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<|newrecord|> nctId: NCT06299644 id: 2023P003282 briefTitle: Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss overallStatus: NOT_YET_RECRUITING date: 2025-05-01 date: 2026-07-01 date: 2026-12-31 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER name: Endo Tools Therapeutics S.A. briefSummary: The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss. conditions: Obesity conditions: Obesity, Morbid conditions: Metabolic Disease conditions: Weight, Body studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Endoscopic Sleeve Gastroplasty - Belt and Suspenders name: Endoscopic Sleeve Gastroplasty - Belt measure: Percent TWL (%TWL) measure: Adverse Events measure: Gastric Emptying measure: Number of participants with improvement in fasting glucose measure: Number of participants with improvement in Hemoglobin A1c (HgA1c %) measure: Improvement in fasting lipids profile measure: Number of participants with a change in ghrelin hormone values measure: Obesity-related comorbidities - hypertension measure: Obesity-related comorbidities - change in hypertension concomitant medications measure: Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications measure: Obesity-related comorbidities - pre-diabetes/diabetes measure: Obesity-related comorbidities - gastroesophageal reflux (GERD) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06299631 id: RECHMPL23_0187 briefTitle: Endoscopic Relapse Risks Evaluation After Ileocolic Resection for Crohn's Disease acronym: RIC-1 overallStatus: COMPLETED date: 2015-01 date: 2023-06 date: 2023-12 date: 2024-03-08 date: 2024-03-08 name: University Hospital, Montpellier class: OTHER name: Carémeau University Hospital, Nîmes briefSummary: Aim of the study:
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To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents.
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Methods:
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From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected.
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Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period.
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Short and long-term outcomes were compared between the two groups.
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Primary outcome:
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Endoscopic recurrence (defined as \> i2 lesions according to Rutgeerts classification) 6 months after surgery conditions: Crohn's Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 133 type: ACTUAL name: Ileocolic resection measure: Endoscopic recurrence rate measure: Resection margins measure: Length of resected specimen measure: Duration of surgery measure: Intra-operative blood loss measure: Postoperative morbidity rate measure: Mortality rate measure: Myenteric plexitis measure: Number of inflammatory cells in myenteric plexuses sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montpellier University Hospital city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06299618 id: ENIGMA-I briefTitle: Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism acronym: ENIGMA-I overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: University College Cork class: OTHER name: University of Southampton name: Carol Davila University of Medicine and Pharmacy name: Microlink PC UK LTE name: Engineering Ingegneria Informatica SpA name: MEDEA SRL name: ORTHOKEY ITALIA SRL briefSummary: The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism. conditions: Autism conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Symptoms of anxiety measure: Symptoms of anxiety measure: Symptoms of depression measure: Symptoms of depression measure: Attention-Deficit/Hyperactivity measure: Sleep disturbance measure: Physical Activity measure: Symptoms of Mental Health Disorders measure: Cognitive Assessment measure: Nutritional Assessment measure: Heart Rate measure: Respiratory Rate measure: Genotype measure: DNA Methylation measure: Hormone Levels measure: Metabolomic Profile sex: ALL minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: University College Cork city: Cork country: Ireland name: Deirdre Murray, PhD role: CONTACT email: enigma@ucc.ie name: Jean Conway, Masters role: CONTACT email: ethereal@ucc.ie lat: 51.89797 lon: -8.47061 facility: University of Medicine and Pharmacy Carol Davila Bucharest city: Bucharest country: Romania lat: 44.43225 lon: 26.10626 facility: University of Southampton city: Southampton country: United Kingdom name: Samuele Cortese, MD role: CONTACT name: Koushik Maharatna, PhD role: CONTACT email: km3@ecs.soton.ac.uk lat: 50.90395 lon: -1.40428 hasResults: False
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<|newrecord|> nctId: NCT06299605 id: SHARE2401 briefTitle: Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori acronym: SHARE2401 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2024-11 date: 2024-03-08 date: 2024-03-08 name: Shandong University class: OTHER name: Binzhou Maternal and Child Health Hospital name: Zibo Maternal and Child Health Hospital name: Zaozhuang Municipal Hospital name: Linyi Yizhou Hospital name: Feicheng Municipal People's Hospital briefSummary: The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated. conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 375 type: ESTIMATED name: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days name: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days name: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days measure: Eradication rate measure: Rate of adverse reactions measure: Patient compliance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299592 id: 2023-1626 id: 1RF1AG082215-01 type: NIH link: https://reporter.nih.gov/quickSearch/1RF1AG082215-01 id: A538900 type: OTHER domain: UW- Madison id: SMPH/PSYCHIATRY/PSYCHIATRY type: OTHER domain: UW- Madison id: Protocol Version 10/15/2023 type: OTHER domain: UW- Madison briefTitle: Comparison of Microglial Activation in Severe Asthma and Healthy Controls acronym: MAIA-SC overallStatus: RECRUITING date: 2024-03-06 date: 2028-08 date: 2028-08 date: 2024-03-08 date: 2024-03-27 name: University of Wisconsin, Madison class: OTHER name: National Institute on Aging (NIA) briefSummary: The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are:
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* How airway inflammation in asthma affects the brain; and,
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* Whether airway inflammation in asthma is related to symptoms of depression and anxiety
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Over the course of 3 visits, participants will:
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* Complete questionnaires
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* Complete computer tasks
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* Undergo allergy skin test and breathing tests
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* Give two blood samples
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* Give a sputum sample
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* Complete brain imaging scans
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Researchers will compare results between participants with asthma, and participants who do not have asthma. conditions: Asthma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: PET/MRI using [18F]FEPPA tracer measure: Binding of [18F]-FEPPA measure: How activated microglia correspond to immune biomarkers in lung and blood measure: Relationship between activated microglia and cognitive function measure: Relationship between activated microglia and psychological symptoms sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Healthy Minds status: RECRUITING city: Madison state: Wisconsin zip: 53703 country: United States name: Janelle Grogan role: CONTACT phone: 608-263-0524 email: jegrogan@medicine.wisc.edu name: Melissa Rosenkranz, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06299579 id: WG-GD11-III-01 briefTitle: GD-11 for Injection in the Treatment of Acute Ischemic Stroke overallStatus: RECRUITING date: 2024-02-29 date: 2025-02-22 date: 2025-12-31 date: 2024-03-08 date: 2024-03-15 name: Beijing Tiantan Hospital class: OTHER name: Jiangsu Wangao Pharmaceutical Co. ltd briefSummary: Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is designed as a multicenter, randomized, double-blind, placebo-parallel controlled trial using a multicenter, randomized, double-blind, placebo-parallel controlled trial design. Subjects are randomly assigned in a 1:1 ratio and random number tables are generated using SAS（Statistics Analysis System）software. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 980 type: ESTIMATED name: GD-11 for injection test group name: Placebo control group measure: Proportion of subjects with mRS score ≤1 on 90th day of treatment sex: ALL minimumAge: 18 Years maximumAge: 81 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital Capital Medical University Beijing status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Yongjun Wang role: CONTACT email: yongjunwang111@aliyun.com name: Yongjun Wang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Linfen Central Hospital status: RECRUITING city: Shangxi state: Linfen City zip: 041099 country: China name: hongguo Dai role: CONTACT email: daihongguo3199@163.com hasResults: False
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<|newrecord|> nctId: NCT06299566 id: CF NGS briefTitle: Perceptions of the CF Screening Protocol Incorporating NGS overallStatus: COMPLETED date: 2022-01-19 date: 2023-02-28 date: 2023-02-28 date: 2024-03-08 date: 2024-03-08 name: King's College London class: OTHER name: University of Warwick name: Coventry University name: Barts & The London NHS Trust name: Cystic Fibrosis Trust briefSummary: Newborn bloodspot screening (from now on referred to as screening) for cystic fibrosis (CF) became part of the national screening programme in 2007. Screening for CF is also well established internationally. The current process works well but has some disadvantages: carrier reporting - which is not the intention of CF screening in the UK (\~200 pa); need for repeat samples which can be costly and contribute to parental worry (\~300 pa.); mutation panels not fully reflecting the ethnic diversity of the birth population; identification of children designated as CF screen positive, inconclusive diagnosis (CFSPID) which can cause uncertainty (\~20-30 pa).
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A trial of NGS in one centre in the UK, for one year found that it was technically feasible at reasonable cost and with an acceptable turn around time. In addition, the trial determined that using NGS could mitigate against some of the disadvantages described above.
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The purpose of this piece of work was to:
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1. Gather, compare and analyse the views of a range of stakeholders on the proposed CF screening protocol incorporating NGS.
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2. Use the outcomes to inform discussions and decisions by the fetal, maternal and child health (FMCH) group and UK National Screening Committee (NSC) about the proposed protocol
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3. Consider what generalisable information on the views of stakeholders on newborn screening could be generated from this exercise to inform other FMCH and UK NSC discussions
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4. Evaluate and learn from the exercise to inform future stakeholder engagement activities by the UK NSC and screening programmes. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ACTUAL measure: Focus groups/interviews/questionnaires exploring stakeholder views of the proposed CF screening protocol incorporating NGS. measure: Focus groups/interviews/questionnaires exploring stakeholder views on equivocal, carrier, false positives/negatives results, late onset/uncertain conditions measure: Q sorts used to develop data and materials FMCH and UK NSC can use to engage stakeholders measure: Surveys to explore principles of engagement for stakeholders sex: ALL minimumAge: 10 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King's College London city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06299553 id: INCB88888-040 PRO-MIND briefTitle: Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) overallStatus: RECRUITING date: 2023-12-04 date: 2025-06-30 date: 2027-06-30 date: 2024-03-08 date: 2024-03-12 name: Incyte Biosciences Italy S.r.l class: INDUSTRY briefSummary: The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL. conditions: DLBCL - Diffuse Large B Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Progression free survival (PFS) measure: Baseline Characteristics measure: Overall Response Rate (ORR) measure: Duration of Response (DoR) measure: Time to next treatment (TTNT) measure: Time to response measure: Overall Survival (OS) measure: Disease Control Rate (DCR) measure: Event Free Survival (EFS) measure: Progression-Free-Survival 2 (PFS2) measure: Information of which treatment the patients will get after tafasitamab discontinuation measure: Safety of tafasitamab combined with lenalidomide measure: Safety of tafasitamab in monotherapy measure: Describe the treatment adherence of lenalidomide and dose reduction. measure: Health-Related Quality of Life (HRQoL) measure: Health-Related Quality of Life (HRQoL) measure: Health economics - Hospitalization measure: Health economics - DLBCL treatment measure: Health economics - Concomitant Treatments measure: Health economics - Monitoring activities measure: Health economics - monitoring activities performed after patients' discharge measure: Health economics - Adverse event treatment measure: Health economics - Unplanned specialist visits measure: Exploratory objectives measure: Exploratory objectives sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Incyte Biosciences Italy S.r.l status: RECRUITING city: Milan zip: 20122 country: Italy name: Nicola Battaglia role: CONTACT phone: +39 3429513636 email: NBattaglia@incyte.com name: Mario Lapecorella role: CONTACT email: MLapecorella@incyte.com name: Pier Luigi Zinzani role: PRINCIPAL_INVESTIGATOR name: Eliana Valentina Liardo role: PRINCIPAL_INVESTIGATOR name: Paolo Corradini role: PRINCIPAL_INVESTIGATOR name: Enrico Derenzini role: PRINCIPAL_INVESTIGATOR name: Francesca Gaia Rossi Dardanoni role: PRINCIPAL_INVESTIGATOR name: Andrès Ferreri role: PRINCIPAL_INVESTIGATOR name: Leonardo Flenghi role: PRINCIPAL_INVESTIGATOR name: Caterina Patti role: PRINCIPAL_INVESTIGATOR name: Maurizio Musso role: PRINCIPAL_INVESTIGATOR name: Annalisa Chiarenza role: PRINCIPAL_INVESTIGATOR name: Adalberto Ibatici role: PRINCIPAL_INVESTIGATOR name: Michele Spina role: PRINCIPAL_INVESTIGATOR name: Alice Di Rocco role: PRINCIPAL_INVESTIGATOR name: Maria Christina Cox role: PRINCIPAL_INVESTIGATOR name: Stefan Hohaus role: PRINCIPAL_INVESTIGATOR name: Andrea Bernardelli role: PRINCIPAL_INVESTIGATOR name: Francesco Piazza role: PRINCIPAL_INVESTIGATOR name: Domenico Pastore role: PRINCIPAL_INVESTIGATOR name: Giuseppe Tarantini role: PRINCIPAL_INVESTIGATOR name: Daniela Dessì role: PRINCIPAL_INVESTIGATOR name: Sofya Kovalchuk role: PRINCIPAL_INVESTIGATOR name: Alberto Fabbri role: PRINCIPAL_INVESTIGATOR name: Antonio Pinto role: PRINCIPAL_INVESTIGATOR name: Ferdinando Frigeri role: PRINCIPAL_INVESTIGATOR name: Mario Annunziata role: PRINCIPAL_INVESTIGATOR name: Elsa Pennese role: PRINCIPAL_INVESTIGATOR name: Caterina Cecilia Stelitano role: PRINCIPAL_INVESTIGATOR name: Mattia Novo role: PRINCIPAL_INVESTIGATOR name: Manuela Zanni role: PRINCIPAL_INVESTIGATOR name: Guido Gini role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06299540 id: 54179060CLL4033 id: 54179060CLL4033 type: OTHER domain: Janssen-Cilag France briefTitle: Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia acronym: QOLIBRI overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-09-30 date: 2026-09-30 date: 2024-03-08 date: 2024-04-25 name: Janssen Cilag S.A.S. class: INDUSTRY briefSummary: The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G). conditions: Leukemia, Lymphocytic, Chronic, B-Cell studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 256 type: ESTIMATED name: Individual Physical Activity Intervention (IPAI) name: Ibrutinib measure: Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5 measure: Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12 measure: Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12 measure: Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12 measure: Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12 measure: Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12 measure: Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5 measure: Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12 measure: Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline measure: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Total Score and Sub Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Total Sleep Time Using Connected Watch measure: Change From Baseline in Total Sleep Score Using Connected Watch measure: Change From Baseline in Sleep Stages Using Connected Watch measure: Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12 measure: Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch measure: Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch measure: Percentage of Participants with Treatment-related Adverse Events measure: Time to Treatment Discontinuation (TTD) measure: Reasons for Treatment Discontinuation measure: Percentage of Participants Who Still Wear the Connected Watch measure: Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch) measure: Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment measure: For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI measure: For Group 1: Percentage of Participants Who Follow the Adapted Physical Activity (APA) Sessions, the Walking Objectives and the APA Appointment as Scheduled With the APA Among Those Who Have Started IPAI measure: For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study measure: For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study measure: For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study measure: For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299527 id: 01032024 briefTitle: Telerehabilitation in Patients With Fibromyalgia overallStatus: COMPLETED date: 2023-05-27 date: 2023-11-15 date: 2024-01-27 date: 2024-03-08 date: 2024-03-13 name: Marmara University class: OTHER briefSummary: Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16). conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ACTUAL name: Exercise Program measure: Visual Analog Scale measure: Revised Fibromyalgia Impact Questionnaire measure: Pain Catastrophizing Scale measure: Hospital Anxiety and Depression Scale measure: 6 Minute Walk Test measure: Arm Curl Test measure: Laser Cursor Assisted Angle Repetition Test (LI-RATT) measure: Short Form - 12 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences city: Istanbul state: Maltepe zip: 1464185881 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06299514 id: 4754 briefTitle: RAFT-P&A Randomized Control Trial overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2028-12-31 date: 2029-12-31 date: 2024-03-08 date: 2024-03-12 name: Lawson Health Research Institute class: OTHER briefSummary: Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.
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A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy. conditions: Atrial Fibrillation conditions: Heart Failure conditions: Pacemaker conditions: Arrhythmia Atrial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1200 type: ESTIMATED name: Pace and Ablate name: Medication measure: Winratio measure: All-cause mortality measure: Cardiovascular mortality measure: Number of heart failure events measure: All-cause hospitalization measure: Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ) measure: Exercise measure: Biochemical marker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Sciences Centre - University Hospital city: London state: Ontario zip: N6A5A5 country: Canada lat: 42.98339 lon: -81.23304 facility: London Health Sciences Research city: London state: Ontario zip: N6G5A5 country: Canada name: Abbie Pardo role: CONTACT phone: 5196612111 phoneExt: 86459 email: abbie.pardo@lhsc.on.ca lat: 42.98339 lon: -81.23304 hasResults: False
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<|newrecord|> nctId: NCT06299501 id: LS 2015-1199 and 2017-24 briefTitle: How Can Child Health Services Identify and Respond to Family Violence overallStatus: COMPLETED date: 2017-08-23 date: 2019-08-31 date: 2019-08-31 date: 2024-03-07 date: 2024-03-08 name: Karolinska Institutet class: OTHER name: Jane and Dan Olsson Foundation for Scientific Purposes name: Region Stockholm briefSummary: Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. This study is a three-armed randomized controlled trial (RCT) conducted to assess the effectiveness of different approaches to identify family violence within CHS. Two different approaches are tested and compared to treatment as usual; 1) information about family violence at home visit when child is newborn, and questions posed to all mothers at the 6-8-week visit; 2) information about family violence at home visit when child is newborn, and questions posed to mothers on evidence based indication. Nurses who are randomized into any of the two intervention arms receive training and supervision. The outcomes of the study are related to knowledge, attitudes, and practices around identification and support in case of family violence and number of identified cases of family violence. conditions: Family Violence conditions: Domestic Violence conditions: Intimate-partner Violence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three-armed study, two intervention groups and one control group primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 85 type: ACTUAL name: Routine questions name: Questions on evidence based indication name: Treatment as usual measure: Knowledge, attitudes and practices measure: Number of cases of family violence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Central Child Health Care (Centrala barnhälsovården) city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06299488 id: PS03 briefTitle: Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia acronym: Sip2Sleep overallStatus: COMPLETED date: 2023-04-05 date: 2023-06-01 date: 2023-07-01 date: 2024-03-07 date: 2024-03-07 name: Lakshmi Nutraceuticals LLC class: INDUSTRY name: People Science, Inc. briefSummary: Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf extract) on sleep. The purpose of this study is to evaluate the effects of taking this combination product on various aspects of sleep. This study is being conducted by People Science, and is sponsored by Lakshmi Nutraceuticals, LLC. The information we gather will help inform how people may use Sip2Sleep® to affect the quality of sleep.
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Participants in this study will complete a number of surveys about their difficulties falling asleep and staying asleep (insomnia), their energy level during the day and health status regarding their quality of sleep.
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There are no major risks associated with this study. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will complete a 5-week study consisting of screening assessments, baseline scales and surveys, objective digital measure, 2 weeks of product use (1 week on - 1 week off - 1 week on), scales and surveys, and end of study assessments and surveys. This is a remote observational study that will use the People Science app-based data collection platform Consumer Health Learning and Organizing Ecosystem (CHLOE) for study participants to report their assessments and collect objective sleep data from personal wearable devices. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study. primaryPurpose: TREATMENT masking: NONE maskingDescription: This study is not blinded. Participants consume the intervention on alternating weeks. All participants receive the intervention count: 77 type: ACTUAL name: Sip2Sleep: Montmorency Cherry and Apocynum Venetum measure: Subjective Sleep Quality measure: Insomnia Sleep Index measure: Generalized Anxiety Disorder-7 (GAD-7) measure: Subjective Alertness measure: Exploratory: Sleep Duration measure: Exploratory: Sleep Latency measure: Participant Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: People Science Inc. city: West Hollywood state: California zip: 90069 country: United States lat: 34.09001 lon: -118.36174 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-03-24 uploadDate: 2024-02-28T17:22 filename: Prot_SAP_000.pdf size: 436932 hasResults: False
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<|newrecord|> nctId: NCT06299475 id: 2023-06755-01 briefTitle: Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC acronym: LOWEC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2026-09 date: 2024-03-07 date: 2024-03-07 name: Karolinska Institutet class: OTHER name: the Swedish Pharmacy Association briefSummary: To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP). conditions: Contraception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A cluster randomized crossover trial primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 600 type: ESTIMATED name: Online counseling and invitation measure: Use of effective contraception measure: Contraceptive use measure: Incidence of pregnancy and abortion measure: Satisfaction with the intervention measure: Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups measure: Process evaluation sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299462 id: PTCy-ATG-001 briefTitle: PTCy and ATG for MSD and MUD Transplants overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2031-06-01 date: 2031-06-01 date: 2024-03-07 date: 2024-03-07 name: Instituto Nacional de Cancer, Brazil class: OTHER_GOV briefSummary: Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).
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Since then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.
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This is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).
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Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.
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The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.
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Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors. conditions: Acute Myeloid Leukemia conditions: Acute Lymphoblastic Leukemia conditions: Myelodysplastic Syndromes conditions: Hodgkin Lymphoma conditions: Non-hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with a matched sibling donor will be assigned to the PTCy+ATG2.5±1.5 arm, while patients with an matched unrelated donor will be assigned to the PTCy+ATG5.0 arm primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: ATG 5.0 name: Cyclophosphamide injection name: ATG 2.5±1.5 measure: Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria measure: Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria measure: Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949 measure: Cumulative incidence of chronic GVHD as defined by the NIH criteria measure: Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria measure: Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse measure: Cumulative incidence of relapse, defined as > 5% blasts in bone marrow or 1% blasts in peripheral blood (acute leukemias/myelodysplasia) or biopsy proven relapse or positve PET-CT (lymphoma) measure: Rate of overall survival measure: Rate of disease-free survival (death or relapse) measure: Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment) measure: Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms) measure: Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL) measure: Measuremnt of quality of life using the FACT-BMT scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-03-23 uploadDate: 2023-03-23T15:38 filename: Prot_SAP_000.pdf size: 322979 hasResults: False
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<|newrecord|> nctId: NCT06299449 id: KFSIRB200-174 briefTitle: Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement overallStatus: RECRUITING date: 2024-03-05 date: 2025-03-15 date: 2025-03-20 date: 2024-03-07 date: 2024-03-12 name: Kafrelsheikh University class: OTHER briefSummary: Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach. conditions: Implant Complication conditions: Dental Implant Failed studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: free-hand socket shield name: AI/guided socket shield measure: Stability Quotient of dental implant measure: pink esthetic score measure: Midfacial Mucosal Alterations measure: facial marginal bone level sex: ALL minimumAge: 19 Years maximumAge: 40 Years stdAges: ADULT facility: faculty of dentistry, kafrelsheikh University status: RECRUITING city: Kafr Ash Shaykh state: Kafrelsheikh zip: 214312 country: Egypt name: walid elamrousy role: CONTACT phone: +201005724781 email: Waled_Hammed@den.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False
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<|newrecord|> nctId: NCT06299436 id: IRB00426760 id: R01HL172830 type: OTHER domain: NHLBI/NIH briefTitle: Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure acronym: HALT-RHF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-03-31 date: 2029-03-31 date: 2024-03-07 date: 2024-03-07 name: Johns Hopkins University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH. conditions: Heart Failure With Reduced Ejection Fraction conditions: Pulmonary Hypertension conditions: Right Heart Failure Due to Left Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Diagnostic accuracy based on Area Under Curve (AUC) measure: Percentage improvement in ex vivo right ventricular tissue sample measure: Predictive capacity (based on likelihood ratio) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299423 id: 3677 briefTitle: Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients acronym: PeRseo overallStatus: RECRUITING date: 2023-11-22 date: 2025-06-30 date: 2025-11-30 date: 2024-03-07 date: 2024-03-08 name: Istituto Clinico Humanitas class: OTHER briefSummary: Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring. conditions: Inflammatory Bowel Diseases conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Single-center, interventional, case-series study with a historical cohort of comparison primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Howdy Senior® device measure: Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV) measure: Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI) measure: Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S) measure: Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery measure: 90-day postoperative complications measure: Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV) measure: Healthcare costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False
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<|newrecord|> nctId: NCT06299410 id: ITI-1284-008 briefTitle: PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-07 date: 2024-03-07 name: Intra-Cellular Therapies, Inc. class: INDUSTRY briefSummary: The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: ITI-1284 10 mg name: ITI-1284 20 mg measure: % Receptor occupancy measure: Pharmacokinetics: AUC0-t measure: Pharmacokinetics: Cmax measure: Pharmacokinetics: Tmax measure: Percentage of subjects with treatment-emergent adverse events measure: Change from baseline in ECG QT interval measure: Change from baseline in aspartate aminotransferase measure: Change from baseline in alanine aminotransferase sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Site 1 city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 hasResults: False
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<|newrecord|> nctId: NCT06299397 id: Inonu-SBF-4 briefTitle: Breastfeeding Education and Humor-Based Practices on Breastfeeding overallStatus: COMPLETED date: 2023-06-14 date: 2023-07-14 date: 2024-02-14 date: 2024-03-07 date: 2024-03-12 name: Inonu University class: OTHER briefSummary: The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'. conditions: Humor as Topic conditions: Breast Feeding conditions: Mother-Child Relations conditions: Breastfeeding, Exclusive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants determined by the researchers before starting the study were divided into experimental and control groups by randomization method. Humor-based breastfeeding education was given to women in the experimental group for 35-45 minutes once a week for 2 weeks on specified days and hours. Breastfeeding education was given in practice. Then, humor was practiced with songs and clown costumes. An interim test was administered one month after this application and a final test was administered three months later. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: After randomization was performed by a researcher independent of the study, it was decided by lottery method which group would be the experiment and which group would be the control group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 64 type: ACTUAL name: breastfeeding - humor training name: Control Group measure: Breastfeeding Motivation Scale measure: Maternal Attachment Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Simge OZTURK city: Bartin zip: 74100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False
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<|newrecord|> nctId: NCT06299384 id: R44MH133517 type: NIH link: https://reporter.nih.gov/quickSearch/R44MH133517 briefTitle: The Use of Voice-Based AI in 988 Crisis Counseling overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-06 date: 2026-08 date: 2024-03-07 date: 2024-03-07 name: Lyssn.io, Inc. class: INDUSTRY name: ProtoCall Services, Inc. briefSummary: Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. Our goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities. conditions: Suicide conditions: Suicide and Self-harm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: LyssnCrisis measure: Post-Call Survey measure: Call-taker crisis counseling fidelity measure: System Usability Scale (SUS) measure: Acceptability of Intervention Measure; AIM measure: Intervention Appropriateness Measure; IAM measure: Feasibility of Intervention Measure; FIM sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299371 id: MA-NSCLC-II-033 briefTitle: Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2029-04-15 date: 2024-03-07 date: 2024-03-07 name: Liaoning Tumor Hospital & Institute class: OTHER briefSummary: This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Adebrelimab name: paclitaxel for injection (albumin bound) name: Cisplatin or Carboplatin measure: Pathological complete response rate measure: Major pathologic response rate measure: R0 rate measure: Event Free Survival measure: Overall Survival measure: Objective response rate measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299358 id: KMU_MPEPE_1 briefTitle: Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-06 date: 2024-08-15 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Infantile colic is a developmental disorder that reduces comfort levels in infants with intense crying crises and has negative effects on the infant and family. The study is planned to measure the effect of the combination of maternal heart sound simulation, aromatic foot massage and maternal heart sound simulation and aromatic foot massage on the colic and comfort levels of infants with infantile colic. It is aimed to alleviate colic symptoms, increase comfort levels, regulate daily crying and sleep durations (increase in sleep durations, decrease in crying durations) and support the development of infants in this context by using maternal heart sound simulation, aromatic foot massage and their combined application. conditions: Nurse's Role conditions: Infantile Colic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Type and Purpose of the Study The study was designed as a randomized experimental study. Sample of the Study G\* Power 3.1.9.7. program was used to calculate the sample size (Faul et al., 2007). As a result of the analysis, the sample size was calculated as 28 people for each of the three groups, and considering the possible data losses, it was decided to take 30 people for each group.
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In the study, computer-aided randomization (random.org) program was used to determine the groups. Stratified randomization was preferred to ensure group similarity. In stratification, the number of weeks of age, gender and feeding patterns of the babies were used. After stratification, block randomization was used to decide which group the babies would be in.
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SPSS 22.0 package program will be used for data analysis. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In the study, interviews will be conducted at different times so that mothers or caregivers do not encounter mothers/caregivers in other groups. In this way, participant blinding will be ensured. Since the study will be conducted with newborns, no study will be conducted on other blinding techniques and biases. In order to prevent bias in the data evaluation process, each baby will be numbered by the researcher during the application and these numbers will be used by the statistical expert in statistical evaluations. The statistical expert will not learn the identity information of the participants and will only perform statistics according to the numbering. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Foot massage name: Mother heart sound name: Foot massage and maternal heart sound measure: Changes in colic scale ratings induced by maternal heart sound measure: Changes in comfort scale ratings as a result of maternal heart sound measure: Changes in colic scale assessments induced by foot massage measure: Changes in comfort scale assessments induced by foot massage sex: ALL minimumAge: 2 Weeks maximumAge: 16 Weeks stdAges: CHILD facility: Karamanoglu Mehmetbey University city: Karaman state: Center zip: 70100 country: Turkey lat: 37.18111 lon: 33.215 hasResults: False
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<|newrecord|> nctId: NCT06299345 id: 1870394-1 briefTitle: The Effect of Motor Imagery Dosage on Motor Learning in Healthy Adults overallStatus: COMPLETED date: 2022-03-01 date: 2022-04-20 date: 2022-04-28 date: 2024-03-07 date: 2024-03-12 name: Ahmed Mahmoud Kadry class: OTHER name: Concordia University Wisconsin briefSummary: The goal of this clinical trial is to compare the effects of different durations of Motor Imagery (MI) practice and physical practice on motor performance enhancement in healthy adults. The main questions it aims to answer are:
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* Does Motor Imagery (MI) practice improve motor performance?
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* How do different doses of MI practice (low vs. high) compare to no MI practice in enhancing motor performance?
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Participants:
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* Be randomly assigned to one of three groups: no MI practice (control group), low dose MI practice (6 minutes per session), or high dose MI practice (12 minutes per session).
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* Complete nine sessions over three weeks, practicing a timed mirror tracing task.
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* Have their performance measured in each session by the time taken to complete the task and the number of errors made.
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Compared the control group, low dose MI group, and high dose MI group to see if there are significant differences in motor performance enhancement, aiming to determine the effectiveness of MI and the optimal dose for practice. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: The participants were blinded about which group they were allocated (control or intervention) whoMasked: PARTICIPANT count: 27 type: ACTUAL name: Motor imagery training name: NO motor imagery training measure: Time measure: Errors sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Concordia University Wisconsin city: Mequon state: Wisconsin zip: 53097 country: United States lat: 43.21573 lon: -88.02962 facility: Kafrelshaikh University city: Kafr Ash Shaykh zip: 12623 country: Egypt lat: 31.11174 lon: 30.93991 hasResults: False
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<|newrecord|> nctId: NCT06299332 id: DO611503A briefTitle: Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction overallStatus: RECRUITING date: 2023-06-23 date: 2024-05 date: 2025-05 date: 2024-03-07 date: 2024-03-07 name: InMode MD Ltd. class: INDUSTRY briefSummary: The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED). conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open-label clinical study. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Device treatment measure: Change in ED symptoms, following the RF treatment measure: Change in sexual activity leading to optimal penetration measure: Evaluate efficacy of the RF treatment for erectile function measure: Evaluate efficacy of the RF treatment for erectile function measure: Evaluate efficacy of the RF treatment for erectile function measure: Evaluate efficacy of the RF treatment for hardness of erection measure: Measuring pain level during the procedure sex: MALE minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LC Medical 140 W 58th St, Suite A New York, NY 10019 status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Lanna Cheuck role: CONTACT phone: 929-492-2052 lat: 40.71427 lon: -74.00597 facility: Washington Heights Urology status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Robert Valenzuela role: CONTACT phone: 212-781-9696 lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06299319 id: 149-2021 briefTitle: Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD acronym: PAP-OCD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-09 date: 2024-03-07 date: 2024-03-07 name: Centre for Addiction and Mental Health class: OTHER briefSummary: Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD).
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The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Psilocybin measure: Feasibility of administering psilocybin (25 mg) in adults with treatment-resistant OCD measure: Incidence of adverse events (Safety and Tolerability) measure: Change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score from baseline measure: Proportion of participants who respond to treatment measure: Changes in Patient Health Questionnaire (PHQ-9) from Baseline to Week 3 measure: Change in the Clinical Global Impression (CGI) scale from Baseline to Week 3 measure: Change in the World Health Organization Quality of Life Short Version (WHOQOL-BREF) score from Baseline to Week 3 measure: Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) from Baseline to Week 3 measure: Change in Generalized Anxiety Disorder (GAD-7) scores from Baseline to Week 3 measure: Changes in behavioural assessments for well-being (Warwick-Edinburgh Mental Wellbeing Scale; WEMWBS) from Baseline to Week 3 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-20 uploadDate: 2024-02-14T17:40 filename: Prot_SAP_000.pdf size: 879497 hasResults: False
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<|newrecord|> nctId: NCT06299306 id: D3250R00116 briefTitle: REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma acronym: REACT-Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-01-31 date: 2026-01-31 date: 2024-03-07 date: 2024-03-21 name: AstraZeneca class: INDUSTRY briefSummary: This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany. conditions: Asthma, Bronchial studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1650 type: ESTIMATED measure: Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment. measure: Changes in the AIRQ® total score measure: Bi-weekly changes in the AIRQ® total score over time measure: Changes in the AIRQ® impairment domain score measure: Changes in the AIRQ® risk domain score measure: Proportion of patients with prescribed use of oral corticosteroids (OCS) measure: Proportion of patients with self-reported OCS use measure: Proportion of patients with a change in other asthma therapies measure: Treatment switches (change in prescribed therapies) over time and time on treatment. measure: Assessment of the patient satisfaction with digital and analog healthcare measure: Assessment of the patient-reported 1-year prior healthcare utilization measure: Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare measure: Assessment of the provider preferences in digital versus analog healthcare monitoring. measure: Assessment of the patient preferences towards remote monitoring and healthcare delivery. measure: Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS measure: Changes in laboratory parameter - IgE level measure: Changes in lung function parameters - Tiffenau-Index measure: Correlations between environmental factors and patients' asthma exacerbations measure: Correlation between environmental factors and changes in AIRQ® score measure: Changes in laboratory parameter - blood eosinophil measure: Changes in laboratory parameter - blood neutrophil measure: Changes in laboratory parameter - FeNO measure: Changes in laboratory parameter - C-reactive protein (CRP) level measure: Changes in lung function parameters - FEV1 % sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06299293 id: 21C306 briefTitle: Facial Emotion Recognition in Anorexia Nervosa acronym: FER_AN overallStatus: COMPLETED date: 2023-02-01 date: 2024-02-01 date: 2024-02-01 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER briefSummary: Altered emotional processing is reported in Anorexia Nervosa. However, this capability is generally measured through explicit measures, like self-report questionnaires and facial emotion recognition tasks. Instead, no previous research has investigated implicit emotional processing in this clinical condition. In the implicit facial emotion recognition task grounded on the implicit "redundant target effect", individuals generally respond faster when two identical targets are presented simultaneously rather than when presented alone; moreover, the competitive presence of a distractor (that is another emotion or a neutral expression) affects the correct recognition of the target. The ability to recognize and detect facial expressions is explored about two main emotions, fear and anger, because of their role in the intra- and interindividual psychological processing. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ACTUAL name: Facial Emotion Recognition Test measure: Behavioural measure relative to recognition ability measure: Behavioural measure relative to the detection ability sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe city: Piancavallo state: VCO zip: 28824 country: Italy hasResults: False
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<|newrecord|> nctId: NCT06299280 id: Igdir180 briefTitle: The Effect Of Dual-Task Training On Motor And Cognitive Performance In School-Age Children acronym: Dual-task overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-15 date: 2024-09-01 date: 2024-03-07 date: 2024-03-15 name: Igdir University class: OTHER briefSummary: The aim of the study is to investigate the effect of dual task training on performance in school-age children. Although studies on this subject in the world are limited, a comprehensive study on school-age children is needed.
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MATERIAL AND METHOD:
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* Evaluation will begin by applying demographic information and the Physical Activity Survey for Children.
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* The evaluations to be made will primarily evaluate the child's performance on a single cognitive task in a supported sitting position on a chair, without a motor task.
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* To evaluate single motor performance, a 2-minute walk test and a 30-second sit-stand test will be applied.
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* Dual task evaluations will be carried out by adding a cognitive task while applying the 2-minute walk and 30-second sit-to-stand test.
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* Walking speed will be evaluated with the 10m walk test.
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* Balance parameter will be evaluated with functional reaching test.
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* Using the Visual Analog Scale (VAS), participating children will be asked to score the difficulty of cognitive and motor performance as a number between 0 and 10.
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* Walking speeds will be normalized by measuring lower extremity lengths.
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* The children will be randomly divided into two groups and the study group will be given dual-task training by creating dual-task situations during the activities carried out in physical education classes.
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* After 4 weeks, appropriate analyzes will be made with the data obtained as a result of the evaluations performed by the same evaluator.
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As a result of this study, motor and cognitive performance in single-task conditions in typically developing children will be revealed. Additionally, changes in this performance will be detected in dual-task situations. The gains to be obtained as a result of the training will also reveal the importance of implementing dual task training in school-age children. conditions: Healthy conditions: Child, Only studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomised controlled primaryPurpose: OTHER masking: DOUBLE maskingDescription: double-blind whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: dual task training name: single task training measure: Physical Activity Questionnaire for Children (PAQ-C) measure: Physical Activity Questionnaire for Adolescent (PAQ-A) measure: Single cognitive task performance measure: 2-minute walk test measure: 30-second sit-stand test measure: 10m walk test. (single-task conditions) measure: 10m walk test. (dual-task conditions) measure: functional reaching test. measure: Visual Analog Scale (VAS) measure: lower extremity lengths assessment sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06299267 id: Igdir181 briefTitle: The Effect of Dual Task on Manual Skill Performance in Children and Adolescents acronym: Dual-task overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-07-15 date: 2024-03-07 date: 2024-03-07 name: Igdir University class: OTHER briefSummary: The aim of the study is to investigate the effect of dual-task conditions on manual dexterity performance in typically developing young people and children between the ages of 7-18.
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MATERIAL AND METHOD:
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* Demographic information, dominant extremity will be noted and the evaluation will begin by applying the Physical Activity Questionnaire for Children.
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* The evaluations will primarily evaluate the child's performance on a single cognitive task
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* The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or adolescent.
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* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.
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* the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.
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* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the -9-Hole Test and writing a paragraph.
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* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.
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As a result of this study, manual dexterity performance and cognitive performance in single-task conditions in typically developing children and adolescents will be revealed. Additionally, changes in this performance will be detected in dual-task situations. conditions: Child, Only conditions: Adolescent Development studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: dual task conditions measure: single cognitive task measure: Visual Analogue Scale (VAS) measure: 9-Hole Peg Test.-Single task measure: 9-Hole Peg Test and writing a given paragraph.-Dual task measure: writing a given paragraph.-Single task measure: writing a given paragraph.-Dual task sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06299254 id: 21C305 briefTitle: Placebo Effect About Fatigue in Obesity acronym: POF overallStatus: RECRUITING date: 2023-03-01 date: 2024-02-27 date: 2025-03-01 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER name: University of Turin, Italy briefSummary: Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels. conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Placebo-Natural History measure: Behavioural outcome of fatigue measure: The individual level of perceived fatigue sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe status: RECRUITING city: Piancavallo state: VCO zip: 28824 country: Italy name: Federica Scarpina, PhD role: CONTACT phone: +39032351 phoneExt: 4003 email: f.scarpina@auxologico.it hasResults: False
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<|newrecord|> nctId: NCT06299241 id: 01C313 briefTitle: Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity acronym: PREFISAR overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-21 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-07 name: Istituto Auxologico Italiano class: OTHER briefSummary: The primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. The secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient. conditions: Obesity conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED measure: Fat free mass measure: Evaluation of lower limb muscle strength measure: Senior Fitness Test (SFT) measure: Physical performance test (PPT) measure: Fat mass measure: Questionnaire SF-12 (Short Form Health Survey) measure: Oswestry Disability Index questionnaire sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano, Site Piancavallo city: Oggebbio state: Verbania zip: 28824 country: Italy lat: 45.99088 lon: 8.64663 hasResults: False
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<|newrecord|> nctId: NCT06299228 id: HSA briefTitle: Is Sensorimotor Training Effective Following a Distal Radius Fracture? overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-07 date: 2024-04-29 name: Hand Surgery Associates LLC class: OTHER name: Touro University Nevada name: Orthopaedic Specialty Group PC, Fairfield briefSummary: The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist. conditions: Distal Radius Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Experimental Group name: Control Group measure: Active Joint Position Sense (AJPS) measure: Patient Rated Wrist and Hand Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hand Surgery Associates status: RECRUITING city: Olyphant state: Pennsylvania zip: 18447 country: United States name: Nancy Naughton, OTD role: CONTACT phone: 570-780-8681 email: nancynaughton10@gmail.com name: Lori Algar, OTD role: CONTACT phone: 2034514938 email: Lori.Algar@gmail.com lat: 41.46841 lon: -75.60297 hasResults: False
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<|newrecord|> nctId: NCT06299215 id: APHP240044 briefTitle: Factors and Prognosis of Obstructive Pyelonephritis Patients acronym: PYELO-OBS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-01 date: 2026-03-01 date: 2024-03-07 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.
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Most of the available data on this condition comes from small, retrospective, single-centre series.
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To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.
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The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients. conditions: Pyelonephritis conditions: Prognostic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function. measure: Death measure: Stage 3 Acute kidney injury (KDIGO classification) measure: failure to recover renal function measure: the incidence of acute renal failure defined by KDIGO 1 measure: the incidence of acute renal failure defined by KDIGO 2 and 3 measure: the incidence of Renal replacement therapy measure: the incidence of non-recovery of renal fuction measure: The number of days alive without Renal replacement therapy measure: The number of days alive without catecholamines measure: The number of days alive without antibiotics measure: The number of days alive without measure: Death rate sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Saint Louis city: Paris zip: 75010 country: France name: Maxime Dr COUTROT, MD role: CONTACT name: François DEPRET, MD role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06299202 id: 69HCL23_0204 id: ID-RCB type: OTHER domain: 2023-A01905-40 briefTitle: Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy acronym: CERePred overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-03-07 date: 2024-03-07 name: Hospices Civils de Lyon class: OTHER briefSummary: Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment).
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