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<\|newrecord\|> nctId: NCT06337175 id: 000000230988 briefTitle: Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction overallStatus: RECRUITING date: 2021-06-01 date: 2023-10-30 date: 2024-04-30 date: 2024-03-29 date: 2024-03-29 name: Kafrelsheikh University class: OTHER briefSummary: The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction. conditions: Ischemic Stroke conditions: Alteplase Adverse Reaction studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study consisted of two distinct groups. The first group comprised 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction. primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Alteplase name: Alteplase measure: predictors of the hemorrhagic infarction type 1 measure: predictors of the hemorrhagic infarction type 2 measure: predictors of the parenchymal hematoma type 1 measure: predictors of the parenchymal hematoma type 2 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33155 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg name: sherihan R ahmed, MD role: CONTACT phone: 2001007481842 email: sherihanrezk2016@gmail.com lat: 31.11174 lon: 30.93991 hasResults: False
<\|newrecord\|> nctId: NCT06337162 id: UPCC 20223 id: IRB#855195 type: OTHER domain: University of Pennsylvania IRB briefTitle: Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC) acronym: HCC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-09-01 date: 2024-03-29 date: 2024-03-29 name: Abramson Cancer Center at Penn Medicine class: OTHER name: Incyte Corporation briefSummary: This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: INCB099280 measure: Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy measure: Acute Cellular Rejection of Liver Transplant Within 3 Months measure: Acute Cellular Rejection of Liver Transplant Within 1 Year measure: Toxicity Rates by Category and Grade measure: Proportion of Patients Downstaged measure: Pathologic Complete Response Rate measure: Recurrence-Free Survival at 1 Year After Transplant measure: Overall Survival at 1 Year After Transplant sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abramson Cancer Center at University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Jennifer Walsh role: CONTACT phone: 215-615-5858 email: Jennifer.Walsh4@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06337149 id: APHP230348 id: IDRCB: 2023-A00006-39 type: REGISTRY domain: IDRCB ANSM briefTitle: Relationship Between Breathing and Attention in Children With Ondine Syndrome acronym: OndineCo overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-01 date: 2026-09-01 date: 2024-03-29 date: 2024-03-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Congenital central hypoventilation syndrome (CCHS) is a rare disorder of autonomic and respiratory regulation that alters oxygen delivery to the brain. CCHS patients are at risk for broad neurocognitive deficits. Patients retain ventilatory activity when awake through a respiratory-related cortical network but the need to mobilise cortical resources to breathe lead to breathing-cognition interferences during cognitive tasks. The purpose of this study is to assess the relationship between breathing pattern and attention in CCHS children conditions: Ondine Syndrome conditions: Congenital Central Hypoventilation Syndrome (CCHS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task) measure: Wechsler scale measure: Nepsy II test sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Robert Debre Hospital status: RECRUITING city: Paris zip: 75019 country: France name: Christophe DELCLAUX, MD, PhD role: CONTACT phone: +331 40 03 41 90 email: christophe.delclaux@aphp.fr name: Benjamin DUDOIGNON, MD role: CONTACT phone: +331 40 03 41 90 email: benjamin.dudoignon@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06337136 id: 2022-A01837-36 briefTitle: neonAtal motoR paTtErn autoMatIc analySis acronym: AIMOTHERNeo overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-03-29 date: 2024-03-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales: facial mimicry, cry, posture and movement. Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathy/brachial plexus paralysis/early neonatal bacterial infection/stroke/etc ... conditions: Automated Computer Analysis conditions: Neonatal Motor Pattern studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: comparison of the computer score with the clinical examination measure: Comparison of the evolution of neurological examination and posture based on the day of life for each patient and each group of patients sex: ALL minimumAge: 1 Day maximumAge: 15 Days stdAges: CHILD facility: Department of paediatric neurological care and intentive care unity (PICU), Raymond Poincaré hospital - APHP city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 hasResults: False
<\|newrecord\|> nctId: NCT06337123 id: K-38 briefTitle: Physica TT Tibial Plate Follow up Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12 date: 2027-12 date: 2024-03-29 date: 2024-03-29 name: Limacorporate S.p.a class: INDUSTRY briefSummary: This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications. conditions: Knee Arthropathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 130 type: ESTIMATED name: Device: Physica TT TIbial Plate and Physica Porous KR name: Device: Physica TT TIbial Plate and Physica Porous PS measure: Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery measure: Changes in Range of Motion over time up to 2 years after surgery measure: Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery. measure: Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery. measure: Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery. measure: Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery measure: Survival rate (Kaplan-Meier) at 2 years after surgery measure: Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Casa di Cura San Camillo Hopital city: Forte Dei Marmi state: Lucca zip: 55042 country: Italy name: Alessandro Tripodo role: CONTACT name: Alessandro Tripodo role: PRINCIPAL_INVESTIGATOR lat: 43.96388 lon: 10.17478 facility: Ospedale Privato Accreditato Sol et Salus city: Torre Pedrera state: Rimini zip: 47922 country: Italy name: Marco Fravisini role: CONTACT name: Marco Fravisini role: PRINCIPAL_INVESTIGATOR lat: 44.10694 lon: 12.51274 facility: Casa di Cura Carmona city: Messina zip: 98100 country: Italy name: Marcello La Bruna role: CONTACT name: Marcello La Bruna role: PRINCIPAL_INVESTIGATOR lat: 38.19394 lon: 15.55256 facility: Istituto Clinico Porta Sole city: Perugia zip: 06100 country: Italy lat: 43.1122 lon: 12.38878 hasResults: False
<\|newrecord\|> nctId: NCT06337110 id: 20436A briefTitle: A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-05-25 date: 2024-05-25 date: 2024-03-29 date: 2024-03-29 name: H. Lundbeck A/S class: INDUSTRY briefSummary: The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Lu AF28996 measure: Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces) measure: AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity measure: Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material measure: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material measure: T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material measure: AUC0-infinity of Lu AF28996 measure: Cmax of Lu AF28996 measure: Tmax of Lu AF28996 measure: T½ of Lu AF28996 sex: MALE minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT facility: Fortrea Clinical Research Unit Ltd city: Holbeck state: Leeds zip: LS11 9EH country: United Kingdom lat: 53.25 lon: -1.18333 hasResults: False
<\|newrecord\|> nctId: NCT06337097 id: 2023-1021 id: NCI-2024-02687 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy overallStatus: RECRUITING date: 2024-02-02 date: 2026-12-31 date: 2028-12-31 date: 2024-03-29 date: 2024-04-29 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects. conditions: Immune Checkpoint Therapy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 880 type: ESTIMATED name: Troponin surveillance name: Standard of care measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Nicolas Palaskas, MD role: CONTACT phone: 713-606-3957 email: nlpalaskas@mdanderson.org name: Nicolas Palaskas, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06337084 id: MNPR-101-D001 briefTitle: Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors overallStatus: RECRUITING date: 2024-04-10 date: 2025-04 date: 2025-06 date: 2024-03-29 date: 2024-04-11 name: Monopar Therapeutics class: INDUSTRY briefSummary: The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies.
Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (e.g., 2 hours after injection plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.
The amount of radioactivity injected will range between 37-74 MBq (±10%). conditions: Solid Tumor, Adult conditions: Bladder Cancer conditions: Urothelial Carcinoma conditions: Triple-negative Breast Cancer conditions: Lung Cancer conditions: Colorectal Cancer conditions: Gastric Cancer conditions: Ovarian Cancer conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 12 type: ESTIMATED name: Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan measure: assess dosimetry and biodistribution of product measure: assess tumor Standard Uptake Values (SUV) of product measure: assess pharmacokinetics (PK) levels of product measure: assess tumor uptake to background and tumor uptake to liver ratios of product sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Melbourne Theranostic Innovation Centre (MTIC) status: RECRUITING city: North Melbourne state: Victoria zip: 3051 country: Australia name: Referral Coordinator role: CONTACT phone: 03 9454 5800 lat: -37.80132 lon: 144.95822 hasResults: False
<\|newrecord\|> nctId: NCT06337071 id: AM2023MCV4Ⅱ briefTitle: A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-06 date: 2025-06 date: 2024-03-29 date: 2024-03-29 name: Aimei Vacin BioPharm (Zhejiang) Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination. conditions: Meningococcal Meningitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1200 type: ESTIMATED name: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine name: ACYW135 Meningococcal Polysaccharide Vaccine measure: Immunogenicity 1 measure: Immunogenicity 2 measure: Immunogenicity 3 measure: Safety 1 measure: Immunogenicity 4 measure: Immunogenicity 5 measure: Immunogenicity 6 measure: Immunogenicity 7 measure: Immunogenicity 8 measure: Immune persistence 1 measure: Immune persistence 2 measure: Safety 2 measure: Safety 3 measure: Safety 4 sex: ALL minimumAge: 3 Months maximumAge: 15 Years stdAges: CHILD facility: Yunnan Center For Disease Control and Prevention city: Kunming state: Yunnan zip: 650022 country: China name: ZHENG Yan role: CONTACT phone: +8687163627796 email: yaqueer_zy@163.com lat: 25.03889 lon: 102.71833 hasResults: False
<\|newrecord\|> nctId: NCT06337058 id: KSUHULYAKAMALAK001 briefTitle: Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause Period overallStatus: COMPLETED date: 2020-06-15 date: 2021-06-15 date: 2022-12-15 date: 2024-03-29 date: 2024-03-29 name: Hülya KAMALAK class: OTHER briefSummary: The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used. conditions: Sexual Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 164 type: ACTUAL name: Experimental group (motivational interview) measure: Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F) measure: Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F) measure: Sexual Quality of Life-Female Questionnaire (SQOL-F) measure: Sexual Quality of Life-Female Questionnaire (SQOL-F) measure: Sexual Self-Efficacy Scale (SSES) measure: Sexual Self-Efficacy Scale (SSES) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kahramanmaras Sutçu Imam University city: Kahramanmaraş country: Turkey lat: 37.5847 lon: 36.92641 hasResults: False
<\|newrecord\|> nctId: NCT06337045 id: AF-rehab briefTitle: Atrial Fibrillation, Prevention and Rehabilitation overallStatus: COMPLETED date: 2019-02-01 date: 2020-06-30 date: 2020-06-30 date: 2024-03-29 date: 2024-03-29 name: Odense University Hospital class: OTHER name: Department of Cardiology, Odense University Hospital, Odense, Denmark. name: Health Center, Municipality of Svendborg, Svendborg, Denmark. name: Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark. name: The Danish Heart Association, Funen, and local committee in Svendborg, Denmark briefSummary: Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.
The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.
There were the following four secondary objectives:
1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.
2. To explore the participant's needs and preferences of the interventions.
3. To explore changes in HRQoL, anxiety and depression.
4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.
The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression. conditions: Atrial Fibrillation conditions: Prevention conditions: Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Eligible participants were diagnosed with AF at the hospital and had symptomatic AF rated by the modified European Heart Rhythm Association (mEHRA) score ≥2B. If the patient was eligible based on the mEHRA-score, at least one of the following risk factors had to be present: hypertension, diabetes, obesity, smoking, excessive alcohol consumption, physical inactivity, sleep apnoea, anxiety, depression, or mental vulnerability. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ACTUAL name: Complex prevention and rehabilitation intervention measure: HeartQoL measure: The hospital anxiety and depression scale (HADS) measure: Experience of participating, experiences needs and preferences of interventions measure: Feasibility of collecting patient reported outcomes (PROMs). The PROMs was the HeartQoL and the hospital anxiety and depression scale. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, Odense University Hospital city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: Health Center, Municipality Svendborg city: Svendborg state: Region Of Southern Denmark zip: 5700 country: Denmark lat: 55.05982 lon: 10.60677 hasResults: False
<\|newrecord\|> nctId: NCT06337032 id: GS-US-380-6684 briefTitle: A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2034-03 date: 2034-03 date: 2024-03-29 date: 2024-03-29 name: Gilead Sciences class: INDUSTRY briefSummary: The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.
The primary objectives of this study are as follows:
* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
* To evaluate the safety of the study drug(s) in participants with HIV-1. conditions: HIV-1-infection studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 350 type: ESTIMATED name: F/TAF (High Dose Tablet) name: F/TAF (Low Dose Tablet) name: F/TAF (Lowest Dose Tablet) name: F/TAF (High Dose TOS) name: F/TAF (Low Dose TOS) name: F/TAF (Lowest Dose TOS) name: E/C/F/TAF name: E/C/F/TAF (Low Dose) name: Cobicistat (High Dose) name: Cobicistat (Low Dose) name: Cobicistat (TOS) name: B/F/TAF (High Dose) name: B/F/TAF (Low Dose) name: B/F/TAF (High Dose TOS) name: B/F/TAF (Low Dose TOS) name: B/F/TAF (Lowest Dose TOS) name: 3rd ARV Agent name: Nucleos(t)ide reverse transcriptase inhibitors (NRTI) name: ATV name: DRV name: Lopinavir Boosted with ritonavir (LPV/r) measure: Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06337019 id: IRMO briefTitle: The Italian Registry of Malnutrition in Oncology acronym: IRMO overallStatus: RECRUITING date: 2022-10-25 date: 2027-10 date: 2027-10 date: 2024-03-29 date: 2024-04-03 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER name: Istituto di Ricerche Farmacologiche Mario Negri IRCCS briefSummary: The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL. conditions: Cancer conditions: Cancer Metastatic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Cohort observational measure: Overall survival measure: Progression-free survival measure: Treatment toxicity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Tumori Giovanni Paolo II, status: NOT_YET_RECRUITING city: Bari state: BA country: Italy name: Antonella Daniele role: CONTACT lat: 41.11148 lon: 16.8554 facility: IRCCS Saverio De Bellis status: RECRUITING city: Castellana Grotte state: BA country: Italy name: Giovanni de Pergola role: CONTACT name: Rosalisa Cici role: CONTACT lat: 40.88643 lon: 17.16549 facility: Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: BO country: Italy name: Alessandra Longhi role: CONTACT name: Toni Ibrahim role: CONTACT lat: 44.49381 lon: 11.33875 facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS status: RECRUITING city: Meldola state: FC country: Italy name: Patrizia Serra role: CONTACT lat: 44.12775 lon: 12.0626 facility: IRCCS Ospedale Policlinico San Martino status: NOT_YET_RECRUITING city: Genova state: GE country: Italy name: Samir Guseppe Sukkar role: CONTACT lat: 44.40478 lon: 8.94438 facility: IRCCS Ospedale San Raffaele, Milano status: RECRUITING city: Milano state: MI country: Italy name: Roberto Mele role: CONTACT lat: 45.46427 lon: 9.18951 facility: Centro di Riferimento Oncologico status: RECRUITING city: Aviano state: PN country: Italy name: Renato Cannizzaro role: CONTACT lat: 46.07056 lon: 12.59472 facility: IOV Istituto Oncologico Veneto status: RECRUITING city: Padova state: PV country: Italy name: Maria Teresa Nardi role: CONTACT name: Marco Tonello role: CONTACT lat: 45.40797 lon: 11.88586 facility: AUSL IRCCS Reggio-Emilia status: RECRUITING city: Reggio Emilia state: RE country: Italy name: Debora Pezzuolo role: CONTACT lat: 44.69825 lon: 10.63125 facility: IDI IRCCS - Istituto Dermopatico dell'Immacolata status: RECRUITING city: Roma state: RM country: Italy name: Cristina Fortes role: CONTACT lat: 41.89193 lon: 12.51133 facility: Istituto Nazionale Tumori Regina Elena status: RECRUITING city: Roma state: RM country: Italy name: Lupe Sanchez Mete role: CONTACT lat: 41.89193 lon: 12.51133 facility: Policlinico Universitario Agostino Gemelli status: RECRUITING city: Roma state: RM country: Italy name: Carmelo Pozzo role: CONTACT name: Maria Cristina Mele role: CONTACT lat: 41.89193 lon: 12.51133 facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS status: RECRUITING city: Candiolo state: TO country: Italy name: Filippo Montemurro role: CONTACT name: Valentina Casalone role: CONTACT lat: 44.95858 lon: 7.59812 facility: IRCCS Sacro Cuore Don Calabria status: RECRUITING city: Negrar state: VR country: Italy name: Stefania Gori role: CONTACT lat: 45.52918 lon: 10.93899 facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale status: NOT_YET_RECRUITING city: Napoli country: Italy name: Vincenzo Quagliariello role: CONTACT lat: 40.85216 lon: 14.26811 facility: Fondazione IRCCS Policlinico San Matteo, Pavia status: RECRUITING city: Pavia country: Italy name: Riccardo Caccialanza role: CONTACT name: Paolo Pedrazzoli role: CONTACT lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06337006 id: SÜKAEK 2023/14/1 briefTitle: Laryngeal Mask Airway Failure in Pediatric Patients overallStatus: RECRUITING date: 2023-09-15 date: 2024-04-15 date: 2024-05-15 date: 2024-03-29 date: 2024-03-29 name: Samsun University class: OTHER briefSummary: There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs, which are increasingly used especially in short surgical procedures.
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data. conditions: Airway Management studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Placement of the laryngeal mask airway measure: Evaluation of the success of placement of the laryngeal mask airway sex: ALL minimumAge: 2 Years maximumAge: 12 Years stdAges: CHILD facility: Samsun University status: RECRUITING city: Samsun state: Canik zip: 55090 country: Turkey name: OZGUR KOMURCU, 1 role: CONTACT phone: 90 505 5273180 email: zgrkom@gmail.com name: Hatice SELCUK KUSDERCİ role: PRINCIPAL_INVESTIGATOR lat: 41.27976 lon: 36.3361 hasResults: False
<\|newrecord\|> nctId: NCT06336993 id: liuxianguiji briefTitle: Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-16 date: 2023-12-15 date: 2024-03-29 date: 2024-03-29 name: Zhejiang Provincial Tongde Hospital class: OTHER briefSummary: The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally. conditions: Low Back Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 71 type: ACTUAL name: herbal compound name: Celecoxib measure: Visual Analogue Scale measure: Oswestry disability index measure: Japanese Orthopaedic Association Scores measure: the adverse reactions of digestive or other system sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongde Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06336980 id: 31021 briefTitle: Creating Welcoming Faith Communities for People With Serious Mental Illnesses overallStatus: RECRUITING date: 2024-01-22 date: 2025-12 date: 2025-12 date: 2024-03-29 date: 2024-03-29 name: Temple University class: OTHER name: National Institute on Disability, Independent Living, and Rehabilitation Research briefSummary: The goal of this intervention study is to test a behavioral intervention to increase inclusionary practices toward individuals with serious mental illness in faith communities. The main questions it aims to answer are:
1. To determine if the behavior-based intervention leads to an increase in inclusionary practices (e.g., conducting outreach with mental health agencies).
2. To determine if the behavior-based intervention is effective in increasing inclusive practices by members and leaders of faith communities.
3. To determine if the intervention leads to a greater understand of mental illness and a decrease in stigmatizing beliefs by congregation members.
4. To determine if the intervention results in individuals with serious mental illness and their family members reporting less discrimination and increased inclusion.
Congregations will be asked to create an inclusion committee that will then work on developing systems and changing congregational practices to become more inclusive. All congregation members will be invited to a half-day training that will provide information on mental illness and inclusion, and will provide tips and strategies when they encounter situations or behaviors that are less familiar to them. All congregation members will be given the opportunity to participate in a survey about congregational practices. conditions: Other studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 700 type: ESTIMATED name: Increasing Inclusionary Practices in Faith Communities measure: Inclusionary practices measure: Indicators of Welcome measure: Mental Health Knowledge Questionnaire measure: Social Distance Scale measure: Community Attitudes Toward the Mentally Ill measure: Reported and Intended Behavior Scale measure: Sense of Belonging Scale measure: University of California Los Angeles Loneliness Scale measure: Lerman Quality of Life Interview sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Temple Univeristy status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19121 country: United States name: Crystal Slanzi, PhD role: CONTACT email: crystal.slanzi@temple.edu lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06336967 id: 855282 briefTitle: Testing a Wellness App for First Responders, Military Personnel and Veterans overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-09-01 date: 2026-01-01 date: 2024-03-29 date: 2024-04-08 name: University of Pennsylvania class: OTHER name: Nlyten Corp briefSummary: The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants. conditions: Mental Health Wellness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: GUIDE measure: PERMA-Profiler Overall Wellbeing Score measure: Patient Health Questionnaire for depression symptoms (PHQ-8) measure: Generalized Anxiety Disorder (GAD-7) measure: WHO Well-being Index (WHO-5) measure: Personal Wellbeing Score (PWS) measure: Difficulties in Emotion Regulation Scale Short Form (DERS-SF) measure: Positive Emotion (Positive emotion subscale of the PERMA-Profiler) measure: Social Connectedness (Engagement and Relationship subscales of PERMA-Profiler) measure: Social Connectedness (Number of posts/comments in the app) measure: Personal Growth (Meaning and Accomplishment subscales of the PERMA-Profiler) measure: Personal Growth (Total GUIDE lessons and courses completed) measure: Utrecht Work Engagement Scale (UWES-17) measure: Maslach Burnout Inventory (MBI) measure: Job Retention (Employment status) measure: Feasibility of Intervention Measure (FIM) measure: Acceptability of Intervention Measure (AIM) measure: Intervention Appropriateness Measure (IAM) measure: System Usability Scale (SUS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19146 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06336954 id: MA-NSCLC-#-037 briefTitle: Adibelimab, Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-07-31 date: 2026-12-31 date: 2024-03-29 date: 2024-03-29 name: Second Affiliated Hospital of Xi'an Jiaotong University class: OTHER briefSummary: This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Adibelimab measure: Progression-free survival time (PFS) measure: Objective Response Rate measure: Duration of Response measure: Overall Survival measure: Treatment-Related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336941 id: 32822 briefTitle: "Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON) acronym: HOUSTON overallStatus: RECRUITING date: 2018-06-07 date: 2025-12-31 date: 2030-12-31 date: 2024-03-29 date: 2024-03-29 name: University of Pisa class: OTHER briefSummary: Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.
In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions. conditions: Oral Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 400 type: ESTIMATED name: Ultrasound measure: Depth of invasion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Università di Pisa status: RECRUITING city: Pisa zip: 56126 country: Italy name: Rossana Izzetti, DS, PhD role: CONTACT phone: +39050993037 email: rossana.izzetti@unipi.it lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06336928 id: 1B-23-6 id: NCI-2024-01332 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 1B-23-6 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2030-04-01 date: 2024-03-29 date: 2024-03-29 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer. conditions: Breast Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 490 type: ESTIMATED name: Non-Interventional Study measure: Assess the sensitivity and specificity of LBx as a screening method for breast cancer sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Keck Medicine of USC Koreatown city: Los Angeles state: California zip: 90020 country: United States name: Bomi Choi role: CONTACT phone: 323-865-0451 email: Bomi.Choi@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Los Angeles General Medical Center city: Los Angeles state: California zip: 90033 country: United States name: Kimberly Arieli, RN role: CONTACT phone: 323-865-0451 email: Kimberly.Arieli@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Kimberly Arieli, RN role: CONTACT phone: 323-865-0451 email: Kimberly.Arieli@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC Norris Oncology/Hematology-Newport Beach city: Newport Beach state: California zip: 92663 country: United States name: Kristy Massopust role: CONTACT phone: 949-474-5733 email: Massopust_K@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 hasResults: False
<\|newrecord\|> nctId: NCT06336915 id: 121.NUR.2022.D briefTitle: Physician-Nurse Dyad Rounding: A Collaborative Approach to Improve Unit-Level Metrics overallStatus: RECRUITING date: 2023-01-03 date: 2024-12-30 date: 2024-12-30 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The project will be implemented on one unit at a time until the co-rounding process has been implemented on each Medical-Surgical unit. This study will involve the geo-localized hospitalist on the designated unit and the nursing staff involved in clinical patient care conditions: Wellness, Psychological studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Physician-Nurse Dyad Rounding measure: Difference in percentage of discharged patients before 1400 (Mon-Fri) after project implementation compared to before implementation measure: Difference in Top Box Patient Satisfaction Scores and Doctor Domain measure: Difference in LOS of private hospitalist patients after project implementation compared to before implementation measure: Difference in collaboration and build positive relationships scores after project implementation compared to before implementation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Institute at Methodist Health System status: RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Colette N Ndjom, MS role: CONTACT phone: 410-947-4681 phoneExt: 74681 email: ColetteNgoNdjom@mhd.com name: Loretta W Bedell, MPH role: CONTACT phone: 214-947-4680 phoneExt: 74680 email: lorettabedell@mhd.com name: Lauren Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Methodist Dallas Medical Center status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Colette N Ndjom, MS role: CONTACT phone: 214-947-4681 email: mhsirb@mhd.com name: Loretta W Bedell, MPH role: CONTACT phone: 217-947-4680 email: mhsirb@mhd.com name: Lauren Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06336902 id: 3C-23-11 id: NCI-2024-01368 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 3C-23-11 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-29 date: 2024-03-29 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer. conditions: Metastatic Colorectal Adenocarcinoma conditions: Stage IV Colorectal Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Balstilimab name: Biospecimen Collection name: Botensilimab name: Computed Tomography name: Dietary Intervention name: Magnetic Resonance Imaging name: Vitamin C measure: Proportion of patients who adhere to the fast mimicking diet measure: Incidence of adverse events (AEs) measure: Overall response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Los Angeles General Medical Center city: Los Angeles state: California zip: 90033 country: United States name: Charlean Ketchens, RN role: CONTACT phone: 323-865-0451 email: Charlean.Ketchens@med.usc.edu name: Rabia Rehman role: CONTACT phone: 323-865-0451 email: Rabia.Rehman@med.usc.edu name: Diana Hanna, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Charlean Ketchens, RN role: CONTACT phone: 323-865-0451 email: Charlean.Ketchens@med.usc.edu name: Rabia Rehman role: CONTACT phone: 323-865-0451 email: Rabia.Rehman@med.usc.edu name: Diana Hanna, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06336889 id: 092.TRA.2018.D briefTitle: Pelvic Angioembolization: A Prospective Multi-Institutional Study (Data From All Campuses Will be Used) overallStatus: RECRUITING date: 2017-10-26 date: 2024-10 date: 2024-10 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization. conditions: Pelvic Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Pelvic Angioembolization measure: Mortality outcome measure: transfusion requirements measure: thromboembolic events measure: Patient demographics(age, sex) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Dallas Medical Center status: RECRUITING city: Dallas state: Texas zip: 75201 country: United States name: Jennifer Burris, MD role: CONTACT phone: 214-947-1280 email: clinicalresearch@mhd.com lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06336876 id: 080.EDU.2019.R briefTitle: Perceived Coping, Meaning, and Joy at Work overallStatus: RECRUITING date: 2020-06-30 date: 2024-12 date: 2024-12 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The aim of this study is to assess and describe employee characteristics associated with perceived horizontal inter-collegial workplace uncivil behavior within nursing services, and identify any relationships with meaning and joy in work (MJW), and assess job satisfaction. conditions: Undefined studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 84 type: ESTIMATED name: Survey measure: Workplace Incivil Behavior measure: Meaning, Joy in Work measure: Occupational Coping Self-Efficacy measure: Demographic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Richardson Medical Center status: RECRUITING city: Richardson state: Texas zip: 75082 country: United States name: Maxine Adegbola, RN role: CONTACT phone: 214-876-9767 email: maxineadegbola@mhd.com name: Maxine Adegbola, RN role: PRINCIPAL_INVESTIGATOR name: David Irvan, RN role: SUB_INVESTIGATOR name: Terri Daugherty, RN role: SUB_INVESTIGATOR name: Joanna Bender, RN role: SUB_INVESTIGATOR name: Tabitha Moore, RN role: SUB_INVESTIGATOR name: Sharon Blackerby, RN role: SUB_INVESTIGATOR name: Katherine Hartdegen, RN role: SUB_INVESTIGATOR name: Melissa Miller, RN role: SUB_INVESTIGATOR name: Shannon Jackson, RN role: SUB_INVESTIGATOR name: Obed Thomas, RN role: SUB_INVESTIGATOR lat: 32.94818 lon: -96.72972 hasResults: False
<\|newrecord\|> nctId: NCT06336863 id: STU-2023-1151 briefTitle: Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-08 date: 2026-12 date: 2024-03-29 date: 2024-04-05 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients." conditions: Kidney Transplant Immunosuppression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Allosure and TruGraf name: Immunosuppression Taper measure: Incidence of acute kidney graft rejection measure: Incidence of facilitation to Belatacept monotherapy measure: Patient Survival after Immunosuppression Wean measure: Kidney Graft Failure after Immunosuppression Wean measure: Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean measure: Incidence of Proteinuria after Immunosuppression Wean measure: Incidence of de-novo donor specific antibodies (dnDSA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Southwestern Medical Center city: Dallas state: Texas zip: 75390 country: United States name: David Wojciechowski, DO role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-06 uploadDate: 2024-03-28T09:25 filename: Prot_SAP_000.pdf size: 293395 hasResults: False
<\|newrecord\|> nctId: NCT06336850 id: 069.GID.2020.D briefTitle: Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement overallStatus: RECRUITING date: 2020-12-23 date: 2025-01-01 date: 2025-01-01 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies. conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement measure: Portal Pressure Gradient Measurements from Hepatic and Portal Veins measure: Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension measure: Clinical significance between portal pressure gradient measurement and portal hypertension sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Dallas Medical Center status: RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Prashant Kedia, MD role: CONTACT lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06336837 id: 24-3T/48 briefTitle: False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study overallStatus: RECRUITING date: 2024-03-15 date: 2024-06-01 date: 2024-12-01 date: 2024-03-29 date: 2024-04-01 name: Ege University class: OTHER briefSummary: Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). During the diagnosis and treatment process in children with leukemia, a large number of peripheral or catheter blood cultures are performed. When the culture results are positive, it is accepted that the infection has grown. In some cases, a positive peripheral blood culture result may not be clinically significant. An agent belonging to the skin flora of the patient or the healthcare professional taking the field culture may also cause the blood culture result to be positive. This is called contamination or false positive blood culture. Contaminated cultures may cause prolonged hospitalization, additional medical interventions, unnecessary initiation of antibiotic treatment and related antibiotic resistance, toxicity due to additional drugs and an increase in hospital costs. The peripheral blood culture contamination rate, which is accepted as a quality indicator in some countries, should be below 3%.
In this context, this study aimed to determine the prevalence of false positive peripheral blood cultures by examining the peripheral blood culture results obtained during routine follow-ups from children hospitalized with leukemia in the pediatric hematology clinic. The data will be collected retrospectively covering three years before March 2024 when the ethics committee approval was obtained. Since the relevant clinic cares for approximately 25 new children diagnosed with leukemia annually, the study sample is planned as 75 cases. conditions: Nurse's Role conditions: Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 75 type: ESTIMATED measure: blood culture contamination rate sex: ALL minimumAge: 0 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ege University status: RECRUITING city: İzmir zip: 35100 country: Turkey name: Seda ARDAHAN SEVGILI, PhD role: CONTACT phone: 00905544318390 email: sedardahan@gmail.com name: Figen YARDIMCI, PhD role: CONTACT email: figenyardimci@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06336824 id: EVOS 1.2 dated 25/10/2023 briefTitle: Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia acronym: EVOS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-03-29 date: 2024-04-05 name: Clinical Research Centre, Malaysia class: OTHER briefSummary: The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB. conditions: Staphylococcus Aureus Bacteremia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 290 type: ESTIMATED name: Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid name: IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline measure: Rate of SAB-relapse measure: Number of days of hospitalization measure: Rate of all-cause mortality measure: Rate of complications related to IV therapy measure: Rate of Clostridium difficile diarrhoea measure: Rate of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Sultanah Aminah city: Johor Bahru state: Johor zip: 80100 country: Malaysia name: Wei Xuan Tuang role: CONTACT email: weixuan0706@gmail.com lat: 1.4655 lon: 103.7578 facility: Hospital Sultanah Bahiyah city: Alor Setar state: Kedah zip: 05460 country: Malaysia name: Sharifah Baizura Syed Alwi role: CONTACT email: baizura1973@hotmail.my lat: 6.12104 lon: 100.36014 facility: Hospital Sultan Abdul Halim city: Sungai Petani state: Kedah zip: 08000 country: Malaysia name: Noralfazita An role: CONTACT email: noralfazitaa@moh.gov.my lat: 5.647 lon: 100.48772 facility: Hospital Tuanku Ja'afar city: Seremban state: Negeri Sembilan zip: 70300 country: Malaysia name: Tiang Koi Ng role: CONTACT email: tiangkoi79@yahoo.com lat: 2.7297 lon: 101.9381 facility: Hospital Pulau Pinang city: George Town state: Penang zip: 10450 country: Malaysia name: Chuan Huan Chuah role: CONTACT email: chchuah7@yahoo.com lat: 5.41123 lon: 100.33543 facility: Hospital Seberang Jaya city: Seberang Jaya state: Penang zip: 13700 country: Malaysia name: Peng Peng Ang role: CONTACT email: angpp2209@gmail.com lat: 5.39085 lon: 100.41044 facility: Hospital Raja Permaisuri Bainun city: Ipoh state: Perak zip: 30450 country: Malaysia name: Steven Lim role: CONTACT email: stevenlimcl@gmail.com lat: 4.5841 lon: 101.0829 facility: Hospital Ampang city: Ampang state: Selangor zip: 68000 country: Malaysia name: Suraya Hanim Abdullah Hashim role: CONTACT email: surayahanim.abdullahhashim@gmail.com facility: Hospital Sultan Idris Shah Serdang city: Kajang state: Selangor zip: 43000 country: Malaysia name: Kah Chuan Lim role: CONTACT email: ck7902@gmail.com lat: 2.99424 lon: 101.78875 facility: Hospital Tengku Ampuan Rahimah city: Klang state: Selangor zip: 41200 country: Malaysia name: Azureen Azmel role: CONTACT email: aazmel@gmail.com lat: 3.03333 lon: 101.45 facility: Hospital Selayang city: Selayang Baru Utara state: Selangor zip: 68100 country: Malaysia name: Anuradha P. Radhakrisnan role: CONTACT email: anurapr70@gmail.com lat: 3.2549 lon: 101.6668 facility: Hospital Melaka city: Melaka zip: 75400 country: Malaysia name: Wee Fu Gan role: CONTACT email: ganweefu@gmail.com lat: 2.196 lon: 102.2405 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-25 uploadDate: 2024-03-28T09:13 filename: Prot_SAP_001.pdf size: 749936 hasResults: False
<\|newrecord\|> nctId: NCT06336811 id: DEU active-pasive VR briefTitle: Virtual Reality Distraction During Phlebotomy in Children acronym: activeVR overallStatus: COMPLETED date: 2023-05-30 date: 2023-12-30 date: 2023-12-30 date: 2024-03-29 date: 2024-03-29 name: Dokuz Eylul University class: OTHER briefSummary: This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit. conditions: Pain, Acute conditions: Child, Only conditions: Anxiety and Fear studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Before blood collection, the "Emotional Appreance Scale for Children" was evaluated by a non-researcher nurse. Pediatric patients between the ages of 6 and 12, from whom blood would be collected, were distributed to groups according to the randomization scheme. whoMasked: INVESTIGATOR count: 150 type: ACTUAL name: passive virtual reality distraction name: active virtual reality distraction measure: procedure related pain measure: anxiety measure: fear measure: emotional apperance sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Gülçin Özalp Gerçeker city: İzmir zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06336798 id: STUDY00005871 id: K23HL166775 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL166775 briefTitle: Bioenergetic Effect of Pioglitazone in CLD-PH overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-08 date: 2028-08 date: 2024-03-29 date: 2024-04-01 name: Emory University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is:
• Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD.
Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo). conditions: Pulmonary Hypertension conditions: Pulmonary Hypertension Due to Lung Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Pioglitazone 30mg name: Placebo name: Labs measure: Change in Mitochondrial metabolism parameters: Spare respiratory capacity measure: Change in Mitochondrial metabolism parameters: Maximal respiration measure: Change in Mitochondrial metabolism parameters: Basal respiration measure: Number of hypoglycemia incidences measure: Number of participants with leg edema measure: Change in BNP levels measure: Change in Six minute walk distance (6MWT) measure: Change in Borg dyspnea score measure: Change in NYHA/WHO Functional Classification measure: Change in University of California San Diego Shortness of Breath Questionnaire score measure: Change in emPHasis-10 Questionnaire score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336785 id: 04-2023-HIT-K&S briefTitle: Kiss and Smile HIT overallStatus: RECRUITING date: 2023-11-02 date: 2024-11-30 date: 2025-11-30 date: 2024-03-29 date: 2024-04-01 name: Erevna Innovations Inc. class: OTHER briefSummary: The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.
The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression). conditions: Aesthetic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Restylane line of dermal fillers and Dysport neuromodulator measure: Global Aesthetic Improvement Scale (GAIS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc. status: RECRUITING city: Montréal state: Quebec zip: H3R3A1 country: Canada name: Andreas Nikolis, MD role: CONTACT phone: 514-488-0163 email: research@vicpark.com lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06336772 id: 10-2023-GAL-SHYP briefTitle: Restylane Shaype Versus Juvederm Volux for Chin Augmentation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-23 date: 2024-10-31 date: 2024-11-01 date: 2024-03-29 date: 2024-04-01 name: Erevna Innovations Inc. class: OTHER briefSummary: This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin conditions: Chin Retrusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Restylane Shaype name: Juvéderm Volux measure: Statistically significant group differences in the average three-dimensional volumetric increase since baseline measure: Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale) measure: Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale) measure: Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc. city: Montréal state: Quebec zip: H3R3A1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06336759 id: 2021-10-GAL-JWL briefTitle: Safety and Efficacy of Fillers for Contouring the Jawline overallStatus: COMPLETED date: 2021-11-11 date: 2022-12-14 date: 2023-11-10 date: 2024-03-29 date: 2024-04-01 name: Erevna Innovations Inc. class: OTHER briefSummary: The study aims to evaluate the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, addressing concerns about contour deficits in patients seeking aesthetic treatments. conditions: Jawline Contour Deficit studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Restylane Defyne name: Restylane Lyft measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc. city: Montréal state: Quebec zip: H3R3A1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06336746 id: RHenningsson briefTitle: Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-03-31 date: 2024-03-29 date: 2024-04-17 name: Karlstad Central Hospital class: OTHER briefSummary: The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent.
The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions.
In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning
During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery. conditions: Heart Failure, Systolic conditions: Robotic Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Esophageal Doppler measure: Change of Stroke Volume during Trendelenburg position and pneumoperitoneum. measure: % Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected measure: % change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad city: Karlstad state: Värmland zip: 65230 country: Sweden name: Ragnar N Henningsson, Associate Professor role: CONTACT phone: +461083317434 email: ragnar.henningsson@regionvarmland.se lat: 59.3793 lon: 13.50357 hasResults: False
<\|newrecord\|> nctId: NCT06336733 id: APHP220828 briefTitle: Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy acronym: KIN-ATTACK-FMF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03-03 date: 2026-09-15 date: 2024-03-29 date: 2024-03-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of
* on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine.
* compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment. conditions: FMF studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: ANAKINRA measure: Mean number of FMF-attacks per month at 6 months of treatment. measure: Cumulative days of FMF attack treatment measure: AIDAI (Auto-inflammatory Diseases activity index) score measure: Number of painful days and severity of FMF attacks occurring between randomization and M6 measure: Quality of life score measured by EuroQOL questionnaire (EQ-5D5L) measure: Number of local cutaneous reactions at 6 months (erythema and oedema involving the injection sites) in the anakinra arm measure: Proportion of Adverse events sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Médecine interne Hopital Tenon city: Paris zip: 75020 country: France name: Léa SAVEY role: CONTACT phone: 00 33 1 56 01 60 77 email: lea.savey@aphp.fr name: Sophie Georgin-Lavialle, MD,PHD role: CONTACT phone: 0 33 1 56 01 74 31 email: sophie.georgin-lavialle@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06336720 id: HMI-SA-PoNS-STK001 briefTitle: PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study overallStatus: RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-08-30 date: 2024-03-29 date: 2024-04-29 name: Helius Medical Inc class: INDUSTRY briefSummary: Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.
Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.
Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up. conditions: Chronic Stroke Survivors studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Portable Neuromodulation Stimulator (PoNS) measure: Primary safety endpoints sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brooks Rehabilitation status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States name: Mark Bowden, PhD. PT role: CONTACT phone: 904-345-6626 email: Mark.Bowden@Brooksrehab.org lat: 30.33218 lon: -81.65565 facility: Shepherd Center status: RECRUITING city: Atlanta state: Georgia zip: 30309 country: United States name: Cathy Furbish, PT, DPT, CCRP role: CONTACT phone: 404-350-7591 email: cathy.furbish@shepherd.org lat: 33.749 lon: -84.38798 facility: Neurology Center of New England, P.C. status: RECRUITING city: Foxboro state: Massachusetts zip: 02035 country: United States name: Rachel O'Donnell role: CONTACT phone: 781-551-5812 phoneExt: 101 email: rodonnell@myneurodr.com name: MD role: CONTACT lat: 42.06538 lon: -71.24783 facility: Rehabologym Corp status: RECRUITING city: Tarrytown state: New York zip: 10591 country: United States name: Avrielle Peltz, MA OTR/L role: CONTACT phone: 914-603-8600 email: avrielle.peltz@rehabologym.com lat: 41.07621 lon: -73.85875 hasResults: False
<\|newrecord\|> nctId: NCT06336707 id: HS-20089-103 briefTitle: HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-04-08 date: 2028-04-08 date: 2024-03-29 date: 2024-03-29 name: Hansoh BioMedical R&D Company class: INDUSTRY briefSummary: HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.
This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1048 type: ESTIMATED name: HS-20089 name: Adebrelimab name: Bevacizumab name: Cisplatin / carboplatin measure: Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy measure: Incidence and severity of adverse events (AEs) measure: Observed maximum plasma concentration (Cmax) of HS-20089 measure: Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089 measure: Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089 measure: Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measure: Duration of response (DoR) assessed by investigators according to RECIST 1.1 measure: Disease control rate (DCR) assessed by investigators according to RECIST 1.1 measure: Progression-free survival (PFS) assessed by investigators according to RECIST 1.1 measure: Overall survival (OS) measure: Percentage of participants with antibodies to HS-20089 in serum sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336694 id: SYSUFAH2021-025 briefTitle: A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma overallStatus: COMPLETED date: 2021-01-01 date: 2022-10-31 date: 2023-07-30 date: 2024-03-29 date: 2024-03-29 name: First Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment. conditions: Pancreatic Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 302 type: ACTUAL name: surgery or diagnostic staging laparoscopy measure: diagnosed with peritoneal metastases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shi Siya city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06336681 id: #12966 briefTitle: Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB) acronym: IMT_EIB overallStatus: RECRUITING date: 2022-02-10 date: 2025-08 date: 2025-08 date: 2024-03-29 date: 2024-03-29 name: Indiana University class: OTHER briefSummary: Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance. conditions: Exercise Induced Bronchospasm conditions: Exercise Induced Asthma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: PrO2Fit Device measure: Exercise-Induced Bronchoconstriction (EIB) Severity measure: Maximum Inspiratory Pressure and Sustained Maximum Inspiratory Pressure measure: 16-km Cycling Time-Trial Time to Completion measure: 16-km Cycling Time-Trial Power Output measure: Constant Load Performance measure: Perception of Breathing Intensity and Unpleasantness and Leg Fatigue measure: Deoxygenation of the respiratory and limb locomotor muscles by near-infrared spectroscopy measure: Femoral blood flow (FBF) of the limb locomotor muscles by ultrasound measure: Lung Volumes sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: School of Public Health-Bloomington status: RECRUITING city: Bloomington state: Indiana zip: 47405 country: United States name: Tim Mickleborough, Ph.D. role: CONTACT phone: 812-855-0753 email: tmickleb@indiana.edu lat: 39.16533 lon: -86.52639 hasResults: False
<\|newrecord\|> nctId: NCT06336668 id: REB23-1283 briefTitle: Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-28 date: 2026-02-28 date: 2024-03-29 date: 2024-04-01 name: University of Calgary class: OTHER briefSummary: Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.
The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks. conditions: Feeding; Difficult, Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective randomized-controlled crossover trial comparing 2 different HMFs and 2 intestinal rSO2S periods in random order: 6 hours while on B-HMF and 6 hours on H-HMF with at least 6 hours washing period primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Randomizing the participants to either Bovine-HMF or Human Milk based-HMF will mask the Investigator whoMasked: INVESTIGATOR count: 18 type: ESTIMATED name: Human milk-based HMF measure: Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy measure: Changes in SMA doppler peak flow velocity (PSV) measure: Changes in SMA doppler end-diastolic velocity (EDV) measure: Changes in SMA doppler Porcelout's resistance index (RI) sex: ALL maximumAge: 30 Weeks stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06336655 id: 153309 briefTitle: Physiology of Unloading VA ECMO Trial overallStatus: RECRUITING date: 2024-04-15 date: 2028-02-01 date: 2029-02-01 date: 2024-03-29 date: 2024-04-25 name: University of Utah class: OTHER name: University of Minnesota briefSummary: The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for non-postoperative cardiogenic shock (CS). The main aims of the study are:
1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO
2. To determine the effects on myocardial function of adding LV unloading to ECMO
3. To test the effects on myocardial recovery of adding LV unloading to VA ECMO
Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups. conditions: Cardiogenic Shock studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: IABP measure: Change in pulmonary capillary wedge pressure measure: Change in pulmonary artery diastolic pressure measure: Change in left ventricular end diastolic diameter measure: Change in N-terminal pro b-type natriuretic peptide measure: Hemodynamic stability measure: Global cardiovascular function measure: Difference in partial pressure of carbon dioxide (pCO2) measure: Lactate measure: Cardiac BIN1 measure: Troponin I measure: Tumor necrosis factor alpha measure: Ejection fraction percentage measure: Interferon gamma measure: Limb ischemia measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah status: RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Joseph E. Tonna, MD, FAAEM role: CONTACT phone: 801-587-9373 email: joseph.tonna@hsc.utah.edu lat: 40.76078 lon: -111.89105 hasResults: False
<\|newrecord\|> nctId: NCT06336642 id: 2023-0933 id: NCI-2024-02452 type: OTHER domain: NCI-CTRP Clinical Trials Registry briefTitle: Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2030-03-31 date: 2032-03-31 date: 2024-03-29 date: 2024-03-29 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer. conditions: Dyspnea studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: SPOT-ON Early Start name: SPOT-ON Delayed Start measure: Primary Outcome Measure: 1.Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: David Hui, MD role: CONTACT phone: 713-792-6258 email: dhui@mdanderson.org lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06336629 id: WIN2023 briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-15 date: 2024-10 date: 2024-10 date: 2024-03-29 date: 2024-03-29 name: Sun Pharmaceutical Industries Limited class: INDUSTRY briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice. conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Winlevi (clascoterone) 1% & Duac gel measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16. measure: Percent of total lesion reduction at week 16 compared to baseline measure: Percent of inflammatory lesion reduction at week 16 compared to baseline measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline. measure: Tolerability measures of erythema based on 5-point severity scale measure: Tolerability measures of dryness based on 5-point severity scale measure: Tolerability measures of peeling based on 5-point severity scale measure: Assessment of skin oiliness based on 5-point severity scale measure: Tolerability measures of burning/stinging based on 6-point severity scale measure: Tolerability measures of pruritus based on 6-point severity scale sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Skin Sciences, PLLC city: Louisville state: Kentucky zip: 40217 country: United States lat: 38.25424 lon: -85.75941 hasResults: False
<\|newrecord\|> nctId: NCT06336616 id: 31164 briefTitle: Getting Out of the House: Using Behavioral Activation to Increase Community Participation overallStatus: RECRUITING date: 2024-02-15 date: 2026-08 date: 2026-12 date: 2024-03-29 date: 2024-04-10 name: Temple University class: OTHER name: National Institute on Disability, Independent Living, and Rehabilitation Research briefSummary: The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.
The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:
1. To determine if the intervention leads to increases the frequency and variety of activities.
2. To determine if the intervention leads to increases in community mobility.
3. To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.
4. To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).
Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.
For data collection, participants will also be asked to:
1. Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;
2. Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and
3. Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.
The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group. conditions: Major Depressive Disorder conditions: Schizo Affective Disorder conditions: Schizophrenia conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 52 type: ESTIMATED name: Behavior Activation measure: Activity Logs measure: Participation Checklist measure: Behavior Activation for Depression Scale measure: Temple University Community Participation Measure measure: Community Mobility (Global Positioning System; GPS) measure: Community Mobility (Global Positioning System; GPS) measure: Lerman Quality of Life Interview measure: New General Self-Efficacy Scale (adapted to participation) measure: Recovery Assessment Scale (RAS) measure: Activity Assessment Scale measure: Capabilities and Opportunities for Participation Questionnaire measure: Self-Control and Self-Management Scale measure: Habit Strength Scale measure: University of California Los Angeles Loneliness Scale measure: Lehman Quality of LIfe (QOL) Interview Social Relations sub scale measure: Hopkins Symptoms Checklist measure: The Life Engagement Test measure: The University of Rhode Island Change Assessment Measure (URICA) measure: Reward Probability Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Temple University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19120 country: United States name: Crystal Slanzi role: CONTACT lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06336603 id: WIN2022 briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-15 date: 2024-09 date: 2024-09 date: 2024-03-29 date: 2024-03-29 name: Sun Pharmaceutical Industries Limited class: INDUSTRY briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice. conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Winlevi (clascoterone) 1% & Adapalene 0.3% gel measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16. measure: Percent of total lesion reduction at week 16 compared to baseline measure: Percent of inflammatory lesion reduction at week 16 compared to baseline measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline measure: Tolerability measures of erythema based on 5-point severity scale measure: Tolerability measures of dryness based on 5-point severity scale measure: Tolerability measures of peeling based on 5-point severity scale measure: Assessment of skin oiliness based on 5-point severity scale measure: Tolerability measures of burning/stinging based on 6-point severity scale measure: Tolerability measures of pruritus based on 6-point severity scale sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Skin Sciences, PLLC city: Louisville state: Kentucky zip: 40217 country: United States lat: 38.25424 lon: -85.75941 hasResults: False
<\|newrecord\|> nctId: NCT06336590 id: Pro2024000249 briefTitle: Student Exercise and Sleep Timing Study - Part 2 acronym: SiESTa 2 overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2026-12-01 date: 2026-12-16 date: 2024-03-29 date: 2024-03-29 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality.
Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration.
Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger).
Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity. conditions: Sleep conditions: Mood conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 62 type: ESTIMATED name: Morning Exercise measure: Sleep Quality measure: Mood measure: Stress measure: Productivity sex: ALL minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: College Avenue Gym city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 facility: Cook/Douglass Rec Center city: New Brunswick state: New Jersey zip: 08901 country: United States name: Assistant Director of Operations role: CONTACT phone: 848-932-8063 email: samantha.plum@rutgers.edu lat: 40.48622 lon: -74.45182 facility: Rutgers Fitness Center city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 facility: Rutgers Sleep Lab city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 facility: Livingston Rec Center city: Piscataway state: New Jersey zip: 08854 country: United States name: Assistant Director of Operations role: CONTACT phone: 848-932-8063 email: samantha.plum@rutgers.edu lat: 40.49927 lon: -74.39904 facility: Werblin Rec Center city: Piscataway state: New Jersey zip: 08854 country: United States name: Assistant Director of Operations role: CONTACT phone: 848-932-8063 email: samantha.plum@rutgers.edu lat: 40.49927 lon: -74.39904 hasResults: False
<\|newrecord\|> nctId: NCT06336577 id: 2024/0003 briefTitle: Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France acronym: ARBT21 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-29 name: Centre Hospitalier Sud Francilien class: OTHER briefSummary: The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France. conditions: Down Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 250 type: ESTIMATED name: lower respiratory tract disease measure: distribution of lower respiratory tract diseases sex: ALL minimumAge: 1 Day maximumAge: 17 Years stdAges: CHILD facility: Centre Hospitalier Sud Francilien city: Corbeil-Essonnes zip: 91106 country: France name: Yousra MESBAHI role: CONTACT phone: 0161697760 email: yousra.mesbahi@chsf.fr lat: 48.60603 lon: 2.48757 hasResults: False
<\|newrecord\|> nctId: NCT06336564 id: 71168623.6.0000.5544 briefTitle: Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2026-12 date: 2024-03-28 date: 2024-03-28 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM. conditions: Menopause conditions: Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Pelvic floor muscle training name: Microablative Radiofrequency measure: Resolution or improvement of episodes of urinary loss assessed by pad test measure: Resolution or improvement of episodes of urinary loss assessed by urinary diary measure: Number of patients with tolerability related to treatment assessed by Likert Scale. measure: Number of patients with adverse effects related to treatment assessed by histopathology. measure: Resolution or improvement of episodes of urinary loss assessed by questionnaire. measure: Recovery of vaginal health assessed by Vaginal Index Maturation measure: Recovery of vaginal health assessed by vaginal pH measure: Improvement of Sexual Function assessed by Female Sexual Function Index measure: Improvement of quality of life assessed by Short-Form Health Survey (SF-36) measure: Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire. measure: Degree of patient satisfaction using a five-point Likert scale. measure: Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS) sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Atenção ao Assoalho Pelvico city: Salvador state: Ba zip: 40.290-000 country: Brazil lat: -12.97111 lon: -38.51083 hasResults: False
<\|newrecord\|> nctId: NCT06336551 id: UniversityAmsterdam briefTitle: Acceptance and Commitment Therapy for Insomnia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-26 date: 2026-01-26 date: 2024-03-28 date: 2024-03-29 name: University of Amsterdam class: OTHER briefSummary: Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown.
The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis.

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