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<\|newrecord\|> nctId: NCT06297278 id: IRB-23-01-5444 id: R01MH132830 type: NIH link: https://reporter.nih.gov/quickSearch/R01MH132830 briefTitle: Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids acronym: BRAINS overallStatus: RECRUITING date: 2024-05-01 date: 2028-04-30 date: 2028-04-30 date: 2024-03-07 date: 2024-04-23 name: Wayne State University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth. conditions: Adolescence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 174 type: ESTIMATED name: Moderate Intensity Exercise measure: Skin Conductance Responding (SCR) measure: Unconditioned Stimulus (US) Expectancy Ratings measure: Fear extinction neural circuitry: Functional activation and coupling measure: Endocannabinoid (eCB) Concentrations measure: Fear Ratings measure: Approach/Avoidance Behavior measure: Amygdala response during extinction recall sex: ALL minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: Tolan Park Medical Building status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: MacKenna Shampine role: CONTACT phone: 313-242-7464‬ email: mackenna.shampine@wayne.edu lat: 42.33143 lon: -83.04575 hasResults: False
<\|newrecord\|> nctId: NCT06297265 id: 1B-23-2 id: NCI-2023-10828 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 1B-23-2 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-07 date: 2024-03-07 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer. conditions: Anatomic Stage 0 Breast Cancer AJCC v8 conditions: Anatomic Stage IA Breast Cancer AJCC v8 conditions: Localized Breast Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Lymphedema Management name: Questionnaire Administration name: Adjuvant breast radiation therapy measure: Rate of compliance of MLD breast massage sessions measure: Assess the effect of MLD breast massage breast edema measure: Assess the effect of MLD breast massage on pain measure: Assess the effect of MLD breast massage on functional status measure: Assess the effect of MLD breast massage on quality of life measure: Assess the effect of MLD breast massage on body image sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Kimberly Arieli, RN role: CONTACT phone: 323-865-0451 email: Kimberly.Arieli@med.usc.edu name: May L. Tao, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06297252 id: RECHMPL23_0189 briefTitle: Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population acronym: GROUP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-09 date: 2024-03-07 date: 2024-03-07 name: University Hospital, Montpellier class: OTHER name: Beziers Hospital briefSummary: Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs.
The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated.
The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment.
Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum. conditions: Pregnancy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 140 type: ESTIMATED name: standardized clinical psychiatric evaluations name: self-administered psychiatric questionnaire assessments name: blood sampling measure: To determine the prevalence of the presence of at least one characterized psychiatric disorder, in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment. measure: To determine the prevalence of each psychiatric disorder characterized during pregnancy at the time of the second-trimester ultrasound, based on a standardized clinical assessment. measure: Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles. measure: Compare the prevalence of psychiatric disorders unknown to the obstetrics team with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. measure: Compare the prevalence of psychiatric disorders unknown to the patient with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. measure: Compare the prevalence of psychiatric disorders unknown to the general practitioner with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. measure: Assess patients' medication compliance using self-administered questionnaires (MARS). measure: Assess patients' treatment beliefs using self-administered questionnaires (BMQ). measure: Determine the sociodemographic, psychological, psychiatric, medical and obstetric factors, as well as those associated with access to care and the care pathway associated with known or unknown diagnoses during pregnancy. measure: Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. measure: Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population. measure: Determine the properties (sensitivity) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population. measure: Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Determine the properties (specificity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Determine the properties (positive predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Determine the properties (negative predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population. measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (PAI). measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (MIBS). measure: Describe how the study will be carried out, either in person or by teleconsultation, and the reasons for this choice. measure: Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297239 id: UC001 briefTitle: Argentine Registry of Lp(a) acronym: GAELpa overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-01 date: 2026-02-01 date: 2024-03-07 date: 2024-03-07 name: School of Medicine. National University of Cuyo class: OTHER briefSummary: The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.
The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.
One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.
Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.
The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care. conditions: Lp(A) conditions: Hypercholesterolemia conditions: Cardiovascular Diseases conditions: Diabete Type 2 conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: prevalence of high level of Lp(a) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Nacional de Cuyo status: RECRUITING city: Mendoza zip: 5500 country: Argentina name: Nicolás F Renna, PhD MD FESC role: CONTACT phone: +5492615714415 email: nicolasfede@gmail.com name: Pablo Corral, MD role: CONTACT lat: -32.89084 lon: -68.82717 hasResults: False
<\|newrecord\|> nctId: NCT06297226 id: CA088-1000 briefTitle: Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma acronym: QUINTESSENTIAL overallStatus: RECRUITING date: 2024-03-21 date: 2026-10-02 date: 2030-06-04 date: 2024-03-07 date: 2024-03-29 name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company class: INDUSTRY briefSummary: The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: BMS-986393 measure: Best overall response (BOR) measure: Best overall response (BOR) measure: BOR of partial response (PR) or better measure: BOR of complete response (CR) [including stringent complete response sCR] measure: Incidence of adverse events (AEs) measure: Incidence of serious adverse events (SAEs) measure: Incidence of adverse event of special interest (AESI) measure: Incidence of participants with clinical laboratory abnormalities measure: Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS) measure: Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC) measure: Duration of response (DOR) assessed by an IRC measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall response rate (ORR) assessed by an Investigator measure: Complete response rate (CRR) assessed by an Investigator measure: Time to response (TTR) assessed by an Investigator measure: Duration of response (DOR) assessed by an Investigator measure: Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator measure: Maximum observed plasma concentration (Cmax) measure: Area under the concentration-time curve (AUC) measure: Time of maximum observed plasma concentration (Tmax) measure: Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales measure: Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales measure: Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Local Institution - 0001 status: NOT_YET_RECRUITING city: Birmingham state: Alabama zip: 35294-3300 country: United States name: Site 0001 role: CONTACT lat: 33.52066 lon: -86.80249 facility: Local Institution - 0025 status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85234 country: United States name: Site 0025 role: CONTACT lat: 33.35283 lon: -111.78903 facility: Local Institution - 0037 status: NOT_YET_RECRUITING city: Little Rock state: Arkansas zip: 72205 country: United States name: Site 0037 role: CONTACT lat: 34.74648 lon: -92.28959 facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Sarah Larson, Site 0028 role: CONTACT phone: 310-829-5471 lat: 34.05223 lon: -118.24368 facility: Local Institution - 0018 status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Site 0018 role: CONTACT lat: 37.77493 lon: -122.41942 facility: Colorado Blood Cancer Institute status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Tara Gregory, Site 0049 role: CONTACT phone: 720-754-4800 lat: 39.73915 lon: -104.9847 facility: Local Institution - 0045 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33176 country: United States name: Site 0045 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Local Institution - 0029 status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Site 0029 role: CONTACT lat: 27.94752 lon: -82.45843 facility: Local Institution - 0009 status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Site 0009 role: CONTACT lat: 33.749 lon: -84.38798 facility: Local Institution - 0004 status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30342 country: United States name: Site 0004 role: CONTACT lat: 33.749 lon: -84.38798 facility: Local Institution - 0005 status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Site 0005 role: CONTACT lat: 41.85003 lon: -87.65005 facility: Local Institution - 0056 status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Site 0056 role: CONTACT lat: 41.85003 lon: -87.65005 facility: Local Institution - 0019 status: NOT_YET_RECRUITING city: Iowa City state: Iowa zip: 52242 country: United States name: Site 0019 role: CONTACT lat: 41.66113 lon: -91.53017 facility: Local Institution - 0016 status: NOT_YET_RECRUITING city: Kansas City state: Kansas zip: 66160 country: United States name: Site 0016 role: CONTACT lat: 39.11417 lon: -94.62746 facility: Local Institution - 0026 status: NOT_YET_RECRUITING city: Saint Matthews state: Kentucky zip: 40207 country: United States name: Site 0026 role: CONTACT lat: 38.25285 lon: -85.65579 facility: Local Institution - 0039 status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Site 0039 role: CONTACT lat: 42.35843 lon: -71.05977 facility: Local Institution - 0036 status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Site 0036 role: CONTACT lat: 42.35843 lon: -71.05977 facility: Local Institution - 0033 status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Site 0033 role: CONTACT lat: 44.02163 lon: -92.4699 facility: Local Institution - 0010 status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Site 0010 role: CONTACT lat: 38.62727 lon: -90.19789 facility: Local Institution - 0034 status: NOT_YET_RECRUITING city: New Brunswick state: New Jersey zip: 08903 country: United States name: Site 0034 role: CONTACT lat: 40.48622 lon: -74.45182 facility: Local Institution - 0046 status: NOT_YET_RECRUITING city: Buffalo state: New York zip: 14263 country: United States name: Site 0046 role: CONTACT lat: 42.88645 lon: -78.87837 facility: Local Institution - 0002 status: NOT_YET_RECRUITING city: New York state: New York zip: 10029 country: United States name: Site 0002 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Local Institution - 0003 status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States name: Site 0003 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Local Institution - 0031 status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Site 0031 role: CONTACT lat: 35.9132 lon: -79.05584 facility: Local Institution - 0054 status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Site 0054 role: CONTACT lat: 39.12713 lon: -84.51435 facility: Local Institution - 0032 status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Site 0032 role: CONTACT lat: 39.96118 lon: -82.99879 facility: Local Institution - 0038 status: NOT_YET_RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Site 0038 role: CONTACT lat: 45.52345 lon: -122.67621 facility: Local Institution - 0043 status: NOT_YET_RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Site 0043 role: CONTACT lat: 36.16589 lon: -86.78444 facility: Local Institution - 0035 status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75390-88520 country: United States name: Site 0035 role: CONTACT lat: 32.78306 lon: -96.80667 facility: Local Institution - 0027 status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Site 0027 role: CONTACT lat: 29.76328 lon: -95.36327 facility: Local Institution - 0055 status: NOT_YET_RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Site 0055 role: CONTACT lat: 29.42412 lon: -98.49363 facility: Local Institution - 0050 status: NOT_YET_RECRUITING city: Salt Lake City state: Utah zip: 84143 country: United States name: Site 0050 role: CONTACT lat: 40.76078 lon: -111.89105 facility: Local Institution - 0011 status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98109 country: United States name: Site 0011 role: CONTACT lat: 47.60621 lon: -122.33207 facility: Local Institution - 0015 status: NOT_YET_RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States name: Site 0015 role: CONTACT lat: 43.07305 lon: -89.40123 facility: Local Institution - 0020 status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 4N2 country: Canada name: Site 0020 role: CONTACT lat: 51.05011 lon: -114.08529 facility: Local Institution - 0021 status: NOT_YET_RECRUITING city: Montréal state: Quebec zip: H4A 3J1 country: Canada name: Site 0021 role: CONTACT lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06297213 id: R-2487-SS-01 briefTitle: R-2487 in Patients With Sjogren's Syndrome (SS) acronym: R-2487-SS-01 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-08-30 date: 2026-08-30 date: 2024-03-07 date: 2024-04-12 name: Rise Therapeutics LLC class: INDUSTRY briefSummary: The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.
Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured. conditions: Sjogren's Syndrome conditions: Sjögren conditions: Sjögren Syndrome, Unspecified studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: R-2487 measure: Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration measure: Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) measure: Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297200 id: 24-050 briefTitle: Low-Intensity Focused Ultrasound and the Complex Patient overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-03-07 date: 2024-03-07 name: Virginia Polytechnic Institute and State University class: OTHER name: Salem VA Medical Center name: Washington DC VA Medical Center briefSummary: Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population. conditions: Opioid Use Disorder conditions: Chronic Pain conditions: Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions. count: 25 type: ESTIMATED name: Low-Intensity Focused Ultrasound name: Low-Intensity Focused Ultrasound - sham measure: Incidence of Treatment-Emergent Adverse Events via a neurological examination measure: Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire measure: Changes in Heart Rate (HR) measure: Changes in Respiration Rate (RR) measure: Changes in mood via visual analog mood scale (VAMS) measure: Changes in Blood Pressure (BP) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fralin Biomedical Research Institute at VTC city: Roanoke state: Virginia zip: 24016 country: United States name: Jessica Florig, MPH role: CONTACT phone: 540-526-2261 email: jnw@vtc.vt.edu name: Wynn Legon, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.27097 lon: -79.94143 hasResults: False
<\|newrecord\|> nctId: NCT06297187 id: C-CUSAWH-001 briefTitle: Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-23 date: 2024-07 date: 2024-08 date: 2024-03-07 date: 2024-03-07 name: Integra LifeSciences Corporation class: INDUSTRY briefSummary: The study is a single arm, retrospective, single-center, post market registry.
The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata. conditions: Vulvar Intraepithelial Neoplasia conditions: Condylomata Acuminata studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 75 type: ESTIMATED name: CUSA (Cavitronic Ultrasonic Surgical Aspirator) measure: Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata measure: Primary Site Recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Center for Cancer and Blood Disorders city: Dallas state: Texas zip: 76014 country: United States lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06297174 id: BE23-035 briefTitle: Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-08-26 date: 2024-09-17 date: 2024-09-20 date: 2024-03-07 date: 2024-03-07 name: Pharma Nueva class: INDUSTRY briefSummary: Objectives:
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
Study Design:
An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period conditions: Healthy Vollunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 44 type: ESTIMATED name: Racecadotril 100 mg Capsules name: HIDRASEC® measure: Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril measure: Peak Plasma Concentration (Cmax) of Racecadotril sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297161 id: B1871065 briefTitle: A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML). overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2029-12-31 date: 2029-12-31 date: 2024-03-07 date: 2024-03-07 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.
This study is seeking for participants who are:
* Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.
* willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.
The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study. conditions: Chronic Leukemia Myelogenous studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Bosulif measure: Incidence of AEs measure: Hematologic response: CHR, not achieved measure: Cytogenetic response: CCyR, PCyR, mCyR, not achieved measure: Molecular response: EMR, MMR, MR4.0, MR4.5, not achieved measure: Relapse after Bosulif response sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297148 id: 2023/590816 briefTitle: The HIP Self-management Study acronym: HIPS overallStatus: RECRUITING date: 2024-03-12 date: 2026-07-01 date: 2027-01-01 date: 2024-03-07 date: 2024-03-21 name: Oslo University Hospital class: OTHER name: Oslo Metropolitan University name: Fysiofondet name: University of Oslo briefSummary: The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT).
The main purpose of the study is:
1. To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS).
* H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS.
* H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS.
2. To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS.
Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care.
Follow-up will be at 3-, 6- and 12-months. conditions: GTPS - Greater Trochanteric Pain Syndrome conditions: Gluteal Tendinopathy conditions: Trochanteric Bursitis conditions: Lateral Hip Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Self-management name: Usual care measure: Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G) measure: Numeric rating scale (NRS) measure: Painful sites measure: The Pain Self-Efficacy Questionnaire (PSEQ) measure: EuroQoL-5 dimensions-5 Level (Eq-5D-5L) measure: Hopkins Symptoms checklist-10 (HSCL-10) measure: iMTA Medical Consumption Questionnaire (iMCQ) measure: iMTA Productivity Cost Questionnaire (iPCQ) measure: Expectations related to VISA-G measure: Expectations on numeric rating scale (NRS) measure: Global rating of change (GROC) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital, Ullevål status: RECRUITING city: Oslo zip: 0450 country: Norway name: Marianne Bakke Johnsen, PhD role: CONTACT phone: + 47 92439663 email: m.b.johnsen@medisin.uio.no name: Marianne Bakke Johnsen, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.91273 lon: 10.74609 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-22 uploadDate: 2024-03-07T09:23 filename: SAP_001.pdf size: 1180746 hasResults: False
<\|newrecord\|> nctId: NCT06297135 id: HSR-2023-020 briefTitle: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits overallStatus: RECRUITING date: 2024-02-01 date: 2025-03-31 date: 2025-03-31 date: 2024-03-07 date: 2024-03-07 name: Okinawa Institute of Science and Technology Graduate University class: OTHER name: Miyazaki International College name: Japan society for the promotion of science briefSummary: This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Behavioral Parent Training measure: Number of videos viewed measure: Percentage of completed daily ratings measure: Participant satisfaction measure: Parent-rated child's difficulties with daily transitions measure: Parent-rated child's impairment related to transition difficulties measure: Positive parenting measure: Negative parenting measure: Parenting stress measure: ADHD symptoms measure: ODD symptoms sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Okinawa Institute of Science and Technology Graduate University status: RECRUITING city: Onna state: Okinawa zip: 904-0495 country: Japan name: Emi Furukawa, PhD role: CONTACT phone: +81989668814 email: adhd@oist.jp name: Emi Furukawa, PhD role: PRINCIPAL_INVESTIGATOR facility: Miyazaki International College status: RECRUITING city: Miyazaki zip: 889-1605 country: Japan name: Aya Kasai, PhD role: CONTACT phone: +81985855931 email: akasai@sky.miyazaki-mic.ac.jp name: Aya Kasai, PhD role: PRINCIPAL_INVESTIGATOR lat: 31.91667 lon: 131.41667 hasResults: False
<\|newrecord\|> nctId: NCT06297122 id: APHP240002 briefTitle: Severe Group A Streptococcus Infections in Paris, France, 2018-2023 acronym: IGASI overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-07 date: 2024-03-12 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Streptococcus pyogenes, commonly referred to as Group A Streptococcus (GAS), has the ability to induce a diverse range of illnesses.
In several European countries and the United States, a notable surge in invasive GAS (iGAS) infections has been documented since mid-2022. This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades. As demonstrated for several viral infections, the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic, such as face mask usage and school closures.
Since November 2022, concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections, and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study. However, this study ended in December 2022 and could only explore short-term trends. The Necker - Enfants malades Hospital in Paris, France, represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections, during, and after the pandemic.
This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic. conditions: Invasive Group A Beta-Haemolytic Streptococcal Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Collection of data from the patient's medical file measure: Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions measure: Age of children age with group A Streptococcus (GAS) infections measure: Proportion of children needing surgical intervention for the management of GAS infection measure: Proportion of cases admitted in the PICU for GAS infection measure: Proportion of deaths from GAS infection measure: Hospital length of stay for the management of GAS infection measure: Distribution of infection type of GAS infection measure: Proportion of healthcare-associated infections during the management of GAS infection sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Jérémie Cohen, M.D., PhD role: CONTACT phone: 1 44 49 48 72 phoneExt: +33 email: jeremie.cohen2@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06297109 id: S-20230033 briefTitle: Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery overallStatus: RECRUITING date: 2023-09-12 date: 2027-08-31 date: 2027-08-31 date: 2024-03-07 date: 2024-03-07 name: Hospital of South West Jutland class: OTHER name: University of Southern Denmark briefSummary: Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.
Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.
Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.
The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:
* Does using PSIs provide accurate movements of the maxilla pieces?
* Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?
* Does using PSIs provide stable movements of the maxilla pieces after 2 years?
* Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?
Participants will get orthognathic surgery as part of their normal orthodontic treatment.
Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method. conditions: Retrognathia conditions: Malocclusion, Angle Class II studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The care provider and the investigator are blinded up to the selection of the device used for the surgery, as blinding is no longer possible from this state. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Patient-specific implants name: Conventional mini-plates measure: The accuracy of segmental Le Fort I bone movements measure: The stability of segmental Le Fort I bone movements measure: The stability of the upper airway measure: The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire measure: The Jaw Functional Limitation Scale measure: The STOP-BANG - Snorting, Tiredness, Observed apnea, blood Pressure, BMI, Age, Neck circumference, Gender questionnaire measure: The Epworth Sleepiness Scale questionnaire measure: The occlusion including horizontal/vertical overlap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Southern Denmark status: RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Michael B Holte, ph.d. role: CONTACT phone: +4520645760 email: Michael.Boelstoft.Holte@rsyd.dk lat: 55.47028 lon: 8.45187 hasResults: False
<\|newrecord\|> nctId: NCT06297096 id: NIGRIR_004NINTOC-TU briefTitle: Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease acronym: NINTOC-TU overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-30 date: 2028-03-30 date: 2024-03-06 date: 2024-03-21 name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland class: NETWORK name: Medical Research Agency, Poland briefSummary: The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks. conditions: Systemic Sclerosis conditions: Interstitial Lung Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Tocilizumab name: Nintedanib name: Standard therapy measure: The decrease in forced vital capacity (FVC) of the lungs measure: Change in percent lung involvement measure: Assessment of absolute changes in DLCO measure: Assessment of the absolute changes in predicted FVC% measure: Change in the Six-minute walk test (6MWT) result measure: Change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score measure: A change in the patient's global assessment of disease activity measure: A change in the physician's global assessment of disease activity measure: Assessment of the absolute changes from baseline in total scores in St. George's Respiratory Questionnaire (SGRQ) measure: Assessment of absolute changes compared to baseline values on the modified Rodnan skin Score (mRSS) measure: Percentage of participants with threshold improvement from baseline in modified Rodnan skin Score (mRSS) measure: Percentage of participants with modified Rodnan skin Score (mRSS) improvement greater than or equal to (>/=) 20%, 40%, or 60% sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centrum Wsparcia Badań Klinicznych city: Warsaw state: Mazowieckie zip: 02-637 country: Poland name: Justyna Kwiatkowska-Golańska role: CONTACT phone: 22 6880632 phoneExt: +48 email: justyna.kwiatkowska-golanska@spartanska.pl name: Maria Maślińska, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False
<\|newrecord\|> nctId: NCT06297083 id: 100992 briefTitle: Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy acronym: HILO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-02 date: 2027-12 date: 2024-03-06 date: 2024-04-08 name: Murdoch Childrens Research Institute class: OTHER briefSummary: This study will compare the effectiveness of three different treatments to treat peanut allergy conditions: Peanut Allergy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a three-arm, multi-center, head-to-head randomized study primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants, outcome assessors, other research staff, treating clinicians, investigators and trial statistician will be blinded to treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 130 type: ESTIMATED name: Peanut Oral Powder [PEANUT POWDER] name: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) measure: Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment. measure: Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment measure: Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE) measure: Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ). measure: Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size. measure: Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels measure: Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant measure: Difference between treatment arms in participant experience as assessed from qualitative interviews measure: Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) measure: Difference between clinical outcome groups in quality adjusted life year (QALY) will be estimated at 32 months using the Food Allergy Quality of Life Form (FAQLQ) mapped to the generic health utility instrument Assessment of Quality of Life-6D (AQoL-6D) measure: Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment measure: Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment sex: ALL minimumAge: 1 Year maximumAge: 10 Years stdAges: CHILD facility: Womans and Childrens Hospital city: Adelaide state: South Australia zip: 5006 country: Australia name: Michael Gold role: CONTACT phone: +61881617000 email: Michael.gold@adelaide.edu.au lat: -34.92866 lon: 138.59863 facility: Murdoch Childrens Research Institute city: Melbourne state: Victoria zip: 3052 country: Australia name: Julie Burns role: CONTACT phone: +61399366184 email: hilo.study@mcri.edu.au lat: -37.814 lon: 144.96332 hasResults: False
<\|newrecord\|> nctId: NCT06297070 id: STUDY20231406 briefTitle: Lifestyle Care for Fertility Outcome Evaluation acronym: PROWESS overallStatus: RECRUITING date: 2024-01-24 date: 2025-06-01 date: 2025-08-01 date: 2024-03-06 date: 2024-03-08 name: Christine Kaiser, LAc, DACM class: OTHER briefSummary: An observational outcome evaluation of the Lifestyle Care for Fertility program. conditions: Fertility Issues studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 55 type: ESTIMATED name: Whole Health Lifestyle Care for Reproductive Well-being pilot program measure: Servings of Fruit measure: Servings of Vegetables measure: Glasses of Water measure: Caffeinated Beverages measure: Aerobic Exercise measure: Strengthening Exercise measure: Stretching Exercise measure: Sleep Hygiene measure: Hours of Sleep measure: Self Care - Biofeedback measure: Self Care - Breathing Exercises measure: Self Care - Guided Imagery measure: Self Care - Mindfulness/Meditation measure: Self Care - Progressive Relaxation measure: Self Care - Journaling/Gratitude Journaling measure: Self Care - Tai Chi/Chi Gong measure: Self-Care - Massage Therapy measure: Self Care - Acupuncture/Acupressure measure: Self Care - Nature Walking measure: PROMIS Sleep Disturbance 8a measure: Perceived Stress Scale - 4 measure: Infertility Self Efficacy measure: Chemical pregnancy measure: Stress Change (level of stress: none [0] to worst possible [10]) - SMA measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA measure: Stress Change (level of stress: none [0] to worst possible [10]) - HWC measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC measure: Recruitment Rate measure: Retention Rate measure: Pace of Accrual measure: Data Completeness measure: Helpfulness of group sessions in addressing needs measure: Coverage of important issues in the sessions measure: Helpfulness of tools presented in nutrition session measure: Helpfulness of tools presented in movement session measure: Helpfulness of tools presented in relaxation and sleep session measure: Helpfulness of tools presented in integrate session measure: Enjoyed group sessions measure: Enjoyed health and wellness coaching session measure: Group setting was beneficial measure: Comfortable in group setting measure: Helpfulness of individual health coaching sessions measure: Feedback questionnaire: Location Preference question 1 measure: Feedback questionnaire: Location Preference question 2 measure: Feedback questionnaire: Number of Sessions question. measure: Feedback questionnaire: Length of Sessions question. measure: Rating of level of support during each SMA measure: Rating of level of support during HWC measure: Overall level of satisfaction during each SMA measure: Overall level of satisfaction during each HWC sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University Hospitals Cleveland Medical Center status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Christine Kaiser, DACM LAc role: CONTACT phone: 216-285-4070 email: Christine.Kaiser@UHhospitals.org name: Jessica Surdam, MPH role: CONTACT phone: 216-844-7925 email: Jessica.Surdam@UHhospitals.org lat: 41.4995 lon: -81.69541 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-20 uploadDate: 2024-01-10T14:17 filename: Prot_SAP_000.pdf size: 238937 hasResults: False
<\|newrecord\|> nctId: NCT06297057 id: 2021.07 briefTitle: Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings acronym: MEEGOPTI overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-03-06 date: 2024-03-06 name: IRCCS San Camillo, Venezia, Italy class: OTHER name: University Ghent name: University of Padova briefSummary: The study aims to optimize and validate protocols for acquiring neurophysiological data, specifically resting state functional connectivity, using advanced research techniques (hdEEG and MEG) and a user-friendly device (MUSE). Previous studies have extensively explored functional connectivity repeatability in resting conditions using functional MRI, yet few have focused on hdEEG and MEG data. Additionally, the impact of subjects' eye conditions (open or closed) during resting state recordings on network identification remains debated.
The investigation involves assessing the effect of eye conditions on brain network identification and determining the most stable and repeatable measures of functional connectivity over time. This analysis is crucial for discerning whether observed changes in patients' functional connections are intrinsic to the methodology or indicative of genuine physiological alterations.
The study aims to optimize protocols for rehabilitation by evaluating changes in functional connectivity metrics during and between experimental sessions. Furthermore, it seeks to identify the conditions (eyes closed or open) that yield more reliable and repeatable functional measurements.
Following the optimization of advanced techniques, the study explores the feasibility of utilizing the MUSE EEG system in clinical settings. MUSE, known for its portability and user-friendliness, has demonstrated quality in experimental psychology and clinical research. The objective is to establish relevant functional correspondences between measurements obtained through research techniques (hdEEG and MEG) and those acquired with MUSE.
The primary goal is to establish a protocol highlighting subjects' responses to acoustic stimuli or a reproducible pattern of resting state activity. The secondary objectives include investigating temporal and spatial characteristics of neurophysiological signals in healthy subjects over time and defining prognostic biomarkers for monitoring patients undergoing rehabilitation. This comprehensive approach aims to enhance the understanding of resting state functional connectivity and its applications in clinical settings.
Therefore, to meet these goals, the present study will consist of multiple recordings of brain activity: by high-density electroencephalography (hdEEG), magnetoencephalography (MEG), and low-density EEG with a MUSE handheld device, during five experimental blocks on healthy subjects. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Neurophysiological Recordings measure: Neurophysiological data acquisition protocol - resting state measure: Neurophysiological data acquisition protocol - resting state measure: Neurophysiological data acquisition protocol - auditory stimulation sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: San Camillo IRCCS s.r.l. city: Venice-Lido state: Venice zip: 30126 country: Italy lat: 45.4131 lon: 12.3742 hasResults: False
<\|newrecord\|> nctId: NCT06297044 id: 2017.20 briefTitle: Neural and Cognitive Correlates of Pragmatic Abilities acronym: APACS_Neuro overallStatus: ACTIVE_NOT_RECRUITING date: 2018-03-29 date: 2025-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-06 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.
This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans. conditions: Right Hemispheric Stroke conditions: Left Hemispheric Stroke conditions: Traumatic Brain Injury conditions: Right Hemispheric Brain Tumor conditions: Left Hemispheric Brain Tumor conditions: Mild Cognitive Impairment conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 324 type: ESTIMATED name: Neuropsychological assessment measure: Pragmatic Profile measure: Theory of Mind measure: Functional Communication Abilities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Camillo IRCCS s.r.l. city: Venice-Lido state: Venice zip: 30126 country: Italy lat: 45.4131 lon: 12.3742 hasResults: False
<\|newrecord\|> nctId: NCT06297031 id: 2020/20 briefTitle: Heat Application to the Sacral Region and Pain Level During the First Stage of Labor overallStatus: COMPLETED date: 2020-04-01 date: 2021-05-01 date: 2021-05-30 date: 2024-03-06 date: 2024-03-06 name: Istanbul Demiroglu Bilim University class: OTHER briefSummary: The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process. conditions: Heat Exposure conditions: Labor Pain conditions: Apgar Score conditions: Duration of Labor studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 134 type: ACTUAL name: heat application measure: Change From Baseline labor Pain at three times measure: Duration of the first stage of labor measure: Change From Baseline APGAR score after delivery measure: Change From Baseline Fetal Heart Rate sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Demiroglu Bilim University city: Istanbul zip: 34384 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06297018 id: February 18, 2024 briefTitle: Bioenergy, Depression, Anxiety and Stress After Liver Transplantation overallStatus: TERMINATED date: 2024-01-01 date: 2024-02-02 date: 2024-02-09 date: 2024-03-06 date: 2024-03-06 name: Istanbul Aydın University class: OTHER briefSummary: In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Interventional Crossover Assignment primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: Experimental whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ACTUAL name: Bioenergy application measure: Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Semra Bulbuloglu city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06297005 id: 21/FFP-P/10154 briefTitle: The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study acronym: ECHO overallStatus: RECRUITING date: 2023-10-09 date: 2027-08-31 date: 2027-08-31 date: 2024-03-06 date: 2024-04-12 name: University College Dublin class: OTHER name: Royal College of Surgeons, Ireland briefSummary: Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy.
The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age. conditions: Vaping conditions: Pregnancy Related conditions: Pediatric Respiratory Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED measure: Incidence of preterm birth measure: Incidence of low birth weight measure: Incidence of wheeze during the first two years of life measure: Incidence of smoking and vaping measure: Estimated foetal weight measure: Trends in carbon monoxide levels measure: Blood pressure measurements (both diastolic and systolic) measure: Urine cotinine measurements measure: Incidence of maternal cough, wheeze and/or asthma measure: Maternal history of abnormal cervical screening cytology measure: Incidence of pre-eclampsia and/or hypertension during pregnancy measure: Incidence of birth complications measure: Edinburgh postnatal depression score measure: APGAR scores at 1, 5 and 10 minutes after birth measure: Admission to neonatal intensive care measure: Incidence of neonatal complications measure: Neonatal and paediatric anthropometric measurements over first two years of life measure: Neonatal body composition measurements measure: Incidence of respiratory illnesses measure: Number of attendances/admissions to hospital measure: Frequency of prescribed respiratory medications use measure: Barkely Functional Impairment score (BFIS) measure: Early Executive Functions Questionnaire (EEFQ) measure: Infant Behaviour Questionnaire (IBQ) measure: Child Behaviour Checklist (CBCL) measure: Early Childhood Behaviour Questionnaire (ECBQ) measure: Bayley Scales of Infant and Toddler Development (BSID) sex: FEMALE minimumAge: 18 Years maximumAge: 46 Years stdAges: ADULT facility: Rotunda Hospital status: RECRUITING city: Dublin zip: D01 P5W9 country: Ireland name: Adele Reddin, BSc/MSc role: CONTACT email: areddin@rotunda.ie lat: 53.33306 lon: -6.24889 facility: National Maternity Hospital, Holles Street status: RECRUITING city: Dublin zip: D02 YH21 country: Ireland name: Emma Doyle, BSc/MSc role: CONTACT email: emma.doyle@nmh.ie lat: 53.33306 lon: -6.24889 facility: Coombe Womens Hospital status: RECRUITING city: Dublin zip: D08 XW7X country: Ireland name: Eibhlin Cary Healy, MRCPI role: CONTACT email: ehealy@coombe.ie name: Mariapia Dado, BSc/MSc role: CONTACT phone: +35314085571 phoneExt: 4541 email: MDado@coombe.ie lat: 53.33306 lon: -6.24889 hasResults: False
<\|newrecord\|> nctId: NCT06296992 id: B2023:035 briefTitle: Type 1 Diabetes, Exercise and Mentoring Trial acronym: TEAM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-05 date: 2024-03-06 date: 2024-03-06 name: University of Manitoba class: OTHER name: Juvenile Diabetes Research Foundation name: Canadian Institutes of Health Research (CIHR) briefSummary: The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D. conditions: Type 1 Diabetes conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 12-week TEAM peer mentor program measure: Enrollment rates measure: Adherence to the intervention arms measure: Retention for follow-up measurements measure: Physical activity measure: Quality of Life (DQOL) measure: Quality of Life (PedsQL 4.0) measure: Diabetes Distress measure: Mastery measure: Autonomy measure: Motivation for physical activity (LCE) measure: Readiness for change measure: Motivation to engage in exercise measure: Motivation for Physical Activity (EMI-2) sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06296979 id: 0881-N-23 briefTitle: Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity. overallStatus: RECRUITING date: 2024-03-20 date: 2026-12-01 date: 2026-12-01 date: 2024-03-06 date: 2024-04-15 name: University of Seville class: OTHER briefSummary: Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology. conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Phrenic nerve neuromodulation name: common Physical therapy measure: Numeric Pain Rating Scale measure: Algometry measure: Goniometry passive measure: Quick Dash questionnaire measure: Goniometriy active sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Centro de Salud Ronda Histórica status: RECRUITING city: Sevilla zip: 41008 country: Spain name: Deseada López Carballo, Dra role: CONTACT email: deseada.lopez.sspa@juntadeandalucia.es lat: 37.38283 lon: -5.97317 facility: Centro de Salud las Letanías status: RECRUITING city: Sevilla zip: 41013 country: Spain name: Alicia Valero Sáinz role: CONTACT phone: 649532242 phoneExt: +34 email: aliciavalerio@hotmail.com lat: 37.38283 lon: -5.97317 facility: Centro de Salud Bellavista status: RECRUITING city: Sevilla zip: 41014 country: Spain name: María Isabel Morilla Párraga role: CONTACT phone: 609582376 phoneExt: +34 email: fisioaljarafe@gmail.com lat: 37.38283 lon: -5.97317 hasResults: False
<\|newrecord\|> nctId: NCT06296966 id: VP-VSJ-110-2201 briefTitle: A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye overallStatus: RECRUITING date: 2024-02-29 date: 2024-07 date: 2024-07 date: 2024-03-06 date: 2024-03-06 name: Vanda Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye. conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: VSJ-110 name: Placebo measure: Schirmer's Tear Test measure: Ocular Staining measure: Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanda Investigational Site status: RECRUITING city: Andover state: Massachusetts zip: 01810 country: United States name: Vanda Pharmaceuticals Inc. role: CONTACT phone: 202-734-3400 email: clinicaltrials@vandapharma.com lat: 42.65843 lon: -71.137 hasResults: False
<\|newrecord\|> nctId: NCT06296953 id: PeriSaFe01 id: CIV-23-11-044875 type: OTHER domain: Swedish Medical Product Agency briefTitle: Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis acronym: PeriSaFe01 overallStatus: RECRUITING date: 2024-03-15 date: 2024-09-01 date: 2024-12-01 date: 2024-03-06 date: 2024-04-22 name: STB INN AB class: INDUSTRY name: Scandinavian CRO name: Region Halland briefSummary: This will be an explorative, proof-of-principle, open, multi-center investigation.
The investigation aims to investigate the safety of the PERIsign system and the ability of physicians to differentiate between healthy individuals and subjects with involuntary muscle defense as a sign of peritonitis by utilizing PERIsign data. The investigation will include a total of 20 subjects admitted to hospital for suspected appendicitis and planned for emergency surgery and 20 healthy volunteers. Both male and female subjects aged 18-70 years will be enrolled.
All subjects will undergo PERIsign examinations. Subjects with suspected appendicitis will undergo 1-2 PERIsign examinations before their planned appendectomy surgery. For the healthy volunteers, there is only 1 PERIsign examination. During each examination, 4 PERIsign curves will be obtained, one from each quadrant of the abdomen. The attending physician will interpret the appearance of the PERIsign curves of all subjects, including those from the healthy volunteers. The duration of the PERIsign examination will be documented, and usability data will be gathered, including the need for sensor adjustments, subject perception of the examination, and any discomfort experienced. In addition, blinded physicians will evaluate all subjects' PERIsign curves and determine whether each subject has involuntary muscle defense as a sign of peritonitis. These blinded physicians will have access to all 4 PERIsign curves obtained during each examination, while other data will not be disclosed to them.
Safety will be evaluated through analysis of reported adverse events and device deficiencies conditions: Appendicitis Acute conditions: Appendicitis conditions: Abdominal Pain conditions: Peritonitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 40 type: ESTIMATED name: PERIsign examination measure: Proportion of subjects experiencing any adverse events during the examination measure: Proportion of device deficiencies during the evaluation measure: To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system measure: Proportion of examinations of the PERIsign system that its performed without usability issues. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hallands Sjukhus Halmstad status: RECRUITING city: Halmstad country: Sweden name: Cleas Hjalmarsson, Ass. Prof. role: CONTACT name: Åsa Anveden, PhD role: SUB_INVESTIGATOR lat: 56.67446 lon: 12.85676 facility: Hallands Sjukhus Varberg status: RECRUITING city: Varberg country: Sweden name: Claes Hjalmarsson, ass. Prof role: CONTACT name: Stefan Lindskog, ass. prof role: PRINCIPAL_INVESTIGATOR lat: 57.10557 lon: 12.25078 hasResults: False
<\|newrecord\|> nctId: NCT06296940 id: WEST 2.0 briefTitle: Written Exposure in Substance Treatment acronym: WEST overallStatus: RECRUITING date: 2022-12-01 date: 2024-06-15 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Potomac Health Foundations class: OTHER name: University of Maryland, Baltimore County briefSummary: The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone? conditions: Posttraumatic Stress Disorder conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We are conducting a randomized controlled trial of approximately 50 randomized subjects (up to 100 total enrollments) who will be assigned 1:1 to treatment as usual (TAU) or TAU+WET. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Written Exposure Therapy name: Treatment as Usual measure: Efficacy of WET measure: Feasibility of WET delivered in residential SUD treatment context measure: Acceptability of WET delivered in residential SUD treatment context sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maryland Treatment Centers status: RECRUITING city: Baltimore state: Maryland zip: 21229 country: United States name: Kevin Wenzel, PhD role: CONTACT phone: 410-233-1400 email: kwenzel@marylandtreatment.org name: Marc Fishman, MD role: CONTACT phone: 410.233.1400 email: mfishman@marylandtreatment.org lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06296927 id: SumeyyeKose-E.138186 briefTitle: The Effect of the Emotional Freedom Technique on Perceived Pain, Situational Anxiety, Cortisol and Satisfaction Levels in Mammography Screening. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-01 date: 2025-03-01 date: 2024-03-06 date: 2024-03-06 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxiety, salivary cortisol and satisfaction level during mammography screening. conditions: Mammography Screening conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a randomized controlled two-group study. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 76 type: ESTIMATED name: Emotional Freedom Technique measure: Anxiety measure: Pain Level measure: Satisfaction Level measure: Cortisol Level sex: FEMALE minimumAge: 40 Years maximumAge: 50 Years stdAges: ADULT facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center city: Istanbul country: Turkey name: SUMEYYE KOSE role: CONTACT phone: 2163961630 phoneExt: 6173 email: sumeyyekose28@gmail.com name: Sümeyye Köse, Phd Student role: PRINCIPAL_INVESTIGATOR name: Handan Özcan, Assoc.Prof role: PRINCIPAL_INVESTIGATOR name: Türkinaz Aşti, Prof.Dr. role: SUB_INVESTIGATOR name: Fatih Hacımustafaoğlu, Lecturer Dr. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06296914 id: 89776 briefTitle: A mHealth System for Patients With POTS overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Jami Warren class: OTHER briefSummary: Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to "long COVID." POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis. conditions: POTS - Postural Orthostatic Tachycardia Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: POTSapp name: Waitlist Control measure: Change in POTSapp Usability as measured by uMARS measure: Change in POTSapp Usage measure: Change in POTSapp Usability as measured by Health-ITUES measure: Change in POTSapp Effectiveness as measured by Message Effectiveness scale measure: Change in Participant Quality of Life measure: Change in Doctor Patient Communication (DPC) measure: Adapted IBS Perceived Stigma Scale measure: Cognitive Learning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40506 country: United States name: Jami Warren, PhD role: CONTACT phone: 859-323-1100 email: jami.warren@uky.edu lat: 37.98869 lon: -84.47772 hasResults: False
<\|newrecord\|> nctId: NCT06296901 id: 202310353 briefTitle: To Wipe or Not To Wipe?: That Is The Question overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-10 date: 2024-03-06 date: 2024-03-06 name: Joanna A. Orzel class: OTHER briefSummary: The primary aim of this randomized control trial is to characterize whether a mid-stream clean catch sample using a cleansing wipe in the setting of symptomatic UTI in a female patient is associated with a lower rate of contamination. We hypothesize that using a perineal cleansing wipe at the time of a midstream urine sample will decrease rates of contamination for female patients with a symptomatic UTI. conditions: Urinary Tract Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 600 type: ESTIMATED name: Perineal Wipe measure: Rate of Contamination sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06296888 id: P-2022-673 id: 2203718 type: OTHER domain: De Videnskabsetiske Medicinske Komiteer briefTitle: Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome acronym: RABAAF overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-01 date: 2024-03-15 date: 2024-08-09 date: 2024-03-06 date: 2024-03-06 name: Jim Hansen class: OTHER name: University Hospital, Gentofte, Copenhagen name: Biosense Webster, Inc. briefSummary: Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.
Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.
A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.
In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ACTUAL name: Radiofrequency balloon catheter ablation measure: Proportion of durably isolated PVs observed at repeat EP study measure: Proportion of patients with durable isolation of all PVs observed at repeat EP study measure: Proportion of patients remaining free from recurrence of ATA after the initial PVI measure: Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI measure: Complications measure: Proportion of patients remaining free from recurrence of ATA after the repeat EP study measure: Difference in the effect of AF related symptoms on quality of life between baseline, after the initial PVI, and after the repeat EP study sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gentofte Hospital city: Hellerup zip: 2820 country: Denmark lat: 55.73204 lon: 12.57093 hasResults: False
<\|newrecord\|> nctId: NCT06296875 id: KAMM briefTitle: The Krill Ageing Muscle Mechanisms (KAMM) Study acronym: KAMM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-06 date: 2024-03-08 name: University of Glasgow class: OTHER briefSummary: This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oil
Objective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length).
Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy.
Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 parallel group design primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: All supplements will be matched for taste and look whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Vegetable oil name: Krill oil measure: Grip strength measure: Neuromuscular junction transmission instability measure: Gait speed measure: Knee extensor maximal torque measure: Vastus lateralis muscle cross sectional area measure: Vastus lateralis pennation angle measure: Vastus lateralis fascicle length measure: Erythrocyte fatty acid composition measure: Knee extensor force steadiness measure: Vastus lateralis motor unit conduction velocity measure: Vastus lateralis and vastus medialis intramuscular coherence measure: Hand flexor muscles intermuscular coherence measure: Cortico-muscular coherence between sensory motor cortex and hand extensor muscles measure: Femoral Nerve Stimulation measure: Transcranial Magnetic Stimulation (TMS) measure: TMS Inhibition measure: TMS Excitation measure: Gait characteristics during 4m walk test and the timed up and go test measure: Gait cycle with leg support parameters sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: University of Glasgow city: Glasgow country: United Kingdom lat: 55.86515 lon: -4.25763 hasResults: False
<\|newrecord\|> nctId: NCT06296862 id: STUDY00005563 briefTitle: Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-06 date: 2024-03-06 date: 2024-03-06 name: University of Georgia class: OTHER name: Emory University briefSummary: The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Dietary Approaches to Stop Hypertension Diet measure: B-natriuretic peptide (BNP) measure: N-terminal-proBNP (NT-proBNP) measure: Systolic and Diastolic Pulmonary Artery Pressures sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT facility: Emory Clinical Cardiovascular Research Center (ECCRI) city: Atlanta state: Georgia zip: 30322 country: United States name: Arshed A Quyyumi, MD, PhD role: CONTACT phone: 404-727-6635 email: quyyum@emory.edu lat: 33.749 lon: -84.38798 hasResults: False
<\|newrecord\|> nctId: NCT06296849 id: 00007344 briefTitle: Dyadic Financial Incentive Treatments for Dual Smoker Couples overallStatus: RECRUITING date: 2024-01-18 date: 2028-05 date: 2028-05 date: 2024-03-06 date: 2024-03-12 name: University of Georgia class: OTHER name: McMaster University name: University of Kentucky briefSummary: Smokers partnered with other smokers (i.e., dual-smoker couples) represent \~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.
The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population. conditions: Smoking, Cigarette studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 900 type: ESTIMATED name: Financial Incentive Treatment (FIT) measure: Point-Prevalence Abstinence at End of Treatment measure: Point-Prevalence Abstinence After Treatment measure: Point-Prevalence Abstinence at First Follow-up measure: Point-Prevalence Abstinence at Second Follow-up measure: Partner Point-Prevalence Abstinence measure: Smoking Heaviness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Georgia status: RECRUITING city: Athens state: Georgia zip: 30602 country: United States name: Michelle R vanDellen, PhD role: CONTACT email: mvd@uga.edu lat: 33.96095 lon: -83.37794 hasResults: False
<\|newrecord\|> nctId: NCT06296836 id: 2024-001 briefTitle: Effect of Continuing Versus Holding Metformin During Hospitalizations. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-06-30 date: 2024-03-06 date: 2024-03-06 name: University of Illinois at Chicago class: OTHER name: Emily Hanners name: Dulal Bhaumik name: Avisek Datta name: Peggy Choye name: Hailey Soni name: Annesti Elmasri name: Julie Jun name: Colin Goodman briefSummary: A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, parallel, prospective trial. primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Metformin measure: Mean glucose levels measure: Incidence of hyperglycemia greater than 300 mg/dl. measure: Incidence of hypoglycemia (Glu = 54 - 70). measure: Incidence of moderate hypoglycemia (Glu < 54) measure: Incidence of severe hypoglycemia (Glu < 54 with symptoms) measure: Mean lactic acid levels. measure: Incidence of lactic acid levels greater than 2.0. measure: Mean anion gap. measure: Incidence of anion gap > 11 measure: Incidence of elevated lactic acid level or anion gap. measure: Incidence of inadvertently not continuing metformin on discharge measure: GI adverse effects measure: Mortality measure: Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60612 country: United States lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06296823 id: 22-0466 briefTitle: Biomarkers for Peripheral Circadian Clocks in Humans overallStatus: RECRUITING date: 2023-09-01 date: 2027-08-31 date: 2027-08-31 date: 2024-03-06 date: 2024-03-06 name: University of Colorado, Boulder class: OTHER name: University of Colorado, Denver briefSummary: The purpose of this project is to improve our understanding of peripheral circadian rhythms in humans. Circadian clocks are present in most tissues of the body with importance for optimal physiological function, health, and behavior. This project will utilize simulated jetlag protocols to systematically test novel hypotheses about the regulation of peripheral circadian rhythms in humans. Specifically, we will examine how changes in the time of when we are exposed to light and the timing of when we eat impacts proteins in the blood and saliva that represent rhythms from clocks in the brain (e.g., rhythms of the hormones melatonin and cortisol coordinated by the brain) and rhythms from clocks in body tissues (e.g., proteins made by immune and bone cells, and cells in the stomach and liver). We also aim to discover new blood-based biomarkers of peripheral rhythms in humans. We anticipate our findings will be the first step in developing novel circadian based treatments for aligning peripheral clocks under conditions such as jetlag, and for developing novel circadian biomarkers that will advance our scientific understanding of circadian rhythms. conditions: Circadian Rhythms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: Simulated jetlag protocol measure: PYY measure: Ghrelin measure: Leptin measure: CRP measure: OMD measure: PAI-1 measure: IgE measure: CCL18 measure: PTH measure: Glucose measure: Insulin measure: Proteomics measure: Melatonin measure: Cortisol measure: Core body temperature measure: Skin temperature measure: Cognition measure: Blood pressure measure: Metabolomics (grant application planned to analyze not currently funded) measure: Oral microbiome (grant application planned to analyze not currently funded) measure: Skin microbiome (grant application planned to analyze not currently funded) sex: ALL minimumAge: 17 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Sleep and Chronobiology Laboratory status: RECRUITING city: Boulder state: Colorado zip: 80303 country: United States name: Kenneth Wright role: CONTACT phone: 303-735-1923 email: sleep.study@colorado.edu lat: 40.01499 lon: -105.27055 hasResults: False
<\|newrecord\|> nctId: NCT06296810 id: 23-0847 briefTitle: Adaptive DBS to Offset STN Dysregulation During Exercise in PD overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-03-06 date: 2024-03-06 name: University of Colorado, Denver class: OTHER briefSummary: The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: aDBS measure: identification of L-beta frequency peak power sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06296797 id: 5R18HS029432-02 type: AHRQ link: https://reporter.nih.gov/quickSearch/5R18HS029432-02 id: R18HS029432 type: AHRQ link: https://reporter.nih.gov/quickSearch/R18HS029432 briefTitle: Patient-centered Information on Permanent Contraception overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-06 date: 2024-03-06 name: University of California, San Francisco class: OTHER name: Essential Access Health name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives.
Participants will:
* Complete a baseline survey
* Receive access to web-based educational resources
* Complete a brief follow up survey immediately after exploring these web-based resources
* Complete a follow-up survey 3 months after enrolling
The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization. conditions: Contraception conditions: Reproductive Behavior conditions: Contraception Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: Control arm: Existing educational website name: Advancing Access Website measure: Perceived Access to Long Acting Contraceptives measure: Person-Centered Contraceptive Counseling Measure measure: Consumer Assessment of Healthcare Providers and Systems measure: Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI) measure: Knowledge of Long-Acting Contraceptives measure: Use of preferred method of contraception measure: Would recommend website to a friend measure: Suggestions for how to improve web-based resources for people considering permanent contraception. sex: FEMALE minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Eleanor Schwarz, MD, MS role: CONTACT email: eleanor.schwarz@ucsf.edu name: Hannah Begna, MS role: CONTACT email: hannah.begna@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False
<\|newrecord\|> nctId: NCT06296784 id: PG/2021/8551 briefTitle: An E-health Psychoeducation for People With Bipolar Disorders overallStatus: COMPLETED date: 2021-05-26 date: 2021-11-15 date: 2021-11-15 date: 2024-03-06 date: 2024-04-05 name: University of Cagliari class: OTHER name: Alessandra Perra briefSummary: This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic conditions: Bipolar Disorder conditions: Psychoeducation conditions: COVID-19 Pandemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Open-label cross-over randomized controlled trial (two arms) primaryPurpose: TREATMENT masking: NONE count: 36 type: ACTUAL name: e-health psychoeducation measure: Generalized Anxiety Disorder (GAD-7) measure: Hamilton Depression Rating Scale (HDRS21) measure: Short Form Health Survey (SF-12) measure: Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Giovanni di Dio Hospital city: Cagliari state: CA zip: 09100 country: Italy lat: 39.23054 lon: 9.11917 hasResults: False
<\|newrecord\|> nctId: NCT06296771 id: 12345678280233 id: UBath type: REGISTRY domain: Chatwalai briefTitle: The Effect of a Combined Aerobic and Resistance Exercise (CARE) Training Programme on Cardiometabolic Outcomes in Individuals With Chronic Spinal Cord Injury: A Randomised Controlled Trial acronym: CARE training overallStatus: NOT_YET_RECRUITING date: 2024-05-22 date: 2025-02-22 date: 2025-05-22 date: 2024-03-06 date: 2024-03-06 name: University of Bath class: OTHER briefSummary: The goal of this study is to investigate the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on the cardiometabolic health outcomes of individuals with chronic spinal cord injury. This study is a randomised controlled trial conducted at a single centre, consisting of two parallel arms. The main questions it aims to answer are:
1. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on cardiometabolic disease biomarker outcomes in individuals with chronic SCI

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