pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effects of Dual-task Aerobic Exercise
NCT Number: NCT06461130
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sedentary Behavior
Interventions: OTHER: Study Group|OTHER: Control Group
Sponsor: Istanbul Medipol University Hospital
Collaborators: University of Yalova|Istanbul Gedik University
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-09-10
Completion Date: 2024-05-30
Locations: Ebrar Atak, Yalova, 77100, Turkey

Summary:
The aim of this study was to examine the acute effect of dual-task aerobic exercise on cognitive load and myocardial oxygen consumption in healthy sedentary individuals. In this study: 1. Does dual-task exercise applied in addition to aerobic training have an acute effect on cognitive load in healthy sedentary individuals? 2. Does dual-task exercise applied in addition to aerobic training in healthy sedentary individuals have an acute effect on myocardial oxygen consumption, which reflects the indirect oxygen consumption of the heart? The questions were answered.

Primary Outcome Measures: Cognitive load assessment, Cognitive load change was assessed with the Montreal Cognitive Function Assessment Scale (MOCA)., Time to acute change in measurements 1 hour before the application and 1 hour after the application.|Myocardial oxygen consumption assessment, Myocardial oxygen consumption was calculated using the Double Product formula of the data obtained from blood pressure and pulse measurement., Time to acute change in measurements 1 hour before the application and 1 hour after the application.
Secondary Outcome Measures: Reaction time evaluation, Reaction time was determined by measuring the distance the ruler caught after the ruler was released., Time to acute change in measurements 1 hour before the application and 1 hour after the application.
Beetroot Juice: Anaerobic Performance and Fatigue in Swimmers
NCT Number: NCT06461117
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutrition, Healthy
Interventions: OTHER: Beetroot Juice|OTHER: Plesabo Drink
Sponsor: Istanbul Bilgi University
Sex: MALE
Age: CHILD, ADULT
Enrollment: 14
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-10-01
Completion Date: 2023-11-30
Locations: İstanbul Bilgi University, İstanbul, Turkey

Summary:
The effects of beet juice supplementation on different types of physical performance have been examined in many studies. However, although the number of studies, including the effect of beet juice on physical performance, measuring blood lactate and fatigue levels in swimmers, is limited, most studies focused on acute intake. This study investigated the effects of beetroot juice on anaerobic performance, fatigue, and blood lactate in adolescent male swimmers.Swimmers underwent a single-blind intervention, consuming either a 2x250 ml placebo (0.6 mmol NO3- ) or beetroot juice (8 mmol NO3-) (rich in nitrate, NO3-) for six days. Performance was measured through an 8x100-meter maximal effort swim, with blood lactate and perceived fatigue assessed before and after.

Primary Outcome Measures: Freestyle Time Trial (TT) Swimming Performance Test, Performance Test, Swimmers' 8x100 m maximum effort swimming performance times were measured and recorded for 3 weeks, before the intervention, on Saturday after consuming placebo drink and beet juice, under similar conditions.|Blood Lactate Measurement, Blood Lactate Lactate, Blood lactate measurement was measured and recorded before the intervention, after consuming placebo drink and beetroot juice, and after completing the 8x100 m maximum effort swimming performance, under similar conditions, for 3 weeks.|Borg Fatigue Scale, Fatigue, Swimmers' fatigue was measured for 3 weeks using a Borg Fatigue Scale after performance tests. Minimum and maximum score is 0-10. Higher scores indicate greater fatigue.
the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia
NCT Number: NCT06461091
Acronym: TMI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Lymphoblastic Leukemia
Interventions: RADIATION: TMI
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-04-30

Summary:
Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.

Primary Outcome Measures: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS)., Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS)., 1YEAR
Secondary Outcome Measures: (1) Rate of granulocyte and platelet hematopoietic recovery., (1) Rate of granulocyte and platelet hematopoietic recovery., 1YEAR|(2) Incidence of toxicity related to the conditioning regimen., (2) Incidence of toxicity related to the conditioning regimen., 1YEAR
Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery.
NCT Number: NCT06461052
Acronym: Harmonie
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ambulatory Surgery
Interventions: PROCEDURE: music therapy
Sponsor: Hopital Foch
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 198
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-03-12
Completion Date: 2025-01-15
Locations: DRCI FOCH Hospital, Suresnes, 92150, France|FOCH Hospital, Suresnes, 92150, France

Summary:
This is a monocentric, prospective, before-and-after, open-label controlled study, two groups of 99 patients each: "control" group - usual care - versus "intervention" group "Intervention" group - patient information via an explanatory video followed by a 15-minute music therapy session of the patient's choice in the operating waiting room.

Primary Outcome Measures: Compare the proportion of patients with high anxiety (Visual Analog Score (VAS) for pain greater than or equal to 40/100) in operating waiting room between the two groups (before and after implementation of the actions)., The primary endpoint was the presence or absence of high anxiety in operating waiting room (T2), measured by an VAS score \> 40/100. A range of scores from 0-100. A higher score indicates greater pain intensity., up to 24 hours
Secondary Outcome Measures: Compare anxiety levels in preoperative reception unit (T1) and in post anesthesia care unit room (T3) between the two groups: Amsterdam Preoperative Anxiety and Information Scale (APAIS) and VAS score, VAS score and APAIS in preoperative reception unit (T1) and in post anesthesia care unit room (T3). A range of scores from 0-100. A higher score indicates greater pain intensity. The APAIS scale is a six-item questionnaire graded on a five-point Likert scale from 1=not at all to 5=extremely, up to 24 hours|Compare anxiety levels in operating waiting room (T2), VAS score in operating room waiting room (T2). A range of scores from 0-100. A higher score indicates greater pain intensity., up to 24 hours|Compare the time to loss of consciousness measured in the operating room between both groups, Time to loss of consciousness measured in the operating room (time between injection of hypnotic agent (propofol) and a sleep depth measurement less than 60), up to 24 hours|Compare the amount of propofol (mg/kg) at induction required to achieve loss of consciousness between the two groups., Amount of propofol (mg/kg) at induction required to achieve loss of consciousness, up to 24 hours|Evaluate the level of satisfaction of each action implemented using a specific questionnaire at the end of the program., Level of satisfaction using a specific questionnaire at the end of the Licker scale, up to 24 hours|Evaluate the proportion of dropouts for each action, i.e. the proportion of patients who did not viewed the video until the end, or did not complete the entire music therapy session., Action completed in full or partially yes or no, up to 24 hours
L9LS MAb in Malian Infants
NCT Number: NCT06461026
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Malaria
Interventions: BIOLOGICAL: L9LS|OTHER: Normal Saline
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: National Institutes of Health (NIH)|University of Washington|Harvard School of Public Health (HSPH)|Indiana University School of Medicine, Indiana University
Sex: ALL
Age: CHILD
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-19
Completion Date: 2025-08
Locations: Faladje MRTC Clinic, Faladje, Région De Koulikoro, Mali|Kalifabougou MRTC Clinic, Kalifabougou, Région De Koulikoro, Mali|Torodo MRTC Clinic, Torodo, Région De Koulikoro, Mali

Summary:
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.

Primary Outcome Measures: Incidence of local and systemic AEs occurring within 7 days after the administration of study agent., Measured through Day 7|Severity of local and systemic AEs occurring within 7 days after the administration of study agent., Measured through Day 7|Measurement of study agent in sera of recipients., Measured day 7, 28, 84, 140, 196 and 280
Secondary Outcome Measures: Total IgG anti-NANP antibody titers measured by ELISA., Measured 28 days and 84 days after the third R21/Matrix-MTM vaccination.|Measurement of Anti-Drug Antibodies (ADA) to L9LS in sera of recipients., Measured at day 28, 224 and 280
Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy
NCT Number: NCT06460987
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Finerenone|IgA Nephropathy|Proteinuria|Safety Issues
Interventions: DRUG: Finerenone|DRUG: RAS inhibitor|DRUG: Immune Suppressant
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 245
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-01
Completion Date: 2024-03-31
Locations: Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy, Yiwu, Zhejiang, China

Summary:
IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.

Primary Outcome Measures: percentage change in PCR from baseline to 6 months, Collect PCR data before enrolment and at month 6 and calculate the percentage change, 6 month
Secondary Outcome Measures: percentage change in PCR from baseline to 1, 2 and 3 months, Collec PCR before enrolment and at months 1, 2 and 3, then calculate the percentage change, 1, 2 and 3 month|frequency of patients with a 30% and 50% decrease in PCR, Calculate the number of patients with \>30% or \>50% reduction in proteinuria during the 6-month follow-up period, 6 month|the level of change in eGFR, Collection of eGFR before enrolment and at months 6, 6 month|the level of change in blood sodium, Collection of blood sodium before enrolment and at months 6, 6 month|the level of change in serum creatinine, Collection of serum creatinine before enrolment and at months 6, 6 month|the level of change in albumin, Collection of albumin before enrolment and at months 6, 6 month
The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer
NCT Number: NCT06460974
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patients With Breast Cancer
Interventions: OTHER: stress ball
Sponsor: Mersin University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06
Completion Date: 2024-12
Locations: Mersin University, Mersin, 33110, Turkey

Summary:
This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.

Primary Outcome Measures: Distress Thermometer, Distress level is determined by a visual analog scale ranging from "0-10". Patients express the psychological distress they feel with the numbers on the thermometer; "0 points" means that the patient does not experience any distress, and "10 points" means that the patient experiences the highest level of distress, 6 months|State-Trait Anxiety Inventory, It evaluates the state of anxiety felt by the individual due to the stressful situation he is in. The first 20 items, consisting of short statements, measure the individual's state anxiety level., 6 months|General Comfort Scale, The scale contains a total of 48 items in a four-point Likert type and consists of four sub-dimensions (physical, psycho-spiritual, environmental, and socio-cultural sub-dimensions)., 6 months
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
NCT Number: NCT06460948
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Arginine Vasopressin Deficiency|Oxytocin Deficiency
Interventions: DRUG: Norethindrone Acetate-Ethinyl Estradiol
Sponsor: Elizabeth Austen Lawson
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06
Completion Date: 2026-06

Summary:
This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that:

1. Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.
2. Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.

Primary Outcome Measures: Change in peripheral oxytocin concentration from 0 to 24 hours, Change in peripheral oxytocin concentration from 0 to 24 hours, Time points: time 0 min (baseline) and 24 hours
Secondary Outcome Measures: Area under the curve of salivary oxytocin from baseline to 48 hours following Estrogen-progestin administration in patients with arginine-vasopressin deficiency compared to healthy controls, Difference from baseline to oxytocin peak (blood and saliva) between patients with arginine-vasopressin deficiency compared to healthy controls.

Correlation between oxytocin area under the curve and psychopathology and quality of life measures across groups., From time 0 min (baseline) to 48 hours
The Effect of Online Sexual Health Training Given to Nursing Students on Knowledge, Attitude and Self-Efficacy
NCT Number: NCT06460935
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Education|Nursing Students|Randomized Controlled Trial|Sexual Health
Interventions: BEHAVIORAL: sexual health training
Sponsor: Marmara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 57
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-11-04
Completion Date: 2023-12-31
Locations: Marmara University, Istanbul, 34854, Turkey

Summary:
Nurses play an important role in providing sexual health care to individuals. In this study, online sexual health training will be implemented in an innovative way by supporting the use of models in the process of providing sexual counseling to the patients of nursing students. The most commonly used PLISSIT model will be taught to nursing students while providing sexual counseling to patients and its effectiveness will be determined.

Primary Outcome Measures: Knowledge of Sexual Healthcare Scale, The scale was designed to measure the knowledge of nursing students about sexual health care. The scale consists of 31 items. Each item was rated as "yes", "no" and "I don't know". 1 point is given for the correct answer, 0 points for the wrong answer and the answer I don't know. A score between 0-31 can be obtained from the scale., baseline, week 8|Self Efficacy for Sexual Healthcare Scale, The scale measures nursing students' self-efficacy in providing sexual health services. The scale consists of 3 sub dimensions and a total of 15 items. Each item is rated on a 5-point Likert scale ranging from 1= strongly disagree, 2= disagree, 3= undecided, 4= agree, 5= strongly agree. The total score ranges from 15 to 75 points., baseline, week 8|Attitude to Sexual Healthcare Scale, The scale determines the attitudes of nursing students towards sexual health services. The scale consists of 3 subdimensions and a total of 18 questions. Each item on the 5-point Likert scale is rated as 5 = strongly agree, 4 = agree, 3 = undecided, 2 = disagree, and 1 = strongly disagree. The scores that can be obtained from the scale vary between 18 and 90., baseline, week 8
Secondary Outcome Measures: Student Opinion Form on Sexual Health Education, It determines the thoughts of the students about the model taught in education and the satisfaction of the students from the education., baseline, week 8|Sexual Myths Scale, The scale has been reported to be a useful tool to reveal whether a person's knowledge is based on sexual myths. In this 5-point Likert-type scale, consisting of 28 items, statements are evaluated between "1 points (I never agree), "5 points (I totally agree). The scale consists of 8 sub-dimensions and 28 items. The total score that can be obtained from the scale can vary between 28-140., baseline, week 8
Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
NCT Number: NCT06460909
Acronym: PrePS HV
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hallux Valgus Surgery
Interventions: OTHER: Psychological support
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-02-02
Completion Date: 2025-02-02
Locations: Orthopedia and traumatological department, Boulogne-Billancourt, 92100, France

Summary:
Catastrophizing is a negative evaluation of events. What surgery concerns, pain catastrophizing is one of the main risks of postoperative pain and / or poor functional recovery. The best survey to evaluate pain catastrophizing is the PCS (Pain Catastrophizing Scale). According to the authors, catastrophizers report more negative pain related thoughts, more emotional distress and more pain than non-catastrophizers. The PCS is a significant predictor of pain intensity and so of poor functional recovery.

It is already well known that anxiety and catastrophizing predict postoperative pain.

The actual studies focus mainly on functional recovery of knee and hip arthroplasties, but less on pain and functional recovery of hallux valgus surgery.

According to several authors, adapted psychological support of preoperative catastrophizing could allow a better postoperative evolution.

Our hypothesis is that a preoperative psychological consultation of catastrophizing patients is efficient to lower pain catastrophizing in adult patients undergoing a surgical operation for hallux valgus.

The first objective is to evaluate the impact of a psychological support of preoperative pain catastrophizing during a hallux valgus surgery.The principal evaluation scale is the pain catastrophizing score before and after surgery.

The second objective is to evaluate the pain and functional recovery of pain catastrophizing patients. The criteria of this survey are: anxiety score (usual and actual), pain and function according to the FAOS (Foot and Ankle Outcome Score) pain (Analogic Visual Scale).

Primary Outcome Measures: Impact of preoperative psychological support on pain catastrophizing, By State portion of the Spielberger State-Trait Anxiety Inventory STAI., at baseline
Secondary Outcome Measures: Pain evaluate of catastrophizing patients, By American Orthopaedic Foot and Ankle Society (AOFAS)., at baseline
Effects of Eccentric Banded Leg Curls Versus Eccentric Cable Leg Curls Exercises in Cricket Players
NCT Number: NCT06460883
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hamstring Muscle|Muscle Strength|Treatment Efficacy
Interventions: OTHER: eccentric cable leg curls|OTHER: eccentric banded leg curls
Sponsor: Riphah International University
Sex: MALE
Age: CHILD, ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-09-26
Locations: Pakistan Cricket Board, Lahore, 05450, Pakistan

Summary:
Hamstring injuries are highly prevalent among cricket players, comprising 10% of all injuries in field-based team sports. Eccentric strength deficits and imbalances in muscle strength are linked to a higher risk of such injuries. Our randomized clinical trial aims to assess eccentric hamstring strength using eccentric banded leg curls and eccentric cable leg curl exercises, measured by the Nordbord device. This tool provides accurate measurements of eccentric hamstring strength, power, and endurance, crucial for injury prevention in athletes. Thirty-two male professional cricketers will participate, divided into two groups receiving different exercise plans. Each group will perform 15 reps in 3 sets with rest intervals, four times a week for four months. The Nordbord device will assess hamstring strength before and after the exercise plan. Statistical analysis will be done using SPSS V25, employing descriptive statistics for frequency distribution and inferential statistics such as t-tests to compare outcomes between treatment groups.

Primary Outcome Measures: Eccentric hamstring strength, The NordBord is a great tool for measuring hamstring strength of each leg allowing for tracking of overall strength gains and side-to-side imbalances., 4 months
Effects of MDRT vs CEE on Pulmonary Functions, Chest Expansion and Asthma Control in Asthma Patients
NCT Number: NCT06460857
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma
Interventions: OTHER: Manual Diaphragmatic Release Technique|OTHER: Chest Wall Expansion Exercises
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-08-01
Locations: Zohra Shafi Free Trust Hospital, Lahore, Punjab, 05466, Pakistan

Summary:
To determine the effects of manual diaphragmatic release technique (MDRT) versus chest wall expansion exercises on pulmonary function, chest wall expansion and asthma control in patients with asthma.

Primary Outcome Measures: Pulmonary Function, Changes from baseline Pulmonary function test will be measured through Digital SpirometerDigital Spirometer is a hand held device that measures Forced Expiratory Volume 1 (FEV1) in the first second patient exhale and Forced Vital Capacity (FVC)., 4th week|Chest Expansion, Changes from baseline Chest expansion is measured by using a measuring tape at 2 different levels of rib cage, upper chest expansion is measured at the third intercostal space at the level of clavicular line and spinous process of fifth thoracic vertebra. Lower chest expansion is measured at the tip of xiphoid process and the spinous process of tenth thoracic vertebra measurements will be taken at the end of deep inspiration and expiration., 4th week
Secondary Outcome Measures: Asthma Control Test, Changes from baseline will be measured through Asthma Control Test (ACT) is a questionnaire that consists of 5 questions on a scale from 1 to 5 of symptoms. The questions are about limitations due to asthma and symptoms in the past 4 week. A lower score then 19 corresponds with poor asthma control., 4th week|Modified Borg Scale, Changes from baseline will be measured through The modified Borg scale is an 11-point numerical scale rating the difficulty of breathing from "breathing is causing no difficulty at all" (zero point) to "breathing difficulty is maximal" (10 points)., 4th week
Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa Patients (ENVISION)
NCT Number: NCT06460844
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Retinitis Pigmentosa
Interventions: GENETIC: RTx-015
Sponsor: Ray Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-05
Locations: Retina Vitreous Associates Medical Group, Beverly Hills, California, 90211, United States|UCI Alpha Clinic, Orange, California, 92868, United States

Summary:
A Phase 1, open-label, non-randomized, dose-escalation study, where approximately 9 eligible patients with retinitis pigmentosa will be enrolled sequentially in up to 3 dose cohorts of RTx-015. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-015 in the study eye at Visit 3 (Day 0) and be followed for a total of 12 months.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events, The number of patients in each cohort with treatment-emergent adverse events categorized using MedDRA v24.0 or higher, 12 months
Secondary Outcome Measures: Best Corrected Visual Acuity (BCVA) at Month 6 and Month 12, Change from baseline to Month 6 and Month 12 after injection with RTx-015 in BCVA, 6 and 12 Months|Low Luminance Visual Acuity (LLVA) at Month 6 and Month 12, Change from baseline to Month 6 and Month 12 after injection with RTx-015 in LLVA, 6 and 12 Months|Multi luminance mobility at Month 6 and Month 12, Change from baseline to Month 6 and Month 12 after injection with RTx-015 in Visual Change from baseline to Month 6 and 12 in mobility performance at multiple luminance levels, 6 and 12 Months|Contrast Sensitivity at Month 6 and Month 12, Change from baseline to Month 6 and Month 12 after injection with RTx-015 in Contrast Sensitivity, 6 and 12 Months|Full-field static visual field testing at Month 6 and Month 12, Change from baseline to Month 6 and Month 12 after injection with RTx-015 in the total area in which objects can be seen, 6 and 12 Months|Low Vision Quality of Life at Month 6 and Month 12, Change from baseline in low vision quality of life at Month 6 and Month 12. An algorithm will be applied to assess a total score. Higher scores are a worsening of the condition., 6 and 12 Months
A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation
NCT Number: NCT06460831
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Atrial Flutter
Interventions: DEVICE: Microcatheter|DEVICE: OTW
Sponsor: Shanghai Chest Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2024-12-31
Locations: Shandong University of Traditional Chinese Medicine, Jinan, Shandong, 250000, China|Ren Ji Hospital, Shanghai, Shanghai, 200030, China|Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China|Yuhuan Second People's Hospital, Taizhou, Zhejiang, 318000, China|Changshu Hospital of Traditional Chinese Medical, Changshu, 215500, China

Summary:
The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to:

Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.

Primary Outcome Measures: Acute rate of mitral isthmus block, Efficacy endpoints, During catheter ablation procedures|Procedural complications, Safety endpoints, During catheter ablation procedures|Recovery rate of the mitral isthmus line, Long-term primary efficacy endpoints, beyond 3 months after the ablation procedure.
Secondary Outcome Measures: Procedural characteristics, Periprocedural period|Hospitalization costs, Periprocedural period
Surgical Sample Collection- Sampling During Uterine Surgery
NCT Number: NCT06460818
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Women's Health
Sponsor: PinkDx, Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-27
Completion Date: 2024-11-29
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.

Primary Outcome Measures: Number of participants with optimal vaginal samples obtained during the collection process, Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples., 9 months
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis
NCT Number: NCT06460805
Acronym: axSEND
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Axial Spondyloarthritis|Ankylosing Spondylitis|Inflammation|Dysbiosis|Arthritis|Spondylitis|Spondylarthritis|SpA|AxSpA
Interventions: DIETARY_SUPPLEMENT: Partial enteral nutrition
Sponsor: NHS Greater Glasgow and Clyde
Collaborators: University of Glasgow
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-25
Completion Date: 2025-08-01
Locations: NHS Greater Glasgow and Clyde, Glasgow, United Kingdom|University of Glasgow, Glasgow, United Kingdom

Summary:
People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients.

In this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.

Primary Outcome Measures: Change in faecal butyrate at 2 weeks on a PEN diet, 2 weeks
Ultrasound-guided Peripheral Nerve Blocks - a Database
NCT Number: NCT06460792
Acronym: Blockbase
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Regional Anesthesia
Interventions: PROCEDURE: Ultrasound-guided peripheral nerve block
Sponsor: Nordsjaellands Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-04
Completion Date: 2029-06-04
Locations: Dept of Anesthesiology, Nordsjællands Hospital, Hillerød, 3400, Denmark

Summary:
Peripheral nerve blocks are often used in anaesthesia. They can be used as the only method of anaesthesia during surgery or in combination with other methods, e.g., general anaesthesia and sedation. Moreover, peripheral nerve blocks are used to treat postoperative pain, alleviate pain in trauma patients, and for painful procedures.

For a method to be clinically useful, it is essential to understand the factors contributing to high success rates. It is equally important to know the complications related to the method. Finally, it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance. Therefore, we aim to establish a prospective and ongoing database to gain insight into 1) Factors contributing to block quality, e.g., success rate and nerve block duration; 2) Frequencies and types of nerve injuries and bleeding complications associated with the block procedure; 3) Tracking of block performance by anaesthesiologists.

Primary Outcome Measures: Block Success, Clinical evaluation of nerve function, 2 hours
Gross Motor Function and Living Skills in CP
NCT Number: NCT06460779
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-28
Completion Date: 2024-08-05
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
Cerebral palsy (CP) is non-progressive disorder, which undergoes mishap to the developing brain and it affects a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease".Through social and community participation, children and youth with cerebral palsy (CP) form friendships, gain knowledge, learn skills, express creativity, and determine meaning and purpose in life. The purpose of this study is (1) to determine whether social and community participation of children and youth with CP differ based on age, sex, and gross motor function, and (2) to identify the types of activities in which social and community participation are highest

Primary Outcome Measures: Washington Group Short Set of Disability Questions, The WG-SS is intended for use in censuses and surveys To maximize international comparability, the WG-SS obtains information on difficulties a person may have in undertaking basic functioning activities that apply to people in all cultures and societies and of all nationalities and so are universally applicable., 6 weeks|Child and Adolescent Scale of Participation, The CASP is a 20-items 4-scales parent-report instrument covering attendance and involvement in the areas "home", "community", "school", and "living activities"., 6 weeks|Communication Function Classification System, The CFCS is a tool used to classify the everyday communication of an individual with cerebral palsy into one of five levels according to effectiveness of communication. It consists of five levels which describe everyday communication ability, 6 weeks
Secondary Outcome Measures: WHODAS 2.0 participation in home and community in children with cerebral palsy, practical, generic assessment instrument that can measure health and disability at population level. It captures the level of functioning in 6 domains of life, 6 weeks
Validity and Reliability of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity Questionnaire
NCT Number: NCT06460766
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rheumatic Diseases|Pediatric ALL|Children, Only
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2024-10
Locations: Istanbul University-Cerrahpasa, Istanbul, Turkey

Summary:
No tool has been found to evaluate behaviors that may hinder or facilitate physical activity in individuals with pediatric rheumatic diseases. In this sense, the importance of examining physical activity barriers and facilitators in children with rheumatic diseases is clear. We believe that our study will guide the increase in physical activity, which is very important for reducing disease risks in individuals with pediatric rheumatic diseases. The aim of our study is to examine the validity and reliability of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire in individuals with pediatric rheumatic diseases (juvenile idiopathic arthritis, juvenile fibromyalgia syndrome, juvenile dermatomyositis).

Primary Outcome Measures: Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire (Time Frame: Change from baseline to 7 day), To assess the perceived facilitators and barriers of physical activity in patients with inflammatory arthritis, the IFAB Questionnaire, developed by Davergne et al. The IFAB consists of 10 items measuring factors that either encourage or hinder physical activity. The total score ranges from 70 to 70, a high score indicates a higher level of facilitators and/or a lower level of barriers. In our study, patient's perceived facilitators and barriers to physical activity will be evaluated with IFAB., Time Frame: Change from baseline to 7 day|Fear Avoidance Beliefs Questionnaire-Physical Activity (FABQ-PA), The fear-avoidance beliefs related to physical activity and work effects in low back pain were developed by Waddell et al. The physical activity section consists of 5 questions, with the first question not included in scoring. Each question is evaluated on a scale of 0-6, and patients can score a minimum of 0 and a maximum of 24 points. In our study, patient's fear avoidance beliefs will be evaluated with FABQ-PA., Baseline|Motivation Scale For Participation In Physical Activity (MSPPA), MSPPA was developed by Tekkursun Demir and Cicioglu. It was developed to assess children's motivation to participate in physical activity. The scale, which consists of 16 items, is in the 5-point Likert type. In our study, patient's motivations about physical activity will be evaluated with MSPPA., Baseline
Comb Effect of 4-7-8 Breathing Technique and Stationary Cycle on PP, QOL and Dyspnea in Post CABG Patients.
NCT Number: NCT06460740
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-cardiac Surgery
Interventions: OTHER: 4-7-8 breathing technique|OTHER: Stationary Cycling
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2024-07-01
Locations: Medicare Cardiac and General Hospital, Karachi, Sindh, 74800, Pakistan

Summary:
To determine the combined effects of 4-7-8 breathing technique and stationary cycle on physical performance, quality of life and dyspnea in post CABG patients.

Primary Outcome Measures: Physical Performance 6MWT, Changes from baseline The 6-minute walk test (6MWT) was developed by American Thoracic society and was officially introduced in 2002, coming along with a comprehensive guideline. The 6MWT is an easy, safe, reliable and simple cardiopulmonary sub maximal functional testing modality, used to assess functional capacity and to evaluate the cardiac and pulmonary rehabilitation treatment or intervention. (16) The individuals were requested to walk as far-off as they are able to on a smooth area for about 6 minutes. Individuals were permitted to take a rest or stop from walking if it was required then continue again as quick as they can. The distance covered by individuals for this test was measured in meters., 4th week
Secondary Outcome Measures: SF-36 Quality of Life Questionnaire version 2.0, Changes from baseline the 36 item Short-Form Survey (SF-36) is an outcome measure standardized structured questionnaire that is internationally and widely approved to evaluate the quality of life (QOL) of post CABG patients. The questionnaire was developed and used for collecting a data. The content validity was obtained from 7 experts. The questionnaire was found to be valid in assessing QOL. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales., 4th week|Modified Borg Dyspnea Scale, Changes from baseline Borg rate of perceived exertion (RPE) or Rate of perceived dyspnea (RPD) is an outcome measuring scale was developed by Swedish researcher Gunnar Borg in the 1998, allowing the individuals to rate their level of exertion during exercise subjectively American College of Sports Medicine (ACSM), 2010. It is proposed for all patients who underwent and going through Rehabilitation and endurance training as well as used in research. It scores from 0 to 10, using numeric values to rate how much effort an activity takes or to rate the difficulty of breathing. The zero point in a scale, indicates breathing is causing no difficulty at all or no exertion at all progressing through to ten point where breathing difficult is at maximum point., 4th week
Task Oriented Training on Static Versus Dynamic Surface on Balance in CP
NCT Number: NCT06460727
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: task oriented exercise training on dynamic surface|OTHER: task oriented exercise training on static surface
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-06-12
Completion Date: 2024-08-15
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement which are due to a non-progressive interference, lesion, or abnormality of the developing/immature brain . It is clinically categorized into four groups according to the predominant motor syndrome: extra-pyramidal or dys-kinetic, spastic quadriplegia and spastic diplegia. The purpose of this current study is to determine the effect of a selected task-oriented training on balance and functional mobility in children with cerebral palsy. This will be a randomized clinical trial, data will be collected from Elite Physio and Special children center from Faisalabad. Study will be conducted on 22 patients.

Inclusion criteria of this study is children who can walk with or without walking aids from age between 6 to 12 years old. Cerebral palsy children who has any musculoskeletal deformity in any of two limb, visual auditory, perceptual and auditory deficits, seizures or epilepsy , having botulinum toxin injections will be excluded.

Group A will be provided with task oriented exercise training on dynamic surface.

Group B will be provided with task oriented exercise training on static surface.Pre and post session balance and functional mobility will be assessed by Time up and Go scale and Functional Mobility scale.

Primary Outcome Measures: Functional Mobility scale, A child's functional mobility level in everyday life is defined by the FMS over a distance of 5 m, 50 m, and 500 m, which correspond to the home, school, and community settings, respectively. For each distance, an ordinal rating from 1 to 6 is assigned depending on the amount of assistance required for the child's mobility, 8 weeks|Time Up and Go Test:, Children with CP who are ambulatory will be evaluated for balance, anticipatory postural control, and functional mobility using the Timed Up and Go (TUG) test. It can distinguish between children with various CP subtypes and those at levels I-III of the Gross Motor.

Function Classification System (GMFCS) based on their performance. The TUG is a responsive and reliable test, 8 Weeks
Effects of Shockwave Therapy on Crouched Gait Due to Hamstring Flexibility in Cerebral Palsy Children
NCT Number: NCT06460714
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: Shock wave therapy, stretching and orthosis|OTHER: Stretching, strengthening and orthosis
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-04-05
Completion Date: 2024-07-10
Locations: Punjab Special School, Lahore, Punjab, Pakistan

Summary:
Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Assessment will be measured Pre and Post treatment by goniometer of crouched gait in standing and lying on couch. Crouched gait will be measured by Knee flexion in standing and lying. To measure hamstring flexibility ROM of knee extension is measured with 90 flexion at hip joint. Spasticity in this study will be assessed by GMFM-88 and modified Ashworth scale.

Primary Outcome Measures: Modified Ashwarth Scale, The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to evaluate muscle tone and spasticity in individuals with neurological conditions such as spastic cerebral palsy. It is a reliable and valid method for grading muscle resistance during passive movement. interrater reliability of AS and MAS varied from moderate to good. ICC scores of AS were between 0.54 and 0.78 and MAS were between 0.61-0.87. Test-retest results of AS and MAS varied from poor to good. ICC values were between 0.31 and 0.82 for AS and between 0.36 and 0.83 for MAS, 8 weeks|GMFM-88, The Gross Motor Function Measure-88 (GMFM-88) is widely used tool for assessing changes in gross motor function among children with cerebral palsy. It comprising 88 items across five domains. GMFM-A includes activities such as lying and rolling, GMFM-B includes sitting, Crawling and kneeling includes in GMFM-C, GMFM-D includes standing and walking, running and jumping includes in GMFM-E. The reliability of GMFM-88 is 0.75 to 1.0., 8 weeks|Goniometer, A goniometer is a measurement tool commonly used in rehabilitation and physical therapy to assess the range of motion (ROM) of various joints in the body. It consists of a stationary arm and a movable arm with a protractor-like scale, allowing for precise measurement of joint angles. By aligning the stationary arm with the joint's axis and the movable arm with the body segment, the goniometer provides objective measurements of joint flexibility, mobility, and muscle strength. The goniometer provides valuable quantitative data that can guide treatment planning, monitor patient progress, and assess functional outcomes related to joint movement and mobility., 8 weeks