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Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies. |
Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery. conditions: Episiotomy; Complications conditions: Laceration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 56 type: ACTUAL name: Low-Level Laser Therapy measure: To compare two techniques: Low-level laser and cryotherapy measure: Pain reduction assessed by the Visual Analog Scale (VAS). measure: Pain reduction assessed by McGill Pain Scale measure: Evaluate reduction of swelling using the REEDA scale. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hospital de Clínicas de Porto Alegre city: Porto Alegre zip: RS country: Brazil lat: -30.03306 lon: -51.23 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-04 uploadDate: 2024-04-12T18:23 filename: Prot_SAP_000.pdf size: 47665 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-04 uploadDate: 2024-04-12T18:21 filename: ICF_001.pdf size: 66023 hasResults: False |
<|newrecord|> nctId: NCT06370897 id: 337421 briefTitle: Prediction & Mechanisms of Recovery Following IEDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-09 date: 2024-04-17 date: 2024-04-17 name: University of Plymouth class: OTHER briefSummary: Inner Ear Decompression sickness (IEDS) accounts for 20% of all types of decompression sickness (the bends) in divers. The condition commonly affects the peripheral vestibular system (inner ear). IEDS results in acute symptoms of dizzyness (vertigo) and imbalance. Even with the recommended treatment of hyperbaric oxygen therapy some people do not recovery fully. However, even in the presence of a permanent vestibular deficit many people can show a behavioural recovery where symptoms improve over time. Recovery can be aided by vestibular rehabilitation (VR) which is now routine for acute IEDS but was not provided before 2021, and is not widespread across the UK (United Kingdom) or world, meaning people may have a suboptimal recovery. |
This project will investigate if and how people recover after an acute episode of IEDS and whether people who had IEDS in the past show changes in the central (brain) processing of vestibular function and in symptoms of dizziness, balance and posture. |
This project has two main parts. Part one is a prospective observational study where people with an acute onset of IEDS are serially monitored while they are receiving hyperbaric treatment and VR over 10-14 days. Part two is a retrospective observational study where who have had IEDS in the past 15 years are re-assessed in a one-off session. The tests in both parts involve clinical tests and specialist eye movement recordings that assess vestibular function. We will also determine the site of any vestibular pathology by using selective stimulation of the vestibular end organ or nerve and assess whether there are any changes in how the structure and function of central vestibular pathways in the brain. In people with chronic IEDS with vestibular symptoms we will offer participants a course of VR over 12 weeks and assess whether this is associated with any improvement in symptoms. conditions: Decompression Sickness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 41 type: ESTIMATED measure: Side of peripheral vestibular damage: Prospective cohort measure: Site of peripheral vestibular damage: Prospective cohort measure: Extent of peripheral vestibular damage: Prospective cohort measure: Side of peripheral vestibular damage: Retrospective cohort measure: Site of peripheral vestibular damage:Retrospective cohort measure: Extent of peripheral vestibular damage:Retrospective cohort measure: VOR gain v HIT: Prospective Study measure: VOR gain: Prospective Study measure: VOR Time constant:Prospective Study measure: Patient reported outcome measure: Prospective Study measure: Clinical measure of walking: Prospective Study measure: Clinical measure of balance: Prospective Study measure: Posturography: Prospective Study measure: Perception of verticality: Prospective Study measure: Functional MRI response to an optokinetic stimulus: Prospective Study measure: Vestibular Evoked myogenic Potentials latency: Prospective Study measure: Vestibular Evoked myogenic Potentials amplitude: Prospective Study measure: VOR gain: Retrospective Study measure: VOR Time constant: Retrospective Study measure: Patient reported outcome measure: Retrospective Study measure: Clinical measure of walking: Retrospective Study measure: Clinical measure of balance: Retrospective Study measure: Posturography: Retrospective Study measure: Perception of verticality: Retrospective Study measure: Functional MRI response to an optokinetic stimulus: Retrospective Study measure: Vestibular Evoked myogenic Potentials latency: Retrospective Study measure: Vestibular Evoked myogenic Potentials amplitude: Retrorospective Study sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370884 id: SURG-2023-29833 briefTitle: Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection overallStatus: RECRUITING date: 2024-02-01 date: 2025-10-01 date: 2026-02-01 date: 2024-04-17 date: 2024-04-17 name: University of Minnesota class: OTHER briefSummary: This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT or a saline solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT or saline, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT/saline, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics). conditions: Recurrent Clostridioides Difficile Infection conditions: Colonic Surgery studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients undergoing colon resection. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The study will be double-blinded; assignments of study staff to either the blinded or unblinded team will be made in advance of enrollment of the first study participant and will be recorded as such on regulatory documents (e.g., blinded/unblinded DOA). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 20 type: ESTIMATED name: IMT name: Saline solution measure: Evaluate safety of IMT in patients undergoing colon surgery measure: compare fecal microbiota prior to and after IMT measure: Evaluate engraftment of donor microbiota measure: Evaluate changes in circulating markers of inflammation: WBC measure: Evaluate changes in circulating markers of inflammation: Hemoglobin measure: Evaluate changes in circulating markers of inflammation: Platelets measure: Evaluate changes in circulating markers of inflammation: Electrolytes measure: Evaluate changes in circulating markers of inflammation measure: Evaluate changes in circulating markers of inflammation: alkaline phosphatase measure: Evaluate changes in circulating markers: Albumin measure: Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids measure: Evaluate changes in microbial metabolites: Fecal IgA measure: Compare baseline microbiome characteristics with changes over time after IMT sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Kathryn Vera, PhD role: CONTACT phone: 612-625-5018 email: [email protected] lat: 44.97997 lon: -93.26384 hasResults: False |
<|newrecord|> nctId: NCT06370871 id: 1403-0006 id: 2022-502985-26-00 type: REGISTRY domain: CTIS (EU) id: U1111-1292-9594 type: REGISTRY domain: WHO Registry briefTitle: Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-06-04 date: 2026-07-03 date: 2028-10-13 date: 2024-04-17 date: 2024-04-24 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse. |
The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer. |
Participants are put into 3 groups by chance: |
* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks |
* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks |
* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma. |
There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group. |
Participants can continue treatment in the study as long as they benefit from it and can tolerate it. |
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing. conditions: Advanced Soft Tissue Sarcoma conditions: Undifferentiated Pleomorphic Sarcoma (UPS) conditions: Myxofibrosarcoma (MFS) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 263 type: ESTIMATED name: Brigimadlin name: Ezabenlimab name: Gemcitabine name: Docetaxel measure: Progression-free survival measure: Overall survival measure: Objective response measure: Duration of objective response measure: Disease control measure: Duration of disease control measure: Occurrence of treatment-emergent adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5 measure: Occurrence of treatment-emergent AEs leading to study drug discontinuation measure: Mean change from baseline to Week 12 in the domain fatigue (based on items from the European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) and the EORTC item library) measure: Mean change from baseline to Week 12 in the domain fatigability (based on items from the EORTC QLQ-C30 and the EORTC item library) measure: Mean change from baseline to week 12 in the domain physical functioning (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain pain (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain dyspnea (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain global health status / quality of life (based on items from the EORTC QLQ-C30) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370845 id: 0000-00000; kt24timper briefTitle: Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure acronym: OLFO-Brain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-10-30 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Inhalation - Natural Odour name: Inhalation - Placebo measure: Detection of a natural odour in human CSF measure: Abundance of a natural odour in human CSF of obese versus lean participants measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF. measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Katharina Timper, Prof. Dr. med. role: CONTACT phone: 0041 61 328 57 42 email: [email protected] name: Isabel M Hofer role: CONTACT phone: 0041 61 328 68 14 email: [email protected] lat: 47.55839 lon: 7.57327 hasResults: False |
<|newrecord|> nctId: NCT06370832 id: 22-5171 briefTitle: Inspiratory Muscle Training in Lung Transplant Candidates overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-09-30 date: 2027-09-30 date: 2024-04-17 date: 2024-04-17 name: University Health Network, Toronto class: OTHER name: Canadian National Transplant Research Program name: Canadian Institutes of Health Research (CIHR) name: Ozmosis Research Inc. briefSummary: Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: 1) To evaluate the feasibility of a randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, safety and outcome ascertainment. 2)To establish whether IMT improves pre-transplant dyspnea perception, diaphragm structure and function, HRQoL and post-transplant ICU, hospital and 3-month outcomes. 3)To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area, oxidative capacity, inflammatory markers and diaphragm muscle thickness and function. Methods: Prospective study of 50 LTx candidates recruited from the pulmonary rehabilitation program at University Health Network (UHN). Participants will have baseline evaluations of maximal inspiratory pressure (MIP), dyspnea, respiratory muscle endurance, diaphragm thickness and thickening fractions, as well as health-related quality of life questionnaires. After baseline assessments, participants will be randomized to the two study groups: IMT or usual care. IMT will be progressed weekly (max of 70% total MIP) until transplant. Participants will have repeat assessments (from baseline) at 4,8 and 12 weeks and then every 3 months until transplant (final assessment 3 months post-LTx). conditions: Inspiratory Muscle Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-lung transplant candidates will be randomized to one of two groups: (1) IMT + exercise training; or (2) exercise training alone. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Ascertainment of post-transplant clinical outcomes (including histopathology assessments) will be blinded by assessors to study group up to 3 months post-transplant. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: IMT and exercise training group measure: Study Recruitment According to Research Team Records measure: Participant Retention in the Study According to Research Team Records measure: Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary measure: Adverse Events and IMT Training Side Effects Reported by Participants measure: Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only) measure: Respiratory Muscle Endurance Test measure: Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale measure: Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale measure: Mood Assessed by Depression, Anxiety, and Stress Scale measure: Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire measure: Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure measure: Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire measure: Pulmonary Function Testing (Spirometry) measure: Aerobic Endurance Assessed by the Six-Minute Walk Test measure: Physical Function Assessed by the Short Physical Performance Battery measure: Pre-Transplant Hospitalizations measure: Peri-Transplant Mechanical Ventilation Bridging measure: Post-Transplant Duration of Mechanical Ventilation (Days) measure: WIND Weaning Classification measure: Post-Transplant Hospital Length of Stay (Days) measure: Post-Transplant Discharge Disposition measure: Primary Graft Dysfunction measure: Post-Transplant Mortality measure: Days Alive and at Home at 90 Days (DAAH90) measure: Diaphragm Thickness and Thickening Fraction Assessed by Ultrasound measure: Histopathology Analyses of Diaphragm Biopsies (Optional) measure: Biochemical Analyses of Diaphragm Biopsies (Optional) measure: Mitochondrial Respirometry Analyses of Diaphragm Biopsies (Optional) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada name: Dmitry Rozenberg, MD, PhD role: CONTACT phone: 416-340-4800 phoneExt: 7358 email: [email protected] lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06370819 id: NN9541-4923 id: U1111-1292-3441 type: OTHER domain: Universal Trial Number id: 2023-506381-32 type: OTHER domain: EU CT Number briefTitle: A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-19 date: 2025-04-19 date: 2024-04-17 date: 2024-04-17 name: Novo Nordisk A/S class: INDUSTRY briefSummary: NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: NNC0519-0130 measure: Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment measure: Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment measure: AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure measure: Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Research Organisation GmbH city: Berlin zip: 10117 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False |
<|newrecord|> nctId: NCT06370806 id: INTERAPNEA-Women briefTitle: Lifestyle Intervention for Obstructive Sleep Apnea in Women acronym: INTERAPNEA-W overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-17 date: 2024-04-17 name: Universidad de Granada class: OTHER name: Fundación BBVA name: Universidad Loyola Andalucia briefSummary: Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Weight loss and lifestyle intervention measure: Apnoea-hypopnoea index (AHI) measure: Oxygen desaturation index (ODI) measure: Oxygen saturation (SaO2) mean measure: Oxygen saturation (SaO2) nadir measure: Sleep efficiency measure: Light sleep (N1 and N2 stages) measure: Deep sleep (N3 stage) measure: Rapid eye movement (REM) sleep measure: Excessive daytime sleepiness (EDS) measure: Sleep Quality measure: Wake After Sleep Onset (WASO) measure: Fat mass (kg) measure: Visceral adipose tisue (g) measure: Body weight (kg) measure: Neck circumference (cm) measure: Chest circumference (cm) measure: Waist circumference (cm) measure: Mean blood pressure (mm HG) measure: Plasma glucose (mg/dL) measure: Change in total cholesterol (mg/dL) from baseline to post-intervention measure: Change in total triglycerides (mg/dL) from baseline to post-intervention sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370793 id: NBU-2024-011 briefTitle: Ningbo Severe Mental Disorders Cohort acronym: NEED overallStatus: ACTIVE_NOT_RECRUITING date: 2018-07-01 date: 2023-12-31 date: 2026-12-31 date: 2024-04-17 date: 2024-04-18 name: Ningbo University class: OTHER name: The Affiliated Kangning Hospital of Ningbo University briefSummary: In recent years, the prevalence of severe mental disorders in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with severe mental disorders and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-diagnosis, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with severe mental disorders. |
Currently, NEED has accumulated data on more than 50,000 patients with severe mental disorders and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies. conditions: Severe Mental Disorder conditions: Schizophrenia conditions: Bipolar Disorder conditions: Schizo-Affective Psychosis conditions: Paranoid Psychoses conditions: Mental Retardation conditions: Epileptic Psychosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 57212 type: ACTUAL name: Patient with severe mental disorder without intervention measure: Risk of circulatory system diseases measure: Risk of endocrine system diseases measure: Risk of pulmonary system and allergy diseases measure: Risk of gastrointestinal system diseases measure: Risk of musculoskeletal system diseases measure: Risk of urogenital system diseases measure: Risk of hematological system diseases measure: Risk of cancers measure: Risk of neurological system diseases measure: Risk of suicide measure: Risk of violence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ningbo Mental Health Information System city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 hasResults: False |
<|newrecord|> nctId: NCT06370780 id: 5UG3AI176592-02 type: NIH link: https://reporter.nih.gov/quickSearch/5UG3AI176592-02 briefTitle: Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically acronym: EPI-LoVE overallStatus: RECRUITING date: 2024-02-09 date: 2025-04-30 date: 2025-04-30 date: 2024-04-17 date: 2024-04-26 name: University of California, Los Angeles class: OTHER name: Florida State University name: University of California, Irvine name: University of North Carolina, Chapel Hill name: AIDS Healthcare Foundation briefSummary: Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE maskingDescription: N/A - all participants get the app count: 1000 type: ESTIMATED name: EPI LOVE measure: Incidence of HIV Viral Suppression measure: Level of Adherence to HIV medication measure: Level of Adherence based on HIV appointments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Pamina Gorbach, DrPh, MHS role: CONTACT phone: 310-794-2555 email: [email protected] name: Valerie El-Alfi, MA role: CONTACT email: [email protected] lat: 34.05223 lon: -118.24368 hasResults: False |
<|newrecord|> nctId: NCT06370767 id: 25634 briefTitle: Peer Facilitated Waitlist Controlled Transportation Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-17 date: 2024-04-17 name: Temple University class: OTHER briefSummary: The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses: |
1. Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills. |
2. Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community. |
3. Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention. |
Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews. conditions: Serious Mental Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either start the intervention program immediately, or be placed on an 8-week waitlist. Once randomized, the participant will again be randomized into a treatment condition: 1) peer-mediated bikeshare training intervention; or 2) peer-mediated public travel training intervention. 20 participants from each condition who have not opted out of being in the GPS subsample will be randomly assigned to be invited to a GPS subgroup. primaryPurpose: OTHER masking: NONE count: 180 type: ESTIMATED name: Bike-Share Travel Training name: Public Transportation Travel Training measure: Temple University Community Participation Measure measure: LASA Sedentary Behaviors Questionnaire measure: Transportation Appraisal Scale measure: Indego Skills Survey measure: SEPTA Skills Survey measure: University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified) measure: National Household Travel Survey measure: GPS measure: Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version) measure: University of California, Los Angeles, Loneliness Scale measure: Pearlin Mastery Scale (Coping) measure: SF- 36 v2 measure: The PERMA - Profiler Measure measure: Recovery Assessment Scale (RAS) measure: Group Identification Scale (GIS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-07 uploadDate: 2024-04-10T09:43 filename: Prot_SAP_000.pdf size: 450285 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-07 uploadDate: 2024-04-10T09:43 filename: ICF_001.pdf size: 235105 hasResults: False |
<|newrecord|> nctId: NCT06370754 id: 2401289-19-2403 briefTitle: Newly Emerging Immunotherapy for Pancreatic Cancer Treatment acronym: FD-IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2027-04-30 date: 2024-04-17 date: 2024-04-17 name: Fudan University class: OTHER briefSummary: This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: JS001 name: JS004 name: JS007 name: JS015 name: Irinotecan Liposome Injection name: 5-Fluorouracil (5-FU) name: Leucovorin (LV) name: Nab paclitaxel name: Gemcitabine measure: Incidence of dose-limiting toxicity (DLT) (phase IB) measure: Objective Response Rate (ORR) (phase II) measure: Objective Response Rate (ORR) (phase IB) measure: Disease control rate (DCR) measure: Duration of Response (DOR) measure: Progression free survival (PFS) measure: Overall Survival (OS) measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06370741 id: OkanUni. briefTitle: Effect of Stretching Exercises on Plantar Fascia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-06 date: 2024-04-17 date: 2024-04-17 name: Okan University class: OTHER briefSummary: The plantar fascia (PF) extends over the calcaneal bone with a thin band corresponding to the calcaneal periosteum, continuing as the paratenon of the Achilles tendon.The triceps surae complex, serving as the main extensor and propulsion system of the foot, involves the Achilles tendon, posterior part of the calcaneus, and Plantar Aponeurosis, all integrated with the fibrous skeleton of the triceps surae. Plantar fasciitis, a prevalent musculoskeletal condition affecting individuals of various ages and activity levels (Hye Chang Rhim), is a primary cause of heel pain in adults. Studies have identified the superior efficacy of stretching protocols targeting the Achilles tendon and/or plantar fascia compared to alternative treatments. However, the limitations of traditional approaches become apparent when considering the intricate biomechanics of the foot and ankle. Conventional calf stretches often prove inadequate for addressing its specific lengthening requirements. While contemporary methods like PF-Specific Stretching integrate plantar fascia and calf stretches, their reliance on individual upper extremity strength introduces potential limitations. |
Therefore, although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be aimed to determine whether an instrument aid to be designed will have an effect and which method is more effective. In this way, it is planned to guide clinicians in the rehabilitation of possible pathologies specific to the plantar fascia in clinical practice. |
Myotonometry is a convenient method to assess the stiffness of the plantar fascia because it is cheap, simple and fast. Previous studies have shown that MyotonPRO can reliably assess the stiffness of the plantar fascia. Although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be determined whether stretching with an instrument to be designed will have an effect and which method is more effective with or without an instrument. conditions: Stretch conditions: Plantar Fascia; Contracture conditions: Fasciitis, Plantar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pilot study primaryPurpose: DEVICE_FEASIBILITY masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Stretching with/without device measure: Plantar Fascia Mechanical Properties sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370728 id: 18621 id: J2A-MC-GZPJ type: OTHER domain: Eli Lilly and Company briefTitle: A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-07-15 date: 2024-07-15 date: 2024-04-17 date: 2024-04-29 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Orforglipron name: Carbamazepine measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron measure: PK: Maximum Observed Concentration (Cmax) of Orforglipron sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ICON Early Phase Services city: San Antonio state: Texas zip: 78209 country: United States role: CONTACT phone: 210-255-5437 name: Robert Bass role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False |
<|newrecord|> nctId: NCT06370715 id: 18269 id: I8B-MC-ITTA type: OTHER domain: Eli Lilly and Company briefTitle: A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-04-17 date: 2024-04-17 name: Eli Lilly and Company class: INDUSTRY name: Cipla Ltd. briefSummary: The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India. |
The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks). conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: Insulin Lispro-aabc name: Insulin Glargine measure: Percentage of Participants with at least 1 Episode of Hypoglycemia measure: Percentage of Participants with Severe Hypoglycemic Events measure: Percentage of Participants with Nocturnal Hypoglycemia Events measure: Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events measure: Change from Baseline to Week 26 in Body Weight measure: Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score measure: Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c) measure: Percentage of Participants Achieving HbA1c Less Than (<) 7% measure: Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values measure: Change from Baseline to Week 26 in Bolus Insulin Dose, Basal Insulin Dose, and Basal: Bolus Ratio measure: Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King George Hospital, Visakhapatnam city: Vizag state: Andhra Pradesh zip: 530002 country: India name: Bongi Vivekanand role: PRINCIPAL_INVESTIGATOR lat: 17.68009 lon: 83.20161 facility: Diabetes Research Centre city: Royapuram state: Chennai zip: 600013 country: India name: VIJAY VISHWANATHAN role: PRINCIPAL_INVESTIGATOR lat: 13.11405 lon: 80.29474 facility: Vijyaratna Dibetes Diagnosis Treatment Centre city: Ahmedabad state: Gujarat zip: 380007 country: India name: Sanjeev Phatak role: PRINCIPAL_INVESTIGATOR lat: 23.02579 lon: 72.58727 facility: Center for Diabetes and Endocrine Care city: Bengaluru state: Karnataka zip: 560043 country: India name: K M Prasanna Kumar role: PRINCIPAL_INVESTIGATOR lat: 12.97194 lon: 77.59369 facility: Chellaram Diabetes Institute city: Pune state: Maharashtra zip: 411021 country: India name: Unnikrishnan Gopalkrishnan role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Sahyadri Super Speciality Hospital city: Pune state: Maharashtra country: India name: Uday Phadke role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: S. P. Medical College & A G Hospital city: Bikaner state: Rajasthan zip: 334003 country: India name: Bal Kishan Gupta role: PRINCIPAL_INVESTIGATOR lat: 28.01762 lon: 73.31495 facility: Rajasthan University of Health Sciences city: Jaipur state: Rajasthan zip: 302033 country: India name: Sudhir Bhandari role: PRINCIPAL_INVESTIGATOR lat: 26.91962 lon: 75.78781 facility: Kovai Diabetes Speciality Center and Hospital city: Coimbatore state: Tamil Nadu zip: 641009 country: India name: Ramanathan Balamurugan role: PRINCIPAL_INVESTIGATOR lat: 11.00555 lon: 76.96612 facility: Osmania Medical College & Hospital city: Hyderabad state: Telangana zip: 500012 country: India name: Rakesh Sahay role: PRINCIPAL_INVESTIGATOR lat: 17.38405 lon: 78.45636 facility: Brij Medical Center Pvt. Ltd. city: Kanpur state: Uttar Pradesh zip: 208020 country: India name: brij mohan role: PRINCIPAL_INVESTIGATOR lat: 26.46523 lon: 80.34975 facility: Medical College & Hospital, Kolkata city: Kolkata state: West Bengal zip: 700073 country: India name: Animesh Maiti role: PRINCIPAL_INVESTIGATOR lat: 22.56263 lon: 88.36304 hasResults: False |
<|newrecord|> nctId: NCT06370702 id: 23-054 briefTitle: Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines overallStatus: RECRUITING date: 2023-10-06 date: 2026-12-31 date: 2027-06-30 date: 2024-04-17 date: 2024-04-17 name: TriHealth Inc. class: OTHER briefSummary: Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States. conditions: Deep Vein Thrombosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 2500 type: ESTIMATED name: Handgrip Exercises measure: Deep vein thrombosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Good Samaritan Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45220 country: United States name: Rachel Baker, PhD, RN role: CONTACT phone: 513-569-6191 email: [email protected] lat: 39.12713 lon: -84.51435 facility: Bethesda North Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Rachel Baker, PhD, RN role: CONTACT phone: 513-569-6191 email: [email protected] lat: 39.12713 lon: -84.51435 hasResults: False |
<|newrecord|> nctId: NCT06370689 id: PRE-OX briefTitle: Comparison of Three Pre-oxygenation Strategies overallStatus: NOT_YET_RECRUITING date: 2024-05-23 date: 2024-12-31 date: 2025-07-30 date: 2024-04-17 date: 2024-04-17 name: Institute of Mountain Emergency Medicine class: OTHER briefSummary: Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers. |
Study endpoints |
Primary Endpoint: |
The time taken from the start of preoxygenation until reaching an expiratory oxygen concentration (FeO2) of ≥ 90% or a maximum preoxygenation time of 3 min. |
Secondary endpoints: |
* Changes in regional ventilation within the posterior lung regions from baseline to the time when FeO2≥ 90% is achieved, assessed using electrical impedance tomography (EIT) |
* Difference in Oxygen Reserve Index (ORi) when FeO2≥ 90% is achieved |
Number of participants 15 participants per subgroup, i.e. 45 participants in total. |
Inclusion criteria |
* Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II |
* Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3 |
* Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day. |
After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow. conditions: Emergencies conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 45 type: ESTIMATED name: Preoxygenation measure: Difference in Oxygen Reserve index (ORi) after 3 minutes of preoxygenation measure: Difference in expiratory oxygen concentration (FeO2) after 3 minutes of preoxygenation measure: Time to Oxygen Reserve index (ORi) = 1.0 sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370676 id: ESO-TIP briefTitle: Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location acronym: ESO-TIP overallStatus: NOT_YET_RECRUITING date: 2024-05-23 date: 2024-12-31 date: 2025-07-30 date: 2024-04-17 date: 2024-04-17 name: Institute of Mountain Emergency Medicine class: OTHER briefSummary: Background An accurate measurement of the core body temperature (CBT) is of pivotal importance in the management of severely hypothermic patients. For instance, triage decisions for or against extracorporeal rewarming of hypothermic patients in cardiac arrest strongly depend on CBT. CBT measurement with an oesophageal probe is currently considered the gold standard in hypothermic patients with a secured airway in the prehospital setting, with the tip of the probe placed into the distal third of the oesophagus (i.e., posteriorly to the heart and distal to the tracheal bifurcation). However, the correct placement of the probe tip cannot be verified in the prehospital setting, and it is unknown how incorrect placement affects temperature readings. |
Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements (i.e., temperature readings not reflecting the real CBT). Particularly, a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings, especially when the patient is ventilated with cold air. The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement. |
Methods Experimental, interventional study on 16 healthy volunteers. During the test oesophageal temperature is measured while participants are breathing ambient air first at 20°C (baseline) followed by cold (-20°C) ambient air in supine position for 20 minutes each test in an environmental simulator (terraXcube). Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus (i.e., correct position) or too high in the oesophagus, i.e. behind the trachea. conditions: Emergencies conditions: Hypothermia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The participant is blinded for the location of the oesophageal temperature probe tip. whoMasked: PARTICIPANT count: 16 type: ESTIMATED name: Oesophageal temperature measurement measure: Difference in core body temperature between the two tip positions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370663 id: SDZLEC2023-109-01 briefTitle: First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-04-17 date: 2024-04-17 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Combining radiotherapy with Hepatic Arterial Infusion Chemotherapy primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Radiotherapy name: HAIC (GEMOX) name: Chemotherapy measure: Adverse Events measure: Progression-Free Survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinbo Yue status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Jin Bo Yue, Doctor role: CONTACT phone: 0531-67626929 email: [email protected] lat: 36.66833 lon: 116.99722 hasResults: False |
<|newrecord|> nctId: NCT06370650 id: soh-med-24-1-9 briefTitle: Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-08 date: 2024-01-25 date: 2024-06-30 date: 2024-04-17 date: 2024-04-17 name: Sohag University class: OTHER briefSummary: For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed. conditions: Management of Stable Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: platelet rich plasma, narrow band UVB measure: Improvement of vitiligo sex: ALL minimumAge: 15 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine, Sohag University city: Sohag zip: 82515 country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False |
<|newrecord|> nctId: NCT06370637 id: Survey Protocol briefTitle: Efficacy of Cream for Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea acronym: Survey overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-17 date: 2024-04-17 name: Scotiaderm class: OTHER briefSummary: Scotiaderm Inc. has developed a cream formulation to be used in the treatment of MASD caused diarrhea or fecal incontinence. This study aims to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence. conditions: Incontinence-associated Dermatitis conditions: Moisture Associated Skin Damage (MASD) (E.G., Incontinence-Associated Dermatitis [IAD], Perspiration, Drainage) conditions: Fecal Incontinence Incontinence-associated Dermatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The aim of this study is to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A total of 40 patients will be enrolled in the study. If the patient agrees to participate and written consent is given to participate, the research coordinator will assess the eligibility criteria of the patient based on the inclusion and exclusion criteria. Participants will be provided 2x2cm patch test on the forearm to test for contact dermatitis to the cream D after obtaining consent. Participants do not react to the Cream D will be randomized. Participants who react will be excluded from the study. The research coordinator will have a list for arm 1 and arm 2 where the code for the participant enrolled will be entered daily. The first participants to be enrolled on any given day will be assigned to arm 1, and the second patient to arm 2. The research coordinator will have 40 envelopes with the protocols coded with arm 1 or arm 2, and cream containers also coded with arm 1 and arm 2. whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: MASD Control Arm measure: Analysis of Efficacy and Safety for Cream D Primary Outcome measure: Analysis of Efficacy and Safety for Cream D Secondary Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06370624 id: 2022/03OCT/360 briefTitle: PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment. acronym: PEDI-REAVASC overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-17 date: 2025-09-15 date: 2025-10-01 date: 2024-04-17 date: 2024-04-17 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores. |
The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours. |
A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned. conditions: Encephalopathy, Hypoxic-Ischemic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will be followed - with both the standard of care continuous EEG monitoring and near infrared spectroscopy (NIRS) \& the MRI-scan performed at the same time. primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: MRI-scan measure: quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE) sex: ALL minimumAge: 1 Hour maximumAge: 14 Months stdAges: CHILD facility: Cliniques Universitaires Saint Luc city: Brussels zip: 1200 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06370611 id: 2314027 briefTitle: Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery. (RECARD Trial) acronym: RECARD overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-09-30 date: 2026-09-30 date: 2024-04-17 date: 2024-04-17 name: Ivy susanne Modrau, MD class: OTHER name: Aalborg University Hospital briefSummary: An increasing number of older patients undergo heart surgery. Despite seemingly successful outcomes, these vulnerable patients may face prolonged decreased functional capacity, reduced self-efficacy, and impaired quality of life after discharge. Early engagement in physical activity and education plays a key role in health and well-being after heart surgery The goal of this clinical trial is to evaluate the effectiveness of an app-based exercise program and weekly calls from a physiotherapist in the early stages after open heart surgery. |
Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group, which will be introduced to an individually tailored exercise program as an addition to standard care. |
Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery. |
All participants will undergo assessments at enrollment and during follow-up. Physical performance will be evaluated through physical tests. General well-being, quality of life, self-reported physical activity, and cost-effectiveness of the intervention will be assessed through questionnaires. Muscle health will be examined through blood sampling, CT scans, and muscle biopsies. |
The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function. conditions: Cardiac Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Bi-center, prospective, randomized, controlled, parallel (1:1), two-arm, open-label, blinded evaluation (PROBE) trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Allocation cannot be concealed from the participants, care providers or investigator. Outcome assessors will be blinded regarding allocation. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Early mobile health intervention supplemented by weekly calls from a physiotherapist measure: Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU measure: Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU measure: Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU measure: Change (Δ) in WHO-5-score baseline vs. 6-week FU measure: Change (Δ) in ASS-2-score baseline vs. 6-week FU measure: Change (Δ) in MDI-2-score baseline vs. 6-week FU measure: Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU measure: Change (Δ) in EuroQol-score baseline vs. 6-week FU measure: Change in skeletal muscle mass maximum 3 months prior to surgery vs. 6-week FU measure: Cost-effectiveness analysis measure: Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU measure: Changes in markers of inflammation through blood samples baseline vs. 6-week FU measure: Changes in markers of nutrition through blood samples baseline vs. 6-week FU measure: Changes in markers of liver function through blood samples baseline vs. 6-week FU measure: Changes in markers of kidney function through blood samples baseline vs. 6-week FU measure: Changes in markers of hormone levels through blood samples baseline vs. 6-week FU sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Aarlborg University Hospital city: Aalborg zip: 9000 country: Denmark name: Stian Ingemann-Molden, PT, MHSc role: CONTACT phone: +45 97664210 email: [email protected] lat: 57.048 lon: 9.9187 facility: Aarhus University Hospital city: Aarhus zip: 8200 country: Denmark name: Rikke Daugaard, PT, MHSc role: CONTACT phone: +45 41282266 email: [email protected] lat: 56.15674 lon: 10.21076 hasResults: False |
<|newrecord|> nctId: NCT06370598 id: TP-122 briefTitle: Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia acronym: RECOVER overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-05 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: Technophage, SA class: INDUSTRY name: VectorB2B briefSummary: Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone. conditions: Pneumonia, Ventilator-Associated studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: TP-122A measure: Evaluate safety and tolerability following nebulization of multiple doses of TP-122A measure: Proportion of subjects achieving "Clinical Cure" CR measure: Time to achieve "Clinical Cure" CR measure: Proportion of subjects achieving "Eradication" or "Presumed Eradication" MR of TP-122A target bacteria measure: Time to achieve "Eradication" or "Presumed Eradication" MR sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH Nantes city: Nantes country: France name: Antoine Roquilly, MD role: CONTACT name: Antoine Roquilly, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False |
<|newrecord|> nctId: NCT06370585 id: SOPH229-0823/I briefTitle: Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2024-09-30 date: 2024-09-30 date: 2024-04-17 date: 2024-04-17 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects. conditions: Dry Eye Disease conditions: Ocular Surface Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, double-masked, single-center, randomized, controlled clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: PRO-229 name: Lagricel® Ofteno PF measure: Incidence Unexpected Related Adverse Reactions measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in ocular surface staining using SICCA ocular staining score scale measure: Incidence of chemosis measure: Incidence of grade 3 or 4 conjunctival hyperemia. measure: Adherence to treatment (adherence) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06370572 id: CIRB23-1162 id: U54AG063546 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG063546 briefTitle: Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-05 date: 2025-05 date: 2024-04-17 date: 2024-04-19 name: University of Chicago class: OTHER name: National Institute on Aging (NIA) name: University of North Carolina, Chapel Hill briefSummary: The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD. conditions: Dementia conditions: Hip Pain conditions: Emergency Department Patient conditions: Pain in Advanced Dementia Scale studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale. primaryPurpose: TREATMENT masking: NONE count: 1899 type: ESTIMATED name: PAINAD EHR Prompt measure: Percentage of eligible patients receiving a PAINAD assessment upon ED arrival measure: Change in time to administration of first analgesic medication measure: Change in pain score for patients receiving a repeat PAINAD assessment sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Chicago city: Chicago state: Illinois zip: 60637 country: United States name: Teresita M Hogan, MD role: CONTACT phone: 773-702-9500 name: Teresita M Hogan, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Michelle Meyer, PhD, MPH, CPH role: CONTACT phone: (919) 966-6442 name: Michelle Meyer, PhD, MPH, CPH role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False |
<|newrecord|> nctId: NCT06370559 id: 339042 briefTitle: Relationship Between Repetitive Negative Thinking and CBT Outcomes overallStatus: COMPLETED date: 2022-01-01 date: 2024-02-01 date: 2024-02-01 date: 2024-04-17 date: 2024-04-17 name: South London and Maudsley NHS Foundation Trust class: OTHER briefSummary: The goal of this observational study is to learn about the role of repetitive negative thinking (measured by the RTQ) in adult populations from an anxiety disorders and trauma clinic. |
The main questions it aims to answer are: |
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