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<|newrecord|> nctId: NCT06270303 id: 2023-00383-01 briefTitle: Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2036-03-01 date: 2024-02-21 date: 2024-02-21 name: Göteborg University class: OTHER name: Johann Wolfgang Goethe University Hospital name: Charite University, Berlin, Germany name: King's College London name: Queen Mary University of London name: Geistlich Pharma AG name: Vastra Gotaland Region briefSummary: The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?
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200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated. conditions: Periodontitis conditions: Furcation Defects studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The project will be conducted as a two-armed randomized controlled trial in multiple clinical centers. The primary outcome will be assessed at 1 year post-surgery with a subsequent follow-up of 10 years. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Clinical assessments following intervention will be conducted by assessors unaware of group allocation. whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Access flap & surgical debridement name: Application of bone substitute material (BioOss Collagen) measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Patient satisfaction assessed by visual analogue scale. measure: Patient satisfaction assessed by visual analogue scale. measure: Patient discomfort as expressed on a visual analogue scale. measure: Patient discomfort as expressed on a visual analogue scale. measure: Esthetic appreciation as expressed on a visual analogue scale. measure: Esthetic appreciation as expressed on a visual analogue scale. measure: Rate of adverse events. measure: Rate of adverse events. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Change of inflammatory markers. measure: Change of inflammatory markers. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Periodontology, Institute of Odontology city: Göteborg zip: 40530 country: Sweden name: Jan Derks, PhD role: CONTACT phone: 0046 76 618 3124 email: [email protected] name: Jan Derks, PhD role: PRINCIPAL_INVESTIGATOR name: Karolina Karlsson, PhD role: SUB_INVESTIGATOR name: Kostas Bougas, PhD role: SUB_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06270290 id: 327648 briefTitle: The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls acronym: COSP-RBD overallStatus: RECRUITING date: 2024-04-22 date: 2025-03-30 date: 2025-03-30 date: 2024-02-21 date: 2024-04-23 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER briefSummary: The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).
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The main questions it aims to answer are:
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* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?
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* Is this proportion higher to that in control patients without a diagnosis of RBD?
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Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.
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Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ. conditions: REM Sleep Behavior Disorder conditions: Concussion, Brain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 140 type: ESTIMATED name: Exposure to contact sports or history of concussions measure: Proportion of history of contact sports practice / concussion in RBD and control participants. measure: Differences in concussions characteristics between RBD and control participants. measure: Demographic or clinical differences between RBD participants with and without concussions history. sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guy's & St Thomas' NHS Foundation Trust status: RECRUITING city: London zip: SE1 9RT country: United Kingdom name: Gill Radcliffe role: CONTACT phone: 02071888070 email: [email protected] lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06270277 id: 30.01.2024-4272 briefTitle: Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease overallStatus: COMPLETED date: 2024-02-14 date: 2024-02-20 date: 2024-02-21 date: 2024-02-21 date: 2024-02-22 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues. conditions: Inflammatory Bowel Diseases conditions: Psychosocial Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adolescents with Inflammatory bowel diseases and healthy control group in same age will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). primaryPurpose: DIAGNOSTIC masking: NONE count: 159 type: ACTUAL name: Pediatric Quality of Life Inventory (PedsQL) name: Strengths and Difficulties Questionnaire (SDQ) measure: Pediatric Quality of Life Inventory (PedsQL) score measure: Strengths and Difficulties Questionnaire (SDQ) sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Sisli Hamidiye Etfal Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06270264 id: 111-2023 briefTitle: Nociception Monitoring in Intensive Care overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-15 date: 2024-01-01 date: 2024-02-21 date: 2024-02-21 name: Haseki Training and Research Hospital class: OTHER briefSummary: Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care. conditions: Unconscious State conditions: Pressure Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, prospective and controlled primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: the Nociception level index monitoring measure: total fentanyl consumption measure: systolic blood pressure measure: heart rate sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital city: Istanbul state: Sultangazi country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06270251 id: PSYCH-2023-32292 briefTitle: Modeling Tic Change During Behavior Therapy for Tics overallStatus: RECRUITING date: 2024-03-01 date: 2028-03-01 date: 2028-09-01 date: 2024-02-21 date: 2024-04-01 name: University of Minnesota class: OTHER briefSummary: Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.
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CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.
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The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. conditions: Chronic Tic Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CBIT measure: Tic Severity measure: Sheehan Disability scale measure: Behavior Rating Inventory of Executive Function measure: Ask Suicide-Screening Questions (ASQ) measure: Child Attitudes Toward Illness Scale (CATIS) measure: Rosenberg Self-Esteem Scale measure: Caregiver Strain Questionnaire measure: Clinical Global Impressions (CGI) measure: Parent/Adult Tic Questionnaire measure: Premonitory Urge for Tics Scale measure: Tic Suppression Task measure: Stop signal task sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Brianna Wellen role: CONTACT lat: 44.97997 lon: -93.26384 hasResults: False
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<|newrecord|> nctId: NCT06270238 id: 2023-11-164 briefTitle: Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients overallStatus: RECRUITING date: 2024-02-13 date: 2025-09-30 date: 2025-09-30 date: 2024-02-21 date: 2024-02-29 name: Samsung Medical Center class: OTHER name: National Research Foundation of Korea name: Ministry of Food and Drug Safety, Korea name: Seoul National University Hospital name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: Severance Hospital name: Kumoh National Institute of Technology name: NEUROPHET briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: High-Frequency1 name: cTBS1 name: High-Frequency2 name: cTBS2 name: High-Frequency3 name: cTBS3 measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Won Hyuk Chang, PhD role: CONTACT phone: +82-2-3410-6068 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06270225 id: SSGJ-613-PGF-II-01 briefTitle: A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. overallStatus: RECRUITING date: 2024-03-30 date: 2024-06 date: 2024-12 date: 2024-02-21 date: 2024-04-10 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment. conditions: Gout Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg name: Colchicine 0.5 mg measure: Numbers of acute gout flares measure: Numbers of acute gout flares measure: Proportions of subjects with at least 1 acute gout flare measure: Proportions of subjects with at least 1 acute gout flare measure: Time from randomization to first acute flare. measure: Duration of acute gout flares. measure: Duration of acute gout flares. measure: Subject's overall assessment of response to treatment measure: Investigator's overall assessment of response to treatment measure: 36-item Short Form Survey (SF-36) measure: Adverse events (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Huashan Hospital Fudan University-Rheumatology status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China name: Hejian Zou, MD role: CONTACT phone: +86 13311881366 email: [email protected] name: Hejian Zou role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06270212 id: CIV-ID 23-08-043797 briefTitle: Medical Device for Airway Patency During Sedation acronym: STAIRWAY-2 overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Stairway Medical AB class: INDUSTRY name: Lund University briefSummary: OVERALL SYNOPSIS
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PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants
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* of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position
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* of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position.
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PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration
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* of adjuvant manual airway support and ventilation
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* of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\])
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* of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and
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* of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients. conditions: Airway Obstruction conditions: Sedation Complication conditions: Perioperative Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective randomized unpaired, and paired crossover, evaluations of study outcome measures in healthy volunteer study participants (PART A), and prospective randomized unpaired evaluation of study outcome measures in study patients (PART B).
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The number of arms reported below (3) refers to unpaired comparisons (PARTS A-B). primaryPurpose: PREVENTION masking: SINGLE maskingDescription: For practical reasons, study participants, sedationists and study investigators on site cannot be masked to study interventions.
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However, procedural interventionists on site and study investigators scrutinizing study outcome data will be masked to study interventions.
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The number of enrolled study participants reported below (46) refers to evaluable ones. whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: STAIRWAY name: NO DEVICE measure: Transpharyngeal distance during moderate-to-deep steady-state sedation. measure: Duration of manual airway support during PS for clinical procedures. measure: Transpharyngeal distance during mild steady-state sedation. measure: Duration of interrupted capnometric monitoring during sedation. measure: Duration of manual airway support during induction of steady-state sedation. measure: Sedational comfort measure: Conditions for sedation measure: Conditions for procedural intervention sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Malmö state: Skåne zip: 20502 country: Sweden name: Magnus Ljungvall, MD role: CONTACT phone: +46-705445502 email: [email protected] name: Jonas Åkeson, PhD, Professor role: CONTACT phone: +46-708311113 email: [email protected] lat: 55.60587 lon: 13.00073 hasResults: False
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<|newrecord|> nctId: NCT06270199 id: PULMESCELL-2 briefTitle: Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia. overallStatus: RECRUITING date: 2024-01-11 date: 2025-12 date: 2026-12 date: 2024-02-21 date: 2024-02-21 name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal class: OTHER briefSummary: Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients. conditions: Bronchopulmonary Dysplasia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Group Assignment primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Control name: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions name: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions measure: Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia measure: feasibility variable measure: Incidence of BPD and PH in very low birth weight babies treated with MSC measure: Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen measure: Exitus on week 36 and 40 of post-menstrual age or at hospital discharge measure: Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. measure: Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs). measure: Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. measure: Changes in modified respirator score during therapy and up to week 36 of port-menstrual age measure: Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age measure: Date of hospital discharge and respiratory care at discharge. measure: Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). measure: Duration of invasive and non-invasive mechanical ventilation. measure: Use of postnatal corticosteroids indicated measure: Respiratory readmission rates. measure: Bayley Neurodevelopmental Scale at 24 months measure: Date and cause of death. sex: ALL minimumAge: 1 Month maximumAge: 28 Weeks stdAges: CHILD facility: Complejo Hospitalario La Coruña status: RECRUITING city: La Coruña country: Spain name: Alejandro Dávila role: CONTACT lat: 43.37135 lon: -8.396 facility: Hospital Clínico San Carlos status: RECRUITING city: Madrid country: Spain name: Luis Arruza role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario La Paz status: RECRUITING city: Madrid country: Spain name: Paloma Lopez role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Carlos Haya status: RECRUITING city: Málaga country: Spain name: Tomás Sánchez Tamayo role: CONTACT lat: 36.72016 lon: -4.42034 facility: Hospital Vírgen del Rocío status: RECRUITING city: Sevilla country: Spain name: Antonio Pavón Delgado role: CONTACT name: María José Moreno Valera role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: Hospital Universitario y Politécnico La Fe status: RECRUITING city: Valencia country: Spain name: Máximo Vento role: CONTACT lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06270186 id: 20-AOIP-04 briefTitle: Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach acronym: GoodDiagNMD overallStatus: WITHDRAWN date: 2023-11 date: 2024-11 date: 2024-11 date: 2024-02-21 date: 2024-02-21 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Type 1 myotonic dystrophy (MD1) is a genetic and hereditary disease that primarily affects muscle tissue, resulting in myotonia (difficulty relaxing after contraction) and atrophy (progressive muscle weakening with decreased muscle volume). It also affects eyes, heart, endocrine system, gastrointestinal system and central nervous system. Specific cognitive abilities are impaired in patients with MD1 such as attention, visio-spatial or visio-building abilities as well as executive dysfunctions.
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Currently, the cognitive assessment of MD1 patients is based on classical neuropsychological tests, which are time-consuming and require a MD1 expert neuropsychologist. Moreover, it is usually very difficult for MD1 patients to accept performing these tests, and when they agree to perform them, they usually give up before the end. This finding is more frequent in MD1 patients with high level of cognitive impairment.
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In order to overcome these difficulties in assessing cognitive functions of MD1 patients, the investigators decided to use innovative tools such as virtual reality, which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet, glasses and joysticks.
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The start-up My Cyber Royaume from Lille, in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi, have developed a software "Good Diag NMD" which uses virtual reality to assess cognitive disorders, more specifically executive functions in patients with type 1 myotonic dystrophy. conditions: Myotonic Dystrophy 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 0 type: ACTUAL name: Type 1 myotonic dystrophy measure: Evaluate the feasibility of the use "Good Diag NMD" software in the evaluation of cognitive executive dysfunctions in patients with dystrophy myotonia 1 measure: Establish a possible relationship between the genotype of DM1 patients and the scores obtained during "Good Diag NMD" session measure: To compare the satisfaction score of type 1 myotonic dystrophy patients between classic neuropsychological tests and the Good Diag NMD session measure: Compare the scores of "Good Diag NMD" session (scores of perseveration, inhibition and flexibility) with the scores of the classical neuropsychological tests measure: Establish a possible correlation between the severity of the disease, the severity of muscular impairment and the scores of Good Diag NMD session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270173 id: TWM-C-2202 briefTitle: Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures overallStatus: RECRUITING date: 2024-02-16 date: 2025-07-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Wiltrom Co., Ltd. class: INDUSTRY name: Maxis Medical GmbH briefSummary: The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis. conditions: Osteoporotic Vertebral Compression Fractures studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) measure: Proportion of participants with study success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Friedrichshafen status: NOT_YET_RECRUITING city: Friedrichshafen state: Baden-Württemberg zip: 88048 country: Germany name: Ludwig Oberkircher, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 47.65689 lon: 9.47554 facility: University Hospital Mannheim status: NOT_YET_RECRUITING city: Mannheim state: Baden-Württemberg zip: 68167 country: Germany name: Frederic Bludau, PD Dr med role: PRINCIPAL_INVESTIGATOR lat: 49.4891 lon: 8.46694 facility: Johann Wolfgang Goethe University Frankfurt/Main status: NOT_YET_RECRUITING city: Frankfurt am Main state: Hesse zip: 60596 country: Germany name: Thomas Vogl, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 50.11552 lon: 8.68417 facility: Krankenaus Mechernich status: RECRUITING city: Mechernich state: North-Rhine-Westphalia zip: 53894 country: Germany name: Robert Pflugmacher, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 50.59304 lon: 6.65224 hasResults: False
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<|newrecord|> nctId: NCT06270160 id: KampalaLivelihoodsStudy briefTitle: Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda overallStatus: RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-12-31 date: 2024-02-21 date: 2024-03-01 name: University of Toronto class: OTHER briefSummary: Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.
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Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala. conditions: Financial Stress conditions: Social Functioning conditions: Social Skills studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey after the study is complete. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 432 type: ESTIMATED name: HIVST name: mHealth name: Creating Futures Livelihoods program measure: Number of participants engaged in HIV testing measure: Number of participants with knowledge of their HIV status measure: Number of participants linked to confirmatory HIV testing measure: Frequency of linkage to HIV care measure: Brief HIV Knowledge Questionnaire measure: Sexual Risk sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Young African Refugees for Integral Development status: RECRUITING city: Kampala country: Uganda name: Robert Hakiza role: CONTACT phone: 256 2009 12345 email: [email protected] lat: 0.31628 lon: 32.58219 hasResults: False
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<|newrecord|> nctId: NCT06270147 id: 16935 briefTitle: Timing of TAP Blocks in Bariatric Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-06-28 date: 2024-06-28 date: 2024-02-21 date: 2024-02-21 name: McMaster University class: OTHER briefSummary: This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs. conditions: Opioid Use conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Bupivacaine-epinephrine measure: Opioid Consumption measure: Length of Stay measure: Anesthesia requirements measure: Sedation requirements measure: Nausea and vomiting measure: Respiratory Status measure: Opioid consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270134 id: 14410 briefTitle: Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2029-01 date: 2029-01 date: 2024-02-21 date: 2024-02-21 name: McMaster University class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel. conditions: Hemolysis conditions: Renal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. primaryPurpose: TREATMENT masking: NONE count: 5000 type: ESTIMATED name: Bicarbonate measure: Non-elective hospitalizations or mortality measure: Hospitalizations and fractures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270121 id: R2111483 briefTitle: Development of a Healthcare Service Platform for Successful Aging overallStatus: RECRUITING date: 2020-10-21 date: 2026-11-30 date: 2030-11-30 date: 2024-02-21 date: 2024-02-21 name: Sunmi Song class: OTHER briefSummary: The goal of this living-lab clinical trial is to test the effectiveness of digital health monitoring and feedback platform for community dwelling older adults. The main questions it aims to answer are:
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* Identify digital sensing variables that are predictive of mental and physical health declines and health emergencies of older adults
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* Develop digital health monitoring service to inform individualized daily health status of older adults users
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* Develop ICT network to share the daily health status and emergency signals with community based healthcare service providers and family caregivers if an older adult user approves of them to receive their health information.
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Participants will be asked to participate in a living lab using a wearable sensor, motion sensor, and smartphone applications for 6 weeks and also take part in pre-mid-post surveys to evaluate the usability, accuracy, and effectiveness of the digital healthcare service platform to improve health managements and connections with community and family caregivers.
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If there is a comparison group: Researchers will compare age and gender matched control group to see if health status of the living-lab group is better than the control group. conditions: Depression in Old Age conditions: Chronic Pain conditions: Sleep Disorder Insomnia Chronic studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Control group was informed that they participated in the study with a repeated measure survey about digital healthcare for elderly without detailed descriptions on the living-lab intervention. whoMasked: PARTICIPANT count: 84 type: ESTIMATED name: Living-lab digital intervention group measure: Patient Health Questionnaire-9 (PHQ-9) measure: Sleep fragmentation index measure: Daily steps measure: Intensity of physical activity measure: Heart rate variability measure: Geriatic depression measure: SF-12 Quality of life measure: Pain related functional limitations measure: Chronic pain sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Korea University status: RECRUITING city: Seoul zip: 02841 country: Korea, Republic of name: Sunmi Song, PhD role: CONTACT phone: +821087489593 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06270108 id: 22/SS/0040 id: 299382 type: OTHER domain: Integrated Research Application System briefTitle: The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia acronym: RESTORE overallStatus: RECRUITING date: 2022-11-14 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-03-05 name: King's College London class: OTHER name: South London and Maudsley NHS Foundation Trust briefSummary: The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are:
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To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy.
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To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline.
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To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures.
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To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology.
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The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia. conditions: Treatment-resistant Schizophrenia conditions: Treatment-responsive Schizophrenia conditions: Healthy Controls studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a basic science study the purpose of which is to to explore the responsivity of glutamate in treatment-resistant schizophrenia to a given challenge (riluzole). primaryPurpose: BASIC_SCIENCE masking: NONE count: 288 type: ESTIMATED name: Riluzole measure: Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration measure: Correlation of glutamate (using magnetic resonance spectroscopy) with brain functional measures at baseline (using functional magnetic resonance imaging) measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with longitudinal change in brain functional measures (using functional magnetic resonance imaging) measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with changes in psychopathology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Psychiatry, Psychology and Neuroscience status: RECRUITING city: London zip: SE5 8AB country: United Kingdom name: James Scott role: CONTACT phone: +44 207 848 0002 email: [email protected] name: Guy Gitlin-Leigh role: CONTACT email: [email protected] name: Oliver D Howes role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06270095 id: C21-57 briefTitle: " Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft" acronym: AVISAN overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-04 date: 2024-02-21 date: 2024-02-21 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV name: Université Paris Cité name: National Agency for Sanitary Safety of the Food of the Environment and Labor briefSummary: The subject of the study focuses on commercial aircraft's cabins air quality, under conditions of both fume events and non-fume events. It also delves into the immediate and delayed repercussions of these events on the health of aviation crew members. The expological facet of this study is directed at the detection and quantification of organophosphorus compounds originating from engine oils. The epidemiological facet is geared towards the identification of potential neurological consequences. conditions: Neurologic Symptoms conditions: Neurologic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: Neurocognitive, neuromuscular and neurosensitive tests. measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge measure: Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies measure: Neuromuscular test to evaluate muscle strength assessment measure: Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight measure: Characteristics of plane and fume event and possible causes of fume event measure: Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe. sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270082 id: IK595-001 briefTitle: Study of IK-595 in RAS- or RAF-altered Advanced Tumors overallStatus: RECRUITING date: 2023-12-18 date: 2027-07 date: 2027-07 date: 2024-02-21 date: 2024-03-12 name: Ikena Oncology class: INDUSTRY briefSummary: This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit. conditions: Solid Tumor, Adult conditions: Colorectal Cancer conditions: Pancreatic Cancer conditions: Malignant Melanoma conditions: Ras (Kras or Nras) Gene Mutation conditions: BRAF Gene Mutation conditions: CRAF Gene Mutation conditions: Non-Small Cell Lung Carcinoma conditions: Thyroid Carcinoma conditions: Gliomas, Malignant studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Dose Escalation: BOIN design Dose Expansion: 4 genetically/molecularly defined cohorts using Simon 2-stage adaptive design primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: IK-595 measure: Treatment-emergent adverse events, including treatment-related adverse events, and serious adverse events measure: Dose Limiting Toxicities measure: Treatment-Emergent Adverse Events measure: Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595 measure: Pharmacokinetics of IK-595: half-life (t1/2) measure: Pharmacokinetics of IK-595: Area Under the Curve (AUC) measure: Pharmacokinetics of IK-595: Maximum Plasma Concentration (Cmax) measure: Pharmacokinetics of IK-595: Minimum Plasma Concentration (Cmin) measure: To evaluate pERK fold change from baseline in paired tumor biopsies measure: Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-595 as a single agent measure: Antitumor activity: Median progression-free survival (PFS) of IK-595 as a single agent measure: Antitumor activity: Median overall survival (OS) of IK-595 as a single agent sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Midwest status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States name: Jacob Goldberg, BA role: CONTACT phone: 616-954-5554 email: [email protected] name: Nehal J Lakhani, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 42.96336 lon: -85.66809 facility: University of Pittsburgh Medical Center- Hillman Cancer Center status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Jason Luke, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: Sarah Cannon Research Institute status: NOT_YET_RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States name: Meredith McKean, MD role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Next Oncology- San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Carmen Gonzalez role: CONTACT phone: 210-580-9521 email: [email protected] name: Anthony W Tolcher, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: Next Oncology- Virginia Cancer Specialists status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Blake Paterson role: CONTACT phone: 703-783-4505 email: [email protected] name: Alexander Spira, MD role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 hasResults: False
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<|newrecord|> nctId: NCT06270069 id: 2024-001 briefTitle: Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-28 date: 2025-02-28 date: 2024-02-21 date: 2024-02-21 name: International Institute of Behavioral Medicines class: OTHER briefSummary: This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. Relationships among the different outcome measures will be also evaluated. conditions: Low Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Excercise-based therapy measure: NRS measure: Gauge of pain measure: ODI measure: PCS measure: TSK measure: PSEQ measure: GPE sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270056 id: 1058 briefTitle: Evaluation of Telemedicine Medical Abortion Service in Ecuador overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-02 date: 2025-02 date: 2024-02-21 date: 2024-02-21 name: Gynuity Health Projects class: OTHER briefSummary: This research seeks to demonstrate that a telemedicine model for the provision of legal abortion services in Ecuador is safe, feasible and acceptable to users requesting a medication abortion and who are less than 12 weeks pregnant. conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Misoprostol measure: Adverse events (safety) measure: Feasibility of telemedicine service measure: Acceptability of telemedicine service sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: El Comité de Derechos Sexuales y Reproductivos de Ecuador (CODESER) city: Ambato country: Ecuador name: Maria Fernanda Morales role: CONTACT phone: 593 998220369 email: [email protected] lat: -1.24908 lon: -78.61675 facility: Cemoplaf city: Quito country: Ecuador name: Gabriela Rivera role: CONTACT phone: 593 995512828 email: [email protected] lat: -0.22985 lon: -78.52495 facility: Federación Nacional de Obstetrices y Obstetras del Ecuador (FENOE) city: Quito country: Ecuador name: Paola Tito role: CONTACT phone: 593 22951737 email: [email protected] lat: -0.22985 lon: -78.52495 hasResults: False
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<|newrecord|> nctId: NCT06270043 id: 809622 briefTitle: Focal Therapy for Localized Prostate Cancer overallStatus: RECRUITING date: 2024-02-01 date: 2034-02-01 date: 2034-02-01 date: 2024-02-21 date: 2024-02-26 name: University of California, San Diego class: OTHER briefSummary: This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Focal Therapy measure: Oncological Response measure: Erectile Dysfunction measure: Incontinence measure: Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego status: RECRUITING city: La Jolla state: California zip: 92121 country: United States name: Juan Javier-DesLoges, MD role: CONTACT phone: 858-657-8786 email: [email protected] lat: 32.84727 lon: -117.2742 hasResults: False
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<|newrecord|> nctId: NCT06270030 id: JX07002 id: CTR20240460 type: OTHER domain: China Center for Drug Evaluation (CDE), NMPA briefTitle: Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia overallStatus: COMPLETED date: 2024-03-04 date: 2024-04-10 date: 2024-04-10 date: 2024-02-21 date: 2024-04-23 name: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. class: INDUSTRY name: LENZ Therapeutics, Inc briefSummary: Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia conditions: Presbyopia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 21 type: ACTUAL name: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution name: LNZ100 (Aceclidine) ophthalmic solution name: Placebo (Vehicle) ophthalmic solution measure: Cmax measure: Tmax measure: AUC0-t measure: AUC0-∞ measure: T1/2 measure: Safety: adverse event reporting sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai General Hospital city: Shanghai state: Shanghai zip: 200080 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06270017 id: 282242 briefTitle: Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer Using Zebra Fish Avatars acronym: ZEBRA-COLON overallStatus: RECRUITING date: 2022-01-10 date: 2025-12-31 date: 2028-12-31 date: 2024-02-21 date: 2024-02-21 name: University Hospital, Linkoeping class: OTHER briefSummary: In order to improve and individualize cancer treatment personalized treatments developed much further. Colon cancer is treated with surgery and thereafter adjuvant oncological treatment. The selection of chemotherapy is today mainly done according to best guess. Today only a small fraction of oncological treatment may be known to be effective in a person before treatment start, most often it is trial and error. A fast reliable system for looking at response to different treatments in each unique patient is much needed and would, if successful, completely change the way we give oncological treatment today. This system would also be possible to use to evaluate new treatments and if successful, implement in the clinical setting. In this project we will implant a part of the patient's tumour tissue into a zebrafish embryo and evaluate tumour growth and frequency of metastatic disease as well as response to given oncological treatment.
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2.2 Objective: The objective of this project is to explore the usefulness of zebrafish (Danio Rerio) embryo models to determine tumor biology and treatment response in colon cancer. An overarching goal would be, before start of any oncological treatment in a patient, to have evaluated the response of oncological treatment in the zebrafish avatar and only treat with a combination of drugs known to have effect against the patient's own tumour.
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2.3 Study design: This protocol describes a series of prospective studies in different cohorts of patients with colon cancer to investigate the applicability of zebrafish embryo models. The common denominator of the sub-studies is prospective collection of tumor tissue implanted in zebrafish embryos in order to evaluate if the model is robust enough for growing colon cancer tissue and evaluate growth pattern and response to chemotherapy. This study protocol is designed according to and in adherence with the SPIRIT guidelines.
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2.4 Intervention: In all sub-studies the intervention is inoculation of tumor cells in zebrafish embryos followed by observation of tumor behavior and testing of treatments. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Evaluation of patients derived colon cancer tumour cell growth in zebra fish embryos and response evaluation of combinations of chemotherpy primaryPurpose: DIAGNOSTIC masking: NONE count: 300 type: ESTIMATED name: Chemotherapy drug measure: Tumour growth measure: response evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Per Sandström status: RECRUITING city: Linköping state: Ostergotland zip: 58185 country: Sweden name: Per Sandström, Prof role: CONTACT phone: +46734058581 email: [email protected] name: Bergthor Bjornsson, MD PhD role: CONTACT phone: +46101033666 email: [email protected] lat: 58.41086 lon: 15.62157 hasResults: False
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<|newrecord|> nctId: NCT06270004 id: nonsurgical periodontal briefTitle: Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-11-01 date: 2024-12-01 date: 2024-02-21 date: 2024-02-21 name: University of Baghdad class: OTHER briefSummary: 1. To assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months) .
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2. To evaluate the response of clinical periodontal parameters ( plaque index ,bleeding on probing ,probing pocket depth ,clinical attachment loss)following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals (one month and three months) conditions: Non Surgical Periodontal Therapy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: smoker and non smoker patients with unstable periodontitis primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: nonsurgical periodontal therapy measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients. measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients. measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269991 id: SBA23/083 briefTitle: Fascial Anthropometry in Archery Athletes overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-06 date: 2025-09-06 date: 2024-02-21 date: 2024-02-21 name: Hacettepe University class: OTHER briefSummary: In archery, the body morphological and anthropometric characteristics of the prominent athletes change. It is important to examine facial anthropometry, especially since the athlete's equipment touches the facial area, and there are no studies on this subject. The aim of this study is to determine the relationship between facial anthropometric measurements and anthropometry-related parameters and sports performance in archery athletes. conditions: Sports Physical Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: evaluation of cervical region biomechanic measure: fat tissue distribution measure: head circumference measure: extremity circumference measure: extremity lengt measurement measure: knee and elbow diameter measure: nose width measure: chin width measure: face width measure: head width measure: nose protrusion measure: nose lenght measure: head lenght measure: face lenght measure: lip lenght measure: Assessment of Perıpheral Muscle Strength measure: postural analysis measure: Evaluation of shooting performance measure: The seated medicine ball throw (SMBT) measure: Closed Kinetic Chain Upper Extremity Stability Test measure: Upper Quarter Y Balance Test sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Aynur Demirel role: CONTACT phone: +905545295057 phoneExt: 178 email: [email protected] name: Nisanur Kutay role: CONTACT phone: +905515549957 email: [email protected] name: Nisanur Kutay role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06269978 id: OSU-23195 id: NCI-2023-10497 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: R21CA282536 type: NIH link: https://reporter.nih.gov/quickSearch/R21CA282536 briefTitle: Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer overallStatus: RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2025-12-31 date: 2024-02-21 date: 2024-03-27 name: Arjun Mittra class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer. conditions: Metastatic Colorectal Carcinoma conditions: Metastatic Malignant Neoplasm in the Peritoneum conditions: Stage IV Colorectal Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Diagnostic Laparoscopy name: Fluorouracil name: Magnetic Resonance Imaging name: Oxaliplatin name: Surgical Procedure measure: Maximum tolerated dose (MTD) measure: Incidence of adverse events measure: Area under the curve measure: Clearance measure: Volume of distribution measure: Half-life measure: Tumor-cell intrinsic effects in response to IP 5FU+oxaliplatin measure: Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin measure: Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin measure: Rate of conversion from unresectable to resectable measure: Overall response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Arjun Mittra, MD role: CONTACT phone: 614-293-6529 name: Arjun Mittra, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06269965 id: 2023-A02181-44 briefTitle: Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair acronym: REGENECUFF overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-15 date: 2027-04-15 date: 2024-02-21 date: 2024-02-29 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream.
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Rotator cuff surgery is an increasingly popular procedure practiced in France. In limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired.
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Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.
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In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing. conditions: Cuff Rotator Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 204 type: ESTIMATED name: Regeneten® adding measure: Rotator cuff healing quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269952 id: MVarmafalk briefTitle: Intimate Partner Violence Among People Who Inject Drugs - Prevalence, Risk Factors and Experiences overallStatus: RECRUITING date: 2023-10-05 date: 2025-03 date: 2028-12 date: 2024-02-21 date: 2024-02-21 name: Region Stockholm class: OTHER_GOV briefSummary: There are around 15,6 million people who inject drugs (PWID) worldwide, of which around 3,5 million are women who inject drugs (WWID) (1). In Sweden, estimates suggest 8000-21000 PWID (2). PWID are exposed to substantial health risks that are directly linked to injection drug use, such as blood borne viruses (hepatitis and HIV), overdoses and skin and tissue infections. Additionally psychiatric disorders are common and PWID's general health is often neglected (3,4,5).
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In Sweden, harm reduction units such as needle and syringe programs (NSP) have scaled-up in recent years. In Stockholm the first NSP opened in 2013 and the second in 2018. In 2022, 4600 individuals were enrolled in the program since it opened, of which approximately 25% were women. Around 2000 were active participants, defined as having visited the program at least once during the last 12 months. In 2021 54% of the participants stated amphetamine as the last drug injected, 31% heroin, 4% buprenorphine and 11% other drugs. Most participants were between 30-49 years of age. In addition to distribution of sterile needles and injection paraphernalia, the NSP staff (nurses, doctors, midwifes, counselors) provides services such as testing for blood borne viruses, vaccinations, wound care, take-home naloxone, reproductive health services, counselling, support in contact with social service and referrals for substance use disorder treatment and hepatitis C/HIV treatment.
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Gender-based violence (GBV) is a global health issue and WHO estimates that one in three women globally have been exposed to some sort of partner violence during their lifespan (7). Intimate partner violence (IPV) is defined as violent behavior between two people who have a close relationship, such as partners, ex-partners, siblings, relatives, friends and alike. In Sweden around 14% of women and 5% of men are exposed to physical violence in an intimate partner relationship during their lifespan however 20-25% of women and around 17% of men are exposed to psychological violence during their lifespan (8; 9). The prevalence of IPV among PWID is estimated to be significantly higher than in the general population (10). A study from USA found the risk of IPV to be three times higher and the prevalence estimated between 35-57% (7). In international studies, IPV exposure is found to be a significant risk factor for needle sharing among WWID (11, 12). There are other well-known consequences of IPV including impact on sexual and reproductive health rights, physical and psychological wellbeing, increased risk of contracting HIV and hepatitis C (13; 14). IPV exposure disproportionately affects WWID worldwide, however studies in Sweden on IPV exposure in the PWID population is scarce. To date there are studies that address this among women with substance use disorders but none with an exclusive focus on PWID or WWID. In clinical research of women diagnosed with substance use disorders (SUD) with psychiatric comorbidities and social challenges, one study indicates that the majority (91%, n=79) of women had been exposed to some form of IPV (15). Another study of women with SUD (n=52), 50% reported exposure of serious violence and the majority (96%) reported exposure to psychological violence (10). There are different types of IPV; psychological, physical, sexual, financial, latent, digital, neglect, honor related, aftermath of IPV (16). Our research team has previously carried out a qualitative interview study among WWID at the Stockholm NSP in 2019 to investigate reasons and barriers for participation among women (17). The interviews illustrated that IPV is common. In the proposed studies, for this doctoral thesis, we have chosen to focus on physical, sexual, psychological and financial violence among PWID motivated by findings in our previous research.
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PWID and specifically WWID are regarded as groups who are especially vulnerable for IPV exposure and should therefore be prioritized in the national efforts to prevent IPV (15). However, there are no studies estimating the prevalence and frequency of IPV among PWID in Sweden. Previous international studies suggest that PWID are exposed to IPV to a greater extent than the general population, and women with substance use disorders are exposed to an alarming degree of violence (15). In Sweden there are no tailored interventions for PWID or WWID who are exposed to IPV, it is reasonable to believe that there is a need for a multi-faceted program for PWID exposed to IPV, however this is still unexplored.
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The overall aim of this project is to increase knowledge about IPV among PWID and WWID as particularly vulnerable groups in regards to IPV. More specifically, the aim is to investigate the prevalence and frequency of different types of IPV among PWID at the Stockholm NSP and to explore the experiences' of IPV, needs and preferences for IPV support among WWID to facilitate tailored support and prevention programs for those exposed. conditions: People Who Inject Drugs, Injection Risk Behaviour, Gender-based Violence, Intimate Partner Violence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: No intervention measure: Intimate partner violence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Needle syringe program status: RECRUITING city: Stockholm country: Sweden name: Malin Värmå Falk role: CONTACT lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06269939 id: R-1253-24 briefTitle: Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and MCI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-30 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Kessler Foundation class: OTHER briefSummary: The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in an aging population. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: STEM measure: Verbal Leaning task measure: Participation in Everyday life measure: Functional Neuroimaging sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kessler Foundation city: East Hanover state: New Jersey zip: 07936 country: United States name: Samantha Schmidt role: CONTACT phone: 973-323-3686 email: [email protected] lat: 40.8201 lon: -74.36487 hasResults: False
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<|newrecord|> nctId: NCT06269926 id: IRB00431182 briefTitle: Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-04 date: 2024-02-21 date: 2024-02-23 name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. class: OTHER name: Johns Hopkins University briefSummary: The purpose of this study is to understand if cognitive behavioral therapy can improve pain-related thought patterns and pain-related impairment in adults with cerebral palsy. conditions: Cerebral Palsy conditions: Pain, Chronic conditions: Pain Catastrophizing conditions: Brain Diseases conditions: Central Nervous System Diseases conditions: Coping Strategies conditions: Catastrophizing Pain conditions: Coping Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators will randomize 40 adults with cerebral palsy and pain-related impairment in daily activities into two study arms: Group 1 (Education-CBT) will receive enhanced usual care (a pain education booklet in addition to usual medical care) followed by Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a once weekly, 12-week group therapy course). Group 2 (CBT-Education) will instead receive CBT-CP first. To maintain reasonable therapy cohort sizes (n=10 per cohort), each group (n=20 participants) will consist of two separate therapy cohorts (n=10 each). Participants will be evaluated at the beginning of the study, and then once every 3 months during the 12-month duration of the study. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Cognitive Behavioral Therapy for Chronic Pain name: Pain education measure: Pain Catastrophizing measure: Global Impressions of Change measure: Pain Interference measure: Pain Intensity measure: Anxiety/Mood symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kennedy Krieger Institute city: Baltimore state: Maryland zip: 21205 country: United States name: Paul Salib, B.S role: CONTACT phone: 443-923-9272 email: [email protected] name: Eric Chin, M.D role: PRINCIPAL_INVESTIGATOR name: Paul Salib, B.S role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06269913 id: 23-0826 briefTitle: A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-02-21 date: 2024-03-26 name: University of Calgary class: OTHER name: Mitacs name: Natural Sciences and Engineering Research Council, Canada briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females. conditions: Iron Deficiencies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FeSC measure: Iron Status measure: Hemoglobin measure: Upper Gut Microbiome measure: Lower Gut microbiome measure: Exercise Capacity measure: Hemoglobin Mass measure: Gastrointestinal Symptoms 1 measure: Gastrointestinal Symptoms 2 measure: Sleepiness measure: Stress and Recovery sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06269900 id: RC23_0358 briefTitle: Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype acronym: HAP-DEX overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2026-03-14 date: 2026-08-15 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial. conditions: Hospital Acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Dexamethasone name: Placebo measure: Clinical cure rate at the test-of-cure visit (TOC visit) measure: The rate of all-cause mortality on Day 28. measure: Rate of death measure: Rate of pleural empyema at Day 28. measure: Rate of microbiological failure measure: Rate of pneumonia relapse measure: Duration of hospitalization and hospital-free days measure: Rates of non-respiratory hospital-acquired infection measure: Antibiotic-free days at Day 28 measure: Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days measure: Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event) measure: Rate of gastric ulcer measure: Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale measure: Changes in subjective well-being with the Satisfaction With Life Scale (SWLS) measure: Changes in health-related quality of life measured with the Short Form (SF)-36 measure: the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Angers city: Angers country: France lat: 47.46667 lon: -0.55 facility: CHU Brest city: Brest country: France name: Xavier CHAPALAIN role: CONTACT email: [email protected] lat: 48.3903 lon: -4.48628 facility: CHU Caen city: Caen country: France name: Clément GAKUBA role: CONTACT email: [email protected] lat: 49.18585 lon: -0.35912 facility: CHU Clermont - Ferrand city: Clermont-Ferrand country: France name: Russell CHABANNE role: CONTACT email: [email protected] lat: 45.77966 lon: 3.08628 facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France name: Pierre COUHAULT role: CONTACT email: [email protected] lat: 45.77966 lon: 3.08628 facility: CHU Beaujon city: Clichy country: France name: Emmanuel WEISS role: CONTACT email: [email protected] lat: 48.90018 lon: 2.30952 facility: CHU Limoges city: Limoges country: France name: Bruno FRANCOIS role: CONTACT email: [email protected] lat: 45.83153 lon: 1.25781 facility: CHU Marseille city: Marseille country: France name: Marc LEONE role: CONTACT email: [email protected] lat: 43.29551 lon: 5.38958 facility: CHU Nancy city: Nancy country: France name: Gérard AUDIBERT role: CONTACT email: [email protected] lat: 48.68439 lon: 6.18496 facility: CHU Nantes (HGRL) city: Nantes zip: 44000 country: France lat: 47.21725 lon: -1.55336 facility: CHU Nantes city: Nantes zip: 44000 country: France name: Antoine ROQUILLY role: CONTACT phone: +33253482835 email: [email protected] lat: 47.21725 lon: -1.55336 facility: CHU Nantes (HGRL) city: Nantes country: France name: Mickael VOURC'H role: CONTACT email: [email protected] lat: 47.21725 lon: -1.55336 facility: CHU Pitié Salpétrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: CHU Poitiers city: Poitiers country: France name: Claire DAHYOT FIZELIER role: CONTACT email: [email protected] lat: 46.58333 lon: 0.33333 facility: CHU Rennes city: Rennes country: France name: Yoann LAUNEY role: CONTACT email: [email protected] lat: 48.11198 lon: -1.67429 facility: CHU Rennes city: Rennes country: France name: Jean-Marc TADIE role: CONTACT email: [email protected] lat: 48.11198 lon: -1.67429 hasResults: False
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<|newrecord|> nctId: NCT06269887 id: Karabuk-001 briefTitle: Dominant Non-Dominant Upper Extremity in Gender overallStatus: RECRUITING date: 2023-11-07 date: 2024-03-15 date: 2024-03-30 date: 2024-02-21 date: 2024-03-12 name: Karabuk University class: OTHER briefSummary: There are strength and functional differences between non-dominant and dominant extremities. This is important in the hand and extremity rehabilitation process. This situation also differs between genders. Comparison of the dominant and non-dominant limb can provide important clinical or rehabilitation field-related information. It is reported in the literature that manual dexterity, grip strength and joint position sense may differ between extremities. However, the relationship between this situation and the difference between genders has not been explained. It is thought that examining this difference can be extremely useful in determining achievable goals in hand rehabilitation and in customizing care for different groups. conditions: Upper Extremity Problem conditions: Gender Issues studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 210 type: ESTIMATED measure: Hand Preference measure: Grip Strength measure: Joint Position Sense measure: Manual Dexterity sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Karabük University status: RECRUITING city: Karabük zip: 78000 country: Turkey name: Metehan YANA Phd role: CONTACT phone: 05072665522 email: [email protected] lat: 41.20488 lon: 32.62768 hasResults: False
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<|newrecord|> nctId: NCT06269874 id: ASPERA-ANOCA id: 20240124 type: OTHER domain: JohannesGU briefTitle: Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment acronym: ASPERA-ANOCA overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2024-07-31 date: 2024-08-31 date: 2024-02-21 date: 2024-02-23 name: Johannes Gutenberg University Mainz class: OTHER briefSummary: The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.
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Goals of this study are:
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1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.
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2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).
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3. Time required for IMR measurements conditions: Microvascular Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized 1:1 to one of the two study arms and then the following study procedures will repeated in cross-over. Randomization will be done by using a computer-generated random sequence (medcalc, mariakerke, BE). primaryPurpose: DIAGNOSTIC masking: DOUBLE maskingDescription: Patients and outcome assessors will be blinded to the randomization group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: microvascular function assessment measure: Agreement between intravenous and intracoronary adenosine responses (IMR) measure: Agreement between secondary parameters and reproducibility as compared with absolute measure: Time required for IMR measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of Cardiology, Cardiology I, university hospital Mainz city: Mainz state: Rheinland-Pfalz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 hasResults: False
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<|newrecord|> nctId: NCT06269861 id: GaziUtipNBDundar003 briefTitle: Comparison of Body Weights Via Visual Estimation, Anthropometric Calculation, and Actual Measured in Critically Ill Patients overallStatus: RECRUITING date: 2023-11-01 date: 2024-08-31 date: 2024-10-31 date: 2024-02-21 date: 2024-02-21 name: Gazi University class: OTHER briefSummary: Rapid and accurate determination of body weight in adult intensive care patients is very important for both calculating target tidal volume during invasive mechanical ventilation support and dose dependent drug administration. In this patient group, measuring actual body weight with a calibrated scale by standing the patient up is often impossible due to acute illness. Instead, estimated body weight determined by health care personnel or estimated body weights calculated according to anthropometric measurements are used. These calculations have some limitations in showing actual body weight, and there is some controversial information in current literature regarding their validity in critically ill patients. There is newly developed patient transfer scale called Marsden M-999® manufactured by Marsden Weighing Machine Group Ltd, which has the advantage of being used in patients who are unable to stand up, in rapidly and accurately measuring the current body weight in critically ill patients. This study aimed to evaluate the validity of these methods by comparing the body weights calculated by visual estimation and various anthropometric methods in critically ill Turkish patients with the actual weight measured by the mentioned scale. conditions: Critically Ill conditions: Body Weight studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SCREENING masking: DOUBLE maskingDescription: To avoid self-calibration, all measurements will be recorded by a different doctor other than the primary care physician.
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The all calculations will be performed by a different doctor other than the primary care physician. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: patient transfer scale measure: determining actual weight measure: determining the ideal estimated body weight in critically ill patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University status: RECRUITING city: Ankara state: Yenimahalle zip: 06560 country: Turkey name: Nazlıhan Boyacı Dündar, assist.prof. role: CONTACT phone: +905054790794 email: [email protected] name: Kamil İnci, assist.prof. role: CONTACT phone: +905442122545 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06269848 id: ITaDeBo briefTitle: Identification of Sports Talents in Boxers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-29 date: 2024-03-11 date: 2024-06-30 date: 2024-02-21 date: 2024-03-01 name: Dynamical Business and Science Society - DBSS International SAS class: NETWORK briefSummary: This study aims to identify sporting talents by profiling a group of young boxers residing in the State of Mexico using unsupervised machine learning methods. This study is supported by Asociación de Boxeo del Estado de México AC (ABEM) and powered by DBSS. conditions: Body Composition conditions: Exercise Test conditions: Psychological Well-Being studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 178 type: ACTUAL measure: Anthropometry-Based Analysis of Adiposity measure: The acceleration of the fists in straight boxing punches measure: Number of punches thrown within a specific timeframe measure: Punch impact force measure: Reactive force index measure: Cardiorespiratory fitness measure: Isometric Mid-Thigh Pull measure: Load-velocity profile measure: Well-being profile measure: Ways of Coping Questionnaire measure: Attention and Perceptual Processes sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Centro Ceremonial Otomí city: México zip: 50868 country: Mexico lat: 19.42847 lon: -99.12766 hasResults: False
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<|newrecord|> nctId: NCT06269835 id: NAOTAN-IOE briefTitle: Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia overallStatus: RECRUITING date: 2024-02-28 date: 2024-12 date: 2024-12 date: 2024-02-21 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: systemic therapy name: Intermittent Oro-Esophageal Tube Feeding name: Persistent Nasogastric Tube Feeding measure: The Oral Motor Assessment Scale measure: Pneumonia measure: Hemoglobin measure: Total Protein measure: Albumin measure: Prealbumin measure: body weight measure: upper arm circumference measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale for Infants measure: Feeding amount sex: ALL minimumAge: 6 Months maximumAge: 12 Months stdAges: CHILD facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06269822 id: SSR, HRV, QEEG in TLE briefTitle: Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP overallStatus: COMPLETED date: 2022-09-01 date: 2023-11-25 date: 2024-01-01 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: The study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy; using different electrophysiological techniques.
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Moreover, it aimed at finding any correlation between electrophysiological tests and SUDEP risk. conditions: Temporal Lobe Epilepsy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 54 type: ACTUAL name: Sympathetic skin response, heart rate variability test, quantitative EEG measure: Detection of autonomic dysfunction (sympathetic domain) among cases of temporal lobe epilepsy measure: Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy measure: Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Neurophysiology unit- Kasr alainy-Cairo University city: Cairo state: Cairo Governorate zip: Cairo, Egypt country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06269809 id: s67279 briefTitle: Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial acronym: TACROM overallStatus: RECRUITING date: 2023-05-04 date: 2025-05-30 date: 2025-05-30 date: 2024-02-21 date: 2024-02-21 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Amsterdam UMC, location VUmc name: Bichat Hospital name: Rennes University Hospital briefSummary: This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time. conditions: Fibroid Uterus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric non-blinded randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: Temporary clipping of the uterine arteries and the utero-ovarian ligmants. name: No temporary clipping of the uterine arteries and the utero-ovarian ligmants. measure: Peri-operative blood loss: Estimated blood loss measure: Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL measure: Peri-operative blood loss: Need for peri-operative blood transfusion measure: Hospitalisation time measure: Operation time in minutes measure: Number of patients with complications postoperatively, graded by Clavien Dindo classification measure: Number of patients requiring secondary hemostatic measures sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Wouter Froyman, MD, PhD role: CONTACT phone: +3216342612 email: [email protected] lat: 50.87959 lon: 4.70093 facility: Department of Gynecology and Obstetrics, Hopital Bichat status: NOT_YET_RECRUITING city: Paris country: France name: Martin Koskas, MD, PhD role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: Service de gynécologie, Centre Hospitalier Universitaire de Rennes status: NOT_YET_RECRUITING city: Rennes country: France name: Vincent Lavoué, MD, PhD role: CONTACT lat: 48.11198 lon: -1.67429 facility: Amsterdam UMC, locatie VUmc status: NOT_YET_RECRUITING city: Amsterdam country: Netherlands name: Robert De Leeuw, MD, PhD role: CONTACT email: [email protected] lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06269796 id: little-dcdq briefTitle: Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder overallStatus: COMPLETED date: 2021-03-01 date: 2021-07-31 date: 2021-09-30 date: 2024-02-21 date: 2024-04-03 name: University of Thessaly class: OTHER briefSummary: This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment. conditions: Motor Skills Disorders conditions: Child Development conditions: Child, Preschool studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 424 type: ACTUAL name: Little Developmental Coordination Disorder Questionnaire (LDCDQ) name: Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2) measure: Parent Screening Questionnaire for Motor Coordination Difficulties (DCD) measure: Screening Test for Detection of Developmental Coordination Disorder (DCD) sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD facility: Human Performance & Rehabilitation Laboratory, Department of Physiotherapy, University of Thessaly city: Lamía state: Pthiotis zip: 35100 country: Greece lat: 38.9 lon: 22.43333 hasResults: False
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<|newrecord|> nctId: NCT06269783 id: STUDY00022968 briefTitle: Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis overallStatus: RECRUITING date: 2024-01-10 date: 2024-10-31 date: 2024-10-31 date: 2024-02-21 date: 2024-02-22 name: Penn State University class: OTHER briefSummary: The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period. conditions: Kidney Stone conditions: Urolithiasis conditions: Nephrolithiasis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 155 type: ESTIMATED name: sipIT measure: Urine volume (intervention) measure: Urine volume (maintenance) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Pennsylvania State University status: RECRUITING city: University Park state: Pennsylvania zip: 16802 country: United States name: Shiyu Li, PhD role: CONTACT email: [email protected] lat: 40.80201 lon: -77.85639 hasResults: False
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<|newrecord|> nctId: NCT06269770 id: Tapentadol briefTitle: Tapentadol vs Tramadol in Total Knee Arthroplasty overallStatus: RECRUITING date: 2023-05-01 date: 2025-05-01 date: 2025-06-01 date: 2024-02-21 date: 2024-02-22 name: University of Thessaly class: OTHER briefSummary: Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR). conditions: Total Knee Replacement conditions: Post-operative Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Tapentadol name: Tramadol measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Neuropathic pain measure: Quality of life postoperatively measure: Patient Satisfaction measure: Depression measure: Function measure: Outcome measure: Arthritis impact measure: Health Status measure: Pain severity sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Of Larissa status: RECRUITING city: Larissa state: Thessaly zip: 41110 country: Greece lat: 39.63689 lon: 22.41761 hasResults: False
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<|newrecord|> nctId: NCT06269757 id: 23-01514 briefTitle: Exercise Program for ITB Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-08-01 date: 2026-04-01 date: 2024-02-21 date: 2024-02-21 name: NYU Langone Health class: OTHER briefSummary: Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes. conditions: Iliotibial Band Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Individualized Exercise Program name: Standard Physical Therapy measure: Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score measure: Visual Analogue Scale (VAS) Score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269744 id: 23-01032 briefTitle: Proactive Outreach With FIT acronym: PROOF overallStatus: ENROLLING_BY_INVITATION date: 2024-03-13 date: 2025-07-31 date: 2026-04-30 date: 2024-02-21 date: 2024-03-29 name: NYU Langone Health class: OTHER briefSummary: The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: Proactive Screening Outreach measure: Proportion of Participants who Complete FIT Test by Month 6 measure: Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6 sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: Brooklyn state: New York zip: 11203 country: United States lat: 40.6501 lon: -73.94958 facility: Community Health Care Network of New York city: Brooklyn state: New York zip: 11206 country: United States lat: 40.6501 lon: -73.94958 hasResults: False
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<|newrecord|> nctId: NCT06269731 id: Thyroid cancer briefTitle: Anxiety & Depression in Thyroid Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-02-21 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: 1. To identify the prevalence of both anxiety and depression in thyroid cancer patients
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2. To assess quality of life in thyroid cancer patients conditions: Thyroid Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 159 type: ESTIMATED name: Hamilton depression Rating Scale measure: the prevalence of anxiety in thyroid cancer patients measure: the prevalence of depression in thyroid cancer patients measure: assess quality of life in thyroid cancer patients sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269718 id: CMRPG8N0471 briefTitle: The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia overallStatus: RECRUITING date: 2023-12-01 date: 2024-07-31 date: 2024-07-31 date: 2024-02-21 date: 2024-02-21 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The aims of this study are:
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1. Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function
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2. To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.
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3. To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: swallowing therapy name: IOPI therapy measure: the change from baseline to time of swallowing muscle strength measure: the change from baseline to time of Masster thickness measure: the change from baseline to time of tongue muscles thickness measure: the change from baseline to time of general muscle mass measure: Measure the change in grip strength (by Jamar hand dynamometer) measure: the change from baseline to time of swallowing functions measure: the change from baseline to time of clinical nutrition status measure: the change from baseline to time of swallowing functions 100 ml water test measure: the change from baseline to time of quality of life sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGungMH status: RECRUITING city: Kaohsiung zip: 833 country: Taiwan name: Yuchi Huang, MD role: CONTACT phone: 886-7-7317123 phoneExt: 6286 email: [email protected] lat: 22.61626 lon: 120.31333 hasResults: False
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