pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.
NCT Number: NCT06479668
Acronym: SOM-EMO-TND
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Attention Deficit Disorder With or Without Hyperactivity (ADHD)|Autism Spectrum Disorder (ASD)
Interventions: BEHAVIORAL: Trier Social Stress Task
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2027-07-01

Summary:
The aim of this protocol is to disentangle the links between symptoms of emotion dysregulation, sleep disorders and cognitive deficits by measuring the effects of an emotional induction task on childrens' sleep with autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD).

Primary Outcome Measures: change micro-awakening index, polysomnography, At Day 0 and Day 3
Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
NCT Number: NCT06479655
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Effect of Drug
Interventions: DRUG: Fentanyl|DRUG: Morphine
Sponsor: Universiti Sains Malaysia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2025-09-30
Locations: Mohd Zulfakar Mazlan, MBBS, Kota Bharu, Kelantan, 16150, Malaysia

Summary:
The primary aim of this clinical trial is to compare the effectiveness of fentanyl vs morphine as analgosedation in mechanically ventilated adult patients in the ICU. This study also aims to compare the outcomes of patients between the two groups.

The main questions it aims to answer are :

1. Does propofol and fentanyl infusion as analgo-sedation achieve targeted sedation score at 12 and 24 hours compared to propofol and morphine infusion in mechanically ventilated adult patients in the intensive care unit (ICU)?
2. Is there a difference between the proportion of patients requiring rescue sedation dose between the fentanyl and morphine groups?

Primary Outcome Measures: RASS score at 12 and 24 hours, To determine the proportion of patients achieving the targeted sedation guided by RASS score at 12 and 24 hours in both fentanyl and morphine group., 24 hours from study drug initiation|Rescue sedation doses, To determine the proportion of patients requiring rescue sedation doses between fentanyl and morphine group, 24 hours from study drug initiation
Secondary Outcome Measures: Duration of mechanical ventilation, To compare the duration of mechanical ventilation between the fentanyl and morphine groups, 90 Days|Length of ICU stay, To compare the length of ICU stay between the fentanyl and morphine groups, 90 days|14 days mortality rate, To compare 14-day mortality rates between the fentanyl and morphine groups, 14 days from randomization
A Long-term Follow-up Study in Participants Who Received CS-101
NCT Number: NCT06479616
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Beta-Thalassemia
Interventions: GENETIC: CS-101
Sponsor: Children's Hospital of Fudan University
Sex: ALL
Age: CHILD
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-18
Completion Date: 2027-06
Locations: Children's Hospital of Fudan University, Shanghai, Shanghai, 201102, China

Summary:
This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 (NCT06065189)

Primary Outcome Measures: Frequency and severity of SAEs and CS-101 related AES as assessed by CTCAE v5.0, CommonTerminology Criteria for Adverse Events（CTCAE）has 5 levels of AE determination, increasing in severity as the level increases, Signing of informed consent up to 2 years post CS-101 infusion|Occurrence of all-cause death, Signing of informed consent up to 2 years post CS-101 infusion|New malignancies and hematologic disorders, Based on ICD-11, Signing of informed consent up to 2 years post CS-101 infusion|Occurrence of achieving transfusion independence for at least 12 consecutive months, From 3 months after last RBC transfusion up to 2 years post CS-101 infusion
Secondary Outcome Measures: Change in fetal hemoglobin(HbF) concentration over time, up to 2 years post-CS-101 infusion|Change in total hemoglobin(Hb) concentration over time, up to 2 years post-CS-101 infusion|Chimerism level in Peripheral blood and bone marrow Proportion of alleles with intended genetic modification in peripheral blood leukocytes and bone marrow over time, Proportion of alleles with intended genetic modification in peripheral blood leukocytes and bone marrow over time, up to 2 years post-CS-101 infusion
US & HILT Comparative Effect on Neuropathic Pain, Strength & QOF in Diabetic Foot
NCT Number: NCT06479577
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot|Diabetic Neuropathies
Interventions: OTHER: ultrasound|OTHER: high intensity laser therapy
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-02-01
Completion Date: 2024-07-01
Locations: Bahawalpur medical and dental hospital, Bahawalpur, Punjab, 63100, Pakistan

Summary:
To compare the effects of therapeutic ultrasound and high intensity laser therapy on neuropathic pain , strength and quality of life in patients with diabetic foot

Primary Outcome Measures: michigan neuropathy screening instrument, MNSI is designed to screen for the presence of diabetic neuropathy the first part consist of 15 self administered questions on foot sensations ,pain ,numbness etc second part is brief physical examination of feet, 8th week|foot and ankle disability index, FADI is designed to assess functional limitations related to foot and ankle conditions it has 26 items each item scored from 0 -4 FADI has totel 104 points, 8th week
Effects of Free Weight and Machine Training With and Without Aerobic Training Among Body Builders
NCT Number: NCT06479564
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sports Physical Therapy
Interventions: OTHER: free weight training and machine training|OTHER: Aerobic Exercises
Sponsor: Riphah International University
Sex: MALE
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-11-23
Completion Date: 2024-05-30
Locations: Pakistan Sports Academy, Lahore, Pakistan

Summary:
Effects of free weight and machine training with and without aerobic training among body builders.

Primary Outcome Measures: 1 Repetition Maximum, A 1 Repetition Maximum (1 RM) test is a commonly used method in the fitness and strength training realm to assess an individual's maximum strength for a specific exercise. (18) The test involves determining the maximum amount of weight a person can lift for a single repetition of a given exercise., 8 weeks|Yo-Yo test, The 20-meter multistage shuttle test, also known as the "Beep Test" or "Yo-Yo Test," is a commonly used aerobic fitness test. (20)The test involves continuous running between two lines 20 meters apart in response to audio signals. . If a participant fails to reach the line before the beep, they are given a warning. After a second warning, the test is concluded, and the level reached is recorded., 8 weeks|Muscle Mass, Measuring muscle size using an inches tape, also known as a tailor's tape or a body tape measure, is a simple and effective way to track changes in muscle size and monitor your fitness progress, 8 weeks
Caval-aorta Index and Perfusion Index on Predict Hypotension After Spinal Anaesthesia in Elderly
NCT Number: NCT06479512
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia, Spinal
Interventions: DEVICE: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-06-01
Locations: Ankara Bilkent City Hospital, Ankara, Ankara, Çankaya, Turkey, 06800, 06800, Turkey

Summary:
The aim of our study was to predict hypotension by using caval aorta index and perfusion index in elderly patients who may develop hypotension after spinal anesthesia.

Primary Outcome Measures: caval aorta index for predicting hypotension in the elderly, to determine the threshold value for the caval aorta index in determining hypotension using logistic regression analysis, 1 hour
Secondary Outcome Measures: perfusion index for predicting hypotension in the elderly, to determine the threshold value for baseline perfusion index in determining hypotension using logistic regression analysis, 1 hour|systolic blood pressure, recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation, 1 hour|diastolic blood pressure, recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation, 1 hour|mean arterial pressure, recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation, 1 hour|hearth rate, recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation, 1 hour|perfusion index, recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation, 1 hour|oxygen saturation, recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation, 1 hour|bromage scale motor blocage score, bromage scale score is a score between 0 and 3. bromage 0 means full movement of the leg and knee, bromage 3 means full motor blockade of the legs. the time to reach bromage 3 will be recorded, 1 hour|T10 dermatome, time to reach T10 dermatome level, 1 hour|dermatomal level, the highest dermatome level achieved with spinal anesthesia, 1 hour|use ephedrine, dose of ephedrine used, 1 hour
Effects of Pilate Versus Aerobic Exercises on Dyspnea , Functional Capacity and Anxiety Status in Patients With COPD
NCT Number: NCT06479499
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD Patients
Interventions: OTHER: Pilates Exercises|OTHER: Aerobic Exercises
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-23
Completion Date: 2024-06-18
Locations: Riphah international university, Lahore, Punjab, 54000, Pakistan

Summary:
This study aims to compare the effects of Pilates, with its emphasis on proper breathing and muscle activation, and aerobic exercises, known for improving cardiovascular fitness, on dyspnea, anxiety, and functional capacity in COPD patients.

Primary Outcome Measures: Dyspnea, The modified Medical Research Council scale (mMRC scale) is largely used in the assessment of dyspnea in chronic respiratory diseases. The mMRC scale is a 5-point (0-4) scale based on the severity of dyspnea. It is a quantitative assessment tool only for breathlessness. It assesses the effectiveness of treatment on an individual bass. Compare the effectiveness of a treatment within a population and Predict survival times and rates., 8th weeks|Functional Capacity, In the context of COPD functional capacity refers to a person's ability to perform daily activities and exercise without experiencing excessive shortness of breath or fatigue. It is an important measure to assess the function of a person with COPD therefore in present study it will be assessed by 6 minutes' walk distance., 8th weeks|Anxiety, The Self rating anxiety scale is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms. Answering the statements, a person should indicate how much each statement applies to him or her within a period of one or two weeks prior to taking the test. Each question is scored on a Likert-type scale of 1-4 (based on these replies: "a little of the time", "some of the time", "good part of the time", "most of the time"). Some questions are negatively worded to avoid the problem of set response. Overall assessment is done by total score., 8th weeks
Clinimetric Properties of Performance-based Measures of Physical Function in Patients With COPD
NCT Number: NCT06479486
Acronym: COPD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: DIAGNOSTIC_TEST: Assigned Interventions
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-12
Locations: Hearts International Hospital, Islamabad, AL, 44000, Pakistan

Summary:
A COPD (Chronic obstructive pulmonary disease), is a group of progressive lung diseases. COPD is a preventable and treatable respiratory disorder largely caused by smoking and long term exposure to chemical irritants. This study aims to provide essential insights into the reliability, validity, responsiveness and Interpretability of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols.

Primary Outcome Measures: 6MWT (Six-Minute Walk Test), A six-minute walk test to assess your fitness or functional condition. Using a pulse oximeter, the researchers will take your blood pressure, pulse, and oxygen saturation before you start walking. The following instructions will be given to participants. The competitors will walk as close to a chair or cone as they can for six minutes at their regular pace. After that, they will turn around and continue walking back and forth for an additional six minutes. It was shown that this test had good test-retest reliability., 6 week|2MWT (Two-Minute Walk Test), The 2MWT is a functional exercise test designed to evaluate an individual's aerobic capacity and endurance over a shorter duration compared to the 6MWT., 6 week|Timed Up and GO (TUG), It is designed to assess an individual's mobility and requires the participant to stand up from a seated position, walk a distance of three meters, turn around, walk back to the chair, and sit down., 6 week|30 seconds sit to stand test (30SSTS):, Used to assess lower extremity strength, balance, and functional capacity in patients with chronic obstructive pulmonary disease (COPD). It involves measuring the number of times a patient can rise from a seated position to a full standing position and then return to sitting within a 30-second period. The test is typically conducted in a chair with a standardized height and armrest comapred TUG test, 6 week
Radiotherapy to All Residual Lesions After Chemoimmunotherapy
NCT Number: NCT06479473
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Extensive-stage Small Cell Lung Cancer
Interventions: RADIATION: Radiotherapy to all residual lesions|DRUG: Chemoimmunotherapy
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-03-31
Locations: Anhui Provincial Hospital, Hefei, Anhui, 230011, China

Summary:
Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis. First-line chemotherapy could only achieve an overall survival of approximately 10 months. CREST study demonstrated that the addition of thoracic radiotherapy to the patients who responded to chemotherapy could increase the 2-year survival rate from 3% to 13%. CASPIAN and IMpower 133 trials have established the standard modality of first-line chemoimmunotherapy for extensive-stage small-cell lung cancer and prolonged the overall survival to 13 months. Both the addition of thoracic radiotherapy and immunotherapy to chemotherapy were able to improve the survival. Recently, several retrospective studies have demonstrated the effectiveness and safety of the combination of thoracic radiotherapy and chemoimmunotherapy. In a prospective study, 4-6 cycles of first-line chemotherapy with Adebrelimab followed by thoracic radiotherapy achieved the progression-free survival of 10.1 months and overall survival of 21.4 months, which was longer than chemoimmunotherapy. Another study demonstrated not only thoracic radiotherapy, but also radiotherapy to metastatic lesions could ameliorate survival. Therefore, we supposed that whether radiotherapy to all residual lesions after first-line chemoimmunotherapy could further improve survival for patients with extensive-stage small-cell lung cancer.

Primary Outcome Measures: Progression-free Survival, The survival time from diagnose of the disease to progression of the disease, 3 years
Secondary Outcome Measures: Overall Survival, The survival time from diagnose of the disease to death, 3 years
Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients
NCT Number: NCT06479460
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Neoadjuvant|HER2-positive Breast Cancer|Circulating Tumor DNA
Interventions: DIAGNOSTIC_TEST: ctDNA-MRD
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-08
Completion Date: 2026-03-31
Locations: Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China

Summary:
1. To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population;
2. To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.

Primary Outcome Measures: Postoperative pathological pCR rate, Postoperative pathological pCR rate of HER-2 positive breast cancer patients after completing neoadjuvant therapy and undergoing surgical resection, 2024.3 -- 2026. 3
Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder
NCT Number: NCT06479447
Acronym: PORTAL-PTSD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PTSD
Interventions: OTHER: PORTAL-PTSD
Sponsor: University of Chicago
Collaborators: Chicago Family Health Center|National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 17000
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-15
Completion Date: 2026-07-14
Locations: CFHC East Chicago, Chicago, Illinois, 60617, United States|CFHC South Chicago, Chicago, Illinois, 60617, United States|CFHC Pullman, Chicago, Illinois, 60628, United States|CFHC Roseland, Chicago, Illinois, 60628, United States|CFHC Chicago Lawn, Chicago, Illinois, 60629, United States

Summary:
This study aims to implement and evaluate a more timely approach to post-traumatic stress disorder (PTSD) diagnosis and management, entitled Patient Outcome Reporting for Timely Assessments of Life with Post-Traumatic Stress Disorder (PORTAL-PTSD) in a primary care setting with a high prevalence of trauma, specifically the South Side of Chicago, in partnership with Chicago Family Health Center (CFHC).

Primary Outcome Measures: PTSD screening rates, Number and proportion of patients who were screened for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5)., every 6 months post-intervention for 2 years|PTSD diagnoses rates, Number and proportion of patients who screen positive for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5)., every 6 months post-intervention for 2 years|PTSD prescribed treatment rates, Treatment rate is measured as proportion of patients with PTSD and prescribed treatment out of total patients diagnosed with PTSD. Receipt of treatment is defined by completion of PCBH services or at least 3-months of therapy for PTSD for patients who choose to not receive PCBH services., every 6 months post-intervention for 2 years|PTSD symptoms severity, Patient-reported improvement in PTSD symptoms severity as measured by the 20-item Post-Traumatic Stress Disorder Checklist (PCL)., every 6 months post-intervention for 2 years
Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls
NCT Number: NCT06479434
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome|Insulin Resistance
Interventions: DRUG: Metformin
Sponsor: Aga Khan University
Collaborators: University of Karachi
Sex: FEMALE
Age: ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-24
Completion Date: 2025-12-30
Locations: DBBS, Karachi, Sind, 74800, Pakistan

Summary:
The goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is necessary to improve PCOS symptoms versus simple lifestyle modification.

Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks. They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. The blood sample will be used to measure the hormonal and inflammatory profile. In addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.

Primary Outcome Measures: Change in hormonal profile and menstural Cycle after Metformin use, Serum reproductory hormone levels (follicle stimulating hormone, testosterone), inflammatory hormones (tumor necrosis factor, c reactive protein) will be measured at day 0 and after 8 weeks of intervention, 8 weeks
Secondary Outcome Measures: Change in symptoms associated with PCO after intervention, Subjects will be asked to score on a Likert scare (0-5) change in the mood swings, menstural cycle frequency, facial hair quantity and quality, and dietary and bowel movement improvement., 8 weeks
A Clinical Study for Developing Artificial Intelligence(AI)-Based Clustering Model for Personalized Medicine in Acute Respiratory Failure
NCT Number: NCT06479421
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Respiratory Failure
Sponsor: Samsung Medical Center
Collaborators: Ministry of Science and ICT, Republic of Korea
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-14
Completion Date: 2025-02-28
Locations: Samsung Medical Center, Seoul, Gangnam, 06351, Korea, Republic of

Summary:
We will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory failure. and clinical characteristics and prognosis will be compared.

Primary Outcome Measures: Hospital Mortality, clinical outcomes - Hospital Mortality, From date of admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year
Secondary Outcome Measures: ICU Mortality, clinical outcomes - ICU Mortality, From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 6 months|Hospital length of stay, clinical outcomes - Hospital length of stay, From date of hospital admission until the date of hospital discharge, assessed up to 1 years|ICU length of stay, clinical outcomes - ICU length of stay, From date of ICU admission until the date of ICU discharge, assessed up to 6 months
The Effect of Virtual Reality (VR) Versus Conventional Vestibular Rehabilitation and Progressive Muscle Relaxation (PMR) to Improve Balance and Stress Among Patients of Persistent Postural Perceptual Dizziness (PPPD).
NCT Number: NCT06479408
Acronym: VR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Persistent Postural Perceptual Dizziness
Interventions: OTHER: progressive muscle relaxation (PMR) technique and vestibular rehabilitation exercises|OTHER: virtual reality (VR)
Sponsor: Shalamar Institute of Health Sciences
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2024-12-28
Locations: Shalamar School of Allied Health Sciences, Lahore, Punjab, 54000, Pakistan

Summary:
To compare the effect of virtual reality (VR) versus conventional vestibular rehabilitation and progressive muscle relaxation (PMR) to improve balance and stress among patients of persistent postural perceptual dizziness (PPPD).

Primary Outcome Measures: balance, Both groups will be given 3 treatment sessions per week . A thorough evaluation will be done again at the end of intervention period to find the difference between pre and post- interventional scores.Balance will be measured by using miniBESTest ( balance evaluation system test) with a cut of range 0-28 points there will be 14 items each item is categorised in three levels in whole while 0 representing low level of function and 2 representing the highest level of function., 2 months
Secondary Outcome Measures: stress, Both groups will be given 3 treatment sessions per week. A thorough evaluation will be done again at the end of intervention period to find the difference between pre and post- interventional scores.stress will be calculated by using perceived stress scale which will incude 10 questions each question is categorised into 5 likert scales with scoring ranging as 0-13 (low stress), 14-26 (moderate stress), 27-40 (high stress), 2 months
Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program VS Task-Oriented Training (TOT) Improving Gross Motor Function in Children With Cerebral Palsy
NCT Number: NCT06479395
Acronym: PEDALS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: Pediatric Endurance and Limb Strengthening (PEDALS) program|OTHER: Task-Oriented Training (TOT)
Sponsor: Shalamar Institute of Health Sciences
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2024-12-30
Locations: Rising Sun institute for Special children Mughalpura campus Lahore, Lahore, Punjab, 54000, Pakistan

Summary:
To compare the Effects of Pediatric endurance and limb strengthening (PEDALS) program VS Task-oriented Training (TOT) improving gross motor function among children with Cerebral Palsy.

Primary Outcome Measures: gross motor function, The improving gross motor functions i.e A) lying and rolling B) sitting C) crawling and kneeling D) standing and E) walking, running, and jumping., 12 weeks
Study of the ETX-4143 2.0 Device in Subjects With Eye Pain
NCT Number: NCT06479382
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eye Pain
Interventions: DEVICE: ETX-4143 2.0
Sponsor: EyeCool Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-10-15

Summary:
A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects with eye pain

Primary Outcome Measures: Reduction of eye pain, Patient reported level of eye pain, Eight weeks|Adverse events, Adverse events related to treatment, Eight weeks
CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
NCT Number: NCT06479356
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Hodgkin Lymphoma|Large B-cell Lymphoma
Interventions: BIOLOGICAL: Relma-cel
Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-12-31
Locations: Tianjin Cancer Hospital, Tianjin, Tianjin, China

Summary:
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.

Primary Outcome Measures: Objective response rate (ORR) in LBCL subjects, Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects, 3 months
Secondary Outcome Measures: Objective response rate (ORR), Objective response rate (ORR) in 3 month evaluated by IRC of LBCL subjects, 3 months|Best objective response rate ( Best ORR) in LBCL subjects, Best objective response rate (ORR) evaluated by the investigator and IRC of LBCL subjects, up to 1 year after Relma-cel infusion|Complete response rate (CRR) in LBCL subjects, Complete response rate (CRR) at any time points evaluated by the investigator, up to 1 year after Relma-cel infusion|Progression-free survival (PFS), Progression-free survival, up to 1 year after Relma-cel infusion|Overall survival (OS), Overall survival, up to 1 year after Relma-cel infusion|Duration of response (DOR), Time from first response (PR or CR) to disease progression or death from any cause, up to 1 year after Relma-cel infusion|Pharmacokinetic(PK)-Cmax of Relma-cel, Maximum observed concentration of Relma-cel in peripheral blood, up to 1 year after Relma-cel infusion|Pharmacokinetic(PK)-Tmax of Relma-cel, Time to maximum concentration of Relma-cel in peripheral blood, up to 1 year after Relma-cel infusion|Pharmacokinetic(PK)-AUC of Relma-cel, Area under the concentration vs time curve of Relma-cel, up to 1 year after Relma-cel infusion|Adverse events (AEs), These adverse events would be measured by assessment scale method according to NCI-CTCAE v5.0 classification standard, up to 1 year after Relma-cel infusion
Talk With Me Baby to Enhance the Early Home Language Environment
NCT Number: NCT06479278
Acronym: TWMB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Language Development|Speech|Infant Development|Infant Behavior|Language, Child|Language
Interventions: BEHAVIORAL: Talk with Me Baby
Sponsor: IDeA States Pediatric Clinical Trials Network
Collaborators: National Institutes of Health (NIH)|University of Kansas
Sex: ALL
Age: CHILD
Enrollment: 66
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2026-01
Locations: Kansas University Medical Center, Kansas City, Kansas, 66160, United States|West Virginia University, Morgantown, West Virginia, 26506, United States

Summary:
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:

Will the TWMB program increase the time a caregiver talks to their infant?

Participants will:

1. Come to at least four well-child checkups
2. Receive the TWMB program from the provider during the checkups
3. Record their conversations with their infant before they receive the program and after they receive the program four times.

Primary Outcome Measures: Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Conversational Turn Count percentile score from Baseline to Post-Intervention, 12 months|Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Adult Word Count percentile score from Baseline to Post-Intervention, 12 months
Manipulating Cognitive Intensity During Aerobic Exercise
NCT Number: NCT06479265
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cognitive Decline
Interventions: OTHER: Phyical/Cognitve Exercise
Sponsor: University of Southern California
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-15
Completion Date: 2022-05-15
Locations: Clinical Exercise Research Center, Los Angeles, California, 90033, United States

Summary:
The purpose of this study is to investigate the performance effects of manipulating the properties of a cognitively engaging aerobic task. The overall goal of this proposal is to determine how changes in aspects of the task (selection time, number of sorting options) and inclusion of different dual task walking interferences can be used to challenge the cognitive domain of executive function in a range of healthy adults. The investigators hope to learn how to challenge people cognitively during exercise to promote mental benefits. Participants are invited as a possible participant because are a healthy adult. 40 participants will take part in the study. This research is being funded by the Clinical Exercise Research Center (CERC) in the Division of Biokinesiology and Physical Therapy on the University of Southern California Health Sciences Campus.

Primary Outcome Measures: Cognitive Task Performance, Score of the Wisconsin Card Sorting Task 64 for each Trial, 90 minutes - 120 minutes
Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
NCT Number: NCT06479239
Acronym: Panc 002
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Pancreas Cancer|Pancreatic Cancer
Interventions: DRUG: EGFR FPBMC
Sponsor: University of Virginia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2031-03

Summary:
The purpose of this study is to understand the safety and estimate the efficacy of combining anti-cluster of differentiation 3 (CD3) x anti-Epidermal Growth Factor Receptor (EGFR) bispecific antibody fresh peripheral blood mononuclear cells (EGFR FPBMC) for patients with relapsed and/or refractory pancreas cancer. Participants receive 8 weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.

Primary Outcome Measures: Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only), As defined in the protocol, Through the dose escalation phase (during the first 8 infusions only, about 8 weeks after starting study treatment))
Secondary Outcome Measures: Overall Response Rate, Number/Percentage of participants that have a partial or complete response to study treatment, Through the dose escalation phase (during the first 8 infusions only, about 8 weeks after starting study treatment))|Progression free survival, Time from start of treatment to time of progression or death from any cause, whichever occurs first., Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)|Overall Survival, Time from start of treatment to time of death from any cause., Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)|Specific cytotoxicity by PBMCs against pancreatic cancer cell lines, In blood samples, Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment|Development of antibodies to pancreatic cancer antigens, In blood samples, Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment|Survival of EGFR FPBMCs after multiple infusions, In blood samples, Prior to study treatment, prior to each of the first 5 infusions, (optionally) about 1-2 days after each of the first 8 infusions, and about 8-10 weeks after starting study treatment
Effect of Mouthwash in Reducing the Symptoms Associated With Flu and Cold Viruses
NCT Number: NCT06479226
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Healthy
Interventions: DRUG: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash
Sponsor: Colgate Palmolive
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2022-06-05
Completion Date: 2022-10-06
Locations: Federal University of Pelotas, Pelotas, Rio Grande Do Sul, Brazil

Summary:
The aim of this study will be to evaluate the efficacy of regular cleaning of the oropharynx (via gargling) on the incidence of symptoms associated with flu and colds. The working hypothesis is that there will be a significant reduction in symptoms associated with flu and colds after using the mouthwash product, compared to the experimental control regime. A total of 150 individuals will be randomized to one of the two experimental regimens and followed for a period of 90 days. The experimental regimen consists of toothbrushing followed by gargling with a cetylpyridinium chloride (CPC) (0.075%) and zinc containing alcohol free rinse and the control regimen consists of toothbrushing alone. Participants will be instructed to brush their teeth twice a day for two minutes. Those allocated to the test regime will gargle with 20 ml of the mouthwash after each brushing. At the initial visit, participants will receive the products and instructions for use, as well as a daily log questionnaire. Participants will be asked to send their daily records once a week, using a messaging application. The proportion of days without any of the evaluated symptoms will be used as the main outcome. In addition, soft and hard tissue exams will be performed at the initial consultation, after 30 and 90 days of follow-up by a blinded researcher. Potential adverse events will be collected throughout the study. The groups will be compared using the chi-square test and one-way analysis of variance (ANOVA) will be used to compare the treatment group symptom rates between groups. The significance level will be set at 95%.

Primary Outcome Measures: Upper Respiratory Symptom, any upper respiratory system associated with colds and flu according to the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Daily Symptom Report., 90 days
REACH (Restore Energy, Activity Can Help) Lupus Study
NCT Number: NCT06479213
Acronym: REACH
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Systemic Lupus Erythematosus|Fatigue
Interventions: BEHAVIORAL: REACH Peer Coaching Program|BEHAVIORAL: REACH Mobile Health Application
Sponsor: Tufts Medical Center
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-13
Completion Date: 2025-06-01
Locations: Tufts Medical Center, Boston, Massachusetts, 02111, United States

Summary:
The goal of this clinical trial is to pilot test the REACH peer coaching program for fatigue in people with systemic lupus erythematosus. The main questions it aims to answer are:

1. Is the REACH program feasible and acceptable to participants?
2. What is the impact of the REACH program on fatigue?

Researchers will compare the REACH peer coaching program to the REACH mobile health application to see if the REACH program works to reduce fatigue.

Participants will:

* Use the REACH mobile health application to set weekly movement goals and log daily physical activity
* Meet weekly with their REACH peer coach (if they have one) to talk about their movement goals and progress
* Complete weekly symptom surveys
* Complete study surveys when they start the program, in the middle of the program, at the end of the program, and 12 weeks after the program ends
* Participate in an interview to provide feedback on the program

Primary Outcome Measures: Feasibility, Enrollment rates (subjects enrolled/eligible individuals approached)., 6 months|Adherence, Proportions of educational modules, activity logs, and coaching sessions completed., 12 months|Acceptability, Net Promoter Scores for the educational modules, REACH app, and REACH peer coaching intervention. Interviews exploring the acceptability of study procedures (e.g. data collection methods, study assessments, functionality of the mobile app) and engagement with educational modules and peer coaches., 12 to 24 weeks
Secondary Outcome Measures: Fatigue, Effect size estimate of change in fatigue using the Fatigue Severity Scale, 12 weeks and 24 weeks
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer
NCT Number: NCT06479187
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Metastatic Prostate Cancer|Hormone Sensitive Prostate Cancer|Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions: DRUG: 18F-rhPSMA-7.3|DEVICE: PET/CT
Sponsor: Brigham and Women's Hospital
Collaborators: Dana-Farber Cancer Institute|Blue Earth Diagnostics
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-30
Completion Date: 2027-06-20
Locations: Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States

Summary:
The goal of this clinical trial is to learn if serial PSMA-PET/CT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment approaches.

The main questions it aims to answer are:

What is the proportion of men with residual PSMA-avid disease on PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer? Do the findings on PSMA-PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer correlate with other markers of disease status, like PSA?

Participants will:

Receive standard of care treatment for metastatic hormone sensitive prostate cancer Undergo a PSMA-PET/CT scan before starting treatment Undergo a PSMA-PET/CT scan after 6 months of treatment Have a chart review every 3 months for 1 year after the 6 month PSMA-PET/CT scan

Primary Outcome Measures: Proportion of patients with residual PSMA-avid disease on 18F-rhPSMA7.3 PSMA PET after 6 months of treatment for metastatic hormone sensitive prostate cancer, metric use is percent of men with residual PSMA avid disease compared to all men undergoing the scan., At the time of the 18F-rhPSMA-7.3 PSMA-PET/CT scan done 6 months after starting therapy for metastatic hormone sensitive prostate cancer
Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke
NCT Number: NCT06479174
Acronym: CHAMPS-TR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic
Interventions: BEHAVIORAL: CHAMPS-TR
Sponsor: University of New Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-30
Completion Date: 2025-06-30

Summary:
People living with the cognitive effects of stroke are at risk for recurrent stroke and further cognitive decline. Also problematic is that stroke risk clusters in families and biological family members of people who have ischemic stroke may also be at increased risk of stroke and/or cognitive decline. The primary goal of this study is to test the feasibility of a virtually delivered cognitive strategy training and health coaching program to reduce vascular risk and promote brain health in persons with stroke and their biological family members.

Primary Outcome Measures: American Heart Association Life's Essential 8 Metrics, metric scores for vascular risk; score is calculated on a 0-100 scale where 100 is ideal, baseline, up to 7 weeks, and up to 24 weeks|Cardiovascular risk factors, Aging, and Incidence of Dementia (CAIDE), Risk profile score for cognitive decline; score is composed of weightings by reference to age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity. Scores range from 0-15 with higher scores indicating greater risk., baseline, up to 7 weeks, and up to 24 weeks
Secondary Outcome Measures: Oral Trail Making Test Part B, Test of mental sequencing and switching; score with total number of seconds to complete up to 300, total number of errors, and total correct, baseline and up to 24 weeks|Number Span Test Forward and Backward, Test of working memory; scored with number of correct trials (0-14), and longest span forward (0, 3-9) and longest span backward (0, 2-8). Higher numbers are greater number of correct items., baseline and up to 24 weeks|Multiple Errands Test Home Version, Test of executive function impact on everyday life; total score of 0-14 with higher levels indicating less impairment; additional sub-scores for errors made and strategies used using total scores., baseline and up to 24 weeks|Mark VCID2 Clinical Cognitive Assessment Battery, Test of cognitive impairment and dementia; total scores on all sub-scores for each included measure., baseline and up to 24 weeks|PROMIS Self-Efficacy for Managing Medications, Test of self efficacy for managing medications; scoring with item-level calibrations using HealthMeasures Scoring Service, baseline, up to 7 weeks, and up to 24 weeks|PROMIS Self-Efficacy for Managing Symptoms, Test of self efficacy for managing symptoms; scoring with item-level calibrations using HealthMeasures Scoring Service, baseline, up to 7 weeks, and up to 24 weeks