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With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags. conditions: Crohn Disease conditions: Colitis, Ulcerative conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 456 type: ESTIMATED name: Remote monitoring measure: Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years. measure: Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group. measure: Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire". measure: Number of telephone/email contacts with the IBD team within one year and within two years. measure: Number of contacts with the general practitioner for IBD related reasons within one year and within two years. measure: Absence at work or school within one year and within two years in the intervention group versus the control group will be measured using the WPAI IBD questionnaire. measure: Quality of life in the intervention group versus the control group will be measured using the European Quality of Live Five Dimension Five Level Scale. measure: Number of patients refusing to participate in this trial and the reason why. measure: Reasons to stop remote monitoring. measure: Patient's compliance, measured via missing data in the intervention versus the control group measure: Satisfaction with the program in the intervention group. measure: System usability in the intervention group. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338917 id: File 2022 DI 61 briefTitle: Mental Health and Vigorous-intensity Physical Activity acronym: +MoveMENT overallStatus: ENROLLING_BY_INVITATION date: 2023-09-10 date: 2026-01-31 date: 2026-01-31 date: 2024-04-01 date: 2024-04-01 name: University of Vic - Central University of Catalonia class: OTHER name: IRIS-CC name: AGAUR briefSummary: People with severe mental illness have unhealthy lifestyles and habits, such as sedentary behavior and physical inactivity. Which are associated with a higher prevalence of premature mortality and chronic comorbidities.
The aim of this study is to evaluate the efficacy of a physical activity program, which pretends to increase the number of vigorous-intensity physical activity bouts in their daily life, as a habit, combining High Intensity Interval Training (HIIT) and Vigorous Intensity Life-Style Physical Activity (VILPA). Secondary aims are to evaluate the efficacy of the program on fitness, physical activity and sedentary behavior level and patron; depressive, mania and psychotic symptomatology, functionality and cognitive functioning; quality of life and mood. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participants in both groups are not aware of the existence of the other group. The health provider in the control group is aware of the existence of the intervention group but does not know which intervention is being carried out. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Vigorous-intensity physical activity program measure: Psychotic symptomatology measure: Depression symptomatology measure: Depression severity measure: Mania symptomatology measure: Mania severity measure: Disability measure: Quality of life measure: Cognitive functioning measure: Mood measure: Subjective physical activity patron measure: Subjective sedentary behaviour patron measure: Perception of physical fitness measure: Objective physical activity patron measure: Objective sedentary behavior patron measure: Cardiorespiratory endurance measure: Velocity measure: Agility measure: Lower limb strength measure: Subjective perception of joy measure: Subjective perception of calm measure: Subjective perception of energy measure: Subjective perception of time spent measure: Subjective perception of the received information measure: Subjective perception of respect received sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vic city: Vic state: Barcelona zip: 08500 country: Spain lat: 41.93012 lon: 2.25486 hasResults: False
<\|newrecord\|> nctId: NCT06338904 id: PID2022-141225OB-I00 briefTitle: Brief Problem-solving Intervention in Different Formats for the Prevention of Suicide in Adults Over 50 acronym: SOLPROSU50+ overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-01 date: 2024-04-01 name: University of Santiago de Compostela class: OTHER name: Ministry of science and innovation of Spain briefSummary: Suicide represents a personal tragedy and an enormous global public health problem. One of the most vulnerable groups is adults 50 years and older. Despite this stage of life is particularly amenable to the implementation of targeted suicide prevention strategies, we have few studies of the efficacy of psychological interventions, those that do exist have methodological limitations, and none were implemented in formats other than face-to-face, which limits their accessibility. There is a need for brief psychological interventions that can be administered in both face-to-face and remote formats, do not require long training periods, and are effective in different contexts: for example, problem-solving therapy. The main objective of this project is to evaluate the efficacy of a brief problem-solving psychological intervention for targeted suicide prevention in people aged 50 years and older, administered in face-to-face, conference call, and smartphone app formats. A randomized controlled trial will be performed. Participants will be recruited through healthcare centers in the Autonomous Community of Galicia (Spain). To be included, participants must: (a) be at least 50 years old, (b) reside in Galicia, and (c) present suicidal ideation. Subjects will be excluded if they: (a) present serious mental health or medical disorders; (b) have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research; (c) do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate; or (d) plan to move in the next 18 months. At pre-intervention information will be collected on sociodemographic, family, personal history, current suicide risk and other clinical variables. 212 participants will be randomly assigned to (1) a problem-solving-based psychological intervention delivered face-to-face (PSPI-FF; experimental group 1); (2) a problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC; experimental group 2); (3) a problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A; experimental group 3); or (4) a usual care control group (UCCG). Participants in the experimental groups will complete the six sessions/modules of the interventions. Finally, subjects in all groups will be evaluated at post-intervention and 3, 6 and 12-month follow-ups. conditions: Suicide studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 212 type: ACTUAL name: Problem-solving-based psychological intervention measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. measure: Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline social support to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Treatment adherence measure: Satisfaction with the service received measure: Sociodemographic, familial, personal history, and current suicide risk variables sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Group on Mental Health and Psychopatology city: Santiago de Compostela state: A Coruña zip: 15782 country: Spain lat: 42.88052 lon: -8.54569 hasResults: False
<\|newrecord\|> nctId: NCT06338891 id: ACPM34 briefTitle: Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks overallStatus: RECRUITING date: 2024-05-01 date: 2024-08-30 date: 2025-05-01 date: 2024-04-01 date: 2024-04-01 name: University of Palermo class: OTHER briefSummary: Familial Mediterranean Fever (FMF) is a chronic hereditary autoinflammatory disease caused by mutations in the MEditerranean FeVer (MEFV) gene which codes for pyrin. Dysfunction of this protein determines an inappropriate response to inflammatory stimuli. The clinical course of the disease is characterized by recurrent episodes of fever and inflammation of the serous membranes, which manifest with chest, abdominal and joint pain. Several studies suggest a possible association between acute FMF attacks and dietary triggers, including wheat. However, it is still unclear to what extent wheat is responsible for the reactivation of FMF and if, between one acute attack and another, patients with FMF experience other symptoms, both gastrointestinal and extraintestinal, characteristic of gluten/wheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten/Sensitivity, NCGS/NCWS).
Therefore, this study aims to evaluate the appearance of symptoms compatible with an acute attack of FMF following the ingestion of wheat or other foods, and the prevalence of self-perceived gluten/wheat sensitivity in patients with FMF. conditions: Familial Mediterranean Fever conditions: Non-celiac Gluten Sensitivity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Main questionnaire name: Secondary questionnaire measure: Prevalence of the self-perception of wheat as a potential trigger of acute attack in patients with familial Mediterranean fever (FMF) measure: Prevalence of the self-perception of other foods, other than wheat, as potential triggers of an acute attack in patients with FMF measure: Prevalence of self-reported NCGS/NCWS in patients with FMF measure: Genetic differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Genetic differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Genetic differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Ethnic group differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Ethnic group differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Ethnic group differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Education level differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Education level differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Education level differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Working activity differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Working activity differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Working activity differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Gastrointestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Extraintestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Extraintestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Gastrointestinal symptoms duration differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: FMF specific drugs intake differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in number/year of FMF attacks between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in FMF specific drugs intake adherence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in marital status between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in marital status between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in marital status between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in age at FMF diagnosis between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in age at FMF symptom's onset between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. sex: ALL minimumAge: 6 Months maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Palermo status: RECRUITING city: Palermo state: Sicily zip: 90127 country: Italy name: Pasquale Mansueto role: CONTACT phone: 00390916554815 email: pasquale.mansueto@unipa.it name: Pasquale Mansueto role: PRINCIPAL_INVESTIGATOR name: Antonio Carroccio role: SUB_INVESTIGATOR name: Aurelio Seidita role: SUB_INVESTIGATOR lat: 38.13205 lon: 13.33561 hasResults: False
<\|newrecord\|> nctId: NCT06338878 id: 2023PI087 briefTitle: PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes acronym: PATHWAY-HF overallStatus: RECRUITING date: 2024-03-01 date: 2027-01 date: 2029-01 date: 2024-04-01 date: 2024-04-01 name: Pr. Nicolas GIRERD class: OTHER briefSummary: This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: All-cause post-hospitalization mortality measure: Rehospitalization for heart failure measure: Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations measure: Influenza and pneumococcal vaccination status measure: Evolution of renal function measure: All-cause Rehospitalization measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU de Nancy status: RECRUITING city: Nancy country: France name: Laura FILIPPETTI role: CONTACT email: l.filippetti@chru-nancy.fr lat: 48.68439 lon: 6.18496 hasResults: False
<\|newrecord\|> nctId: NCT06338865 id: Study00003146 briefTitle: Short Title: Standard vs. Lower Pressure Pneumoperitoneum overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-01 date: 2024-04-01 name: Cedars-Sinai Medical Center class: OTHER briefSummary: This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Patients and post-anesthesia care unit nurses will be masked. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 294 type: ESTIMATED name: Carbon dioxide name: Bupivacaine name: Oxycodone measure: Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10) measure: First reported pain score in PACU (numerical rating scale, 0-10) measure: Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10) measure: Inpatient morphine milligram equivalents measure: Total number of 5mg oxycodone pills taken in the 2 weeks following discharge measure: Need for insufflation pressure increase intra-operatively due to inadequate visualization measure: Operative time measure: Estimated blood loss measure: Intraoperative complications measure: Conversion to laparotomy measure: Postoperative length of stay measure: Surgeon-reported adequacy of assigned insufflation pressure measure: Need for adjustment of insufflation pressure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338852 id: 4347 briefTitle: Awareness of Gynaecologists About Role of Physical Therapy in Genital Prolapse overallStatus: COMPLETED date: 2023-03-03 date: 2023-06-03 date: 2023-07-03 date: 2024-04-01 date: 2024-04-01 name: Cairo University class: OTHER briefSummary: The aim of this study will be to detect if there is awareness of gynecologists about the role of physical therapy in genital prolapse.
Physical therapy plays an important role in assessment, prevention and treatment of pelvic floor dysfunction and genital prolapse, it helps to stimulate and strength pelvic floor muscle.
Physical therapy treatments for the pelvic floor may include bladder training, pelvic floor muscles training with or without biofeedback, vaginal cones, electro stimulation or other adjuncts to training. conditions: Genital Prolapse studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 370 type: ACTUAL name: Socio demographic and evaluation questionnaires measure: Socio demographic and evaluation questionnaires sex: ALL minimumAge: 29 Years maximumAge: 44 Years stdAges: ADULT facility: Faculty of physical therapy cairo university city: Cairo zip: 37617692 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06338839 id: D8450R00006 briefTitle: Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia acronym: TETRAMER overallStatus: RECRUITING date: 2023-12-28 date: 2024-11-30 date: 2024-11-30 date: 2024-04-01 date: 2024-04-01 name: AstraZeneca class: INDUSTRY briefSummary: A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice.
The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis conditions: Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 6000 type: ESTIMATED measure: Prevalence of ATTR-CM in patients with HFpEF in routine clinical practice in the Russian Federation measure: demographic and clinical characteristics, and test results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Akhtubinsk country: Russian Federation lat: 48.27955 lon: 46.17217 facility: Research Site status: RECRUITING city: Astrakhan country: Russian Federation lat: 46.34968 lon: 48.04076 facility: Research Site status: RECRUITING city: Beslan country: Russian Federation lat: 43.19217 lon: 44.54313 facility: Research Site status: RECRUITING city: Izhevsk country: Russian Federation lat: 56.84976 lon: 53.20448 facility: Research Site status: RECRUITING city: Kaluga country: Russian Federation lat: 54.5293 lon: 36.27542 facility: Research Site status: RECRUITING city: Krasnodar country: Russian Federation lat: 45.04484 lon: 38.97603 facility: Research Site status: RECRUITING city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Research Site status: RECRUITING city: Smolensk country: Russian Federation lat: 54.7818 lon: 32.0401 facility: Research Site status: RECRUITING city: Vladimir country: Russian Federation lat: 56.13655 lon: 40.39658 facility: Research Site status: RECRUITING city: Vladivostok country: Russian Federation lat: 43.10562 lon: 131.87353 facility: Research Site status: RECRUITING city: Volgograd country: Russian Federation lat: 48.71939 lon: 44.50183 facility: Research Site status: RECRUITING city: Yaroslavl country: Russian Federation lat: 57.62987 lon: 39.87368 hasResults: False
<\|newrecord\|> nctId: NCT06338826 id: ANRS0250s-BI-LIGHT briefTitle: Study Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses acronym: BI-LIGHT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-28 date: 2027-02-28 date: 2024-04-01 date: 2024-04-01 name: ANRS, Emerging Infectious Diseases class: OTHER_GOV briefSummary: The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy conditions: HIV Infections conditions: HBV Coinfection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Interventional, sequential, Phase IIA equivalent, multicenter, open-label, randomized, non-comparative study evaluating, for 96 weeks, the safety in terms of HBV virological control of 2 antiviral therapy relief strategies, in HIV-1 and HBV co-infected patients with prolonged virological success (undetectable HIV-1 and HBV viral loads for ≥ 2 years) and on unmodified antiviral therapy for ≥ 1 year.
Participants will be randomized 1:2:2 into 3 parallel arms:
* Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF
* Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days
* Arm 3 (B7): Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR). The choice of dual therapy is left to the discretion of the investigator. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ESTIMATED name: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI name: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) measure: The proportion of participants with HBV virological failure at 96 weeks. measure: • HBV virological success rate at 48 weeks measure: • HIV virological success rate at 48 and 96 weeks measure: • Time to virological failure (rebound HBV and/or HIV viral load) measure: • The rate of participants with at least one HBV viral load blip until W48 and until W96 measure: • Selection of HBV resistance mutations at the time of virological failure measure: • Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96 measure: • Evolution of CD4 from W0 to W48 and W96 measure: • Evolution of total cholesterol from W0 to W48 and W96 measure: • Evaluation of the adherence by self-reported questionnaire measure: • Evaluation of quality of life using the Pro-Qol self-questionnaire measure: Evolution of CD8 T lymphocytes from W0 to W48 and W96 measure: Evolution of the CD4/CD8 ratio from W0 to W48 and W96 measure: Evolution of LDL-c from W0 to W48 and W96 measure: Evolution of HDL-c from W0 to W48 and W96 measure: Evolution of triglycerides from W0 to W48 and W96 measure: Evolution of fasting blood sugar from W0 to W48 and W96 measure: HBV virological success rate at 96 weeks between arms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338813 id: Merve Unutmaz briefTitle: Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus overallStatus: COMPLETED date: 2022-10-30 date: 2023-02-22 date: 2023-03-01 date: 2024-04-01 date: 2024-04-01 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Although many measurement techniques have been tried for intra-abdominal pressure, the Kron technique is currently the gold standard method. However, the search for other methods continues due to its long application time, the need for more equipment, and impracticality. Consequently, the investigators sought to investigate a quicker and more accessible method suitable for successful intra-abdominal pressure measurement in the emergency department. This study aimed to compare intra-abdominal pressure measurements in patients diagnosed with ileus using a digital manometer and the Kron Technique. conditions: Ileus studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SCREENING masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Digital Manometry measure: Digital manometer measuring for Intraabdominal Pressure sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06338800 id: PSY-2324-S-0134 briefTitle: One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: Accare class: OTHER briefSummary: The goal of this study is to evaluate one session with exposure with Virtual Reality (VR) in in children and adolescents, aged 8-18 years with an anxiety disorder. The main questions it aims to answer are:
1. What are the expectations of children and adolescents and therapists with VR exposure?
2. What is the acceptability of the VR session (positive and negative effects)?
3. What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR. conditions: Anxiety Disorders conditions: Exposure conditions: Social Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: During ongoing treatment for their anxiety disorder 30 children and adolescents (8-18 years) with an anxiety disorder will receive a session of exposure with VR. Before the session expectations of VR exposure will be assessed. Before and after the session willingness to participate in exposure in vivo will be measured. During the session anxiety, idiosyncratic expectations, and self-efficacy are measured. After the session, positive effects, experiences, and negative side effects will be asked for. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: One session exposure with Virtual Reality measure: Willingness to participate in exposure in vivo measure: Idiosyncratic expectations measure: Anxiety measure: Expectations of Virtual Reality measure: Acceptability sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338787 id: 23-0826.2 briefTitle: A Novel Iron-Based Supplement for Athletes Aged 14-17 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-04-01 date: 2024-04-01 name: University of Calgary class: OTHER name: Mitacs name: Natural Sciences and Engineering Research Council, Canada briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females. conditions: Iron Deficiencies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FeSC measure: Iron Status measure: Hemoglobin measure: Lower Gut microbiome measure: Exercise Capacity measure: Gastrointestinal Symptoms 1 measure: Gastrointestinal Symptoms 2 measure: Sleepiness measure: Stress and Recovery sex: FEMALE minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06338774 id: 202310129 id: R33AG078041 type: NIH link: https://reporter.nih.gov/quickSearch/R33AG078041 briefTitle: Cognitive Control to Boost Physical Activity Adherence acronym: BOOST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-11-30 date: 2024-04-01 date: 2024-04-02 name: University of Iowa class: OTHER name: Northeastern University name: National Institute on Aging (NIA) briefSummary: This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are:
* Can cognitive training designed to improve cognitive control improve physical activity adherence?
* What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence?
Participants will
* Complete a 6-week home-based, computerized cognitive training program
* Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer
* Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer
* Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Six week parallel group intervention, followed by a 12 week exercise program. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Cognitive training name: Exercise measure: Physical Activity Adherence sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Psychological and Brain Sciences Building city: Iowa City state: Iowa zip: 52242 country: United States name: Michelle W Voss, PhD role: CONTACT phone: 319-335-2057 email: michelle-voss@uiowa.edu name: Ruthina Malone role: CONTACT phone: 319-335-2407 email: ruthina-malone@uiowa.edu name: Michelle Voss, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.66113 lon: -91.53017 facility: Center for Cognitive and Brain Health city: Boston state: Massachusetts zip: 02115 country: United States name: Charles Hillman, PhD role: CONTACT phone: 617-373-8342 email: c.hillman@northeastern.edu name: Virginia Davis role: CONTACT phone: 617-373-3448 email: vi.davis@northeastern.edu name: Charles Hillman, PhD role: PRINCIPAL_INVESTIGATOR name: Arthur F Kramer, PhD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06338761 id: E-cigarette PCI briefTitle: Switching to E-cigarette After PCI acronym: E-cig-PCI overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-01 date: 2024-04-01 name: Samsung Medical Center class: OTHER briefSummary: Despite the increasing popularity of electronic cigarettes (E-cigarettes), the prognostic impact of switching to E-cigarettes in smokers with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains uncertain. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 17442 type: ESTIMATED name: Smoking cessation name: Switching to E-cigarette measure: MACE measure: Cardiovascular death measure: All-cause death measure: Spontaneous myocardial infarction measure: Repeat revascularization sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Ki Hong Choi, MD role: CONTACT phone: 82-2-3410-3419 email: cardiokh@gmail.com lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06338748 id: 24-157 briefTitle: Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery acronym: DexcomG7 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-01 date: 2024-04-01 name: The Cleveland Clinic class: OTHER name: DexCom, Inc. briefSummary: This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated. conditions: Continuous Glucose Monitoring studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients undergoing heart surgery at the Cleveland Clinic (main campus) who would normally be tested for high sugar levels by poking a finger and using a test strip. primaryPurpose: OTHER masking: NONE maskingDescription: The study will involve using blinded Dexcom G7 continuous glucose monitoring (CGM) devices count: 28 type: ESTIMATED name: Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick point of care (POC) while patients are in the CVICU measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States name: Kimberly Jenkins role: CONTACT phone: 216-445-4791 email: jenkink@ccf.org name: Kimberly Jenkins role: CONTACT phone: (216) 445-4791 email: jenkink@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06338735 id: 14540 briefTitle: Ultra-High Frequency Ultrasonography in Sjögren's Syndrome acronym: UltraSjögren overallStatus: RECRUITING date: 2016-01-11 date: 2026-12-31 date: 2030-12 date: 2024-04-01 date: 2024-04-01 name: University of Pisa class: OTHER briefSummary: Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR/EULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands. conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 800 type: ESTIMATED name: Ultra-High Frequency Ultrasound scan of minor salivary glands measure: OMERACT score measure: Correspondence between ultrasonography and histology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pisa status: RECRUITING city: Pisa zip: 56126 country: Italy name: Rossana Izzetti role: CONTACT phone: +39050993037 email: rossana.izzetti@unipi.it name: Rossana Izzetti role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06338722 id: 23-397 briefTitle: Making it Work Program for Systemic Sclerosis overallStatus: RECRUITING date: 2023-12-08 date: 2024-07-31 date: 2024-09-30 date: 2024-04-01 date: 2024-04-01 name: University of New Mexico class: OTHER briefSummary: The purpose of this clinical trial is to see if an online intervention program for people with Systemic Sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. The program is called Making it Work Systemic Sclerosis.
Researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better.
People in the Making it Work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. People in the wait list control group will complete the questionnaires and participate in the program at a later point in time. conditions: Scleroderma, Systemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention receives the Making it work program Wait list Control receives usual care but will be offered the program after the intervention groups finish primaryPurpose: TREATMENT masking: NONE maskingDescription: People will know what group they are in when they are invited to attend the intervention sessions count: 50 type: ESTIMATED name: Making it Work Systemic Sclerosis measure: Job Related Self-efficacy Scale measure: Job Self-Efficacy Scale measure: Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale measure: The Work Instability Scale sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of New Mexico status: RECRUITING city: Albuquerque state: New Mexico zip: 87131-0001 country: United States name: Janet L Poole, PhD role: CONTACT phone: 505-272-8276 email: jpoole@salud.unm.edu lat: 35.08449 lon: -106.65114 hasResults: False
<\|newrecord\|> nctId: NCT06338709 id: 11-002 briefTitle: Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP® overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-08 date: 2026-08 date: 2024-04-01 date: 2024-04-01 name: Advanced Bariatric Technology class: INDUSTRY name: NAMSA briefSummary: Overweight and obesity are at epidemic proportions in the world population as well as in the United States, where nearly 42% of the adult population(1) is considered to meet the definition of obesity, namely a body mass index ("BMI") ≥ 30 kg/m2. Well-established links between obesity and increased morbidities and mortality make treatment of the utmost importance; however, there continues to be a significant unmet need for more effective treatments for obesity. Bariatric surgery is recognized as an effective treatment for obese patients, particularly in more severe cases where surgical restriction of the stomach's capacity and outlet size are considered necessary. The BariClip® is a laparoscopically implanted device for treatment of obesity and serves as an alternative to current existing technology for use in bariatric surgery. The BariClip® is a medical device, non-adjustable, resembling a clip that is placed parallel to the greater curvature of the stomach, causing restriction of the gastric lumen in a vertical fashion. This multi-center, randomized, moderate-lifestyle (program of diet and exercise) controlled pivotal study of the BariClip® device is intended to gather data to objectively support its safety and effectiveness for the treatment of obesity in adults and to ultimately support marketing authorization of this device as a viable alternative to existing bariatric surgical procedures. Specifically, this study aims to look at efficacy of the BariClip® device with regards to weight loss metrics and secondary health metrics and safety of the BariClip® device with regards to serious adverse events. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 165 type: ESTIMATED name: BariClip® Device Treatment measure: Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects measure: Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group measure: Weight and Height will be combined to report BMI in kg/m^2 measure: Blood Pressure (BP) in mmHg, both systolic and diastolic measure: Diagnosis and/or Change in Severity of Diabetes Mellitus (DM) measure: Weight in kilograms measure: Height in meters measure: Waist Circumference in centimeters measure: Incidence of Serious Adverse Events (SAEs) sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338696 id: COA-CREC070/2023 briefTitle: Thailand ATTR-CM Registry overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2030-06-30 date: 2024-04-01 date: 2024-04-01 name: Mahidol University class: OTHER name: Pfizer briefSummary: The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand. conditions: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: No intervention measure: Rate of death measure: Rate of heart failure hospitalization measure: Transthyretin (ATTR) amyloidosis medication sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine at Chulalongkorn University city: Bangkok country: Thailand name: Sarinya Puwanant, MD role: CONTACT name: Sarinya Puwanant, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Faculty of Medicine Ramathibodi hospital, Mahidol University city: Bangkok country: Thailand name: Teerapat Yingchoncharoen, MD role: CONTACT name: Teerapat Yingchoncharoen, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Faculty of Medicine Siriraj Hospital, Mahidol University city: Bangkok country: Thailand name: Kanchalaporn Jirataiporn, B.N.S role: CONTACT name: Srisakul Chirakarnjanakorn, MD role: PRINCIPAL_INVESTIGATOR name: Adisak Maneesai, MD role: SUB_INVESTIGATOR name: Porntera Sethalao, MD role: SUB_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Phramongkutklao Hospital city: Bangkok country: Thailand name: Hutsaya Prasitdumrong, MD role: CONTACT name: Hutsaya Prasitdumrong, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Faculty of Medicine Chiang Mai University city: Chiang Mai country: Thailand lat: 18.79038 lon: 98.98468 facility: Queen Sirikit Heart Center of The Northeast city: Khon Kaen country: Thailand name: Vichai Senthong, MD role: CONTACT name: Vichai Senthong, MD role: PRINCIPAL_INVESTIGATOR lat: 16.44671 lon: 102.833 facility: Faculty of Medicine, Thammasat University city: Pathum Thani country: Thailand name: Adisai Buakhamsri, MD role: CONTACT name: Adisai Buakhamsri, MD role: PRINCIPAL_INVESTIGATOR lat: 14.01346 lon: 100.53049 facility: Prince of Songkla University city: Songkhla country: Thailand lat: 7.19882 lon: 100.5951 hasResults: False
<\|newrecord\|> nctId: NCT06338683 id: QRCH-2024001 briefTitle: Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer overallStatus: RECRUITING date: 2024-03-20 date: 2027-03-20 date: 2028-03-20 date: 2024-03-29 date: 2024-03-29 name: Qinghai Red Cross Hospital class: OTHER briefSummary: This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival. conditions: Advanced Cancer conditions: Olanzapine conditions: Progression Free Survival studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 230 type: ESTIMATED name: Olanzapine 2.5 MG name: Standard anti-tumor treatment name: Nutritional advice measure: Comparing the difference in Median PFS between the two groups measure: Comparing the difference in Median OS between the two groups measure: Comparing the difference in ORR between the two groups measure: Comparing the difference in the incidence of ≥3% weight loss between the two groups measure: Comparing the difference in BMI between the two groups measure: Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups measure: Comparing the difference in Quality of life in the overall stage between the two groups measure: neutrophil-to-lymphocyte ratio measure: platelet-to-lymphocyte ratio measure: C-reactive protein (CRP) concentration measure: concentration of albumin measure: Level of interleukin (IL)-6 and IL-8 measure: Comparing the difference in the side effects of olanzapine treatment between the two groups sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qinghai Red Cross Hospital status: RECRUITING city: Xining state: Qinghai zip: 810000 country: China name: Qiuxia Dong, Dr role: CONTACT phone: 0971-8267613 email: 2816278916@qq.com lat: 36.62554 lon: 101.75739 hasResults: False
<\|newrecord\|> nctId: NCT06338670 id: CLTD5839 briefTitle: Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users acronym: RECONNECT overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-11-22 date: 2024-11-22 date: 2024-03-29 date: 2024-03-29 name: Cochlear class: INDUSTRY name: Avania briefSummary: This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors. conditions: Hearing Loss, Mixed Conductive-Sensorineural conditions: Hearing Loss, Conductive studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Within-subject primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Cochlear Osia 3 Sound Processor name: Cochlear™ Osia® 2 Sound Processor measure: Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL measure: Change (within subject) in word recognition score in quiet measured at 65 dB SPL measure: Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz measure: Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips measure: Percentage of participants who preferred Osia 3 over Osia 2 sound processor sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The HEARing CRC city: Melbourne state: Victoria zip: 3053 country: Australia name: Robert Cowan role: CONTACT phone: +61418780198 email: r.cowan@unimelb.edu.au lat: -37.814 lon: 144.96332 hasResults: False
<\|newrecord\|> nctId: NCT06338657 id: 7H-23-5 id: NCI-2024-01367 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 7H-23-5 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2026-04-04 date: 2027-04-04 date: 2024-03-29 date: 2024-03-29 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill cancer cells. FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller. This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Magnetic Resonance Imaging name: PEOX-based Polymer Encapsulated Paclitaxel FID-007 name: Tumor Resection measure: Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007 measure: Incidence of adverse events (AEs) measure: Major pathologic response rate measure: Complete pathologic response rate measure: Rate of locoregional recurrence measure: Rate of distant metastasis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Los Angeles General Medical Center city: Los Angeles state: California zip: 90033 country: United States name: Sandy Tran, MS role: CONTACT phone: 323-865-0451 email: Sandy.tran@med.usc.edu name: Jacob S. Thomas, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Sandy Tran, MS role: CONTACT phone: 323-865-0451 email: Sandy.tran@med.usc.edu name: Jacob S. Thomas, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06338644 id: HelwanUY briefTitle: Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients. acronym: Palbociclib overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-09-01 date: 2026-09-01 date: 2024-03-29 date: 2024-03-29 name: Helwan University class: OTHER briefSummary: Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies conditions: Hormone-receptor-positive Breast Cancer conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Palbociclib measure: 1-year Progression free survival (PFS) measure: Neutropenia sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338631 id: 43C301 briefTitle: Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess" acronym: OB-KID overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-29 date: 2024-03-29 name: Istituto Auxologico Italiano class: OTHER briefSummary: Overweight and obesity are increasingly prevalent worldwide. Weight excess increases the risk of in developing the metabolic syndrome, which is composed by a set of cardiometabolic risk factors such as abdominal adiposity, dyslipidemia, high blood pressure and elevated fasting glucose levels. Obesity and the metabolic syndrome are known to be risk factors for the development of chronic kidney disease. It is not clear however, whether they can be considered independent risk factors for impaired renal function and renal damage. Whereas obesity may represent an independent risk factor for renal damage, it is not clear yet if the contemporaneous presence of obesity and metabolic alterations is associated with an additional increase in the risk.
It may be important to understand the relationship between obesity, metabolic syndrome and renal health, as treatment strategies may be different for the two metabolic phenotypes of obesity, i.e., metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) patients.
The primary objective of this multicentre observational prospective study is to assess the relationship between metabolic phenotype and reduced renal function (glomerular filtration rate \<90 ml/min/1.73m2 or microalbuminuria 30-300 mg/24h) in a population of 1000 patients with overweight or obesity.
The secondary aim is to study the association between diet quality, consumption of ultra-processed foods and indicators of reduced renal function and renal damage. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Diet measure: Glomerular filtration rate measure: Microalbuminuria measure: Glycemia measure: Body mass index sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istituto Auxologico Italiano, Città Studi ICANS status: RECRUITING city: Milano zip: 20100 country: Italy name: Alberto Battezzati, Prof role: CONTACT phone: +390261911 email: a.battezzati@auxologico.it lat: 45.46427 lon: 9.18951 facility: Programma Infradipartimentale di Dietoterapia nel Trapianto e nell' Insufficienza Renale Cronica, DAI di Medicina Interna ad Indirizzo Specialistico, del Policlinico Federico II di Napoli status: RECRUITING city: Naples country: Italy name: Bruna Guida, Prof. role: CONTACT lat: 40.85216 lon: 14.26811 hasResults: False
<\|newrecord\|> nctId: NCT06338618 id: 1532-N-23 briefTitle: Manual Therapy in Metabolic Liver Disease acronym: OSTEO-EHMet overallStatus: RECRUITING date: 2024-04-03 date: 2024-06 date: 2024-08 date: 2024-03-29 date: 2024-04-05 name: University of Seville class: OTHER briefSummary: Hepatic steatosis is a disease that is becoming more common in our society; approximately 40% of the population suffers from non-alcoholic fatty liver. The beneficial effect of manual therapy for the treatment of viscera dysfunctions such as the stomach or colon is known. The objective of this study is to demonstrate the anti-inflammatory effects of visceral manual therapy in patients with metabolic liver disease associated with non-alcoholic fatty liver. conditions: NAFLD, Non-alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: liver treatment protocol measure: Hepatic steatosis index measure: FIB-4 index measure: NAFLD-fibrosis index measure: HOMA index measure: TyG index measure: Change from baseline in algometry measure: Visual analogue Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitary Hospital Juan Ramón Jiménez status: RECRUITING city: Huelva zip: 21005 country: Spain name: Javer Carrasco Sánchez, Dr role: CONTACT phone: 682289772 email: fjcarrascos@icloud.com lat: 37.26638 lon: -6.94004 hasResults: False
<\|newrecord\|> nctId: NCT06338605 id: MEC-2023-0715 briefTitle: Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis acronym: CYSTATINcDK4/6 overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-12 date: 2024-04-01 date: 2024-06-01 date: 2024-03-29 date: 2024-03-29 name: Erasmus Medical Center class: OTHER briefSummary: CDK4/6 inhibitors have led to an improvement of both progression free survival (PFS) and overall survival (OS) in patients with advanced estrogen positive (ER+)/HER2- breast cancer when applied in the first or second line of treatment. Despite the advantages of CDK4/6 inhibitors, these medications can lead to adverse effects. One of the adverse events observed across all types of CDK4/6 inhibitors is an elevation in creatinine levels. An elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. This phenomenon is known as pseudo acute kidney injury (pseudo-AKI).
The incidence of pseudo-AKI in patients using CDK4/6 inhibitors is currently unknown. A method to distinguish pseudo-AKI from AKI is measuring the level of an alternative filtration marker in blood, for example cystatin C. Cystatin C is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. Also, there is no affection by muscle mass or diet. In this study the investigators will explore the incidence of both AKI and pseudo-AKI in patients who are treated with CDK4/6 inhibitor treatment by assessing both creatinine and cystatin C in plasma. conditions: Advanced Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ESTIMATED name: no intervention, observational study of AKI under CDK4/6 inhibitor treatment measure: Pseudo-AKI in patients on CDK4/6 inhibitors measure: Pseudo-AKI in patients on CDK4/6 inhibitors per drug measure: AKI in patients measure: Influencing factors cystatin C levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
<\|newrecord\|> nctId: NCT06338592 id: UUtah_00153806 briefTitle: The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale acronym: MyLungHealth overallStatus: RECRUITING date: 2024-03-28 date: 2025-03-27 date: 2025-12-31 date: 2024-03-29 date: 2024-04-04 name: University of Utah class: OTHER briefSummary: Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making. conditions: Lung Cancer conditions: Lung Neoplasms/Diagnosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a patient randomized trial that includes two sub-studies, with 2 arms each. primaryPurpose: SCREENING masking: NONE count: 42415 type: ESTIMATED name: MyLungHealth name: DecisionPrecision+ measure: Study 1 primary outcome: Percentage of participants identified as eligible for LCS. measure: Study 2 primary outcome: Percentage of participants for whom LDCT was ordered. measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered. measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was completed. measure: Study 2 secondary outcome: Percentage of participants for whom LDCT was completed. measure: Study 2 secondary outcome: Percentage of participants for whom LCS care gap was closed. sex: ALL minimumAge: 50 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States name: Devin Mann, MD role: CONTACT email: devin.mann@nyulangone.org name: Devin Mann, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Utah Health status: RECRUITING city: Salt Lake City state: Utah zip: 84112 country: United States name: Kensaku Kawamoto, MD, PhD, MHS role: CONTACT email: kensaku.kawamoto@utah.edu name: Kensaku Kawamoto, MD, PhD, MHS role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False
<\|newrecord\|> nctId: NCT06338579 id: 2023PPRC04 id: 2023-A01763-42 type: OTHER domain: IDRCB briefTitle: Overview of Self-medication Among French Navy Personnel acronym: AutoMMaN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-04 date: 2024-03-29 date: 2024-03-29 name: Direction Centrale du Service de Santé des Armées class: OTHER briefSummary: The goal of this cross-sectional descriptive observational study is to assess the extent of self-medication among the crews of surface ships at the Toulon naval base. This study could include healthy volunteers, or participants with well-controlled chronic pathologies enabling them to be fit for embarkation, who are currently being deployed for at least 4 weeks on a surface ship at the naval base.
Participants will tick and complete a questionnaire (between 15 and 30 minutes) after 4 consecutive weeks on the ship. conditions: Self Medication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Questionnaire measure: percentage of patients who have self-medication sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338566 id: 2021PPRC10 id: 2023-A01975-40 type: OTHER domain: IDRCB briefTitle: Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle acronym: PROCLOU overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-04 date: 2024-03-29 date: 2024-03-29 name: Direction Centrale du Service de Santé des Armées class: OTHER briefSummary: The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.
Patients will be asked to complete a questionnaire during follow-up consultations. conditions: Ankle Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Follow-up measure: bony outcome of transcalcaneal nailing measure: functional result of the procedure sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338553 id: 231620 briefTitle: GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab acronym: GLP-TEP overallStatus: RECRUITING date: 2024-06 date: 2027-03 date: 2027-03 date: 2024-03-29 date: 2024-04-03 name: Vanderbilt University Medical Center class: OTHER briefSummary: The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under three different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The first meal test is pre-teplizumab, followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In this study, participants with stage 2 T1DM undergoing Teplizumab (TZIELD®) treatment will be randomly assigned to receive single doses of either a GLP-1Ra or a placebo. Three separate MMTT tests will be conducted to assess the effects on blood sugar levels, insulin function, and vascular health. The first test will occur before TZIELD® treatment and participants will receive a placebo at this MMTT. The other two tests will take place 3-5 months after TZIELD® treatment. In these post-treatment tests, the study team will 'cross over', or switch, the order in which participants receive the GLP-1Ra or placebo, with a minimum one-week gap to avoid overlap of effects. For example, a participant may take the GLP-1Ra then placebo or the placebo then the GLP-1Ra. In some cases, the investigator may allow participants who have already received TZIELD® treatment prior to joining the study to skip the pre-treatment test and proceed directly to the post-treatment tests. primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: For applicable participants, a placebo will be given prior to a pre-TZIELD® meal test. For participants who have already received Teplizumab (TZIELD®) or those who are progressing to the 2 remaining study visits, a GLP-1Ra or placebo will be given in random orders at these two visits. The GLP-1Ra will only be given one time. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Placebo name: Semaglutide (Rybelsus®) measure: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study measure: Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study measure: Determine the impact of GLP-1Ra on endothelial function in a pilot study sex: ALL minimumAge: 12 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Justin M Gregroy, MD, MSCI role: CONTACT phone: (615) 322- 7427 email: metabolism@vumc.org name: Tyler J Smith, DNP, APRN, FNP-C role: CONTACT email: metabolism@vumc.org name: Justin M Gregory, MD, MSCI role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-27 uploadDate: 2024-03-01T16:04 filename: Prot_000.pdf size: 567921 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-21 uploadDate: 2024-03-01T15:15 filename: ICF_001.pdf size: 2385304 hasResults: False
<\|newrecord\|> nctId: NCT06338540 id: A26020822 briefTitle: Relation of Caries Color to Caries Severity and Its Microbial Load overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2024-01-01 date: 2024-07-01 date: 2024-03-29 date: 2024-03-29 name: Mansoura University class: OTHER briefSummary: This study is to find the relation of caries color to caries severity and its microbial load in primary molars. conditions: Relation of Caries Color studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1: Yellow caries color Group 2: dark brown caries color Group 3: light brown caries color Group 4: black caries color primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Black color of caries name: dark brown color of caries name: light brown color of caries name: yellow color of caries measure: Caries color related to history of pain measure: Caries color related to ICDAS measure: Caries color related to pulp exposed measure: Caries color related to microbial load sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Mansoura university city: Mansoura state: Dakahlia zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06338527 id: 2024YX321 briefTitle: Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-06-01 date: 2024-06-15 date: 2024-03-29 date: 2024-03-29 name: Weifang Medical University class: OTHER briefSummary: The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer. conditions: Sleep Quality conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Aromatherapy name: No intervention measure: Sleep quality measure: Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weifang People's Hospital city: Weifang state: Shangdong zip: 261000 country: China name: Shirong Fang, M.D. role: CONTACT email: fsr0536@163.com lat: 36.71 lon: 119.10194 hasResults: False
<\|newrecord\|> nctId: NCT06338514 id: KutahyaHSU-DRYNEEDLE-dorsalgia briefTitle: The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsal Myofascial Pain Syndrome. overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-25 date: 2024-06-25 date: 2024-03-29 date: 2024-03-29 name: Kutahya Health Sciences University class: OTHER briefSummary: Back pain is commonly seen in the working-age population, with the peak occurrence around the age of 40. Its frequency does not increase with age and is not associated with age-related degenerative changes in the spine. Especially when the underlying cause is conditions such as myofascial pain syndrome (MPS), where regional muscle sensitivity in the rhomboid and trapezius areas is prominent, dry needling treatment has become increasingly popular and the subject of numerous studies in recent years. In the diagnosis of MPS, two valuable findings include the detection of a taut band upon palpation and the presence of trigger points in muscle fibers with mild finger pressure. The study we are planning involves a double-blind efficacy trial where real and sham dry needling procedures will be performed under ultrasound guidance, ensuring that both the patient and the evaluator are blinded. This study design has the potential to make a significant contribution to the literature in this field. conditions: Myofascial Trigger Point Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-group, sham-controlled, double-blind, prospective, randomized controlled trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In the dry needling application, patients will be blinded to the groups they are randomized into. The evaluator will also be unaware of which group the patients belong to. The practitioner will perform the procedures in both groups using ultrasound guidance, targeting the standard trigger points in the painful dorsal trapezius and rhomboid muscles in the study group, and targeting subcutaneous fatty tissue in the same regions in the sham group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Real dry needling name: Sham dry needling measure: Visual Analog Scale measure: Patient-Specific Functional Scale measure: Pressure Pain Threshold Measurement measure: What does Oswestry stand for? The Oswestry Disability Index (ODI) measure: The 12-item Short-Form Health Survey version 2 (SF-12v2) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338501 id: 77325224.4.0000.5235 briefTitle: Assessment of Heart Rate Variability, Performance and Dehydration in Muay Thai Athletes overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-06-30 date: 2025-06-30 date: 2024-03-29 date: 2024-03-29 name: Centro Universitário Augusto Motta class: OTHER briefSummary: Known as "Thai boxing," Muay Thai utilizes a combination of upper limb strikes (such as punches and elbow strikes) as well as lower limb strikes (such as kicks and knee strikes), and is thus referred to as the "art of eight limbs." It is practiced worldwide and is a prominent discipline in many mixed martial arts (MMA) training camps. In this sport, training load control involves monitoring and adjusting the quantity and intensity of training according to each athlete's capacity. In the context of combat sports, such as Muay Thai, heart rate variability (HRV) and assessment of body composition by bioelectrical impedance analysis can be used as tools to evaluate training responses. Additionally, HRV can also serve as a tool for assessing recovery after training or competition. If HRV does not return to baseline after training or competition, it may be a sign that the athlete is not fully recovered and may need more time to recuperate before returning to training or competition. Due to the absence of studies in the literature that have assessed a possible association between HRV and dehydration and rehydration processes in amateur Muay Thai athletes, it becomes essential to evaluate this correlation. Given the growing interest in practicing Muay Thai in gyms, assessing the sympathetic-vagal balance, body composition, and performance of these athletes becomes of utmost importance. Therefore, the aim of this study is to investigate the relationship between dehydration indicators, HRV parameters, and performance in the frequency speed kick test (FSKT). Participants will be assessed before and after an eight-week training program, conducted three times a week. Assessments will include resting HRV measurement and FSKT; in addition, bioimpedance will be used to estimate the body composition of participants pre- and post-training. It is expected that the results will reveal changes in HRV, performance, and body composition of the athletes after training. conditions: Nervous System Diseases conditions: Dehydration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Specifical Functional Training Exercises measure: HRV during specifical physical test measure: Correlation with BIA analysis, HRV and Specific Physical Test sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338488 id: KutahyaHSU-DRYNEEDLE-SHOULDER briefTitle: The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-25 date: 2024-06-25 date: 2024-03-29 date: 2024-03-29 name: Kutahya Health Sciences University class: OTHER briefSummary: Myofascial pain can be diagnosed by the presence of one or more myofascial trigger points (MTrPs), defined as hyperirritable spots in taut bands of skeletal muscle fibers palpable by hand. The treatment of myofascial pain primarily relies on the inactivation of MTrPs, often through manual pressure techniques or dry needling. In manual pressure techniques, the physiotherapist applies increasing pressure directly to the MTrP. In dry needling, acupuncture-like filiform needles are applied to the same point. There are two types of dry needling: superficial dry needling, which penetrates only the skin and superficial muscle, and deep dry needling, which involves inserting a needle directly into the MTrP. The sole or adjunct effectiveness of dry needling treatment targeting the trapezius and infraspinatus muscles has been investigated, particularly in patients with shoulder myofascial pain syndrome. In the study we are planning, a double-blinded efficacy trial will be conducted in patients with shoulder myofascial pain syndrome, where real and sham dry needling applications will be performed under ultrasound guidance, with both the patient and the evaluator blinded. This study design has the potential to make a significant contribution to the literature in this field. conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective double-blind randomized sham-controlled study. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In the dry needling application, patients will be blinded to the groups they are randomized into. The evaluator will also be unaware of which group the patients belong to. The practitioner will perform the procedures in both groups using ultrasound guidance, targeting the standard trigger points in the painful shoulder's trapezius and infraspinatus muscles in the study group, and targeting subcutaneous fatty tissue in the same regions in the sham group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Real dry needling name: Sham dry needling measure: Visual Analog Scale measure: Patient-Specific Functional Scale measure: Pressure Pain Threshold Measurement measure: The Shoulder Pain and Disability Index (SPADI) measure: The Quick DASH Outcome Measure measure: The 12-item Short-Form Health Survey version 2 (SF-12v2) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338475 id: 20205703 briefTitle: A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06 date: 2026-06 date: 2024-03-29 date: 2024-03-29 name: University of California, Irvine class: OTHER briefSummary: Building upon the results of a single-arm trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), this trial is a randomized-controlled biobehavioral pilot trial of GET versus a time-and attention matched control (Instrumental Supportive Listening; ISL) in Latino/Hispanic young adult cancer survivors. Outcomes include improved distress symptoms, emotion regulation, goal navigation skills, and changes in stress-sensitive biomarkers.
Participants will be randomized to receive six sessions of GET or ISL delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary and secondary psychological outcomes prior to (T0), immediately after (T1), and twelve weeks after intervention (T2). Additionally, identified biomarkers will be measured at baseline and at T1, and T2. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Goal-Focused Emotion-Regulation Therapy (GET) name: Individual Supportive Listening (ISL) measure: Change in Hospital Anxiety and Depression Scale (HADS) measure: Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII) measure: Change in Salivary Diurnal Cortisol Slope and Daily Output measure: Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score measure: Change in Career Thoughts Inventory (CTI) Global Score measure: Change in Emotion Regulation Questionnaire (ERQ) Scale Scores measure: Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score measure: Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores sex: MALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338462 id: 2000034128 id: R21AI174129 type: NIH link: https://reporter.nih.gov/quickSearch/R21AI174129 briefTitle: Cali Sin Tos Aim 2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-03-29 date: 2024-03-29 name: Yale University class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: The overall objective of this Aim is to design and iteratively adapt a home-based, mHealth- and oral testing facilitated strategy for implementing tuberculosis (TB) contact tracing in Cali, Colombia. Investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mHealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial.
This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy (i.e., nominal group technique). conditions: Tuberculosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: target sample size is an anticipated 120 index persons with TB enrolled over three design cycles primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Chatbot name: Oral testing measure: Implementation of the mHealth strategy to assess feasibility. measure: Oral specimen collection to assess feasibility. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM) city: Cali country: Colombia lat: 3.43722 lon: -76.5225 hasResults: False
<\|newrecord\|> nctId: NCT06338449 id: XZMU-2022-ZK068 briefTitle: The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease overallStatus: COMPLETED date: 2022-10-13 date: 2022-12-20 date: 2022-12-31 date: 2024-03-29 date: 2024-04-02 name: Xuzhou Medical University class: OTHER briefSummary: The purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (NAFLD) in a young population. The primary questions it aims to answer are:
Does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in NAFLD patients? Which of these three exercise regimens is more effective in improving the aforementioned parameters? Is the improvement in liver function related to bile acid metabolism?
Participants will:
Engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen.
Have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen. conditions: Non-alcoholic Fatty Liver Disease NAFLD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The specific exercise plan and grouping are as follows:
Participants were randomly (Using an electronic random number generator) divided into four groups: control group (Control), aerobic training group (AT), resistance training group (RT), and combined aerobic and resistance training group (AT + RT), with each group consisting of 10 individuals, totaling 40 participants. All participants were young adults aged between 18 and 21 years old. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: After the data is obtained, the person analyzing the data will not know the specific grouping and participant information. The groups will be replaced by Group A, B, C, D, and the participants will be indicated by their IDs. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Aerobic training (AT) name: Resistance training (RT) name: Combined aerobic and resistance training (AT + RT) measure: Changes in body weight compared to baseline at 8 weeks measure: Changes in Body Mass Index compared to baseline at 8 weeks measure: Changes in total cholesterol compared to baseline at 8 weeks measure: Changes in triglycerides compared to baseline at 8 weeks measure: Changes in high-density lipoprotein compared to baseline at 8 weeks measure: Changes in low-density lipoprotein compared to baseline at 8 weeks measure: Changes in alanine aminotransferase compared to baseline at 8 weeks measure: Changes in aspartate aminotransferase compared to baseline at 8 weeks measure: Changes in alkaline phosphatase compared to baseline at 8 weeks measure: Changes in gamma-glutamyl transferase compared to baseline at 8 weeks measure: Changes in direct bilirubin compared to baseline at 8 weeks measure: Changes in total bile acids compared to baseline at 8 weeks measure: Changes in adenosine deaminase compared to baseline at 8 weeks measure: Changes in percentage of body fat compared to baseline at 8 weeks measure: Changes in waist-to-hip ratio compared to baseline at 8 weeks measure: Changes in blood glucose compared to baseline at 8 weeks measure: Changes in the level of insulin compared to baseline at 8 weeks measure: Changes in albumin compared to baseline at 8 weeks measure: Changes in C-reactive protein compared to baseline at 8 weeks measure: Changes in other subtypes of bile acids compared to baseline at 8 weeks sex: ALL minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: Outdoor track and field facility of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221000 country: China lat: 34.18045 lon: 117.15707 hasResults: False
<\|newrecord\|> nctId: NCT06338436 id: VAR-2022-05 briefTitle: Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou) overallStatus: COMPLETED date: 2022-12-21 date: 2023-09-26 date: 2023-11-13 date: 2024-03-29 date: 2024-04-02 name: Varian, a Siemens Healthineers Company class: INDUSTRY briefSummary: This study is prospective, single-center, single-arm objective performance criteria.
This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. conditions: Tumor, Solid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a clinical study of prospective, single-arm objective performance criteria primaryPurpose: TREATMENT masking: NONE count: 47 type: ACTUAL name: Proton Radiation Therapy System (ProBeam) measure: Effectiveness evaluation: Local tumor control rate 90 days after the proton radiation treatment completion measure: Safety evaluation: Incidence of Acute radiation injury measure: Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06338423 id: JagiellonianU-08 briefTitle: Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure overallStatus: COMPLETED date: 2015-01-01 date: 2022-12-31 date: 2022-12-31 date: 2024-03-29 date: 2024-03-29 name: Jagiellonian University class: OTHER briefSummary: This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period.
Method Patients
A prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital (Krakow, Poland). It is designed as a single-center, prospective trial with two intervention arms. During the study, we specified 3 periods:
* January 2015 - December 2016 - only standard mattresses were used
* January 2017 - December 2019 - both types of mattresses were used
* January 2020 - December 2022 - only vacuum mattresses were used
Participants Patients aged ≥18 were qualified for LSG due to obesity and divided The first group (Vacuum Mattress group) are those laid on vacuum mattresses during the surgery. The control group consisted of patients for whom a standard operating mattress was used during the surgery. Patients with preoperative chronic renal failure were excluded from the study. Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERABS) Protocol \< 85%.
Procedures and perioperative care All patients underwent LSG. Patients were operated in the beach chair position. In the study group, the patient was laid on vacuum mattresses during the surgery. In the case of control group patients, a standard operating mattress was used during the surgery. Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center\[\]. Blood samples were collected on the first postoperative to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI, and other complications were monitored for 30 days after surgery.
End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment.
Secondary endpoints is the concentrations of RML markers (myoglobin, creatine kinase, creatinine) on the first postoperative day conditions: Rhabdomyolysis conditions: Acute Kidney Injury conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1184 type: ACTUAL name: vacuum mattress name: Standard Mattress measure: Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI) measure: Concentration of myoglobin marker measure: Concentration of creatine kinase marker measure: Concentration of creatinine marker sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University Mecical Collage city: Kraków state: Malopolskie zip: 31-501 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False
<\|newrecord\|> nctId: NCT06338410 id: UHS/Education/126-24/131 briefTitle: Effect of Kangaroo Mother Care on Oxidative Stress and Bonding acronym: KMC overallStatus: COMPLETED date: 2023-08-01 date: 2024-03-20 date: 2024-03-20 date: 2024-03-29 date: 2024-04-01 name: University of Health Sciences Lahore class: OTHER name: Services Hospital, Lahore briefSummary: The goal of this clinical trial is to learn if Kangaroo Mother care can have effect on oxidative stress in premature neonates. It will also learn about the bonding between mother and her premature infant. The main questions it aims to answer are:
* Does Kangaroo mother care lower the biomarker of oxidative stress in premature neonates?
* Is Kangaroo mother care associated with mother-infant bonding? Researchers will compare Kangaroo mother care to Conventional incubator care to see if Kangaroo mother care works to have effect on oxidative stress.
Participants will be:
* given Kangaroo mother care on third day of life or standard incubator care for one hour
* Urine sample for oxidative stress biomarker will be collected via noninvasive method before and after Kangaroo mother care or conventional incubator care from premature neonates.
* Mother-infant bonding scale will be filled by mothers of enrolled premature infants before and after kangaroo mother care and conventional incubator care conditions: Kangaroo Mother Care conditions: Oxidative Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Kangaroo Mother Care measure: biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants measure: Mother- Infant Bonding sex: ALL minimumAge: 3 Days maximumAge: 3 Days stdAges: CHILD facility: Services Hospital, Lahore city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06338397 id: 2023_0455 briefTitle: Social & Affective Cognition in Alzheimer's Disease & Associated Disorders acronym: SOCIALIZE overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2027-05-02 date: 2027-05-02 date: 2024-03-29 date: 2024-03-29 name: University Hospital, Lille class: OTHER name: France Alzheimer briefSummary: Recent studies have shown that individual neuropsychological scores of patients with Alzheimer's disease and Associated Disorders (ADAD) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. Recently, social \& affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. However, no previous studies have assessed the specific relationship between social \& affective cognition \& social behavior in ADAD. Our pilot study aims to explore the correlations between core and extended social \& affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains. conditions: Alzheimer's Disease conditions: Frontotemporal Degeneration (Semantic & Behavioral Variants) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: SCANN measure: Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants. measure: Correlation coefficients between the mini Social cognition & Emotional Assessment - mini-SEA - sub scores and the neuropsychological assessment (as measured by the Social Behavior Observer Checklist - SBOC - score in all participants. measure: Correlation coefficient between the SBOC score with MRI markers in all participants measure: Correlation coefficient between mini-SEA sub scores & MRI markers in all participants. measure: Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. measure: Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338384 id: 44735129 briefTitle: Examining Engagement Trends Among Participants in Peripheral Neuropathy Clinical Research overallStatus: NOT_YET_RECRUITING date: 2025-04 date: 2026-04 date: 2027-04 date: 2024-03-29 date: 2024-03-29 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: This trial aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in peripheral neuropathy clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.
Ultimately, this trial endeavors to deepen our understanding of the factors impacting peripheral neuropathy clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition. conditions: Peripheral Neuropathy studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Number of peripheral neuropathy patients who decide to enroll in a clinical research measure: Rate of peripheral neuropathy patients who remain in clinical trial to trial completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-22 uploadDate: 2024-03-22T09:04 filename: ICF_000.pdf size: 67357 hasResults: False
<\|newrecord\|> nctId: NCT06338371 id: IZTU-TEKBAŞ-001 briefTitle: Effect of Pelvic Floor Muscle Exercise on Sexual Function overallStatus: COMPLETED date: 2021-11-01 date: 2022-04-06 date: 2022-05-06 date: 2024-03-29 date: 2024-03-29 name: Serap Tekbas class: OTHER briefSummary: The goal of this evaluate the effect of pelvic floor muscle exercises on sexual function in women of reproductive age. A randomized controlled trial was conducted in a sample of women of reproductive age, 77 women were randomly assigned to control (n=39) and training (n=38) groups. A form including questions regarding socio-demographic characteristics and the Female Sexual Function Index was applied to all women included in the study. Pelvic floor exercise training was given to the women in the training group and the Female Sexual Function Index was applied to both groups in the 1st, 2nd, and 3rd months. The differences between those who received and those who did not receive training and the effects of regular pelvic exercise on sexual function were evaluated by month.
Research Hypotheses H1: Sexual function scores of women of reproductive age who regularly perform pelvic floor muscle exercises are higher than those who do not exercise.
H2: Sexual function scores are higher for those who regularly exercise their pelvic floor muscles for at least two months conditions: Pelvic Floor Muscle Weakness conditions: Sexuality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 77 type: ACTUAL name: Pelvic Floor exercise training measure: Determining Number of Participants measure: Initial scale application measure: Distribution of participants into groups measure: Providing pelvic floor exercise for training group measure: Female Sexual Function Index measure: Female Sexual Function Index measure: Female Sexual Function Index sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Izmir Tinaztepe University city: İzmir state: Buca zip: 35400 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06338358 id: 44519568 briefTitle: Understanding Participation Habits Among Plaque Psoriasis Patients overallStatus: NOT_YET_RECRUITING date: 2025-04 date: 2026-04 date: 2027-04 date: 2024-03-29 date: 2024-03-29 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: The study intends to investigate the personal experiences of plaque psoriasis patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.
The data collected from this study will help improve future outcomes for all plaque psoriasis as well as those in under-represented demographic groups. conditions: Plaque Psoriasis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients who decide to enroll in a plaque psoriasis clinical research. measure: Number of plaque psoriasis study participants who remain in clinical study until completion. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-22 uploadDate: 2024-03-22T09:21 filename: ICF_000.pdf size: 67831 hasResults: False
<\|newrecord\|> nctId: NCT06338345 id: 38RC23.0222 briefTitle: Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients acronym: KAMELOT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-09-01 date: 2028-09-01 date: 2024-03-29 date: 2024-03-29 name: University Hospital, Grenoble class: OTHER briefSummary: The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients.

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