pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Study of Different Exercise Doses Through Videogames in Older Adults
NCT Number: NCT06526975
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Older Adult
Interventions: OTHER: Gamification exercise through a videogame
Sponsor: University of Castilla-La Mancha
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-10
Locations: Nueva Esperanza Nursing Home, Fuensalida, Toledo, 45510, Spain|Universidad de Castilla La Mancha, Toledo, 45071, Spain

Summary:
The objective of this clinical trial is to assess the feasibility of applying different gamified exercises doses in older adults. It will also learn from possible adverse effects of the intervention.

The main questions this clinical trial aims to answer are:

* Are there any differences between heart rate, perceived exertion and enjoyment between groups?
* Are there any adverse effects? What is the magnitude of these adverse effects?
* Are there any correlations between gamification time and the occurrence of adverse effects?

Primary Outcome Measures: Heart Rate, Heart rate will be measured using polar H10, Heart rate is measured thourought the intervention, once the intervention is finished (10 to 30 minutes) recording of heart rate will stop.|Rate of perceived exertion, Rate of perceived exertion will be measured using Borg (RPE 6-20). Higher values indicate higher levels of perceived exertion, RPE will be measured at half time and once the intervention is finished for both groups.|Exercise satisfaction, It will be measured using Physical Activity Enjoyment Scale (PACES). Higher values indicate higher percieved satisfaction/ enjoyment, It will be measured on the same day intervention finishes, up to 5 hours post-intervention.|Adverse effects, It will be measured using Hooper and Mackinnon wellness questionnaire. Higher values indicate worse perceived effects., 24 and 48 hours post-intervention
5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
NCT Number: NCT06526962
Acronym: HYSTOP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endometrial Polyp
Interventions: DEVICE: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
Sponsor: University of Cagliari
Sex: FEMALE
Age: ADULT
Enrollment: 214
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-07
Completion Date: 2025-05-07
Locations: University of Cagliari, Cagliari, 09042, Italy

Summary:
The primary objective of this study is to compare the performance of two different surgical instruments, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for dual wavelength diode laser, in performing hysteroscopic polypectomy in an outpatient setting.

Primary Outcome Measures: Time required to perform the operative hysteroscopic procedure., The time required to perform the operative hysteroscopic procedure, which will be measured in seconds from the entry into the uterine cavity until the completion of the procedure, defined as the complete resection of the lesion (excluding the time related to the extraction of the resected material)., End of procedure
Secondary Outcome Measures: Need for supplementary instrumentation, The need for supplementary instrumentation to complete the procedure (e.g., 5 Fr cold blade scissors), End of procedure|Effectiveness in removing the lesions, Effectiveness of the procedure (absence/persistence of the lesion), documented by postoperative ultrasound evaluation performed 60 days after the procedure, 60 days|Adverse events, Adverse events related to the procedure (e.g., vagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and adjacent organs), 30 minutes|Quantity of resected tissue, Adequacy of the resected material weight for histological examination (weight in grams), 40 days|Instrument Suitability, Overall suitability of the instrument used (in terms of its cutting and coagulation precision), as judged by the operating surgeon, End of procedure|Pain perception, The level of pain perceived by the patient during the procedure, evaluated using the Visual Analog Scale (VAS, from a minimum value of 1 to a maximum value of 10, where 1 is the best outcome and 10 is the worst outcome), 20 minutes|Level of anxiety during the procedure, Level of anxiety experienced by the patient during the procedure, evaluated using the Hospital Anxiety and Depression Scale (H.A.D.S.), from a minimum value of 0 to a maximum value of 21, where 0 is the best outcome and 21 is the worst outcome), 20 minutes|Patients' quality of life, Changes in the patient's perceived quality of life 60 days after the procedure, evaluated using the EuroQol-5D questionnaire (EuroQol 5-dimension questionnaire, from a minimum value of 0 to a maximum value of 100, where 0 is the worst outcome and 100 is the best outcome)., 60 days
The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support
NCT Number: NCT06526949
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: İntensive Care|Nursing|Reiki
Interventions: BEHAVIORAL: Reiki|OTHER: (Sham Reiki)
Sponsor: University of Yalova
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-15
Completion Date: 2024-12-15
Locations: Yalova Training and Research Hospital, Yalova, Çınarcık, Turkey

Summary:
Patients receiving mechanical ventilation (MV) support in intensive care units (ICU) may have some negative experiences. The most common of these are problems such as pain, agitation, anxiety, deterioration in comfort, dry mouth, thirst, and inadequacy in communication.

Reiki, one of the energy therapies among the non-pharmacological nursing practices that have become widespread in recent years, is one of the healing therapies that contribute to the protection and promotion of well-being, healthy aging, and the treatment of some health deviations and is applied noninvasively with hands.

In the literature, there are many studies suggesting that Reiki has positive effects on pain, anxiety and stress response (heart rate, blood pressure, respiratory rate) in patients with Reiki. It is known that these studies generally consist of health professionals such as cancer, haemodialysis, patients undergoing laparoscopic or endoscopic procedures, haemodialysis patients or nurses. Studies have shown that Reiki is especially effective in cancer patients, preoperative stress, anxiety, postoperative pain and symptom management in chronic diseases. For Reiki application in the intensive care unit, only a few studies conducted in the neonatal intensive care unit were found.

Primary Outcome Measures: Reiki has an effect on pain level in patients receiving mechanical ventilation support., Intensive Care Pain Observation Scale (CPOT): This scale was developed to diagnose pain in ICU patients. The scale consists of four subscales expressing behavioural items such as facial expression, body movements, muscle tension and compliance with ventilation for intubated patients or sounds for extubated patients. Three points and above are considered as pain. Each of the sections is evaluated between 0-2 points and the total score varies between min:0-max:8., 1 year
The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot Care Behavior
NCT Number: NCT06526936
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot
Interventions: BEHAVIORAL: Education
Sponsor: University of Beykent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-13
Completion Date: 2025-06-13
Locations: Idm Dialysis Center, Beylikdüzü, Cumhuriyet Mahallesi, Turkey

Summary:
Diabetic foot causes hospitalization, amputation and serious health problems in individuals. This situation also leads to loss of productivity of the individual, negatively. diabetic foot can be reduced by 85% with good foot care, education and a multidisciplinary team approach. Diabetes is observed in the majority of hemodialysis patients. Foot care becomes even more important if you have more than one chronic disease. The aim of this study is; To determine the effect of "Diabetic foot care training" given to diabetic hemodialysis patients on foot care behavior. The study was planned as a randomized controlled experimental study. It was planned for diabetic hemodialysis patients who were treated in a dialysis center with a study permit.

Primary Outcome Measures: Developing foot care behavior, Providing training with diabetic foot care guidance As data collection forms in the research; The Participant Information Form prepared by the researcher and the Foot Care Behavior Scale (FBS) will be used.

The lowest score that can be obtained on the scale is 15; The highest score is 75. The Cronbach alpha value of the scale was found to have high reliability as 0.83., Trainings are 15-20 minutes, once a week. 8 weeks in total will be given as.
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
NCT Number: NCT06526923
Acronym: SAAVe
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Cystic Fibrosis
Interventions: COMBINATION_PRODUCT: SP-101 and doxorubicin Cohort 1|COMBINATION_PRODUCT: SP-101 and doxorubicin Cohort 2
Sponsor: Spirovant Sciences, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2026-12-31
Locations: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|Columbia University, New York, New York, 10032, United States

Summary:
This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.

Primary Outcome Measures: Incidence and severity of adverse events, Safety and tolerability of SP-101 following a single inhalation dose, as assessed by incidence and severity of treatment emergent adverse events, serious adverse events, and dose limiting toxicities, including clinically significant changes from baseline to scheduled time points in safety parameters., 52 weeks
Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC)
NCT Number: NCT06526884
Acronym: NDC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumonia|Syncope|Congestive Heart Failure|Cellulitis|Pyelonephritis|AKI - Acute Kidney Injury|Diabetic Foot Infection|Osteomyelitis
Interventions: OTHER: Next Day Clinic
Sponsor: University of California, Los Angeles
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1080
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-22
Completion Date: 2025-11-30
Locations: Ronald Reagan UCLA Medical Center, Los Angeles, California, 90024, United States

Summary:
The Next Day Clinic (NDC) is a quality improvement initiative that will be launched and operated by UCLA Health starting July 22, 2024. Its goals are to improve patient care and safety and to maximize cost effectiveness. The way it does this is by identifying patients in the ED who would normally be admitted for low-acuity conditions, and diverting them to a high-acuity clinic the following day called the NDC. This will help decompress the ED and the hospital, and allow for overall higher quality care. The Health System has partnered with UCLA's Healthcare Value Analytics and Solutions \[UVAS\] group which specializes in these types of program evaluations. The analysis conducted by the study team will be used to directly inform NDC operations, scaling, and future plans.

Primary Outcome Measures: Days alive and out of hospital (DAOH), Cumulative number of days alive and not admitted or boarding in a hospital or emergency department, 30 days from index ED visit
Secondary Outcome Measures: Global health-related quality of life, Composite PROMIS-29+2 score (patient reported outcome measurement information system). PROMIS stands for Patient-Reported Outcomes Measurement Information System. High scores mean more of the concept being measured., 30 days from index ED visit|Patient experience, Measured by PSQ-18 (patient satisfaction questionnaire). PSQ stands for Patient Satisfaction Questionnaire. High scores indicate higher levels of satisfaction., 30 days from index ED visit|Financial analysis, Total cost per day of treatment, Through study completion, an average of 12 months|Cost effectiveness analysis, Total cost per day alive and out of hospital, Through study completion, an average of 12 months|Hospitalizations avoided, Each NDC referral with a preceding Plan to Admit order or Bed Request order (regardless of treatment arm) will be considered an avoided hospitalization, given that the presence of one of these orders establishes that the counterfactual for NDC treatment in hospitalization., Through study completion, an average of 12 months|Hospital bed-days saved, For each referral to the NDC, the number of hospital bed-days saved will be established by using the mean length of stay for patients treated per-protocol in the control condition matched for the same presenting illness., Through study completion, an average of 12 months
Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .
NCT Number: NCT06526871
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Movement
Interventions: PROCEDURE: Low-Level Laser acceleration|PROCEDURE: clear aligner therapy
Sponsor: Huda Abdelhakim
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-10-25
Completion Date: 2024-07-03
Locations: AL-Azhar university, Cairo, Egypt

Summary:
The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners

Primary Outcome Measures: • Little irregularity index, The Little Irregularity Index is a quantitative method used to assess the degree of dental crowding. It measures the linear displacement of the contact points of the mandibular anterior teeth (canine to canine) from their ideal positions. This measurement is taken before and after orthodontic treatment using scanned 3D models, allowing for an objective evaluation of alignment improvement., through study completion, an average of 6 months
Secondary Outcome Measures: • Treatment time, The duration of orthodontic treatment, including active treatment phases such as wearing aligners or undergoing procedures like interproximal reduction, is crucially monitored. This active treatment time is distinct from overall treatment duration, which encompasses intervals such as retention phases or breaks between aligner changes., through study completion, an average of 6 months|• Number of aligners, The number of aligners measurement involves determining the total quantity of clear aligners required for a patient's orthodontic treatment., through study completion, an average of 6 months|• Patient comfort and satisfaction, Patient comfort and satisfaction were evaluated using standardized scales, including Visual Analog Scales (VAS) , to assess pain levels, oral discomfort, and overall treatment experience., through study completion, an average of 6 months|• Refinement rate, The refinement rate in orthodontics refers to the frequency and extent of adjustments made to aligners or appliances during treatment to achieve optimal tooth alignment. It is typically measured by assessing the need for additional aligners,, through study completion, an average of 6 months|• Digital cast accuracy, Digital cast accuracy was assessed using 3D surface comparison methods, comparing intraoral scans with traditional plaster models., through study completion, an average of 6 months|• Tooth movement accuracy, This process involved aligning and overlaying 3D models to assess the extent and direction of tooth displacement over time., through study completion, an average of 6 months|• Software predictability, 3D models were superimposed to analyze the accuracy of predicted tooth movements compared to actual outcomes., through study completion, an average of 6 months
A Phase 1 Study of BST02 in Treating Locally Advanced Liver Cancer
NCT Number: NCT06526832
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Locally Advanced Liver Carcinoma
Interventions: BIOLOGICAL: BST02
Sponsor: BioSyngen Pte Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-04
Completion Date: 2025-12-03
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510000, China

Summary:
The goal of this clinical trial is to investigate the BST02, a tumor infiltrating lymphocyte product, collected from the locally advanced liver cancer subjects

The main questions it aims to answer are:

1. Safety and tolerability of BST02.
2. Preliminary efficacy of BST02. Participants will receive a cytoreductive surgery to collect samples for the manufacture of BST02.

Participants will receive BST02 infusion followed by IL-2 infusion. Blood samples will be collected for the analysis of PK and safety.

Primary Outcome Measures: Occurence and incidence of adverse event and severe adverse events., The occurrence and incidence (%) of Adverse Events (AEs) as well as Severe Adverse Events (SAEs) after infusion of BST02 for subjects in each dosing group, From the infusion (D0) to D28|Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT), The highest dose which the patients can tolerate, and the occurence of DLT events., From the infusion (D0) to D28
Secondary Outcome Measures: Tumor response and survival., Including following outcomes: Objective Response Rate (ORR), Disease Control Rate (DCR), Time to Response (TTR), Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS). The tumor responses are judged according to mRECIST criteria., From the infusion (D0) to D672 (2 years)|PK parameter collection, PK testing indicator for BST02: Peripheral blood CXCR3+CD8+ T-lymphocyte count., From before infusion (D-2) to D28
A Phase 1/2 Study of SMP-3124LP in Adults With Advanced Solid Tumors
NCT Number: NCT06526819
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumor
Interventions: DRUG: SMP3124LP
Sponsor: Sumitomo Pharma America, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2029-05
Locations: Sarah Cannon Research Institute at HealthOne, Denver, Colorado, 80218, United States|Ohio State University, Columbus, Ohio, 43210, United States|MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors

Primary Outcome Measures: Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs), 28 days|Number of Participants With Adverse Events and Serious Adverse Events, 6 months|Determine the Objective Response Rate (ORR), 6 months
Secondary Outcome Measures: The maximum concentration (Cmax) of SMP-3124 and SMP-3124LP, 6 months|The area under the curve (AUC) of SMP-3124 and SMP-3124LP, 6 months|The duration of response (DOR) assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, 6 months
The Effect of Use of Kahoot in Pediatric Emergency Nursing Course on Students' Course Success and Motivation Levels
NCT Number: NCT06526806
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child, Only|Nurse's Role
Interventions: OTHER: Kahoot game strategy
Sponsor: Bilecik Seyh Edebali Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-07
Completion Date: 2024-07-17
Locations: Asli Kudubeş, Bilecik, Turkey

Summary:
With the characteristics of the new generation and the innovations brought by the age, it has become inevitable to use new educational, instructive and entertaining methods in nursing education. Considering the problems experienced by nursing students with traditional education, the use of Kahoot will be a remarkable result in the literature. The gamification process with Kahoot encourages thinking skills in situations where the subject is sensitive and challenging, ensuring better retention of information and improving internal motivation. Therefore, in order to make learning efficient and to ensure the active participation of students, it should be processed using different interactive methods in nursing education. Pediatric emergency nursing course is a content-intensive and rich course that blends emergency and pediatric nursing, containing information on child health and development in addition to the learning outcomes of the emergency nursing course. This study was carried out within the scope of the pediatric emergency nursing course; It is thought that it will enable students to repeat the basic concepts of the course, master the terminology, and provide a supportive learning environment for pediatric emergency nursing, which is a difficult field for students, and will contribute to nursing education and nursing literature.

Primary Outcome Measures: Exam score, An increase in the exam score indicates an increase in the level of success., Five months|Motivation Scale for Instructional Material mean scores, An increase in the scale score indicates an increase in the motivation level., Five months
Bronchoscopy Versus Imaging in Diagnosis of Airway Diseases in Critically Ill Children
NCT Number: NCT06526780
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Airway Disease
Interventions: PROCEDURE: Bronchscopy
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11
Completion Date: 2026-05

Summary:
Patients with suspected airway illness often go through a diagnostic assessment that includes chest radiographs, Computed tomography scans, and fiber optic bronchoscopy.

Primary Outcome Measures: Visualization of airway abnormalities by bronchscopy, Direct visualization of airway by bronchscopy, During procedure|Visualization of airway abnormalities by computed tomography scan, Assessment of airway by computed tomography scan with virtual bronchscopy, During procedure
ASF Alport Syndrome Registry
NCT Number: NCT06526741
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alport Syndrome|Thin Basement Membrane Disease|Hereditary Nephritis
Interventions: OTHER: Longitudinal data collection
Sponsor: Alport Syndrome Foundation
Collaborators: Pulse Infoframe Inc
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-24
Completion Date: 2048-08-23
Locations: On-line only: https://asfalportpatientregistry.healthie.net, Scottsdale, Arizona, 85261, United States

Summary:
Alport Syndrome Foundation's (ASF's) Alport Patient Registry (the Registry) is open to individuals living with Alport syndrome in the United States (US) and US territories and outlying islands. The Registry welcomes participants of all ages who have a confirmed clinical diagnosis of Alport syndrome. A confirmed diagnosis could be obtained via genetic testing, biopsy, and/or from a medical professional's clinical assessment of the individual's symptoms and/or family history. Participants can have any form and stage of this disease to be eligible for inclusion in the Registry.

Patient participation in the Registry is crucial to helping attract and advance research, understanding understudied aspects of the disease, and informing clinical trials that may lead to Alport syndrome therapies and/or a cure.

The Registry is accessed through a secure, online application. Participants report their own health history in the Registry and are encouraged to update any changes, at most, every three months.

The security of each participant's information is a top priority. Any detail that could identify an individual participant is kept confidential in the Registry and such data are de-identified to protect the participant's privacy. No electronic health records or social security numbers are requested by or connected to the Registry.

A parent or legal guardian may consent to enroll a child/dren Alport patient(s) under the age of 18 years. An additional assent form is used for individuals ages 7-17. At age 18, participants will be required to re-consent as an adult if they choose to continue to participate in the Registry.

Primary Outcome Measures: Total number of enrolled participants, Reach 750 enrolled participants, 5 years
Hyperbaric Oxygen Therapy in HAMstring Injury (HOTHAM) Trial
NCT Number: NCT06526728
Acronym: HOTHAM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hamstring Injury
Interventions: DRUG: Hyperbaric oxygen
Sponsor: JL Tol
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-03-01

Summary:
The goal of this study is to learn if Hyperbaric Oxygen Therapy is able to accelerate and improve muscle healing following an acute hamstring injury. The main questions it aims to answer are:

1. Does Hyperbaric Oxygen Therapy accelerates the time needed to return to play/-duty following hamstring injury.
2. Does Hyperbaric Oxygen Therapy decrease the amount of reinjuries within 1 year following Return to play/-duty? Besides these questions this study will clinically and radiologically evaluate the healing process over time as well as the occurrence of (serious) adverse events.

Primary Outcome Measures: Time to return to full unrestricted play / time to return to full unrestricted duty., Number of days from initial injury until the athlete is cleard to resume full unrestricted training / Number of days from initial injury until soldier is cleared to resume full unrestricted (physical) duty activities., From date of inclusion until the date of progresion to return to full unrestricted play or -duty. Assessed to up to 1 year
Secondary Outcome Measures: Re-injury registration, Number of re-injuries, 2- and 12 months following injury|Clinical assessment, Clinically assess the hamstring injury over time (Patient reported hamstring scores, Pain scores), physical assessment (palpation, flexibility and isometric strength testing)., Baseline, week 2 and at return to full restricted play/-duty (assessed up to 1 year following injury)|Radiologic assessment, Radiologic assessment of the hamstring injury over time using MRI derived parameters: Aspect of the injury on MRI images by a radiologist., Baseline and week 2|Adverse events, Number of AE-and SAE's, Baseline up until 1 week following last treatment session.
Lung Innate Immunity and Microbiome After Tuberculosis Exposure
NCT Number: NCT06526689
Acronym: LIMBO-TB
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tuberculosis|Latent Tuberculosis
Sponsor: University of Oxford
Collaborators: University College, London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-31
Completion Date: 2028-10-01
Locations: Churchill Hospital, Oxford, Oxfordshire, OX3 7LE, United Kingdom|Centre for Clinical Vaccinology and Tropical Medicine, Oxford, Oxon, OX3 9DZ, United Kingdom|Grove Building, Royal Free NHS Foundation Trust, London, NW3 2QG, United Kingdom|Department of Respiratory Medicine, St Thomas' Hospital, London, SE1 7EH, United Kingdom

Summary:
To characterise the innate pulmonary immune response and respiratory microbiome after recent exposure to M.tb and to evaluate how differences determine the outcome of M.tb exposure

Primary Outcome Measures: The immunological response after recent M.tb exposure measured as the differentials of innate immune cells in the blood and sputum., We will characterise the number and activity of early immunological response to M.tb in the respiratory tract and systemic circulation. Samples of blood and sputum will be utilised to enumerate the proportions of innate immune cells measured by flow cytometry and their activity., At enrolment and Day 84
Secondary Outcome Measures: An assessment of respiratory microbiome diversity in M.tb contacts compared to healthy controls, To characterise the respiratory microbiome after exposure to M.tb by identifying bacterial genetic sequences and calculating both alpha diversity and beta diversity of sputum samples. Baseline and followup sample at day 84 will be investigated to determine robustness of communities., At enrolment and Day 84
Other Outcome Measures: Exploratoring the role of innate immune response and microbiome on determining infection status by M.tb, We will combine data on the microbial communities identified in sputum as well as their diversity and combine it with data on the innate immune responses to explore whether measurements can be used to predict latent TB infection.

Utilised assays may include but will not be limited to:

Flow cytometry ELISAs Ellispots Sequencing data of bacterial isolates from sputum samples., At enrolment and Day 84
Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts
NCT Number: NCT06526676
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Juxtarenal Aortic Aneurysm|Pararenal Aneurysm|Thoracoabdominal Aortic Aneurysm
Interventions: DEVICE: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-01
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches.

Primary Outcome Measures: Number of patients with major adverse events, Total number of patients to experience a major adverse event as defined as any cause mortality, bowel ischemia (requiring surgical therapy), type I myocardial infarction (rise of troponin levels at least 1 value above 99th percentile of upper limit and with at least one of the following: symptoms of acute myocardial ischemia, new ischemic ECG changes, development of new pathological Q waves, imaging evidence of loss of viable myocardium or new regional wall motion abnormalities, or identification of coronary thrombus by angiography or by autopsy), paraplegia (Level 3), renal failure (need for renal replacement therapy or \> 50% decline in eGFR), respiratory failure (respiratory failure requiring ventilatory support \> 24 hours or re-intubation), major stroke., 30 days|Treatment success, Total number of patients to achieve treatment success as defined by: technical success, defined as successful delivery, deployment and withdrawal of the physician-modified endovascular graft with preservation and patency of those branch vessels intended to be preserved; freedom from aneurysm enlargement \>5 mm; freedom from secondary interventions for type I or type III endoleak, stent-graft migration, device integrity failure (e. g., fracture), and patency-related events; and freedom from aneurysm rupture or conversion to open repair., 12 months
Secondary Outcome Measures: Change in Quality of Life, The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability., Baseline, 30 days, 6 months, and annually at 1, 2, 3, 4 and 5 years
Randomizing Vignettes to Understand Contributors to Trust in Primary Care Doctors
NCT Number: NCT06526663
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Care
Interventions: BEHAVIORAL: vignette exposure
Sponsor: Johns Hopkins University
Collaborators: Virginia Polytechnic Institute and State University|National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 576
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-15
Completion Date: 2024-12
Locations: Johns Hopkins University, Baltimore, Maryland, 21205, United States|Virginia Tech, Blacksburg, Virginia, 24061, United States

Summary:
In this proposed work, the investigators plan to generate experimental evidence about trust and overuse of healthcare. The protocol described below is for the first phase of this work to establish the feasibility of modifying feelings of trust via a vignette.

Primary Outcome Measures: Wake Forest Physician Trust Scale (10 item survey), Scores range from 10-50 with higher scores indicating higher trust, Immediately upon completing exposure to the vignette
Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial
NCT Number: NCT06526598
Acronym: IT-PSV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Care|Acute Hypoxic Respiratory Failure|Ventilator-Induced Lung Injury
Interventions: PROCEDURE: PMI-targeted pressure support setting and adjustment|PROCEDURE: VT/RR-targeted pressure support setting and adjustment
Sponsor: Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 640
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-30
Locations: Beijing Shijitan Hospital, Beijing, Beijing, 100038, China

Summary:
The Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in adult participants undergoing pressure support ventilation.

The investigators propose a physiological-oriented assisted ventilation management that, if found effective, could potentially change the clinical practice for mechanical ventilation.

Primary Outcome Measures: Total duration of mechanical ventilation, Defined as the time intervals from intubation and mechanical ventilation to successful weaning. For patients with re-intubation or restoration of mechanical ventilation via tracheostomy within seven days after extubation and discontinuation of ventilation, the thereafter duration will be added., 28 days
Secondary Outcome Measures: Duration of mechanical ventilation after enrollment, Defined as the time intervals from enrollment to successful weaning. For patients with re-intubation or restoration of mechanical ventilation via tracheostomy within seven days after extubation and discontinuation of ventilation, the thereafter duration will be added., 28 days|The time before the first spontaneous breathing trial, Defined as the time interval from intubation and mechanical ventilation to the first spontaneous breathing trial attempt., 28 days|Weaning time, Defined as the time from the first SBT attempt to successful discontinuation of mechanical ventilation., 28 days|Frequency of prolonged weaning, Prolonged weaning is defined as that weaning is still not terminated 7 days after the first separation attempt., 28 days|ICU mortality, Death in the ICU., 28 days|Hospital mortality, Death in the hospital., 28 days|Length of stay in the ICU, Defined as the time interval from enrollment to discharge from ICU or death., 28 days|Length of stay in the hospital, Defined as the time interval from enrollment to discharge from hospital or death., 28 days
Stress Management Program
NCT Number: NCT06526585
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Anxiety
Interventions: BEHAVIORAL: Cyclic Sighing Breathing|BEHAVIORAL: Box Breathing|BEHAVIORAL: Hypnosis|BEHAVIORAL: Audiobook
Sponsor: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12

Summary:
This study will test the immediate and long term (post 4 weeks of daily practice) effectiveness of two breathwork practices, cyclic sighing and box breathing, in comparison to hypnosis and an audiobook about stress, on psychological and physiological variables.

Primary Outcome Measures: Change in fractional amplitude of low-frequency fluctuation (fALFF) signal, Fractional amplitude of low-frequency fluctuation (fALFF) signal, assessed using functional Magnetic Resonance Imaging (fMRI)., Baseline (Day 0) and Endpoint (Day 29)|Change in State Anxiety scale score, The State-Trait Anxiety Inventory (STAI) is an instrument for measuring anxiety in adults. It has 2 scales, State Anxiety (S-Anxiety) and Trait Anxiety (T-Anxiety). The S-Anxiety scale measures anxiety due to temporary conditions and the T-Anxiety measures anxiety on a general or more long-standing scale. The S-Anxiety is a 20 item scale, each item yields a score of 1 to 4. Scores on the STAI S-Anxiety scale increase in response to physical danger and psychological stress, and decrease as a result of relaxation training., First day of at home practice (Day 1) through Last day of at home practice (Day 28)
Pain Measured by NRS and EEG in Acute Pulpitis
NCT Number: NCT06526572
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Pulpitis
Interventions: DIAGNOSTIC_TEST: Brain wave analysis using electroencephalography (EEG).|DIAGNOSTIC_TEST: Numerical rate Scale (NRS)
Sponsor: Cleveland Dental Institute
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-01
Completion Date: 2025-01-31
Locations: Cleveland Dental Institute, Cleveland, Ohio, 44128, United States

Summary:
The aim of the proposed study is to investigate and comprehensively understand pain perception in patients diagnosed with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB).

The study aims to achieve this by utilizing a dual approach that combines subjective self-reporting of pain intensity using the Numeric Rating Scale (NRS) with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).

By integrating these two methods, the study seeks to explore potential correlations between self-reported pain scores and neural responses recorded through EEG, providing insights into the pain experience of this specific patient population.

Ultimately, the goal of the study is to enhance the understanding of pain perception mechanisms in individuals with symptomatic acute pulpitis resistant to IANB and potentially guide the development of more effective and personalized pain management strategies for these patients.

Primary Outcome Measures: Electroencephalography (EEG), Changes in alpha brain waves in patients with acute pulpitis and resistant to alveolar nerve block injection, 3 months|Numerical Rate Scale (NRS), Measuring pain perception using NRS (Scale 0-10 where 0 is no pain and 10 is the most unbearable pain) in patients with acute pulpitis and resistant to alveolar nerve block injection., 3 months
Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty
NCT Number: NCT06526559
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Pelvi-Ureteric Obstruction
Interventions: DEVICE: Barbed suture|DEVICE: PGA suture
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-22
Completion Date: 2025-05-30
Locations: Cairo University Kasr AlAiny Hospitals Urology Department 17B, Cairo, Egypt

Summary:
The main goals of this trial is to study the feasibility and safety of using barbed sutures compared to the conventional PGA (Polyglactin) sutures in minimally invasive dismembered pyeloplasty. The main questions in using barbed sutures would be:

1. Is it safe with similar post-operative outcomes?
2. Does it have any significant complications?
3. Is it easier to handle intra-operatively?

Primary Outcome Measures: Time difference for suture completion, Mean difference of time taken in minutes between each group, 12 months (Intra-operative data)|Difference in complications rate, Mean difference in complications rate between both groups, 18 months (Post-operative data)|Drain output post-operative, Mean difference in total drain output between both groups, 12 months (Early post-operative data)
Secondary Outcome Measures: Difference in total operative time, Mean difference in total operative time post-operative, 12 months (Intra-operative data)|Difference in hospitalization time, Mean difference in hospitalization time, 12 months (Early post-operative data)|Failure rate, Difference in number of patients who needed redo pyeloplasty or any auxiliary procedures, 18 months (Late post-operative data)
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
NCT Number: NCT06526546
Acronym: ADVENT LTO
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 583
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-10

Summary:
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.

Primary Outcome Measures: Chronic success in ADVENT Trial treated subjects compared between treatment groups., Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study:

Detectable AF, AFL+, or AT

* ≥ 30 seconds in duration as adjudicated within the ADVENT Trial
* Investigator assessed ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care\* at the study center post-ADVENT Trial completion
* ≥ 30 seconds in duration recorded on the Holter monitor collected during the ADVENT Trial and the 3-4 Year Holter Monitor.
* ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG

Any Cardioversion for AF, AFL, or AT

Re-ablation for AF, AFL, or AT, 90 day-3 years
Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer
NCT Number: NCT06526520
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Frozen Embryo Transfer
Interventions: DRUG: Exposure to progesterone or HRT medication
Sponsor: ART Fertility Clinics LLC
Sex: FEMALE
Age: ADULT
Enrollment: 5
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-03-31
Locations: ART Fertiltiy Clinic, Abu Dhabi, 60202, United Arab Emirates

Summary:
To investigate the levels of Relaxin in different types of endometrial preparation for a frozen embryo transfer cycle. Up to now it is unclear, whether ovulation with a functional corpus luteum (CL) will be present in a natural proliferative phase (NPP) endometrial preparation approach.

Primary Outcome Measures: Relaxin measurement, Measurement of Relaxin in the different types of frozen embryo transfer, 4 to 6 months
PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics
NCT Number: NCT06526507
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hiv
Interventions: OTHER: Implementation strategy package
Sponsor: University of Washington
Collaborators: National Institutes of Health (NIH)|National Institute of Mental Health (NIMH)
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 17000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-01-01
Completion Date: 2028-12-31

Summary:
This project aims to develop a community of practice; then test a combination of community of practice, quality improvement, and a training toolkit, to enhance implementation and clinical outcomes; and identify patterns attributes associated with successful implementation.

Primary Outcome Measures: Service penetration, Number and proportion of pregnant and postpartum maternal child health clinic (MCH) clients who are screened for PrEP, 1 year|Reach, Number of pregnant and postpartum MCH clients initiated on PrEP each month, 1 year|Adoption (provider), Number, proportion, and representativeness of nurses and HIV testing services (HTS) providers who have begun offering or counseling on PrEP in MCH, 1 year|Adoption (facility), Proportion of facilities per county that have begun offering PrEP in MCH, 1 year
Metformin and Vascular Function in Prediabetes
NCT Number: NCT06526494
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: PreDiabetes
Interventions: DRUG: Metformin|OTHER: Placebo
Sponsor: Diana Jalal
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-18
Completion Date: 2026-10-01
Locations: University of Iowa, Iowa City, Iowa, 52242, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52245, United States

Summary:
The goal of this clinical trial is to investigate whether metformin improves vascular function in individuals with prediabetes. The main questions it aims to answer are:

1. Does metformin improve large conduit artery endothelial function in individuals with prediabetes?
2. Does metformin improve microvascular endothelial function in individuals with prediabetes?

Researchers will compare metformin to a placebo to see if metformin improves vascular function in prediabetes.

The trial duration is 12 weeks. Participants will take metformin or a placebo once a day for 2 weeks. After 2 weeks, participants will take metformin or a placebo twice a day for the remaining 10 weeks. There will be a screening visit, two baseline visits, a 4-week safety visit, and two 12-week end-of-study visits. Adherence will be calculated from pill count and adverse events will be quantified via a questionnaire.

Primary Outcome Measures: Macrovascular endothelial function, Brachial artery flow-mediated dilation, 12 weeks
Secondary Outcome Measures: Microvascular endothelial function, Cutaneous microvascular dilation, 12 weeks