pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Creatine Supplementation on Physical Performance in Vegan Subjects
NCT Number: NCT06483321
Acronym: CREATINVEG
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Deficiency; Diet
Interventions: DIETARY_SUPPLEMENT: Creatine Supplementation|DIETARY_SUPPLEMENT: Placebo
Sponsor: Universidad Francisco de Vitoria
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2024-09-30
Locations: Francisco de Vitoria University, Madrid, 28223, Spain

Summary:
The primary objective of this study is to investigate the effect of creatine monohydrate supplementation on body composition, physical performance, and muscle creatine levels in vegan individuals over four weeks.

Primary Outcome Measures: 30-meter sprint, Time (in seconds) taken to complete the 30-meter distance, 4 weeks|Countermovement jump (CMJ), Force output and calculates jump height based on flight time and take-off velocity, 4 weeks|15-repeated-jumps test, Height of each individual jump,recorded in centimeters, 4 weeks|Body weight, Body weight in kg, 4 weeks|Lean mass, Lean mass in kg, 4 weeks
Secondary Outcome Measures: Maximum isometric force, Peak force exerted during the test, typically recorded inkilograms-force (kg), 4 weeks|Blood creatine, Milligrams of creatine per deciliter of blood (mg/dL) and in micromoles of creatine per liter of blood (micromoles/L), 4 weeks|Blood creatinine, Milligrams of creatinine per deciliter of blood (mg/dL) and in micromoles of creatinine per liter of blood (micromoles/L), 4 weeks
Shortened High-dose Palliative Radiotherapy for Lung Cancer
NCT Number: NCT06483308
Acronym: SHiP-Rt
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stage IV Lung Cancer
Interventions: RADIATION: Radiotherapy
Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-03-31
Locations: University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom|University Hospitals Coventry and Warwcikshire, Coventry, Warwickshire, CV2 2DX, United Kingdom|University Hospitals Birmingham NHS Foundation Trust, Birmingham, West Midlands, B15 2, United Kingdom|The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, West Midlands, SY2 6LG, United Kingdom

Summary:
The SHiP-Rt Study aims to investigate the safety and efficacy of reducing the number of RT fractions and RT duration, compared to the current standard of care (36Gy in 12 fractions over 16 days), by using shortened hypofractionated accelerated palliative radiotherapy (30Gy in 6 alternate-day fractions), aided by contemporary RT planning, verification, and delivery techniques.

Primary Outcome Measures: Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03., 4 weeks of completing RT
Secondary Outcome Measures: Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03, 12 months|Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13), 12 months|Disease response and progression, 12 months|Cost-savings calculations to compare the proposed treatment regime to the standard of care., 12 months|Number of participants offered to participate in the study vs how many consent vs how many complete treatment, 12 months|Time to start systemic therapy from recruitment., 12 months
A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer
NCT Number: NCT06483282
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Small Cell Lung Cancer Limited Stage
Interventions: DRUG: Adebrelimab|DRUG: Apatinib Mesylate|DRUG: Etoposide|DRUG: Carboplatin
Sponsor: Jin Ying
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2026-12-31
Locations: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Summary:
This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-2N0-1M0 or T3N0M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery.

Primary Outcome Measures: pCR, pCR, Pathological Complete Response, defined as the complete absence of all tumor cells in the primary site and lymph nodes., Up to 2 years
Secondary Outcome Measures: MPR, MPR (Major Pathological response,) was defined as residual tumor cells ≤10% in pathological examination of postoperative specimens., Up to 2 years|EFS, EFS (Event-Free Survival) refers to the time from the beginning of randomization to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc., Up to 2 years|OS, OS (Overall Survival), the time from the date of randomization until the death of the participant or the last follow-up., Up to 2 years|ORR, ORR (Objective Response Rate) refers to the proportion of patients whose tumor shrinkage reaches a certain level and remains for a certain period of time, including complete response (CR) and partial response (PR) cases., Up to 2 years|Treatment-Emergent Adverse Events [Safety and Tolerability], Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0., Up to 2 years
Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.
NCT Number: NCT06483243
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG
Sponsor: Chong Kun Dang Pharmaceutical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-04
Completion Date: 2024-05-17
Locations: Chung-Ang University Gwangmyeong Hospital, Gyeonggi-do, Korea, Republic of

Summary:
This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

Primary Outcome Measures: AUCt of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Cmax of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration
Secondary Outcome Measures: AUC∞ of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Tmax of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|T1/2 of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|CL/F of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Vd/F of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration
Optimal Injection Interval for Intra-Detrusor Botulinum Toxin
NCT Number: NCT06483217
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overactive Bladder|Urinary Urgency|Urinary Incontinence|Urge Urinary Incontinence
Interventions: BEHAVIORAL: Patient-directed follow up
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-10
Locations: Louisiana State University Health Science Center, New Orleans, Louisiana, 70112, United States

Summary:
The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are:

* Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone?
* Does symptom control or patient satisfaction change when patients control their own follow up times?

Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.

Primary Outcome Measures: Injection interval, time to repeat injection (days), Days from initial injection to repeat injection, up to 365 days
Secondary Outcome Measures: Patient Satisfaction, Scores from the Surgical Satisfaction Questionnaire (SSQ-8), which contains 8 questions on satisfaction with a likert scale rating of 1-5. Higher scores indicate higher patient satisfaction., 1-2 weeks post-injection|Symptom Control, Scores from the Overactive Bladder Assessment Tool (OAB-Q), which contains 5 questions on symptoms and 5 questions on quality of life with a likert scale rating of 0-5. Higher scores on the symptom section indicate WORSE overactive bladder symptoms and higher scores on the quality of life section indicate higher levels of bother/WORSE quality of life., baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injection
Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis
NCT Number: NCT06483204
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Edema|Bruising|Nasal Obstruction|Postoperative Pain|Postoperative Nausea|Postoperative Complications
Interventions: DRUG: Medrol 4 MG Oral Tablet Includes Medrol Dosepak
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-12

Summary:
This study will be a prospective randomized study to evaluate the effect of medrol dosepaks (oral corticosteroids) on postoperative outcomes among patients undergoing rhinoplasty by Facial Plastic Surgeons at Vanderbilt. Outcomes will include postoperative pain, nausea, and patient experience, with secondary outcomes of swelling and bruising.

Methylprednisolone is an oral corticosteroid that has been shown in multiple RCTs and is used extensively that it can significantly reduce postoperative swelling and bruising in postoperative rhinoplasty patients, however, we have not examined if those effects extend to their pain ratings, nausea, and overall patient experience. Current research on use of steroids in rhinoplasty suggests that its use may decrease pain and nausea and benefit the patients overall experience.

Minimizing complications for any surgery is of upmost importance for surgeons.. However, the benefits of oral corticosteroid use for rhinoplasty patients in the immediate post-operative period are poorly understood and practice patterns vary widely. To identify and quantify the benefits and drawbacks of oral corticosteroid use in the immediate post-operative period for primary rhinoplasty patients, pain, swelling, nausea, patient experience, and post-operative swelling will be studied.

Primary Outcome Measures: Postoperative pain level, Pain measured on a 5 point likert scale from no pain at all to worst pain ever experienced, Daily for 7 days|Nausea, Nausea measured on 5 point likert scale from no pain at all to worst pain ever experienced, Daily for 7 days|Edema, Edema measured based on a reference image. Edema rated based on how far from nose and eyes has any swelling dispersed., Daily for 7 days|Bruising, Bruising measured based on a reference image. Bruising rated based on how far from the nose and eyes did bruising extend to., Daily for 7 days
Unlimited Transportation Passes for Unstable Housed People Living With HIV Trial
NCT Number: NCT06483152
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV
Interventions: OTHER: Metro Transit Pass|OTHER: Standard of Care
Sponsor: The Aliveness Project
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 146
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2025-02
Locations: The Aliveness Project, Minneapolis, Minnesota, 55409, United States

Summary:
The goal of this trial is to learn if providing an unlimited transit pass will improve the health of people living with HIV that are experiencing unstable housing.

The main questions it aims to answer are:

1. Do participants who are provided the transit pass manage their HIV better?
2. Do participants who are provided the transit pass use other social services more that could improve their health and quality of life?

Researchers will compare the group that is provided with the transit pass to a control group that is not provided with the pass.

Participants will fill out a baseline survey and a follow-up survey after 6 months. Researchers will also look at participant's HIV lab tests to see how well their HIV is being managed.

Primary Outcome Measures: Number of Participants with HIV Viral Suppression, Number of participants with a quantitative HIV Viral RNA test with a concentration under 200 copies of HIV per mL (viral suppression) within the last 12 months., 12 months|Number of Participants with an HIV related Medical Visit, Number of participants who have received a HIV viral RNA test during a medical visit within the last 12 months., 12 months
The Benefits of Nature for Mood and Cognition in Persons With and Without Parkinson's Disease
NCT Number: NCT06483126
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease|Mood|Cognition
Sponsor: Boston University Charles River Campus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-07-01
Locations: Vision and Cognition Laboratory, Boston University, Boston, Massachusetts, 02215, United States

Summary:
This online study aims to explore the benefits of nature for mood and cognition in persons with and without Parkinson's disease. For the purpose of this survey, "natural environment" refers to places that primarily consist of natural elements, such as vegetation, water bodies, and landscapes. This includes greenspaces (such as parks, gardens, neighborhood streets lined with trees, forests, or nature reserves) bluespaces (such as next to beaches, lakes, rivers, ponds, or waterfronts), and desert regions, among others.

Primary Outcome Measures: Nature Connection Index, Assesses the extent to which people feel connected to nature., Baseline|Perceived Restorativeness Scale, Assesses the extent to which particular environments have restorative qualities. Higher scores indicate greater perceived restorativeness., Baseline|Center for Epidemiological Studies Depression (CES-D), Assesses depressive symptoms in the general population. Maximum score:60. Higher scores indicate more severe depression., Baseline|Parkinson's Disease Sleep Scale-2, Assesses sleep and nocturnal disturbances in Parkinson's disease. Maximum score: 60. Higher scores indicate more frequent sleep disturbances., Baseline|Parkinson's Disease Questionnaire - 8 (PDQ-8), Assesses Parkinson's disease-specific health-related quality of life. Maximum Score: 32. Higher scores indicate worse quality of life., Baseline|Perceived Stress Scale, Assesses how different situations affect feelings and perception of stress. Maximum score: 40. Higher scores indicate higher perceived stress., Baseline|NIH NeuroQoL measures, Assesses health-related quality of life in adults with neurological disorders. Higher scores on the sub-scales indicate worse outcomes., Baseline|Parkinson's Anxiety Scale (PAS), Assesses the severity of anxiety symptoms in persons with Parkinson's disease. Maximum score:48. Higher scores indicate more severe anxiety., Baseline
DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study
NCT Number: NCT06483113
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myopia|Hyperopia|Presbyopia|Astigmatism
Interventions: DEVICE: Delefilcon A spherical soft contact lenses|DEVICE: Delefilcon A toric soft contact lenses|DEVICE: Delefilcon A multifocal soft contact lenses
Sponsor: Alcon Research
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-01
Locations: Contact Alcon Call Center for Trial Locations, Fort Worth, Texas, 30092, United States

Summary:
The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.

Primary Outcome Measures: Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric, Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses., Baseline|Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric, Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses., Year 1 Follow-Up|Distance visual acuity with study lenses at Baseline - Multifocal, Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses., Baseline|Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal, Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses., Year 1 Follow-Up|Near visual acuity with study lenses at Baseline - Multifocal, Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses., Baseline|Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal, Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses., Year 1 Follow-Up|Incidence of corneal infiltrative events, A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea., Up to Year 1|Incidence of microbial keratitis, Microbial keratitis is a sight-threatening infection of the cornea., Up to Year 1
Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance Using Peripheral Blood Clonotypic Mass Spectrometry
NCT Number: NCT06483100
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma
Interventions: DRUG: Elrantamab|DEVICE: EasyM|DEVICE: clonoSEQ
Sponsor: Washington University School of Medicine
Collaborators: National Comprehensive Cancer Network|Pfizer|Rapid Novor
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2031-09-30
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

Summary:
This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy and tolerability data for a personalized maintenance approach using peripheral blood-based clonotypic mass spectrometry MRD testing (the EasyM assay) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.

Primary Outcome Measures: Event-free survival (EFS), Includes progression, death, or treatment intolerance (discontinuation due to toxicity)., Through completion of follow-up (up to 5 years)
Secondary Outcome Measures: Progression-free survival (PFS), Progression-free survival (PFS) is defined as time to progression or death., Through completion of follow-up (up to 5 years)|Time to next therapy, Time to next therapy (TTNT) is defined as the time to initiation of subsequent anti-myeloma therapy (excluding standard-of-care maintenance)., Through completion of follow-up (up to 5 years)|Maximum depth of response by IMWG criteria, Through completion of end of study visit (up to 36 months)|Proportion of patients achieving MRD-negativity at the 10^6 threshold per the clonoSEQ assay, MRD negativity per the clonoSEQ assay will be defined as less than 1 myeloma cell per 10\^6 bone marrow cells evaluated (i.e. \<10-6), Through completion of end of study visit (up to 36 months)|Proportion of patients discontinuing therapy per MRD-guided protocol, Through completion of treatment (up to 36 months)|Time on treatment during study period, Through completion of treatment (up to 36 months)|Incidence and severity of treatment-related adverse events by CTCAE v5, From start of treatment through 90 days after completion of treatment (up to 39 months)|Overall survival (OS), Overall survival (OS) is defined as time to death., Through completion of follow-up (up to 5 years)
Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy
NCT Number: NCT06483061
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Epilepsy, Temporal Lobe
Interventions: DRUG: Ferumoxytol
Sponsor: University of Alberta
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-09-01
Locations: Peter S. Allen MRI Unit, Edmonton, Alberta, T6G 2R3, Canada

Summary:
Temporal lobe epilepsy (TLE) is a common type of epilepsy and one of the most likely to not be controlled by medication. For patients who do not respond to medication, surgery can result in a cure of seizures. Given the fact that around 50% of patients who undergo surgery are seizure free at 10 years there is a need to improve the understanding of what factors best predict surgical outcomes in order to improve our ability to select candidates for surgery.

The demonstration of abnormalities in the temporal lobe on MRI is one of the best predictors of seizure free surgical outcomes. Recent studies suggest that changes in specific subregions of the hippocampus could be the strongest predictors of surgical success, however the small size of these regions, (millimeters) make them very difficult to study with standard clinical MRI.

Recently new MRI methods have been developed at Wayne State University to image hippocampal blood vessels using ferumoxytol infusion. Feraheme (ferumoxytol) is a drug that is approved in the United States for the treatment of iron deficiency anemia and is currently being studied as an MRI contrast agent in 8 active clinical trials in the United States as well as a Parkinson's Disease study in Canada.

Primary Outcome Measures: Ferumoxytol enhanced cerebral vasculature imaging, Comparison of MRI image acquisition quality with existing images obtained using an established imaging protocol, One injection will be used while the participant is having an MRI|Ferumoxytol enhanced cerebral vasculature imaging, Comparison of microvasculature density of hippocampal subregions between participants with TLE and hippocampal sclerosis and control subjects, One injection will be used while the participant is having an MRI
Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy With Cryoablation in NSCLC
NCT Number: NCT06483009
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Non-Small-Cell Lung Cancer
Interventions: DEVICE: Cryoablation
Sponsor: Shanghai Chest Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-10

Summary:
This study aims to investigate the efficacy and safety of immuno-chemotherapy in combination of cryoablation as the first-line treatment of advanced NSCLC

Primary Outcome Measures: Progression-free survival (PFS), Assessed by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party., up to 3 years
Secondary Outcome Measures: Objective response rate (ORR), Proportion of subjects whose tumors were assessed by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party., up to 3 years|Disease control rate (DCR), Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party., up to 3 year|Duration of response (DOR), The time from onset of response to progression or death due to any reason, whichever occurs earlier, up to 3 years|Safety profile, Number of participants with adverse events as a measure of safety and tolerability., up to 3 years
Other Outcome Measures: Expression of immune factors, Flow cytometry analysis of the expression of immune factors in peripheral blood, an average of 6 weeks since immuno-chemotherapy, and at 1, 3, and 7 days after cryoablation
General Anesthesia on Blood Pressure and Intraocular Pressure in Geriatric Patients Undergoing Cataract Surgery
NCT Number: NCT06482996
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cataract
Interventions: OTHER: Intraocular pressure (IOP) was measured
Sponsor: Umraniye Education and Research Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-20
Completion Date: 2024-09-30
Locations: Umraniye Education and Research hospital, Istanbul, 34764, Turkey

Summary:
The primary aim of the study is to investigate the correlation between preoperative hemodynamics and frailty scores in patients undergoing cataract surgery under general anesthesia. The secondary objective is to explore the relationship between preoperative and postoperative intraocular pressure changes and frailty scores.

Primary Outcome Measures: intraocular pressure during genel anesthesia, intraocular pressure (mmHg), through study completion, an average of 1 day
Secondary Outcome Measures: hemodynamic data, mean arterial pressure (mmHg), through study completion, an average of 1 day
The Effects of VC Versus PC Ventilation on Cerebral and Respiratory Parameters in Patients Undergoing Laparoscopic Gynecologic Surgery
NCT Number: NCT06482983
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia|Gynecologic Cancer|Mechanical Ventilation Complication
Interventions: PROCEDURE: Mechanical Ventilation Mode
Sponsor: Umraniye Education and Research Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-08-31
Locations: Umraniye research and education hospital, Istanbul, Umraniye, 34764, Turkey

Summary:
The aim of the study was to determine whether the use of different mechanical ventilation modes in patients with Trendelenburg position and CO2 insufflation affects respiration and cerebral oxygenation due to postoperative atelectasis, and was to determine whether there was any hemodynamic effect.

Primary Outcome Measures: pulmonary datas in laparoscopic gynecologic surgery., peak airway pressure (minumum 40 cm H2O ,maksimum 40 cm H2O), one week|cerebral datas in laparoscopic gynecologic, NIRS (20% change from baseline value), one week
Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
NCT Number: NCT06482957
Acronym: CAUSAL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sarcoma
Interventions: OTHER: Surveys|OTHER: Blood Collection|OTHER: Saliva Collection|OTHER: Urine Collection|OTHER: Stool Collection|OTHER: Tissue collection|OTHER: Physical Activity Monitoring
Sponsor: Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-01
Completion Date: 2029-04
Locations: Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, 37203, United States

Summary:
This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.

Primary Outcome Measures: Impact of disease on adverse oncologic outcomes, Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs), Approximately six years|Impact of treatment on adverse oncologic outcomes, Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs), Approximately six years|Impact of sociodemographic contributors on adverse oncologic outcomes, Patient-Reported Outcomes Measurement Information System (PROMIS) Scores, Approximately six years|Impact of lifestyle contributors on adverse oncologic outcomes, Patient-reported outcome, Approximately six years
Comparison of Hypoxia Between HFNC and SNC in Patient Undergoing UGI Endoscopic Procedures in Deep Sedation
NCT Number: NCT06482879
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hypoxia
Interventions: DEVICE: Oxygen delivery
Sponsor: National Academy of Medical Sciences, Nepal
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 122
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-01
Completion Date: 2024-02-20
Locations: Anuj Jung Karki, Kathmandu, Bagmati, 44600, Nepal

Summary:
Hypoxia frequently occurs as a complication during upper gastrointestinal endoscopic procedures performed under deep sedation. Traditional oxygen delivery methods, such as the simple nasal cannula, are commonly used to prevent hypoxia in these cases. The high-flow nasal cannula, capable of delivering FiO2 levels of up to 1 and flow rates of up to 70 l/min, offers additional benefits, including positive end-expiratory pressure and reduced dead space. We hypothesized is that the use of high-flow nasal cannula can decrease the incidence of hypoxia in comparison to simple nasal cannula in patients undergoing upper gastrointestinal endoscopic procedures under deep sedation.

This was prospective, comparative observational study conducted in a tertiary care center of Nepal with the primary objective to compare the rates of hypoxia (SpO2 \< 92%) and secondary objectives were to compare interruption of procedure due to hypoxia, minimum hypoxia level and episodes of hypoxia between high flow nasal canula (flow rate of 30l/min with FiO2 of 0.5) and simple nasal canula (flow rate of 6l/min) in patients undergoing upper gastrointestinal endoscopic procedures in semi-prone position in deep sedation using propofol infusion.

The study comprised 125 participants, 58 in simple nasal canula and 67 in high flow nasal cannula group. The incidence of hypoxia in simple nasal cannula and high flow nasal cannula groups, with rates of 37.3% (22/58) and 16.4% (11/67), respectively. The relative risk (RR) of hypoxia was 0.43 (95% CI: 0.23-0.81), with a p-value of 0.009. Procedural interruptions due to hypoxia occurred in 8.6% (5/58) of participants in the simple nasal cannula group and 4.47% (3/67) in the high flow nasal cannula group, with RR of 0.17 (95% CI: 0.02-1.41) and a p-value 0.1. Furthermore, the occurrence of multiple episodes of hypoxia was higher in the simple nasal cannula group compared to the high flow nasal cannula group (5 vs. 0), with a p-value \< 0.001.The use of high flow nasal cannula reduces the occurrence of hypoxia in patients undergoing upper gastrointestinal endoscopic procedures with deep sedation compared to simple nasal cannula.

Primary Outcome Measures: Comparison of incidence of hypoxia between high flow nasal canula and Simple nasal canula, During the procedure
Secondary Outcome Measures: Comparison of frequency of hypoxia between high flow nasal canula and Simple nasal canula, During the procedure|Comparison of interruption of procedure between high flow nasal canula and Simple nasal canula, During the procedure
Synechie Afrer Rhinosug. Proc. 2024
NCT Number: NCT06482866
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Complication of Surgical Procedure
Interventions: OTHER: Cottle's septoplasty and radiocoagulation conchoplasty
Sponsor: Mateusz Jan Stępiński
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 243
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-26
Completion Date: 2024-06-26
Locations: Multidisciplinary Regional Hospital, Gorzów Wielkopolski, Woj. Lubuskie, 66-400, Poland

Summary:
Analyze the factors influencing the development of intranasal adhesions (synechiae), with particular emphasis on the use of nasal septal separators, and to suggest a solution to reduce this complication in the future.

Analyze of the medical documentation. It was not an experimental examination.

Primary Outcome Measures: Synechie, Intranasal synechiae after rhino nasal procedures, Between 2 weeks to 12 month
Safety and Efficacy of EasyCool Catheter
NCT Number: NCT06482840
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrhythmia
Sponsor: MedFact Engineering GmbH
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-08
Completion Date: 2024-08
Locations: Centre Hospitalier International de Carthagène, Tunis, Centre Urbain Nord, 1082, Tunisia

Summary:
The goal of this observational study is to learn about risks and benefit of EasyCool Catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias.

The main question\[s\] it aims to answer are:

* will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure
* what are the adverse events at procedure, after 3 and 6 months

All participants will receive cardiac ablation with EasyCool catheter.

Primary Outcome Measures: Removal of treated cardiac arrythmia, Removal of treated cardiac arrhythmia and absence of recurrence of the arrythmia, 3 months after procedure
Secondary Outcome Measures: Adverse Events, all adverse events in context to procedure and product, at procedure, after 3 and 6 months
Sleep Restriction and Parental History of Hypertension
NCT Number: NCT06482814
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: BEHAVIORAL: Partial sleep deprivation (sleep restriction)|BEHAVIORAL: Normal sleep
Sponsor: Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2028-04
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood pressure compared to a group of individuals whose parents have normal blood pressure.

Primary Outcome Measures: 24-hour Systolic Blood Pressure (BP), Systolic Blood pressure will be measured in mmHg, Day 2, Day 4, Day 7, and Day 9
Secondary Outcome Measures: 24-hour Diastolic blood pressure (DBP), Diastolic blood pressure will be measured in mmHg, Day 2, Day 4, Day 7, and Day 9|Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP), Awake SBP/DBP will be measured in mmHg/mmHg, Day 2, Day 4, Day 7, and Day 9|Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP), Asleep SBP/DBP will be measured in mmHg/mmHg, Day 2, Day 4, Day 7, and Day 9|Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping, SBP/DBP Nocturnal dipping will be measured in percent (%), Day 2, Day 4, Day 7, and Day 9|Catecholamines, Catecholamines will be measured from a 24-hour urine collection., Day 2, Day 4, Day 7, and Day 9|Baroreflex Sensitivity, Baroreflex Sensitivity will be measured from simultaneous electrocardiography (ECG) and noninvasive beat-to-beat BP recording., Day 3, Day 5, Day 8, and Day 10|Endothelial Function, Endothelial function will be estimated from flow-mediated vasodilation using ultrasound., Day 3, Day 5, Day 8, and Day 10|Blood Pressure (BP) response to stressors, BP response to stressors will be measured in mmHg, Day 3, Day 5, Day 8, and Day 10|Heart Rate response to stressors, Heart Rate response to stressors will be measured by ECG, Day 3, Day 5, Day 8, and Day 10|DNA-methylation, Methylated gene markers in peripheral blood mononuclear cells will be obtained, Day 3, Day 5, Day 8, and Day 10|Transcriptomic, Whole transcriptome in peripheral blood mononuclear cells will be obtained, Day 3, Day 5, Day 8, and Day 10
Other Outcome Measures: Arterial Tonometry, Pulse wave velocity will be measured by Applanation tonometry, Day 3, Day 5, Day 8, and Day 10
Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT
NCT Number: NCT06482801
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Liver Cancer|Antibody
Interventions: DRUG: ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2035-12-30
Locations: Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260, China

Summary:
This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).

Primary Outcome Measures: Safety of IT delivery of drugs combination treatment, Safety will be assessed by recording all types of advise effects upon and after the treatment., 5 years|Progression-free survival, Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment., 5 years|Disease control rate, Disease control rate will be defined as objective response rate + steady disease rate., 5 years|Duration of remission (DOR), DOR will be defined as the duration of the cancer remission., 5 years
Secondary Outcome Measures: Overall survival, Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study., 5 years
Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study
NCT Number: NCT06482788
Acronym: AEGIS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophagogastric Junction Adenocarcinoma
Interventions: DRUG: Adebrelimab (anti-PD-L1) + XELOX
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-22
Completion Date: 2027-05-31
Locations: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200025, China

Summary:
The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.

Primary Outcome Measures: Pathological complete response rate (ITT), The proportion of subjects with no cancer cells in the primary tumor and lymph node specimens (ypT0N0), From date of enrolment until surgical resection, an average of 3 months
Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder
NCT Number: NCT06482762
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Bipolar
Interventions: DEVICE: BrainSonix Pulsar 1002
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-31
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
The specific aim of this proposed study is to investigate the feasibility and therapeutic potential of transcranial focused ultrasound (tFUS) as a treatment for bipolar disorder (BD). Specifically, the investigators will study the effects of amygdala tFUS on corticolimbic activation during an emotion regulation task in BD, the effects of amygdala tFUS on corticolimbic resting-state functional connectivity in BD, and explore the relationship between tFUS-associated changes in amygdala activity and mood symptoms. The investigators hypothesize that transcranial focused ultrasound (tFUS) of the amygdala will be associated with decreased amygdala activation and increased ventromedial prefrontal cortex activation during a modified version of the Multi-Source Interference Task (MSIT) paired with affective pictures from the International Affective Picture System (IAPS). The investigators also hypothesize that tFUS of the amygdala will be associated with increased resting-state functional connectivity between the amygdala and ventromedial prefrontal cortex. Finally, the investigators hypothesize that tFUS-associated reductions in amygdala activity could be positively correlated with reductions in depressive symptom scores and global improvement.

Primary Outcome Measures: Corticolimbic network resting-state functional connectivity, Changes in amygdala and ventromedial prefrontal cortex resting-state functional connectivity from pre to post amygdala tFUS, 4 weeks|Mood symptoms, Changes in Young Mania Rating Scale (YMRS) and Beck's Depression Inventory (BDI), 4 weeks
Effect Of Extracorporeal Shockwave Therapy on Tension-Type Headache in Adolescent Females
NCT Number: NCT06482736
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tension-Type Headache
Interventions: DEVICE: Extracorporeal Shockwave Therapy
Sponsor: October 6 University
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-05
Completion Date: 2024-01-22
Locations: Kerolous Ishak Shehata Kelini, Cairo, Egypt

Summary:
Chronic headaches in adolescents can have consequences such as absence from school, inability to maintain social activities, and additional disorders such as anxiety, depression, problems sleeping, and reduced quality of life to investigates the efficacy shock wave diathermy on tension headaches in adolescent females

Primary Outcome Measures: digital algometer, Measure pain intensity pre and post treatment which tested the pain points of the muscles: upper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally., The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.|Electromyography (EMG) for neck muscles, Measure muscle activity pre and post treatmentupper trapezius, levator scapula, sternocleidomastoid, splenius head and neck bilaterally, The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.|Headache impact test questionnaire, The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session., The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
The Effect of Breathing Exercise With Pinwheel on the Quality of Life in Children With Cystic Fibrosis Disease
NCT Number: NCT06482710
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries|Breathing Exercise
Interventions: DEVICE: Pinwheel
Sponsor: Maltepe University
Sex: ALL
Age: CHILD
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-12-01
Completion Date: 2024-05-31
Locations: Maltepe University School of Nursing Istanbul, Maltepe, Turkey., Istanbul, Turkey

Summary:
This study aims to present the results of the effect of pinwheel breathing exercises on the quality of life in children with Cystic Fibrosis (CF). In this randomized controlled study, 81 children with CF who were being monitored by the treatment team in the pediatric chest polyclinic of a state hospital and meeting the inclusion criteria were divided equally into two groups. The children in the first group (intervention group) were instructed to perform breathing exercises with a pinwheel twice a day, at a convenient time in the morning and in the evening, every day for 3 months in their own homes according to the Breathing Exercise Tracking Form (BETF) and to fill in the required fields of the form during this process. The children in the second group (control group) did not perform the pinwheel breathing exercise. The quality of life of the children in both groups was evaluated with the Cystic Fibrosis Questionnaire-Revised (CFQ-R) (age group 6-11).

Primary Outcome Measures: Identifying children's quality of life, The child's routine implementation and follow-up of the breathing exercise was assessed., 3 months of routine implementation and follow-up of breathing exercise and change in quality of life of children.