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The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia. conditions: Coronary Artery Disease conditions: Angina Pectoris studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-Center Prospective Study primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Coronary Sinus Reducer measure: Impact of Coronary Sinus Reducer on Coronary Microcirculation measure: Myocardial Ischemia assessment measure: Angina assessment measure: Functional capacity assessment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Centre Zagreb status: RECRUITING city: Zagreb zip: 10000 country: Croatia name: Josko Bulum, MD, PhD role: CONTACT phone: +385981714090 email: jbulum@gmail.com name: Luka Percin, MD role: CONTACT phone: +385917917252 email: luka.percin555@gmail.com lat: 45.81444 lon: 15.97798 hasResults: False
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<|newrecord|> nctId: NCT06266052 id: 2019/04 briefTitle: Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery overallStatus: ENROLLING_BY_INVITATION date: 2024-01-20 date: 2024-03-20 date: 2024-04-20 date: 2024-02-20 date: 2024-02-20 name: Recep Tayyip Erdogan University class: OTHER briefSummary: The aim of this study is to prospectively evaluate the effectiveness of 4 different flap types used during mandibular impacted wisdom teeth surgery on postoperative quality of life, soft tissue and hard tissue healing at the end of the 3rd month. conditions: Soft Tissue Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Triangular Flap name: Berwick Flap name: Saurez Flap name: Heitz Flap measure: Eudema Amount measure: Pain Level measure: Trismus Level measure: Halitosis Amount measure: bone healing condition sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: RTEU Faculty of Dentistry city: Rize country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False
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<|newrecord|> nctId: NCT06266039 id: 2022-0328-01 id: 2022-A02616-37 type: OTHER domain: French National Agency for the Safety of Medicines (ANSM) briefTitle: Introduction of Long Acting Buprenorphine in France acronym: OBAP overallStatus: RECRUITING date: 2023-03-31 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: University of Bordeaux class: OTHER briefSummary: The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal.
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Main objectives:
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The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbidities
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Main hypotheses:
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1. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of the CS of "Drug use" (i.e., substance addiction severity) at 6 months compared to baseline.
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2. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline. conditions: Addiction Opiate studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 223 type: ESTIMATED measure: The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation measure: The change in addiction severity at 6 months after treatment initiation measure: The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation measure: The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation measure: The change in quality of life with nottingham health profile part 1 and part 2 (NHP1 and NHP2) at 6 months after treatment initiation measure: The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation measure: The change in other use at 6 months after treatment initiation measure: The change in craving at 6 months after treatment initiation measure: The change in other domains of addiction severity at 6 months after treatment initiation measure: The change in Treatment Satisfaction Questionnaire for Medication (TSQM) at 6 months after treatment initiation measure: Cues - craving - use links and others factors variations measure with EMA after treatment initiation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bordeaux status: RECRUITING city: Bordeaux state: Gironde zip: 33000 country: France name: Marc Auriacombe, Professor role: CONTACT phone: +33556561738 email: marc.auriacombe@u-bordeaux.fr lat: 44.84044 lon: -0.5805 hasResults: False
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<|newrecord|> nctId: NCT06266026 id: ThermoBreast briefTitle: ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. acronym: ThermoBreast overallStatus: RECRUITING date: 2023-12-11 date: 2028-12 date: 2029-12 date: 2024-02-20 date: 2024-02-20 name: ThermoMind Ltd. class: INDUSTRY name: Assuta Medical Centers Ltd. name: Hospital of Lithuanian University of Health Sciences Kaunas Clinics name: Institut Gustav Roussy name: M.D. Anderson Cancer Center name: Sheba Medical Center name: The Holy Family Hospital Nazareth name: University College Cork name: Univerzitetni klinicni center Maribor name: Academisch Ziekenhuis Groningen name: Technical University of Munich name: Technion, Israel Institute of Technology name: Vrije Universiteit Brussel name: Cancer Patients Europe name: University Hospital Heidelberg briefSummary: Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.
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Medical Thermography might overcome these limitations: It is a non-invasive , adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.
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To date, there has been no completed or ongoing large-scale, prospective, multicenter, international study that evaluates the diagnostic performance of thermal video streams coupled with advanced Artificial Intelligence algorithms for early-stage breast cancer screening and diagnosis. The proposed study will be crucial for the development of a new imaging modality that aims to be both cost-effective and to carry a minimal level of risk, facilitating screening of women of all age groups and breast densities, enabling early detection of abnormalities caused by malignant processes and improving patient monitoring. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 28000 type: ESTIMATED name: ThermoBreast - AI-based evaluation of dynamic breast thermography imaging measure: Sensitivity (true-positive rate) measure: Specificity (true-negative rate) measure: Cancer detection rate measure: Detection rate of ductal carcinoma in situ (DCIS) measure: Detection rate of tumor category pT1 measure: Recall rate measure: Sensitivity measure: Specificity measure: Positive-predictive value measure: Negative-predictive value measure: Diagnostic performance in the three trial cohorts measure: Proportion of breast quadrant localization measure: Proportion of correct histopathologic subtype identification measure: Proportion of correct tumorbiologic subtype identification measure: Proportion of correct axillary lymph node involvement identification measure: Effect of hormonal status on diagnostic performance measure: Effect of breast density on diagnostic performance measure: Effect of ethnicity on diagnostic performance measure: Timing of ThermoBreast measure: Screening time measure: Cost-effectiveness measure: Lived Experience sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Heidelberg University Hospital status: RECRUITING city: Heidelberg country: Germany name: André Pfob, MD role: CONTACT lat: 49.40768 lon: 8.69079 hasResults: False
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<|newrecord|> nctId: NCT06266013 id: 009 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity overallStatus: NOT_YET_RECRUITING date: 2024-02-14 date: 2024-02-19 date: 2024-03-10 date: 2024-02-20 date: 2024-02-20 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between diaphragmatic fatigue and muscular strength in upper and lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, functionality and muscle tissue oxygen levels.
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According to our hypothesis, the execution of a protocol inducing diaphragmatic fatigue in older adults could influence muscular strength, cardiorespiratory function, exercise capacity, and muscle tissue oxygenation.
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In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.
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Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: inspiratory muscle training measure: Muscle oxygen saturation (SmO2) measure: Functional mobility measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Functional capacity measure: Diaphragm movement curve sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266000 id: PROPAL briefTitle: Comparison of 2 Extracts of Saw Palmetto Versus Placebo on BPH Symptoms overallStatus: RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-03-01 date: 2024-02-20 date: 2024-04-04 name: RDC Clinical Pty Ltd class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on the symptoms of benign prostate hyperplasia (BPH) in 120 generally healthy participants, 45 - 80 years. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Saw palmetto extract 320mg per day name: Commercial Saw palmetto extract 320mg per day name: Palm Oil capsule measure: International Prostate Symptom Score (IPSS) measure: Daily Urinary Frequency Diary measure: Brief Sexual Function Inventory (BSFI) measure: International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) measure: Electrolytes (E/LFT) blood test measure: Liver Function (E/LFT) blood test measure: Inflammatory marker - JM27 measure: Blood pressure measure: Pulse rate measure: Adverse event frequency measure: Adverse event severity measure: Discontinuation due to adverse events sex: MALE minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical Pty Ltd status: RECRUITING city: Brisbane state: Queensland zip: 4006 country: Australia name: Amanda Rao, PhD role: CONTACT phone: +61 414 488 559 email: amanda@rdcglobal.com.au name: David Briskey, PhD role: CONTACT phone: +61 421 784 077 email: david@rdcglobal.com.au lat: -27.46794 lon: 153.02809 hasResults: False
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<|newrecord|> nctId: NCT06265987 id: ECHOQUALITY2 briefTitle: Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-01 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Poitiers University Hospital class: OTHER briefSummary: The objective of this observational study is to identify maternal and fetal characteristics that impact image quality in prenatal ultrasonography. The investigators have assembled a retrospective cohort of 198 patients, each contributing three ultrasound images taken between 18 and 18 weeks and 6 days of gestation. For each image, the investigators assess the quality of two distinct elements as well as the overall image through both subjective and objective evaluations.
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The primary questions the study seeks to address are:
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What maternal and fetal characteristics influence image quality in prenatal ultrasonography? conditions: Ultrasonography conditions: Obstetrics conditions: Fetus conditions: Pregnant Women studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 198 type: ACTUAL measure: Maternal and fetal characteristics can influence quality image in ultrasonography sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital La MILETRIE city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 hasResults: False
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<|newrecord|> nctId: NCT06265974 id: ECHOQUALITY briefTitle: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-01 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Poitiers University Hospital class: OTHER briefSummary: The goal of this observational study is to determine whether the subjective assessment of the quality of obstetrical ultrasonography pictures can be similar to that of an objective tool.
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The main question it aims to answer is:
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Is the subjective assessment of the quality of obstetrical ultrasonography pictures by a young practitioner and an experienced one can be similar to that of an objective tool, such as the contrast-to-noise ratio (CNR)? The contrast-to-noise ratio is commonly used in radiology to evaluate image quality by assessing the ability to distinguish differences between two elements.
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The investigators selected a retrospective cohort of 198 patients, including three pictures per fetus screened between 18 and 18 weeks and 6 days. For each picture, the investigators assessed the quality of two different elements and the entire image, and then calculated the CNR using software. The investigators will compare the three assessment between them conditions: Ultrasonography conditions: Obstetrics studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 198 type: ACTUAL measure: The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital La MILETRIE city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 hasResults: False
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<|newrecord|> nctId: NCT06265961 id: 02.01.2024_39 briefTitle: Efficiency of the Bibliotherapy Method in Developing Cultural Intelligence and Competencies of Nurses overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2024-05-01 date: 2024-05-31 date: 2024-02-20 date: 2024-02-20 name: Eskisehir Osmangazi University class: OTHER briefSummary: The study aims to evaluate the effectiveness of the developmental bibliotherapy method in developing the cultural intelligence and competence of nurses.
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The study will be carried out in an embedded intervention research model using a combination design (Quantitative + Qualitative) in the intervention design, which is one of the advanced mixed methods designs. In the embedded mixed research model where the quantitative approach is dominant, randomized controlled experimental research and qualitative research will be conducted simultaneously.
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1.1. Research questions for the qualitative phase 1.1.1. Research questions for the exploratory phase Q1. How successful are nurses in distinguishing the cultural differences of the individuals they care for? Q2. What are nurses\' views on cross-cultural nursing care? Q4. How do nurses approach the culturally-based behaviors of the individuals they care for? Q5. What are the cultural experiences that nurses have with the individuals they care for?
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1.1.2. Research questions for the integrative phase Q1. What are the contributions of the books read to the cultural intelligence and competence of nurses? Q2. What are the contributions of the stories read to the cultural intelligence and competence of nurses? Q3. What are the contributions of the watched movie to the cultural intelligence and competence of nurses?
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1.1.3. Research questions for the explanatory phase Q1. What effect did bibliotherapy practice have on nurses\' cultural intelligence? Q2. What impact did bibliotherapy practice have on nurses\' cultural competence?
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1.2. Research hypotheses of the quantitative phase
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1. H1. Bibliotherapy intervention will increase the cultural intelligence levels of the nurses in the study group.
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2. H1. The cultural intelligence levels of the nurses in the study group will be higher than the nurses in the control group.
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3. H1. Bibliotherapy intervention will increase the cultural competence of the nurses in the study group.
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4. H1. The cultural competence of the nurses in the study group will be higher than the nurses in the control group. conditions: Cultural Competency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Mixed methods research is defined as "a research approach used in the field of health, social and behavioral sciences in which the researcher collects both quantitative and qualitative data to understand the research problems, integrates two data sets, and then draws conclusions using the advantages of integrating these two data sets." The study will be carried out in an embedded intervention research model using a combination design (Quantitative + Qualitative) in the intervention design, which is one of the advanced mixed methods designs. In the embedded mixed research model where the quantitative approach is dominant, randomized controlled research and qualitative research will be conducted simultaneously. primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Education name: Bibliotherapy measure: Cultural intelligence measure: Cultural competence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskisehir Osmangazi University city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
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<|newrecord|> nctId: NCT06265948 id: comparsion drugs in cancer briefTitle: Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-05 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: ( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries ) conditions: Abdominal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: post operative pain sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265935 id: Ataturk Unıversıty - Neslihan briefTitle: Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08-15 date: 2024-10-15 date: 2024-02-20 date: 2024-02-29 name: Ataturk University class: OTHER briefSummary: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. GDM, which is in the high-risk pregnancy category, causes fatigue during pregnancy due to both hormonal changes and pregnancy complications (1). Fatigue is a general complaint that occurs in almost all physical and mental diseases. Fatigue also negatively affects an individual's well-being, daily performance, activities of daily living (ADLs) and relationships. Fatigue is one of the symptoms that, if not controlled, negatively affects the individual's daily living activities and quality of life (2). While breathing itself is a way of relaxation, it is also a part of all relaxation exercises and is an exercise that can be used in daily life. Breathing correctly and deeply is the first step in learning to relax. (3). It is important to identify fatigue, minimize it, plan daily living activities and improve quality of life in patients with GDM. This study will be conducted as a randomized controlled study to determine the fatigue and quality of life of diaphragmatic breathing exercises, one of the non-pharmacological methods, on pregnant women with gestational diabetes. conditions: Gestational Diabetes Mellitus in Pregnancy conditions: Pregnancy in Diabetic conditions: Fatigue conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomize primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The sample size was calculated as 60 pregnant women by performing GPower analysis, taking into account the tests to be used to calculate the minimum sample size to be included in the study. The sampling will include a total of 60 primiparous pregnant women, including 30 pregnant women diagnosed with gestational diabetes who meet the inclusion criteria for the study, who agree to participate in the study, and 30 pregnant women diagnosed with gestational diabetes who are applied diaphragmatic breathing exercise and who are not applied diaphragmatic breathing exercise. whoMasked: PARTICIPANT count: 2 type: ESTIMATED name: Experimental Group measure: SF-36 Quality of Life Scale: measure: Visual Similarity Scale for Fatigue sex: FEMALE minimumAge: 19 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06265922 id: P.T.REC/012/003937 briefTitle: Cerebellar rTMS in Patients With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2024-04-18 date: 2024-06-02 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis. conditions: Patients With Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participant masking as patients will be divided into two groups High frequecy cerebellar repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation by placing the coil in perpendicular way away from the cerebellum.
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Care provider masking as the physical therapist treating patients will be blind from the application of repetitive transcranial magnetic stimulation whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ESTIMATED name: High frequency repetitive transcranial magnetic stimulation name: Sham repetitive transcranial magnetic stimulation measure: Biodex balance system measure: Berg balance scale measure: Nine-Hole Peg Test (9-HPT) measure: Four square step test (FSST) sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06265909 id: PRW001 briefTitle: Prospective Real World Study on Therapy Prediction Algorithm Training overallStatus: COMPLETED date: 2015-03-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-02-20 name: Mobio Interactive PTE LTD class: INDUSTRY briefSummary: This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. The third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content. conditions: Stress conditions: Emotional Wellbeing studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 67 type: ACTUAL name: AmDTx measure: Objective Stress Level (OSL) measure: Self-Reported Stress (SRS) measure: Self-Reported Mood (SRM) sex: ALL minimumAge: 18 Years maximumAge: 66 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mobio Interactive Pte Ltd city: Singapore zip: 389637 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06265896 id: P.T.REC/012/004948 briefTitle: Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients. conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Kinesio taping name: Pelvic floor exercise training measure: Pelvic floor impact questionnaire- short form 7 (PFIQ-7) measure: King's Health Questionnaire (KHQ) measure: Assessment of pelvic floor muscle strength sex: FEMALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt name: Mai N. Mamdouh, M.Sc. Student role: CONTACT phone: 01014924808 email: G01014924808@gmail.com name: Dalia M. Kamel, Prof. role: CONTACT phone: 01273990045 email: dr-daliakamel@cu.edu.eg name: Ahmed S. Ebrahim, Prof. role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06265883 id: MIIR-16-Retro briefTitle: Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT overallStatus: COMPLETED date: 2019-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-02-20 name: Second Affiliated Hospital of Guangzhou Medical University class: OTHER name: Zhongshan People's Hospital, Guangdong, China name: Affiliate Hospital of Guangdong Medical University name: Jieyang People's Hospital name: Huizhou Municipal Central Hospital name: Guangzhou Development District Hospital name: Shenzhen Traditional Chinese Medicine Hospital name: First People's Hospital of Foshan briefSummary: This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups. conditions: Hepatocellular Carcinoma Non-resectable studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 205 type: ACTUAL name: Len+DEB-TACE+HAIC name: Len+DEB-TACE measure: Time to progression (TTP) measure: objective response rate (ORR) measure: Disease control rate (DCR) measure: overall survival measure: treatment-related adverse events (TRAEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Guangzhou Medical University city: Guangzhou state: Guangdong zip: 510260 country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06265870 id: Parasite in Eosinophilia briefTitle: Specific Versus Empirical Anthelminthic Treatment in Eosinophilia acronym: Eosinophilia overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-04-03 name: Prince of Songkla University class: OTHER briefSummary: There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. In cases where parasite infection is suspected, particularly in developing countries, stool microscopy and serology are recommended. However, limitations such as low sensitivity of stool microscopy, the inconvenience of collecting multiple stool samples, and the high cost and unavailability of serology may arise. Consequently, some physicians opt for empiric anthelminthic regimens in managing eosinophilic patients, even without stool tests or if stool test results are normal. If subsequent complete blood count (CBC) results show a recovery of absolute eosinophil count, it is assumed that eosinophilia was caused by a parasite infection. While some studies demonstrate the efficacy and simplicity of this approach, there is a risk of overestimating parasite infection in eosinophilic patients, potential adverse drug reactions from unnecessary anthelminthic treatment, and the possibility of drug resistance due to inappropriate dosing. To address this gap, no study has yet compared the efficacy between specific anthelminthic treatment based on test results and empirical anthelminthic treatment in eosinophilic patients. Therefore, the investigators are conducting this study. conditions: Eosinophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 700 type: ESTIMATED name: Albendazole name: Ivermectin or albendazole measure: Eosinophilia recovery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265857 id: IOE-naoxiaoxueguan briefTitle: Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients overallStatus: RECRUITING date: 2024-02-28 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. conditions: Cerebral Small Vessel Diseases conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Video Fluoroscopic Swallowing Study measure: Functional Oral Intake Scale measure: Body mass index measure: Serum albumin measure: Hemoglobin measure: Pneumonia measure: Activities of daily living measure: World Health Organization Quality of Life Assessment Instrument Brief Version sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thai Rehabilitation Community Center status: RECRUITING city: Ban Phon Ko country: Thailand name: Cop Kun role: CONTACT hasResults: False
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<|newrecord|> nctId: NCT06265844 id: IOE-Biyanai briefTitle: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Hemoglobin measure: Serum albumin measure: Body Mass Index measure: Serum prealbumin measure: Depression measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale measure: Swallowing-Quality of Life questionnaire measure: Feeding amount sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Martin Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Xi Maheen, Master role: CONTACT lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06265831 id: BU-FHS-NC-03 briefTitle: The Effect of Face Hand Fan Application on Dyspnea acronym: HandfanCOPD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2023-11-30 date: 2024-03 date: 2024-02-20 date: 2024-02-20 name: Bartın Unıversity class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: Diagnosing and managing dyspnea in patients with COPD is very important. Although pharmacological and non-pharmacological methods are used in the management of dyspnea, it is recommended that pharmacological methods be supported by non-pharmacological methods. Hand fan application, which is one of the non-pharmacological methods used in dyspnea management, provides an increase in self-efficacy in patients in addition to the stimulation of cold air flow to the trigeminal nerve branches, mucosa and skin. Although there are studies reporting that applying cold air to the face with a hand fan is effective in reducing the severity of dyspnea in different patient groups, the number of studies examining the effectiveness of applying cold air to the face with a hand fan in patients with COPD is quite limited. This project was planned to determine the effect of applying cold air to the face with a fan on the severity of dyspnea and quality of life in COPD patients. conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group: two groups, an intervention group and a control group, receiving complementary therapy. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Hospitalized patients with a diagnosis of COPD will be randomized into two groups. The intervention group will have a hand fan applied to the face and be monitored for a week, and the control group will receive routine care at the clinic. Investigators will evaluate outcome measures. whoMasked: PARTICIPANT count: 61 type: ACTUAL name: Hand-fan application to the face measure: Modified Borg Scale measure: Saint George Respiratory Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmiye ÇÖMLEKÇİ city: Bartın zip: 74100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False
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<|newrecord|> nctId: NCT06265818 id: 2024-KY-0126 briefTitle: The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder acronym: ABE-S overallStatus: RECRUITING date: 2024-03-01 date: 2024-05 date: 2024-05 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups. conditions: Respiratory Rhythm Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation training name: Active Breathing Exercises measure: The Penetration-Aspiration Scale measure: The Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray Secretion Scale measure: Swallowing Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06265805 id: 2024-KY-0125-015 briefTitle: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients acronym: IOE-Xinli overallStatus: RECRUITING date: 2024-02-28 date: 2024-12-30 date: 2024-12-30 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Generalized Anxiety Disorder 7 measure: Patient Health Questionnaire-9 measure: Self-made questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hsinchu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu, Master role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False
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<|newrecord|> nctId: NCT06265792 id: 2024-KY-0125 briefTitle: Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea acronym: OSA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2024-12-15 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:
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• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Stellate ganglion block measure: Epworth Sleepiness Scale measure: Apnea-Hypopnea Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06265779 id: 2024-KY-0122 briefTitle: Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia acronym: IOE+JLCJ-S overallStatus: RECRUITING date: 2024-02-29 date: 2024-11-30 date: 2024-12-15 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. conditions: Cerebral Infarction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Transcranial direct current stimulation measure: Penetration Aspiration Scale measure: Functional Oral Intake Scale measure: Swallowing Quality of Life Questionnaire measure: Patient Health Questionnaire-9 measure: Body weight measure: Nutritional status-total protein measure: Nutritional status-albumin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06265766 id: NL85511.041.24 id: 85511 type: OTHER domain: ABR number briefTitle: Brain STimulation for Arm Recovery After Stroke 2 acronym: B-STARS2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-03-31 date: 2029-12-31 date: 2024-02-20 date: 2024-02-20 name: Jord Vink class: OTHER briefSummary: Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.
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Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.
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Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.
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Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.
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Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.
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Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Sham cTBS treatment is delivered with a sham TMS-coil. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 454 type: ESTIMATED name: cTBS measure: Upper extremity section of the Fugl-Meyer Assessment measure: Upper extremity section of the Fugl-Meyer Assessment measure: Action Research Arm Test measure: modified Rankin Scale measure: Hand section of Stroke Impact Scale measure: Participation section of Stroke Impact Scale measure: EuroQol-5D measure: Nine Hole Peg Test measure: Ipsilesional corticospinal excitability measure: iMTA medical consumption and productivity cost questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Reade city: Amsterdam country: Netherlands name: Marijn Mulder-Kampen role: CONTACT lat: 52.37403 lon: 4.88969 facility: Revalidatie Friesland city: Beetsterzwaag country: Netherlands name: Wietske Rienstra role: CONTACT lat: 53.05914 lon: 6.07711 facility: Revant city: Breda country: Netherlands name: Marissa Riemens role: CONTACT lat: 51.58656 lon: 4.77596 facility: Tolbrug city: Den Bosch country: Netherlands name: Cynthia Klinkers role: CONTACT lat: 51.27 lon: 5.59167 facility: Basalt city: Den Haag country: Netherlands name: Kangdi Zhu role: CONTACT lat: 52.07667 lon: 4.29861 facility: MRC Aardenburg city: Doorn country: Netherlands name: Lisa Kruisheer role: CONTACT lat: 52.03343 lon: 5.34571 facility: Libra Blixembosch city: Eindhoven country: Netherlands name: Daphne Stranders role: CONTACT lat: 51.44083 lon: 5.47778 facility: University Medical Center Groningen city: Groesbeek country: Netherlands name: Henk Meulenbelt role: CONTACT lat: 51.77667 lon: 5.93611 facility: Merem city: Hilversum country: Netherlands name: Maijke van Bloemendaal role: CONTACT name: Karin Peek role: CONTACT lat: 52.22333 lon: 5.17639 facility: Adelante city: Hoensbroek country: Netherlands lat: 50.92387 lon: 5.92528 facility: Basalt city: Leiden country: Netherlands name: Annelies Mantje role: CONTACT lat: 52.15833 lon: 4.49306 facility: Sint Maartenskliniek city: Nijmegen country: Netherlands name: Nelleke Kooiman role: CONTACT lat: 51.8425 lon: 5.85278 facility: Libra Leijpark city: Tilburg country: Netherlands name: Iris Habets role: CONTACT lat: 51.55551 lon: 5.0913 facility: De Hoogstraat city: Utrecht country: Netherlands name: Mirjam Kouwenhoven role: CONTACT lat: 52.09083 lon: 5.12222 facility: Heliomare city: Wijk Aan Zee country: Netherlands name: Deborah Wit role: CONTACT lat: 52.4936 lon: 4.59409 facility: Vogellanden city: Zwolle country: Netherlands name: Bente Visser role: CONTACT lat: 52.5125 lon: 6.09444 hasResults: False
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<|newrecord|> nctId: NCT06265753 id: Gastrocimemius spasticity id: E-60116787-020-474196 type: REGISTRY domain: Pamukkale University Ethics Comitee briefTitle: Gastrocinemius Function Massage on Lower Extemity Spasticity acronym: Spasticity overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-23 date: 2024-06-01 date: 2024-09-01 date: 2024-02-20 date: 2024-02-20 name: Pamukkale University class: OTHER briefSummary: This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients. conditions: Stroke conditions: Stroke Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the study, 2 different groups (experimental and control) will be formed by using randomisation method. In addition to 45 minutes of classical physiotherapy exercises, 10 minutes of gastrocinemius function massage will be applied to the experimental group, while 10 minutes of sham massage and 45 minutes of classical physiotherapy exercises will be applied to the control group. The application will continue 2 days a week for 6 weeks. Spasticity, gait parameters and fall risks of the participants will be evaluated before and after the treatment with the help of various tests.
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Translated with www.DeepL.com/Translator (free version) primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Gastrocinemius Function Massage name: Sham application measure: Spasticity measure: Gait parameters and fall risk sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Address city: Denizli state: Muş Alparslan University zip: 20100 country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False
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<|newrecord|> nctId: NCT06265740 id: RBHP 2023 GALLOT (PREMABIOTE) id: 2023-A02466-39 type: OTHER domain: 2023-A02466-39 briefTitle: Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota acronym: PREMABIOTE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: Objectives: to assess the relevance of the "RiboTaxa" algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.
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Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth). conditions: Premature Birth conditions: Vaginal Flora studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: vaginal swab measure: Early diagnosis of preterm birth using vaginal microbiota analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand city: Clermont-Ferrand country: France name: Lise Laclautre role: CONTACT name: Denis Gallot role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False
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<|newrecord|> nctId: NCT06265727 id: CRB-701-01 briefTitle: A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors overallStatus: RECRUITING date: 2024-04-01 date: 2027-01-16 date: 2027-01-27 date: 2024-02-20 date: 2024-04-09 name: Corbus Pharmaceuticals Inc. class: INDUSTRY name: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. briefSummary: The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.
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The main questions it aims to answer are:
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What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?
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Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A three part study primaryPurpose: TREATMENT masking: NONE count: 420 type: ESTIMATED name: CRB-701 measure: Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 measure: Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR) measure: Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR) measure: Parts A, B, % C: To characterize the safety profile of CRB-701 measure: Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax) measure: Maximum observed plasma concentration of free MMAE (Cmax) measure: Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax) measure: Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax) measure: Time to reach Cmax of free MMAE (Tmax) measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax) measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax) measure: Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC) measure: Total Area Under the plasma concentration-time curve of free MMAE (AUC) measure: Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moores Cancer Centre at UC San Diego Health status: NOT_YET_RECRUITING city: San Diego state: California zip: 92037 country: United States name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 32.71533 lon: -117.15726 facility: Helen Diller Family Comprehensive Cancer Center - UCSF status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94115 country: United States name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 37.77493 lon: -122.41942 facility: Rocky Mountain Cancer Centres status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 39.73915 lon: -104.9847 facility: Yale Cancer Center status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 41.30815 lon: -72.92816 facility: Florida Cancer Specialists status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32806 country: United States name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 28.53834 lon: -81.37924 facility: University of Chicago status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 41.85003 lon: -87.65005 facility: Hope and Healing Cancer Center status: RECRUITING city: Hinsdale state: Illinois zip: 60521 country: United States name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 41.80086 lon: -87.93701 facility: Dana-Faber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Rodney Carter role: CONTACT lat: 42.35843 lon: -71.05977 facility: Nebraska Hematology Oncology status: RECRUITING city: Lincoln state: Nebraska zip: 68506 country: United States name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 40.8 lon: -96.66696 facility: Carolina BioOncology Institute status: RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 35.41069 lon: -80.84285 facility: Texas Oncology status: NOT_YET_RECRUITING city: Tyler state: Texas zip: 75702 country: United States name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 32.35126 lon: -95.30106 facility: Virginia Cancer Specialists status: NOT_YET_RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 38.84622 lon: -77.30637 facility: Barcelona IOB Hospital Quironsalud (NEXT) status: NOT_YET_RECRUITING city: Barcelona zip: 08023 country: Spain name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 41.38879 lon: 2.15899 facility: Vall d-Hebron Institut d'Oncologia status: NOT_YET_RECRUITING city: Barcelona zip: 08035 country: Spain name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 41.38879 lon: 2.15899 facility: Fundacion Jimenez Diaz (START) status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 40.4165 lon: -3.70256 facility: Hospital Clinico Universitario de Valencia status: NOT_YET_RECRUITING city: Valencia zip: 46010 country: Spain name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 39.46975 lon: -0.37739 facility: Adana Numune Egitim ve Arastirma Hastanesi (Adana City Education and Research Hospital) status: NOT_YET_RECRUITING city: Adana zip: 83114 country: Turkey name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 37.00167 lon: 35.32889 facility: Ankara Etlik City Hospital status: NOT_YET_RECRUITING city: Ankara country: Turkey name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 39.91987 lon: 32.85427 facility: Ankara University status: NOT_YET_RECRUITING city: Ankara country: Turkey name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 39.91987 lon: 32.85427 facility: Istanbul Medeniyet University status: NOT_YET_RECRUITING city: Istanbul zip: 34720 country: Turkey name: Rodney Carter role: CONTACT email: Clincal@corbuspharma.com lat: 41.01384 lon: 28.94966 facility: University of Birmingham NHS Foundation Trust status: NOT_YET_RECRUITING city: Birmingham zip: B15 2TH country: United Kingdom name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 52.48142 lon: -1.89983 facility: University of Cambridge NHS Foundation Trust status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0QQ country: United Kingdom name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 52.2 lon: 0.11667 facility: Velindre Cancer Centre status: NOT_YET_RECRUITING city: Cardiff zip: CF15 7QZ country: United Kingdom name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 51.48 lon: -3.18 facility: Leeds University Hospitals NHS Trust status: NOT_YET_RECRUITING city: Leeds zip: LS9 7LP country: United Kingdom name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 53.79648 lon: -1.54785 facility: Guy's and St Thomas' Clinical Research Facility status: NOT_YET_RECRUITING city: London zip: SE1 9RT country: United Kingdom name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 51.50853 lon: -0.12574 facility: Imperial Experimental Cancer Medicine Centre status: NOT_YET_RECRUITING city: London zip: W12 0NN country: United Kingdom name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 51.50853 lon: -0.12574 facility: The Christie Hospital status: NOT_YET_RECRUITING city: Manchester zip: M20 4BX country: United Kingdom name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 53.48095 lon: -2.23743 facility: University of Southampton status: NOT_YET_RECRUITING city: Southampton zip: SO16 6YD country: United Kingdom name: Rodney Carter role: CONTACT email: clinical@corbuspharma.com lat: 50.90395 lon: -1.40428 facility: University of Liverpool - Clatterbridge Medical Centre status: NOT_YET_RECRUITING city: Wirral zip: CH63 4JY country: United Kingdom name: Rodney Carter role: CONTACT email: Clinical@corbuspharma.com lat: 53.37616 lon: -3.10501 hasResults: False
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<|newrecord|> nctId: NCT06265714 id: LB.02.01/VII/005/KEP005/2022 briefTitle: The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia overallStatus: COMPLETED date: 2021-07-23 date: 2023-09-06 date: 2023-09-23 date: 2024-02-20 date: 2024-02-20 name: Indonesia University class: OTHER briefSummary: Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients. conditions: Cardiovascular Diseases conditions: Acute Coronary Syndrome conditions: Heart Failure conditions: Heart Disease, Coronary conditions: Infections conditions: Sepsis conditions: Stroke conditions: Shock conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 12950 type: ACTUAL measure: Alive measure: Death measure: Readmitted to ICCU measure: Rehospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. dr. I.G.N.G. Ngoerah General Hospital city: Denpasar state: Bali country: Indonesia lat: -8.65 lon: 115.21667 facility: Dr. Kariadi General Hospital city: Semarang state: Central Java country: Indonesia lat: -6.99306 lon: 110.42083 facility: Dr. Saiful Anwar General Hospital city: Malang state: East Java country: Indonesia lat: -7.9797 lon: 112.6304 facility: Dr. Iskak General Hospital city: Tulung Agung state: East Java country: Indonesia lat: -5.3578 lon: 105.04623 facility: Prof. Dr. R. D. Kandou Manado General Hospital city: Manado state: North Sulawesi country: Indonesia lat: 1.48218 lon: 124.84892 facility: Dr. Wahidin Sudirohusodo General Hospital city: Makassar state: South Sulawesi country: Indonesia lat: -5.14861 lon: 119.43194 facility: Dr. M. Djamil Padang General Hospital city: Padang state: West Sumatra country: Indonesia lat: -0.94924 lon: 100.35427 facility: National Cardiovacular Center Harapan Kita city: Jakarta country: Indonesia lat: -6.21462 lon: 106.84513 facility: Sardjito General Hospital city: Yogyakarta country: Indonesia lat: -7.80139 lon: 110.36472 hasResults: False
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<|newrecord|> nctId: NCT06265701 id: IRB0148200 briefTitle: Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms? overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-03-12 date: 2024-03-12 date: 2024-02-20 date: 2024-03-13 name: Cornell University class: OTHER briefSummary: The goal of this clinical trial is to explore the efficacy of a reflective journaling intervention-"Me Through Time"- in decreasing levels of derailment, and its impact on downstream depressive symptoms. conditions: Depression conditions: Depressive Symptoms conditions: Derailment conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Investigators will utilize a single-blind approach where participants will not be made aware of the purpose of the intervention. Participants in both arms will be told that the purpose of the study is "to determine the efficacy of a novel five-session journaling intervention, which explores concepts related to self-continuity". This is partly true for those in the experimental arm. The main purpose of the study is twofold: (1) to explore the efficacy of the experimental journaling intervention's in reducing levels of derailment and (2) to test the hypothesis that decreasing derailment- a temporal discordance of the self- will lead to a decrease in depressive symptoms. whoMasked: PARTICIPANT count: 116 type: ACTUAL name: Derailment-Focused Reflective Journaling name: Everyday Tasks Reflective Journaling measure: Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5 measure: Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Positive and Negative Affect on the Positive and Negative Affect Schedule (PANAS) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Optimism Versus Pessimism on the Life Orientation Test - Revised (LOT - Revised) at Week 2 (Session 6/Post-Assessment sex: ALL minimumAge: 18 Years maximumAge: 29 Years stdAges: ADULT facility: Cornell University city: Ithaca state: New York zip: 14850 country: United States lat: 42.44063 lon: -76.49661 hasResults: False
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<|newrecord|> nctId: NCT06265688 id: CTMX-2051-101 briefTitle: First In Human Study of CX-2051 in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-04-02 date: 2027-11-30 date: 2029-03-31 date: 2024-02-20 date: 2024-04-18 name: CytomX Therapeutics class: INDUSTRY briefSummary: The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 124 type: ESTIMATED name: CX-2051 measure: Safety and tolerability of CX-2051 measure: Determine the recommended Phase 2 dose (RP2D) measure: Objective response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of disease control (DODC) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dana-Farber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Carolina BioOncology Institute, PLLC status: RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States lat: 35.41069 lon: -80.84285 facility: Sarah Cannon Research Institute, LLC status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False
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<|newrecord|> nctId: NCT06265675 id: E1-4066/2023 briefTitle: Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve overallStatus: RECRUITING date: 2024-01-24 date: 2025-01-24 date: 2025-06-24 date: 2024-02-20 date: 2024-02-20 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Phenol name: Celestone name: Lidocain measure: Numeric Rating Scale (NRS) measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) measure: Patient Global Impression of Change (PGIC) measure: Sixt Minute Walk Test (6MWT) measure: The Timed-Up and Go test measure: Frequency of analgesic usage sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gaziler status: RECRUITING city: Ankara state: Çankaya country: Turkey name: Rabia Layık, Assist. Dr. role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06265662 id: 66701100301 briefTitle: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2025-09 date: 2024-02-20 date: 2024-02-20 name: Chulalongkorn University class: OTHER briefSummary: The goal of this quasi-experimental study is to test the effectiveness of a digital health program designed to prevent non-communicable diseases (NCDs) in employees within a workplace setting in Thailand. The main questions it aims to answer are:
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