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<|newrecord|> nctId: NCT06281925 id: 22-01363 briefTitle: Cryotherapy & Oxaliplatin overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10-31 date: 2025-12-31 date: 2024-02-28 date: 2024-03-29 name: NYU Langone Health class: OTHER briefSummary: The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy. conditions: Colon Cancer conditions: Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cryotherapy Gloves measure: Proportion of Participants with Peripheral Neuropathy at Visit 2 measure: Proportion of Participants with Peripheral Neuropathy at Visit 3 measure: Proportion of Participants with Peripheral Neuropathy at Visit 4 measure: Proportion of Participants with Peripheral Neuropathy at Visit 5 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: Mineola state: New York zip: 11501 country: United States lat: 40.74927 lon: -73.64068 facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06281912 id: 4504/23 briefTitle: Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients acronym: MELCAYA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-11 date: 2024-11 date: 2024-02-28 date: 2024-02-28 name: Azienda Ospedaliera di Perugia class: OTHER briefSummary: This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease conditions: Early Melanoma conditions: Advanced Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ESTIMATED measure: rate of objective response measure: adverse event incidence sex: ALL minimumAge: 12 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Aix-Marseille Universite city: Marseille country: France lat: 43.29551 lon: 5.38958 facility: Institut Curie city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Ospedale universitario della Charité city: Berlino country: Germany lat: 52.52437 lon: 13.41053 facility: German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ) city: Heidelberg country: Germany lat: 49.40768 lon: 8.69079 facility: University Children's Hospital Tuebingen city: Tuebingen country: Germany lat: 48.52266 lon: 9.05222 facility: Universita Degli Studi Di Firenze city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Fondazione Irccs Istituto Nazionale Dei Tumori city: Milano country: Italy lat: 45.46427 lon: 9.18951 facility: Universita Cattolica Del Sacro Cuore city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie) city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Institut Catala D'Oncologia city: Barcellona country: Spain lat: 41.38879 lon: 2.15899 facility: Instituto de Investigaciones Biomédicas August Pi i Sunyer city: Barcellona country: Spain lat: 41.38879 lon: 2.15899 facility: Karolinska University Hospital city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06281899 id: 01/2022 briefTitle: Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus acronym: PRODAPA-CKD overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-28 date: 2024-02-28 name: Anemia Working Group Romania class: OTHER name: Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania name: Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania name: Carol Davila University of Medicine and Pharmacy briefSummary: This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus conditions: Chronic Kidney Diseases conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Dapagliflozin 10 mg Tab name: Low protein diet measure: Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death measure: Rate of decline in the estimated Glomerular Filtration Rate measure: Variation of albuminuria measure: Variation of HbA1C measure: Variation of serum cholesterol levels measure: Variation of serum bicarbonate levels measure: Variation of serum potassium levels measure: Variation of serum sodium levels measure: Variation of hemoglobin levels measure: Variation of hematocrit levels measure: All cause hospitalizations measure: Variation in body weight measure: Variation in BMI measure: Variation in handgrip strength measure: Variation in serum albumin levels measure: Variation in CRP levels measure: Changes in the quality of life measure: Compliance to the protein intake measure: Compliance to the energy intake measure: Compliance to carbohydrate intake sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Carol Davila University of Medicine and Pharmacy Bucharest status: RECRUITING city: Bucharest country: Romania name: Liliana Garneata, Assoc Prof role: CONTACT phone: +40722619358 email: lilianagarna@yahoo.com name: Elena Cuiban, MD role: CONTACT phone: +40748975315 email: elenacuiban@yahoo.com lat: 44.43225 lon: 26.10626 hasResults: False
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<|newrecord|> nctId: NCT06281886 id: GASTO-10107 briefTitle: Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2023-12-01 date: 2026-12-01 date: 2026-12-01 date: 2024-02-28 date: 2024-02-28 name: Sun Yat-sen University class: OTHER briefSummary: This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma conditions: Esophageal Squamous Cell Carcinoma conditions: Efficacy conditions: Toxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Induction Immunotherapy-Toripalimab name: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin name: Radiotherapy name: Apatinib name: Capecitabine measure: Progression free survival rate measure: Overall survival measure: Objective response rate measure: Local-regional progression-free survival measure: Incidence of Treatment-related Adverse Events measure: Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer) measure: Distant metastasis-free survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Bo Qiu, Professor role: CONTACT phone: +86-020-87343031 email: qiubo@sysucc.org.cn lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06281873 id: 0645 briefTitle: Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy overallStatus: COMPLETED date: 2023-03-27 date: 2023-09-01 date: 2024-02-07 date: 2024-02-28 date: 2024-02-28 name: Alexandria University class: OTHER briefSummary: the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis. conditions: Oroantral Fistula studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ACTUAL name: closure by PRF membrane measure: Evaluation of the soft tissue wound's healing measure: Secondary radiographic outcomes, assessment of bone formation sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry city: Alexandria zip: 562589 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06281860 id: PITHAC id: 2023-00099 type: REGISTRY domain: BASEC briefTitle: Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration acronym: PITHAC overallStatus: RECRUITING date: 2023-11-24 date: 2025-12-01 date: 2026-02-01 date: 2024-02-28 date: 2024-02-28 name: Dr Jean Yannis PERENTES class: OTHER briefSummary: Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD). conditions: Mesothelioma, Malignant conditions: Carcinoma, Non-Small-Cell Lung conditions: Carcinoma Breast Stage IV conditions: Ovarian Cancer conditions: Esophageal Cancer conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Open-label, non-randomised monocentric Phase I clinical trial study with cisplatin dose escalation administered by PITHAC. primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Cisplatine Teva® measure: Dose Escalation and Maximum Tolerated Dose determination (Part A): measure: Expansion phase (Part B): measure: Dose Escalation and MTD determination (Part A): measure: Expansion phase (Part B): measure: Dose Escalation and MTD determination (Part A):Exploratory outcomes measure: Expansion phase (Part B):Exploratory outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire Vaudois status: RECRUITING city: Lausanne country: Switzerland name: Jean-Yannis PERENTES role: CONTACT name: Jean Yannis PERENTES role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 hasResults: False
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<|newrecord|> nctId: NCT06281847 id: CCTx-001-AML-001 briefTitle: An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia acronym: RESOLVE AML001 overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2041-08 date: 2024-02-28 date: 2024-02-28 name: Advesya SAS class: INDUSTRY briefSummary: The purpose of this adaptive Phase 1/2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r/r Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r/r AML and provide a potential novel treatment option. conditions: Acute Myeloid Leukemia, in Relapse conditions: Acute Myeloid Leukemia Refractory studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study comprises 4 periods:
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* The pre-treatment period will consist of screening for eligibility, leukapheresis and a pre-treatment evaluation (prior to Lymphodepleting Chemotherapy (LDC)).
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* The treatment period will start with LDC, followed by CCTx-001 infusion 2 to 7 days after completion of LDC. A first response evaluation will be performed at approximately 28 days after CCTx-001 infusion.
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* The post-treatment period will consist of further clinical activity and safety follow-up visits at regular timepoints after CCTx-001 infusion, starting after the Month 3 visit up to the Month 24 visit.
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* The long-term follow-up period will start after the Month 24 visit up to 15 years post CCTx-001 infusion. primaryPurpose: TREATMENT masking: NONE count: 143 type: ESTIMATED name: CCTx-001 measure: Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001 measure: Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 measure: Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001 measure: Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 measure: Phase 2: To assess the safety of CCTx-001 measure: Phase 2: To assess HRQoL for patients treated with CCTx-001 measure: Phase 2: To assess HRQoL for patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 measure: Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Besançon Regional and University Hospital city: Besançon Cedex country: France name: Eric Deconinck role: CONTACT name: Eric Deconinck role: PRINCIPAL_INVESTIGATOR lat: 47.24878 lon: 6.01815 facility: Hospital Saint Louis city: Paris country: France name: Nicolas Boissel role: CONTACT name: Nicolas Boissel role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Ludwig-Maximilians University of Munich city: Munich country: Germany name: Marion Subklewe role: CONTACT name: Marion Subklewe role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 facility: University Hospital Ulm city: Ulm country: Germany name: Elisa Sala role: CONTACT name: Elisa Sala role: PRINCIPAL_INVESTIGATOR lat: 48.39841 lon: 9.99155 facility: Vall d'Hebron University Hospital city: Barcelona country: Spain name: Pere Barba role: CONTACT name: Pere Barba role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Karolinska University Hospital city: Stockholm country: Sweden name: Stephan Mielke role: CONTACT name: Stephan Mielke role: PRINCIPAL_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06281834 id: 2024P000306 briefTitle: Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-02 date: 2027-06 date: 2024-02-28 date: 2024-02-28 name: Brigham and Women's Hospital class: OTHER name: APIN Public Health Initiatives name: University of Cape Town briefSummary: Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population. conditions: Pediatric HIV Infection conditions: Latent Tuberculosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective single-arm, open-label, pharmacokinetic and safety study primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Rifapentine name: Dolutegravir measure: Dolutegravir AUC during weekly rifapentine/isoniazid measure: Rifapentine AUC measure: Proportion of participants experiencing severe (grade 3 or 4) clinical or laboratory adverse events sex: ALL minimumAge: 4 Weeks maximumAge: 11 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06281821 id: 4947 [Study 2] briefTitle: Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study overallStatus: RECRUITING date: 2024-02-06 date: 2024-12-01 date: 2024-12-01 date: 2024-02-28 date: 2024-02-28 name: Boston University Charles River Campus class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention. conditions: Alcohol Drinking conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Compare an intervention to an assessment only control condition primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes assessor at follow-up timepoint is masked to condition. Baseline assessment occurs prior to randomization whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: mhealth-pc measure: Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale measure: Time Line Follow-Back-30 Day Weekly Drinking measure: Time Line Follow-Back 30-Day Heavy Episodic Drinking measure: Perceptions of Treatment Questionnaire measure: Systems Usability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston University status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Maya Kratzer, BA role: CONTACT phone: 857-225-8843 lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06281808 id: R490 briefTitle: Photon Counting Detector CT Image Quality overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2026-09-01 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: Reto Sutter, MD class: OTHER briefSummary: This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard. conditions: Diagnostic Imaging conditions: Tomography, X Ray Computed studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 200 type: ESTIMATED name: Photon Counting Detector CT measure: Image Quality PCD CT measure: Diagnostic Accuracy PCD CT sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06281795 id: 1.24. briefTitle: Neuromodulation of the Autonomic Nervous System in Athletes acronym: NANSA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-31 date: 2026-01-31 date: 2024-02-28 date: 2024-02-28 name: Bakulev Scientific Center of Cardiovascular Surgery class: OTHER_GOV name: Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION name: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION briefSummary: There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels. conditions: Efficacy, Self conditions: Fatigue; Muscle, Heart conditions: Fatigue, Mental conditions: Fatigue; Combat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization of active stimulation vs. sham stimulation primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 125 type: ESTIMATED name: tVNS measure: Dynamics of maximum oxygen consumption (VO2max). measure: The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism. measure: Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism. measure: The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism. measure: The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism. measure: The dynamics of RMSSD. measure: HF dynamics measure: Dynamics of the LF/HF ratio. sex: ALL minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION city: Krasnodar country: Russian Federation lat: 45.04484 lon: 38.97603 hasResults: False
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<|newrecord|> nctId: NCT06281782 id: PRP with topical retinoids briefTitle: Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris overallStatus: RECRUITING date: 2024-01-01 date: 2024-04 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.
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Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .
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Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.
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Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.
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For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.
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PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment. conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Topical retinoids versus topical retinoids wit PRP in acne vulgaris treatment primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: topical retinoids and platalet rich plasma measure: change of acne lasions sex: ALL minimumAge: 12 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine status: RECRUITING city: Assiut country: Egypt name: Howida Abdalla role: CONTACT email: d.howida@windowslive.com lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06281769 id: NL82101.000.22 briefTitle: Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision overallStatus: RECRUITING date: 2024-02-26 date: 2025-01-01 date: 2025-01-01 date: 2024-02-28 date: 2024-03-06 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER name: Angiogenesis Analytics briefSummary: The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway). conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 438 type: ESTIMATED name: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision name: MRI targeted biopsy pathway measure: Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI. measure: Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway. measure: Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway). measure: Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway. measure: Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC - location VUmc status: RECRUITING city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 facility: Andros Clinics status: RECRUITING city: Baarn country: Netherlands lat: 52.21167 lon: 5.2875 facility: Spaarne Gasthuis status: RECRUITING city: Hoofddorp country: Netherlands lat: 52.3025 lon: 4.68889 facility: St. Antonius status: RECRUITING city: Nieuwegein country: Netherlands lat: 52.02917 lon: 5.08056 facility: Fransiscus Gasthuis status: RECRUITING city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-15 uploadDate: 2024-01-12T04:56 filename: Prot_SAP_000.pdf size: 1638356 hasResults: False
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<|newrecord|> nctId: NCT06281756 id: STUDY00022285 id: 1UG3HL161342-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3HL161342-01A1 briefTitle: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia overallStatus: RECRUITING date: 2024-03-14 date: 2027-02 date: 2028-02 date: 2024-02-28 date: 2024-03-20 name: Milton S. Hershey Medical Center class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems. conditions: Insomnia conditions: Insomnia Chronic conditions: Insomnia, Primary conditions: Blood Pressure conditions: Blood Pressure, High studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Both prescribing physicians and participants will be blind to phenotype and treatment groups. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 600 type: ESTIMATED name: Cognitive Behavioral Treatment for Insomnia (CBT-I) name: Trazodone name: Placebo measure: Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) measure: Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) measure: Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment measure: Insomnia Severity Index (ISI) Score following CBT-I measure: Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) measure: Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) measure: Evening Cortisol levels following CBT-I measure: Insomnia Severity Index (ISI) Score following RCT measure: PSG Total Sleep Time (TST) following RCT measure: Actigraphy Total Sleep Time (TST) following RCT measure: Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) measure: Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) measure: Evening Cortisol levels following RCT measure: Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Jewish Health status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80206-2761 country: United States name: Roxane Horberg role: CONTACT phone: 303-270-2850 email: horbergr@njhealth.org name: Rachel Johnson role: CONTACT phone: 303 398-1058 email: johnsonr@njhealth.org lat: 39.73915 lon: -104.9847 facility: Penn State University status: RECRUITING city: Hershey state: Pennsylvania zip: 17033 country: United States name: Carrie Criley role: CONTACT phone: 717-531-4123 email: ccriley@pennstatehealth.psu.edu lat: 40.28592 lon: -76.65025 facility: University of Pittsburgh status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15213-3203 country: United States name: Laurie Brar role: CONTACT phone: 412-723-7998 email: brarlk@upmc.edu lat: 40.44062 lon: -79.99589 facility: Université Laval status: NOT_YET_RECRUITING city: Quebec zip: G1V 0A6 country: Canada name: Manon Lamy role: CONTACT phone: 418 656-2131 phoneExt: 412467 email: manon.lamy@psy.ulaval.ca lat: 46.81228 lon: -71.21454 hasResults: False
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<|newrecord|> nctId: NCT06281743 id: LST-Ped Survey briefTitle: Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children acronym: LSTPedSurvey overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-02-28 date: 2024-03-15 name: Göteborg University class: OTHER briefSummary: The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians. conditions: Pediatric Disorder conditions: Critical Illness conditions: Ethics, Narrative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Survey measure: Attitudes and experiences -questionnaire sex: ALL minimumAge: 1 Year maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06281730 id: 23-009197 briefTitle: Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy overallStatus: RECRUITING date: 2024-05 date: 2044-02 date: 2044-02 date: 2024-02-28 date: 2024-04-09 name: Mayo Clinic class: OTHER briefSummary: The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA. conditions: In Utero Procedure Affecting Fetus or Newborn studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Karl Storz New Generation Fetoscope - curved 11508AAK name: Karl Storz New Generation Fetoscope - straight 11506AAK measure: Adverse events measure: Serious Adverse Events measure: Device malfunctions measure: Mean gestational age at delivery measure: Successful Completion measure: Satisfaction scores measure: Live births measure: Neonatal deaths sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Minnesota status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06281717 id: IRB-P00045047 briefTitle: A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2030-08-30 date: 2024-02-28 date: 2024-02-28 name: Alireza Shamshirsaz class: OTHER briefSummary: The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.
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This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age. conditions: Congenital Diaphragmatic Hernia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Fetal Endotracheal Occlusion (FETO) measure: Successful Ballon Placement measure: Successful Balloon Removal measure: Balloon placement operative time measure: Balloon removal operative time measure: Type of FETO release measure: Maternal Complications measure: Gestational age at delivery measure: Fetal lung volume measure: O/E LHR measure: Infant survival measure: Oxygen dependency measure: Number of infants requiring ECMO measure: NICU stay measure: Ventilator support measure: Presence of periventricular leukomalacia measure: Presence of neonatal sepsis measure: Presence of intraventricular hemorrhage measure: Retinopathy of prematurity measure: Presence of gastro-esophageal reflux measure: CDH repair type measure: Pulmonary function measure: Infant Neurodevelopment measure: Route of delivery measure: Maternal hospitalization sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Brittany Gudanowski role: CONTACT phone: 617-919-6658 email: Brittany.Gudanowski@childrens.harvard.edu name: Maternal Fetal Care Center role: CONTACT phone: 617-355-6512 email: MFCCFetalResearchStudies-dl@childrens.harvard.edu name: Alireza Shamshirsaz, MD role: PRINCIPAL_INVESTIGATOR name: Eyal Krispin, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06281704 id: AK101-102 briefTitle: A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis overallStatus: COMPLETED date: 2020-11-26 date: 2022-05-17 date: 2022-12-31 date: 2024-02-28 date: 2024-02-28 name: Akeso class: INDUSTRY briefSummary: This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis. conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: AK101 IV name: AK101 SC name: Placebo name: AK101 IV/AK101 SC measure: Adverse Events measure: Adverse Events measure: Elimination half-life (T1/2) of AK101 measure: Mean residence time (MRT) of AK101 measure: Area under curve (AUC) of AK101 measure: Apparent distribution volume (VD/F) of AK101 measure: Systemic clearance (CL/F) of AK101 measure: Maximum (peak) plasma concentration (Cmax) of AK101 measure: Time to maximum plasma concentration (Tmax) of AK101 measure: Proportion of subjects with clinical response at Week8(per Adapted Mayo Score without physician's global assessment). measure: Proportion of subjects with clinical response at Week8(per the Mayo score). measure: Immunogenicity index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu state: Anhui zip: 233099 country: China lat: 32.94083 lon: 117.36083 facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Fujian Medical University city: Fuzhou state: Fujian zip: 350004 country: China lat: 26.06139 lon: 119.30611 facility: Nanfang Hospital city: Guangzhou state: Guangdong zip: 510515 country: China lat: 23.11667 lon: 113.25 facility: The Sixth Affiliated Hospital of Sun Yat-Sen University city: Guanzhou state: Guangdong zip: 510665 country: China facility: The Second Hospital of Hebei Medical University city: Shijiazhuang state: Hebei zip: 050004 country: China lat: 38.04139 lon: 114.47861 facility: People's Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China lat: 30.58333 lon: 114.26667 facility: Nanjing First Hospital city: Nanjing state: Jiangsu zip: 210012 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221004 country: China lat: 34.18045 lon: 117.15707 facility: Shengjing Hospital of China Medical University city: Shengyang state: Liaoning zip: 110000 country: China facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Tianjing People's Hospital city: Tianjing state: Tianjing zip: 300122 country: China hasResults: False
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<|newrecord|> nctId: NCT06281691 id: GreenBladder briefTitle: GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit overallStatus: ENROLLING_BY_INVITATION date: 2023-04-28 date: 2024-07-01 date: 2025-11-30 date: 2024-02-28 date: 2024-02-28 name: Jørgen Bjerggaard Jensen class: OTHER name: Cepheid name: Laborie Medical Technologies Inc. name: Vingmed Danmark A/S name: OneMed A/S briefSummary: The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland. conditions: Urinary Bladder Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Xpert® Bladder Cancer Detection Test measure: Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, Aarhus University Hopsital city: Aarhus zip: 8000 country: Denmark lat: 56.15674 lon: 10.21076 facility: Queen Ingrid's Hospital city: Nuuk zip: 3900 country: Greenland lat: 64.18347 lon: -51.72157 hasResults: False
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<|newrecord|> nctId: NCT06281678 id: CIBI363A202 briefTitle: A Study of IBI363 in Subjects With Advanced Solid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: Innovent Biologics (Suzhou) Co. Ltd. class: INDUSTRY briefSummary: This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies. conditions: Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: IBI363 measure: Objective response rate (ORR) measure: Adverse Event （AE） measure: Dose-limiting Toxicity （DLT） sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medcial Center Research Institute city: Fairway state: Kansas zip: 66205 country: United States name: Saqib Abbasi role: CONTACT phone: 913-945-7545 email: sabbasi@kumc.edu lat: 39.02223 lon: -94.6319 hasResults: False
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<|newrecord|> nctId: NCT06281665 id: STUDY23080099 id: K23HL168356 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL168356 briefTitle: Treatment With Aspirin After Preeclampsia: TAP Trial acronym: TAP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2026-04-01 date: 2024-02-28 date: 2024-04-04 name: Alisse Hauspurg class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital. conditions: Hypertensive Disorder of Pregnancy conditions: Pre-Eclampsia conditions: Hypertension conditions: Eclampsia conditions: Gestational Hypertension conditions: Cardiovascular Diseases conditions: Toxemia conditions: Pregnancy Complications conditions: Vascular Diseases conditions: Hypertension, Pregnancy Induced conditions: Hypertension;Pre-Eclamptic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pilot randomized, single-center, double-blind placebo-control study of low-dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or similar-appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two additional study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring. primaryPurpose: OTHER masking: TRIPLE maskingDescription: Participants, Investigators and outcomes assessors will be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Low-dose aspirin name: Placebo measure: Percent of participants eligible, enrolled and retained (feasibility) measure: Study visit systolic BP measure: Study visit diastolic BP measure: Study visit systolic BP measure: Study visit diastolic BP measure: Study visit mean arterial pressure measure: Study visit mean arterial pressure measure: Anti-hypertensive medication use measure: Anti-hypertensive medication use measure: Therapeutic intensity score measure: Therapeutic intensity score measure: Mean home systolic blood pressure measure: Mean home diastolic blood pressure measure: Mean home mean arterial pressure measure: Mean daytime systolic blood pressure measure: Mean nocturnal systolic blood pressure measure: Mean daytime diastolic blood pressure measure: Mean nocturnal diastolic blood pressure measure: Mean nocturnal mean arterial pressure measure: Mean daytime mean arterial pressure measure: Mean overall mean arterial pressure measure: Mean overall systolic blood pressure measure: Mean overall diastolic blood pressure measure: Classification of hypertension measure: Classification of hypertension measure: Endothelial function EC50% measure: Endothelial function EC50% measure: Endothelial function Emax measure: Endothelial function Emax measure: Endothelial function change in Emax measure: Endothelial function change in EC50% measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in mean arterial pressure sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of Pittsburgh Magee-Womens Hospital city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sila Yavan, MS role: CONTACT phone: 412-417-4981 email: yavans@upmc.edu name: Alisse K Hauspurg, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06281652 id: Cognichess briefTitle: Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline acronym: Cognichess overallStatus: RECRUITING date: 2024-02-13 date: 2025-02-13 date: 2025-02-13 date: 2024-02-28 date: 2024-03-01 name: University of Milano Bicocca class: OTHER briefSummary: The goal of this clinical trial\]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are:
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* Do Go and Chess improve cognition?
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* Is a game better than the other? Is the effect of both games on cognition synergistic?
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* Do Go and Chess improve quality of life?
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* Do Go and Chess improve mood?
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* Do Go and Chess improve lifestyle?
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Participants will be randomized to one of four groups:
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* Group intervention with Go, once a week, for 12 weeks
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* Group intervention with Chess, once a week, for 12 weeks
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* Group intervention with Go and Chess, twice a week, for 12 weeks
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* Control group conditions: Mild Cognitive Impairment conditions: Subjective Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Go classes name: Chess classes measure: General cognition measure: Digit Span Forward measure: Digit Span Backwards measure: Trail Making Test - part A measure: Trail Making Test - part B measure: Semantic fluency measure: Quality of life indicator measure: Depression measure: Lifestyle sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS San Gerardo dei Tintori status: RECRUITING city: Monza state: Lombardia zip: 20900 country: Italy name: Lucio Tremolizzo, MD, PhD role: CONTACT phone: +390392339082 email: lucio.tremolizzo@unimib.it name: Federico Emanuele Pozzi, MD role: SUB_INVESTIGATOR lat: 45.58005 lon: 9.27246 hasResults: False
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<|newrecord|> nctId: NCT06281639 id: RAPID briefTitle: RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-02-28 date: 2024-02-28 name: University of Minnesota class: OTHER briefSummary: The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box. conditions: Congenital Heart Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: RAPID measure: RAPID imaging quality sex: ALL maximumAge: 1 Year stdAges: CHILD facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55414 country: United States name: Gwenyth Fischer, MD role: CONTACT phone: 612-625-6678 email: fisch662@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False
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<|newrecord|> nctId: NCT06281626 id: 2024_RIPH_01_Preservatif briefTitle: Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25 acronym: Préservatif overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-10-01 date: 2024-02-28 date: 2024-02-28 name: Université de Reims Champagne-Ardenne class: OTHER briefSummary: For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.
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In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022). conditions: Comdom studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED name: Data collection measure: use of free male condoms sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Ufr Medecine Urca city: Reims zip: 51100 country: France lat: 49.25 lon: 4.03333 facility: Université de Reims Champagne Ardenne city: Reims zip: 51100 country: France lat: 49.25 lon: 4.03333 hasResults: False
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<|newrecord|> nctId: NCT06281613 id: 2024-AMCOPTEO briefTitle: Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-03 date: 2024-04-01 date: 2024-04-05 date: 2024-02-28 date: 2024-03-08 name: University of Pavia class: OTHER briefSummary: The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.
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Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.
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Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1). conditions: Skeletal Malocclusion studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 40 type: ESTIMATED name: AMCOP group name: High-pull headgear measure: Change in cephalometric angular measurements measure: Linear regressions measure: Change in cephalometric linear measurements sex: ALL minimumAge: 7 Years maximumAge: 11 Years stdAges: CHILD facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06281600 id: REC: 23/SW/0042 id: 326109 type: OTHER domain: IRAS ID briefTitle: An Intervention Study Using HMOs to Improve IBS Symptoms acronym: GUT-HEAL-IBS overallStatus: RECRUITING date: 2024-02-20 date: 2025-08-20 date: 2025-09-20 date: 2024-02-28 date: 2024-02-29 name: Glenn Gibson class: OTHER name: Royal Berkshire NHS Foundation Trust briefSummary: There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms.
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IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life.
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IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit" \[8\]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS.
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Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens \[9\]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation.
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Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high.
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Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS.
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This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over.
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With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. We aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Every individual involved in undertaking this trial will be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: Human milk oligosaccharide name: Maltodextrin placebo measure: IBS-SSS measure: Change in anxiety and depression scores (ADS) measure: Improvement of the Pittsburgh Sleep Quality Index (PSQI). measure: Changes in faecal microbiota e.g. Bifidobacterium sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The University of Reading status: RECRUITING city: Reading state: Berkshire zip: RG6 6LA country: United Kingdom name: Patricia Sanz Morales role: CONTACT phone: +447843865554 email: p.sanzmorales@pgr.reading.ac.uk name: Glenn Gibson, Prof. role: SUB_INVESTIGATOR lat: 51.45625 lon: -0.97113 hasResults: False
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<|newrecord|> nctId: NCT06281587 id: SNFyodorov briefTitle: Pathogenetic Risk Factors for Corneal Graft Rejection overallStatus: COMPLETED date: 2011-01 date: 2019-01 date: 2019-01 date: 2024-02-28 date: 2024-02-28 name: The S.N. Fyodorov Eye Microsurgery State Institution class: OTHER_GOV briefSummary: There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection.
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Investigators analysed data from 493 patients who underwent penetrating keratoplasty between 2011 and 2019. Keratoplasty outcomes were followed up at subsequent clinic visits until December 2021. Then, 93 medical records were selected (taking into account the completeness of the medical records) and divided into two groups based on the primary diagnosis that was an indication for keratoplasty: high-risk and low-risk patients. Investigators then estimated the survival time (clear graft) of the corneal graft using Kaplan-Meier statistical survival analysis. Investigators also investigated the factors that influence corneal graft opacity. conditions: Graft Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 93 type: ACTUAL name: penetrating keratoplasty measure: Cohort group Kaplan-Meier survival analysis (clear graft engraftment) sex: ALL minimumAge: 13 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT city: Krasnodar zip: 350012 country: Russian Federation lat: 45.04484 lon: 38.97603 hasResults: False
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<|newrecord|> nctId: NCT06281574 id: S67346 briefTitle: What Are the Determinants for RTW After SA acronym: RTW after SA overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-13 date: 2025-02-01 date: 2025-02-01 date: 2024-02-28 date: 2024-03-06 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.
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Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.
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This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW. conditions: Shoulder Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Questionnaires measure: Return to work measure: Type of shoulder arthroplasty measure: WORQ-UP (work-related questionnaire for upper extremity disorders) measure: SSV (Subjective Shoulder Value) measure: SST (Dutch translation of the Simple Shoulder Test) measure: OSS (Oxford Shoulder Score) measure: Self-made questionnaire measure: Belgisch Kenniscentrum over welzijn op het werk (BeSWIC) sex: ALL minimumAge: 18 Years maximumAge: 63 Years stdAges: ADULT facility: UZ Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False
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<|newrecord|> nctId: NCT06281561 id: FirstAHXiamenU-YB briefTitle: Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-30 date: 2024-12-31 date: 2024-02-28 date: 2024-04-16 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.
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Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.
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Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality. conditions: Postoperative Sleep Disturbance studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Normal Saline name: Dexmedetomidine measure: Change from baseline sleep quality at after intervention measure: Pittsburgh sleep quality index(PSQI) measure: Early recovery evaluated by Aldrete rating scale measure: Later Recovery evaluated by QoR-40 questionnaire sex: FEMALE minimumAge: 23 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06281548 id: 23-2937 id: 1F31DA058452 type: NIH link: https://reporter.nih.gov/quickSearch/1F31DA058452 briefTitle: Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs overallStatus: RECRUITING date: 2024-02-29 date: 2024-04-30 date: 2024-04-30 date: 2024-02-28 date: 2024-03-06 name: University of North Carolina, Chapel Hill class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.
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This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement. conditions: Stigma, Social conditions: Substance Use studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: RESTART measure: Change in Stigma Resistance Scale (SRS) Score measure: Change in Substance Abuse Self-Stigma Scale (SASSS) Score measure: Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment) measure: Percentage of Prospective Participants Recruited into Study (Feasibility - Enrollment) measure: Time to Sample Saturation (Feasibility - Recruitment) measure: Percentage of Participants Retained in Study (Feasibility - Retention) measure: Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User) measure: Percentage of Participants with High Text Message Frequency (Feasibility - User) measure: Percentage of Participants with High Text Messaging Comfort (Feasibility - User) measure: Percentage of Participants with Cell Phone Device Challenges (Feasibility - User) measure: Percentage of Participants with Cell Phone Plan Challenges (Feasibility - User) measure: Percentage of Participants who Read Messages Daily (Feasibility - User) measure: Change in Adult Dispositional Hope Scale Score measure: Change in Rosenberg Self-Esteem Scale Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SHRPS Syringe Service Program status: RECRUITING city: Portsmouth state: Ohio zip: 45662 country: United States name: Adams L Sibley, MPH role: CONTACT phone: 423-227-9198 email: asibley@live.unc.edu name: Abby Spears role: CONTACT phone: 740-357-9773 email: abby@sciotoconnect.org lat: 38.73174 lon: -82.99767 hasResults: False
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<|newrecord|> nctId: NCT06281535 id: 21789 briefTitle: Early Versus Conventional Loading for Fully Guided Immediate Implant Placement overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-05-31 date: 2024-06-15 date: 2024-02-28 date: 2024-02-28 name: Ain Shams University class: OTHER name: Assiut University briefSummary: Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Implant loading measure: Implant stability sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06281522 id: University of Health Sciences briefTitle: The Importance of Inflammatory Markers Calculated From Preoperative and Postoperative Peripheral Blood Results in the Diagnosis and Treatment of Patients Operated for Hydatid Cyst of the Lung (Lung Echinococcus Granulosus) acronym: Echinococcusis overallStatus: RECRUITING date: 2023-12-18 date: 2024-03-30 date: 2024-06-30 date: 2024-02-28 date: 2024-02-28 name: Abdullah Adiyaman class: OTHER briefSummary: This study aims to investigate the role of these laboratory findings in the differential diagnosis and management of pulmonary hydatid cyst (PHC) by examining the number of euzonophils, neutrophils, lymphocytes, platelets and neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and systemic immune inflammatory index values in the peripheral blood of patients diagnosed with pulmonary hydatid cyst (PHC) in the preoperative period and post-operative 3rd month. Although we have extensive data on hydatid liver cysts, there is limited information in the literature on the laboratory values of patients with PHC. This study aims to provide more scientific basis for the diagnosis and management of PHC and is considered as an inexpensive, reproducible and easily calculable method to improve the accurate diagnosis and management of AKH in clinical practice. conditions: Lung Hydatid Cyst studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 54 type: ESTIMATED name: Operated patients with hydatid cyst of the lung measure: Calculation of laboratory markers sex: ALL minimumAge: 18 Years maximumAge: 83 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences, Van Training and Research Hospital status: RECRUITING city: Van country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False
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<|newrecord|> nctId: NCT06281509 id: S68374 briefTitle: Palmaris Longus Muscle and Dupuytren acronym: Palmaris overallStatus: RECRUITING date: 2024-02-16 date: 2025-02-01 date: 2025-02-01 date: 2024-02-28 date: 2024-03-07 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand. Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition. conditions: Dupuytren's Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups: Patients with Dupuytren Disease and healthy control group. They will be age matched (50 years of age or higher) with the objective to have a proportionate division (50/50) between the genders. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: No masking will be done in this study count: 240 type: ESTIMATED name: Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands. name: Ultrasound measure: PLM in the DD versus control measure: PML in mild versus severe DD-group measure: PLM presence in DD affected group measure: PLM presence in control group measure: Dominant versus non-dominant hand measure: Male versus female population sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaire Ziekenhuizen KU Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Ilse Degreef, Prof. Dr. role: CONTACT phone: +32 16 33 88 43 email: ilse.degreef@uzleuven.be name: Anna Tarasiuk role: CONTACT phone: +32 16 33 88 18 email: orthopedie.research@uzleuven.be lat: 50.87959 lon: 4.70093 hasResults: False
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<|newrecord|> nctId: NCT06281496 id: Rigshospitalet, Hematology briefTitle: AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation acronym: AlloCare overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-01 date: 2026-12-01 date: 2024-02-28 date: 2024-02-29 name: Rigshospitalet, Denmark class: OTHER name: Danish Cancer Society briefSummary: A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase. conditions: Hematological Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One site, two arm randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: AlloCare measure: EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100) measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark name: Mette Schaufuss Engedal, MSc role: CONTACT phone: +45 51896699 email: mette.schaufuss.engedal@regionh.dk name: Mary Jarden, Professor role: CONTACT email: mary.jarden@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06281483 id: APCs in chronic skin ulcers briefTitle: PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01 date: 2024-02-28 date: 2024-02-28 name: Kafrelsheikh University class: OTHER name: Helwan University briefSummary: To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment. conditions: Chronic Non-healing Skin Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: platelet-rich plasma name: platelet-rich fibrin name: Surgical debridement, normal saline washing and dressing coverage measure: Objective assessment of ulcer size for effectiveness, using Image J software. measure: Pain assessment measure: Any adverse effects related to treatment modality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Badr Hospital - Helwan University and Kafrelseikh University Hospital status: RECRUITING city: Cairo country: Egypt name: Mohamed Aboshabana Hussein, Assistant Lecturer role: CONTACT phone: 01007981008 email: dr.mohamedaboshabana@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06281470 id: WS016-Ⅰ-01 briefTitle: The Safety and Tolerability of WS016 in Healthy Chinese Volunteers overallStatus: COMPLETED date: 2023-02-13 date: 2023-06-15 date: 2023-06-15 date: 2024-02-28 date: 2024-02-28 name: Waterstone Pharmaceutical (Wuhan) Co., LTD. class: INDUSTRY briefSummary: This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo. conditions: Hyperkalemia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ACTUAL name: WS016 Single Dose(6g) name: WS016 Single Dose(12g) name: WS016 Single Dose(24g) name: WS016 Single Dose(36g) name: WS016 Single Dose(48g) name: SAD matching placebo name: WS016 Multiple Dose(12g) name: WS016 Multiple Dose(24g) name: WS016 Multiple Dose(48g) name: MAD matching placebo measure: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Zhejiang Xiaoshan Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06281457 id: 5-24-0030: 2.1 id: R01EY035300 type: NIH link: https://reporter.nih.gov/quickSearch/R01EY035300 briefTitle: Probing the Role of Feature Dimension Maps in Visual Cognition: Impact of Task Demands (Expt 2.1) overallStatus: RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-04-18 name: University of California, Santa Barbara class: OTHER name: National Eye Institute (NEI) briefSummary: How does one know what to look at in a scene? Imagine a "Where's Waldo" game - it's challenging to find Waldo because there are many 'salient' locations in the picture, each vying for one's attention. One can only attend to a small location on the picture at a given moment, so to find Waldo, one needs to direct their attention to different locations. One prominent theory about how one accomplishes this claims that important locations are identified based on distinct feature types (for example, motion or color), with locations most unique compared to the background most likely to be attended. An important component of this theory is that individual feature dimensions (again, color or motion) are computed within their own 'feature maps', which are thought to be implemented in specific brain regions. However, whether and how specific brain regions contribute to these feature maps remains unknown.
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