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<\|newrecord\|> nctId: NCT06283797 id: RECHMPL22_0346 id: 2023-A01661-44 type: OTHER domain: ANSM briefTitle: Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes acronym: APATDIAGNOSIS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2027-05 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Montpellier class: OTHER name: Hopital Universitaire Robert-Debre name: University Hospital, Tours name: University Hospital, Angers name: University of Virginia briefSummary: The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.
The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.
An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase. conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control study in parallel groups, followed by a non randomized extension primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: OmniPod 5 name: Dexcom G6 name: PAID questionnaires measure: Glycated hemoglobin (HbA1c) level measure: Percent of time spent in the 70-180 mg/dl glucose range measure: Percent of time spent in the 70-140 mg/dl glucose range measure: Mean glucose level measure: Percent of time spent with glucose level below 70 mg/dl measure: Percent of time spent with glucose level below 54 mg/dl measure: Percent of time spent with glucose level above 180 mg/dl measure: Percent of time spent with glucose level above 250 mg/dl measure: Coefficient of glucose variability measure: Score of PAID questionnaire for parents measure: Score of PAID questionnaire for children measure: Stimulated plasma C-peptide level 10-min after 1mg IV glucagon measure: Number of needed interventions by the parents/guardians or care providers measure: Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent in the 70-180 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent in the 70-140 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of mean glucose level between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level below 70 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level below 54 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level above 180 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level above 250 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of coefficient of glucose variability between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of score of PAID questionnaire for parents between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of score of PAID questionnaire for children between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of stimulated plasma C-peptide level 10-min after 1mg IV glucagon between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of number of needed interventions by the parents/guardians or care providers between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent in the 70-180 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent in the 70-140 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period measure: Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level below 70 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level below 54 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level above 180 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level above 250 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the coefficient of glucose variability between the 2 initially randomized groups at the end of the extension period measure: Difference in the score of PAID questionnaire for parents between the 2 initially randomized groups at the end of the extension period measure: Difference in the score of PAID questionnaire for children between the 2 initially randomized groups at the end of the extension period measure: Difference in the stimulated plasma C-peptide level 10-min after 1mg IV glucagon between the 2 initially randomized groups at the end of the extension period measure: Difference in the number of needed interventions by the parents/guardians or care providers between the 2 initially randomized groups at the end of the extension period measure: Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs measure: Relatedness of treatment-emergent SUSARs, SAEs, ARs and AEs measure: Severity of treatment-emergent SUSARs, SAEs, ARs and AEs sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University Hospital, Angers city: Angers country: France name: Régis Coutant, MD role: CONTACT phone: 02 41 35 56 55 phoneExt: +33 email: recoutant@chu-angers.fr lat: 47.46667 lon: -0.55 facility: University Hospital, Montpellier city: Montpellier country: France name: Eric Renard, MD role: CONTACT phone: 04 67 33 83 82 phoneExt: +33 email: e-renard@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: Robert Debré Hospital, AP-HP city: Paris country: France name: Elise Bismuth Reisman, MD role: CONTACT phone: 01 40 03 20 67 phoneExt: +33 email: elise.bismuth@aphp.fr lat: 48.85341 lon: 2.3488 facility: University Hospital, Tours city: Tours country: France name: Yannis Chartier, MD role: CONTACT phone: 06 85 67 93 35 phoneExt: +33 email: Y.CHARTIER@chu-tours.fr lat: 47.38333 lon: 0.68333 hasResults: False
<\|newrecord\|> nctId: NCT06283784 id: YOVIS Capsules briefTitle: Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients overallStatus: COMPLETED date: 2021-09-05 date: 2021-11-02 date: 2022-05-18 date: 2024-02-28 date: 2024-03-18 name: Biofarma class: INDUSTRY name: Hippocrates Research briefSummary: This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days.
The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days) conditions: Diarrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double blind, randomized, placebo-controlled study. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics. Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste. Product test and placebo capsules will be indistinguishable.
Investigational food supplement products will be packed in an individual way for each subject included in the investigation. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: Yovis Capsules name: Placebo measure: Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy measure: Severity and duration of AAD measure: Severity and duration of AAD measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Impact of bowel habits on QoL measure: Effects of YOVIS, versus placebo, at each visit on the overall health status measure: Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo measure: Global Patient's self-reported acceptance at the end of study measure: Global acceptability (investigator) at the end of study sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Practitioner Ambulatory city: Sanremo state: Italy/Imperia zip: 18038 country: Italy lat: 43.81725 lon: 7.7772 hasResults: False
<\|newrecord\|> nctId: NCT06283771 id: TU-BOZKUL-007 briefTitle: The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-09-15 date: 2025-05-15 date: 2024-02-28 date: 2024-03-01 name: Tarsus University class: OTHER name: Mersin University briefSummary: In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\*Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analysis as further analy conditions: Wearable Technology conditions: Hypothermia conditions: Shivering conditions: Thermal Comfort Perception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study primaryPurpose: OTHER masking: TRIPLE maskingDescription: An independent biostatistician, who is not involved in the study, will select 70 individuals from the list of students enrolled between 1-250 by computer-generated randomization. The information that the volunteers included in the research sample were assigned to group A (experimental) and B (control) according to the randomization table will be kept by the researcher and the socks with the same appearance, with and without heating feature will be numbered from 1 to 70 according to the randomization table and given to the researcher. Thus, the practitioner will be blinded as he/she does not know which sock has a heating feature and which one does not. Healthy volunteers will be blinded because they do not know which group they are in. The data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will also be blinded to group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Heated socks to be developed with wearable technology measure: Body temperature measure: Shivering level measure: Thermal comfort perception measure: Descriptive Characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283758 id: PARADISE HTN-III briefTitle: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-07 date: 2026-10 date: 2024-02-28 date: 2024-03-04 name: Suzhou Municipal Hospital class: OTHER name: The Affiliated Jiangning Hospital of Nanjing Medical University name: The First Affiliated Hospital with Nanjing Medical University name: Affiliated Hospital of Nantong University briefSummary: This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control. conditions: Hypertension conditions: Blood Pressure conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: focused power ultrasound mediate inferior perirenal adipose tissue modification name: Sham-control group measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Office Systolic Blood Pressure measure: Office Systolic Blood Pressure measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Home Blood Pressure measure: Home Blood Pressure measure: Blood pressure control rate measure: Antihypertensive drug load index measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Jiangning Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Yuqing Zhang role: CONTACT phone: 13851672168 name: Qin Tao role: CONTACT phone: 1585062208 name: Yuqing Zhang role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: The first Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Fang Zhou role: CONTACT phone: 13815401066 email: zhoufang7408@163.com name: Wei Sun role: CONTACT phone: 13815860536 email: shunwee@126.com name: Fang Zhou role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Affiliated Hospital of Nantong University city: Nantong state: Jiangsu zip: 210000 country: China name: Hongzhuan Sheng role: CONTACT phone: 13515203348 name: Jian Zhuo role: CONTACT phone: 18206297131 name: Hongzhuan Sheng role: PRINCIPAL_INVESTIGATOR lat: 32.03028 lon: 120.87472 facility: Suzhou Municipal Hospital city: Suzhou state: Jiangsu zip: 210000 country: China name: Yanhui Sheng role: CONTACT phone: 13851647530 email: yhshengnjmu@163.com name: Yang Hua role: CONTACT phone: 13851624359 email: 759150674@qq.com name: Yanhui Sheng role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False
<\|newrecord\|> nctId: NCT06283745 id: 73225 briefTitle: Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia overallStatus: NOT_YET_RECRUITING date: 2024-03-23 date: 2027-03-22 date: 2027-03-22 date: 2024-02-28 date: 2024-02-28 name: Stanford University class: OTHER briefSummary: This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia. conditions: Paraosmia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PRP injections will be given to one arm while sham saline injections will be given to the other arm. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Platelet-rich Plasma (PRP) name: Saline measure: Change in Sniffin Sticks Parosmia Test (SSParoT) measure: Change in questionnaire of olfactory disorders (QOD) scale score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Sinus Center / Stanford University School of Medicine city: Palo Alto state: California zip: 94304 country: United States name: Homer Abaya, BS role: CONTACT phone: 650-725-6500 email: habaya@stanford.edu name: Maxime Fieux, MD, PhD role: CONTACT phone: +33621611643 email: fieuxma@stanford.edu name: Zara Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False
<\|newrecord\|> nctId: NCT06283732 id: 20392 briefTitle: A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience. overallStatus: COMPLETED date: 2023-11-15 date: 2024-02-15 date: 2024-02-15 date: 2024-02-28 date: 2024-03-05 name: Amway Corp class: INDUSTRY name: Citruslabs briefSummary: The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires. conditions: Digestive System Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 70 type: ACTUAL name: Greens powder measure: Digestive Health Improvement measure: Quality of Life and Well-being Enhancement sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Citruslabs city: Santa Monica state: California zip: 90404 country: United States lat: 34.01945 lon: -118.49119 hasResults: False
<\|newrecord\|> nctId: NCT06283719 id: ZG006-002 briefTitle: Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-28 date: 2024-02-28 name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd class: INDUSTRY briefSummary: This is a multicenter, open-label phase I/II study, divided into 2 parts:
Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.
Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer. conditions: Small Cell Lung Cancer conditions: Neuroendocrine Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 105 type: ESTIMATED name: ZG006 measure: Objective response rate (ORR) measure: Number of participants with adverse events (AEs) measure: Number of participants with serious adverse events (SAEs) measure: Duration of response (DOR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai country: China name: Shun Lu role: CONTACT name: Shun Lu, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06283706 id: 1000081113 briefTitle: The Tryptophan Requirement in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-01 date: 2025-12-01 date: 2024-02-28 date: 2024-03-01 name: The Hospital for Sick Children class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.
The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need. conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Tryptophan measure: Determination of tryptophan requirement in adults >60 years of age. sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283693 id: RojdaBAYARYILDIRIM briefTitle: The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-05-10 date: 2025-06-10 date: 2024-02-28 date: 2024-02-28 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol.
Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. conditions: Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels conditions: Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled classical experimental study primaryPurpose: OTHER masking: SINGLE maskingDescription: Computer-assisted randomization will be used in the study, and participants will be randomized to an intervention or control list control group in a 1:1 ratio by entering the number of samples to be reached through the program whose URL address is https://www.randomizer.org. Women who apply to the infertility outpatient clinic by the researcher and volunteer for the study who meet the sample selection criteria will be given numbers according to the order of outpatient clinic registration. A randomization sequence will be created according to these numbers and women will be assigned to the intervention and control groups by computer-assisted randomization. Since the study is a thesis, blinding will not be possible due to its nature. whoMasked: PARTICIPANT count: 86 type: ESTIMATED name: mindfulness-based stress reduction measure: Informed Voluntary Consent Form (Annex 1) measure: Identifying Characteristics Information Form (Annex 2) measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Saglık Bilimleri Universitesi city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06283680 id: 2024 briefTitle: The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-28 date: 2024-04-28 date: 2024-05-31 date: 2024-02-28 date: 2024-04-08 name: Aylin Seylam Küşümler class: OTHER name: Koşuyolu Yüksek İhtisas Training and Research Hospital briefSummary: The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list. conditions: Lung Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 213 type: ESTIMATED name: Lung transplantation measure: BMI measure: Nutrition risk index sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OkanU city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06283667 id: NN9536-4872 id: U1111-1266-3863 type: OTHER domain: World Health Organization (WHO) briefTitle: Special Use - Results Surveillance on Long-term Use With Wegovy® overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2025-06-30 date: 2028-01-31 date: 2024-02-28 date: 2024-02-28 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks). conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Semaglutide measure: Number of Adverse Reactions (ARs) measure: Number of Adverse Events (AEs) measure: Number of serious adverse events (SAEs) measure: Number of Serious Adverse Reactions (SARs) measure: Change in body weight (Percent (%)) measure: Change in body weight (Kilograms (Kg)) measure: Change in waist circumference measure: Change in BMI (Body Mass Index) measure: Change in body weight after treatment discontinuation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novo Nordisk Investigational Site city: Tokyo state: Chiyoda City zip: 100-0005 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False
<\|newrecord\|> nctId: NCT06283654 id: VUmc 2018.539 briefTitle: Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation acronym: relievED overallStatus: COMPLETED date: 2018-09-30 date: 2021-09-30 date: 2023-01-31 date: 2024-02-28 date: 2024-04-26 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device , which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 204 type: ACTUAL name: 1-lead ECG measure: number of ED visits measure: ratio of the number of cardioversions emergency vs planned sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC -vumc city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False
<\|newrecord\|> nctId: NCT06283641 id: NN8022-7780 id: U1111-1289-9747 type: OTHER domain: World Health Organization (WHO) briefTitle: Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan. overallStatus: ENROLLING_BY_INVITATION date: 2024-02-23 date: 2025-02-28 date: 2025-02-28 date: 2024-02-28 date: 2024-04-04 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.
The study will last for about 26 weeks. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 288 type: ESTIMATED name: Liraglutide measure: Incidence of adverse events (AEs) by preferred term (PT) measure: Number of adverse drug reaction (ADRs) measure: Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) measure: Number of unexpected AEs and unexpected ADRs measure: Number of unexpected SAEs and unexpected SADRs measure: Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label measure: Body weight loss Percent (%) (Adult) measure: Body weight loss (%) (Adult) measure: Body weight loss Kilogram(Kg) (Adult) measure: Body weight loss (kg) (Adult) measure: The proportion of adult subjects losing at least 5% of baseline body weight measure: The proportion of adult subjects losing at least 5% of baseline body weight measure: The proportion of adult subjects losing more than 10% of baseline body weight measure: The proportion of adult subjects losing more than 10% of baseline body weight measure: The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda® measure: Change in body mass index (BMI) (kg/m^2) (Adolescent) measure: Change in body mass index (BMI) (kg/m^2) (Adolescent) measure: Change in body mass index (BMI) (%) (Adolescent) measure: Change in body mass index (BMI) (%) (Adolescent) measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent) measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent) measure: Body weight loss (%) (Adolescent) measure: Body weight loss (%) (Adolescent) measure: Body weight loss (kg) (Adolescent) measure: Body weight loss (kg) (Adolescent) measure: The proportion of adolescent subjects losing at least 4% of baseline BMI measure: The proportion of adolescent subjects losing at least 4% of baseline BMI measure: The proportion of adolescent subjects losing at least 10% of baseline BMI measure: The proportion of adolescent subjects losing at least 10% of baseline BMI measure: The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda® sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei City zip: 100229 country: Taiwan lat: 25.04776 lon: 121.53185 facility: National Taiwan University Hospital city: Taipei City zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06283628 id: STUDY00023737 briefTitle: Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves acronym: LMB-RFA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Milton S. Hershey Medical Center class: OTHER briefSummary: The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation. conditions: Lumbar Spondylosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The subjects with bilateral low back pain will undergo radiofrequency ablation of the lumbar medial branch nerves using one approach (traditional) on one side and different approach (parasagittal) on the other side. One arm will use the traditional approach on the left and the parasagittal approach on the right. The other arm will use parasagittal approach on the left and the traditional approach on the right, primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: We will do computer randomization for the sides for each approach for all the subjects. The subjects will be assigned numbers, and the particular procedural approach for each side will be concealed in the numbered envelopes. The numbers on the envelopes will correspond to the numbers assigned to the patients. The envelopes will be opened by a treating physician in the procedure room. The patient and the assessor (who will not be the treating physician) will not know which procedural approach was used for the sides. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: Radiofrequency ablation of lumbar medial branch nerves. measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: Oswestry Disability index (ODI) measure: Oswestry Disability index (ODI) measure: Oswestry Disability index (ODI) measure: Number of subjects who ceased requiring analgesia measure: Number of subjects who ceased requiring analgesia measure: Number of subjects who ceased requiring analgesia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Penn State Hershey College of Medicine city: Hershey state: Pennsylvania zip: 17033 country: United States name: Nancy Ruth Jarbadan, BS role: CONTACT phone: 717-531-6135 email: njarbadan@pennstatehealth.psu.edu lat: 40.28592 lon: -76.65025 hasResults: False
<\|newrecord\|> nctId: NCT06283615 id: 2024-01-01 briefTitle: Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency overallStatus: RECRUITING date: 2024-03-12 date: 2024-11-30 date: 2024-11-30 date: 2024-02-28 date: 2024-03-22 name: Jinling Hospital, China class: OTHER briefSummary: Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
The primary and secondary outcomes will be collected. conditions: Intestinal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Vitamin D measure: Quality of life score measure: Muscle function status measure: Serum vitamin D levels measure: Hepatic and renal function measure: Bone mineral density measure: Thyroid and parathyroid-related hormones measure: Nutritional status indicators measure: Number of participants with treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinying Wang status: RECRUITING city: Nanning state: Jiangsu zip: 210002 country: China name: Xinying Wang, MD role: CONTACT phone: +86 13913028866 email: wangxinying@nju.edu.cn name: Xuejin Gao, MD role: CONTACT phone: +86 18251937684 email: 547625433@qq.com name: Xinying Wang, MD role: PRINCIPAL_INVESTIGATOR name: Xuejin Gao, MD role: SUB_INVESTIGATOR lat: 22.81667 lon: 108.31667 hasResults: False
<\|newrecord\|> nctId: NCT06283602 id: 2020/17 briefTitle: Oral Health in Children and Adolescents With Obesity and Normal Weight overallStatus: COMPLETED date: 2020-01-01 date: 2021-03-05 date: 2021-04-29 date: 2024-02-28 date: 2024-02-28 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.
82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD). conditions: Pediatric Obesity conditions: Pediatric Dentistry studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 82 type: ACTUAL name: oral health status measure: the results of DMFT, plaque and gingival indies measure: the results of dmft, BEWE, ICDAS-II, probing dept measure: Comparison of demographic attributes between obese and normal weights measure: biochemical parameters of obese individuals measure: other biochemical parameters of obese individuals sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Aslı Soğukpınar Önsüren city: Mersin country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
<\|newrecord\|> nctId: NCT06283589 id: INZ701-401 briefTitle: The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis overallStatus: RECRUITING date: 2024-02-12 date: 2024-07-19 date: 2024-08-19 date: 2024-02-28 date: 2024-02-28 name: Inozyme Pharma class: INDUSTRY briefSummary: The purpose of this study is to determine if multiple doses of INZ-701, given once per week over 4 weeks are safe and increase pyrophosphate (PPi) levels in hemodialysis-dependent (HD) end stage kidney disease (ESKD) study participants who have low PPi levels. In addition, the effect of hemodialysis on the PK of INZ-701 and PPi levels will be evaluated. conditions: Calciphylaxis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The SEAPORT 1 (INZ701-401) study is a Phase 1, open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of INZ-701, given once per week over 4 weeks, in study participants with end-stage kidney disease undergoing hemodialysis. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: INZ-701 measure: Determine if INZ-701 increases PPi levels measure: Assess the Time to Maximum Serum Concentration (Tmax) measure: Assess the Maximum Serum Concentration (Cmax) of INZ-701 measure: Assess the Area under the concentration-time curve over the dosing interval (AUCtau) measure: Assess the Clearance after extravascular administration of drug (CL/F) sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Florida Nephrology Research status: RECRUITING city: Coral Springs state: Florida zip: 33071 country: United States name: Ashgar Chaudhry, MD role: CONTACT phone: 954-510-7620 email: info@flkidney.com lat: 26.27119 lon: -80.2706 facility: Elixia Health status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States name: Steven Zeig role: CONTACT phone: 954-900-1101 email: info@elixiacrc.com lat: 26.0112 lon: -80.14949 hasResults: False
<\|newrecord\|> nctId: NCT06283576 id: PANCAID-00-08 briefTitle: Pancreatic Cancer Initial Detection Via Liquid Biopsy acronym: PANCAID overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2027-12-31 date: 2027-12-31 date: 2024-02-28 date: 2024-04-24 name: Karolinska University Hospital class: OTHER name: Umeå University briefSummary: The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas \[N0M0\]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM). conditions: Pancreatic Cancer conditions: IPMN, Pancreatic conditions: Individuals at Risk conditions: Chronic Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Liquid biopsy measure: Cancer detection measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gastrocentrum, KarolinskaUniversity Hospital city: Stockholm zip: 14186 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06283563 id: 2023/5474 briefTitle: Online Physical Activity Tracking in Patients With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2025-02-15 date: 2025-02-28 date: 2024-02-28 date: 2024-02-28 name: Inonu University class: OTHER briefSummary: This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Physical activity tracking name: No physical activity tracking measure: Smartphone pedometer measure: Smartphone pedometer measure: International Physical Activity Questionnaire - Short Form measure: International Physical Activity Questionnaire - Short Form measure: Beck Depression Inventory II measure: Beck Depression Inventory II measure: Beck Anxiety Inventory measure: Beck Anxiety Inventory measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: Multiple Sclerosis Quality of Life-54 measure: Multiple Sclerosis Quality of Life-54 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283550 id: INNO-6052 briefTitle: Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-08 date: 2024-02-28 date: 2024-02-29 name: Innovaderm Research Inc. class: OTHER briefSummary: This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping. conditions: Chronic Hand Eczema studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Abrocitinib 200 mg name: Abrocitinib 100 mg name: Placebo measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) measure: Reduction from baseline in hand Physician's Global Assessment (PGA) measure: Change from baseline in Hand Eczema Severity Index (HECSI) measure: Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE) measure: Patient Global Assessment (PaGA) measurements measure: Change from baseline in hand Dermatology Life Quality Index (DLQI) measure: Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) measure: Change from baseline in pain Numerical Rating Scale (NRS) measure: Change from baseline in itch Numerical Rating Scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innovaderm Research Inc. city: Montréal state: Quebec zip: H2X 2V1 country: Canada name: Rosanna Ottoni, BSc role: CONTACT phone: 514-521-4285 phoneExt: 107 email: rottoni@innovaderm.com lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06283537 id: KÜBAP-01/2023-39 briefTitle: Online Episiotomy Simulation Training for Midwifery Students overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-05-30 date: 2024-02-28 date: 2024-02-28 name: Kastamonu University class: OTHER briefSummary: Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.
Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data. conditions: Training Group, Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A comparative randomized controlled trial primaryPurpose: OTHER masking: SINGLE maskingDescription: After all students in the face-to-face education and online education groups complete their applications, the students will practice on the material one by one in the school environment and will be evaluated through the Episiotomy Skill Evaluation Form. In the evaluation, a blinding technique will be used to prevent the person conducting the study interventions from making an evaluation in favor of the intervention group. For this purpose, the faculty member conducting the research initiatives will not take part in the evaluation, instead the evaluation will be made by two different field experts. The experts to be consulted for the evaluation will consist of people working as academicians in the field of obstetrics, nursing and midwifery. After the evaluation, students will have to fill out the survey (Student Information Form) and scale (Student Satisfaction and Self-Confidence in Learning Scale). whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Effect of training method measure: episiotomy skill performances measure: Satisfaction with education measure: Self-confidence in learning sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283524 id: ETNA-TrainMS briefTitle: Eye-tracking Investigation of Clinical Measures in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-10-18 date: 2026-03-18 date: 2024-02-28 date: 2024-02-28 name: Innodem Neurosciences class: INDUSTRY briefSummary: The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in MS patients to train machine learning algorithms that will support the development and performance assessment of a sensitive and non-invasive eye-tracking software application. The training of our machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Eye-Tracking measure: Predictive power of eye-movement biomarkers (EMBs) for MS severity in relationship to Expanded Disability Status Scale (EDSS) measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS). measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Rey Auditory Verbal Learning Test (RAVLT) as part of the Brief International Cognitive Assessment for MS (BICAMS). measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS). measure: Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC). measure: Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Genge Partners, Inc. city: Montréal state: Quebec zip: H4A 3T4 country: Canada name: Yousri Benchaar role: CONTACT phone: 514-906-3876 phoneExt: 6026 email: YBenchaar@gengepartners.com name: Alexander Saveriano, MD role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06283511 id: IJB-RESTART briefTitle: Evaluation of the RESTART Survival Programme overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-08 date: 2026-12 date: 2024-02-28 date: 2024-02-28 name: Jules Bordet Institute class: OTHER briefSummary: The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme. conditions: Invasive Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: educational workshops measure: Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions. measure: assessment of quality of life measure: assessemnt of health literacy via HLQ questionnaire measure: assessment of professional status measure: assessment of level of physical activity measure: assessment of emotionnal distress measure: assessment of the intensity of residual fatigue measure: assessment of sleep quality measure: Measuring the rate of participation in the programme measure: assessment of quality of life measure: assessment of emotionnal distress sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283498 id: DO612574A briefTitle: Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder overallStatus: ENROLLING_BY_INVITATION date: 2023-11-10 date: 2025-11 date: 2026-07 date: 2024-02-28 date: 2024-03-01 name: InMode MD Ltd. class: INDUSTRY briefSummary: The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder
The main questions it aims to answer are:
•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\]
Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.
Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment. conditions: Overactive Bladder Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Device Morpheus8V measure: Change in urgency incontinence episodes after 3 month measure: Change in urgency incontinence episodes after 1 month measure: Change in urgency incontinence episodes measure: Change in urgency incontinence episodes measure: Analysis to assess the urinary frequency measure: Analysis to assess urinary frequency measure: Analysis to assess the urinary frequency. measure: Analysis to assess the urinary frequency. measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Assessment of the impact of the treatment on Overactive Bladder symptoms measure: Patient-reported Pain assessment measure: Patient-reported outcome measure measure: Patient-reported outcome measure measure: Patient-reported outcome measure measure: Patient-reported outcome measure sex: FEMALE minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mickey Karram MD city: Corona Del Mar state: California zip: 92625 country: United States lat: 33.59808 lon: -117.87311 facility: Institute for Female Pelvic Medicine city: Knoxville state: Tennessee zip: 37932 country: United States lat: 35.96064 lon: -83.92074 hasResults: False
<\|newrecord\|> nctId: NCT06283485 id: Study Artificial intelligence briefTitle: Real-time Anatomy Recognition Tool Accuracy Research for Ultrasound-guided PENG and Suprainguinal Fascia Iliaca Blocks overallStatus: RECRUITING date: 2023-12-15 date: 2024-04-01 date: 2024-05-25 date: 2024-02-28 date: 2024-02-28 name: Konya City Hospital class: OTHER name: Betül Afşar briefSummary: Background and rationale: Ultrasound-guided regional anesthesia is a widely used pain control method today. A critical aspect of the procedure is accurate visualization of anatomical structures on ultrasound to precisely define target areas. Distinguishing surrounding tissues with an imaging model that automatically recognizes sonoanatomy in ultrasound images will reduce unintended intraneural injections or injury to other anatomical structures in close proximity and increase patient safety.
Research question; How can we improve the ultrasound images we frequently use in regional blocks by integrating them with artificial intelligence to reduce complications and improve applications? And what is the accuracy of the developed artificial intelligence support during imaging?
Research purpose; This work; We aim to further increase the safety of different regional block positions, minimize the risk of complications, and improve ultrasound visualization by developing an artificial intelligence model (AI Model-Artificial Intelligence) that automatically identifies and segments anatomical landmarks, provides visual guidance for inexperienced colleagues, and improves the performance of the developed model during application. aims to demonstrate its accuracy.
Hypothesis; Numerous studies have shown that the use of ultrasound and neurostimulators in practice increases the success, onset and quality of nerve blocks, but due to the low incidence of major complications and the absence of comparable randomized studies, no definitive statement can be made as to whether ultrasound reduces the overall rate of nerve damage. An imaging model that automatically marks sonoanatomy with artificial intelligence in ultrasound images can reduce unintended intraneural injections or injury to other anatomical structures in close proximity and improve patient safety. conditions: Artificial Intelligent conditions: Ultrasound Therapy; Complications conditions: Nerve Block studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: ultrasound examination measure: Artificial intelligence Program size measure: Score of assessment the pictures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasin Tire status: RECRUITING city: Konya state: Meram zip: 42140 country: Turkey name: Yasin Tire role: CONTACT phone: +905055367970 email: dryasintire@hotmail.com name: Betül Afşar role: CONTACT lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06283472 id: 1805574553; Aims 14-16 id: 2P60AA007611-403343 type: OTHER_GRANT domain: National Institute on Alcohol Abuse and Alcoholism id: 2P60AA007611 type: NIH link: https://reporter.nih.gov/quickSearch/2P60AA007611 briefTitle: Enhancing Prospective Thinking in Early Recovery (BEAM) acronym: BEAM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-01 date: 2027-02-01 date: 2024-02-28 date: 2024-03-01 name: Indiana University class: OTHER briefSummary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:
* Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues?
* Will high-intensity EFT cues effect greater treatment-seeking interest?
* Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity)
* Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS?
* Will the novel behavioral SS decision-making task activate the nucleus accumbens?
Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups. whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: High-Intensity Cue name: Low-Intensity Cue measure: Increase Prospective Thinking measure: Delayed Rewards sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283459 id: 301-23-101 briefTitle: Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2025-09-30 date: 2024-02-28 date: 2024-04-05 name: Imunon class: INDUSTRY briefSummary: This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365). conditions: SARS CoV 2 Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 74 type: ESTIMATED name: IMNN-101 measure: Number of participants with local and systemic reactogenicity adverse events and all adverse events measure: Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain. measure: Number of participants with GMT of serum spike binding IgG antibodies measure: Number of participants with a magnitude and phenotype of cytokine producing S protein-specific T cells, as measured by flow cytometry and/or ELISpot. measure: Number of participants with seroresponse rate (SRR). sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center city: Boston state: Massachusetts zip: 02215 country: United States name: Elizabeth Oginni role: CONTACT email: ooginni@bidmc.harvard.edu name: Ai-Ris Y Collier, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: DM Clinical Research city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Kyle Bramble role: CONTACT email: kyle.bramble@dmclinical.com name: Kem Yenal, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06283446 id: 1805574553; Aims 11-13 id: 1R21AA029760-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AA029760-01 briefTitle: Enhancing Prospective Thinking in Early Recovery acronym: NERF overallStatus: RECRUITING date: 2023-12-20 date: 2024-07-31 date: 2024-07-31 date: 2024-02-28 date: 2024-02-28 name: Indiana University class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:
Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues? Will high-intensity EFT cues effect greater treatment-seeking interest? Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS? Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups. whoMasked: PARTICIPANT count: 98 type: ESTIMATED name: High-Intensity Cue name: Low-Intensity Cue measure: Increase Prospective Thinking measure: Delayed Rewards sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Indiana University School of Medicine - Goodman Hall status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Sarah Turo, BA role: CONTACT phone: 317-963-7220 email: sturo@iu.edu name: Colton Lind, BS role: CONTACT phone: 317-963-2554 email: cmlind@iu.edu name: Brandon G Oberlin, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 hasResults: False
<\|newrecord\|> nctId: NCT06283433 id: NL83813.078.23 briefTitle: A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT acronym: ADVANCEDOPAT overallStatus: RECRUITING date: 2023-10-25 date: 2024-11 date: 2024-11 date: 2024-02-28 date: 2024-02-28 name: Erasmus Medical Center class: OTHER briefSummary: The Outpatient Parenteral Antibiotic Therapy (OPAT) service consists of providing antimicrobial therapy through parenteral infusion without hospitalization. This service is provided to stable patients otherwise ready for hospital discharge. Generally, the clinical monitoring for this patient population is minimal. However, clinical monitoring of vancomycin, an antibiotic widely used during OPAT, can be intensive primarily due to therapeutic drug monitoring. To ensure optimal treatment and minimize nephrotoxicity and microbial resistance, TDM and monitoring of serum creatinine levels are crucial during vancomycin therapy. TDM of vancomycin with OPAT presents a challenge for patients who must frequently travel to blood sampling facilities or the hospital for measurements. An alternative sampling method for TDM is the dried blood spot (DBS) method, which involves collecting a small drop of capillary blood from a finger prick onto filter paper. By implementing the DBS sampling method, the amount of outpatient visits regarding vancomycin treatment in OPAT can be reduced. Furthermore, the addition of measuring a biochemical parameter, such as renal function with serum creatinine, could lead to even less outpatient visits during OPAT. To date, studies investigating the effectiveness of DBS sampling of vancomycin and creatinine in terms of reducing outpatient visits have not yet been conducted in the OPAT population. conditions: Infection, Bacterial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 84 type: ESTIMATED name: Finger Prick name: Venipuncture measure: To compare the number of outpatient visits in the control group versus the intervention group at day 28 measure: Outcomes regarding outpatient visit measure: Sampling outcomes measure: Satisfaction with blood sampling based on the theoretical framework of acceptability questionnaire (TFA) measure: Cost outcomes measure: Clinical outcomes measure: TDM outcomes measure: Logistical outcomes sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC status: RECRUITING city: Rotterdam country: Netherlands name: Birgit Koch, PharmD role: CONTACT lat: 51.9225 lon: 4.47917 hasResults: False
<\|newrecord\|> nctId: NCT06283420 id: CarDia_WP5_P1_IRB:25059/23 briefTitle: Metabolic Response to Iniciation of Heart Failure Therapy acronym: GliF overallStatus: NOT_YET_RECRUITING date: 2024-02-21 date: 2025-12-20 date: 2026-12-20 date: 2024-02-28 date: 2024-02-28 name: Vojtech Melenovsky, MD, PhD class: OTHER_GOV briefSummary: This protocol is part of the CarDia project - National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), funded by the European Union - Next Generation EU. The protocol is part of Work Package 5 (WP5): metabolic disorders in heart failure.
The goal of this observational protocol is to monitor the biochemical and metabolomic response to the initiation of therapy for heart failure with standard drugs (SGLT2i, sGC stimulators, ARNI) and whether this early response (within first 3 months) predicts the further course of the disease.
The protocol will examine how parameters reflecting neurohumoral activation, response to hypoxia, systemic metabolism of energy substrates, parameters of iron metabolism, HIF1A activation in peripheral blood behave over time after starting standard heart failure terapiy (baseline, 1 day, 1 week, 1 month, 3 month). This project can provide valuable information on how to identify people who respond more poorly to the treatment being introduced and are more at risk of an adverse course of the disease. Patients will be compared to patients who have no change of therapy over early observation period (3 mo), who will serve as controls. This is observational study, so decision to inicialize therapy will be based on medical indication.
Patients with heart failure treated at the IKEM Cardiocenter will have blood drawn at several defined intervals before and after the start of clinically indicated treatment. Some patients will also undergo genetic DNA testing to determine the variability of genes regulating the metabolic neurohumoral response to heart failure. Patients will be contacted at intervals of 1 and 2 years and the incidence of clinical events will be monitored. The study is observational in nature and inclusion in the study does not affect the course of care provided or the choice of pharmacotherapy. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: hematocrit measure: HIF response measure: hepcidin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical end Experimental Medicine - IKEM city: Prague country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False
<\|newrecord\|> nctId: NCT06283407 id: ICF briefTitle: ICF-based Comparison on Musculoskeletal Health in Poland and Spain overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-06-03 date: 2024-11-04 date: 2024-02-28 date: 2024-03-01 name: University of Rzeszow class: OTHER name: Sanidad de Castilla y León briefSummary: Musculoskeletal conditions are a major cause of disability worldwide. These conditions are often associated with chronicity, which is a challenge for healthcare systems to address. Health care must be person-centred and take into account the individual perspective from which the disease is experienced. The lived experience of health conditions depends to a large extent on contextual factors. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. The aim of this study is to identify differences in musculoskeletal health between the Polish and Spanish populations using the ICF as a frame of reference. conditions: Musculoskeletal Diseases or Conditions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 800 type: ESTIMATED name: ICF-based cross-country comparative analysis measure: Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions measure: Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rzeszow city: Rzeszów zip: 35-959 country: Poland name: Agnieszka Wiśniowska-Szurlej role: CONTACT lat: 50.04132 lon: 21.99901 hasResults: False
<\|newrecord\|> nctId: NCT06283394 id: 854803 briefTitle: AHA (American Heart Association) Food is Medicine Test of Choice Architecture and Salience of Incentives overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-06-01 date: 2024-02-28 date: 2024-04-19 name: University of Pennsylvania class: OTHER briefSummary: The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI \> 30) and diabetes (last A1C\>8 in the last 90 days). The main questions it aims to answer are:
Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment among those identified as eligible, rates of Instacart platform use, amount of the subsidy used each week, and amounts of healthy foods ordered.
Aim 2: Examine strategies to optimize the user experience of trial participation, including communication strategies and on-boarding, to increase uptake and engagement in this and subsequent studies.
Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with $5 per week to cover service and delivery fees and delivery tips for 3 months.
Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month for 3 months to be used on produce (fruits and vegetables). conditions: Obesity conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Storefront Choice Architecture name: Fresh Funds name: Loss Framing measure: The primary outcome will be the percentage of food purchasing expenditures spent on eligible healthy foods. measure: Percentage of the $160 subsidy used each month in the intervention arms. measure: Change in hemoglobin A1c measure: Qualitative results sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283381 id: 4264 briefTitle: The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty acronym: ESGIS overallStatus: RECRUITING date: 2024-02-01 date: 2025-01-31 date: 2026-06-30 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:
* Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.
* Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).
The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG conditions: Obesity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Esomeprazole measure: The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: IVO BOSKOSKI role: CONTACT phone: +390630155701 email: ivo.boskoski@policlinicogemelli.it name: IVO BOSKOSKI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06283368 id: 2021/11-06 briefTitle: Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Malignant Thyroid Nodules overallStatus: COMPLETED date: 2016-01 date: 2021-01 date: 2021-01 date: 2024-02-28 date: 2024-03-01 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. In addition to vocal cord injury, which is the most important complication of thyroid surgery, hypocalcemia due to hypoparathyroidism and surgical wound complications (such as hematoma, and fistula) can also be observed, and malignancy surgery increases the risk of recurrent laryngeal nerve injury. Therefore, it is important to differentiate these groups using non-invasive methods before surgery.
Tumor-related inflammation is activated as a result of bone marrow and inflammation induced by malignancies. Insufficiently controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Lymphocyte monocyte ratio and red blood cell distribution are parameters (RDW, RDW-CW) previously studied in terms of cancers.
Our aim in this study is to reveal the RDW, RDW-CW, and LMR calculated from complete blood count parameters in the preoperative period, as an indicator of malignant inflammatory response, in a non-invasive and inexpensive way before surgery or biopsy is performed to distinguish nodular goiter and thyroid malignancy. conditions: Thyroid Neoplasms Benign conditions: Thyroid Nodule conditions: Thyroid Cancer conditions: Thyroid Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 172 type: ACTUAL name: Thyroidectomy, Bilaterally Total name: Thyroidectomy, Unilaterally Total name: Thyroidectomy, Complementary name: Thyroidectomy, Near Total measure: Determining benign thyroid nodules measure: Determining malignant thyroid nodules sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283355 id: IRB00433691 briefTitle: Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-06-01 date: 2025-12-31 date: 2024-02-28 date: 2024-02-28 name: Johns Hopkins University class: OTHER briefSummary: This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity. conditions: Staphylococcus Aureus conditions: Microbial Colonization conditions: Neonatal Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 175 type: ESTIMATED name: Nasal Microbiota Transplant (NMT) name: Placebo measure: Neonatal nasal microbiome diversity after intervention sex: ALL minimumAge: 0 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21287 country: United States name: Danielle Koontz role: CONTACT phone: 443-287-9040 email: dkoontz1@jhmi.edu name: Aaron Milstone role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06283342 id: Konya Pediatric Hematology briefTitle: Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency overallStatus: COMPLETED date: 2018-01-01 date: 2019-01-01 date: 2019-02-01 date: 2024-02-28 date: 2024-02-28 name: Konya Meram State Hospital class: OTHER briefSummary: This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy. conditions: Iron Deficiency Anemia in Childbirth conditions: Infant Nutrition Disorders conditions: Iron Deficiencies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2 type: ACTUAL measure: Ferritine level measure: Hemoglobin level measure: Prophylactic iron use rate measure: Iron-sufficient supplementary food intake rate of babies measure: Breast milk usage rate sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Konya Training and Research Hospital city: Konya zip: 42090 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06283329 id: echographic VC curarization briefTitle: Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints overallStatus: COMPLETED date: 2023-12-01 date: 2023-12-31 date: 2023-12-31 date: 2024-02-28 date: 2024-02-28 name: General Administration of Military Health, Tunisia class: NETWORK briefSummary: Through recent studies residual curarization (RC) remains frequent but serious event, that could be easily avoided in the presence of a paraclinical monitoring and by antagonization of curares. However, conventional monitors focus only on peripheral muscles, whereas ultrasonography allows direct visualization of laryngeal muscles, particularly the vocal cords, which are directly influenced by neuromuscular blocking agents. The aim of the study was to evaluate the ultrasound mobility of the vocal cords after awakening and extubation of general anesthesia compared to their preoperative mobility and its correlation with clinical and paraclinical diagnostic criteria (DG) for RC. conditions: Residual Curarization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ACTUAL name: vocal cords echography measure: Echographic mobility of vocal cords at different times in post extubation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elaskri Haythem city: Tunis zip: 1008 country: Tunisia lat: 36.81897 lon: 10.16579 hasResults: False
<\|newrecord\|> nctId: NCT06283316 id: 11347 briefTitle: Systemic Treatments for Alopecia Areata Registry acronym: STA2R overallStatus: RECRUITING date: 2024-01-17 date: 2099-12-31 date: 2099-12-31 date: 2024-02-28 date: 2024-02-28 name: Erasmus Medical Center class: OTHER briefSummary: A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes. conditions: Alopecia Areata conditions: Alopecia Totalis conditions: Alopecia Universalis conditions: Hair Loss conditions: Hair Diseases conditions: Alopecia conditions: Alopecia Drugs conditions: Autoimmune Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Effectiveness of systemic treatments measure: Safety of systemic treatments measure: Epidemiological data measure: Physician Reported - Severity of Alopecia Tool (SALT Score) measure: Dermatology Life Quality Index (DLQI, 10 items) measure: Alopecia Areata Symptom Impact Scale (AASIS, 13 items) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus University Medical Center status: RECRUITING city: Rotterdam country: Netherlands name: DirkJan Hijnen, MD, PhD role: CONTACT phone: 0031 10 704 01 10 email: d.hijnen@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False
<\|newrecord\|> nctId: NCT06283303 id: MVR-T3011-HAI-01 briefTitle: A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2025-11-30 date: 2025-11-30 date: 2024-02-28 date: 2024-02-29 name: China Medical University, China class: OTHER name: Immvira Co., Limited briefSummary: This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: T3011 hepatic artery infusion name: toripalimab name: regorafenib measure: Treatment Emergent Adverse Event（TEAE） measure: Objective response rate (ORR) measure: Overall survival (OS) measure: Progression-free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283290 id: D3250R00122 briefTitle: PROPE Severe Asthma Study in Egypt overallStatus: RECRUITING date: 2024-03-12 date: 2024-07-31 date: 2024-07-31 date: 2024-02-28 date: 2024-04-19 name: AstraZeneca class: INDUSTRY briefSummary: Asthma is a syndrome characterized by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Patients present clinically with recurrent wheezing, shortness of breath, cough, and chest tightness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025.
Severe asthma is not considered a single disease; instead, it is divided into several phenotypes, owing to the variety of inflammatory, clinical, and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied by a high concentration of eosinophils require greater healthcare resource use, greater disease management costs, and a much more impaired QoL than those who do not present with raised eosinophilia.
While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses, and inflammatory processes involved represent an added challenge for health care professionals. Thus, severe asthma management is a complex endeavor, and a thorough and up-to-date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making.
This cross-sectional, multicenter study aims to determine the prevalence of oral corticosteroid (OCS) use among severe asthma patients who attend to different sites specialized in the management of severe asthma across Egypt. In addition, the prevalence of eosinophilic phenotype of blood eosinophil count ≥ 150 cells/mm3, prevalence of atopic phenotype, and asthma control will also be studied. conditions: Severe Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: To describe the prevalence (frequency) of OCS use among severe asthma patients as defined by chronic treatment and/or bursts of OCS use. measure: To describe the demographic characteristics of severe eosinophilic asthma patients. measure: To describe the clinical characteristics of severe eosinophilic asthma patients. measure: To discover the average OCS dose per year used among severe asthma patients. measure: To determine the prevalence of the eosinophilic phenotype measure: To determine the prevalence of the eosinophilic phenotype measure: To determine the prevalence of the total serum IgE measure: To determine the annual severe asthma exacerbation rate in the past twelve months among severe asthma patients in Egypt measure: To evaluate asthma control of severe asthma patients measure: To evaluate comorbidities related to OCS use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Mansoura state: Dakahlia country: Egypt lat: 31.03637 lon: 31.38069 facility: Research Site status: RECRUITING city: Zagazig state: Sharkia country: Egypt lat: 30.58768 lon: 31.502 facility: Research Site status: RECRUITING city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 facility: Research Site status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 facility: Research Site status: NOT_YET_RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06283277 id: fetal macrosomia briefTitle: Fetal Clavicular Measurement to Predict Fetal Macrosomia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-10-30 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.
The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia. conditions: Macrosomia, Fetal conditions: Large for Gestational Age conditions: Shoulder Dystocia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 240 type: ESTIMATED name: Obstetric Ultrasound measure: Third trimester clavicle length measurement measure: Establish the relationship between third-trimester clavicle length and shoulder dystocia measure: Mode of delivery measure: Gestational age at the time of delivery. measure: Neonatal Apgar score. measure: Neonatal bi-acromial diameter measure: Neonatal birth weight measure: Neonatal need for NICU measure: Neonatal actual clavicle length sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283264 id: Coeliac Disease in type2 DM briefTitle: Assessment of Coeliac Disease in Patients With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-12-01 date: 2026-12-30 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status conditions: Celiac Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: 1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic control sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283251 id: 23-590 briefTitle: PediRISE Feasibility overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Dana-Farber Cancer Institute class: OTHER name: American Cancer Society, Inc. name: Children's Cancer Research Fund briefSummary: The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.
The names of the study groups in this research study are:
* PediRISE Program Group
* Usual Care Group conditions: Pediatric Cancer conditions: Financial Stress conditions: Financial Hardship conditions: Disparities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: PediRISE Resource Program measure: Rate of Participant Consent measure: 6-Month Follow Up Rate for PediRISE Program Group measure: 6-Month Follow Up Rate for Usual Care Group sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Kira Bona, MD, MPH role: CONTACT phone: 617-632-4688 email: Kira_Bona@dfci.harvard.edu name: Kira Bona, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Kira Bona, MD, MPH role: CONTACT phone: 617-632-4688 email: Kira_Bona@dfci.harvard.edu name: Kira Bona, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06283238 id: Pro00115121 briefTitle: Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON) overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-03-25 date: 2027-03-25 date: 2024-02-28 date: 2024-02-28 name: Duke University class: OTHER briefSummary: The goal of this observational study is to examine genetic changes that may contribute to immunotherapy resistance in gastroesophageal cancer. This information can potentially lead to the identification of new immunotherapeutic targets as well as improve the ability to identify those patients more likely to respond to immunotherapy.
This study does not include any treatment or investigational drugs.
Participants will be asked:
* to enroll before beginning standard care of treatment for their cancer
* for blood, archived tumor tissue, and fresh tumor tissue Researchers will compare participants who are not getting immunotherapy to identify potential differences in expression levels of a gene. conditions: GastroEsophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED name: Immune checkpoint inhibitor (ICI) or chemotherapy alone measure: Number of participants with Complete Response (CR) measure: Number of participants with Partial Response (PR) measure: Number of participants with Stable Disease measure: Number of participants with Progressive Disease sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06283225 id: RCT004_PilotPia briefTitle: Pilot Study to Investigate the Effect of a Dysmenorrhoea App overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-07 date: 2024-07 date: 2024-02-28 date: 2024-03-01 name: Endo Health GmbH class: INDUSTRY briefSummary: The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants. conditions: Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention group and control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Pia-App measure: Dysmenorrhea Symptom Interference Scale (DSI) measure: Moos Menstrual Distress Questionnaire, Form C (MDQ) measure: Visual analog scale (VAS) measure: Depression Anxiety Stress Scale mit 21 Items (DASS-21) measure: German Version of Pain Self-Efficacy Questionnaire (FESS) measure: Fatigue Severity Scale (FSS) measure: Pain Disability Index (PDI) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06283212 id: ETX-DS-005 briefTitle: A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome acronym: UK Only overallStatus: RECRUITING date: 2024-04 date: 2029-12 date: 2029-12 date: 2024-02-28 date: 2024-04-17 name: Encoded Therapeutics class: INDUSTRY briefSummary: EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \< 48 months. The study follows and open-label, dose-escalation design. conditions: Dravet Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 4 type: ESTIMATED name: ETX101 measure: Proportions of participants experiencing any treatment-emergent adverse events (AEs), serious adverse events (SAEs), related AEs, AEs with severity Grade ≥ 3, AEs resulting in study discontinuation, and AEs with fatal outcome. measure: Change from baseline in the standard score of the Vineland Adaptive Behavior Scales - Third Edition Adaptive Behavior Composite at Week 52. measure: Percent change in monthly countable seizure frequency (MCSF) to Week 52, with countable seizures defined as generalized tonic-clonic/clonic, focal motor with clearly observable clinical signs, tonic bilateral, and atonic seizures. measure: Change from baseline in the raw score of the Bayley Scales of Infant and Toddler Development® 4th Edition receptive language sub-domain at Week 52. sex: ALL minimumAge: 6 Months maximumAge: 47 Months stdAges: CHILD facility: Queen Elizabeth Hospital status: RECRUITING city: Glasgow zip: G51 4TF country: United Kingdom name: Patricia Clark role: CONTACT phone: 0141 232 7600 email: Patricia.Clark2@ggc.scot.nhs.uk lat: 55.86515 lon: -4.25763 facility: Great Ormond Street Hospital status: NOT_YET_RECRUITING city: London zip: WC1N3JH country: United Kingdom name: Helen Cross, MD role: CONTACT email: helen.cross10@nhs.net lat: 51.50853 lon: -0.12574 facility: Sheffield Children's Hospital status: NOT_YET_RECRUITING city: Sheffield zip: S10 2TH country: United Kingdom name: Research Team role: CONTACT email: research.sheffchild@nhs.net lat: 53.38297 lon: -1.4659 hasResults: False
<\|newrecord\|> nctId: NCT06283199 id: ORL-ORT-025 briefTitle: Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases. overallStatus: RECRUITING date: 2021-04-06 date: 2027-12-31 date: 2027-12-31 date: 2024-02-28 date: 2024-03-01 name: Ente Ospedaliero Cantonale, Bellinzona class: OTHER briefSummary: Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.
After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month. conditions: Musculoskeletal Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED measure: Difference in pain level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna country: Italy name: Alessandro Di Martino, MD role: CONTACT phone: 0039 051 6366567 email: alessandro.dimartino@ior.it lat: 44.49381 lon: 11.33875 facility: EOC - Orthopaedics and Traumatology Service status: RECRUITING city: Lugano zip: 6900 country: Switzerland name: Christian Candrian, Prof.Dr.med role: CONTACT phone: +41 (0) 91 811 61 23 email: christian.candrian@eoc.ch lat: 46.01008 lon: 8.96004 hasResults: False
<\|newrecord\|> nctId: NCT06283186 id: CSEULS-PI-004/2024 briefTitle: Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals overallStatus: RECRUITING date: 2024-04-23 date: 2025-07-31 date: 2025-07-31 date: 2024-02-28 date: 2024-04-24 name: Centro Universitario La Salle class: OTHER briefSummary: This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Aerobic exercise name: Aerobic exercise measure: Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle measure: International Physical Activity Questionnaire (IPAQ) measure: Fatigue Assessment Scale (FAS) measure: Heart rate measure: Rate of perceived exertion (RPE) measure: Physical Activity Readiness Questionnaire (PAR-Q) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: CSEU LaSalle status: RECRUITING city: Madrid zip: 28023 country: Spain name: Álvaro Reina-Varona, MSc role: CONTACT phone: 0034 + 649001863 email: alvaroreina93@gmail.com name: Álvaro Reina-Varona, MSc role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06283173 id: 23-401 briefTitle: HRIPT for Collagen Dressing overallStatus: COMPLETED date: 2024-01-31 date: 2024-03-22 date: 2024-03-22 date: 2024-02-28 date: 2024-04-16 name: Covalon Technologies Inc. class: INDUSTRY name: ALS Beauty and Personal Care briefSummary: The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site. conditions: Skin Sensitisation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This will be a single center, with no randomization or blinding, study design in 50 healthy adult subjects, age 18-70 years. Based on prior experience approximately 75 subjects will be enrolled to ensure 50 subjects complete the study. primaryPurpose: OTHER masking: NONE count: 57 type: ACTUAL name: ColActive Plus Collagen Matrix Dressing measure: Skin sensitization reaction using Berger and Bowman scale measure: Skin irritation reaction using Berger and Bowman scale measure: Skin sensitization reaction using Berger and Bowman scale measure: Skin sensitization reaction using Berger and Bowman scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ALS Beauty and Personal Care city: Torrance state: California zip: 90501 country: United States lat: 33.83585 lon: -118.34063 hasResults: False
<\|newrecord\|> nctId: NCT06283160 id: 2023/834 briefTitle: Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy acronym: PROMETHEE overallStatus: RECRUITING date: 2024-03-01 date: 2026-05-30 date: 2026-05-30 date: 2024-02-28 date: 2024-04-12 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.

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