pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Efficacy of Implementing Nurse-performed Ultrasound-guided Peripheral Intravenous Access in Oncology Patients
NCT Number: NCT06578494
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Supportive Care
Interventions: DEVICE: Ultrasound
Sponsor: Faroese Hospital System
Collaborators: The National Hospital of the Faroe Islands|University of the Faroe Islands|University of Aarhus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-16
Completion Date: 2026-02-16

Summary:
The purpose of this study is to investigate the clinical efficacy of nurse-performed ultrasound-guided intravenous access in oncology patients on the oncological outpatient unit in the National Hospital of the Faroe Islands.

Primary Outcome Measures: First attempt success rate, Placement of a functional peripheral intravenous catheter on the first attempt. Defined as retraction of the needle, blood in the plastic catheter, smooth insertion of the plastic catheter and subsequent flush with isotonic saline without signs of extravasal placement., The time frame for the outcome measure first attempt succes rate for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Secondary Outcome Measures: Number of skin punctures, Total number of insertion attempts i.e., number of skin punctures needed to successfully insert a peripheral intravenous catheter, The time frame for the outcome measure number of attempts for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.|Patient's satisfaction, Arbitrary Likert scale 0-5, The time frame for the outcome measure patient´s satisfaction for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.|Patient's experience of pain, Numerical Rating Scale (NRS) scale 0-10, The time frame for the outcome measure patient´s experience of pain for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.|Durability, Is the chemotherpy session completed successfully (yes/no). Defined as intravenous chemotherapy successfully infused with only one peripheral intravenous catheter used., The time frame for the outcome measure durability for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.|Intravenous complications, Intravenous complications such as e.g., infiltration, extravasation, vessel occlusion etc., The time frame for the outcome measure intravenous complications for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.
The Effectiveness of Postural Stabilization Exercises in Patients With Chronic Neck Pain
NCT Number: NCT06578481
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain
Interventions: OTHER: Exercises
Sponsor: European University of Lefke
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-06-28
Completion Date: 2022-12-30
Locations: European University of Lefke, Lefka, Gemikonağı, 99790, Cyprus

Summary:
This study aimed to evaluate the effect of postural stabilization exercises given in addition to cervical stabilization on craniovertebral angle, neck disability index, and quality of life in people with chronic neck pain.Sixty women with chronic neck pain between the ages of 20-60 were included in the study and the individuals were randomly divided into two groups. Individuals in the first group underwent cervical stabilization (CS) exercises and additional scapular and lumbopelvic stabilization (SLPS) exercises three times a week for 6 weeks. The second group was treated with only CS exercises for the same period. In addition, stretching exercises and a 20-minute hot pack were applied to the muscles around the neck of all patients. Craniovertebral angle (CVA) was measured by photogrammetry. Disability level was measured by the Neck Disability Index (NDI). The Turkish version of the Short Form-36 (SF-36) was used to assess quality of life.

Primary Outcome Measures: Craniovertebral Angle Measurement, The craniovertebral angle (CVA) is formed by the intersection of a horizontal line passing through the seventh cervical vertebra in the sagittal plane and a line going to the tragus of the ear, 6 weeks|Neck Disability Index, The Neck Disability Index was used to assess the disability of people with chronic neck pain during daily activities, 6 weeks|Health Related Quality of Life, The Turkish version of the Short Form-36 (SF-36) is used to assess health-related quality of life. Short Form-36 (SF-36) is a self-assessment scale and analyses 8 dimensions of health, 6 weeks
Deep TMS of Neural Circuits Associated With Stimulant Use Disorder
NCT Number: NCT06578429
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Methamphetamine Use Disorder|Transcranial Magnetic Stimulation
Interventions: DEVICE: Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active|DEVICE: Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham
Sponsor: Stanford University
Collaborators: VA Palo Alto Health Care System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2026-12-31
Locations: VA Palo Alto Health Care System, Palo Alto, California, 94304, United States

Summary:
This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with a methamphetamine use disorder (MUD).

Primary Outcome Measures: Insula Function, The primary measure of SN function will include insula activation during the monetary incentive delay task, anticipation of loss contrasted with no loss, 1-4 days post-treatment|Percentage of Days Abstinent, Methamphetamine use outcomes will be assessed using the TimeLine Follow Back (TLFB) Method, which utilizes calendar cue to recall recent, self-reported substance use, combined with objective biomarker data, 3 months post-treatment
Secondary Outcome Measures: Other Salience Network Function, The secondary measures of SN function will include insula to PFC functional connectivity, and dACC to insula functional connectivity using the same task as the primary measure., 1-4 days post-treatment|Resting-State Salience Network, The investigators will also utilize whole-brain, voxel-wise analyses for the task with stringent error correction, as well as insula activation and insula to dACC functional connectivity during resting state fMRI., 1-4 days post-treatment|Binary Relapse, Binary (yes/no) relapse after treatment via self-report, 3 months post-treatment
The Development of Stuttering in Young Children
NCT Number: NCT06578416
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stuttering|Stuttering, Childhood|Stuttering, Developmental
Interventions: DIAGNOSTIC_TEST: Standardized assessments of speech and language abilities
Sponsor: Michigan State University
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2027-06
Locations: Developmental Speech Lab, East Lansing, Michigan, 48824, United States

Summary:
The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and they complete several child-friendly experiments. During these experiments, brain activity will be recorded using specialized caps while children describe pictures, children will speak in two virtual-reality scenarios, and produce speech while keeping to a beat.

Primary Outcome Measures: Stuttering Assessment, Assess child's speech for presence and severity of stuttering, 1 x each year for up to 5 years|Speech and language abilities, Standardized assessment of speech sound production abilities; expressive and receptive language, oral mechanism assessment, hearing screening, 1 x each year for up to 5 years|fNIRS recording of cortical hemodynamic responses, fNIRS recording of hemodynamic responses during picture description task, 1 x each year for up to 5 years|EEG recording of event-related brain potentials, EEG recording of event-related brain potentials during picture identification (recorded using an EEG cap), 1 x each year for up to 5 years|fNIRS recording of brain activity, functional near-infrared spectroscopy recordings of brain hemodynamic responses during a picture description task (recorded using an fNIRS cap), 1 x each year for up to 5 years|Speech production synchronization, Produce the word "pop" to the beat under different feedback conditions, 1 x each year for up to 5 years|Virtual reality speaking scenarios, Record looking events during virtual reality scenarios (classroom of children and kitten), 1 x each year for up to 5 years|Virtual reality speaking scenarios, Record skin conductance during virtual reality scenarios (classroom of children and kitten), 1 x each year for up to 5 years|Virtual reality speaking scenarios, Record pulse oximetry during virtual reality scenarios (classroom of children and kitten), 1 x each year for up to 5 years
The Epidemiology of Acute Respiratory Distress Among Children, A Retrospective Cross-Sectional Study
NCT Number: NCT06578377
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Respiratory Distress
Interventions: OTHER: descriptive study
Sponsor: Mofid Children Hospital
Collaborators: Dr Fatemeh Shojaeian, Dr seyed mohamadsadegh mousavi-kiasary, Dr Samira Sayyah
Sex: ALL
Age: CHILD, ADULT
Enrollment: 154
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-10-01
Completion Date: 2019-12-30
Locations: Mahdis Bayat, Tehran, 1766884349, Iran, Islamic Republic of

Summary:
l Respiratory distress is still a major concern in pediatric medicine. l In this study we evaluated the symptoms and causes of respiratory distress among children in a tertiary hospital.

l We found that tachypnea is the most common symptom and asthma is the most common cause of respiratory distress in children.

Primary Outcome Measures: The most common symptom, six months|The most common cause of respiratory distress, six months
Effect of Educational Program About Preconception Care on Knowledge and Attitude of Adolescents University Students
NCT Number: NCT06578364
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preconception Care
Interventions: DEVICE: Educational Program about Preconception Care
Sponsor: Delta University for Science and Technology
Sex: ALL
Age: ADULT
Enrollment: 400
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-01-01
Completion Date: 2024-06-30
Locations: Amira Hussin Mohammed, Gamasa, 35712, Egypt

Summary:
This quasi-experimental study used a pre-test-post-test design to assess the effectiveness of the teaching program. A sample of 400 students from El Mansoura University was selected using a simple random sample. The participants were given a pre-test questionnaire to evaluate their knowledge and attitude towards PCC. The educational program consisted of a single session, which included a lecture, pictures, videos, and discussions. The post-test was administered immediately after the program

Primary Outcome Measures: knowledge and attitude towards Preconception care (PCC), The questionnaire includes sections on socio-demographic factors, obstetrics, family planning, and disease-related factors, as well as sections for knowledge and attitude questions, The educational program consisted of a single session, which included a lecture, pictures, videos, and discussions. The post-test was administered immediately after the program.
TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
NCT Number: NCT06578351
Acronym: TRAM
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atopic Dermatitis|Pediatric ALL
Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-08
Completion Date: 2026-12-31
Locations: Mount Elizabeth Hospital, Singapore, 228510, Singapore

Summary:
TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research platform.

Primary Outcome Measures: user experience using a survey form to evaluate user's understanding of OneBiome report, user experience of reading and understanding the microbiome and eating pattern analysis reports., Up to age 18 months|user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern, User experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime., Up to age 18 months
Secondary Outcome Measures: HCP reported applicability of OneBiome concept by parents via a survey form, HCP reported applicability of microbiome/eating pattern profiles of their patients for their general practice, and to assess parents' overall feedback on OneBiome concept., Up to age 18 months
Other Outcome Measures: Association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life, To investigate association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life including mode of delivery, antibiotic prophylaxis, infant feeding patterns and diet., Up to age 18 months|Association between microbiome composition, dietary/eating patterns, and gut health parameters, To determine any association between microbiome composition, dietary/eating patterns, and gut health parameters (stool consistency, frequency, colour, constipation, gastrointestinal infection, antibiotic intake) including stool images., Up to age 18 months
"Critical State" Early Warning Score After CHD Surgery and Rapid Response Team
NCT Number: NCT06578312
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Congenital Heart Disease
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sex: ALL
Age: CHILD
Enrollment: 4115
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2024-07-01
Locations: Fuwai hospital, Beijing, 100037, China

Summary:
By establishing a warning scoring tool for the early \&#34;critical state\&#34; after congenital heart disease surgery, the multidisciplinary rapid response team is proactively activated, forming an integrated treatment model of early warning-team decision-making-organ assistance.

Primary Outcome Measures: event occurrence-an inclusion of composite clinical diagnose, critical status included clinical diagnose：arrhythmia（ventricular tachycardia、ventricular fibrillation、refractory supraventricular tachycardia

）,prognosis（death or live）,bedside thoracotomy,CPR,ECMO,extracorporeal circulation establishment,renal replacement therapy,peritoneal dialysis, hemofiltration. If one of the above diagnosis and treatment used in patients, they would be divided to case group., Within 48 hours after surgery
Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer
NCT Number: NCT06578299
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Breast Cancer Stage IV
Interventions: DRUG: Inetetamab and Paclitaxel ± Pertuzumab
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2027-08-30

Summary:
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.

Primary Outcome Measures: PFS, PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first., Until progression, assessed up to approximately 24 months
Secondary Outcome Measures: Objective Response Rate (ORR), ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., Until progression, assessed up to approximately 24 months|Clinical Benefit Rate (CBR), Clinical benefit rate was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) or stable disease（SD）\>6 months determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart., Until progression or death, assessed up to approximately 24 months|Overall Survival (OS), OS is defined as the time from the participant's first dose of study treatment to the date of death., Up to approximately 3 years|Number of Participants With Adverse Events (AEs), Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0)., Up to approximately 3 years
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
NCT Number: NCT06578286
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: ARX788
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2030-09-30

Summary:
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Primary Outcome Measures: Objective remission rate (ORR), The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1., Until progression, assessed up to approximately 24 months
Secondary Outcome Measures: Disease control rate (DCR), The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1., Baseline through end of study, assessed up to 24 months]|Duration of relief (DOR), Time from the date of first documented response until the date of documented progression or death in the absence of disease progression, Until progression, assessed up to approximately 24 months|Progression-free survival (PFS), Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause., Until progression or death, assessed up to approximately 36 months]|Overall survival (OS), Time to death due to any cause, Until death, assessed up to approximately 50 months|The number of subjects experiencing adverse event TEAEs, Occurrence of AEs according to CTCAE v5.0, Up to follow-up period, approximately 50 months
NeuroGlove PD Study Clinical
NCT Number: NCT06578273
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Parkinson Disease
Interventions: DEVICE: NeuroGlove
Sponsor: NeuroGlove LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-08-22
Completion Date: 2024-08-22
Locations: NeuroGlove, Minneapolis, Minnesota, 55416, United States

Summary:
Safety and Feasibility of Peripheral Sensory Stimulation of the Hand in the Treatment of Parkinson's Disease

Primary Outcome Measures: Use the UPDRS to Evaluate safety and feasibility of device, Evaluate safety and feasibility of device use on subjects with active symptoms, monitoring motor symptoms and subjects' sense of well-being. The UPDRS - United Parkinson's Disease Rating scale - developed for research and clinical evaluation will be used. The form has a severity scale with ratings from 0-4 with 0 meaning no severity and 4 meaning extreem severity, 4 weeks|Use Custom Satisfaction Scale to Rate and severity of adverse events related to the use of the NeuroGlove., The Satisfaction scale will assess ease of use, satisfaction, feelings of symptom reduction among other questions with a 5 point scale: Strongly Agree, Agree, Neutral, Disagree, and Strongly Disagree, 4 weeks
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
NCT Number: NCT06578247
Acronym: QuANTUM-WILD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Leukemia
Interventions: DRUG: Quizartinib|DRUG: Placebo|DRUG: Chemotherapy
Sponsor: Daiichi Sankyo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-30
Completion Date: 2030-06-26

Summary:
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Primary Outcome Measures: Overall Survival (Arm A vs Arm B), Overall survival (OS) is defined as the time from randomization until death from any cause., Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
Secondary Outcome Measures: Event-free survival (Arm A vs. Arm B), Event-free survival (EFS) is defined as failure to achieve Complete Remission (CR) (as assessed by Independent Review Committee (IRC)) at end of induction, relapse after CR, or death due to any cause, whichever occurs first, Date of randomization up to approximately 42 months|Duration of complete response (Arm A vs. Arm B), Duration of complete response (DoCR) is defined as time from the first documented CR until documented relapse or death due to any cause, whichever comes first, Date of randomization up to approximately 42 months|Relapse-free survival (Arm A vs. Arm B), Relapse-free survival (RFS) is defined as time from randomization, for participants who achieve CR in the Induction Phase, until relapse or death due to any cause, whichever comes first, Date of randomization up to approximately 42 months|Complete remission rate (Arm A vs. Arm B), Complete remission rate (CR) is defined as proportion of of participants who achieved a CR, At end of Induction Phase, up to approximately 120 days|Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B), Proportion of participants achieving CR with minimal or measurable residual disease (MRD) negativity, At end of Induction Phase (Cycle 1 or Cycles 1 and 2) and at the end of 2 cycles (2 cycles of induction or 1 cycle induction and 1 cycle consolidation)(1 Induction cycle is up to 60 days, 1 Consolidation cycle is 28 days), up to approximately 120 days|Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B), Treatment-emergent adverse events (TEAE) are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of quizartinib/placebo to 30 days after the last dose date of quizartinib/placebo)., Date of first dose up to 30 days after last dose, up to approximately 42 months
Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
NCT Number: NCT06578234
Acronym: HYPER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Chronic Coronary Syndrome|Coronary Artery Disease|Ischemic Heart Disease
Interventions: DRUG: Adenosine
Sponsor: Region Skane
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-30
Completion Date: 2026-12-31

Summary:
Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.

Primary Outcome Measures: Myocardial hyperemia, The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g)., During adenosine infusion, 4-6 minutes
Secondary Outcome Measures: Heart rate response, Compare heart rate (beat/min) at standard and high dose adenosine, During adenosine infusion, 4-6 minutes|Blood pressure response, Compare systolic blood pressure (mmHg) at standard and high dose adenosine, During adenosine infusion, 4-6 minutes|Symptoms, Compare presence of symptoms (evaluated using a Borg10-scale) at standard and high dose adenosine, During adenosine infusion, 4-6 minutes
Other Outcome Measures: Sex, The association between sex (female and male) and adenosine response, In questionnaire obtained approximately 30 minutes before CMR examination|Age, The association between age (years) and adenosine response, In questionnaire obtained approximately 30 minutes before CMR examination|Ejection fraction, The association between ejection fraction (%) assessed from CMR images and adenosine response, Measured in the obtained short-axis cine images within approximately 6 months after acquisition|Serum-caffeine, The association between serum caffeine levels (mg/L) assessed from blood samples and adenosine response, Blood samples are analysed within 9 months
The Effects of Kegel Pelvic Floor Muscle Exercises on Urinary Retention and Comfort Levels
NCT Number: NCT06578221
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nurses|Comfort|Surgery
Interventions: OTHER: Kegel Pelvic Floor Muscle Exercise Group
Sponsor: Saglik Bilimleri Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-14
Completion Date: 2024-12-01
Locations: Büşra Demirci, Ankara, University Of Health Sciences, Turkey

Summary:
This study was planned as a randomized controlled trial to investigate the effects of Kegel pelvic floor muscle exercises on urinary retention and comfort levels of patients after lumbar disc herniation surgery.

Primary Outcome Measures: Effect of Kegel pelvic floor muscle exercises on urinary retention of patients after lumbar disc herniation surgery., Kegel pelvic floor muscle exercises will affect the urinary retention of patients after lumbar disc herniation surgery. This situation will be evaluated with the Postoperative Data Collection Form. The Postoperative Data Collection form, which was created by the researchers as a result of a literature review, includes a total of 10 questions including postoperative pain, vital signs, and postoperative (postoperative first 8 hours) urinary retention signs and symptoms (pressure in the lower abdomen, pain in the lower abdomen, feeling of restlessness, desire to urinate within 8 hours?)., After completing Kegel pelvic floor muscle exercises in the first 8 hours after surgery.
Secondary Outcome Measures: Effect of Kegel pelvic floor muscle exercises on comfort level after lumbar disc herniation surgery, Kegel pelvic floor muscle exercises will affect comfort level of patients after lumbar disc herniation surgery. The comfort level of the patients will be evaluated with VAS. VAS is used to convert some unmeasurable values into numerical values. VAS is a horizontal line with a length of 10 cm. According to VAS, 0 is the lowest level and 10 is the highest level. Patients will be asked to mark these levels on the 10 cm line., After completing Kegel pelvic floor muscle exercises in the first 8 hours after surgery.
Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD
NCT Number: NCT06578156
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD
Interventions: DEVICE: Nasal High Flow Cannula|DEVICE: Nasal Low Flow Cannula
Sponsor: University of Miami
Collaborators: American Thoracic Society
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2027-12-31
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.

Primary Outcome Measures: 6-minute walk test, The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The distance walked in meters over 6 minutes will be measured., 30 minutes
Secondary Outcome Measures: Breathing measured by the Borg dyspnea scale, This is a patient self-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, where "0" indicated no difficulty breathing, and "10" indicates a maximal breathing difficulty., 30 minutes
Effects of Synbiotics on Obesity
NCT Number: NCT06578143
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity
Interventions: OTHER: Placebo|OTHER: Synbiotics
Sponsor: Leeuwenhoek Laboratories Co. Ltd.
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-10-15
Completion Date: 2025-03-01

Summary:
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. The purpose of this trial is to evaluate the impact of a synbiotics product developed by Leewenhoek Laboratories Co., Ltd., on human obesity and its related biomarkers. Participants will be randomly assigned to either the experimental group or the control group in a double-blind trial. The intervention involves the experimental group taking the synbiotics product twice daily, two capsules per dose, after meals for six weeks. The control group will take an equal amount of placebo daily. During the trial, participants' body weight will be recorded weekly, and their body weight, waist circumference, hip circumference, body fat composition, and skeletal muscle mass will be measured before and after the intervention. Additionally, fasting blood samples and blood samples collected at 30, 60, 90, and 120 minutes after consuming the nutritional supplements will be analyzed. The study will compare body fat percentage, body weight, BMI, waist circumference, hip circumference, skeletal muscle mass, and obesity-related biomarkers in blood between the experimental and control groups. The trial results will be used to assess the efficacy of the synbiotics product in improving obesity and its related biomarkers.

Primary Outcome Measures: Body fat percentage, The difference in body fat percentage between experimental group and control group., Up to six weeks
Statistical Learning as a Novel Intervention for Cortical Blindness
NCT Number: NCT06578117
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic|Hemianopia, Homonymous|Hemianopsia|Occipital Lobe Infarct|Visual Field Defect, Peripheral|Vision Loss Partial|Quadrantanopia|Stroke Hemorrhagic
Interventions: DEVICE: Vision Training and Learning Task
Sponsor: University of Rochester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2027-10-01
Locations: University of Rochester Medical Center, Rochester, New York, 14642, United States

Summary:
This project aims to develop a novel visual training paradigm for use in visually-intact participants and those sufferings from stroke-induced visual impairments. Our task design is built upon theories of statistical learning to reduce the overall training burden while still producing profound improvements to visual abilities. Efficacy will be first established in visually-intact controls before testing in stroke survivors to assess the feasibility of this form of learning in the damaged visual system.

Primary Outcome Measures: Explicit Learning - Response Time, Reaction time (ms) when performing motion discriminations for the final stimulus of a statistically-linked triplet will be compared against reaction times for stimuli with identical motion directions, presented with alternative placement within a triplet. Comparisons will be made only for correct responses in the final 20% of overall testing session trials., Baseline|Implicit Learning - Triplet Familiarity, Participant familiarity with statistically-linked triplets of motion will be assessed via a two-interval, forced-choice task. Familiarity will be measured as a percentage of comparisons in which the more prevalent triplet is selected as more familiar. Familiarity of high-probability, low-probability, and null-probability triplets will be compared following training., Baseline
PULSED AF Post-Approval Study
NCT Number: NCT06578104
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: DEVICE: PulseSelect™ PFA system
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 580
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12-01
Completion Date: 2029-06-01

Summary:
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Primary Outcome Measures: Efficacy-Freedom from Atrial Fibrillation, Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system., 36-months after the index ablation procedure|Safety- Freedom from Device/Procedure Related Adverse Events, Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system., 6 months post-ablation]
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
NCT Number: NCT06578065
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Anastomosis
Interventions: DEVICE: Echelon Circular™ Powered Stapler|DEVICE: 2-row circular staplers manual
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 540
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2026-09-01
Locations: Consorci Corporació Sanitària Parc Taulí de Sabadell, Sabadell, Barcelona, 08208, Spain|Hospital General Universitario Gregorio Marañón, Madrid, 28007, Spain|Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, 30120, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain

Summary:
Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms:

* ECPS group: Echelon Circular™ Powered Stapler (n=270)
* MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.

Primary Outcome Measures: Anastomotic leakage rates differences between both groups at 30 postoperative days, To assess whether ECPS have an impact on left-sided colorectal AL rate compared to current manual circular staplers (MCS)., Through study completion, an average of 1 year
Secondary Outcome Measures: Postoperative endoluminal bleeding rate differences between both groups., To assess whether ECPS improve haemostasis in the anastomotic line, Through study completion, an average of 1 year|Morbidity differences between groups according to the Clavien-Dindo classification., To evaluate whether ECPS have an impact in postoperative morbidity, Through study completion, an average of 1 year|Re-intervention rate differences between both groups, To evaluate whether ECPS have an impact in re-interventions rate, Through study completion, an average of 1 year
Phase 1 Clinical Trial of CordSTEM-ST
NCT Number: NCT06578039
Acronym: CBT210-POI_P1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Premature Ovarian Insufficiency
Interventions: BIOLOGICAL: umbilical cord-derived mesenchymal stem cell
Sponsor: CHABiotech CO., Ltd
Sex: FEMALE
Age: ADULT
Enrollment: 6
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-05
Locations: CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, 463-712, Korea, Republic of

Summary:
This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects.

Primary Outcome Measures: Number of adverse events, Number of adverse event cases reported, up to 6 months after the IP administration|Abnormality cases in lab test results, Number of clinically significant abnormalities found in lab test results., up to 6 months after the IP administration|Abnormality cases physical exam results, Number of clinically significant abnormalities found in physical exam results, up to 6 months after the IP administration|Abnormality cases in vital signs, Number of clinically significant abnormalities found in vital signs, up to 6 months after the IP administration
Secondary Outcome Measures: Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level, blood Follicle Stimulating Hormone (FSH) level measured in mIU/ml, up to 6 months after the IP administration|Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level, blood Anti-Mullerian Hormone (AMH) level measured in ng/ml, up to 6 months after the IP administration|Percent change from baseline blood Estradiaol (E2) level, blood Estradiaol (E2) level measured in pg/ml, up to 6 months after the IP administration|Percent change from baseline in number of mature follicles, number of mature follicles measured in number of follicles, up to 6 months after the IP administration|Percent change from baseline in number of antral follicles, number of antral follicles measured in number of follicles, up to 6 months after the IP administration|Percent change from baseline in endometrial thickness, endometrial thickness measured in cm, up to 6 months after the IP administration|Status of menstruation resumption, Collected by patient interview, up to 6 months after the IP administration
Developing Resilience Skills and Social Competence in Youth in a School Setting
NCT Number: NCT06578026
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychosocial Functioning
Interventions: BEHAVIORAL: Resilience Builder Program
Sponsor: The Catholic University of America
Sex: ALL
Age: CHILD
Enrollment: 169
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-06-16
Completion Date: 2020-03-13
Locations: Montgomery County Public Schools, Rockville, Maryland, 20850, United States

Summary:
Our study aimed to answer the question: Can a resilience-based intervention improve the psychosocial and educational outcomes of students with psychosocial difficulties? We examined the effectiveness of a resilience-based group intervention, the Resilience Builder Program® (RBP), with students in low-SES school settings to determine if this treatment improves psychosocial and educational outcomes.

Primary Outcome Measures: Resiliency scales for children and adolescent (RSCA), self-report of child's resilience; score 0-100; higher scores = stronger resilience, 1 month
Secondary Outcome Measures: Behavior assessment system for children, 2nd edition (BASC), parent, child, and teacher report across varied psychosocial subscales; score 0-100; scores vary based on subscale, higher scores can indicate greater impairment or better functioning, 1 month
Other Outcome Measures: Academic competence evaluation scales (ACES), teacher report of student's academic engagement and motivation; score 0-100; higher scores = better functioning, 1 month
Effect of Acupressure-Ice Message on Primary Dysmenorrhea
NCT Number: NCT06578013
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Dysmenorrhea
Interventions: OTHER: acupressure ice massage|OTHER: pelvic rocking exercises
Sponsor: Cairo University
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2024-12-15
Locations: Doaa Ashraf Abd El-Ghany, Cairo, Egypt

Summary:
This study will be conducted to determine the effect of acupressure ice massage on primary dysmenorrhea.

Primary Outcome Measures: Pain intensity assessment, It will be assessed for each participant in both groups (A \& B) before and after treatment, using the visual analogue scale (VAS). The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of " no pain at all " and " worst pain imaginable ". It's simplicity, reliability and validity as well as its ratio scale properties make the VAS the optional tool for describing pain intensity., 3 months|Assessment of pain pressure threshold, A pressure algometer will be used to measure pain pressure thresholds (PPTs) for all participants in both groups before and after treatment, coinciding with peak menstrual pain on the first day of menstruation. Six specific points around the umbilicus and lower back will be assessed, with each point measured twice using a 1-cm² probe applied at 30kPa/s. The areas will be cleaned with alcohol before testing. Two points will be measured 4cm bilaterally from the umbilicus, two more 4cm below these, one 4cm below the umbilicus, and one in the lumbar region at S2-S4. The mean values of these points will be used for PPT data analysis., 3 months|Menstrual distress questionnaire (MDQ), It will be used pre and post- treatment to assess the severity of symptoms of primary dysmenorrhea for all participants in both groups (A \& B). The MDQ consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5 point rating scale from 0-4. For each items, there is 5 options i.e. No, mild, moderate, severe and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven sub-scales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, arousal control). Overall Score was interpreted as follows :\< 50 - mild , 50 to 70 - moderate and \>70 severe., 3 months
Role of Medical Treatment in Endometriosis Patients Undergoing ICSI
NCT Number: NCT06577974
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis
Interventions: DRUG: Combined contraceptive pills (Yasmin)
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 129
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-03-01
Locations: ART unit, Obstetrics and Gynecology Department, Cairo University, Cairo, Egypt|Cairo University/Obstetrics and Gynecology Department/ART Unit, Cairo, Egypt

Summary:
The aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility.

Primary Outcome Measures: Fertilisation rate, Number of embryos, 2 weeks from starting induction
Secondary Outcome Measures: clinical pregnancy rate, appearance of intrauterine gestational sac, 2 weeks from embryo transfer