to placebo in children 6 to 12 years old with ADHD., secondaryOutcomes measure: Change from baseline in ADHD-RS-5 total score at Week 4., secondaryOutcomes measure: Changes in ADHD-RS-5 inattention subscale score from baseline to each visit in the Double-Blind Treatment Period, secondaryOutcomes measure: Changes in ADHD-RS-5 hyperactivity/impulsivity subscale score from baseline to each visit in the Double-Blind Treatment Period., secondaryOutcomes measure: Change in CGI-S score from baseline to each visit in the Double-Blind Treatment Period, secondaryOutcomes measure: CGI-I scores from V3 at each visit in the Double-Blind Treatment Period, secondaryOutcomes measure: Change in WREMB-R score from baseline to each visit in the Double-Blind Treatment, secondaryOutcomes measure: Proportion of subjects with adverse events (AEs) occurring during the study, secondaryOutcomes measure: Proportion of subjects with serious adverse events (SAEs) occurring during the study, secondaryOutcomes measure: Changes in respiratory rate during the study, secondaryOutcomes measure: Changes in heart rate during the study, secondaryOutcomes measure: Changes in body temperature during the study, secondaryOutcomes measure: Changes in systolic blood pressure during the study, secondaryOutcomes measure: Changes in diastolic blood pressure during the study, secondaryOutcomes measure: Change from baseline in QT intervals from resting EKGs, secondaryOutcomes measure: Change from baseline in QTcF intervals from resting EKGs, secondaryOutcomes measure: Change from baseline in heart rate resting EKGs, secondaryOutcomes measure: Change from baseline in QRS intervals from resting EKGs, secondaryOutcomes measure: Change from baseline in PR intervals from resting EKGs, secondaryOutcomes measure: Change in CSHQ score from baseline to each visit in the Double-Blind Treatment Period, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Beijing anding hospital capital medical university, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking university sixth hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06359886, orgStudyIdInfo id: FMASU MD 292/2022, briefTitle: B-lynch Transverse Compression Suture, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa?, conditionsModule conditions: Blood Loss, Surgical, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A Pilot Study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: B-Lynch Transverse Compression Suture, outcomesModule primaryOutcomes measure: Intraoperative blood loss, primaryOutcomes measure: Postoperative blood loss, primaryOutcomes measure: Number of received blood components, primaryOutcomes measure: Peripartum haemoglobin level drop, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University, status: RECRUITING, city: Cairo, zip: 21526, country: Egypt, contacts name: Ahmed S Zeerban, Msc, role: CONTACT, phone: +201003119968, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06359873, orgStudyIdInfo id: LAD-AF, briefTitle: Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2022-09-30, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: Based on the data of inpatients with hypertension and a cross-sectional study with a large sample size, this study aims to find the early warning value of the left anteroposterior atrial diameter for the possible occurrence of atrial fibrillation in patients with hypertension, and compare the advantages and disadvantages of the above two methods for the early warning of the risk of atrial fibrillation in patients with hypertension, so as to achieve the purpose of early identification of high-risk groups that may develop atrial fibrillation., conditionsModule conditions: Atrial Fibrillation, conditions: Hypertension,Essential, conditions: Left Atrial Dilatation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 58427, type: ACTUAL, armsInterventionsModule interventions name: CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD), outcomesModule primaryOutcomes measure: left atrial diameter (LAD), primaryOutcomes measure: CHA2DS2-VASc score, primaryOutcomes measure: C2HEST score, primaryOutcomes measure: Atrial fibrillation (AF), secondaryOutcomes measure: Area under the curve (AUC) of LAD and occurrence of AF, secondaryOutcomes measure: AUC of CHA2DS2-VASc score and occurrence of AF, secondaryOutcomes measure: AUC of C2HEST score and occurrence of AF, otherOutcomes measure: the LAD cutoff value, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 2ndChongqingMU, city: Chongqing, state: Chongqing, zip: 400010, country: China, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06359860, orgStudyIdInfo id: ST-1898-203, briefTitle: A Study of ST-1898 for Unresectable or Metastatic Melanoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-07, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Beijing Scitech-Mq Pharmaceuticals Limited, class: INDUSTRY, descriptionModule briefSummary: ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets., conditionsModule conditions: Unresectable or Metastatic Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: ST-1898 tablets, outcomesModule primaryOutcomes measure: Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs), primaryOutcomes measure: Phase Ib Dose Escalation: Recommended Phase 2 Dose (RP2D), primaryOutcomes measure: Phase II Expansion: Objective Response Rate (ORR), secondaryOutcomes measure: Phase Ib Dose Escalation: Trough concentration of ST-1898, secondaryOutcomes measure: Phase Ib Dose Escalation: Peak concentration of ST-1898, secondaryOutcomes measure: Phase Ib Dose Escalation: ORR, secondaryOutcomes measure: Phase Ib Dose Escalation: PFS, secondaryOutcomes measure: Phase Ib Dose Escalation: DoR, secondaryOutcomes measure: Phase Ib Dose Escalation: DCR, secondaryOutcomes measure: Phase Ib Dose Escalation: TTP, secondaryOutcomes measure: Phase II Dose Expansion: The Number and frequency of treatment-related adverse events and serious adverse events (SAEs), secondaryOutcomes measure: Phase II Dose Expansion: Trough concentration of ST-1898, secondaryOutcomes measure: Phase II Dose Expansion: Peak concentration of ST-1898, secondaryOutcomes measure: Phase II Dose Expansion: PFS, secondaryOutcomes measure: Phase II Dose Expansion: DoR, secondaryOutcomes measure: Phase II Dose Expansion: DCR, secondaryOutcomes measure: Phase II Dose Expansion: TTP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Cancer Hospital & Institute, status: RECRUITING, city: Beijing, zip: 100142, country: China, contacts name: Jun GUO, MD, role: CONTACT, phone: 0086-10-88121122, email: [email protected], contacts name: Chuanliang CUI, MD, role: CONTACT, phone: 0086-10-88196348, email: [email protected], contacts name: Jun GUO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06359847, orgStudyIdInfo id: ST-1898-202, briefTitle: Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Beijing Scitech-Mq Pharmaceuticals Limited, class: INDUSTRY, descriptionModule briefSummary: ST-1898, a multi-targeted tyrosine kinase inhibitor, has demonstrated strong inhibitory activity for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT, etc. The primary purpose of this study is to evaluate the efficacy of ST-1898 tablets in patients with locally advanced or metastatic RAIR-DTC after failure of at least first-line TKI systemic therapy. All subjects will receive ST-1898 180 mg orally once daily until disease progression or intolerable toxicity., conditionsModule conditions: Differentiated Thyroid Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: ST-1898 tablets, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: The number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs), secondaryOutcomes measure: PFS, secondaryOutcomes measure: PFS6m, secondaryOutcomes measure: DCR, secondaryOutcomes measure: DOR, secondaryOutcomes measure: OS, secondaryOutcomes measure: Thyroglobulin (Tg), secondaryOutcomes measure: Thyroglobulin Antibody (TgAb), secondaryOutcomes measure: Pharmacokinetic (PK) Parameter: Tmax, secondaryOutcomes measure: Pharmacokinetic (PK) Parameter: T1/2, secondaryOutcomes measure: Pharmacokinetic (PK) Parameter: Cmax, secondaryOutcomes measure: Pharmacokinetic (PK) Parameter: AUC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Yansong Lin, MD, role: CONTACT, contacts name: Xin Zhang, MD, role: CONTACT, contacts name: Yansong Lin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06359834, orgStudyIdInfo id: 4-2023-1693, briefTitle: Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-04-10, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography., conditionsModule conditions: Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Remimazolam besylate, interventions name: Propofol, outcomesModule primaryOutcomes measure: Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine, status: RECRUITING, city: Seoul, zip: 120-752, country: Korea, Republic of, contacts name: Moon Jae Chung, MD, role: CONTACT, phone: +82-2-2228-1981, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06359821, orgStudyIdInfo id: Z-001, briefTitle: Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, descriptionModule briefSummary: A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting Radiopharmaceutical, in metastatic castration resistant prostate cancer, conditionsModule conditions: Metastatic Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: ZA-001, outcomesModule primaryOutcomes measure: The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ, primaryOutcomes measure: Adverse Event, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359808, orgStudyIdInfo id: KY20232370, briefTitle: Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients., conditionsModule conditions: Colitis, Ulcerative, conditions: Sleep Quality, conditions: Gastrointestinal Microbiome, conditions: Autonomic Nervous System Imbalance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Disease activity, primaryOutcomes measure: Heart Rate Variability (HRV), primaryOutcomes measure: Functional Magnetic Resonance Imaging, primaryOutcomes measure: Neurotransmitter Agents, primaryOutcomes measure: Gastrointestinal Microbiome, secondaryOutcomes measure: Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Generalized Anxiety Disorder (GAD-7), secondaryOutcomes measure: Inflammatory Bowel Diseases Questionnaire (IBDQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359795, orgStudyIdInfo id: FAPI-TED, briefTitle: Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT, outcomesModule primaryOutcomes measure: Diagnostic accuracy, secondaryOutcomes measure: The value to predict therapy response, secondaryOutcomes measure: Diagnostic accuracy comparison, secondaryOutcomes measure: FAPI expression and SUV metrics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept. of Nuclear Medicine, Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Hui Li, Dr., role: CONTACT, phone: 86-13121136769, email: [email protected], contacts name: Lingge Suo, Dr., role: CONTACT, phone: 86-010-82264935, email: [email protected], contacts name: Hui Li, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06359782, orgStudyIdInfo id: NL76082.058.20, briefTitle: Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH), acronym: CIAO@SAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Haaglanden Medical Centre, class: OTHER, collaborators name: Leiden University Medical Center, collaborators name: Takeda, descriptionModule briefSummary: Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response., conditionsModule conditions: Subarachnoid Hemorrhage, Aneurysmal, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, multicenter, randomized, double-blind, placebo-controlled, phase II trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: C1 Esterase Inhibitor Injection [Cinryze], interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with delayed cerebral ischemia (DCI), primaryOutcomes measure: Number of participants with complications during hospitalization., secondaryOutcomes measure: Number of participants with cerebral infarction on brain CT, secondaryOutcomes measure: Number of participants dying, secondaryOutcomes measure: Neurological condition measured by Glasgow Coma Scale, secondaryOutcomes measure: Complement activity markers measured in serum and CSF, secondaryOutcomes measure: Inflammatory markers measured in serum and CSF, secondaryOutcomes measure: Number of days in the hospital, secondaryOutcomes measure: Number of ICU days, secondaryOutcomes measure: Number of ventilator days, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359769, orgStudyIdInfo id: GROUPCET, briefTitle: Group Cognitive Evolutionary Therapy for Depression, acronym: GRCET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Bucharest, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.Participants will be allocated in one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist. The intervention will consist of two 8-hour sessions of Group Cognitive Therapy, in two consecutive days.The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention., conditionsModule conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Group Cognitive Evolutionary Therapy, outcomesModule primaryOutcomes measure: Depressive symptomatology, primaryOutcomes measure: Anxiety symptomatology, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Perceived stress, secondaryOutcomes measure: Social provisions, secondaryOutcomes measure: Satisfaction with life, secondaryOutcomes measure: Self-perceived mate value, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359756, orgStudyIdInfo id: BRAIN-SAVE1, briefTitle: Ischemic Postconditioning in Carotid Surgery, acronym: BRAIN-SAVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Institute for Cardiovascular Diseases "Dedinje", class: OTHER, descriptionModule briefSummary: Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT)., conditionsModule conditions: Ischemic Postconditioning, conditions: Carotid Surgery, conditions: Stroke, conditions: Carotid Artery Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Ischemic postconditioning in carotid surgery, interventions name: Eversion Carotid Endarterectomy, outcomesModule primaryOutcomes measure: Number of Participants with perioperative stroke, primaryOutcomes measure: Number of Participants with perioperative death, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Cardiovascular Diseases Dedinje, status: RECRUITING, city: Belgrade, zip: 11000, country: Serbia, contacts name: Jovan Petrović, MD, role: CONTACT, phone: +381113601705, email: [email protected], contacts name: Slobodan Pešić, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False
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protocolSection identificationModule nctId: NCT06359743, orgStudyIdInfo id: 271/7, briefTitle: Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery., conditionsModule conditions: Post Hysterectomy Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Quadratus Lamborum versus superior hypogatric, outcomesModule primaryOutcomes measure: Opioid consumption decrease, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of medicine, Zagazig university, city: Zagazig, state: Sharkia, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06359730, orgStudyIdInfo id: 253/26-March-2024, briefTitle: Incidence and Risk Factors of Low Anterior Resection Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-12-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2022-12-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: LARS score questionnaire, outcomesModule primaryOutcomes measure: age, primaryOutcomes measure: sex, primaryOutcomes measure: medical disease, primaryOutcomes measure: site of tumor, primaryOutcomes measure: neoadjuvant therapy, primaryOutcomes measure: site of anastmosis, primaryOutcomes measure: type of meso-rectal excision, primaryOutcomes measure: adjuvant therapy, primaryOutcomes measure: type of surgery, primaryOutcomes measure: type of anastmosis, primaryOutcomes measure: LARS score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zagazig University Hospitals, city: Zagazig, zip: 44519, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06359717, orgStudyIdInfo id: ZU-10490, briefTitle: Prospective Validation of PSMA-RADS, acronym: PSMA-RADS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: This is a prospective, multicenter study aimed at evaluating the diagnostic accuracy and reliability of the Prostate-Specific Membrane Antigen Reporting and Data System (PSMA-RADS) version 1.0 in detecting prostate cancer using 68Ga-PSMA-11 PET/CT imaging. The study also compared the performance of PSMA-RADS v1.0 with the updated version 2.0.Key points:* 186 patients with newly diagnosed or recurrent prostate cancer underwent 68Ga-PSMA-11 PET/CT imaging.* Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v1.0, then retrospectively using v2.0.* Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards.* Inter-rater agreement was evaluated using Fleiss\' kappa statistic.* The study aimed to validate the diagnostic utility of PSMA-RADS v1.0 and compare it to the updated v2.0., conditionsModule conditions: Cancer Prostate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0, secondaryOutcomes measure: Inter-rater Agreement of PSMA-RADS v1.0 and v2.0, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohammad Abd Alkhalik Basha, city: Zagazig, state: Select, zip: 44631, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-21, uploadDate: 2024-04-05T07:38, filename: Prot_SAP_000.pdf, size: 692777, hasResults: False
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protocolSection identificationModule nctId: NCT06359704, orgStudyIdInfo id: kevinszc, briefTitle: Intervention for Emotions in Caregivers of Dementia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes)., conditionsModule conditions: BPSD, conditions: Expressed Emotion, conditions: Depressive Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: controlled arm with waitlist treatment, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Caregivers Of dementia Processing Emotions (COPE) program, outcomesModule primaryOutcomes measure: Expressed emotions, secondaryOutcomes measure: depressive symptoms, secondaryOutcomes measure: social dynamics, secondaryOutcomes measure: BPSD, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359691, orgStudyIdInfo id: 4UH3HL154302, type: NIH, link: https://reporter.nih.gov/quickSearch/4UH3HL154302, secondaryIdInfos id: 4UH3HL154302, type: NIH, link: https://reporter.nih.gov/quickSearch/4UH3HL154302, briefTitle: Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of the study is to promote equitable hypertension (HTN) management across the diverse patient population found in Los Angeles County Department of Health Services (LAC DHS) clinics.To achieve this goal, the study team will conduct provider- and patient-focused outreach strategies to understand how to best support adoption of blood pressure management practices already available within LAC DHS.LAC DHS clinics will be randomly assigned to one of three study conditions: 1) provider-focused outreach, 2) patient-focused outreach, and 3) usual outreach. The study will occur across 3 years with patient- and provider-focused outreach occurring in Year 1 and 2. In Year 3, study initiated patient- and provider-focused outreach will stop, and clinic use of patient- and provider-focused outreach practices will be observed by the study team.Provider-focused outreach includes increasing cultural awareness of factors that hinder and support blood pressure control, increasing access to blood pressure medications, and providing blood pressure management education. Patient-focused outreach includes using culturally sensitive educational materials and reminders to improve patient understanding of blood pressure, education on how to manage the condition, and increasing awareness of available blood pressure management resources. Clinics assigned to the usual outreach condition will operate as per usual in Year 1 but will receive patient- and provider-focused outreach in Year 2., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Three-armed crossover trial design to test effectiveness and sustainment of our implementation strategies across LAC DHS clinics and the communities they serve., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 540, type: ESTIMATED, armsInterventionsModule interventions name: Patient-focused strategies, interventions name: Provider-focused strategies, interventions name: Patient- and provider-focused strategies, outcomesModule primaryOutcomes measure: Overall provider adoption of evidence based practices, secondaryOutcomes measure: Provider/Care Team EBP Acceptability, Appropriateness, Feasibility, secondaryOutcomes measure: Blood Pressure (BP) Control, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Olive View-UCLA Medical Center, city: Sylmar, state: California, zip: 91342, country: United States, contacts name: Soma Wali, MD, role: CONTACT, phone: 747-210-3205, email: [email protected], geoPoint lat: 34.30778, lon: -118.44925, hasResults: False
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protocolSection identificationModule nctId: NCT06359678, orgStudyIdInfo id: NL85844.015.23, briefTitle: The Northstar Trial, acronym: Northstar, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, descriptionModule briefSummary: The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy., conditionsModule conditions: Flutter, Atrial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: NorthStar, outcomesModule primaryOutcomes measure: Accuracy of Catheter Localization, secondaryOutcomes measure: Influences of breathing pattern, secondaryOutcomes measure: Influences of procedure duration, secondaryOutcomes measure: Influences of complications during ablation, secondaryOutcomes measure: Influences of patient characteristics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, country: Netherlands, contacts name: Marco Gotte, role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
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protocolSection identificationModule nctId: NCT06359665, orgStudyIdInfo id: HSR230544, briefTitle: Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Brent DeGeorge, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are:* Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug.* Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis?* Is Turmeric safe for participants with thumb-joint arthritis?Participants will:* take 4 weeks of daily Turmeric capsules,* take 4 weeks of daily placebo capsules* answer daily surveys about how they are feeling and functioning., conditionsModule conditions: Arthritis of Carpometacarpal Joint of Left Thumb, conditions: Arthritis of Carpometacarpal Joint of Right Thumb, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study design will be a double-blind, randomized controlled trial with crossover., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind Randomized Controlled Trial, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Curcumin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score, primaryOutcomes measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition, secondaryOutcomes measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score, secondaryOutcomes measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition, secondaryOutcomes measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score, secondaryOutcomes measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition, secondaryOutcomes measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score, secondaryOutcomes measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition, secondaryOutcomes measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score, secondaryOutcomes measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score, secondaryOutcomes measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index, secondaryOutcomes measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index, secondaryOutcomes measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH)., secondaryOutcomes measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition, secondaryOutcomes measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI), secondaryOutcomes measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition, secondaryOutcomes measure: Number of Participants With Treatment-Related Adverse Events, secondaryOutcomes measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure, secondaryOutcomes measure: Change from Baseline in heart rate, secondaryOutcomes measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure, secondaryOutcomes measure: Change from Baseline in heart rate, secondaryOutcomes measure: Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST), secondaryOutcomes measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium, secondaryOutcomes measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR), secondaryOutcomes measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin, secondaryOutcomes measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide, secondaryOutcomes measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin, secondaryOutcomes measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR), secondaryOutcomes measure: Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets, secondaryOutcomes measure: Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin, secondaryOutcomes measure: Change from baseline in serum complete blood count (CBC) parameters: Hematocrit, secondaryOutcomes measure: Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV), secondaryOutcomes measure: Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359652, orgStudyIdInfo id: IRB24-0421, briefTitle: Get Fit for Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program., conditionsModule conditions: Thoracic, conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation Program (Apple Watch Series 6 with exercise flipbook), outcomesModule primaryOutcomes measure: The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation., secondaryOutcomes measure: Number of Participants with Postoperative Complications, secondaryOutcomes measure: Number of Participants length of hospital stay post-operative., secondaryOutcomes measure: Number of Participants discharge to not-home post-operative., eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Chicago, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Viviana Camacho, role: CONTACT, phone: 773-795-4391, email: [email protected], contacts name: Leila Yazdanbakhsh, role: CONTACT, phone: 773-834-5087, email: [email protected], contacts name: Maria Madariaga, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06359639, orgStudyIdInfo id: USM/JEPeM/KK/23080645, briefTitle: Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Michelle Choong Poh Kin, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of cognitive restructuring in reducing breakup distress and promoting personal growth among Malaysian young adults. Cognitive restructuring is a therapy skill that focuses on changing unhelpful thoughts. The main question it aims to answer is: Are there differences in their breakup distress and personal growth after receiving cognitive restructuring compared to counselling? Participants will receive five online sessions of either cognitive restructuring or counselling. Data on participants' breakup distress and personal growth will be collected before and after completion of sessions. The hypothesis is that cognitive restructuring will reduce breakup distress and increase personal growth more than counselling., conditionsModule conditions: Breakup Distress, conditions: Posttraumatic Growth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive restructuring, interventions name: Supportive counselling, outcomesModule primaryOutcomes measure: Breakup distress, primaryOutcomes measure: Posttraumatic growth, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359626, orgStudyIdInfo id: YHP2205, briefTitle: Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-09, primaryCompletionDateStruct date: 2024-07-19, completionDateStruct date: 2024-07-24, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Yuhan Corporation, class: INDUSTRY, descriptionModule briefSummary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers, conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: two-way crossover, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: YHP2205, interventions name: YHR2401, outcomesModule primaryOutcomes measure: Area under the plasma drug concentration-time curve [AUCt], primaryOutcomes measure: Maximum plasma concentration [Cmax], secondaryOutcomes measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf], secondaryOutcomes measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf], secondaryOutcomes measure: Time of peak concentration [Tmax], secondaryOutcomes measure: Terminal phase of half-life [t1/2], eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359613, orgStudyIdInfo id: 029/IRC/BMR, briefTitle: Efficacy Assessment of Gluten Free Cupcakes, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-03, primaryCompletionDateStruct date: 2019-12-15, completionDateStruct date: 2020-01-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Veterinary and Animal Sciences, Lahore - Pakistan, class: OTHER, descriptionModule briefSummary: Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ)., conditionsModule conditions: Celiac Disease in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The product will be provided to intervention group (n=50) in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2/day) providing approximately 20%DV of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group (n=50), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: nutrient rich food product, interventions name: food product, outcomesModule primaryOutcomes measure: Body Weight, primaryOutcomes measure: Height of the patients, primaryOutcomes measure: Mid upper Arm Circumference (MUAC), primaryOutcomes measure: Body Mass Index (BMI), primaryOutcomes measure: Complete Blood Count (CBC), primaryOutcomes measure: Total Protein, primaryOutcomes measure: Lipid Profile, primaryOutcomes measure: Liver Enzymes, primaryOutcomes measure: Serum Electrolytes, secondaryOutcomes measure: Gastrointestinal Symptoms, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: UVAS, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06359600, orgStudyIdInfo id: HS-10501-101, briefTitle: A Study of HS-10501 Tablets in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: HS-10501 tablet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events(AE), serious AEs and AE leading to withdrawal from treatment., primaryOutcomes measure: Number of participants with clinically significant abnormalities in lab tests, primaryOutcomes measure: Number of participants with clinically significant change from baseline in vital signs, primaryOutcomes measure: Change from baseline in Electrocardiogram (ECG), secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-t, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - Cmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - Tmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - t1/2, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501 - CL/F, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501- Vz/F, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501-λz, secondaryOutcomes measure: Pharmacokinetic (PK) profile of HS-10501- AUC0-τ, secondaryOutcomes measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT), secondaryOutcomes measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT), secondaryOutcomes measure: body weight changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The second hospital of Anhui University, status: RECRUITING, city: Hefei, state: Anhui, zip: 230601, country: China, contacts name: Wei Hu, MD, role: CONTACT, phone: 13856086475, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06359587, orgStudyIdInfo id: H22-03005, briefTitle: Re-Purposing the Ordering of Routine Laboratory Tests in Hospitals in British Columbia, acronym: RePORT-BC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: Providence Health & Services, collaborators name: Vancouver Coastal Health, collaborators name: Fraser Health, collaborators name: Interior Health, collaborators name: Northern Hospital, Australia, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Island Health, descriptionModule briefSummary: The goal of this stepped-wedge cluster randomized trial is to assess the impact of a laboratory test overuse intervention bundle on laboratory test utilization in 6 health authorities (16 hospitals) in British Columbia. The main question it aims to answer is if the intervention bundle, inclusive of healthcare provider and patient engagement tools, can be effectively implemented for hospitalized medical inpatients in 16 hospitals across BC and reduce laboratory test over-use. Researchers will compare hospital clusters that receive the intervention at different (sequential) time points to see if there are significant changes in the measured outcomes after the intervention., conditionsModule conditions: Hospital Acquired Condition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Intervention Arm (Intervention Bundle Implementation):This arm involves the time periods where hospital units are actively receiving the intervention bundle, including healthcare provider (HCP) and patient engagement tools.Control Arm (No Intervention Bundle Implementation):This arm represents the time periods when the hospital units do not receive the intervention bundle. This time period is the control period. Each hospital will contribute to intervention and control period data., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 700000, type: ESTIMATED, armsInterventionsModule interventions name: Laboratory test overuse (LTO) Bundle, outcomesModule primaryOutcomes measure: Change in number of target laboratory tests ordered per patient-day with LTO bundle compared to control period without LTO bundle, secondaryOutcomes measure: Change in number of total laboratory tests ordered per patient-day with the LTO bundle, secondaryOutcomes measure: Rate of hospital re-admissions and mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359574, orgStudyIdInfo id: IRB-24-0209, briefTitle: Core Competency Model for Corrections, acronym: CCM-C, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Charlotte, class: OTHER, collaborators name: North Carolina Department of Adult Corrections, collaborators name: North Carolina Department of Health and Human Services, descriptionModule briefSummary: The overall goal of this project is to design, implement, and revise the Core Competency Model for Corrections (CCM-C), an evidence-based Self-Directed Violence (SDV) prevention training program for correctional mental health providers in the North Carolina Department of Adult Corrections (DAC). The proposed specific aims are:Aim 1: To create the CCM-C training program. Aim 2: To assess preliminary training effectiveness. Aim 3: To gather training program quality improvement feedback from corrections stakeholders., conditionsModule conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Core Competency Model for Corrections (CCM-C) Self-Directed Violence Prevention Training, outcomesModule primaryOutcomes measure: Feasibility, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Appropriateness, primaryOutcomes measure: Usability, secondaryOutcomes measure: Perceived self-directed violence prevention skills, secondaryOutcomes measure: Willingness to intervene with a suicidal person, secondaryOutcomes measure: Beliefs about incarcerated persons engaging in self-directed violence, secondaryOutcomes measure: Self-directed violence prevention knowledge, secondaryOutcomes measure: Perceived importance of training, otherOutcomes measure: Compassion fatigue: Job burnout, otherOutcomes measure: Compassion fatigue: Traumatic stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: North Carolina Department of Adult Corrections, city: Raleigh, state: North Carolina, zip: 27699, country: United States, geoPoint lat: 35.7721, lon: -78.63861, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-14, uploadDate: 2024-03-20T14:21, filename: ICF_000.pdf, size: 256435, hasResults: False
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protocolSection identificationModule nctId: NCT06359561, orgStudyIdInfo id: 2023-2201 - Cervical lead, briefTitle: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients With Cervical Lead Placement, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-05, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Rijnstate Hospital, class: OTHER, collaborators name: Saluda Medical Pty Ltd, descriptionModule briefSummary: This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement., conditionsModule conditions: Chronic Pain Syndrome, conditions: Multi Focal Pain, conditions: Failed Neck Surgery Syndrome, conditions: Polyneuropathies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: cervical lead placement, outcomesModule primaryOutcomes measure: Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS), secondaryOutcomes measure: Pain distribution using Patient Reported Dermatomal Coverage Map, secondaryOutcomes measure: Assessment of holistic outcomes: quality of life in seven domains (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance) assessed by the PROMIS-29 questionnaire, secondaryOutcomes measure: Pain-related medication intake., secondaryOutcomes measure: Programming parameters., secondaryOutcomes measure: Programming parameters., secondaryOutcomes measure: Evaluate stimulation sensation (awareness and quality), secondaryOutcomes measure: Evaluate stimulation coverage in pain region(s), secondaryOutcomes measure: Posture Change Measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rijnstate Hospital, city: Arnhem, state: Gelderland, zip: 6815AD, country: Netherlands, geoPoint lat: 51.98, lon: 5.91111, hasResults: False
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protocolSection identificationModule nctId: NCT06359548, orgStudyIdInfo id: XH-24-002, briefTitle: PEELED INTERNAL LIMITING MEMBRANE REPOSITION, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling., conditionsModule conditions: Macular Holes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Peeled ILM Reposition, interventions name: ILM Peeling, outcomesModule primaryOutcomes measure: The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively, secondaryOutcomes measure: The MH closure rate, secondaryOutcomes measure: The range of inner retinal dimpling, secondaryOutcomes measure: Postoperative retinal thickness, secondaryOutcomes measure: The fixation stability and sensitivity threshold, secondaryOutcomes measure: mfERG P1 wave density amplitudes, secondaryOutcomes measure: M-score values, secondaryOutcomes measure: NEI-VFQ-25 questionnaire scores, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School, status: RECRUITING, city: Shanghai, country: China, contacts name: Tian Tian, Dr., role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06359535, orgStudyIdInfo id: HSK21542-IIT-02, briefTitle: An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-11-06, completionDateStruct date: 2024-11-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Mengchang Yang, class: OTHER, descriptionModule briefSummary: This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron drugs) for the prevention of postoperative nausea and vomiting and related adverse reaction treatment data. It was transformed into an effect indicator, and the possible costs involved in the study were analyzed, reasonable price parameters of HSK21542 injection were set, and the economic value of HSK21542 was explored., conditionsModule conditions: Nausea and Vomiting, Postoperative, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: HSK21542, interventions name: Placebo, outcomesModule primaryOutcomes measure: Total direct medical costs, direct non-medical costs, indirect costs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Provincial People's Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Mengchang Yang, Doctor, role: CONTACT, phone: +8618140049936, email: [email protected], contacts name: Mengchang Yang, role: PRINCIPAL_INVESTIGATOR, contacts name: Yu He, role: SUB_INVESTIGATOR, contacts name: Mengxia Lan, role: SUB_INVESTIGATOR, contacts name: Ai Wei, role: SUB_INVESTIGATOR, contacts name: Lina Yang, role: SUB_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06359522, orgStudyIdInfo id: 22.0334, briefTitle: PDA Occlusion Using NIRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-18, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Louisville, class: OTHER, collaborators name: Norton Healthcare, descriptionModule briefSummary: Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy., conditionsModule conditions: Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients who are being treated for PDA closure either via transcatheter occlusion or medical closure as part of routine care are eligible for this study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: NIRS monitor, outcomesModule primaryOutcomes measure: Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings., primaryOutcomes measure: Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol., secondaryOutcomes measure: Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment., eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Norton Children's Hospital, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: Scott D Duncan, MD, role: CONTACT, phone: 502-629-5283, email: [email protected], contacts name: Janice E. Sullivan, MD, role: CONTACT, phone: 502-629-5283, email: [email protected], contacts name: Joshua D Kurtz, MD, role: SUB_INVESTIGATOR, contacts name: Joshua Lee, MD, role: SUB_INVESTIGATOR, contacts name: John N Juneau, MD, role: SUB_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False
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protocolSection identificationModule nctId: NCT06359509, orgStudyIdInfo id: SYS6020-001, briefTitle: Study of SYS6020 in BCMA-positive Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2032-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: BCMA Targeted CAR T-cells, outcomesModule primaryOutcomes measure: Incidence of adverse events (AEs), primaryOutcomes measure: Dose limiting toxicities (DLTs), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Percentage of subjects who achieved complete response or strict complete response (CR/sCR), secondaryOutcomes measure: Percentage of subjects who achieved very good partial response (VGPR) and higher response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06359496, orgStudyIdInfo id: CT2024-ZJU-OBS8, briefTitle: Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-04-02, completionDateStruct date: 2024-04-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05., conditionsModule conditions: Zhejiang University, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: No intervention factor, outcomesModule primaryOutcomes measure: Postoperative complications were evaluated by postoperative imaging reports and serological indicators, primaryOutcomes measure: The survival rate of each group was evaluated by follow-up survey and K-M curve, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiao Xu, city: Hangzhou, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06359483, orgStudyIdInfo id: 108/2021, briefTitle: The Impact of Meal Frequency on Bone Remodeling in Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-19, primaryCompletionDateStruct date: 2021-07-04, completionDateStruct date: 2021-07-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Jordan, class: OTHER, collaborators name: United Arab Emirates University, descriptionModule briefSummary: The study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. They were randomly assigned to three or eight daily meals for three consecutive days over two phases. Blood samples were obtained at the beginning and end of each phase, and P1NP levels were analyzed. The results showed a substantial drop in P1NP levels compared to the baseline, indicating that meal frequency influences bone development. There were no significant changes between the groups eating three and eight meals per day. The study emphasizes the importance of dietary patterns in bone health and advises additional research to understand the relationship between meal frequency and bone metabolism., conditionsModule conditions: Healthy Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Meal Frequency Manipulation, outcomesModule primaryOutcomes measure: The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels.", eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Jordan, city: Amman, country: Jordan, geoPoint lat: 31.95522, lon: 35.94503, hasResults: False
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protocolSection identificationModule nctId: NCT06359470, orgStudyIdInfo id: CaiUni, briefTitle: the Modified Reversed Contralateral Axial Rotation Position, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-05, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2024-01-14, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Noha Khaled Shoukry, class: OTHER, descriptionModule briefSummary: This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine, conditionsModule conditions: Disc Prolapse With Radiculopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test was assessed at the three times of testing, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Positioning technique, outcomesModule primaryOutcomes measure: Straight leg raising test, secondaryOutcomes measure: Foraminal cross sectional area, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, city: Giza, zip: 12556, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06359457, orgStudyIdInfo id: P.T.REC/012/005016, briefTitle: Correlation Between Serum Progesterone Level And Primary Dysmenorrhea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study will be conducted to determine Correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females, conditionsModule conditions: Primary Dysmenorrhea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Serum progesterone level, primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Physical and psychological symptoms, eligibilityModule sex: FEMALE, minimumAge: 17 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359444, orgStudyIdInfo id: ONZ-2023-0453, briefTitle: Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD, acronym: CENSORIAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, collaborators name: University Hospital, Ghent, descriptionModule briefSummary: Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent., conditionsModule conditions: Exercise Therapy, conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized in two groups: (a) combined aerobic and strength and (b) combined high intensity and strength., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The training will be given by the care provider, but in exercise therapy it is not possible to mask. The assessor will assess the patients without knowing in which group they will be randomized. Randomization will be done by an external person who is only involved for randomization. The investigator, who will be analysing data afterwords, will only see 1 or 2 as group number, but will not know which number is corresponding to which group., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: Combined aerobic + strength training, interventions name: Combined strength + HIIT training, outcomesModule primaryOutcomes measure: Liver steatosis by CAP, primaryOutcomes measure: Liver steatosis on ultrasound, secondaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Liver transaminases, secondaryOutcomes measure: Maximal exercise test, secondaryOutcomes measure: Strength, secondaryOutcomes measure: Cardiovascular function, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Heigth, secondaryOutcomes measure: BMI, secondaryOutcomes measure: waist, secondaryOutcomes measure: BIA, secondaryOutcomes measure: Interleukine, secondaryOutcomes measure: TNF-alfa, secondaryOutcomes measure: Hepatokines, secondaryOutcomes measure: Myokines, secondaryOutcomes measure: Adipokines, secondaryOutcomes measure: SF-36, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-29, uploadDate: 2024-03-23T04:06, filename: SAP_000.pdf, size: 133707, hasResults: False
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protocolSection identificationModule nctId: NCT06359431, orgStudyIdInfo id: 1604/CE/CNERSH/SP, briefTitle: A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: GICMED, class: OTHER, descriptionModule briefSummary: Objective: The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum. In addition, establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care.Study sites: The study will be carried out in six health facilities in the centre region of Cameroon.Study Period: The study is expected to take 11 months; 4 months for protocol development and approval, 4 months for the training and implementation phase with data collection, 3 months for data analysis, reporting writing and dissemination.Study design: The study will be a multicentre, randomised control single blind trial. Patient participation will be a single study visit. Eligible subjects, consenting to participate will act as their own controls, and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum. The order of usage of the specula will be randomised, and the women will be blinded on knowing which speculum is being used at a particular time. Level of patient comfort will be evaluated using a visual analogue scale, percentage visualisation of the cervix will be determined following insertion of each of the specula, and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine.Patient population: All women between the ages of 21 years and 49 years who come in for consultation.Enrolment size: 81 women will be enrolled in the study. Study procedure: A speculum examination will be done on the day of consultation. Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires. Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum, while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine. The remote clinicians will be blinded on the diagnosis proposed by the clinician on site.Primary endpoints: The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort with the novel smart speculum compared to the Standard of care speculum (traditional speculum), reliability of the speculum in carrying out cervical cancer screening using telemedicine.Ethical considerations: The protocol will be submitted for the approval of the National Human Health Research Committee. Written informed consent will be sought for all participants before enrolment into the study., conditionsModule conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: Novel Smart Speculum, interventions name: Standard speculum, outcomesModule primaryOutcomes measure: Visualization, primaryOutcomes measure: Reliability in cervical cancer screening using a questionnaire, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 49 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06359418, orgStudyIdInfo id: 2024-007-KY, briefTitle: Acupuncture for Obesity With Prediabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2026-12-10, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences, class: OTHER, collaborators name: Hubei Hospital of Traditional Chinese Medicine, collaborators name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, collaborators name: Dongfang Hospital Beijing University of Chinese Medicine, collaborators name: Guangdong Provincial Hospital of Traditional Chinese Medicine, collaborators name: Heilongjiang Academy of traditional Chinese Medicine, descriptionModule briefSummary: The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes., conditionsModule conditions: Obesity, conditions: Pre-diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture, interventions name: Sham acupuncture, outcomesModule primaryOutcomes measure: The percentage change in body weight from baseline to week 12, secondaryOutcomes measure: The percentage change in body weight compared to the baseline, secondaryOutcomes measure: Achievement of a reduction in body weight of 5% or more compared to the baseline, secondaryOutcomes measure: Achievement of a reduction in body weight of 7% or more compared to the baseline, secondaryOutcomes measure: The change in 1hPG from baseline and percentage of patients who returned to normal, secondaryOutcomes measure: The change in 2hPG from baseline and percentage of patients who returned to normal, secondaryOutcomes measure: The change in FPG from baseline and percentage of patients who returned to normal, secondaryOutcomes measure: The change in HbA1c from baseline and percentage of patients who returned to normal, secondaryOutcomes measure: The change in waist circumference from baseline, secondaryOutcomes measure: The change in BMI from baseline, secondaryOutcomes measure: The change in WHR from baseline, secondaryOutcomes measure: The change in WHtR from baseline, secondaryOutcomes measure: The change in blood pressure from baseline, secondaryOutcomes measure: Changes in appetite VAS score from baseline, secondaryOutcomes measure: The change in FINS from baseline, secondaryOutcomes measure: The change in HOMA-IR from baseline, secondaryOutcomes measure: The change in HOMA-β from baseline, secondaryOutcomes measure: The change in Serum total cholesterol from baseline, secondaryOutcomes measure: The change in Triglyceride from baseline, secondaryOutcomes measure: The change in Low-Density Lipoprotein Cholesterol from baseline, secondaryOutcomes measure: The change in High-Density Lipoprotein Cholesterol from baseline, secondaryOutcomes measure: The change in Serum Uric Acid from baseline, secondaryOutcomes measure: Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline., secondaryOutcomes measure: Changes of the PHQ-4 score from the baseline., otherOutcomes measure: Expectance assessment, otherOutcomes measure: Assessment of belief in acupuncture, otherOutcomes measure: Blinding assessment, otherOutcomes measure: Safety assessment, otherOutcomes measure: Adherence assessment of acupuncture, otherOutcomes measure: Adherence assessment of life modification, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, city: Beijing, country: China, contacts name: Zhishun Liu, PhD, role: CONTACT, phone: +861088002331, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06359405, orgStudyIdInfo id: UBeykentUni, briefTitle: Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation, acronym: RCS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Beykent, class: OTHER, descriptionModule briefSummary: This study aims to objectively evaluate student nurses' crisis management skills in drug safety simulation and examine an effective intervention to improve these skills through a randomized controlled study. The research aims to provide important findings that will contribute to the determination of strategies to increase the competencies of student nurses in the fields of drug safety and crisis management.Research Hypotheses:H1: The application of drug safety simulation has an effect on the crisis management skill level of nursing students.The aim of the intervention is to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will provide students with the opportunity to recognize, assess, and effectively intervene in medication errors in real-world scenarios.The simulation program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor providing feedback to students. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided, conditionsModule conditions: Nurse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was planned as a randomized controlled study to evaluate the crisis management skills of student nurses in drug safety simulation., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: The researchers declare that the data obtained from randomly formed groups will be numbered and entered into the statistical analysis program to hide the identity information and that two researchers will be assigned during the entry., whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: drug safety simulation, outcomesModule primaryOutcomes measure: The effect of drug safety simulation application on the crisis management skill level of nursing students., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359392, orgStudyIdInfo id: DNZNC466DGR7, secondaryIdInfos id: 1R21NR020383-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21NR020383-01, briefTitle: Palliative Care Messaging for American Indians, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: South Dakota State University, class: OTHER, collaborators name: Great Plains Tribal Leaders Health Board, collaborators name: National Institute of Nursing Research (NINR), descriptionModule briefSummary: The investigators will be conducting a randomized trial in 3 reservation communities to test the efficacy of the narrative as culture-centric health promotion model for increasing American Indian tribal members' palliative care knowledge and intentions to discuss palliative care., conditionsModule conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: No message, interventions name: Culture-centric message, interventions name: General messge, outcomesModule primaryOutcomes measure: Palliative Care Knowledge Scale (PaCKS), primaryOutcomes measure: Knowledge of Care Options (KOCO), primaryOutcomes measure: Hospice and Palliative Care Questionnaire (HPCQ), primaryOutcomes measure: Identification and Transportation with Palliative Care Message, primaryOutcomes measure: Attitudes and Intentions to Discuss Palliative Care, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Dakota State University, city: Rapid City, state: South Dakota, zip: 57701, country: United States, contacts name: Mary J Isaacson, PhD, RN, RHNC, CHPN, FPCN, role: CONTACT, phone: 605-670-0975, email: [email protected], contacts name: Karla Hunter, PhD, role: CONTACT, phone: 605-212-0894, email: [email protected], contacts name: Mary J Isaacson, PhD, RN, RHNC, CHPN, FPCN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.08054, lon: -103.23101, hasResults: False
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protocolSection identificationModule nctId: NCT06359379, orgStudyIdInfo id: S22-11168, briefTitle: Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Shuttle Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy., conditionsModule conditions: Glioblastoma, IDH-wildtype, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Ropidoxuridine, outcomesModule primaryOutcomes measure: Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0., primaryOutcomes measure: adiographic response rate, disease control rate, best overall response, and duration of overall response in patients treated with oral ropidoxuridine at 960 and 1200 mg daily doses, assessed using the Response Assessment in Neuro-Oncology criteria., primaryOutcomes measure: Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., primaryOutcomes measure: Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily, primaryOutcomes measure: Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., primaryOutcomes measure: Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., primaryOutcomes measure: Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., secondaryOutcomes measure: Overall survival at 12 months, secondaryOutcomes measure: Radiographic Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Best Overall Response, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Six-Month Progression-Free Survival, secondaryOutcomes measure: Fraction of patients with tumor progression outside of the treatment area., secondaryOutcomes measure: Quantification of 9 relevant neurologic domains based on the NANO scale., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lombardi Comprehensive Cancer Center at Georgetown University, city: Washington, state: District of Columbia, zip: 20007, country: United States, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Sylvester Comprehensive Cancer Center, city: Miami, state: Florida, zip: 33136, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: John Theurer Cancer Center at the Hackensack University Medical Center, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, locations facility: Memorial Sloan Kettering Cancer Center, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Allegheny General Hospital, city: Pittsburgh, state: Pennsylvania, zip: 15212, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22903, country: United States, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False
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protocolSection identificationModule nctId: NCT06359366, orgStudyIdInfo id: ShenzhenH-guo, briefTitle: Perineal Massage Combined With Hip Joint Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Shenzhen Hospital of Southern Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. The main questions it aims to answer are:Does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? Does the perineal massage combined with hip joint training improve the flexibility of the hip joint? Researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function.Participants will:receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete Demographic sociological, ICI-Q-LF, Wexner constipation and hip motion questionnaires, conditionsModule conditions: Pelvic Floor Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: when the participants are enrolled in this study, they will be allocated to groups randomly by an independent researcher and sign the consent form. The care providers will not know the outcomes of this study, they just provide treatment for pregnant women; therefore, the care providers could be masked. an independent investigator will send a questionnaire to the participant, and the investigator does not know the intervention participants received; thus they could be masked., whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: perineal massage combined hip joint training, outcomesModule primaryOutcomes measure: pelvic floor function(constipation), primaryOutcomes measure: pelvic floor function (urinary incontinence score), secondaryOutcomes measure: hip motion, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359353, orgStudyIdInfo id: B-1902-520-004, briefTitle: Effect of Pitavastatin on Bone, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-04-08, primaryCompletionDateStruct date: 2022-02-10, completionDateStruct date: 2023-12-19, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Seoul National University Bundang Hospital, class: OTHER, collaborators name: JW Pharmaceutical, descriptionModule briefSummary: This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence.The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies., conditionsModule conditions: Osteoporosis, Osteopenia, conditions: Hypercholesterolemia, conditions: Menopausal Osteoporosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Pitavastatin, outcomesModule primaryOutcomes measure: Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months, secondaryOutcomes measure: Change in blood C-Telopeptide of Type I Collagen levels, secondaryOutcomes measure: Change in blood Osteocalcin levels, secondaryOutcomes measure: Change in urinary N-Telopeptide of Type I Collagen levels, secondaryOutcomes measure: Change in blood Procollagen Type 1 N-Terminal Propeptide levels, secondaryOutcomes measure: Change in blood LDL-cholesterol levels, secondaryOutcomes measure: Change in blood HbA1c levels, secondaryOutcomes measure: Changes in bone mineral density, otherOutcomes measure: Changes of the outcomes after 12 months, eligibilityModule sex: FEMALE, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Bundang Hospital, city: Seongnam, state: Gyeonggi, zip: 463-707, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False
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protocolSection identificationModule nctId: NCT06359340, orgStudyIdInfo id: OBOT-2018C2-13158, briefTitle: Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-03-13, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Public Health Management Corporation, class: OTHER, collaborators name: Boston University, collaborators name: Patient-Centered Outcomes Research Institute, collaborators name: Philadelphia College of Osteopathic Medicine, collaborators name: University of Pennsylvania, descriptionModule briefSummary: Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, the investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined., conditionsModule conditions: Opioid-use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 440, type: ESTIMATED, armsInterventionsModule interventions name: Psychosocial treatment, outcomesModule primaryOutcomes measure: Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry, secondaryOutcomes measure: Days Retained in Office-Based Buprenorphine Treatment, secondaryOutcomes measure: Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry, secondaryOutcomes measure: Changes in multidimensional problem severity from baseline through one year post-study entry, secondaryOutcomes measure: Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry, secondaryOutcomes measure: Changes in ED utilization from baseline to one year post-study entry, secondaryOutcomes measure: Changes in opioid overdose rates, secondaryOutcomes measure: Changes in treatment satisfaction from baseline to one year post-study entry, otherOutcomes measure: Job satisfaction and stress, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Philadelphia College of Osteopathic Medicine, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19131, country: United States, contacts name: David S Festinger, Ph.D., role: CONTACT, phone: 215-871-6546, email: [email protected], geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06359327, orgStudyIdInfo id: Pro00075623, briefTitle: Effect of Consumption of Pep19 on Quality of Life, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-07-17, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Proteimax Biotechnology Israel LTD, class: INDUSTRY, descriptionModule briefSummary: Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods. Pep19 has no effect on the brain, heart, pancreas or skeletal muscle. It is highly purified, not allergenic or mutagenic, and free of microbes, metals and other contaminants. Preliminary, open-label, uncontrolled studies have shown that Pep19 is well tolerated in rodents, dogs, and humans. This placebo-controlled study will evaluate the effects of two doses of Pep19™ -- 2 mg and 5 mg - on quality of life and sleep quality in obese subjects., conditionsModule conditions: Quality of Life, conditions: Obesity, conditions: Sleep Quality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Pep19 2 mg, interventions name: Pep19 5 mg, outcomesModule primaryOutcomes measure: Improvement on QoL, primaryOutcomes measure: Improvement on Sleep quality, secondaryOutcomes measure: Temperature, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: circumference, secondaryOutcomes measure: blood tests, secondaryOutcomes measure: Body fat, secondaryOutcomes measure: Body weight, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Precision Clinical Research, LLC, status: RECRUITING, city: Sunrise, state: Florida, zip: 33351, country: United States, contacts name: Jason Haffizulla, MD, role: CONTACT, geoPoint lat: 26.13397, lon: -80.1131, hasResults: False
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protocolSection identificationModule nctId: NCT06359314, orgStudyIdInfo id: STU00219362, briefTitle: Anxiety Lowering and Deprescribing Through Emotion Regulation, acronym: ALDER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are:* Is ALDER relevant to and satisfactory for older adult BZRA users?* Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications?Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after., conditionsModule conditions: Benzodiazepine Dependence, conditions: Anxiety Disorders, conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: ALDER, outcomesModule primaryOutcomes measure: Feasibility of intervention, primaryOutcomes measure: Acceptability of intervention, primaryOutcomes measure: Adoption of intervention, secondaryOutcomes measure: Patient benzodiazepine receptor agonist (BZRA) use, secondaryOutcomes measure: Patient attitude towards deprescribing BZRAs, secondaryOutcomes measure: Patient-reported sleep disturbance, secondaryOutcomes measure: Patient-reported anxiety, secondaryOutcomes measure: Patient-reported stress, secondaryOutcomes measure: Patient-reported depression, secondaryOutcomes measure: Patient-reported positive affect, secondaryOutcomes measure: Patient-reported meaning and purpose, secondaryOutcomes measure: Patient-reported comorbidities, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359301, orgStudyIdInfo id: H-34, briefTitle: H-34 DELTA Revision Cup, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-14, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Limacorporate S.p.a, class: INDUSTRY, descriptionModule briefSummary: THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup., conditionsModule conditions: Hip, Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 49, type: ESTIMATED, armsInterventionsModule interventions name: DELTA Revision acetabular cup, outcomesModule primaryOutcomes measure: Harris Hip Score (HHS), secondaryOutcomes measure: ROM measurement, secondaryOutcomes measure: Oxforn Hip Score (OHS), secondaryOutcomes measure: Survival rate, secondaryOutcomes measure: Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup, secondaryOutcomes measure: Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP, status: RECRUITING, city: Otwock, zip: 05-400, country: Poland, contacts name: Jerzy Bialecki, role: CONTACT, geoPoint lat: 52.10577, lon: 21.26129, hasResults: False
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protocolSection identificationModule nctId: NCT06359288, orgStudyIdInfo id: 2023/01.11/2023/6, briefTitle: Preterm Newborn Mothers' Anxiety and Self-Efficacy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2024-03-23, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Kocaeli University, class: OTHER, descriptionModule briefSummary: The aim of this study was to evaluate the effect of QR code supported infant care training given to mothers of preterm newborns on maternal self-efficacy and maternal anxiety level ., conditionsModule conditions: Nursing Care, conditions: Mother-Infant Interaction, conditions: Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was conducted experimentally with a pre-test and post-test control group., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Double blinding was used in the study. For this purpose, the participants were not specified in which group they belonged to the research. Therefore, a separate informed consent form was prepared for each group. In order to avoid bias in the analysis of the research data, statistician blinding was also applied.While coding the research data, the research groups were coded as A and B, and the statistician was prevented from knowing which letter represented which group., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Group receiving QR code supported training, outcomesModule primaryOutcomes measure: Perceived Maternal Self-Efficacy Scale (PMES)- Survey, secondaryOutcomes measure: State-Trait Anxiety Inventory (STAI)- Survey Scale, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kocaeli University, city: Kocaeli, state: İzmit, zip: 41380, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False
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protocolSection identificationModule nctId: NCT06359275, orgStudyIdInfo id: iPULSAR-PC, briefTitle: PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: PD-1, interventions name: Nab-paclitaxel, interventions name: Gemcitabine, interventions name: PULSAR, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Progression-free survival (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Surgical Conversion Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanhai, country: China, contacts name: Weijing Zhang, role: CONTACT, phone: 021-64175590, email: [email protected], hasResults: False
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protocolSection identificationModule nctId: NCT06359262, orgStudyIdInfo id: KI-HAS-001, briefTitle: Evaluating the Hope@School Prevention Program, acronym: Hope@School, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2027-01-01, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).The primary objectives of the study are:To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health., conditionsModule conditions: Mental Health Wellness 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3220, type: ESTIMATED, armsInterventionsModule interventions name: Hope@School, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: KIDSCREEN-27 Child version, secondaryOutcomes measure: KIDSCREEN-27 Parent version, secondaryOutcomes measure: Mental Health-Promoting Knowledge (MHPK-10), secondaryOutcomes measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1, secondaryOutcomes measure: Digital Addiction Scale for Children (DASC), secondaryOutcomes measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359249, orgStudyIdInfo id: V.3-06/02/2024, briefTitle: Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-28, completionDateStruct date: 2026-12-28, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, class: OTHER, collaborators name: Universitat de Vic, descriptionModule briefSummary: Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term., conditionsModule conditions: Constipation Chronic Idiopathic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: change of habits, interventions name: change of habits + auto abdominal massage, outcomesModule primaryOutcomes measure: Degree of constipation, primaryOutcomes measure: Stool characteristics, primaryOutcomes measure: Quality of life focused on patients with constipation, primaryOutcomes measure: The number of laxatives taken by each participant, secondaryOutcomes measure: Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cristina Segura Bayona, city: Igualada, state: Barcelona, zip: 08700, country: Spain, geoPoint lat: 41.58098, lon: 1.6172, hasResults: False
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protocolSection identificationModule nctId: NCT06359236, orgStudyIdInfo id: 122S049, briefTitle: Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO", statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: The primary purpose of this project is to observe the effects of Cognitive Behavioral Psychotherapy-based weight-loss mobile application (Bi' Kilo) in 4 essential areas (Anthropometric, Biochemical, Psychometric, Cognitive) in overweight and obese individuals and to test whether these effects will persist after ten weeks. In this context, the original value of the proposed study is that a mobile application will be produced that is suitable for the culture and whose effectiveness has been scientifically proven.In our current project proposal, the measurements of the participants will be evaluated holistically together with both tests and inventories, as well as physical measurements and biochemical data. In this study, the usability of the mobile application to be developed will also be evaluated and reported.The study group of the research will consist of overweight and obese individuals. The first stage will be a pilot study to identify the shortcomings of the Bi'Kilo mobile application. After eliminating the deficiencies of the Bi' Kilo mobile application, a working group will be formed in the second phase of the research. At this stage, the sample will be divided into two different groups within the scope of the study and a study group and a control group will be formed.The study consists of three phases as preparation, implementation, and follow-up. Measurements of the participants will be made at the beginning (Anthropometric, Biochemical, Psychometric, Cognitive), at the end of the six-week implementation phase (Anthropometric), and at the end of the four-week follow-up phase (Anthropometric, Biochemical, Psychometric, Cognitive)., conditionsModule conditions: Weight Loss, conditions: Obesity, conditions: Overweight and Obesity, conditions: Eating Behavior, conditions: Eating Habit, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: BI'KILO Intervention, outcomesModule primaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Waist Circumference (WC), secondaryOutcomes measure: Hip Circumference, secondaryOutcomes measure: Waist-Hip Ratio (WHR), secondaryOutcomes measure: Body Fat Percentage (BFP), secondaryOutcomes measure: Visceral Fat, secondaryOutcomes measure: Blood Glucose Level, secondaryOutcomes measure: Blood Insulin Level, secondaryOutcomes measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), secondaryOutcomes measure: Serum Leptin Level, secondaryOutcomes measure: Serum Ghrelin Level, secondaryOutcomes measure: Emotional Eating Scale (EES) Turkish Form, secondaryOutcomes measure: Mindful Eating Questionnaire (MEQ) Turkish Form, secondaryOutcomes measure: Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0), secondaryOutcomes measure: Motor Screening Task (MOT), secondaryOutcomes measure: Spatial Working Memory (SWM), secondaryOutcomes measure: Stop Signal Task (SST), secondaryOutcomes measure: Rapid Visual Information Processing (RVP), secondaryOutcomes measure: Cambridge Gambling Test (CGT), otherOutcomes measure: Demographic Information Form, otherOutcomes measure: Structured Clinical Interview for DSM-5 Disorders (SCID-5), otherOutcomes measure: The Eating Disorder Assessment for DSM-5 (EDA-5), otherOutcomes measure: Blood ACTH Level (ACTH), otherOutcomes measure: Blood Growth Hormone Level (GH), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eskisehir Osmangazi University Faculty of Medicine, city: Eskişehir, country: Turkey, geoPoint lat: 39.77667, lon: 30.52056, hasResults: False
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protocolSection identificationModule nctId: NCT06359223, orgStudyIdInfo id: 2400602, briefTitle: Effect of Coffee Consumption on Pain and Intestinal Motility After Caesarean Section:, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: Purpose: It will be performed to minimize the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.Design: It will be conducted as a randomized controlled experimental study. Method: It will consist of women who had cesarean section surgery at Necmettin Erbakan University Faculty of Medicine Hospital between April and July 2024. The sample of the research; The sample will consist of women who meet the selection criteria and voluntarily agree to participate in the research. Considering the possible 10% data loss in randomized controlled studies, a total of 50 women, 25 in each group, were planned to be sampled. Data will be collected using a personal information form and visual pain scale (VAS). . Immediately before coffee application (6-12-18 hours after surgery), women\'s pain intensity and bowel motility will be evaluated. Women will then be asked to consume 100 ml of unsweetened caffeinated coffee at 6, 12 and 18 hours after surgery. 6,12,18. Half an hour after coffee consumption, women will be evaluated for pain using VAS. In the control group, no procedure will be applied and pain assessment will be made with VAS at the same hours.Conclusion: It is aimed to reduce the pain and increase intestinal motility of patients who consume coffee after cesarean section.Key Words: Caesarean Section, Coffee, Pain, Motility, conditionsModule conditions: Operation, conditions: Cesarean Section, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: coffee consumption, interventions name: control group, outcomesModule primaryOutcomes measure: Postoperative Pain, primaryOutcomes measure: intestinal motility, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KTO Karatay Unıversty, city: Konya, state: Karatay, zip: 42000, country: Turkey, contacts name: HÜMEYRA YÜKSEL, Ph.D Student, role: PRINCIPAL_INVESTIGATOR, contacts name: Hafize Tüzmen, Ph.D student, role: SUB_INVESTIGATOR, contacts name: Merve Yazar, Ph.D student, role: SUB_INVESTIGATOR, contacts name: Jule Horasanlı, MD, role: SUB_INVESTIGATOR, contacts name: Serap Sayar, Assis. Prof., role: SUB_INVESTIGATOR, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06359210, orgStudyIdInfo id: 4973, secondaryIdInfos id: 4R33CA256656-03, type: NIH, link: https://reporter.nih.gov/quickSearch/4R33CA256656-03, briefTitle: Sustaining Physical Activity After Cancer Exercise Sessions, acronym: SPAACES, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Colorado State University, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating in a community-based exercise oncology program. The main questions it aims to answer are:* Aim 1: Examine the feasibility and acceptability of the intervention among cancer survivors and community partners. The researchers will utilize quantitative surveys, focus groups, and semi-structured interviews to collect information about feasibility, implementation, adaptation, and sustainability.* Aim 2: Examine the effects of the intervention among cancer survivors. The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program.Participants will participate in a community-based exercise oncology program and then return to three months of free living. Based on the PA measured at the three-month follow-up, participants will be categorized as a "Responder" or "Incomplete Responder", and then randomized to the PA maintenance intervention. Researchers will compare those that are classified as Responders (meeting exercise guidelines for cancer survivors) and Incomplete Responders (not meeting guidelines for cancer survivors) to see what level of intervention is needed to influence sustainable behavior change in this population., conditionsModule conditions: Exercise Oncology, conditions: Physical Activity Behavior, conditions: Behavior Change Interventions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: An adaptive design results in a final total of 4 possible subgroups, depending upon responder/non-responder status, and researchers plan to compare the proportion of participants achieving the minimum exercise guidelines for cancer survivors within the responders and incomplete responder subgroups. Admittedly however, it is not possible to fully elucidate the analyses the researchers will conduct, as researchers cannot predict the number of subgroups that participants will represent at the end of the trial (e.g., if there are no "incomplete responders" the design reduces to randomization to only two groups), nor the number of participants who will be in those subgroups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Responder Monthly Behavior Change Discussion Sessions, interventions name: Incomplete Responder Monthly Behavior Change Discussion Sessions, interventions name: Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions, outcomesModule primaryOutcomes measure: Physical Activity program, secondaryOutcomes measure: Quality of Life (QOL), secondaryOutcomes measure: Physical Fitness - Aerobic, secondaryOutcomes measure: Physical Fitness - muscular strength and endurance, otherOutcomes measure: Feasibility and acceptability of the PA maintenance intervention components, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anschutz Medical Center, status: NOT_YET_RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Ryan Marker, PhD, PT, role: CONTACT, phone: 720-848-0300, email: [email protected], contacts name: Ryan Marker, PhD, PT, role: SUB_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Colorado State University, status: RECRUITING, city: Fort Collins, state: Colorado, zip: 80526, country: United States, contacts name: Heather J Leach, PhD, role: CONTACT, phone: 970-491-8951, email: [email protected], contacts name: Heather J Leach, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.58526, lon: -105.08442, locations facility: University of Wyoming, status: RECRUITING, city: Laramie, state: Wyoming, zip: 82072, country: United States, contacts name: Derek Smith, PhD, role: CONTACT, phone: 307-766-5271, email: [email protected], contacts name: Derek Smith, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.31137, lon: -105.5911, hasResults: False
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protocolSection identificationModule nctId: NCT06359197, orgStudyIdInfo id: 2024-17022-GRA, briefTitle: Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-08-10, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hamilton Health Sciences Corporation, class: OTHER, descriptionModule briefSummary: Caffeine is one of the most widely consumed substances worldwide. This study looks to test and measure the changes in different biomarkers in the blood before and after having caffeine using capillary and venous blood sampling methods. A biomarker is a measurable indicator of biological processes. The primary goal of this clinical trial is to evaluate participant rate and adherence. It will also learn about how caffeine affects different biomarkers that may be related to cardiovascular disease. Finally, it will assess the accuracy of the capillary blood samples compared to the venous blood samples. The main questions it aims to answer are:* What is the feasibility of recruiting and retaining participants?* Are the study procedures appropriate to be translated to a larger future study?Researchers will compare caffeine to a placebo (a look-alike substance that contains no drug) to see ifParticipants will:* Be randomly assigned to the control group or the caffeine group. Individuals in the control group will be taking a placebo pill with no effect and those in the caffeine group will be taking 400mg of caffeine in pill form.* Be asked to undergo a fast of at least 8 hours overnight before taking two placebo pills or the 400 mg of caffeine via two caffeine pills. They will be required to stay fasted for 6 hours after taking the pill as well. The total time fasted will be at least 14 hours.* Have blood collected using three different methods before taking the two pills, 3 hours after taking the pills and 6 hours after taking the pills. The 3 methods include intravenous (IV) blood sampling, finger prick and collection on Whatman 903 Protein Saver Card and collection using the TASSO+ device. The TASSO+ blood collection device is a small capillary blood collection device that is designed to be easy to use and able to be used outside of a hospital/lab setting. Whatman 903 Protein Saver Cards are special filter paper with five circles for samples, that are designed for the collection and storage of blood., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: An external party will prepare an equal number of kits (n=18) containing all the required materials for the participants, both in the placebo and caffeine group. They will assign a unique random number to each of the packages; each number will correlate to either the placebo or caffeine group. When a participant agrees to the study, they will be given a unique participant ID number ranging from 0-36. Then, the external party will use a random number generator to pick the kit given to that participant. They will record the number associated with that kit, and link the kit number to the participant ID for tracking purposes. At the end of the study, the investigators will determine which participants received caffeine vs placebo based on the assigned random numbers., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Caffeine Pill, interventions name: Placebo, interventions name: TASSO+ Device, interventions name: Finger prick and collection on Whatman Protein 903 Saver Cards, interventions name: Intravenous Sampling, outcomesModule primaryOutcomes measure: Participant rate, primaryOutcomes measure: Participant Adherence, primaryOutcomes measure: Participant satisfaction, secondaryOutcomes measure: Significant changes in biomarkers observed after the ingestion of caffeine, secondaryOutcomes measure: Determine the correlation between capillary sampling and intravenous sampling, secondaryOutcomes measure: Determine the stability of capillary samples, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: David Braley Research Institute, city: Hamilton, state: Ontario, zip: L8L 2X2, country: Canada, contacts name: Luca Malatesta, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: [email protected], contacts name: Megan Robertson, role: CONTACT, phone: 905-527-527-4322, phoneExt: 40311, email: [email protected], contacts name: Guillaume Pare, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Hamilton General Hospital, city: Hamilton, state: Ontario, zip: L8L 2X2, country: Canada, contacts name: Luca Malatesta, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: [email protected], contacts name: Megan Robertson, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: [email protected], contacts name: Guillaume Pare, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: McMaster University, Department of Pathology and Molecular Medicine, city: Hamilton, state: Ontario, zip: L8S 4L8, country: Canada, contacts name: Luca Malatesta, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: [email protected], contacts name: Megan Robertson, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: [email protected], contacts name: Guillaume Pare, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, hasResults: False
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protocolSection identificationModule nctId: NCT06359184, orgStudyIdInfo id: GO21/1011, briefTitle: Yoga, Mother's Stress and Baby, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems., conditionsModule conditions: Mother-Child Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 55, type: ACTUAL, armsInterventionsModule interventions name: yoga, interventions name: control, outcomesModule primaryOutcomes measure: Perceived Stress Scale (PSS), primaryOutcomes measure: Infancy and Early Childhood Feeding Process Mother's Attitudes Scale, primaryOutcomes measure: Pittsburg Sleep Quality (PSQI), primaryOutcomes measure: Period Adaptive Eating Behavior Scale, primaryOutcomes measure: Brief Infant/Child Sleep Questionnaire (BISQ), eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ayşe Nur Ozan, city: Istanbul, state: Sarıyer, zip: 34460, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06359171, orgStudyIdInfo id: RBHP 2023 LANHERS, briefTitle: Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT, acronym: ARTH-e3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the EARS questionnaire. In addition, other questionnaires presented in the appendix (KOOS, TSK, EPAP, EQ-5D-3L, pain) will be given to all patients in order to meet the secondary evaluation criteria., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The investigators plan to conduct a multicenter, prospective, comparative, randomised trial. Participants will be randomized to one of two groups: control or experimental. In each group (control or experimental), each participant will be able to use the application for a period of 6 months.* Control group: physician's advice with examples of self-exercise (knee osteoarthritis booklet) + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet.* Intervention group: download the application + adapted physical activity session with an APA/physiotherapist + delivery of the knee osteoarthritis booklet + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The investigating physician who will carry out the inclusion visit will know the result of the randomization which will be carried out during the consultation. The second evaluator, who will carry out the end-of-study visit, will not know the patient's group. As a result, the assessment will be neutral and the second assessor will evaluate the patient without being influenced by the study group., whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Application ARTH-e, outcomesModule primaryOutcomes measure: Exercise Adherence Rating Scale, secondaryOutcomes measure: Pain Visual Analog Scale, secondaryOutcomes measure: EPAP questionnaire, secondaryOutcomes measure: TSK questionnaire, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, secondaryOutcomes measure: EQ-5D-3L questionnaire, secondaryOutcomes measure: Mobility, secondaryOutcomes measure: Average number of steps per day, secondaryOutcomes measure: Parameters for use of the ARTHE application, secondaryOutcomes measure: Functional tests - 30 sec chair lifts, secondaryOutcomes measure: Functional tests - Stair Climbing Test, secondaryOutcomes measure: Functional tests - 6MWT, secondaryOutcomes measure: Functional tests - quadriceps isometric strength test with dynamometer, secondaryOutcomes measure: Medico-economic analysis, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Clermont-Ferrand, city: Clermont-Ferrand, country: France, contacts name: Lise Laclautre, role: CONTACT, phone: 04 73 75 11 95, email: [email protected], contacts name: Charlotte Lanhers, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CH Emile Roux, city: Le Puy-en-Velay, country: France, contacts name: Gaëlle VIAL, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.04366, lon: 3.88523, locations facility: CHU Montpellier, city: Montpellier, country: France, contacts name: Isabelle TAVARES FIGUEIREDO, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU Nantes, city: Nantes, country: France, contacts name: Alban FOUASSON CHAILLOUX, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
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protocolSection identificationModule nctId: NCT06359158, orgStudyIdInfo id: eStethoscope for Med Student, briefTitle: Enhancing Respiratory Auscultation Skills Among Medical Students: Digital Stethoscopes in Medical Education, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Chung Shan Medical University, class: OTHER, collaborators name: Ministry of Education, Taiwan, descriptionModule briefSummary: Objectives: This study aims to assess the effectiveness of a novel digital stethoscope curriculum integrated into respiratory auscultation training for medical students. It seeks to compare the auscultation proficiency gained through this innovative approach with that from traditional teaching methods, to understand the potential of digital stethoscopes in reinvigorating clinical skills training.Methods: In a single-center, controlled, longitudinal, randomized experimental design, 84 medical students undergoing clinical clerkship rotations at Chung Shan Medical University Hospital were enrolled. Participants were randomly assigned to either the intervention group, receiving training with digital stethoscopes and the Eko auscultation software, or the control group, following a traditional curriculum. Pre- and post-intervention assessments measured auscultation skills, and student feedback on teaching quality was collected. The primary outcome was the improvement in auscultation proficiency, while secondary outcomes included student engagement and feedback on the educational approach.Expected Results: The investigators hypothesize that the integration of digital stethoscopes into the curriculum will significantly improve the auscultation skills of medical students compared to traditional methods. Enhanced engagement and positive feedback from students are anticipated, underscoring the pedagogical value of incorporating digital health technologies in medical education., conditionsModule conditions: Auscultation, conditions: Breathing Sound, conditions: Asthma, conditions: Pneumonia, conditions: Pleural Effusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ACTUAL, armsInterventionsModule interventions name: Digital stethoscope use, outcomesModule primaryOutcomes measure: Pre-test and Post-test using the Zuvio Interactive Response System (Zuvio, Taipei, Taiwan), primaryOutcomes measure: Student Feedback, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chung Shan Medical University Hospital, city: Taichung, state: South, zip: 402, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
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protocolSection identificationModule nctId: NCT06359145, orgStudyIdInfo id: EIT and COPD, briefTitle: Prediction of COPD Severity Using Electrical Impedance Tomography, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD., conditionsModule conditions: Electric Impedance, conditions: Respiratory Function Tests, conditions: Pulmonary Disease, Chronic Obstructive, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: The predictive power of EIT and PFT for CT visual scoring of emphysema, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PLA, status: RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Zhimei Duan, role: CONTACT, phone: 13716376758, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06359132, orgStudyIdInfo id: TeleConvert-AF, briefTitle: mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients., acronym: TeleConvert-AF, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV., conditionsModule conditions: Atrial Fibrillation, conditions: Arrhythmia, conditions: Mobile Health, conditions: Electrical Cardioversion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV unnecessary scheduled ECV appointments, secondaryOutcomes measure: Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions, secondaryOutcomes measure: Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire, secondaryOutcomes measure: Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments, secondaryOutcomes measure: Number of patients with paroxysmal AF, secondaryOutcomes measure: Time to recurrence of AF, secondaryOutcomes measure: Time period of monitoring heart rate and rhythm using the mHealth-based application, secondaryOutcomes measure: Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center, status: RECRUITING, city: Maastricht, state: Limburg, country: Netherlands, contacts name: Dominik Linz, role: CONTACT, phone: 043-3877098, email: [email protected], contacts name: Astrid Hermans, role: CONTACT, phone: 043-3871613, email: [email protected], geoPoint lat: 50.84833, lon: 5.68889, locations facility: Viecuri Medical Center, status: RECRUITING, city: Venlo, state: Limburg, country: Netherlands, contacts name: Wilfred Heesen, role: CONTACT, phone: (077) 320 56 04, email: [email protected], geoPoint lat: 51.37, lon: 6.16806, hasResults: False
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protocolSection identificationModule nctId: NCT06359119, orgStudyIdInfo id: IMAPing SUBDEP, briefTitle: Implementation of Apnoea Test for Patients With Suspected Brain Death, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged, class: OTHER_GOV, collaborators name: Veszprém County Ferenc Csolnoky Hospital, descriptionModule briefSummary: This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death., conditionsModule conditions: Brain Death, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of apnoea tests, primaryOutcomes measure: Timeframe between apnoea tests, primaryOutcomes measure: Preoxygenation, primaryOutcomes measure: Baseline arterial carbon dioxide (CO2) level, secondaryOutcomes measure: Detection of possible spontaneous breath movements, secondaryOutcomes measure: Satisfaction with current practice, otherOutcomes measure: Continuous positive airway pressure (CPAP), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359106, orgStudyIdInfo id: 2024.3.1, briefTitle: Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: China Medical University, China, class: OTHER, descriptionModule briefSummary: This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery., conditionsModule conditions: Oxygenation Index, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1098, type: ESTIMATED, armsInterventionsModule interventions name: 80% Oxygen, interventions name: 40% Oxygen, outcomesModule primaryOutcomes measure: Oxygenation Index, secondaryOutcomes measure: pH value in blood gas analysis 48 hours after the operation, secondaryOutcomes measure: oxygen inhalation time, secondaryOutcomes measure: inspired oxygen concentration, secondaryOutcomes measure: oxygen uptake rate, secondaryOutcomes measure: 7 days pulmonary complications, secondaryOutcomes measure: 30-day Mortality, secondaryOutcomes measure: PaCO2 in blood gas analysis 48 hours after the operation, secondaryOutcomes measure: Lactic acid in blood gas analysis 48 hours after the operation, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fourth Affiliated Hospital of China Medical University, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110001, country: China, contacts name: Ayong Tian, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: the First Hospital of China Medical University, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110001, country: China, contacts name: Wenfei Tan, M.D.,Ph.D, role: CONTACT, phone: 024-83283100, email: [email protected], geoPoint lat: 41.79222, lon: 123.43278, locations facility: Beijing Friendship Hospital, Capital Medical University, status: NOT_YET_RECRUITING, city: Beijing, country: China, contacts name: Yun Wang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Sichuan Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Chendu, country: China, contacts name: Qian Shi, role: CONTACT, locations facility: Chifeng Municipal Hospital, status: NOT_YET_RECRUITING, city: Chifeng, country: China, contacts name: Jiannan Song, role: CONTACT, geoPoint lat: 42.26833, lon: 118.96361, locations facility: First Affiliated Hospital of Chongqing Medical University, status: NOT_YET_RECRUITING, city: Chongqi, country: China, contacts name: Ke Wei, role: CONTACT, geoPoint lat: 27.00943, lon: 117.18179, locations facility: Dalian Third People's Hospital, status: NOT_YET_RECRUITING, city: Dalian, country: China, contacts name: Shiling Zhao, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: First Affiliated Hospital, Dalian Medical University, status: NOT_YET_RECRUITING, city: Dalian, country: China, contacts name: Yong Luan, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: First Affiliated Hospital of Harbin Medical University, status: NOT_YET_RECRUITING, city: Harbin, country: China, contacts name: Kun Wang, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: Harbin Medical University Cancer Hospital, status: NOT_YET_RECRUITING, city: Harbin, country: China, contacts name: Fei Han, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: First Hospital, Jilin University, status: NOT_YET_RECRUITING, city: Jilin, country: China, contacts name: Xuesong Song, role: CONTACT, geoPoint lat: 43.85083, lon: 126.56028, locations facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine, status: NOT_YET_RECRUITING, city: Jinan, country: China, contacts name: Yongliang Chi, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: First Medical University and Shandong Provincial Qianfoshan Hospital, status: NOT_YET_RECRUITING, city: Jinan, country: China, contacts name: Jianbo Wu, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: First Affiliated Hospital of Kunming Medical University, status: NOT_YET_RECRUITING, city: Kunming, country: China, contacts name: Jianlin Shao, role: CONTACT, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Affiliated Hospital of Qingdao University, status: NOT_YET_RECRUITING, city: Qingdao, country: China, contacts name: Wei Feng, role: CONTACT, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Liaoning Cancer Hospital and Institute, status: NOT_YET_RECRUITING, city: Shenyang, country: China, contacts name: Zeqing Huang, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shenzhen People's Hospita, status: NOT_YET_RECRUITING, city: Shenzhen, country: China, contacts name: Chaoran Wu, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: First Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijia Zhuang, country: China, contacts name: Li Wang, role: CONTACT, geoPoint lat: 34.17775, lon: 109.84894, locations facility: Second Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijia Zhuang, country: China, contacts name: Lining Huang, role: CONTACT, geoPoint lat: 34.17775, lon: 109.84894, locations facility: Tianjin Fifth Central Hospital, status: NOT_YET_RECRUITING, city: Tianjin, country: China, contacts name: Shimin Shan, role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, locations facility: YANBIAN University Hospital（Yanbian Hospital）, status: NOT_YET_RECRUITING, city: Yanbian, country: China, contacts name: Yongshan Nan, role: CONTACT, hasResults: False
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protocolSection identificationModule nctId: NCT06359093, orgStudyIdInfo id: 14422023557605, briefTitle: Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the quantity of saliva, as one of the potential etiological factors, will be assessed., conditionsModule conditions: Non-carious Cervical Lesions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1532, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital., secondaryOutcomes measure: Associated risk indicators for all participants. 3.Salivary assessment regarding flow rate and pH for subgroup diagnosed with non-carious cervical lesions., eligibilityModule sex: ALL, minimumAge: 41 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06359080, orgStudyIdInfo id: 120200004OL, briefTitle: Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL), statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-08, primaryCompletionDateStruct date: 2022-12-11, completionDateStruct date: 2022-12-11, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: JelikaLite LLC, class: INDUSTRY, descriptionModule briefSummary: The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open Label StudyThis will be an one-arm, open label study. Participants who were in the placebo condition in the previous study, will receive the treatment. Participants who were in the active condition in the previous study will repeat the course of treatment after the intermission of 3-6 months (depending on when they completed the study)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Cognilum TM: Light Treatment Condition, outcomesModule primaryOutcomes measure: Change in Autism Symptoms, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Dr. Steingold Psychology PC, city: Brooklyn, state: New York, zip: 11229, country: United States, geoPoint lat: 40.6501, lon: -73.94958, locations facility: Dr. Steingold Psychology PC, city: New York, state: New York, zip: 10019, country: United States, geoPoint lat: 40.71427, lon: -74.00597, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2022-05-01, uploadDate: 2024-04-08T10:25, filename: Prot_000.pdf, size: 332012, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2022-05-01, uploadDate: 2024-04-08T10:25, filename: SAP_001.pdf, size: 134095, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-05-01, uploadDate: 2024-04-08T10:26, filename: ICF_002.pdf, size: 172416, hasResults: False
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protocolSection identificationModule nctId: NCT06359067, orgStudyIdInfo id: APHP240295, briefTitle: A Real-World Study of Bispecific Antibodies in Multiple Myeloma, acronym: BISPEMM, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP)., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ACTUAL, armsInterventionsModule interventions name: Treated by bispecific antibodies, teclistamab or elranatamab in usual care, interventions name: Not treated by bispecific antibodies in usual care, outcomesModule primaryOutcomes measure: Infection rate, secondaryOutcomes measure: Global survival, secondaryOutcomes measure: Progression-free survivals, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assistance Publique - Hôpitaux de Paris (AP-HP), city: Paris, state: IDF, zip: 75004, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06359054, orgStudyIdInfo id: CelalBayarNRG, briefTitle: The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-11, primaryCompletionDateStruct date: 2023-05-15, completionDateStruct date: 2023-09-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: Currently, F-18 FDG PET/CT is routinely used for breast cancer staging and treatment response assessment. Most breast cancers express Estrogen Receptor (ER) and Progesterone Receptor (PR) and this subtype shows lower activity on FDG imaging. 68Ga DOTATATE PET/CT is an effective imaging option for somatostatin receptor (SSTR) positive neuroendocrine tumors. There are case reports showing 68Ga DOTATATE uptake in non-Hodgkin lymphoma, meningioma, breast cancer, thyroid adenoma and papillary carcinoma. There are also histochemical studies showing that SSTR is a potential radiopharmaceutical target for ER+/PR+ breast cancer . Its hypothesized that 68Ga DOTATATE PET/CT may be superior to 18F FDG PET/CT primarily in hormone receptor (HR) positive breast cancer. In this study, its aimed to compare the uptake pattern of breast cancer lesions and HR status with 68Ga DOTATATE and 18F FDG uptake in lesions., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: 18F FDG PET/CT, interventions name: 68Ga DOTATATE PET/CT, outcomesModule primaryOutcomes measure: Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manisa Celal Bayar University Faculty of Medicine, General Surgery Department, city: Manisa, zip: 45030, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, locations facility: Manisa Celal Bayar University Faculty of Medicine, Nuclear Medicine Department, city: Manisa, zip: 45030, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, hasResults: False
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protocolSection identificationModule nctId: NCT06359041, orgStudyIdInfo id: CAB-201-004, briefTitle: RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2029-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Cabaletta Bio, class: INDUSTRY, descriptionModule briefSummary: RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis, conditionsModule conditions: Generalized Myasthenia Gravis (gMG), designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: CABA-201, outcomesModule primaryOutcomes measure: To evaluate incidence and severity of adverse events (AEs), secondaryOutcomes measure: To evaluate the incidence and severity of adverse events (AEs), secondaryOutcomes measure: To characterize the pharmacodynamics (PD), secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To evaluate disease-related biomarkers, secondaryOutcomes measure: To evaluate efficacy by change in Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over time., secondaryOutcomes measure: To evaluate efficacy by change in Quantitative Myasthenia Gravis (QMG) score over time., secondaryOutcomes measure: To evaluate efficacy by change in Myasthenia Gravis Composite (MGC) score over time., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06359028, orgStudyIdInfo id: 300103, briefTitle: Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: HALEON, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste., conditionsModule conditions: Dentin Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 111, type: ACTUAL, armsInterventionsModule interventions name: Stannous fluoride toothpaste, interventions name: Crest cavity protection toothpaste, outcomesModule primaryOutcomes measure: Change from Baseline in Schiff Sensitivity Score at Day 56, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Day 56, secondaryOutcomes measure: Change from Baseline in Schiff sensitivity score at Day 28, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Day 28, secondaryOutcomes measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Salus Research, city: Fort Wayne, state: Indiana, zip: 46825, country: United States, geoPoint lat: 41.1306, lon: -85.12886, hasResults: False
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protocolSection identificationModule nctId: NCT06359015, orgStudyIdInfo id: 41138, secondaryIdInfos id: 605095, type: OTHER, domain: DDD, briefTitle: Metformin and Esomeprazole in Preterm Pre-eclampsia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-02-11, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Christiana Care Health Services, class: OTHER, descriptionModule briefSummary: The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia., conditionsModule conditions: Preeclampsia Severe, conditions: Pre-Eclampsia, conditions: Preeclampsia, conditions: Preeclampsia Second Trimester, conditions: Preeclampsia Complicating Childbirth, conditions: Preeclampsia Puerperium, conditions: Preterm, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups: experimental and control. The control group receives expectant management. The experimental group receives expectant management and medication treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ACTUAL, armsInterventionsModule interventions name: Metformin, interventions name: Esomeprazole, outcomesModule primaryOutcomes measure: Mean plasma difference in sFlt-1, secondaryOutcomes measure: Mean plasma difference in vascular endothelial growth factor (VEGF), secondaryOutcomes measure: Mean plasma difference in placental growth factor (PIGF), secondaryOutcomes measure: Mean plasma difference in soluble endoglin (sEng), secondaryOutcomes measure: sFlt-1:PIGF ratio, secondaryOutcomes measure: Prolongation of gestation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Christianacare Health System, city: Newark, state: Delaware, zip: 19718, country: United States, geoPoint lat: 39.68372, lon: -75.74966, hasResults: False
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protocolSection identificationModule nctId: NCT06359002, orgStudyIdInfo id: BYON4413.001, secondaryIdInfos id: 2023-507781-13-00, type: CTIS, briefTitle: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Byondis B.V., class: INDUSTRY, descriptionModule briefSummary: This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS., conditionsModule conditions: Relapsed / Refractory AML, conditions: Relapsed / Refractory MDS, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: BYON4413, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (dose escalation), primaryOutcomes measure: Composite Complete Remission Rate (expansion), secondaryOutcomes measure: Incidence and severity of adverse events, secondaryOutcomes measure: Number of patients with dose modifications, secondaryOutcomes measure: Rate of early death, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) BYON4413, secondaryOutcomes measure: Time to Cmax (Tmax) BYON4413, secondaryOutcomes measure: Area under the curve (AUC) BYON4413, secondaryOutcomes measure: Percentage of patients with confirmed anti-BYON4413 antibodies, secondaryOutcomes measure: Composite Complete Remission Rate (dose escalation), secondaryOutcomes measure: Percentage of blasts in bone marrow change from baseline, secondaryOutcomes measure: Percentage of blasts in peripheral blood change from baseline, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Relapse-free survival, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358989, orgStudyIdInfo id: Insulin resistance, briefTitle: Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults, conditionsModule conditions: Insulin Resistance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: HOMA IR, outcomesModule primaryOutcomes measure: Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358976, orgStudyIdInfo id: Spasticity splint and FMV, briefTitle: Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Arab American University (Palestine), class: OTHER, descriptionModule briefSummary: Title: The Effect of Vibrating Splint on Hand Function After StrokeSummary:This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements., conditionsModule conditions: Spasticity as Sequela of Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: The interventional study model for this clinical study is a pilot randomized controlled trial. Participants will be randomly assigned to one of three arms: Group A (vibrating splint intervention), Group B (standard splint intervention), or Group C (control group receiving no splint intervention). This model allows for the comparison of different interventions and the evaluation of their effectiveness in improving hand function and reducing spasticity after stroke. Randomization helps ensure that each group is comparable in terms of baseline characteristics, minimizing bias and increasing the validity of the study results., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: In this clinical trial, due to the nature of the interventions, it may not be possible to mask or blind the participants or therapists to the treatment received. However, efforts will be made to blind the outcome assessors who will be responsible for evaluating the participants' hand function, spasticity, and other outcome measures. Blinding the outcome assessors helps minimize potential bias and ensures the objective assessment of the intervention's effectiveness. By keeping the assessors unaware of the participants' group allocations, the integrity and reliability of the study findings can be enhanced., whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Vibration plus anti-spastic hand splint, interventions name: Anti-spastic hand splint, interventions name: Vibration, outcomesModule primaryOutcomes measure: Modified Ashworth Scale (MAS), primaryOutcomes measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE), primaryOutcomes measure: Range of Motion Assessment, primaryOutcomes measure: Numeric pain rating scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arab American University, city: Jenin, zip: 240, country: Palestinian Territory, occupied, contacts name: Hisham Arab Alkabeya, PhD, role: CONTACT, phone: 0595637776, email: [email protected], geoPoint lat: 32.45943, lon: 35.30086, hasResults: False
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protocolSection identificationModule nctId: NCT06358963, orgStudyIdInfo id: 131, briefTitle: CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy, TAC of Saliva., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-05-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Amirhossein Farahmand, class: OTHER, descriptionModule briefSummary: Comparative evaluation of CoQ10 and Omega-3 as adjuncts to periodontal therapy and total antioxidant capacity of saliva (randomized Double-Blind Clinicalials), conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-blind, Controlled design., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The research was conducted using a double-blind methodology. To ensure impartiality, both the omega-3, Coq10, and control groups were given medications that had identical appearance, packaging, and color. To further eliminate bias, a clinician who had no involvement in the study labeled teh medications as A, B, and C (empty) based on their content, and distributed them among teh patients., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Receive 30 mg of Coq10, interventions name: Non-Medicare Drugs, outcomesModule primaryOutcomes measure: reduction of bleeding on probing, secondaryOutcomes measure: total Antioxidant capacity of saliva, eligibilityModule sex: ALL, minimumAge: 28 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Amirhossein Farahmand, city: Tehran, zip: 1947833113, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False
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protocolSection identificationModule nctId: NCT06358950, orgStudyIdInfo id: ALKS 2860-201, briefTitle: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1, acronym: Vibrance-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alkermes, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone., conditionsModule conditions: Narcolepsy Type 1, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: ALKS 2680, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6, secondaryOutcomes measure: Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6, secondaryOutcomes measure: Mean weekly cataplexy rate (WCR) as derived by subject cataplexy, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alkermes Investigational Site, status: RECRUITING, city: Huntersville, state: North Carolina, zip: 28708, country: United States, geoPoint lat: 35.41069, lon: -80.84285, hasResults: False
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protocolSection identificationModule nctId: NCT06358937, orgStudyIdInfo id: #7/2023, briefTitle: Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Mahmoud Salem, class: OTHER, descriptionModule briefSummary: The aim of the present study is to compare the efficacy of LANAP to conventional scaling and root planing in the management of stage II periodontitis., conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Laser Assisted New Attachment Procedure using ND:YAG laser, interventions name: Laser Assisted New Attachment Procedure using diode laser, interventions name: Scaling and Root Planing using ultrasonic and curettes, outcomesModule primaryOutcomes measure: Microbiological assessment of Fusobacterium nucleatum, primaryOutcomes measure: Microbiological assessment of Porphyromonas gingivalis, primaryOutcomes measure: Microbiological assessment of Tannerella forsythia, secondaryOutcomes measure: Gingival index, secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Clinical attachment loss, secondaryOutcomes measure: Probing depth, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Alexandria University, status: RECRUITING, city: Alexandria, country: Egypt, contacts name: Mahmoud Salem, BDS, role: CONTACT, phone: 111 144 7745, phoneExt: +20, email: [email protected], geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06358924, orgStudyIdInfo id: FDASU-RecID032004, briefTitle: Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-13, primaryCompletionDateStruct date: 2023-08-25, completionDateStruct date: 2023-09-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year., conditionsModule conditions: Tooth Hypersensitivity, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This clinical study was conducted to evaluate the effect of using different desensitizing agents:1. As recommended by manufacturer2. Casein phosphopeptide-amorphous calcium phosphate/fluoride (CPP-ACPF) containing desensitizing agent3. Hydroxyapatite/fluoride/xylitol containing desensitizing agent4. Poly (amido amine) dendrimer with carboxylic acid terminal functional group containing desensitizing agent.On patients subjected to bleaching procedure using hydrogen peroxide containing bleaching agent.The clinical evaluation included:1. Post-bleaching hypersensitivity.2. Post-bleaching long-term shade stability., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: This clinical trial was double blinded trial in which both the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also the outcome assessors were blinded to the treatment that each participant had received., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Potassium nitrate with fluoride, interventions name: Casein phosphopeptide-amorphous calcium phosphate with fluoride, interventions name: Hydroxyapatite with fluoride, interventions name: PAMAM-carboxylic acid dendrimer, outcomesModule primaryOutcomes measure: Post-bleaching hypersensitivity, primaryOutcomes measure: Shade stability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Ain Shams University, city: Cairo, state: El Weilli, zip: 4393005, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06358911, orgStudyIdInfo id: FDASU-RecID022001, briefTitle: A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-13, primaryCompletionDateStruct date: 2023-08-05, completionDateStruct date: 2023-09-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: This study assessed the impact of four desensitizing agents on both color stability and dental sensitivity following a bleaching procedure, spanning from the 24-hour to the 1-year follow-up assessment periods., conditionsModule conditions: Tooth Hypersensitivity, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This clinical study will be conducted to evaluate the effect of using 4th generation Poly amido amine dendrimer (PAMAM-COOH) as a desensitizing agent and compared with three different commercially available desensitizing materials: 3% potassium nitrate and 0.11% fluoride (Ultra EZ), as described by manufacturer, Casein-phosphopeptide-amorphous calcium phosphate with F, (MI paste plusTm), and Hydroxyapatite, Fluoride and Xylitol, Hydroxyapatite and F (ReminPro), on:1. Long-term Post-bleaching hypersensitivity.2. Long-term Post-bleaching shade stability. For Patients treated with 40% hydrogen-peroxide bleaching agent., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: This clinical trail was a double blinded trail in which the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also outcome assessors were blinded to the treatment that each participant had received, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Poly amido amine dendrimer (PAMAM), interventions name: Manufacturer's desensitizing agent, Ultra EZ, interventions name: MI paste plus, desensitizing agent, interventions name: Hydroxyapatite and F (ReminPro), desensitizing agent, outcomesModule primaryOutcomes measure: Post-bleaching dental hypersensitivity, primaryOutcomes measure: Shade stability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry - Ain Shams University, city: Cairo, state: El Weili, zip: 4393005, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06358898, orgStudyIdInfo id: 20221207, briefTitle: Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment., conditionsModule conditions: Insomnia, conditions: Depression, conditions: Adolescent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 343, type: ESTIMATED, armsInterventionsModule interventions name: Standard dCBT-I, interventions name: Modified Mood enhanced CBT-I (M-dCBT-I), outcomesModule primaryOutcomes measure: Depressive symptoms, secondaryOutcomes measure: Assessor-rated depressive symptomatology, secondaryOutcomes measure: Overall severity of depression symptoms, secondaryOutcomes measure: Severity of insomnia symptoms, secondaryOutcomes measure: Sleep-wake pattern, secondaryOutcomes measure: Sleep-related beliefs and cognitions, secondaryOutcomes measure: Daytime sleepiness, secondaryOutcomes measure: Anxiety and depression symptoms, secondaryOutcomes measure: Quality of life by KIDSCREEN-27, otherOutcomes measure: Major life events and self-perceived stress, otherOutcomes measure: Chronotype, otherOutcomes measure: Pubertal status, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Department of Psychiatry, the Chinese University of Hong Kong, city: Sha Tin, state: New Territories, country: Hong Kong, geoPoint lat: 22.38333, lon: 114.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06358885, orgStudyIdInfo id: 22-3123, secondaryIdInfos id: R01AA030480, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA030480, briefTitle: IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention, acronym: EBAI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), collaborators name: National Institutes of Health (NIH), collaborators name: Hanoi Medical University, collaborators name: Johns Hopkins University, collaborators name: University of Washington, collaborators name: Washington University School of Medicine, descriptionModule briefSummary: This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI., conditionsModule conditions: HIV-1-infection, conditions: Unhealthy Alcohol Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-arm cluster-randomized implementation trial comparing two strategies to scale-up an evidence-based brief alcohol intervention (BAI), in Vietnam, examining the mechanisms of BAI scale-up and the impact of experiential BAI (EBAI) on clinic staff. The two implementation approaches are facilitation only (FAC) and facilitation plus an experiential brief alcohol intervention (EBAI+FAC)., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 930, type: ESTIMATED, armsInterventionsModule interventions name: Facilitation (FAC), interventions name: Experiential Brief Alcohol Intervention (EBAI), outcomesModule primaryOutcomes measure: Fidelity Score, primaryOutcomes measure: Viral Suppression, secondaryOutcomes measure: BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale, secondaryOutcomes measure: BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers, secondaryOutcomes measure: BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers, secondaryOutcomes measure: Penetration- Proportion of PWH Screened with the AUDIT-C, secondaryOutcomes measure: Penetration - Proportion of PWH who screen positive who receive at least one counseling session, secondaryOutcomes measure: Costs, secondaryOutcomes measure: Sustainability Score: Provider Support of Sustainment Scale (PRESS), secondaryOutcomes measure: AUDIT (total score) - Clinic staff, secondaryOutcomes measure: AUDIT (total score) - PWH, secondaryOutcomes measure: Fidelity (Extended Window), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hanoi Medical University, city: Hanoi, country: Vietnam, contacts name: Le Minh Giang, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: 21.0245, lon: 105.84117, hasResults: False
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protocolSection identificationModule nctId: NCT06358872, orgStudyIdInfo id: 23-39839, briefTitle: Azithromycin for Child Survival in Niger II, acronym: AVENIR II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2028-04-29, completionDateStruct date: 2028-04-29, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Centre de recherche et interventions en santé publique (CRISP), collaborators name: Ministère de la Santé Publique du Niger, collaborators name: Le Programme National de Santé Oculaire, collaborators name: Centre de Recherche Médicale et Sanitaire, collaborators name: Bill and Melinda Gates Foundation, descriptionModule briefSummary: Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years., conditionsModule conditions: Mortality, conditions: Antimicrobial Resistance, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention will involve biannual oral azithromycin MDA to children 1-59 months old distributed by community health workers. The Centre de Santé Integré (CSI) will be randomized to receive azithromycin MDA or delayed treatment in a stepped wedge design for the first 2 years. The delayed intervention arm will receive usual care for the first 2 years, then will receive the intervention for the next 2 years., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants, community health workers delivering the intervention, and team members supervising the program will not be masked. One biostatistician and one data analyst will remain unmasked to prepare the randomization sequence. Masked personnel include outcome assessors as well as the biostatistician and data analyst conducting the data analyses., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 3300000, type: ESTIMATED, armsInterventionsModule interventions name: Azithromycin for Oral Suspension, outcomesModule primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Prevalence of resistance to macrolides - nasopharyngeal swabs, primaryOutcomes measure: Prevalence of resistance to macrolides - nasopharyngeal swabs, primaryOutcomes measure: Load of genetic determinants of resistance to macrolides - rectal swabs, primaryOutcomes measure: Load of genetic determinants of resistance to macrolides - rectal swabs, secondaryOutcomes measure: Number of clinic visits - infectious, secondaryOutcomes measure: Number of clinic visits - infectious, secondaryOutcomes measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs, secondaryOutcomes measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs, secondaryOutcomes measure: Program Cost Per Dose Delivered, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: Program National de Santé Oculaire, city: Niamey, country: Niger, geoPoint lat: 13.51366, lon: 2.1098, hasResults: False
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