pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Combined Effects of Active Cycle Breathing Technique and Buteyko Technique in Post Sternotomy Patients
NCT Number: NCT06476756
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sternotomy
Interventions: OTHER: ACTIVE CYCLE OF BREATHING TECHNIQUE|OTHER: Buteyko techniques
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-03-10
Completion Date: 2024-08-20
Locations: Gulab Devi teaching hospital, Lahore, Punjab, 54000, Pakistan

Summary:
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals. Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques.

Primary Outcome Measures: Borg dyspnea scale, The Borg RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity., base line and 4 week|BREATHLESSNESS, COUGH AND SPUTUM SCALE (BCSS), The BCSS is a three-item patient-reported questionnaire that rates sputum, cough, and dyspnea . This instrument can identify a disease aggravation with sensitivity and specificity., 4 weeks
Comparative Effects of Sensory Integration Therapy and Balance Board Training in Community Dwelling Older Adults
NCT Number: NCT06476743
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Geriatrics
Interventions: OTHER: Sensory Integration Therapy|OTHER: Balance Board Training
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: 2024-02-01
Completion Date: 2024-08-30
Locations: Al-Shifa Malik Hospital, Lahore, Punjab, 54000, Pakistan|Gosha e Shifa Hosital, Lahore, Punjab, 54000, Pakistan

Summary:
Balance plays a significant role in stability and walking and it's essential for improving the quality of life and functional autonomy while reducing the risk of falling. This research intends to shed light on the advantages of sensory integration therapy and balance board training because it is important to addressing the issues related to ageing and their possible effects.

Primary Outcome Measures: Berg Balance Scale, Berg balance scale is used to find and access the balance issues. This scale consists of 14 task which related to everyday life. Each function rates from 0 (worst) to 4 (best) along a dependence and independence sequence. In this test, we gradually reduce the base of support from sitting and standing to single-leg stance, assess a subject's capacity to sustain positions or movements of increasing difficulty. One's ability to change position is also evaluated, 8th week
Secondary Outcome Measures: Time up and go test, The TUG test measures the time, in seconds, taken by an individual to stand up from a standard arm chair, walk at their standard pace a distance of 3 meters, turn, walk back to the chair, and sit down. The TUG is widely used because it is reliable and it tests several important balance and mobility skills, including, sit-to-stand transitions, turning, and gait. Time less than 13.5 seconds indicate good mobility., 8th week|Fall risk assessment tool, The Johns Hopkins Fall Risk Assessment Tool (JHFRAT) is a tool that makes possible to implement a multi-factorial assessment of the risk of falling in a simple way, which requires an average of 5 min for its completion. The maximum score for this tool is 20. Score of 16-20 indicate high risk of fall, while the score between 5-10 indicate low risk of fall., 8th week|Functional Reach Test, Functional reach test is designed to assess the postural stability. During the test, the person stands next to a wall with their arm raised to 90 degrees. They then reach forward as far as possible without taking a step, while maintaining their balance. The distance reached is measured from the starting position to the fingertips at maximum reach.

A score of 6 or less indicate poor postural stability thereby increasing risk of fall.

A score greater than 10 indicates good postural stability and minimum risk of fall, 8th week
Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes
NCT Number: NCT06476730
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy|Gestational Diabetes|Maternal Psychological Distress
Interventions: OTHER: Telerehabilitation exercise program|OTHER: Routine medical care
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-02-28
Locations: Pakistan Railways Hospital, Rawalpindi, Punjab, 44000, Pakistan|AlKhidmat Razi Hospital,Rawalpindi, Rawalpindi, Punjab, 46000, Pakistan

Summary:
Gestational diabetes occurs when the body can't make enough insulin to manage high blood sugar during pregnancy, usually developing between the 24th and 28th weeks. It affects about 14% of pregnancies worldwide. Women with gestational diabetes often feel more anxious and stressed and have a higher risk of depression during and after pregnancy. This study will explore how telerehabilitation can reduce anxiety and depression and show how exercise can improve the health of pregnant women with gestational diabetes.

Primary Outcome Measures: Center of Epidemiologic studies depression scale (CES-D), The CES-DC is an inventory of 20 self-report items regarding depressive symptoms, taking about 5 minutes to completeIn scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology., changes from baseline to 8th week|Strait trait anxiety inventory (STAI), It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale.The total score ranges from 0-63.The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety., changes from baseline to 8th week
Secondary Outcome Measures: Time of delivery, Maternal delivery time in weeks will be noted., At the time of delivery|Mode of delivery, Mode of delivery either vaginal or c-section will be noted., At the time of delivery|Incidence of instrumental delivery, The incidence of instrumental delivery will be noted wither yes or no., At the time of delivery|Incidence of shoulder dystocia, The incidence of shoulder dystocia will be noted wither yes or no., At the time of delivery
Donor-derived Cell-free DNA in Kidney Transplant Recipients
NCT Number: NCT06476717
Acronym: DEFILE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Transplantation|Acute Rejection of Renal Transplant
Interventions: PROCEDURE: Biopsy|DIAGNOSTIC_TEST: Blood Biomarkers - cfDNA|DRUG: Antirejection therapy
Sponsor: Institute for Clinical and Experimental Medicine
Collaborators: Natera, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 143
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-10-21
Completion Date: 2024-12-12
Locations: Institute for Clinical and Experimental Medicine, Prague, 140 21, Czechia

Summary:
Donor-derived cell-free DNA (dd-cfDNA) is a promising non-invasive biomarker of kidney allograft rejection. In this prospective, single center, observational monitoring study, we aim to evaluate a role of dd-cfDNA in predicting kidney allograft injuries, i.e. rejection and non-rejection injuries within 12 months, and to monitor the effect of anti rejection treatment.

Primary Outcome Measures: dd-cfDNA, dd-cfDNA monitoring active rejection and other allograft injuries, 12 months|dd-cfDNA, Monitoring of effects of antirejection treatment, 4 weeks
Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas
NCT Number: NCT06476704
Acronym: PRACTISS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Sarcoma
Interventions: DRUG: Administration of L-TC|RADIATION: HFRT alone
Sponsor: Institut de cancérologie Strasbourg Europe
Collaborators: LEAF4Life, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2030-12-31
Locations: Institut de cancérologie Strasbourg Europe, Strasbourg, 67033, France

Summary:
This is phase II randomized, multicenter study of treatment with liposomal trasncrocetin (L-TC) and preoperative hypofractionated radiotherapy in patients who were aged 18 years or older with documented localised or locally advanced soft-tissue sarcoma of the extremity.

Primary Outcome Measures: Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy., Pathological complete response rate (pCR): defined as the presence of \< 10% residual malignant viable cells. Wardelmann et al. proposed pathological evaluation criteria, At surgery
Secondary Outcome Measures: Evaluation of the acute tolerance o f L-TC, Treatment-related adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, until 5 weeks|Evaluation of the late tolerance o f L-TC, Treatment-related adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, tourough study until 5 years|Evaluation of the necrosis, Median percentage pathologic necrosis on histologic examination, At surgery|Evaluation of the radiological response, Proportion of patients with a complete or partial radiological response (according to RECIST 1.1: Evaluated on MRI, until surgery|Proportion of patients with R0 resection, Number of patients with R0 resection on the number of enrolled patients, At surgery|Evaluation of the Overall Survival (OS), OS will be defined as the length of time from the date of diagnostic by biopsy to the date of death, Until 5 years|Evaluation of the Progression-Free Survival (PFS), PFS will be defined as the length of time from the date of diagnostic by biopsy to the date of relapse, Until 5 years|Evaluation of the Quality of Life (QoL), Use of the European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire (QLQ-C30), Until 5 years
Quality of Life in Young Patients Undergoing Bone Marrow Transplant
NCT Number: NCT06476691
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Quality of Life After Stem Cell Transplantation
Sponsor: Rigshospitalet, Denmark
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2029-10

Summary:
Young patients at the age of 18-29 years undergoing allo-HCT lack studies which specifically describe their unique problems. Validated EORTC QLQ-C30 questionnaires aimed at either children or adults have been used in international studies. But there has been a lack of a questionnaire design that can capture health-related quality of life after cancer treatment with greater relevance for the young patient. Together with young patients and hospital professionals quality of life-related health concerns and unique social and emotional problems were found that were more relevant to the young than to children and adults and validation of a new youth-relevant EORTC QLQ-AYA (AYA: adolescent and young adult) scheme that includes an extra focus on the youths problems has been carried out among young cancer patients. This questionnaire will be made available for testing in our patient population of allo-HCT patients and can for the first time map the quality of life of younger alloHCT patients.

This study includes two cohorts of patients. One is a retrospective/cross sectional study cohort of patients previously undergoing transplantant between 2010 and 2022, the other is a smaller prospective study examining the QoL before and after transplant.

The knowledge from the surveys will be important for health professionals understanding of the young peoples specific problems. Mapping and paying attention to the problems and possible solutions will be an essential component in helping the young allo-HCT patient.

The results will be correlated with clinical data: age, diagnosis, pretreatment with or without high-dose whole-body irradiation, and the nature and degree of late sequelae (survivor toxicity and rehabilitation)

Primary Outcome Measures: To investigate the quality of life in 18-29-year-old young people during and after alloHCT, Using validated questionaires, including a newly developed and validated specifically youth-oriented EORTC QLQ-AYA, In the prospective study each young person will be followed up with questionnaires before (approx. 3 weeks before alloHCT vs. the preliminary examination) and after alloHCT (+3 months, +½ year, +1 year, +2 years after alloHCT
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
NCT Number: NCT06476678
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Neoplasm|Esophageal Polyp|Endoscopic Submucosal Dissection|Bipolar Electrocautery
Interventions: DEVICE: Speedboat™ Ultraslim
Sponsor: Baylor College of Medicine
Collaborators: Creo Medical Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: Baylor College of Medicine, Houston, Texas, 77030, United States

Summary:
Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.

Primary Outcome Measures: Technical success, Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife, Day 1 (procedure day)
Secondary Outcome Measures: Speed of Endoscopic Submucosal Dissection, The speed of endoscopic submucosal dissection as calculated by cm\^2/hour, During Procedure|Number of instruments used, Logging the variable equipment utilized during the procedure, During Procedure|Rate of muscle injury score, As calculated by the Sydney Classification of Deep Mural Injury ranging from Type 0 - Type V with Type V as the most severe score., During Procedure|Rate of post-electrocautery syndrome, Define as post-procedure abdominal pain, fevers, leukocytosis, 24 hours, 2 weeks, and 4 weeks|Change in post-procedural pain score, As calculated by the visual analog pain scale to measure patient pain ranging from 0-10 with 10 being the most pain., 24 hours, 2 weeks, and 4 weeks|Rate of esophageal stricturing, Calculated by number of documented occurrences post-procedure for subjects, Assessed at any follow-up post-procedure endoscopies up to 6 months|Degree of scar formation, Scar formation that occurs in response to electrocautery, Assessed at any follow-up post-procedure endoscopies up to 6 months|Cost of dissection, As calculated upon review of devices used during dissection procedure, During Procedure
A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.
NCT Number: NCT06476665
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Lymphocytic Leukemia
Sponsor: Pfizer
Sex: ALL
Age: CHILD
Enrollment: 29
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-23
Completion Date: 2029-06-22

Summary:
The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. .

BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients. A type of leukemia (blood cancer) that comes on quickly and is fast growing. In acute lymphocytic leukemia, there are too many lymphoblasts (early-stage white blood cells) in the blood and bone marrow. Also called ALL.

The registration criteria for this study are:

* Never used BESPONSA before
* \<18 years at the start of treatment with BESPONSA

All patients in this study will receive BESPONSA according to the prescriptions.

Patients will be followed up as follow.

* Treatment phase: From the day of treatment initiation (Day 1) to Day 28 post-treatment to collect information on safety (e.g., adverse events).
* Follow-up phase: From Day 29 post-treatment to Week 52 to collect information on VOD/SOS.

Primary Outcome Measures: Occurrence of adverse events, Up to 28 days after the last administration|Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome, Up to 52 weeks
Effect of Simple Simulator-based Training on Initial Performance of Novices Iultrasound-guided Adductor Canal Block
NCT Number: NCT06476652
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Anesthesia
Sponsor: Prince of Songkla University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla, 90110, Thailand

Summary:
This prospective descriptive study is effect of simple simulator-based training on initial performance of novices in ultrasound-guided adductor canal block. The main question is Can we improve performance on simple simultor-based training ultrasound-guide adductor canal block?. We evaluate in First-year residents in Anesthesiology, Faculty of medicine, PSU.

Primary Outcome Measures: The efficiency of using a simple model for injecting local anesthesia through the adductor canal under ultrasound guidance assessed by Design and Validation Regional Anaesthesia Procedural skill Assessment tool, To study the efficiency of using a simple model for injecting local anesthesia through the adductor canal under ultrasound by 1st year anesthesia residentassessed by Design and Validation Regional Anaesthesia Procedural skill Assessment tool, 1 year
Secondary Outcome Measures: satisfaction and confidence in teaching assessed by pre- and post-test, satisfaction questions, To study satisfaction and confidence in teaching by using a simple simulator for injecting regional anesthesia through the adductor canal under ultrasound guidance by anesthesiology resident with no prior experience assessed by pre- and post-test, satisfaction question, 1 year
Permissive Hypotension After Cardiac Surgery
NCT Number: NCT06476613
Acronym: PHACS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery
Interventions: OTHER: Permissive Hypotension
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-20
Completion Date: 2026-03-01
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
The objective of this pilot randomized controlled trial is to demonstrate the feasibility of implementing a pragmatic clinical trial randomizing patients to permissive hypotension versus usual care and to determine the impact of permissive hypotension on vasopressor exposure, ICU length of stay, markers of end organ perfusion, and clinically relevant patient outcomes. The data collected from this pilot study will be used as preliminary data for study design and grant applications for a larger multicenter randomized controlled trial.

Primary Outcome Measures: MAP in mmHg, (Mean arterial pressure) measured in millimetres of mercury, Through study completion, an average of 2 to 3 days|Vasoactive-Inotropic Score for duration of pressor need, Weighted sum of all administered vasopressor and inotropic medications and quantifies the amount of pharmacological support in patients, Through study completion, an average of 2 to 3 days
Secondary Outcome Measures: ICU and hospital length of stay, Total ICU and hospital length of stay following cardiac surgery, Through study completion, an average of a week|Duration of inotrope and vasopressor exposure, Total duration of inotrope and vasopressor support required, Through study completion, an average of 2 to 3 days|Duration of end organ support, Total duration for end organ support, Through study completion, an average of 2 to 3 days|Mortality, Occurrence of death during study intervention, Through study completion, an average of a week|Cognitive function assessed using Montreal Cognitive Assessment (MOCA), Brief screening instrument for cognitive function, Through study completion, an average of a week|Tissue perfusion pressure via continuous arterial waveform monitoring, Hemodynamic monitoring to ensure optimal tissue perfusion and oxygen delivery, Through study completion, an average of 2 to 3 days
Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors
NCT Number: NCT06476548
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: BEHAVIORAL: EMI
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-12
Completion Date: 2026-07
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States

Summary:
The purpose of the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed.

Primary Outcome Measures: Open-ended feedback, Participants' feedback will be collected using an open-ended question asking for feedback on the study app., At 4 weeks|Utility of mindfulness practices, Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful)., At 4 weeks|Likability of mindfulness practices, Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like)., At 4 weeks|Retention rate, We will assess the number of participants who complete the end-of-treatment survey., At 4 weeks
Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy
NCT Number: NCT06476535
Acronym: OPIUM
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myeloproliferative Neoplasm|Inflammatory Disease
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-11
Completion Date: 2026-05-31
Locations: Chu Brest, Brest, 29609, France

Summary:
The study will collect cases of MPN patients who also benefit from an anti-inflammatory immunotherapy for another disease. Efficacy and tolerability of the drug will be assessed in this population.

Primary Outcome Measures: Efficacy of the anti-inflammatory immunotherapy, Depending on the indication of the anti-inflammatory treatment, clinical efficacy will be assessed clinically as number of patients reaching complete (total disappearance of initial symptoms- diarrhea, arthritis, fever, skin lesions), partial (improvement of symptoms, but not total disappearance) or absence of response (the treatment did not improve the symptoms). Clinical judgement will be according to the physician appreciation., 1 year|Tolerability of the anti-inflammatory immunotherapy, Tolerability will be assessed as the number of reported unexpected side effects attributed to the treatment as judged by the caring physician, including treatment discontinuation, 1 year
A Study to Assess Serotonin Transporter Occupancy of Healthy Adults Using 11C-DASB PET
NCT Number: NCT06476509
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Major Depressive Disorder
Interventions: DRUG: LV232 40mg|DRUG: Escitalopram 20 mg
Sponsor: Vigonvita Life Sciences
Sex: ALL
Age: ADULT
Enrollment: 8
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-10-01

Summary:
This study was a non-randomized, open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography (PET)

Primary Outcome Measures: Serotonin Transporters occupancy, Percentage of Serotonin Transporters Occupancy in Human Brain after oral LV232 capsule, baseline and 3 hours after administration on Day 1
Secondary Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs)., Incidence of treatment-emergent adverse events (TEAEs), Up to Day 7
Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID
NCT Number: NCT06476496
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long COVID|Pain
Interventions: PROCEDURE: Acupuncture
Sponsor: University of Washington
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2025-06-01
Locations: UW Medicine Primary Care at Northgate, Seattle, Washington, 98125, United States

Summary:
The goal of this preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with long COVID. Researchers will compare pain intensity and impact on general activities over 5 months in those who receive acupuncture treatment compared to patients who are receiving usual long COVID care.

Participants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveys include validated mental and physical health questionnaires. Participants who are randomly selected to receive the intervention will receive 8 acupuncture treatment sessions.

Primary Outcome Measures: Pain, Enjoyment and General Activity (PEG), A pain-related predictor is an easily-understood three-question instrument that asks about average pain, enjoyment of life, and general activity in the past week on a 0 to 10 scale., Weeks 0, 4, 8, 20
Secondary Outcome Measures: Pain Catastrophizing Scale (PCS), A self-report measure of catastrophic thinking related to pain, including subscales of rumination, magnification, and helplessness., Weeks 0, 8, 20|PROMIS-29, A questionnaire covering 7 domains (anxiety, sleep, depression, physical function, pain intensity, social roles, and fatigue) of mental and physical health., Weeks 0, 8, 20|PROMIS Cognitive Function, Assesses patient-perceived cognitive deficits. Facets include mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in cognitive functions., Weeks 0, 8, 20|UW Pain Related Self-Efficacy Scale (PRSE), A measure self-efficacy. Expectation for recovery is measured using an 11-point numerical rating scale (0=no confidence in recovery, 10=complete confidence in recovery) using the question: "How confident are you that your pain will be completely gone or much better 3 months from now?", Weeks 0, 8, 20
Taiwan Interstitial Lung Disease Multi-center Investigation and Registry
NCT Number: NCT06476470
Acronym: TAILI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Interstitial Lung Disease|Comorbidities and Coexisting Conditions|Pulmonary Arterial Hypertension|Treatment Adherence|Function Impaired Respiratory
Sponsor: Taichung Veterans General Hospital
Collaborators: Tri-Service General Hospital|E-DA Hospital|Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-10
Completion Date: 2035-12-31
Locations: Taichung Veterans General Hospital, Taichung, 40705, Taiwan

Summary:
The Taiwan Interstitial Lung Disease (ILD) Multi-center Investigation and Registry aims to evaluate the long-term outcomes of patients with fibrotic interstitial lung disease. This prospective observational registry will collect comprehensive clinical data from multiple centers, including epidemiological information, comorbidities, questionnaire results, routine blood tests, biochemical tests, pulmonary function tests, echocardiograms, and cardiopulmonary exercise tests (CPET), all following a standardized protocol.

Key components of the registry include annual HRCT scans, annual CPETs, biobank blood samples, and biannual echocardiograms and pulmonary function tests.

The main questions the registry aims to answer are:

1. Differences in all-cause mortality among ILD patients of different etiologies.
2. Differences in the annual risk of acute exacerbation among ILD patients of different etiologies.
3. Effectiveness of current anti-fibrotic drugs in treating IPF and ILD of different etiologies.
4. Predictive ability of HRCT imaging features for mortality risk in ILD patients.
5. Impact of comorbidities on the mortality risk of ILD patients.
6. Predictive ability of biomarkers for disease progression and mortality.

Primary Outcome Measures: All-cause mortality, All-cause mortality of the enrolled patients from enrollment to the death event, 10 years|Annual rate of acute exacerbation, The event of visiting the emergency room or being hospitalized will be recorded, through study completion, an average of 1 year
Secondary Outcome Measures: Annual rate of progressive pulmonary fibrosis, By the definition according to ATS 2022 guideline, including symptoms worsening, Lung function declined (FVC decreased more than 5 % or DLCO decreased more than 10% within one year) and the image pattern showed progression on HRCT scan, From date of enrolled until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Use of Facilitated STAIR Coach in Kenya
NCT Number: NCT06476457
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Facilatated STAIR Coach
Interventions: BEHAVIORAL: STAIR Coach
Sponsor: Harvard Medical School (HMS and HSDM)
Collaborators: Aga Khan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-12-01
Completion Date: 2025-12-31

Summary:
The specific aim of this project is to examine the feasibility of using a low cost, low intensity, mobile app-based intervention teaching emotion regulation and interpersonal skills to improve general well-being for those with probable post-traumatic stress disorder (PTSD) in Kenyan clinics.

Primary Outcome Measures: PTSD Checklist for the DSM-5 (PCL-5), The PCL is an 18-item measure assessing symptions of post-trauamatic stress disorder. Higher scores indicate higher levels of trauma related symptoms., pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up|Patient Health Questionnaire (PHQ-9), The PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms., pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Secondary Outcome Measures: Patient Health Questionnaire (PHQ-9), The PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms., pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Association of Sedentary Behaviour and Habitual Diet With Resting Fat Oxidation in Women With Overweight and Obesity
NCT Number: NCT06476444
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Obesity|Healthy
Sponsor: Hacettepe University
Sex: FEMALE
Age: ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-06-10
Locations: Hacettepe University, Ankara, 06100, Turkey

Summary:
The aim of this study is to investigate the relationship between physical activity levels, dietary patterns with fat oxidation at rest in normal lean individuals and those with overweight and obese.

Primary Outcome Measures: Resting fat oxidation, In order to determine the relationship of dietary habits and habitual physical activity levels with resting fat oxidation in healthy overweight, obese and normal weight individuals, resting fat oxidation measurements will be performed with a indirect calorimetry (Cardio Pulmonary Exercise Testing, Quark CPET, Italy).All resting fat oxidation tests will be conducted in the same quiet room under a controlled ambient temperature (22-24 °C) and humidity (35-45%). Subjects will be instructed to arrive at the laboratory at 8 a.m. by car or by bus (avoiding any physical activity after waking up) and having fasted for at least 10-12 hours. In addition to this, they will be advised to avoid any moderate physical activity for the 24 h before the test day or any vigorous intensity exercise in the prior 48 h., From July 2024 to October 2024|The relationship between habitual physical activity level and sedentary behaviour with resting fat oxidation, Participants' habitual physical activity and sedentary behaviour will be measured with an accelerometer (Actigraph, USA) for 4 consecutive days to determine the relationship with resting fat oxidation., July 2024- October 2024|Dietary pattern and fat oxidation, In order to determine the relationship of macronutrient intake and food group consumption with resting fat oxidation, 4-day food consumption records will be obtained from the participants., July 2024- October 2024
The Effect of Distraction During Blood Collection on the Fear and Anxiety Levels of Children
NCT Number: NCT06476418
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fear Anxiety
Interventions: BEHAVIORAL: distraction
Sponsor: Ataturk University
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-03
Completion Date: 2025-12-06
Locations: Ataturk University Nursing of Faculty, Erzurum, 25240, Turkey

Summary:
The project is a randomized controlled trial. The population of the research will consist of children aged 4-6 years old who applied to Erzincan Mengücek Gazi Training and Research Hospital Pediatric Blood Collection Unit between June 2024 and June 2025. The sample of the research will consist of children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research. "Survey Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used to collect data.

Primary Outcome Measures: Child Fear Scale, The scale was developed to measure fear in children undergoing painful medical procedures. The scale is a 0-4 scale showing five faces ranging from a neutral expression (0 = no concern) to a fearful face (4 = severe concern)., 6 months|Child Anxiety Scale - State, The Children's Anxiety Scale State (CAS-D) scale, which resembles a thermometer with horizontal lines, is scored as 0-10. It is a scale developed for children aged 4-10. When introducing the scale to the child, it is said that there is no anxiety, that the anxiety increases as it goes up, and that the anxiety level is very high at the top. The child is then asked to put a line on the part that shows how anxious or angry he or she is., 6 months
Can the Origin of Sperm Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?
NCT Number: NCT06476379
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Male Infertility
Interventions: PROCEDURE: Testicular sperm extraction (TESE)|OTHER: Ejaculate
Sponsor: Ganin Fertility Center
Sex: ALL
Age: ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2025-06-30
Locations: Ganin Fertility Center, Cairo, Maadi, 11728, Egypt

Summary:
There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. This comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (ICSI), specifically focusing on severe male factor infertility patients.

Primary Outcome Measures: Euploidy rate, Defined as the proportion of euploid blastocysts, 15 days post ICSI|Aneuploidy rate, Defined as the proportion of aneuploid blastocysts, 15 days post ICSI|Low mosaic rate, Defined as the proportion of low mosaic blastocysts, Time Frame: 15 days post ICSI|High mosaic rate, Defined as the proportion of high mosaic blastocysts, Time Frame: 15 days post ICSI|Pregnancy rate, defined as the presence of a fetal heartbeat or gestational sac 6-9 weeks post-embryo transfer, 6-9 weeks post-embryo transfer|Implantation rate, defined as the percentage of successfully implanted embryos, 6-9 weeks post-embryo transfer|Ongoing pregnancy rate, defined as a positive heartbeat on ultrasound beyond 12 weeks of gestation, 12 weeks of gestation|Miscarriage rate, defined as pregnancy loss following confirmation of clinical pregnancy, after 6 weeks of gestation
Secondary Outcome Measures: Fertilization rate, Defined as the proportion of fertilizaed oocytes, 1 day|Cleavage rate, Defined as the proportion of cleaved embryos on day 3, 3 days|Blastocyst development rate, Defined as the proportion of blastocysts formed on day 5 or 6, 5-6 days
Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial
NCT Number: NCT06476366
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Chronic Actinic Dermatitis
Interventions: DRUG: Azathioprine|DRUG: Methotrexate
Sponsor: Pak Emirates Military Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-14
Completion Date: 2025-07-30
Locations: Pak Emirates Military Hospital, Rawalpindi, Punjab, Pakistan

Summary:
The aim of this study is to evaluate the efficacy and safety of AZT and MTX in patients with Chronic Actinic Dermatitis (CAD). These drugs have been used successfully as steroid-sparing alternatives in a variety of related dermatoses and this trial may help in paving the path towards the ubiquitous use of these cost-effective and relatively safer drugs in CAD patients of our population. The researchers will try to answer the following questions:

1. Is methotrexate safe and efficacious in treating CAD?
2. Is there a difference in efficacy of methotrexate and azathioprine in the treatment of this disease?

After the enrollment of patients and taking consent, participants will be divided in two treatment groups via lottery method. Group A will be administered oral methotrexate 10mg/week after a test dose while group B will be administered tablet azathioprine at a dose of 0.3mg/kg daily after. Both group of patients will be advised regarding strict sun protection measures (sunblock, hats, sunglasses etc.). The baseline investigations for both groups will include complete blood picture (CBC), liver function tests (LFTs), renal function tests (RFTs), electrocardiogram, chest X-ray and urine analysis while thiopurine methyltransferase (TPMT) levels will be assessed specifically for group B patients. The patients will be followed up at week 4, 12 and 24. CBC, RFTs and LFTs will be done at each follow-up and EASI score will be calculated,

Primary Outcome Measures: EASI-50, A reduction of 50% in the Eczema Area and Severity Index score as compared to baseline score (EASI-50), 6 months
Secondary Outcome Measures: An IGA score of 0-2, Investigator global assessment (IGA) is a subjective measure of disease severity which is assessed by the physician on patient's visit. It ranges from 0 to 4 (0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe), 6 months
Syringe Pressure Analysis: A Critical Examination of the Operator's Burden
NCT Number: NCT06476353
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Back Pain Lower Back Chronic
Interventions: OTHER: Analysis of Force and Pressure Requirements across Syringe Sizes for Pain Management Procedures
Sponsor: Orthospine Advance Health, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-10-01
Completion Date: 2024-05-15
Locations: University Surgery Center, Merced, California, 95340, United States

Summary:
This was a randomized prospective clinical trial conducted from October 1, 2023, to May 15, 2024, at the University Surgery Center in Merced, CA. The project was approved by the MetroWest Medical Center Institutional Review Board (IRB). Patients in each procedure group were categorized into groups and randomly distributed into four sub-groups based on the syringe size used (5ml, 10ml, 20ml, 30ml). A medical grade force sensor device was used to collect the necessary real-time syringe force data. An analysis of variance (ANOVA), and pairwise t test were used to make comparisons between means and determine statistical significance.

Primary Outcome Measures: Measurement of Compression Force in Newtons from Syringe Plunging, Our goal is to measure the different pressures required to administer fluid from various syringe sizes, including 5 ml, 10 ml, 20 ml, and 30 ml syringes across different pain management procedures such as sacroiliac joints, transforaminal epidural space, medial branch blocks, and radiofrequency ablation for comprehensive measurement analysis., During Pain Management Procedure (During Injection, 2-5 Minutes)
Secondary Outcome Measures: Measurement ofPressure in Pascals from Syringe Plunging, Our goal is to measure the different pressures required to administer fluid during different pain management procedures such as sacroiliac joints, transforaminal epidural space, medial branch blocks, and radiofrequency ablation for comprehensive measurement analysis., During Pain Management Procedure (During Injection, 2-5 Minutes)
Robot-Assisted Gait Training With Self-Observation in Stroke Rehabilitation
NCT Number: NCT06476327
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: BEHAVIORAL: experimental 1 group|BEHAVIORAL: experimental 2 group
Sponsor: Sahmyook University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-10
Locations: Chungdam hospital, Seoul, Gangnam-gu, 06063, Korea, Republic of

Summary:
The aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. The main question it aims to answer is:

Does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants?

Participants will be

Group 1 Perform robot-assisted gait training combined with self-observation five times a week for four weeks.

Group 2 Perform robot-assisted gait training five times a week for four weeks.

All groups perform for 30 minutes per session.

Primary Outcome Measures: Balance ability, - Timed up and go test (TUG)

Participants sit on a chair with armrests, rise upon hearing a starting signal, walk 3 meters, return, and sit back down. The speed of this task is measured. Participants may use usual walking aids (cane or walker) but should not receive physical assistance.

- Functional Reach Test (FRT)

Participants stand against a wall with feet fixed vertically, arms raised to 90 degrees, reaching forward as far as possible while measuring the distance (in cm) from the tip of the third metacarpal bone., from enrollment to the end of treatment at 4 weeks|Gait ability, -10 meter walking test (10MWT)

The walking speed is calculated by measuring the time (in seconds) takes for the subject to walk 10 meters. Instructed to walk a total of 14 meters at maximum speed, excluding the first 2 meters and the last 2 meters to account for acceleration and deceleration phases. Participants may use personal walking aids (cane, walker, etc.).

-GAITRite system (CIR Systems Inc., Franklin, New Jersey, USA)

Participants pass over an electronic gait mat to computationally measure temporal and spatial walking variables., from enrollment to the end of treatment at 4 weeks
Secondary Outcome Measures: Cognitive ability, - Mini-Mental Status Examination-Korea, (MMSE-K)

Consists of memory, recall ability, attention, language skills, numerical ability, and constructional ability.

Memory has 10 points, registration has 3 points, attention and calculation have 5 points, recall has 3 points, language function has 7 points, and comprehension and judgment have 2 points, totaling six areas and twelve items, from enrollment to the end of treatment at 4 weeks