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To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure.
This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively. conditions: Esophageal Achalasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: interventional trial primaryPurpose: TREATMENT masking: NONE count: 73 type: ESTIMATED name: POEM with Speedboat Ultraslim measure: Technical success of procedure measure: Clinical success of procedure measure: Frequency of adverse events attributable to the procedure measure: Rate of Gastroesophageal reflux disease measure: Assessment of Gastroesophageal reflux disease severity measure: Change in health-related quality of life after POEM sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED) status: RECRUITING city: Guayaquil state: Guayas zip: 090505 country: Ecuador name: Carlos Robles-Medranda, MD FASGE role: CONTACT phone: +593989158865 email: carlosoakm@yahoo.es role: CONTACT email: carlosoakm@yahoo.es name: Carlos Robles-Medranda, MD role: PRINCIPAL_INVESTIGATOR name: Michel Kahaleh, MD role: SUB_INVESTIGATOR name: Eduardo Albeniz, MD role: SUB_INVESTIGATOR name: Juan Alcivar-Vasquez, MD role: SUB_INVESTIGATOR name: Maria Egas-Izquierdo, MD role: SUB_INVESTIGATOR name: Jorge Baquerizo-Burgos, MD role: SUB_INVESTIGATOR name: Domenica Cunto, MD role: SUB_INVESTIGATOR name: Miguel Puga-Tejada, MD role: SUB_INVESTIGATOR name: Martha Arevalo-Mora, MD role: SUB_INVESTIGATOR name: Raquel Del Valle, MD role: SUB_INVESTIGATOR name: Hannah Pitanga-Lukashok, MD role: SUB_INVESTIGATOR lat: -2.20584 lon: -79.90795 hasResults: False
<|newrecord|> nctId: NCT06264453 id: KH-001-D201 briefTitle: A Study to Evaluate the Efficacy and Safety of KH001 in Patients With Dentin Hypersensitivity overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-08-23 date: 2024-08-30 date: 2024-02-20 date: 2024-02-21 name: HysensBio Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity. conditions: Dentin Hypersensitivity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 171 type: ESTIMATED name: KH001 name: Placebo measure: Change from baseline in Schiff sensitivity score measure: Change from baseline in a Schiff sensitivity score measure: Change from baseline in a Tactile threshold measure: Change from baseline in Visual Analogue Scale sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06264440 id: 283HV104 briefTitle: A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-12 date: 2024-05-07 date: 2024-05-07 date: 2024-02-20 date: 2024-03-25 name: Biogen class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) \[rabeprazole\] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: BIIB122 name: Rabeprazole measure: Maximum Observed Concentration (Cmax) of BIIB122 measure: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122 measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122 measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PPD Development, LP city: Austin state: Texas zip: 78744 country: United States lat: 30.26715 lon: -97.74306 hasResults: False
<|newrecord|> nctId: NCT06264427 id: KVUG - 2022 - 10 briefTitle: Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland overallStatus: RECRUITING date: 2022-07-15 date: 2025-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-02-20 name: Steno Diabetes Center Greenland class: OTHER name: Zealand University Hospital name: University of Copenhagen briefSummary: The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.
The main questions it aims to answer are:
* Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?
* Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?
* What is the prevalence of sleep apnea among high-risk individuals in Greenland?
* Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?
Participants will:
* Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness
* Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy
* Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation
* Blood samples for full genome sequencing conditions: Diabetes Mellitus, Type 2 conditions: Obesity, Morbid conditions: Obstructive Sleep Apnea conditions: MODY conditions: Diabetic Retinopathy conditions: Diabetic Neuropathies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will be examined with whole genom sequencing, and diabetes treatment will be accommodated their diabetic fenotype.
'For the intervention, participants will be screened for obstructive sleep apnea (OSA). Participants with signs of OSA will be offered treatment with Continuos Positive Airway Pressure. primaryPurpose: TREATMENT masking: NONE count: 1000 type: ESTIMATED name: Whole genome sequencing name: VAGUS name: NightOwl name: CPAP measure: Number of participants with MODY diabetes and their complication status measure: Number of participants with diabetic complication measure: Number of participants with obstructive sleep apnea measure: CPAP compliance in Greenlandic patients measure: CPAP treatment effect on quality of life measured with the World Health Organization Well-being Index (WHO-5). measure: CPAP treatment effect on daytime sleepiness measured with the functional outcome of sleep questionnaire (FOSQ-10). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Steno Diabetes Center Greenland, Queen Ingrids Hospital status: RECRUITING city: Nuuk state: Sermersooq zip: 3900 country: Greenland name: Mads Mose Jensen, MD. role: CONTACT phone: +299 34 46 23 email: MMSN@peqqik.gl name: Marit Eika Jørgensen, Md. Ph.d role: CONTACT phone: 34 43 24 email: MAEJ@peqqik.gl lat: 64.18347 lon: -51.72157 hasResults: False
<|newrecord|> nctId: NCT06264414 id: DTT106-III-0123 briefTitle: Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia acronym: AUSTRÁLIA overallStatus: NOT_YET_RECRUITING date: 2025-02 date: 2026-06 date: 2027-07 date: 2024-02-20 date: 2024-02-20 name: EMS class: INDUSTRY briefSummary: The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia conditions: Prostatic Hyperplasia, Benign conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 262 type: ESTIMATED name: DTT106 name: Dutasteride-Tamsulosin measure: Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline. measure: Change in maximum urinary flow rate (Qmax) measure: Decrease in post-void residual volume (PVR) measure: Improvement in urinary symptoms. measure: Improvement in urinary emptying symptoms measure: Improvement in urinary storage symptoms. measure: Improvement in the participant's quality of life in relation to their urinary condition measure: Improvement in the participant's sexual function measure: Improvement in the participant's orgasmic function. measure: Effectiveness of the treatment in improving the participant's sexual desire measure: Effectiveness in improving the participant's satisfaction with sexual relations measure: Overall satisfaction of the participant regarding their sex life. sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: EMS city: Hortolândia state: São Paulo country: Brazil lat: -22.85833 lon: -47.22 hasResults: False
<|newrecord|> nctId: NCT06264401 id: menopausal with osteoporsis briefTitle: Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population. conditions: Postmenopausal Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention: medication the experimental and control groups received (Alendronate) 70 mg 1 tab every week for 4 months.
treatment exercises the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program which include 5 min warming up and 5 min cooling down at the end of the session each exercise was executed for three sets of 15 seconds, which gradually upgraded to three sets of 45-second at the fourth month and 10 sec rest between each set and dynamic resistance exercise performed by each woman for 2 sets for 8-12 repetitions gradually along the study of 90 sec rest between each set for a duration of 60 min including 10 min warming up and 10 min cooling down in form of stretching. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Alendronate name: treatment exercises measure: Dual-energy x-ray absorptiometry measure: Oswestry Disability Index sex: FEMALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: faculty of physical therapy, Cairo university city: Giza zip: 12662 country: Egypt name: Nermeen Abd El Aziem, phd role: CONTACT phone: 01025016087 email: nermeenshaaban93o@yahoo.com lat: 30.00808 lon: 31.21093 hasResults: False
<|newrecord|> nctId: NCT06264388 id: 20231234 id: R21CA282543 type: NIH link: https://reporter.nih.gov/quickSearch/R21CA282543 briefTitle: DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma overallStatus: RECRUITING date: 2024-05-01 date: 2034-05-01 date: 2034-05-01 date: 2024-02-20 date: 2024-04-26 name: Ashish Shah class: OTHER name: Denovo Biopharma LLC name: National Cancer Institute (NCI) briefSummary: The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled. conditions: High Grade Glioma conditions: Anaplastic Astrocytoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: DB107-RRV name: DB107-FC measure: Progression Free Survival measure: Overall Survival measure: Assessment of Tumor Status Measured by Response Assessment in Neuro-oncology (RANO) Criteria measure: Number of Treatment Related Toxicities measure: Durable Response Rate (DRR) measure: Durable Clinical Benefit Rate (DCBR) measure: Duration of Durable Response Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami Hospital status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Leonela Wright, MSN, RN role: CONTACT phone: 305-243-0864 email: lxw612@med.miami.edu name: Ashish Shah, MD role: CONTACT phone: 305-243-6946 email: ashah@med.miami.edu name: Ashish Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False
<|newrecord|> nctId: NCT06264375 id: E-SPORT briefTitle: Effect of a Specific and General Physical Exercise Intervention on Gaming and E-Sport Performance acronym: E-SPORT overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-19 date: 2024-04-19 date: 2024-09-30 date: 2024-02-20 date: 2024-04-23 name: Universitaet Innsbruck class: OTHER briefSummary: The goal of this randomized control intervention study is to test the effect of i) a specific physical training for e-sport and ii) a general physical training on e-sport performance, compared to iii) not training physically at all.
Participants are gamers and e-athletes who play at least \>2hours peer week. The main questions it aims to answer are:
* Does physical training have an effect on e-sport related abilities (hand grip strength, reaction, anticipation)
* Does the training of specific elements, which aim at these abilities "out-game", transfer on the actual skills needed using a keyboard and mouse
Participants will be randomly - but mediated by hours of playing per week - distributed in 1 of 3 groups.
* Group 1 will 3 times per week for 30 minutes perform a specific physical training with focus on abilities needed in e-sport (grip strength, reaction, anticipation) over a timespan of 8 weeks.
* Group 2 will perform a similar physical training (load, intensity) to Group 1, but without specific elements.
* Group 3 will serve as control group without any training.
Researchers will compare Group 1, Group 2 and Groups 3 to see if the different trainings (Group 1 and Group 2) have different effect on e-sport performance and if no training (Group 3) differs in e-sport performance development. conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 8 weeks of intervention, where Group 1 does a specific physical training, Group 2 a general physical training and Group 3 who does not train. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Data is collected and afterwards anonymized during the pre- and post measurement and during the intervention using a weekly questionnaire (activity level, gaming time) count: 28 type: ACTUAL name: Physical exercise measure: Grip Strength (Out-Game) measure: Reaction Time (Out-Game) measure: Anticipation (Out-Game) measure: Whole Body Fitness measure: Gaming Performance - Accuracy/Speed and Anticipation measure: Well-being after training sex: ALL minimumAge: 10 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Department of Sport Science city: Innsbruck state: Tyrol zip: 6020 country: Austria lat: 47.26266 lon: 11.39454 hasResults: False
<|newrecord|> nctId: NCT06264362 id: K23AG081547 type: NIH link: https://reporter.nih.gov/quickSearch/K23AG081547 id: 1K23AG081547-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23AG081547-01 briefTitle: Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia overallStatus: RECRUITING date: 2023-10-09 date: 2027-05-01 date: 2027-05-01 date: 2024-02-20 date: 2024-04-17 name: Drexel University class: OTHER name: National Institute on Aging (NIA) briefSummary: The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts.
In Part 1 - The investigators are inviting the following people to participate in an interview:
1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.
2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.
3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain.
The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems.
For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study.
Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions.
For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch.
In Part 2 - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2.
Please contact us for any questions. conditions: Pain, Chronic conditions: Dementia, Mild conditions: Mobility Limitation conditions: Physical Disability conditions: Osteo Arthritis Knee conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: In Phase 1, 15 dyads and 15 clinicians will be interviewed (a dyad equals one person living with mild to very mild dementia and their care partner) to inform design of the intervention. In Phase 2, 20 people living with mild to very mild dementia will be treated with the new intervention. Their care partners may be involved in treatment. primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: Tailored Physical Activity Program measure: Program parameters measure: Program parameters measure: Feasibility of Intervention Measure measure: Perception of program measure: Numeric Pain Score measure: Zarit Burden Interview-Short Form sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Drexel University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Annalisa Na, PT, PhD role: CONTACT phone: 267-359-5889 email: an838@drexel.edu name: Ben Senderling, MS role: CONTACT phone: 2679800425 email: bms422@drexel.edu lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06264349 id: 05102023 briefTitle: Women and Maternity: Development of a Nutritional Education Project acronym: MATER overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-05-15 date: 2025-11-30 date: 2024-02-16 date: 2024-02-16 name: University of Pavia class: OTHER briefSummary: The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.
Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood. conditions: Pregnancy conditions: Lactation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Quasi-experimental - controlled, non-randomized pilot study primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Lifestyle Educational Intervention measure: Gestational weight gain management measure: Nutritional aspects evaluation during pregnancy and lactation measure: Physical activity evaluation during pregnancy and lactation measure: Smoking habits during pregnancy and lactation measure: Maternal attitude towards infant feeding. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06264336 id: UIC AHS Pilot 2024 briefTitle: Effects of High-intensity Gait Training on Fatigue, Gait, and Neuroplasticity in People With Multiple Sclerosis overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-28 name: University of Illinois at Chicago class: OTHER briefSummary: Nearly 1 million individuals in the United States have multiple sclerosis, which causes fatigue and problems with walking. Fatigue and walking problems are poorly treated, but exercise training, particularly high-intensity walking exercise, may help. This provide insight into whether high-intensity walking exercise can improve fatigue and walking problems in people with multiple sclerosis, which could improve quality of life and reduce economic burden. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: treadmill training measure: Symptomatic fatigue measure: Walking speed measure: Corticomotor excitability measure: Fatigue impact measure: Walking endurance measure: Aerobic capacity measure: Visual processing speed measure: Verbal learning and memory measure: Spatial walking symmetry measure: Temporal walking symmetry measure: Community ambulation measure: Interhemispheric inhibition sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois Chicago status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Brice T Cleland, PhD role: CONTACT phone: 312-996-9056 email: bcleland@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False
<|newrecord|> nctId: NCT06264323 id: UI-5487 briefTitle: Incidence of Acute Injuries in Boxing overallStatus: COMPLETED date: 2017-09-01 date: 2018-05-30 date: 2018-11-30 date: 2024-02-16 date: 2024-02-16 name: University of Iceland class: OTHER briefSummary: A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Participants filled out a questionnaire on previous injuries during boxing training and competition and were evaluated on the Sport Concussion Assessment Tool 3rd edition (SCAT3). Exposure at training and competition was measured and any injuries sustained during the study period were recorded via text messages and phone calls every 2 weeks. conditions: Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 74 type: ACTUAL measure: Questionnaire measure: Sport Concussion Assessment Tool 3rd Edition (SCAT3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Iceland city: Reykjavík zip: 102 country: Iceland lat: 64.13548 lon: -21.89541 hasResults: False
<|newrecord|> nctId: NCT06264310 id: R2R01-WHF-201 briefTitle: To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-03 date: 2024-02-16 date: 2024-02-20 name: River 2 Renal Corp. class: INDUSTRY name: International HealthCare, LLC briefSummary: This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF) conditions: Heart Failure conditions: Worsening Heart Failure (WHF) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomly assigned to one of four cohorts. Three groups will receive R2R01, and one group will receive placebo. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Treatment of all cohorts will be double-blind (all patients, study staff, investigators and Sponsor). Site pharmacist is unblinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Placebo name: R2R01 measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0. measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0. measure: Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30. measure: Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30. measure: Number of patients requiring dose adjustment of oral diuretics during the 30-day follow-up. measure: Number of patients with an event of: WHF-induced SDAC or other outpatient clinic visits requiring additional intensification of the therapy/IV loop diuretics using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of cardiovascular hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of patients with CV mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of patients with all-cause mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Shore Research Institute city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: C&R Research Services USA, Inc. city: Cape Coral state: Florida zip: 33904 country: United States lat: 26.56285 lon: -81.94953 facility: Nature Coast Clinical Research city: Inverness state: Florida zip: 34452 country: United States lat: 28.83582 lon: -82.33037 facility: Jacksonville Center for Clinical Research city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: Amavita Research Services, LLC city: Miami state: Florida zip: 33137 country: United States lat: 25.77427 lon: -80.19366 hasResults: False
<|newrecord|> nctId: NCT06264297 id: 01-22-270-111 briefTitle: High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial acronym: Radiofrequency overallStatus: RECRUITING date: 2023-02-20 date: 2027-01 date: 2027-12 date: 2024-02-16 date: 2024-02-16 name: Consorci Sanitari de Terrassa class: OTHER briefSummary: The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain. conditions: Pulsed Radiofrequency conditions: Lumbar Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 98 type: ESTIMATED name: Radiofrequency measure: OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE measure: DN4 - QUESTIONNAIRE measure: Visual Numeric Scale measure: Categorical scale measure: patient global impression of improvement (pgi-i) score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Consorci Sanitari de Terrassa status: RECRUITING city: Terrassa state: Barcelona zip: 08227 country: Spain name: Maria Martinez Garcia role: CONTACT phone: +34650528215 email: mariamartinezgarcia@gmail.com role: CONTACT email: mariamartinezgarcia@gmail.com name: maria Martinez Garcia role: PRINCIPAL_INVESTIGATOR lat: 41.56667 lon: 2.01667 hasResults: False
<|newrecord|> nctId: NCT06264284 id: 2023PI163 briefTitle: Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward overallStatus: COMPLETED date: 2018-07-19 date: 2023-07-19 date: 2023-07-19 date: 2024-02-16 date: 2024-02-16 name: Central Hospital, Nancy, France class: OTHER briefSummary: We try to evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome on emergency (Red Code) Cesarean Section.
This study occurred in a Level 3 Maternity Ward. conditions: Anesthesia Complication studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 150 type: ACTUAL name: epidural anesthesia name: general anesthesia measure: To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Stanowski city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False
<|newrecord|> nctId: NCT06264271 id: GIP-22-NL-06-203 briefTitle: The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes overallStatus: COMPLETED date: 2022-02-01 date: 2023-12-31 date: 2024-02-01 date: 2024-02-16 date: 2024-02-20 name: Charles University, Czech Republic class: OTHER name: General University Hospital, Prague briefSummary: The study aims to elucidate whether patients with T1D initiating sensor monitoring experience greater improvement in glycemic control (HbA1c) when provided with structured nutrition education compared to those initiating sensor monitoring without such education. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 329 type: ACTUAL name: structured nutrition intervention measure: difference in HbA1c measure: differences in time in range measure: differences in time below range measure: differences in time above range measure: differences in coefficient of variation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charles University city: Prague zip: 12808 country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False
<|newrecord|> nctId: NCT06264258 id: STUDY2023_00000285 briefTitle: Game-based Pediatric Diabetes Education acronym: DVx-T1D overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-16 date: 2024-02-20 name: Carnegie Mellon University class: OTHER name: University of Pittsburgh briefSummary: The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D).
The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps. conditions: Diabetes Mellitus, Type 1 conditions: Behavior, Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 participants (40 in each arm) of 6-12 years old youth with type 1 diabetes (T1D).The investigators will quantify the impact of the mobile game app vs. standard care on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters), physical activity levels and food choices of children (measured using food logs and surveys).
The study will also assess changes in children's knowledge about the measured outcomes and investigate the feasibility and acceptability of game adoption and the barriers and challenges faced by patients, families and clinicians. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: DVx-T1D™ app measure: Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention measure: Change in glucose average and variability measure: Changes in the quality of food consumption measure: Change in game play patterns over time sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: UPMC Children's Hospital of Pittsburgh status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15224 country: United States name: Neha Sudhir role: CONTACT email: sudhirn2@upmc.edu name: Ingrid Libman, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
<|newrecord|> nctId: NCT06264245 id: 2022-126 id: 2023-A00985-40 type: OTHER domain: ID RCB briefTitle: Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects acronym: COMPRESSED overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01-15 date: 2025-01-15 date: 2024-02-16 date: 2024-03-06 name: Institut Pasteur class: INDUSTRY name: Institut de l'Audition briefSummary: The COMPRESSED project is a descriptive, bi-centric and non-invasive study carried out by the CERIAH - IDA - Institut Pasteur and the Haute École Léonard de Vinci in Brussels on volunteer participants identified in two groups :
* be subject to high exposure to compressed sound, as defined by professional participation in events on broadcast platforms using sound signal processing systems, over the last 3 years,
* be subject to moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student following certain distance learning courses. on a videoconferencing platform, alternating with other face-to-face courses, with the ability to listen during breaks, which have been taught for a maximum of 2 years.
The main objective of the COMPRESSED study is to evaluate the auditory effects of exposure to manipulated sounds (compression, filtering, equalisation, accentuation, etc.) from sound distribution platforms on the auditory system of participants who are regularly exposed to these sounds as a result of their professional activity. conditions: Auditory Perception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Audiological profile name: Hearing self-assessments name: Objective and subjective audiological tests name: Self-assessment of exposure sound quality measure: Hearing assessments of participants exposed to manipulated sounds after and before exposure measure: Audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure, measure: Difference between the threshold of the protective reflex of the auditory pathways (middle ear muscles) measured by impedancemetry in the exposed ear when a contralateral noise is presented for a few seconds. measure: Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli measure: Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure. measure: Effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haute Ecole Léonard De Vinci city: Bruxelles country: Belgium name: Patrick Vereheyden, MD role: CONTACT phone: + 32 2 793 41 43 email: Patrick.Verheyden@vinci.be lat: 50.85045 lon: 4.34878 facility: CEntre de Recherche et d'Innovation en Audiologie Humaine city: Paris zip: 75015 country: France name: Paul Avan, MD role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False
<|newrecord|> nctId: NCT06264232 id: AT ELANA 841P-BER-302-19 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-16 date: 2024-02-20 name: [Redacted] hasResults: False
<|newrecord|> nctId: NCT06264219 id: H-24002284 briefTitle: Restoration of the Gut Microbiome After Cesarean Section acronym: RestoreGut overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2026-11-30 date: 2024-02-16 date: 2024-02-16 name: Professor Klaus Bønnelykke class: OTHER briefSummary: This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. We will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section. conditions: Microbial Colonization studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Microbiome restoration - FMT name: Microbiome restoration - FVT name: Placebo name: Vaginal birth, untreated control measure: Microbial development trajectory measure: Microbial development trajectory sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copsac, DBAC city: Gentofte state: Copenhagen zip: 2820 country: Denmark lat: 55.74903 lon: 12.54601 facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark name: Hanne Hegaard, Professor role: CONTACT phone: +45 27583632 email: Hanne.Kristine.Hegaard@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
<|newrecord|> nctId: NCT06264206 id: CALLA_IVF_KIR briefTitle: Effect of Immunomodulatory Treatment on IVF (in Vitro Fertilization) Outcomes in Patients With KIR AA Genotype overallStatus: COMPLETED date: 2022-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-02-16 date: 2024-02-16 name: Calla IVF Center class: OTHER briefSummary: The aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. We compared pregnancy rates in Group KIR AA without immunomodulatory treatment, and pregnancy rates in Group KIR AA with immunomodulatory treatment. conditions: Immunomodulatory Drugs conditions: Killer-cell Immunoglobulin-like Receptors (KIRs) conditions: KIR Alleles (KIR AA) studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 65 type: ACTUAL name: Killer-cell immunoglobulin-like receptors (KIRs) testing measure: the incidence of immune cause of recurrent implantation failure measure: the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA measure: comparation between the pregnancy rates in KIR AA group and KIR Bx group sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Calla Ivf Center city: Oradea state: Bihior zip: 410103 country: Romania lat: 47.0458 lon: 21.91833 hasResults: False
<|newrecord|> nctId: NCT06264193 id: Rowers briefTitle: The Impact of Hypoxia on the Biochemical and Morphological Parameters of Blood in Rowers. acronym: IHOBMPBR overallStatus: COMPLETED date: 2014-11-30 date: 2014-12-21 date: 2014-12-21 date: 2024-02-16 date: 2024-02-16 name: Poznan University of Physical Education class: OTHER briefSummary: The response to hypoxia is very individual and epending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. The results of this study have shown that 18 days of the LH-TL method does not significantly increase the level of EPO and VEGF in rowers. However, reticulocytes, immature red blood cells, have shown significant differences after 18-d LH-TL between groups. Further research should be carried out to investigate an optimal hypoxic dose and time, which will raise EPO, VEGF, and morphology variables. conditions: Hypoxia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The hypoxic group included rowers participating in sports training and the LH-TL method, hypoxic rooms (FiO2=14.5%, corresponds to an altitude of 3000 meters). And the control group participating only in sports training and living in normoxic rooms, at the same sports camp. primaryPurpose: DIAGNOSTIC masking: NONE count: 13 type: ACTUAL name: hypoxia measure: Erythropoietin (EPO) mlU/ml measure: vascular endothelial growth factor (VEGF) mlU/ml measure: creatine kinase (CK) ng/ml measure: Hs C-Reactive Protein (hsCRP) mg/L measure: hemoglobin (Hb)g/dL measure: hematocrit (Htc)% measure: red blood cells (RBC)mln/mm3 measure: white blood cells (WBC)10 3/µL measure: reticulocytes (Ret)‰ measure: SpO2 - oxygen saturation (%) measure: bpm - beats per minute(%) sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06264180 id: RP1-104 briefTitle: VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-01-01 date: 2034-08-31 date: 2024-02-16 date: 2024-02-16 name: Replimune Inc. class: INDUSTRY briefSummary: This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy. conditions: Advanced Melanoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Vusolimogene Oderparepvec name: Nivolumab name: Nivolumab + Relatlimab name: Pembrolizumab name: Single-agent chemotherapy measure: Overall Survival (OS) measure: Progression Free Survival (PFS) measure: Objective Response Rate (ORR) sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06264167 id: NODE briefTitle: NODE (groiN ultrasOunD cancEr) acronym: NODE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-31 date: 2028-03-31 date: 2024-02-16 date: 2024-02-16 name: Queensland Centre for Gynaecological Cancer class: OTHER_GOV name: Royal Brisbane and Women's Hospital briefSummary: This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months. conditions: Vulvar Cancer Stage Ib conditions: Vulvar Cancer Stage II conditions: Lymph Node Metastasis conditions: Groin Node conditions: Ultrasound Therapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Feasibility trial, open label, three-group, randomised clinical trial
30 eligible females aged 18 or older with clinically stage 1b or 2 vulvar cancer will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery:
Participants with normal/negative baseline groin ultrasounds will be randomly assigned to two groups (2:1 randomisation): one group undergoing radical procedures (groin lymph nodes are not removed) with bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months, and the other group undergoing upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).
Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines. primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: High-resolution bilateral groin ultrasound surveillance measure: Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months. measure: Utility of tumour mutations to determine positive lymph node metastasis. measure: Utility of circulating tumour DNA to determine positive lymph node metastasis. measure: Utility of plasma to determine positive lymph node metastasis. measure: Utility of serum to determine positive lymph node metastasis. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Andrew's War Memorial Hospital city: Brisbane state: Queensland zip: 4000 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Andreas Obermair, Prof role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: Royal Brisbane and Women's Hospital city: Brisbane state: Queensland zip: 4029 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Avalon Knott role: CONTACT phone: 07 3346 5073 email: a.knott@uq.edu.au name: Andrea Garrett, Dr role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False
<|newrecord|> nctId: NCT06264154 id: 854051 id: R01CA287474-01 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA287474-01 briefTitle: The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-06 date: 2027-12 date: 2024-02-16 date: 2024-02-16 name: University of Pennsylvania class: OTHER name: National Cancer Institute (NCI) briefSummary: This between-subjects study aims to evaluate the effect of flavor on initial and sustained switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to a six-week regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be instructed to switch (versus smoking cigarettes) over a 6-week period. Flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible cigarettes will be assessed as mechanisms. conditions: Smoking conditions: Tobacco Use conditions: Cigarette Smoking conditions: E-Cig Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 210 type: ESTIMATED name: E-cigarettes measure: Cigarette Consumption measure: Cigarette Smoking Behavior sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06264141 id: NONS-RARS-01 briefTitle: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis acronym: NONS-RARS-01 overallStatus: RECRUITING date: 2024-01-16 date: 2024-06 date: 2024-09 date: 2024-02-16 date: 2024-02-16 name: Sanotize Research and Development corp. class: INDUSTRY briefSummary: A two-week therapy of nitric oxide nasal spray (NONS) vs Placebo (saline nasal spray) initiated immediately after the onset of a new Recurrent Acute Rhinosinusitis (RARS) episode to assess the acceleration to clinical success (cured/much improved symptoms), lack of use of intranasal corticosteroids (INCS) (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide releasing solution (NORS) platform therapy. conditions: Recurrent Acute Rhinosinusitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-week therapy of NONS vs Placebo (saline nasal spray) initiated immediately after the onset of a new RARS episode to assess the acceleration to clinical success (cured/much-improved symptoms), lack of use of INCS (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide-releasing solution (NORS) platform therapy. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: A blinded participant number will be assigned to each randomized participant. Site staff/ physician will then dispense a kit labelled with the authorization number generated during randomization to the individual participant. No study investigators, associates performing assessments or participants will be aware of the study medication in the assigned treatments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 186 type: ESTIMATED name: Nitric Oxide Releasing Solution name: Nasal spray with isotonic saline measure: Primary endpoint is the time to sinus symptoms resolution measure: Time (days) to full recovery from sinusitis (participant reported) measure: Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success) measure: Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure measure: Time (days) to initiation of INCS measure: Proportion of participants requiring INCS measure: Proportion of participants requiring rescue oral ATBs measure: Proportion of participants recovered from sinusitis measure: Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs measure: Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22 measure: Tolerability and safety of NONS measure: Proportion of participants with clinically significant changes from baseline in vital signs measure: Proportion of participants with clinically significant changes from baseline in laboratory parameters measure: Number of participants with clinically significant changes from Baseline in physical examinations measure: Number of ATB courses required as a rescue treatment measure: Time (days) to the initiation of NSAIDs measure: Proportion of participants requiring NSAIDs measure: Time (days) to each symptom being cured or much improved measure: Proportion of participants being cured or much improved for each symptom measure: Proportion of participants achieving at least a 50% reduction in sinusitis symptoms (by MRSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Okanegan Clinical Trials status: RECRUITING city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada name: Cora Withers role: CONTACT phone: 250-862-8141 email: cora@oktrials.ca name: Colleen Maytham, MD role: PRINCIPAL_INVESTIGATOR lat: 49.88307 lon: -119.48568 facility: Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site) status: RECRUITING city: Richmond state: British Columbia zip: V6V 2L1 country: Canada role: CONTACT phone: 604-373-4954 name: Colleen Maytham, MD role: PRINCIPAL_INVESTIGATOR lat: 49.17003 lon: -123.13683 facility: Cliantha Research status: RECRUITING city: Mississauga state: Ontario zip: L4W 1V7 country: Canada name: Patricia Couroux, MD role: PRINCIPAL_INVESTIGATOR lat: 43.5789 lon: -79.6583 facility: Clinical Research of Ontario status: NOT_YET_RECRUITING city: Scarborough state: Ontario zip: M1S 4T7 country: Canada name: Jemilat Smith role: CONTACT phone: 18002474525 phoneExt: 1 email: jemilatsmith@gmail.com lat: 43.77223 lon: -79.25666 facility: Intermed Groupe Santé status: RECRUITING city: Chicoutimi state: Quebec zip: G7H 7Y8 country: Canada name: Nancu Lavoie role: CONTACT phone: 418-602-6620 email: n.lavoie@intermedgs.ca name: Doria Grimard, MD role: PRINCIPAL_INVESTIGATOR lat: 48.41963 lon: -71.06369 facility: Alpha Recherche Clinique LeBourneuf status: RECRUITING city: Québec City state: Quebec zip: G2J 0C4 country: Canada name: Amélie Boulay role: CONTACT phone: 418.704.1112 email: aboulay@alpha-recherche.ca name: Anne-Marie Beaulieu, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: Alpha Recherche Clinique Val-Belair status: RECRUITING city: Québec City state: Quebec zip: G3K 2P8 country: Canada name: Jessica M. M. Petit role: CONTACT phone: 418.847.1112 email: jpetit@alpha-recherche.ca name: Melanie Gauvin role: CONTACT email: mgauvin@alpha-recherche.ca name: Camille Walsh, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False
<|newrecord|> nctId: NCT06264128 id: TheraPAP Comfort briefTitle: TPAP for Comfort in OSA overallStatus: RECRUITING date: 2024-03-08 date: 2024-05-31 date: 2024-06-30 date: 2024-02-16 date: 2024-03-18 name: SleepRes Inc. class: INDUSTRY briefSummary: TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will undergo the same therapy combinations. CPAP (Continuous Positive Airway Pressure) and 2 level of TPAP (TheraPAP - novel CPAP approach pressure is reduced below therapy pressure from inspiration through mid exhalation specifically for comfort) will be assessed against each other in a round robin both backward and forward (6 total binary comparisons) for 2 levels of baseline pressure. primaryPurpose: TREATMENT masking: NONE maskingDescription: There is no specific intent to mask although participants will be naive to CPAP-type therapy, but they will be able to feel the difference. count: 80 type: ESTIMATED name: TPAP name: CPAP measure: CPAP v TPAP Patient Preference via Visual Analog Scale measure: TPAP 1 v TPAP 2 Patient Preference via Visual Analog Scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SleepCenters of Middle Tennessee status: RECRUITING city: Murfreesboro state: Tennessee zip: 37129 country: United States name: Craig Salazar role: CONTACT phone: 615-893-4896 email: csalazar@sleepcenterinfo.com name: WIlliam H Noah, MD role: PRINCIPAL_INVESTIGATOR lat: 35.84562 lon: -86.39027 hasResults: False
<|newrecord|> nctId: NCT06264115 id: Soh-Med-24-01-05MS briefTitle: Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-20 name: Sohag University class: OTHER briefSummary: To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy conditions: Cholecystitis, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Laparoscopic Cholecystectomy measure: Postoperative pain score measure: Operative time measure: length of hospital stay measure: Total postoperative morphine consumption measure: Time of first analgesic sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
<|newrecord|> nctId: NCT06264102 id: 2024/1/1 briefTitle: Influence of Dalcroze Eurhythmics on Pains in Older Women overallStatus: COMPLETED date: 2019-01-11 date: 2019-03-08 date: 2019-07-15 date: 2024-02-16 date: 2024-02-16 name: Poznan University of Physical Education class: OTHER briefSummary: In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain. conditions: Back Pain conditions: Headache conditions: Leg Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 61 type: ACTUAL name: Physical exercise program measure: Pain levels before exercise program measure: Results of pain levels after exercise program sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Poznan University of Physical Education city: Poznań state: Wielkopolska zip: 61-871 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False
<|newrecord|> nctId: NCT06264089 id: 202015 briefTitle: Effects of Preservation Rhinoplasty Nasal Valve Angle and Area overallStatus: COMPLETED date: 2020-08-06 date: 2023-08-30 date: 2023-08-30 date: 2024-02-16 date: 2024-02-16 name: Yuzuncu Yıl University class: OTHER briefSummary: The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery. conditions: Nasal Obstruction, Bilateral studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: Preservation Rhinoplasty Nasal Valve Angle and Area measure: Nasal Obstruction Symptom Evaluation Scale (NOSE) measure: Reformatted coronal Computed tomography sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yaser Said Cetin city: Van zip: 65080 country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False