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<\|newrecord\|> nctId: NCT06296238 id: 2023P000461 briefTitle: Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia overallStatus: ENROLLING_BY_INVITATION date: 2023-02-15 date: 2024-06 date: 2025-02 date: 2024-03-06 date: 2024-03-06 name: Brigham and Women's Hospital class: OTHER name: Addis Continental Institute of Public Health name: Boston Children's Hospital name: New York University briefSummary: The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.
Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.
The main questions it aims to answer are:
1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?
2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?
3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?
We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age. conditions: Prenatal Exposure Delayed Effects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Visual Evoked Potential (VEP) P1 Latency measure: EEG Functional Connectivity measure: Cecile Attention Task measure: Infant Head Circumference measure: Bayley III, Cognition measure: MAAP - Accuracy and Speed measure: Hammersmith Infant Neurological Exam (HINE) sex: ALL minimumAge: 9 Months maximumAge: 27 Months stdAges: CHILD facility: Harvard Medical School city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Addis Continental Institute of Public Health city: Addis Ababa country: Ethiopia lat: 9.02497 lon: 38.74689 hasResults: False
<\|newrecord\|> nctId: NCT06296225 id: CHRO-2023-07 briefTitle: Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase acronym: VIBRAMAIN1 overallStatus: RECRUITING date: 2024-03-05 date: 2025-09-01 date: 2025-12-01 date: 2024-03-06 date: 2024-03-19 name: Centre Hospitalier Régional d'Orléans class: OTHER briefSummary: It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.
The investigations will be carried out by a specialized physiotherapist from the neurology department.
The experiment consists of three successive phases:
* First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.
* Second : Rest period
* Third: control phase with measurement of the maximum grip force every ten minutes without vibration. conditions: Stroke conditions: Stroke, Acute conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Vibration measure: Maximum handgrip strength measured by a digital dynamometer measure: Fatigue evolution measure: Evolution of handgrip strength during the vibration session measured by a digital dynamometer sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH de Chartres status: NOT_YET_RECRUITING city: Chartres country: France name: Valentin BOHOTIN, Dr role: CONTACT email: vbohotin@ch-chartres.fr name: Valentin BOHOTIN, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.44685 lon: 1.48925 facility: CHU d'ORLEANS status: RECRUITING city: Orleans zip: 45067 country: France name: Canan OZSANCAK, Ph role: CONTACT email: canan.ozsancak@chu-orleans.fr name: Andreea AIGNATOAIE, Ph role: PRINCIPAL_INVESTIGATOR lat: 47.90289 lon: 1.90389 facility: Hopital Pitie Salpetriere status: NOT_YET_RECRUITING city: Paris country: France name: Charlotte ROSSO, Pr role: CONTACT email: charlotte.rosso@aphp.fr name: Charlotte ROSSO, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CHU de Tours status: NOT_YET_RECRUITING city: Tours country: France name: Marco PASI, Dr role: CONTACT email: m.pasi@chu-tours.fr name: Marco PASI, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.38333 lon: 0.68333 hasResults: False
<\|newrecord\|> nctId: NCT06296212 id: GLT-07-22 briefTitle: Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2025-09-30 date: 2024-03-06 date: 2024-03-06 name: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica class: INDUSTRY briefSummary: The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia.
The main question it aims to answer is:
• could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia?
Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment.
Eligible patients who meet the study inclusion criteria and complete the required Screening \& Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI \& Patient blinded.
TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered:
* intravenously (with an infusion rate of 10 mL/min)
* 2 times a day (with a dosing interval of 8 hours ± 30 minutes)
* for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5)
* patients will then be required to undergo five Follow-up Visits. conditions: Pneumonia conditions: Myocardial Injury studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 178 type: ESTIMATED name: TAD® 600 mg/4 mL powder and solvent for solution for injection name: Saline solution 0.9% of sodium chloride measure: Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria Pisana city: Pisa state: PI zip: 56126 country: Italy name: Massimiliano Desideri role: CONTACT lat: 43.70853 lon: 10.4036 facility: Fondazione Policlinico Universitario Campus Bio-Medico city: Roma state: RM zip: 00128 country: Italy name: Francesco Grigioni role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata city: Roma state: RM zip: 00133 country: Italy name: Francesco Barillà role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I city: Roma state: RM zip: 00161 country: Italy name: Pasquale Pignatelli role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Sant'Andrea city: Roma state: RM zip: 00189 country: Italy name: Alberto Ricci role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliera Santa Maria city: Terni state: TR zip: 05100 country: Italy name: Giacomo Pucci role: CONTACT lat: 42.56335 lon: 12.64329 facility: Ospedale Ca' Foncello city: Treviso state: TV zip: 31100 country: Italy name: Marcello Rattazzi role: CONTACT lat: 45.66673 lon: 12.2416 hasResults: False
<\|newrecord\|> nctId: NCT06296199 id: 2024-2064 briefTitle: Music, Virtual Reality for Inpatients in IUGM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-05 date: 2024-03-06 date: 2024-03-06 name: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal class: OTHER_GOV briefSummary: Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.
Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety. conditions: Aging conditions: Disorder, Neurologic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: VR name: Music only measure: Feasability measure: Emotions variation measure: Affect variation measure: Well-Being Variation measure: Quality of life variation measure: Anxiety variation sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06296186 id: HT94252310669 briefTitle: Massed Prolonged Exposure for PTSD in Substance Use Treatment acronym: PREVAIL overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-07 date: 2027-08 date: 2024-03-06 date: 2024-03-06 name: Veterans Medical Research Foundation class: OTHER name: University of Minnesota name: Center for Veterans Research and Education briefSummary: The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:
* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?
* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week. conditions: Stress Disorders, Post-Traumatic conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Prolonged Exposure Therapy measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) measure: Time Line Follow back (TLFB) measure: Psychotherapy Completion Rates measure: Patient Health Questionnaire-9 (PHQ-9) measure: Brief Psychosocial Functioning Inventory (B-IPF) measure: Client Satisfaction Questionnaire-8 (CSQ-8) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA San Diego Healthcare System city: San Diego state: California zip: 92161 country: United States name: Sonya Norman, PhD role: CONTACT phone: 858-518-8266 email: sonya.norman@va.gov lat: 32.71533 lon: -117.15726 facility: VA Tampa Healthcare System city: Tampa state: Florida zip: 33612 country: United States name: Brittany Davis, PhD role: CONTACT phone: 813-972-2000 email: brittany.davis@va.gov lat: 27.94752 lon: -82.45843 facility: VA Atlanta Healthcare System city: Atlanta state: Georgia zip: 30033 country: United States name: Kristin Lamp, PhD role: CONTACT email: kristen.lamp@va.gov lat: 33.749 lon: -84.38798 facility: Hines VA Healthcare System city: Chicago state: Illinois zip: 60141 country: United States name: Jonathan Bayer, PhD role: CONTACT email: jonathan.bayer2@va.gov lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06296173 id: MP-02-2024-12094 briefTitle: Open Lung Protective Extubation Following General Anesthesia acronym: OLEXT-3 overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-01 date: 2026-04-01 date: 2024-03-06 date: 2024-03-06 name: Centre hospitalier de l'Université de Montréal (CHUM) class: OTHER name: CHU de Quebec-Universite Laval name: The Ottawa Hospital name: University Health Network, Toronto name: Canadian Institutes of Health Research (CIHR) briefSummary: Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.
Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications. conditions: Intra-abdominal Surgery conditions: Anesthesia conditions: Lung Injury conditions: Ventilator-Induced Lung Injury conditions: Atelectasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: During surgical closure, the definitive ARISCAT score and exclusion criteria will be assessed. Patients will be randomized equally (1:1) using web-based allocation-concealed methods, with stratification by center and ARISCAT risk category. An unblinded research assistant will reveal group allocation to the anesthesiologist and monitor the emergence procedure. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Until surgical closure, all will be blinded to treatment allocation. Only specific healthcare professionals (anesthesiologist, respiratory therapist, operating room nurses, unblinded research assistant) will be present during emergence to maintain blinding. Other healthcare team members will remain blinded. Outcome adjudicators, Executive and Steering committee members, and the data analyst will also be blinded. No mechanism for unblinding is planned, as both interventions follow the same diagnostic and treatment algorithms for adverse effects. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: Protective "open-lung" extubation name: Conventional extubation measure: Average weekly patient recruitment rate measure: Protocol adherence rate measure: Postoperative pulmonary complications outcome completion rate measure: Accuracy of self-reported protocol adherence compared to directly observed protocol adherence measure: Postoperative pulmonary complications measure: Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit measure: Quality of recovery measure: Discharge disposition measure: Days alive and out of hospital measure: Health-related quality of life measure: Lowest oxygen saturation post-extubation in the operating room measure: Time in minutes with oxygen saturation < 85% post-extubation in the operating room measure: Re-intubation rate in the operating room and in the post-anesthesia care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ottawa Hospital city: Ottawa state: Ontario zip: K1H 8L6 country: Canada name: Daniel I. McIsaac, MD role: CONTACT phone: 613-761-4940 email: dmcisaac@toh.ca name: Manoj Lalu, MD role: CONTACT email: mlalu@toh.ca name: Daniel I. McIsaac, MD role: PRINCIPAL_INVESTIGATOR name: Manoj Lalu, MD role: SUB_INVESTIGATOR lat: 45.41117 lon: -75.69812 facility: Unity Health Network city: Toronto state: Ontario zip: M5B 1W8 country: Canada name: Michael C. Sklar, MD role: CONTACT phone: 416-864-5071 email: michael.sklar@mail.utoronto.ca name: Ashwin Sankar, MD role: CONTACT email: ashwin.sankar@mail.utoronto.ca name: Michael C. Sklar, MD role: PRINCIPAL_INVESTIGATOR name: Ashwin Sankar, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre Hospitalier de l'Université de Montréal (CHUM) city: Montréal state: Quebec zip: H2X 0C1 country: Canada name: Martin Girard, MD role: CONTACT phone: 514-890-8000 email: martin.girard@umontreal.ca name: Eva Amzallag, MSC role: CONTACT phone: 514-890-8000 email: eva.amzallag.chum@ssss.gouv.qc.ca name: Michael Chassé, MD role: SUB_INVESTIGATOR name: François Martin Carrier, MD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: CHU de Québec - Université Laval city: Québec zip: G1V 4G2 country: Canada name: Alexis F. Turgeon, MD role: CONTACT phone: 418-525-4444 phoneExt: 66058 email: alexis.turgeon@fmed.ulaval.ca name: Michael Verret, MD role: CONTACT phone: 418-525-4444 phoneExt: 66847 email: michael.verret.med@ssss.gouv.qc.ca name: Alexis F. Turgeon, MD role: PRINCIPAL_INVESTIGATOR name: Michael Verret, MD role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False
<\|newrecord\|> nctId: NCT06296160 id: MRC-01-23-035 id: LUSAM-HD type: OTHER_GRANT domain: COMITE D'ETHIQUE du CHU BRUGMANN c/o Direction Médicale briefTitle: A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis overallStatus: RECRUITING date: 2023-05-28 date: 2024-05-22 date: 2024-05-22 date: 2024-03-06 date: 2024-03-06 name: Hamad Medical Corporation class: INDUSTRY name: Brugmann University Hospital briefSummary: Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will compare two groups according to the dry weight determination method:
(1) Control arm- modification of dry weight according to standardized care only. The standard of care to modify dry weight is what nephrologists use actually to define the best theoretical dry weight, including clinical (blood pressure, edema, shortness of breath, lung auscultation, etc.) and laboratory measures (Protein concentration before and after dialysis sessions ...). (2) Intervention arm- modify patient's dry weight according to standard of care + B lines score on lung ultrasound BLS obtained after the midweek dialysis session, considered as Day one (Day 1) primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: It is a single-blinded trial as the treatment is blinded by Subjects only, meaning that the type of dry weight modification will not be disclosed to the subject, and they will not know which group he/she will be in at the time of consenting to limit the bias in opinion. The investigator and the research team must know the type of treatment, as the investigator will modify the dry weight according to the treatment group. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Intervention Group measure: Assess the effectiveness of adding B-line score evaluation through lung ultrasound to the standard of care to improve pulmonary congestion (measured by B lines score) in hemodialysis patients measure: The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure. measure: The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaysi Saleh status: RECRUITING city: Bruxelles state: Van Gehuchten zip: 1020 country: Belgium name: Nortier Joelle, PHD role: CONTACT phone: +33643250634 email: saleh.kaysi@chu-brugmann.be lat: 50.85045 lon: 4.34878 hasResults: False
<\|newrecord\|> nctId: NCT06296147 id: STUDY23080006 briefTitle: Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy overallStatus: RECRUITING date: 2024-03-10 date: 2024-11-01 date: 2024-11-01 date: 2024-03-06 date: 2024-03-06 name: University of Pittsburgh class: OTHER briefSummary: The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 208 type: ESTIMATED name: Virtual Reality Headset name: Aromatherapy Patch name: Standard of Care measure: Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure. measure: Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure. measure: Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure. measure: Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure. measure: Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh Medical Center Shadyside Hospital status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Divya Natesan, BS role: CONTACT email: din15@pitt.edu name: John Myrga, MD role: CONTACT email: myrgajm@upmc.edu name: Bruce Jacobs, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06296134 id: 17501 briefTitle: Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation acronym: CO-LAM23 overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-06 name: Azienda Sanitaria Universitaria Friuli Centrale class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation. conditions: Pelvic Floor Disorders conditions: Levator Ani Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: perineal massage measure: Comparison of the percentages of women without levator ani muscle co-activation after treatment or after standard care, evaluated at 37-38 weeks of gestation, using chi square test. measure: Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups measure: percentage of women who completely adhere to perineal massage, i.e. who perform the perineal massage once a day, at least 5 days a week, from 34 gestational weeks until delivery. sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Serena Xodo city: Udine zip: 33100 country: Italy name: Serena Xodo role: CONTACT phone: 0432-559699 email: serena.xodo@gmail.com lat: 46.0693 lon: 13.23715 hasResults: False
<\|newrecord\|> nctId: NCT06296121 id: BCD-264-2 briefTitle: A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma acronym: DARVIVA overallStatus: RECRUITING date: 2023-12-21 date: 2025-01 date: 2026-07 date: 2024-03-06 date: 2024-03-06 name: Biocad class: INDUSTRY briefSummary: The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 252 type: ESTIMATED name: BCD-264 name: Darzalex measure: Overall response rate according to IMWG (International Myeloma Working Group) criteria measure: Stringent complete response rate according to IMWG criteria measure: Complete response (CR) rate according to IMWG criteria measure: Very good partial response (VGPR) rate according to IMWG criteria measure: Duration of response measure: Progression-free survival measure: Time to progression measure: Time to response measure: Overall survival measure: Incidence and characteristics of adverse events measure: Proportion of subjects with BAbs/Nabs measure: Time to BAb/NAb development measure: AUC0-168 measure: AUC0-∞ measure: AUC0-336, ss measure: Cmax measure: Cmax, ss measure: Tmax measure: T1/2 measure: Vd measure: Ctrough, ss sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chelyabinsk Regional Clinical Hospital status: RECRUITING city: Chelyabinsk country: Russian Federation name: Alexander Korobkin role: CONTACT phone: +7 (351) 749-37-10 email: chelokb@mail.ru lat: 55.15402 lon: 61.42915 facility: Sverdlovsk Regional Clinical Hospital No. 1 status: RECRUITING city: Ekaterinburg country: Russian Federation name: Tatiana Konstantinova role: CONTACT phone: +7 (343) 363-03-03 email: sokbinfo@mail.ru lat: 56.8519 lon: 60.6122 facility: Kuzbass Regional Clinical Hospital named after S.V. Belyaev status: RECRUITING city: Kemerovo country: Russian Federation name: Marina Kosinova role: CONTACT phone: 8(384-2)39-65-33 email: o5-guz-kokb@kuzdrav.ru lat: 55.33333 lon: 86.08333 facility: Regional Clinical Hospital status: RECRUITING city: Krasnoyarsk country: Russian Federation name: Elena Martynova role: CONTACT phone: +7 (391) 202-68-50 email: kkb@medgorod.ru lat: 56.01839 lon: 92.86717 facility: Moscow City Clinical Hospital 52 status: RECRUITING city: Moscow country: Russian Federation name: Elena Misyurina role: CONTACT phone: +7 (495) 870-36-04 email: gkb52international@gmail.com lat: 55.75222 lon: 37.61556 facility: S.P. Botkin Moscow City Clinical Hospital status: RECRUITING city: Moscow country: Russian Federation name: Vadim Doronin role: CONTACT phone: +7 495 945 9972 email: botkinhospital@zdrav.mos.ru lat: 55.75222 lon: 37.61556 facility: Almazov National Medical Research Centre status: RECRUITING city: Saint Petersburg country: Russian Federation name: Yuri Osipov role: CONTACT phone: +7 (812) 660-37-06 email: fmrc@almazovcentre.ru lat: 59.93863 lon: 30.31413 facility: N.N. Petrov National Medicine Research Center of oncology status: RECRUITING city: Saint Petersburg country: Russian Federation name: Ilya Zyuzgin role: CONTACT phone: +7(812)43-99-555 email: oncl@rion.spb.ru lat: 59.93863 lon: 30.31413 facility: Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency status: RECRUITING city: Saint Petersburg country: Russian Federation name: Sergei Voloshin role: CONTACT phone: +78123097982 email: bloodscience@mail.ru lat: 59.93863 lon: 30.31413 facility: St Petersburg State I.P. Pavlov Medical University status: RECRUITING city: Saint Petersburg country: Russian Federation name: Ivan Moiseev role: CONTACT phone: (812) 338 67 48 email: opmu@spb-gmu.ru lat: 59.93863 lon: 30.31413 facility: State budgetary healthcare institution Leningrad Regional Clinical Hospital status: RECRUITING city: Saint Petersburg country: Russian Federation name: Margarita Ulyanova role: CONTACT phone: 8 (812) 670-18-88 email: lokb@47lokb.ru lat: 59.93863 lon: 30.31413 facility: Samara State Medical University status: RECRUITING city: Samara country: Russian Federation name: Igor Davydkin role: CONTACT phone: 8 (846) 374-91-00 email: clinica@samsmu.ru lat: 53.20007 lon: 50.15 facility: Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory status: RECRUITING city: Sochi country: Russian Federation name: Dmitrii Kirtbaya role: CONTACT phone: (862) 261-43-89 email: onko13@sochi.com lat: 43.59917 lon: 39.72569 facility: Bashkir State Medical University status: RECRUITING city: Ufa country: Russian Federation name: Bulat Bakirov role: CONTACT phone: 8 (347) 272-41-73 email: rectorat@bashgmu.ru lat: 54.74306 lon: 55.96779 hasResults: False
<\|newrecord\|> nctId: NCT06296108 id: I05-310-22 briefTitle: Risk Factors for Acute Kidney Injury in Patients Undergoing Arthroplasty overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-31 date: 2022-12-31 date: 2024-03-06 date: 2024-03-06 name: Ankara University class: OTHER briefSummary: The authors aimed to determine the risk factors associated with postoperative acute kidney injury in patients undergoing total joint arthroplasty. conditions: Postoperative Acute Kidney Injury conditions: Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 911 type: ACTUAL name: acute kidney injury measure: Acute kidney injury in patients undergoing arthroplasty surgery measure: Risk factors causing acute kidney injury in patients undergoing arthroplasty surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University Medical School Anesthesiology and ICU Department city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06296095 id: KDS-CUD-1 briefTitle: To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis overallStatus: ENROLLING_BY_INVITATION date: 2023-08-09 date: 2024-10-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis conditions: Cirrhosis, Liver studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Cell therapy measure: DLT,MTD measure: fibrosis staging and inflammatory grading measure: All-cause mortality measure: TE（Transient elastography） measure: MELD（Model for End-stage Liver Disease） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui province hospital city: Hefei state: Anhui zip: 230000 country: China lat: 31.86389 lon: 117.28083 hasResults: False
<\|newrecord\|> nctId: NCT06296082 id: 49317 briefTitle: Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial acronym: STROKEPOC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2027-06-30 date: 2024-03-06 date: 2024-03-06 name: Universiteit Antwerpen class: OTHER name: McGill University name: Aragon Institute of Health Sciences briefSummary: Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeks
Trial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in \~30° flexion; 7) being able to walk independently with or without aids.
Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up.
The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities. conditions: Stroke conditions: Spasticity as Sequela of Stroke studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Each group will be assessed equally during the 19 weeks of the study duration. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participant will be randomized but ultimately will know which treatment he/she receives. A distinct investigator/assessor and intervention therapist wil be selected to treat or assess the participant whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Botulinum toxin type A name: Dry Needling measure: tonic stretch reflex threshold measure: Passive Resistance measure: Ultrasound Imaging: Morphometric Analysis measure: Ultrasound Imaging: Eco-textural Analysis of Muscle: measure: Dynamometry measure: Gait Analysis measure: 10 Meter Walk Test (10MWT) measure: Timed up and Go Assessment (TUG) measure: Quality of Life EuroQoL 5D measure: EQ visual analogue scale (EQ VAS) measure: Cost-effectiveness measure: Patient Acceptance measure: Frequency and Severity of Adverse Events for DN and BTX A measure: Sample size measure: Sample size and drop out sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06296069 id: SwingIT-stroke briefTitle: Exergames on an Unstable Surface in Stroke Inpatients overallStatus: RECRUITING date: 2024-02-28 date: 2024-07-31 date: 2024-07-31 date: 2024-03-06 date: 2024-04-17 name: Eleftheria Giannouli class: OTHER briefSummary: Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.
This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: exergame-based cognitive-motor training on an unstable surface name: exergame-based cognitive-motor training on an stable surface measure: Security incidents measure: Attrition rate measure: Adherence rate measure: Usability measure: Training Load measure: Enjoyment measure: User experience measure: Training Goals measure: Changes in cognitive flexibility measure: Changes in psychomotor speed measure: Changes in selective attention measure: Changes in inhibition and brain activity measure: Changes in functional mobility measure: Changes in coordination measure: Changes in dynamic balance measure: Changes in static balance measure: Changes in gait measure: Changes in leg proprioception measure: Changes in balance confidence measure: Changes in gait confidence sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rehaklinik Zihlschlacht status: RECRUITING city: Zihlschlacht-Sitterdorf state: Thurgau zip: 8588 country: Switzerland name: Detlef Marks role: CONTACT phone: 071 424 37 51 lat: 47.51401 lon: 9.26776 hasResults: False
<\|newrecord\|> nctId: NCT06296056 id: SDH-combi briefTitle: Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2027-06-01 date: 2024-03-06 date: 2024-03-06 name: Nyamdavaa Tuul class: OTHER briefSummary: To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions. conditions: Colorectal Cancer Stage IV conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Combi measure: Number of Patients with grade 1-5 adverse events and list of adverse event frequency measure: immune response measure: potential efficacy sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06296043 id: SBU-FUT-01 briefTitle: The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-07-15 date: 2024-08-15 date: 2024-03-06 date: 2024-04-01 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome. conditions: Premenstrual Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three groups with su-jok group, progressive muscle relaxation exercise group and control group primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Double (Participant, Outcomes Assessor) Since the application will be performed by the researcher, participant will be blinded in this study. The statistician will be blinded in the evaluation of the data. whoMasked: PARTICIPANT count: 135 type: ESTIMATED name: Progressive Muscle Relaxation Exercise Group name: Su-Jok Intervention measure: PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10) measure: Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined). sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06296030 id: 22-0010 briefTitle: Culturally Tailored ACT for Black Trauma overallStatus: WITHDRAWN date: 2021-09-01 date: 2022-09-01 date: 2023-08-31 date: 2024-03-06 date: 2024-03-06 name: Azusa Pacific University class: OTHER briefSummary: Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.
Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:
Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.
Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.
The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact. conditions: Stress Disorders, Traumatic conditions: Anxiety conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This project's research design is a two-by-two factorial design. Factor one, the type of ACT intervention delivered, has two levels - POOF delivery (level 1) and a classic ACT delivery (level 2). Factor two, the facilitator's first group treatment delivery, also has two levels. There are four (4) group facilitators. The first two facilitators deliver traditional ACT first (level 1), and the second two facilitators deliver POOF first (level 2). Each facilitator providing group treatment will facilitate two groups (classic and POOF), one after the next. However, facilitators will be randomized to the order in which they deliver their first group to reduce experimenter/ clinician history bias. All of the facilitators are licensed, mental health clinicians. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 0 type: ACTUAL name: POOF ACT program name: Classic ACT program measure: Race-Based Traumatic Stress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azusa Pacific University city: Azusa state: California zip: 91702 country: United States lat: 34.13362 lon: -117.90756 hasResults: False
<\|newrecord\|> nctId: NCT06296017 id: AEŞH- EK1- 2023-115 briefTitle: Effectiveness of Conservative Interventions in the Treatment of Trigger Finger overallStatus: RECRUITING date: 2023-10-02 date: 2024-09 date: 2024-12 date: 2024-03-06 date: 2024-04-29 name: Hacettepe University class: OTHER briefSummary: There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF. conditions: Trigger Finger conditions: Stenosing Tenosynovitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Experimental: Extracorporeal Shock Wave Therapy name: Trigger Finger Splint name: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint measure: Visual analog scale measure: Grip and pinch strength measure: Number of trigger measure: Functional assessment measure: Treatment satisfaction measure: Functional assessment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Feray Karademir status: RECRUITING city: Ankara zip: 06100 country: Turkey name: Feray Karademir role: CONTACT phone: 90 505 313 75 82 email: karademirferay@gmail.com name: Feray Karademir role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06296004 id: CAPILLAROSCOPY behcet disease briefTitle: Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-03-06 date: 2024-03-06 name: Assiut University class: OTHER briefSummary: Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease conditions: Behçet's Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S measure: measuring parameter of Nail Fold Capillaroscopy in behcet disease measure: measuring parameter of Optical Coherence Tomography Angiography in behcet disease measure: measuring parameter of Femoral Vein Wall Thickness in behcet disease measure: relation between Nail Fold Capillaroscopy and activity of behcet disease measure: relation between Optical Coherence Tomography Angiography and activity of behcet disease measure: relation between Femoral Vein Wall Thickness and activity of behcet disease sex: ALL minimumAge: 19 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295991 id: 2023/005 briefTitle: The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-21 date: 2024-07-30 date: 2024-03-06 date: 2024-03-06 name: Hacettepe University class: OTHER briefSummary: The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals. conditions: Balanced; Rearrangement conditions: Respiratory Function Test studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Lycra garment measure: Balance parameters measure: Respiratory functions measure: Respiratory muscle strength measurement measure: Gross motor function measurement measure: Functional independence assessment measure: Assessment of activity restriction measure: Quality of life assessment measure: Assessment of posture sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295978 id: 4896 briefTitle: Multimarker Approach in Acute Chest Pain overallStatus: RECRUITING date: 2021-02-01 date: 2024-05-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.
The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation. conditions: Cardiovascular Disease Other studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Biochemical marker assays measure: The predictive value of markers for the risk of cardiovascular events in chest pain measure: Multimarker approach to improve cardiovascular risk stratification sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: ANDREA PICCIONI, Dr. role: CONTACT phone: 0630153161 email: andrea.piccioni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06295965 id: RG1123813 id: NCI-2023-10315 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: FHIRB0020162 type: OTHER domain: Fred Hutch/University of Washington Cancer Consortium id: R01CA272594 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA272594 briefTitle: Clonal Hematopoiesis in Ovarian Cancer Survivors and Risk of Secondary Blood Cancers overallStatus: RECRUITING date: 2024-01-02 date: 2028-12-31 date: 2031-12-31 date: 2024-03-06 date: 2024-03-12 name: University of Washington class: OTHER name: National Cancer Institute (NCI) briefSummary: This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer. conditions: Recurrent Fallopian Tube Carcinoma conditions: Recurrent Ovarian Carcinoma conditions: Recurrent Primary Peritoneal Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: Non-Interventional Study measure: Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients measure: Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors measure: Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fred Hutch/University of Washington Cancer Consortium status: RECRUITING city: Seattle state: Washington zip: 98109 country: United States name: Swisher Lab Research Coordinators role: CONTACT phone: 206-616-8927 email: swisherlabrc@uw.edu name: Elizabeth Swisher role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06295952 id: 23-371 briefTitle: A Study of Pasireotide in People With Prolactinoma overallStatus: RECRUITING date: 2024-02-27 date: 2027-02 date: 2027-02 date: 2024-03-06 date: 2024-03-06 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Evergreen Theragnostics name: Recordati Pharmaceutical company briefSummary: The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma. conditions: Prolactin-Producing Pituitary Tumor studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open label single-center pilot study. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Pasireotide measure: biochemical response rate measure: radiographic response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 name: Andrew Lin, MD role: CONTACT phone: 212-639-8392 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Eliza Geer, MD role: CONTACT phone: 646-608-3797 lat: 40.70038 lon: -73.59291 hasResults: False
<\|newrecord\|> nctId: NCT06295939 id: CA code 016/2565, 012/2566 briefTitle: Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-29 date: 2024-03-15 date: 2024-05-31 date: 2024-03-06 date: 2024-03-29 name: Sanpasitthiprasong Hospital class: OTHER_GOV briefSummary: Research Question:
Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion? Research hypothesis
1. The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care.
2. The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program.
Primary Objectives:
To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs, in comparison to those who have received regular nursing care.
Secondary Objectives:
1. To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs.
2. To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage.
3. To explore other outcomes of pregnancy termination, such as complete abortion, uterine curettage, and post-miscarriage complications. conditions: Pregnancy Loss conditions: Grief conditions: Social Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. The researcher provided information about a research project involving pregnant women diagnosed with fetal demise or abnormalities, who are recommended to undergo pregnancy termination at the third trimester abortion clinic.
2. Pregnant women voluntarily consent to participate in the research by signing the informed consent form.
3. Volunteer participants providing consent will be randomly divided into two groups using the randomization technique with Excel program.
4. Divide into groups of 45 individuals each, totaling 90 participants in the entire sample. primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: social support program name: Routine nursing care measure: The Perinatal Grief Assessment Questionnaire. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Sanpasitthiprasong Hospital city: Ubon Ratchathani zip: 34000 country: Thailand lat: 15.23844 lon: 104.84866 hasResults: False
<\|newrecord\|> nctId: NCT06295926 id: K5236 briefTitle: Serplulimab Combined With CCRT for LS-SCLC. overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2027-01-25 date: 2027-12-31 date: 2024-03-06 date: 2024-03-06 name: Peking Union Medical College Hospital class: OTHER briefSummary: Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis. conditions: Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Serplulimab measure: Progression free survival measure: Overall survival measure: Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 measure: objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06295913 id: HYTOLIVE15 briefTitle: Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases acronym: HYTOLIVE15 overallStatus: RECRUITING date: 2024-03 date: 2024-07 date: 2024-12 date: 2024-03-06 date: 2024-03-06 name: National Research Council, Spain class: OTHER_GOV name: Genosa I+D briefSummary: The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging. conditions: Overweight conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1, hydroxytyrosol-rich extract pill (Hytolive®); Group 2, placebo pill primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Group 1, hydroxytyrosol-rich extract capsule (Hytolive®) name: Group 2, capsule of placebo measure: LDL-ox as marker of oxidative status measure: Emotional well-being determined by Warwick-Edinburgh Mental Well-being Scale measure: Sleep quality determined by Pittsburgh Sleep Quality Index measure: Fatigue test determined by Borg Rating Of Perceived Exertion measure: Fasting glucose measure: Fasting insulin measure: Glycated hemoglobin (HbA1c) measure: Glucagon-like peptide-1 (GLP-1) measure: Total cholesterol measure: High density lipoproteins (HDL) measure: Low density lipoproteins (LDL) triglicéridos, apoliporpotein A1 and B) measure: Triglycerides measure: Apoliporpotein A1 measure: Apoliporpotein B measure: Total antioxidant status (TAS) measure: Total oxidative status (TOS) measure: Oxides of nitrogen (NOx) measure: Thiobarbituric acid reactive substances (TBARS) measure: C reactive protein measure: Interleukine 6 (IL-6) measure: Tumor necrosis factor alpha (TNF-α) measure: Interleukine 10 (IL-10) measure: Alanine aminotransfesare (transaminases ALT) measure: Aspartate aminotransferase (transaminase AST) sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC) status: RECRUITING city: Madrid state: Comunidad Autónoma De Madrid zip: 28040 country: Spain name: Raquel Mateos, PhD role: CONTACT phone: +34 915492300 phoneExt: 436341 email: raquel.mateos@ictan.csic.es name: Mª Ángeles Martín, PhD role: CONTACT phone: +34 915492300 phoneExt: 436340 email: amartina@ictan.csic.es lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06295900 id: 19.10.2023/63 briefTitle: The Effect of Aromatherapy Massage on Sleep Quality overallStatus: RECRUITING date: 2024-01-05 date: 2024-12 date: 2024-12 date: 2024-03-06 date: 2024-03-06 name: Nilgün Erdoğan class: OTHER briefSummary: Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality. conditions: Diabetes Mellitus conditions: Respiratory Failure conditions: Pneumonia conditions: Respiratory Disease conditions: Stroke, Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It will be conducted as a randomized controlled single-blind study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 62 type: ESTIMATED name: Intervention 1 Group name: Intervention 2 Group name: Placebo Control Group measure: Patient Introduction Form measure: Patient Follow-up Form measure: Visual Comparison Sleep Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ömer Halisdemir University Training and Research Hospital status: RECRUITING city: Nigde zip: 51100 country: Turkey name: nilgun erdogan, researcher role: CONTACT phone: 5312599220 email: nilgunerdogan37@gmail.com lat: 37.96583 lon: 34.67935 hasResults: False
<\|newrecord\|> nctId: NCT06295887 id: E-2402 briefTitle: Educational Efficacy of VR vs. Simulator in Emergency Medical Training overallStatus: NOT_YET_RECRUITING date: 2024-04-13 date: 2025-02-28 date: 2025-12-31 date: 2024-03-06 date: 2024-03-08 name: Seoul National University Hospital class: OTHER name: Seoul National University briefSummary: It has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using Sim-man.
In this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. The participants were divided into two groups. One group received a training program using virtual reality technology, and the other group received simulation training using Sim-man. The investigators would like to compare the increase in confidence and satisfaction before and after training.
After the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish. conditions: Simulation Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: control group vs. test group, 1:1 primaryPurpose: OTHER masking: NONE count: 166 type: ESTIMATED name: Educational Program using VR or simulator designed to improve medical intern's performance managing emergency situation measure: self-rated confidence for managing emergency situation measure: self-rated confidence for managing emergency situation measure: performance in managing emergency situation measure: usability of Virtual Reality simulation program using User Experience Questionnaire Short measure: usability of Virtual Reality simulation program using Simulator Sickness Questionnaire measure: usability of Virtual Reality simulation program using System Usability Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295874 id: 12.10.2022/50 briefTitle: The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort overallStatus: RECRUITING date: 2023-01-05 date: 2024-08-30 date: 2024-08-30 date: 2024-03-06 date: 2024-03-06 name: Nilgün Erdoğan class: OTHER briefSummary: Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients. conditions: Respiratory Insufficiency conditions: Pulmonary Disease, Chronic Obstructive conditions: Diabetes Mellitus, Type 2 conditions: High Blood Pressure conditions: Stroke, Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled single blind study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 61 type: ESTIMATED name: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level measure: Patient Introduction Form measure: Patient Follow-up Form measure: Drug Monitoring Form measure: Visual Pain Scale measure: Face Anxiety Scale measure: Comfort Rating Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ömer Halisdemir University Training and Research Hospital status: RECRUITING city: Nigde zip: 51100 country: Turkey name: nilgun erdogan, researcher role: CONTACT phone: 5312599220 email: nilgunerdogan37@gmail.com lat: 37.96583 lon: 34.67935 hasResults: False
<\|newrecord\|> nctId: NCT06295861 id: 2023-1194 briefTitle: Prospective Cohort Study of Panvascular Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-21 date: 2028-11-30 date: 2028-12-31 date: 2024-03-06 date: 2024-03-06 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: To construct a comprehensive big data platform for Chinese people with panvascular disease, and establish a Chinese panvascular disease oriented to guide treatment decisions Cohort and imaging, biological database; According to the clinical features, morphological structure, pathological characteristics of panvascularization, vascular age As the core of the evaluation, a standard evaluation system and a risk prediction model of intervention technology suitable for the diagnosis and treatment of patients with panvascular disease in China were established. Into the Further optimize the treatment strategies, protocols and clinical pathways for panvascular disease to improve patient prognosis and promote its application. conditions: ASCVD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50000 type: ESTIMATED name: no different intervention between the two cohort. measure: Cardiovascular adverse events measure: Cardiovascular mortality measure: Rate of receiving vascular revascularization measure: Readmission rate for vascular reasons sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 facility: Second Affiliated Hospital, School of Medicine, Zhejiang University city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06295848 id: KayseriCH005 briefTitle: The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients acronym: CARDIRA overallStatus: RECRUITING date: 2022-12-15 date: 2024-04-15 date: 2024-06-15 date: 2024-03-06 date: 2024-03-28 name: Kayseri City Hospital class: OTHER_GOV briefSummary: The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.
Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program. conditions: Cardiac Rehabilitation conditions: Rheumatoid Arthritis conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Exercise measure: Framingham Risk Score(FRS) measure: QRISK-3 Risk Score measure: 24-Hour Ambulatory Blood Pressure measure: DAS28 measure: Maximal oxygen consumption (VO2max) measure: The Six-Minute Walk Test (6MWT) measure: The 36-Item Short Form Survey (SF-36) measure: International Physical Activity Questionnaire (IPAQ) - Short Form measure: Beck Depression Inventory (BDI) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty status: RECRUITING city: Kayseri state: Kocasinan zip: 38080 country: Turkey name: HAVVA TALAY ÇALIŞ, PROFESSOR role: CONTACT phone: +905326874541 email: htalaycalis@yahoo.com name: PROFESSOR role: CONTACT lat: 38.73222 lon: 35.48528 hasResults: False
<\|newrecord\|> nctId: NCT06295835 id: CS-2024-0001 briefTitle: Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-03-06 date: 2024-03-22 name: Abbott Point of Care class: INDUSTRY briefSummary: Method comparison study for Potassium (K) and ionized calcium (iCa). conditions: Potassium (K) and Ionized Calcium (iCa) in Capillary Whole Blood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device. primaryPurpose: DIAGNOSTIC masking: NONE count: 200 type: ESTIMATED name: Fingerstick blood draw measure: Performance comparison measure: Performance comparison sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295822 id: CMUH112-REC2-063 briefTitle: The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea overallStatus: RECRUITING date: 2024-03-04 date: 2025-08-31 date: 2026-02-28 date: 2024-03-06 date: 2024-04-10 name: China Medical University Hospital class: OTHER briefSummary: Primary dysmenorrhea is a common under-diagnosed complaint, with a prevalence of about 45-95% in women of childbearing age and about 10-25% in severe cases. Menstrual pain can be classified as primary or secondary. Primary menstrual pain is a crampy pain in the lower abdomen without any pelvic pathology, which usually occurs 6 to 12 months after the first menstruation. Primary menstrual pain is usually most severe on the first day of the menstrual cycle and lasts for 8 to 72 hours. The cause is still unknown, but studies suggest that it may be related to increased prostaglandins, which cause painful contractions of the uterus. The pain is often accompanied by other menstrual discomfort symptoms, including headache, breast tenderness, drowsiness, nausea, vomiting, constipation or diarrhea, and psychological anxiety, depression or irritability. In the case of secondary menstrual pain, there are clear pelvic pathologies, such as endometriosis, uterine fibroids, and pelvic inflammatory disease. conditions: Chinese Medicine conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 82 type: ESTIMATED name: Nuan-gong-ye name: Placebo measure: Visual Analogue Scale (VAS) measure: Short Form McGill Pain Questionnaire (MPQ-SF) sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: China Medical University Hospital status: RECRUITING city: Taichung zip: 404 country: Taiwan name: HSUAN HSUAN WU role: CONTACT phone: +886928030693 email: whh900710@gmail.com lat: 24.1469 lon: 120.6839 hasResults: False
<\|newrecord\|> nctId: NCT06295809 id: V940-007 id: 2023-505712-37 type: OTHER domain: EU CT id: U1111-1292-3589 type: OTHER domain: UTN id: V940 type: OTHER domain: Merck briefTitle: A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) overallStatus: RECRUITING date: 2024-05-06 date: 2029-04-30 date: 2029-04-30 date: 2024-03-06 date: 2024-04-26 name: Merck Sharp & Dohme LLC class: INDUSTRY name: Moderna TX briefSummary: This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints. conditions: Carcinoma, Squamous Cell conditions: Skin Neoplasms studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the Phase 2 of the study design, approximately 600 participants will be randomly assigned into 3 arms in an approximate 5:5:2 ratio (250 to V940 plus pembrolizumab with SOC, 250 participants to SOC only, and 100 participants to pembrolizumab monotherapy with SOC). If the decision is made to expand the study to Phase 3, the 600 participants enrolled in Phase 2 will keep their originally assigned study intervention arms in the Phase 3 Expansion, and 412 new participants will be enrolled and randomly assigned in a 1:1 ratio to receive treatment with either V940 plus pembrolizumab with SOC or SOC only. New participants will not be randomized into the pembrolizumab monotherapy with SOC arm during the Phase 3 Expansion. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1012 type: ESTIMATED name: Pembrolizumab name: V940 name: Surgery measure: Event Free Survival (EFS) measure: Overall response rate (ORR) measure: Freedom from surgery (FFS) rate measure: Pathological complete response (pCR) rate measure: Major pathological response (mPR) rate measure: Disease-free survival (DFS) measure: Disease-specific survival (DSS) measure: Overall Survival (OS) measure: Percentage of participants who experience and adverse event (AE) measure: Percentage of participants who discontinue study intervention due to AEs measure: Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30) measure: Change from baseline in physical functioning score of QLQ (C30 Items 1-5) measure: Change from baseline in Role functioning score of QLQ-C30 Items 6-7 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: One Clinical Research ( Site 3211) status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Study Coordinator role: CONTACT phone: +61862799466 lat: -31.98184 lon: 115.8073 facility: Hadassah Medical Center ( Site 2201) status: RECRUITING city: Jerusalem zip: 9112001 country: Israel name: Study Coordinator role: CONTACT phone: 97226777825 lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center ( Site 2202) status: RECRUITING city: Petah Tikva zip: 4941 492 country: Israel name: Study Coordinator role: CONTACT phone: 97235305201 lat: 32.08707 lon: 34.88747 hasResults: False
<\|newrecord\|> nctId: NCT06295796 id: 8527-008 id: MK-8527-008 type: OTHER domain: Merck briefTitle: A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008) overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2025-04-14 date: 2025-04-14 date: 2024-03-06 date: 2024-04-26 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study. conditions: Renal Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: MK-8527 measure: Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma measure: Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma measure: Maximum concentration (Cmax) of MK-8527 in plasma measure: Time to Maximum concentration (Tmax) of MK-8527 in plasma measure: Apparent terminal half-life (t1/2) of MK-8527 in plasma measure: Apparent Clearance (CL/F) of MK-8527 in plasma measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma measure: Number of participants who experience one or more adverse events (AEs) measure: Number of participants who discontinue study due to an AE measure: AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs) measure: AUC0-inf of MK-8527-TP in PBMCs measure: Cmax of MK-8527-TP in PBMCs measure: Concentration at 168 hours (C168) of MK-8527-TP in PBMCs measure: Concentration at 672 hours (C672) of MK-8527-TP in PBMCs measure: Tmax of MK-8527-TP in PBMCs measure: t1/2 of MK-8527-TP in PBMCs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295783 id: 2023-1059 id: NCI-2024-01955 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2025-02-01 date: 2027-02-01 date: 2024-03-06 date: 2024-03-06 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales. conditions: Radiation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: MDASI-HN name: EORTC QLQ-C30 name: EORTC HN35 measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Amy Moreno, MD role: CONTACT phone: 713-745-4590 email: akmoreno@mdanderson.org name: Amy Moreno, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06295770 id: 23-006712 briefTitle: Obinutuzumab in Treatment of Fibrillary Glomerulonephritis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-06 date: 2024-03-06 name: Mayo Clinic class: OTHER briefSummary: The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN). conditions: Fibrillary Glomerulonephritis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Obinutuzumab measure: Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab measure: Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab measure: Rate of complete or partial remission measure: Improvement in serum albumin measure: Stabilization of kidney function measure: Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Angela Reinke role: CONTACT phone: 507-266-1047 email: Reinke.Angela@mayo.edu name: Nicholas Geroux role: CONTACT phone: 507-266-0956 email: Geroux.Nicholas@mayo.edu name: Ladan Zand role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06295757 id: 2023LS102 briefTitle: Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2027-01-01 date: 2024-03-06 date: 2024-03-06 name: Masonic Cancer Center, University of Minnesota class: OTHER name: National Institutes of Health (NIH) briefSummary: Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes. conditions: Tobacco Use conditions: Cigarette Smoking conditions: Nicotine Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Cigarettes measure: Average Nicotine Level measure: Average Puff Volume sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295744 id: 2023-1724 id: Protocol Version 2/5/2024 type: OTHER domain: UW Madison id: A533300 type: OTHER domain: UW Madison id: UW23114 type: REGISTRY domain: UWCCC OnCore ID briefTitle: Outcomes and Cosmesis With Whole Breast Irradiation and Boost overallStatus: RECRUITING date: 2024-04-17 date: 2029-02 date: 2032-02 date: 2024-03-06 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months. conditions: Early-stage Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Radiation Therapy measure: Harvard Breast Cosmesis Scale Score measure: Change in BREAST-Q Score measure: Incidence of Acute Toxicities measure: Incidence of Late Toxicities measure: Ipsilateral Breast Tumor Recurrence-Free Survival measure: Overall Survival (OS) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UW Carbone Cancer Center status: RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 hasResults: False
<\|newrecord\|> nctId: NCT06295731 id: INBRX106-01-201 id: EU CT type: OTHER domain: 2024-511323-34 briefTitle: INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-05 date: 2024-03-06 date: 2024-03-06 name: Inhibrx, Inc. class: INDUSTRY briefSummary: This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20. conditions: Head and Neck Squamous Cell Carcinoma (HNSCC) studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Phase 2: open label; Phase 3: double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 410 type: ESTIMATED name: INBRX-106 name: Pembrolizumab measure: Phase 2: Objective Response Rate (ORR) measure: Phase 3: Progression-Free Survival (PFS) measure: Phase 3: Overall Survival (OS) measure: Phase 3: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Clinical Benefit Rate (CBR) measure: Phase 3: Time to Chemotherapy (TTCtx) measure: Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference measure: TTCD in physical functioning (PF) measure: TTCD in role functioning (RF) measure: TTCD in Global Health Status/quality of life (GHS/QoL) measure: Incidence and severity of Adverse Events (AEs) measure: Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295718 id: 2023/51 briefTitle: Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy: Validity and Reliability Study overallStatus: ENROLLING_BY_INVITATION date: 2023-07-01 date: 2024-03-02 date: 2024-05-10 date: 2024-03-06 date: 2024-03-06 name: Sahra Şirvan class: OTHER briefSummary: Thanks to tele-assessment methods, it may be possible to evaluate DMD patients without traveling to clinical centers. In recent years, the applicability of remote assessment methods in DMD patients, as in many populations, is being investigated. However, studies have generally focused on a single evaluation parameter such as physical function, a special evaluation method or a special evaluation tool. The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable. If a valid and reliable tele-evaluation method that includes functional performance and quality of life parameters is found to be valid and reliable, the travel burden on patients and caregivers can be eased, patients\' stress and anxiety related to travel can be reduced, caregivers can save time and energy and provide patients with the best possible treatment. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED measure: Timed Performance Tests measure: Brooke Upper Extremity Functional Classification (BUEFS) measure: Vignos Lower Extremity Functional Classification (VAEFS) measure: PedsQL-3.0 Neuromuscular Module by PedsQL Multidimensional Fatigue Scale sex: MALE minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: İstanbul University - Cerrahpaşa city: Istanbul zip: 34758 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06295705 id: 5230588 briefTitle: Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD) acronym: ASD overallStatus: RECRUITING date: 2024-04-02 date: 2025-04 date: 2025-04 date: 2024-03-06 date: 2024-04-11 name: Loma Linda University class: OTHER briefSummary: This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Hip-Hop Dance measure: Child Description of Impact on Social-Emotional Health measure: Parent Perspective of Impact on Social-Emotional Health measure: Change in Social-Emotional Behavior sex: ALL minimumAge: 7 Years maximumAge: 11 Years stdAges: CHILD facility: Loma Linda University Health status: RECRUITING city: Loma Linda state: California zip: 92350 country: United States name: Julie Kugel, OTD role: CONTACT phone: 909-558-4628 phoneExt: 47473 email: jkugel@llu.edu lat: 34.04835 lon: -117.26115 hasResults: False
<\|newrecord\|> nctId: NCT06295692 id: 77242113PSO3005 id: 77242113PSO3005 type: OTHER domain: Janssen Pharmaceutical K.K. briefTitle: A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis overallStatus: RECRUITING date: 2024-02-09 date: 2025-02-19 date: 2027-12-23 date: 2024-03-06 date: 2024-04-25 name: Janssen Pharmaceutical K.K. class: INDUSTRY briefSummary: The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP). conditions: Generalized Pustular Psoriasis conditions: Erythrodermic Psoriasis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: JNJ-77242113 measure: Percentage of Participants With Generalized Pustular Psoriasis (GPP) who Experience Treatment Success Based on Clinical Global Impression (CGI) Scale According to Japanese Dermatological Association (JDA) Total Score at Week 16 measure: Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16 measure: Percentage of Participants With GPP who Experience Treatment Success Based on CGI Scale According to JDA Total Score Over Time measure: Percentage of Participants With EP who Experience Treatment Success Based on CGI Scale Over Time measure: Change From Baseline in Total Score of JDA Severity Index for GPP measure: Change From Baseline in Severity Classification of JDA Severity Index for GPP measure: Change From Baseline in Body Surface Area (BSA) for EP measure: Percentage of Participants who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) measure: Percentage of Participants who Achieve an IGA Score of Cleared (0) measure: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score measure: Percentage of Participants who Achieve a DLQI Score of 0 or 1 measure: Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: JR Sapporo Hospital status: RECRUITING city: Hokkaido zip: 060-0033 country: Japan lat: 43.41104 lon: 142.88878 facility: Ichinomiya Municipal Hospital status: RECRUITING city: Ichinomiya zip: 491-8558 country: Japan lat: 35.3 lon: 136.8 facility: Teikyo University Hospital status: RECRUITING city: Itabashi Ku zip: 173 8606 country: Japan lat: 35.74893 lon: 139.71497 facility: Hospital of the University of Occupational and Environmental Health status: RECRUITING city: Kitakyushu-shi zip: 807-8556 country: Japan lat: 33.85181 lon: 130.85034 facility: Kumamoto University Hospital status: RECRUITING city: Kumamoto zip: 860-8556 country: Japan lat: 32.80589 lon: 130.69182 facility: Nagoya City University Hospital status: RECRUITING city: Nagoya zip: 467 8602 country: Japan lat: 35.18147 lon: 136.90641 facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital status: RECRUITING city: Osaka zip: 550 0006 country: Japan lat: 34.69374 lon: 135.50218 facility: Tohoku University Hospital status: RECRUITING city: Sendai zip: 980-8574 country: Japan lat: 38.26667 lon: 140.86667 facility: Dokkyo Medical University Hospital status: RECRUITING city: Shimotsuga Gun zip: 321-0293 country: Japan facility: Tokyo Medical University Hospital status: RECRUITING city: Shinjuku zip: 160-0023 country: Japan lat: 35.2946 lon: 139.57059 facility: Fujita Health University Hospital status: RECRUITING city: Toyoake zip: 470-1192 country: Japan lat: 35.038 lon: 136.99931 facility: Mie University Hospital status: RECRUITING city: Tsu zip: 514 8507 country: Japan lat: 34.73333 lon: 136.51667 hasResults: False
<\|newrecord\|> nctId: NCT06295679 id: 20180442 briefTitle: A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease overallStatus: RECRUITING date: 2022-12-19 date: 2028-12-19 date: 2028-12-19 date: 2024-03-06 date: 2024-04-25 name: Amgen class: INDUSTRY briefSummary: The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice. conditions: Major Cardiovascular Event conditions: Established Atherosclerotic Cardiovascular Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 7000 type: ESTIMATED measure: Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First measure: Time to CV Death, MI, or Stroke, Whichever Occurs First measure: Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline measure: Percent Change in LDL-C From Baseline measure: Number of Participants Who Experienced Adverse Events measure: Number of Participants Who Experienced Adverse Drug Reactions sex: ALL minimumAge: 18 Years maximumAge: 150 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Haidian Hospital status: RECRUITING city: Beijing state: Beijing zip: 100086 country: China lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 facility: Chongqing Emergency Medical Center status: RECRUITING city: Chongqing state: Chongqing zip: 400014 country: China lat: 29.56278 lon: 106.55278 facility: Chongqing General Hospital status: RECRUITING city: Chongqing state: Chongqing zip: 401121 country: China lat: 29.56278 lon: 106.55278 facility: Dongguan Songshan Lake Central Hospital status: RECRUITING city: Dong Guan state: Guangdong zip: 523127 country: China facility: The First Peoples Hospital of Foshan status: RECRUITING city: Foshan state: Guangdong zip: 528000 country: China lat: 23.02677 lon: 113.13148 facility: The First Affiliated Hospital of Shantou University Medical College status: RECRUITING city: Guangzhou state: Guangdong zip: 510280 country: China lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510280 country: China lat: 23.11667 lon: 113.25 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Jinan University status: RECRUITING city: Guangzhou state: Guangdong zip: 510630 country: China lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510630 country: China lat: 23.11667 lon: 113.25 facility: The Third Peoples Hospital of Huizhou City status: RECRUITING city: Huizhou state: Guangdong zip: 516002 country: China lat: 23.11147 lon: 114.41523 facility: Zhuhai Peoples Hospital status: RECRUITING city: Zhuhai state: Guangdong zip: 519050 country: China lat: 22.27694 lon: 113.56778 facility: The First Peoples Hospital of Yulin status: RECRUITING city: Yulin state: Guangxi zip: 537006 country: China lat: 22.63333 lon: 110.15 facility: The Second Affiliated Hospital of Guilin Medical University status: RECRUITING city: Yulin state: Guangxi zip: 541199 country: China lat: 22.63333 lon: 110.15 facility: The Affiliated Hospital of Guizhou Medical University status: RECRUITING city: Guiyang state: Guizhou zip: 550001 country: China lat: 26.58333 lon: 106.71667 facility: Cangzhou Central Hospital status: RECRUITING city: Cangzhou state: Hebei zip: 061001 country: China lat: 38.31667 lon: 116.86667 facility: Tangshan Gongren Hosipital status: RECRUITING city: Tangshan state: Hebei zip: 063000 country: China lat: 39.63333 lon: 118.18333 facility: Heilongjiang Provincial Hospital status: RECRUITING city: Haerbin state: Heilongjiang zip: 150036 country: China lat: 31.8696 lon: 101.742 facility: Huaihe Hospital of Henan University status: RECRUITING city: Kaifeng state: Henan zip: 475000 country: China lat: 34.7986 lon: 114.30742 facility: Nanyang Central Hospital status: RECRUITING city: Nanyang state: Henan zip: 473000 country: China lat: 32.99472 lon: 112.53278 facility: The Seventh Peoples Hospital of Zhengzhou status: RECRUITING city: Zhengzhou state: Henan zip: 450016 country: China lat: 34.75778 lon: 113.64861 facility: The First Affiliated hospital of Zhengzhou University status: RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China lat: 34.75778 lon: 113.64861 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan state: Hubei zip: 430014 country: China lat: 30.58333 lon: 114.26667 facility: Union Hospital Tongji Medical College Huazhong University of science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Wuhan No 1 Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 facility: Wuhan Third Hospital-Tongren Hospital Of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430060 country: China lat: 30.58333 lon: 114.26667 facility: Hunan Provincial Peoples Hospital status: RECRUITING city: Changsha state: Hunan zip: 410005 country: China lat: 28.19874 lon: 112.97087 facility: Changshu No1 Peoples Hospital status: RECRUITING city: Changshu state: Jiangsu zip: 215500 country: China lat: 29.44395 lon: 118.88005 facility: Changshu NO2 Peoples Hospital status: RECRUITING city: Changshu state: Jiangsu zip: 215523 country: China lat: 29.44395 lon: 118.88005 facility: Nantong First Peoples Hospital status: RECRUITING city: Nantong state: Jiangsu zip: 226000 country: China lat: 32.03028 lon: 120.87472 facility: The first peoples hospital of Kunshan status: RECRUITING city: Suzhou state: Jiangsu zip: 215300 country: China lat: 31.30408 lon: 120.59538 facility: Wuxi Peoples Hospital status: RECRUITING city: Wuxi state: Jiangsu zip: 214023 country: China lat: 31.56887 lon: 120.28857 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu zip: 221006 country: China lat: 34.18045 lon: 117.15707 facility: Jiangxi Provincial People Hospital status: RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China lat: 28.68396 lon: 115.85306 facility: The first affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China lat: 28.68396 lon: 115.85306 facility: The First Hospital of Nanchang status: RECRUITING city: Nanchang state: Jiangxi zip: 330008 country: China lat: 28.68396 lon: 115.85306 facility: The Second Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 13041 country: China lat: 43.88 lon: 125.32278 facility: Dalian Municipal Central Hospital Affiliated Of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116000 country: China lat: 38.91222 lon: 121.60222 facility: The First Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116000 country: China lat: 38.91222 lon: 121.60222 facility: The Second Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116027 country: China lat: 38.91222 lon: 121.60222 facility: The First Affiliated Hospital of Jinzhou Medical University status: RECRUITING city: Jinzhou state: Liaoning zip: 121000 country: China lat: 41.10778 lon: 121.14167 facility: General Hospital of Northern Theater Command status: RECRUITING city: Shenyang state: Liaoning zip: 110016 country: China lat: 41.79222 lon: 123.43278 facility: The Forth Affiliated Hospital of China Medical University status: RECRUITING city: Shenyang state: Liaoning zip: 110032 country: China lat: 41.79222 lon: 123.43278 facility: Tangdu Hospital,Air Force Military Medical University status: RECRUITING city: Xi'an state: Shaanxi zip: 710038 country: China lat: 34.25833 lon: 108.92861 facility: Shaanxi Provincial Peoples Hospital status: RECRUITING city: Xi'an state: Shaanxi zip: 710068 country: China lat: 34.25833 lon: 108.92861 facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China lat: 36.66833 lon: 116.99722 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Shandong Qianfoshan Hospital status: RECRUITING city: Jinan state: Shandong zip: 250014 country: China lat: 36.66833 lon: 116.99722 facility: Shandong Provincial Hospital status: RECRUITING city: Jinan state: Shandong zip: 250021 country: China lat: 36.66833 lon: 116.99722 facility: Affiliated hospital of Jining Medical University status: RECRUITING city: Jining state: Shandong zip: 272009 country: China lat: 35.405 lon: 116.58139 facility: Zibo central Hospital status: RECRUITING city: Zibo state: Shandong zip: 255030 country: China lat: 36.79056 lon: 118.06333 facility: Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200092 country: China lat: 31.22222 lon: 121.45806 facility: The Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi zip: 030001 country: China lat: 37.86944 lon: 112.56028 facility: The First Affiliated Hospital of Xi An Jiaotong University status: RECRUITING city: XI An state: Shanxi zip: 710061 country: China facility: Chengdu First Peoples Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Chengdu Third Peoples Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 61031 country: China lat: 30.66667 lon: 104.06667 facility: Tianjin Peoples Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300120 country: China lat: 39.14222 lon: 117.17667 facility: Tianjin Chest Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300222 country: China lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of Xinjiang Medical University status: RECRUITING city: Urumqi state: Xinjiang zip: 830054 country: China lat: 43.80096 lon: 87.60046 facility: Yanan Hospital of Kunming City status: RECRUITING city: Kunming state: Yunnan zip: 473009 country: China lat: 25.03889 lon: 102.71833 facility: First Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan zip: 650032 country: China lat: 25.03889 lon: 102.71833 facility: Yunnan First Peoples Hospital status: RECRUITING city: Kunming state: Yunnan zip: 650032 country: China lat: 25.03889 lon: 102.71833 facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: the First Peoples Hospital of Xiaoshan District Hangzhou status: RECRUITING city: Hangzhou state: Zhejiang zip: 311201 country: China lat: 30.29365 lon: 120.16142 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou state: Zhejiang zip: 310005 country: China lat: 30.8703 lon: 120.0933 facility: The First Peoples Hospital of Huzhou status: RECRUITING city: Huzhou state: Zhejiang zip: 313000 country: China lat: 30.8703 lon: 120.0933 facility: Jiaxing Second Hospital status: RECRUITING city: Jiaxing state: Zhejiang zip: 314000 country: China lat: 30.7522 lon: 120.75 facility: The first affiliated hospital of Ningbo university status: RECRUITING city: Ningbo state: Zhejiang zip: 315010 country: China lat: 29.87819 lon: 121.54945 facility: Ningbo medical center lihuili hospital status: RECRUITING city: Ningbo state: Zhejiang zip: 315046 country: China lat: 29.87819 lon: 121.54945 facility: Shaoxing Second Hospital status: RECRUITING city: Shaoxing state: Zhejiang zip: 312000 country: China lat: 30.00237 lon: 120.57864 facility: Beijing Anzhen Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Tongji Hospital of Tongji University status: RECRUITING city: Shanghai zip: 200065 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06295666 id: 26.12.2018/901 briefTitle: Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta overallStatus: COMPLETED date: 2019-02-19 date: 2019-11-25 date: 2020-01-20 date: 2024-03-06 date: 2024-03-06 name: Akdeniz University class: OTHER briefSummary: Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis conditions: Periodontitis conditions: Gingival Crevicular Fluid conditions: Interleukin 1-beta conditions: Bactericidal Permeability Protein studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
<\|newrecord\|> nctId: NCT06295653 id: 7-23 briefTitle: Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-30 date: 2025-04-30 date: 2024-03-06 date: 2024-03-06 name: Tanta University class: OTHER briefSummary: The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane measure: measure changes in periimplant mucosal thickness measure: mid-buccal keratinized mucosal width sex: ALL minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: Faculity of Dentistry Tanta University city: Tanta state: Elgarbia zip: 6620012 country: Egypt name: Faten a Seddiq, Faculty Dean role: CONTACT phone: 3335631 phoneExt: +20 email: dean_dent@unv.tanta.edu.eg name: ahmed a abdelsayed role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-03 uploadDate: 2024-03-03T10:57 filename: Prot_SAP_000.pdf size: 472866 hasResults: False
<\|newrecord\|> nctId: NCT06295640 id: 300/2022 briefTitle: Relative Contribution of Brain Insulin Action for Postprandial Metabolism acronym: BrainInsPPM overallStatus: RECRUITING date: 2024-03-18 date: 2025-12 date: 2026-01 date: 2024-03-06 date: 2024-03-27 name: University of Ulm class: OTHER briefSummary: The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.
Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray. conditions: Glucose Metabolism Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, controlled, cross-over design for men. Randomized, controlled, 2x2 factorial cross-over design for women taking the menstrual cycle phase into account. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Oral glucose tolerance test with double-tracer dilution and intranasal insulin spray name: Oral glucose tolerance test with double-tracer dilution and intranasal placebo spray measure: Endogenous glucose production measure: Rate of glucose disappearance measure: Proglucagon cleavage products measure: Glucose tolerance measure: Whole-body insulin sensitivity measure: Insulin secretion measure: Post-absorptive energy expenditure measure: Sex differences measure: Menstrual cycle effects measure: Autonomic nervous system activity sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Universityhospital Ulm status: RECRUITING city: Ulm zip: 89081 country: Germany name: Julia Hummel, Phd role: CONTACT phone: +4973150044744 email: julia.hummel@uniklinik-ulm.de name: Rebecca Spies, MD role: CONTACT email: rebecca.spies@uniklinik-ulm.de lat: 48.39841 lon: 9.99155 hasResults: False
<\|newrecord\|> nctId: NCT06295627 id: SYSKY-2024-115-01 briefTitle: The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies overallStatus: COMPLETED date: 2023-01-30 date: 2023-09-30 date: 2024-01-15 date: 2024-03-06 date: 2024-03-06 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed. conditions: Catheter-associated Urinary Tract Infection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 291 type: ACTUAL name: There were no interventions in retrospective analysis measure: How many patients in the infected group and how many patients in the non-infected group had bladder irrigation measure: How many patients in the infected group and how many patients in the non-infected group were given enema measure: How many times the indwelling catheter was changed in patients in the infected group and patients in the non-infected group respectively measure: How many patients in the infected group and the non-infected group had co-diabetes sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital city: Canton state: Guangdong zip: 510030 country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06295614 id: SPARKL briefTitle: Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease acronym: SPARKL overallStatus: RECRUITING date: 2024-03-01 date: 2029-04-01 date: 2029-04-01 date: 2024-03-06 date: 2024-03-12 name: Ecole Polytechnique Fédérale de Lausanne class: OTHER briefSummary: The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-site, single-arm, non-blinded, non-randomized, interventional primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: ARC-IM System implantation measure: Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system. measure: 10-meter walk test measure: 6-minute walk test measure: Timed up and Go and its cognitive version measure: Freezing of gait circuit measure: Kinematic analysis measure: Muscle analysis measure: Mini Balance Evaluation Systems Test (mini-BESTest) measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III measure: King's Parkinson's disease Pain Scale (KPPS) measure: The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV. measure: Parkinson's Disease Questionnaire-39 (PDQ-39) measure: Activities specific Balance Confidence Questionnaire (ABC-Q) measure: The Freezing of Gait Questionnaire (FOG-Q) measure: Home-use kinematic monitoring measure: Daily falls tracking measure: Satisfaction questionnaire measure: User Evaluation of Satisfaction with technology (QUEST 2.0) measure: System Usability Scale (SUS) measure: Nerve conduction studies (NCS) measure: Somato-sensory evoked potential (SSEP) measure: Cortical signal recording measure: Kinematic analysis in different therapeutic conditions measure: Muscle analysis in different therapeutic conditions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire Vaudois (CHUV) status: RECRUITING city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Jocelyne Dr Bloch, Prof. Dr. role: CONTACT lat: 46.516 lon: 6.63282 hasResults: False
<\|newrecord\|> nctId: NCT06295601 id: 2024/5591 briefTitle: Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-02-15 date: 2025-08-15 date: 2024-03-06 date: 2024-03-06 name: Inonu University class: OTHER briefSummary: This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: Traditional rehabilitation name: Action observation therapy and motor imagery measure: Berg Balance Scale measure: Berg Balance Scale measure: Muscle strength and functional mobility measure: Muscle strength and functional mobility measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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