pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure
NCT Number: NCT06549699
Acronym: MUTTON-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: OTHER: Medically Tailored Meal Program with Traditional Navajo Foods|OTHER: Usual Care
Sponsor: University of Pennsylvania
Collaborators: Indian Health Service|American Heart Association|Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 204
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-10-01
Locations: Gallup Indian Medical Center, Gallup, New Mexico, 87301, United States|Tohatchi Health Clinic, Tohatchi, New Mexico, 87325, United States

Summary:
Study subjects with heart failure will receive either pre-prepared, home-delivered DASH/SRD-compliant meals incorporating local Navajo traditional foods or usual care for 60 days.

Primary Outcome Measures: Hospitalization or Emergency Department Visit, Hospitalization or Visit to Emergency Department (All-cause), 90 days
Secondary Outcome Measures: Cultural Connectedness Scale-California, 60 days|KCCQ-12, 60 days|USDA Adult Food Security: Six Item short Form survey, 60 days|Biomarker Data, albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP, 60 days|Weight/Body Mass Index, Weight and BMI, 60 days|ER visits, All cause, 90 days|Hospitalizations, All cause, 90 days|ER visits or hospitalizations, All cause, 180 days|ER visit for HF, ER visit for volume overload or HF symptoms, 90 days|HF hospitalization, 90 days
A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
NCT Number: NCT06549686
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Osteoarthritis of the Knee
Interventions: BIOLOGICAL: CLS2901C (human [allogeneic] chondrocyte sheets)
Sponsor: CellSeed Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-10-20
Completion Date: 2031-07-31
Locations: Ebina General Hospital/Ebina Medical Plaza, Ebina, Kanagawa, 243-0433, Japan|Tokai University Hospital, Isehara, Kanagawa, 259-1193, Japan|Yokohama Sekishinkai Hospital, Yokohama, Kanagawa, 230-0062, Japan|Yokohama City University Medical Center, Yokohama, Kanagawa, 232-0024, Japan|Juntendo University Hospital, Bunkyō-Ku, Tokyo, 113-8431, Japan

Summary:
To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy + RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee (OAK).

Primary Outcome Measures: KOOS 4 score (The Knee injury and Osteoarthritis Outcome 4 score), Absolute change from baseline KOOS4 (Pain, Symptoms, ADL, QOL) score at postoperative Week 52. The four patient-relevant subscales of KOOS are scored separately: KOOS Pain (9items); KOOS Symptoms (7 items); KOOS ADL (17 items); KOOS QOL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures., 52 weeks
Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
NCT Number: NCT06549673
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Portal Hypertension|Cirrhosis|Varices, Esophageal
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 375
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2031-12-31

Summary:
This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria:

1. effective management or elimination of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete viral suppression in chronic hepatitis B, or long-term alcohol abstinence in alcohol-related liver disease),
2. liver stiffness measurements under 25 kPa, and
3. absence of varices as confirmed by endoscopy

Following the cessation of non-selective beta-blockers, patients will undergo a follow-up endoscopy at the one-year mark. The study's primary endpoint is recurrent varices in 1 year. Success will be defined as the upper bound of the 95% confidence interval for recurrent varices being \<5%. Should this criterion be met, the study will extend to predefined analyses of variceal haemorrhage and hepatic decompensation at 3-and 10-year intervals (funded through local resources; the General Research Fund will cover patient recruitment costs for 1 year). Clinical assessments, laboratory tests, liver and spleen stiffness measurements will be performed at baseline, 3 months, 6 months and 12 months to identify potential predictors of variceal recurrence and assess the feasibility of early identification.

Primary Outcome Measures: Recurrent varices, Upper endoscopy will be repeated to detect recurrent varices after stopping non-selective beta-blockers, 1 year
Secondary Outcome Measures: Prevalence of varices in screening cohort, In the initial screening cohort of all patients who undergo endoscopy, we will calculate the proportion and 95% CI of patients with LSM \<25 kPa who still harbour varices at baseline despite NSBB treatment and removal or suppression of the primary aetiological factor., Baseline|Resumption of NSBB and variceal haemorrhage, For patients discontinuing NSBB, the secondary endpoint is resumption of NSBB or variceal haemorrhage during follow-up., 5 years|Other decompensating events, Other decompensating events include ascites and hepatic encephalopathy post-NSBB cessation, and the statistical methods used will be similar to those for variceal haemorrhage., 5 years
Biomarkers of AKI in Patients Receiving Daratumumab
NCT Number: NCT06549634
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Multiple Myeloma|Light Chain Nephropathy
Interventions: DRUG: Daratumumab
Sponsor: Brigham and Women's Hospital
Collaborators: Janssen Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-10

Summary:
The goal of this prospective observational study is to understand changes in urinary and blood biomarkers associated with acute kidney injury (AKI) in patients newly diagnosed with multiple myeloma and being treated with Daratumumab SC. The aims of the study are:

To measure changes in plasma and urinary biomarkers of AKI before initiation of Daratumumab therapy and 30 days after initiation of therapy.

To establish whether these biomarkers serve to aid in early detection and prevention of AKI

Participants will give urine and blood samples at their normally scheduled lab appointments.

Primary Outcome Measures: Plasma and Urine Biomarkers, The primary outcome(s) will be changes in plasma suPAR and urinary levels of DKK3 between treatment initiation of daratumumab (day 0, or up to 7 days prior) and day +30 (+/-7 days) from the time of treatment initiation., 30 days
Cardiotoxicity of Carbon Monoxide in Patients Treated With Hyperbaric Oxygen Therapy
NCT Number: NCT06549621
Acronym: COCARDIOTOX
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Carbon Monoxide Poisoning
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-25
Completion Date: 2024-10-25
Locations: CHRU de Brest, Brest, 29909, France

Summary:
Carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. Its toxicity is based on the CO binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and ischemia-reperfusion injury.

This study aims to investigate the early and late cardiologic effects of CO in patients treated with hyperbaric oxygen (HBOT) for CO poisoning

Primary Outcome Measures: early and late cardiac injury due to CO poisoning description, clinical manifestation, troponin elevation and/or ECG abnormality during acute CO poisoning description; then late cardiac manifestation and abnormality declared by patients who have had early cardiac abnormality (troponin elevation and/or ECG abnormalities), enrollment (inclusion)
Secondary Outcome Measures: relationship between the source of CO poisoning and cardiac injury, comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test, enrollment (inclusion)|relationship between context of poisoning (domestic, professionnal or intentional poisoning) and cardiac injury, comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test, enrollment (inclusion)|relationship between other possibly associated poisoning and cardiac injury, comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test, enrollment (inclusion)|relationship between severity of neurological symptoms and cardiac injury, comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test, enrollment (inclusion)|relationship between cardiovascular risk factors or preexisting cardio vascular abnormality and cardiac injury, comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test, enrollment (inclusion)
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
NCT Number: NCT06549608
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypertrophic Cardiomyopathy
Interventions: DRUG: Mavacamten
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 685
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-20
Completion Date: 2025-04-18
Locations: St. Paul's Hospital, Vancouver, British Columbia, Canada

Summary:
This real-world study will describe the demographic and clinical characteristics and mavacamten treatment of adult patients with obstructive hypertrophic cardiomyopathy who participated in the Bristol-Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program in Canada.

Primary Outcome Measures: Participant demographics, Baseline|Participant clinical characteristics, Baseline
Secondary Outcome Measures: Dose regimen of mavacamten treatment, Every 3-months up to 14 months|Titration patterns of mavacamten treatment, Up to 14 months|Mavacamten treatment duration, Up to 14 months
Burn Coverage of Burn by Tilapia Fish Skin
NCT Number: NCT06549569
Acronym: TFS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Tilapia Fish Skin in Burn Coverage
Interventions: PROCEDURE: TFS
Sponsor: Aswan University
Sex: MALE
Age: CHILD
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2024-08-01
Locations: Amira Anter, Aswan, Egypt

Summary:
The goal of this experimental study is to compare TFS and regular dressings as coverage for acute thermal burns. The main question it aims to answer is:

Is TFS effective in treating thermal burns? burn induction was done on rabbits to obtain second-degree thermal burn, followed by coverage with TFS

Primary Outcome Measures: Tilapia Fish Skin Coverage in Acute Thermal Burn, 1 year
The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes
NCT Number: NCT06549556
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)|OTHER: Placebo
Sponsor: Al-Rasheed University College
Collaborators: Al-Farabi Kazakh National University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-11-01
Locations: Al-Zahraa Teaching Hospital, Wasit, 52001, Iraq

Summary:
The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are:

1. What are the effects of the tested regimens on the level of IL-1 and IL-15.
2. What are the effects of the tested regimens on the Fasting Blood glucose?
3. What are the effects of the tested regimens on the HbA1C?
4. What are the effects of the tested regimens on the Body Mass Index?
5. What are the effects of the tested regimens on the Lipid profile?
6. What are the effects of the tested regimens on C-reactive protein?
7. What are the effects of the tested regimens on Hematological indices?
8. What are the effects of the tested regimens on Rate pressure product?

Participants will be separated into four groups:

1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days
2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.
3. Group 3 (Diabetes Type 2): 23 Pateins, will be receiving Placebo Capsule per oral once daily for 60 days
4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.

Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on Fasting Blood Glucose, HbA1c, Lipid profile, Rate pressure product, C-reactive protein, Hematological indices, and Body Mass Index. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.

Primary Outcome Measures: Serum IL-1 Level, Measured in Pg/mL, at Baseline, and After 60 days of treatment.|Serum IL-15 Level, Measured in Pg/mL, at Baseline, and After 60 days of treatment.|Fasting Blood Sugar (FBS), Measured in mg/dL, at Baseline, and After 60 days of treatment.|Hemoglobin A1C (HbA1C), Measured in percent from total Hemoglobin, at Baseline, and After 60 days of treatment.|Body Mass Index (BMI), Measured in Kg/m², at baseline, and after 60 days of treatment.
Secondary Outcome Measures: Serum C-reactive protein (CRP), Measured in mg/dL, At baseline, and after 60 days of treatment|Rate Pressure Product, Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg), at Baseline, and after 60 days of treatment.
High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients
NCT Number: NCT06549543
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: OTHER: High Intensity Laser Therapy|OTHER: Transcutaneous Electrical Nerve Stimulation|OTHER: Hotpacks|OTHER: SHAM - High Intensity Laser Therapy
Sponsor: Baskent University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-04-01
Completion Date: 2024-02-01
Locations: Başkent University Faculty of Medicine, Yüreğir, Adana, 01060, Turkey

Summary:
The aim of this prospective, randomized, double-blinded study is to investigate the additional benefits of high-intensity laser therapy (HILT) over conventional physiotherapy, related to pain and function, in patients with knee osteoarthritis (KOA).

Primary Outcome Measures: The Visual Analog Scale (VAS), The VAS was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Min score was 0 and max score was 100. Higher scores on the VAS indicate greater pain., 12 weeks
Secondary Outcome Measures: Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC), The WOMAC was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Higher scores on the WOMAC indicate poorer functional capacity and greater pain and stiffness., 12 weeks|Lequesne Algofunctional Index (LAI), The LAI was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Higher scores on the LAI indicate poorer functional capacity and greater pain and stiffness., 12 weeks
Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections
NCT Number: NCT06549530
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Monkeypox (Mpox)
Interventions: DRUG: MVA-BN
Sponsor: Bavarian Nordic
Collaborators: Coalition for Epidemic Preparedness Innovations
Sex: ALL
Age: CHILD, ADULT
Enrollment: 460
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-16
Completion Date: 2026-05-07

Summary:
All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).

Serum samples for assessment of immune response will be collected at baseline (visit of first vaccination) and at 2 weeks (week 6), 6 months (week 30), and 1 year after the second (last) vaccination.

Primary Outcome Measures: Immunogenicity of 2 doses of MVA BN, Titer of serum neutralizing antibodies against vaccinia virus as measured by plaque reduction neutralization tests (PRNTs) 2 weeks after the second MVA BN vaccination, 2 weeks after the second MVA-BN vaccination|Occurrence of Safety Adverse Events (SAE) & Adverse of Event of Special Interest (AESI) events, Occurrence of any SAE at any time during the trial period Occurrence of any AESI at any time during the trial period, 2 weeks after the second MVA-BN vaccination
Bioequivalence Study of AG2202
NCT Number: NCT06549504
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bioequivalence Study
Interventions: DRUG: AG2202T|DRUG: AG2202R
Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-09

Summary:
The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.

Primary Outcome Measures: AUC, Area under the plasma concentration, Pharmacokinetic plasma samples collected over 36 hour period|Cmax, Peak Plasma Concentration, Pharmacokinetic plasma samples collected over 36 hour period
A Sleep Intervention for Preschoolers in Foster Care
NCT Number: NCT06549491
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep
Interventions: BEHAVIORAL: Sleep Wizard
Sponsor: Bradley Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2026-09-01
Completion Date: 2028-08-31

Summary:
Healthy sleep is critical for optimal health and development, but there are no public health interventions to support sleep for children in foster care. This proposal will develop and implement a digital public-health-level intervention to support foster caregivers in promoting healthy sleep in the young children in their care. The digital intervention approach has the potential to maximize scalability and reach to support foster children and their caregivers on a national level.

Primary Outcome Measures: Foster parent-child interactions and behaviors around sleep, Participant responses on The Parent-Child Sleep Interactions Scale (possible range: 0-48). Higher scores indicate a higher frequency of parent-child interactions and behaviors that have been shown to be associated with poorer child sleep., baseline, and at 2 week and 3 month follow ups|Child sleep, Participant responses on The Children's Sleep Habits Questionnaire (possible range: 33-99). Higher scores indicate more severe child sleep disturbances., baseline, and at 2 week and 3 month follow ups
Secondary Outcome Measures: Child health, Participant responses on The Child Behavior Checklist. Scores are percentile based, with higher scores indicating more severe total problems (e.g., internalizing and externalizing symptoms). Scores in the 95th percentile and below are in the normal range, scores in the 96th to 97th percentile are borderline, and scores in the 98th percentile and above are in the clinical range., baseline, and at 2 week and 3 month follow ups|Foster parent sleep, Participant responses on the Pittsburgh Sleep Quality Index (PSQI). The possible range for the Global PSQI score is 0-21, with higher scores indicating worse sleep quality., baseline, and at 2 week and 3 month follow ups|Foster parent stress, Participant responses on The Parenting Stress Index-4-Short Form. This 36 item measure yields a total stress score with a possible raw score range of 0-180, with higher scores indicating higher levels of stress in the parental role., baseline, and at 2 week and 3 month follow ups|Foster parent health, Participant responses on The Patient-Reported Outcomes Measurement Information System (PROMIS)-General Health 1.2. This is a 10-item measure of global health status. Scores are computed to derive a global physical health (4 items) and mental health (4 items) subscale. Possible scores on each subscale range from 4-20, with higher scores indicating better health/functioning. Two additional items assess general health and social role satisfaction., baseline, and at 2 week and 3 month follow ups
eFLASH for Skin Lesions of Malignant Melanomas
NCT Number: NCT06549439
Acronym: Flash-Skin I
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Melanoma
Interventions: RADIATION: Electron FLASH radiotherapy
Sponsor: University of Zurich
Collaborators: Varian, a Siemens Healthineers Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-07

Summary:
This prospective single center phase I trials aims to assess feasibility and safety of electron FLASH RT for treatment of melanoma skin metastases. Feasibility will be defined as FLASH delivery with an accuracy of +/-10% for each fraction, safety will be confirmed if a maximum of 2 out of 6 patients develop dose limited toxicity.

Primary Outcome Measures: Dose Limiting Toxicity (Safety), H0: More than of 2 out of 6 patients in the primary study cohort (n=6) develop DLT in FLASH-irradiated lesions.

H1: A maximum of 2 out of 6 patients in the primary study cohort (n=6) develop DLT in FLASH-irradiated lesions., 9 months|Dose Accuracy (Feasibility), H0: More than of 2 out of 12 Flash-RT fractions in the primary study cohort (n=6) have a dose deviation larger than ±10%.

H1: A maximum of 2 out of 12 Flash-RT fractions in the primary study cohort (n=6) have a dose deviation larger than ±10%., 9 months
Secondary Outcome Measures: Relief of Pain, Pain will be assessed using an analogic visual pain scale (scale 0-10; 0=no pain, 10=worst pain), 21 months|Relief of Hemorrhage, Hemorrhage will be visually assessed by the investigator, 21 months|Local response assessment, Local response and control of irradiated metastases will be measured as recording of clinical response assessment including photo documentation, 9 months|Late side effects, Late side effects "in radiation field" (≥ 3 months an within 12 months post-treatment) will be measured as recording of late adverse events (CTCAE v5.0); and comparison of Flash- and Conv-irradiated lesions, 21 months
18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer
NCT Number: NCT06549413
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Carcinoma
Interventions: OTHER: Non-Interventional Study
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-23
Completion Date: 2027-12-31
Locations: M D Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
This study is being done to learn how 18F-FSPG PET/CT scan results may be related to the response to chemotherapy and radiation in patients with esophageal cancer.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management
NCT Number: NCT06549387
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amount of Corneal Flattening (Kmax Flattening)|Change in the Endothelial Cell Count
Interventions: PROCEDURE: Corneal cross linking
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-04-30
Locations: Kasr Al Ainy, Cairo, Egypt

Summary:
The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.

Primary Outcome Measures: Amount of corneal flattening, Kmax flattening, 6 months|Change in the endothelial cell count., the stability or decrease in the endothelial cell count., 6 months
Secondary Outcome Measures: Best corrected visual acuity, 6 months
A Retrospective Study on Extranodal DLBCL
NCT Number: NCT06549361
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Lymphoma|Extranodal Lymphoma|Diffuse Large B Cell Lymphoma
Interventions: OTHER: No interventions need to be specified for this study
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5023
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-01
Completion Date: 2023-09-01
Locations: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200000, China

Summary:
The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.

Primary Outcome Measures: Overall Survival (OS), Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause., Time Frame: Baseline up to data cut-off (up to approximately 1 year)|Progression Free Survival (PFS), Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause., Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Secondary Outcome Measures: Clinical characteristics form, Clinical characteristics from data filled into registry forms by physicians and data managers, including but not limited to values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number and location of extranodal localizations., Baseline up to data cut-off (up to approximately 1 year)
Radiation Free Study
NCT Number: NCT06549348
Acronym: RadFree
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Aneurysm
Interventions: RADIATION: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
Sponsor: Philips Clinical & Medical Affairs Global
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 182
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.

Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)

Primary Outcome Measures: To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)., Procedure fluoroscopy time, Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients With Follicular Lymphoma (FL)
NCT Number: NCT06549335
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Follicular Lymphoma
Interventions: DRUG: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2026-12-31
Locations: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Summary:
This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas

Primary Outcome Measures: Objective response rate (ORR), Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria, At the end of Cycle 6 (each cycle is 28 days)
Secondary Outcome Measures: Complete response rate (CR), Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria., At the end of Cycle 6 (each cycle is 28 days)|Partial response rate (PR), Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria., At the end of Cycle 6 (each cycle is 28 days)|Duration of response, Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT., Baseline up to data cut-off (up to approximately 2 years)|2-year progression free survival rate, progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first., Baseline up to data cut-off (up to approximately 2 years)|2-year overall survival rate, progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of death from any cause., Baseline up to data cut-off (up to approximately 2 years)
Trial of JMKX003801 in Healthy Participants
NCT Number: NCT06549309
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: JMKX003801|DRUG: Placebo
Sponsor: Jemincare
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-06-12
Locations: Huashan Hospital Fudan University, Shanghai, Shanghai, China

Summary:
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants

Primary Outcome Measures: Adverse events (AEs), Incidence and features of AEs, From baseline to Day 3
Secondary Outcome Measures: Serum concentrations of JMKX003801, Serum concentrations of JMKX003801, From baseline to Day 3
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
NCT Number: NCT06549296
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus|Systemic Sclerosis|ANCA Associated Vasculitis|Idiopathic Inflammatory Myopathies|Sjogren's Syndrome|Autoimmune Diseases
Interventions: DRUG: RD06-04 CART Cell Injection
Sponsor: Nanjing Bioheng Biotech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2027-08-01
Locations: Xuzhou Medical University Affiliated Hospital, Xuzhou, Jiangsu, 221000, China

Summary:
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS

Primary Outcome Measures: The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment, 2 years
Assessing the Safety, Immunogenicity and Ex-vivo Efficacy of Two Candidate Malaria Transmission Blocking Vaccines, Pfs25-IMX313 and Pfs45/48 Administered Alone and in Combination, in Matrix-M Adjuvant
NCT Number: NCT06549257
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Plasmodium Falciparum Malaria
Interventions: BIOLOGICAL: Pfs25-IMX313, Pfs48/45
Sponsor: University of Oxford
Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2025-12

Summary:
Assessing the safety, immunogenicity and ex-vivo efficacy of two transmission blocking vaccines (Pfs25-IMX313 in Matrix M and Pfs48/45 in Matrix M alone and co-administered) in Burkina Faso, in 18-45 years, 12-17 years and 05-11 year olds.

Primary Outcome Measures: To assess safety and reactogenicity of Pfs25-IMX313-Matrix-M, Pfs48/45-Matrix M administered alone or in combination, in healthy Burkinabé adolescents and children naturally exposed to malaria., Occurrence of solicited local and systemic reactogenicity signs and symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3, 5 and 6 after vaccination).

* Occurrence of unsolicited adverse events (AE) including safety laboratory measures for 28 days following each vaccination
* Occurrence of serious adverse events (SAEs) during the whole study duration
* Occurrence of AEs of special interest (AESIs) during the whole study duration, Through study completion, an average of 8 months from enrollment
Secondary Outcome Measures: To determine the Pfs25 and Pfs48/45 humoral immune response, Pfs25 and Pfs48/45 antibody levels elicited by Pfs25IMX313-Matrix-M and Pfs48/45 in Matrix-M as measured by ELISA at Days 0, 14, 28, 42, 56, 72, 140, 236, Through study completion, an average of 8 months from enrolment|To determine the ex-vivo functional transmission blocking activity of Pfs25 and Pfs48/45 administered alone and in combination, Standard membrane feeding assays (SMFA) and direct membrane feeding assays (DMFA) at Days 0, 14, 28, 42, 56, 72, 140, 236, reported as a percentage of transmission reducing activity compared to controls (% TRA)., Through study completion, an average of 8 months from enrolment
Preoperative Maximum Inspiratory Pressure and Outcomes After Interscalene Block in Obese Patients
NCT Number: NCT06549244
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dyspnea After Interscalene Nerve Block
Interventions: DIAGNOSTIC_TEST: Maximum Inspiratory Pressure monitoring
Sponsor: University of North Carolina, Chapel Hill
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-01
Completion Date: 2024-01-10
Locations: University of North Carolina, Chapel Hill, North Carolina, 27599, United States

Summary:
The study aims to explore if Maximum Inspiratory Pressure can predict postoperative breathlessness in obese patients receiving interscalene blocks for shoulder surgery.

The main question is: does baseline Maximum Inspiratory Pressure have any association with postoperative breathlessness after interscalene blocks in class 2 or higher obese patients (BMI\>35).

Preoperative and postoperative lung volumes, pressures, breathlessness score and respiratory outcomes will be measured on participants already receiving shoulder surgery with interscalene blocks.

Primary Outcome Measures: Incidence of Moderate to Severe Breathlessness, Score of 3 or above on Modified Borg Breathlessness Scale, Baseline (Arrival to pre-operative phase), Recovery (Immediately post-surgical, up to 3 hours)
Secondary Outcome Measures: Oxygen Saturation in post-anesthesia care unit, Measured by pulse oximetry, Recovery (Immediately post-surgical, up to 3 hours)|Post-anesthesia care unit length-of-stay, Total time spent in post-operative phase of care, Recovery (Immediately post-surgical, up to 3 hours)|Duration of Oxygen supplementation in post-anesthesia care unit, Total duration of oxygen supplementation in post-operative phase of care, Recovery (Immediately post-surgical, up to 3 hours)
Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Tragus and Tongue Stimulation.
NCT Number: NCT06549205
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arousal, Confusional
Interventions: DEVICE: device that stimulates the dorsal surface of the tongue|DEVICE: device that stimulates the tragus
Sponsor: University of L'Aquila
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-04-02
Completion Date: 2024-01-12
Locations: Sara Di Nicolantonio, L'Aquila, 67100, Italy

Summary:
this study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level.

Primary Outcome Measures: Changes on Low Frequency parameter (LF), Whether or not HRV parameter (LF) improve following tongue and tragus stimulation will be assessed by photopletismographic wave, 12 minutes|Changes on Root mean square standard deviation (RMSSD) parameter, Whether or not HRV parameter (RMSSD) improve following tongue and tragus stimulation will be assessed by photopletismographic wave, 12 minutes
ACT-Together (Acting on Cancer Testing-Together)
NCT Number: NCT06549153
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: OTHER: Education Content|OTHER: Focus Group
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-12-01
Completion Date: 2027-12-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To determine the feasibility of a group-based education intervention to improve adherence to recommend surveillance and risk reducing procedures, with a focus at medically underserved women and racial/ethnic minorities with BRCA 1 and 2.

Primary Outcome Measures: Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Effects of an Augmented Reality Exercise Program in Older Adults
NCT Number: NCT06549140
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Augmented Reality Exercise Program|Traditional Exercise Program|Control Group
Interventions: OTHER: Augmented reality exercise program|OTHER: Traditional exercise program
Sponsor: Universidade da Madeira
Collaborators: Élvio Rúbio Gouveia|Hildegardo Noronha|Francisco Santos|Mara Dionísio|Eva Freitas|Pedro Campos|Paulo Bala
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01
Completion Date: 2025-04

Summary:
This research aims to examine the effects of an augmented reality (AR) exercise program on physical fitness (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory).

Primary Outcome Measures: Physical fitness, Physical fitness will be assessed using the fitness test battery proposed by Rikli \& Jones (1999), including: 30-s chair stand test to assess lower-body strength, arm curl test to evaluate upper-body strength, back scratch test to examine upper-body flexibility, chair seat and reach test to assess lower-body flexibility, 8-foot up-and-go test to assess agility and dynamic balance, and the 6-min walk test to evaluate aerobic endurance., Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.|Physical activity, Physical activity levels will be measured using accelerometry during each exercise session., Participants enrolled in exercise programs will be monitored using accelerometry. Individual data will be collected in all exercise sessions (total of 48 sessions).|Body composition, Body composition will be evaluated using the InBody 770, which allows a hand-to-foot biolectrical analysis. Bodyweight, body fat percentage, and fat-free mass will be used for analysis., Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.|Cognitive function, Participants' cognitive function will be examined through the Cognitive Telephone Screening Instrument and the Mini Mental State Examination., The assessment will be conducted at baseline, at week 6, at week 13 and at week 18.
Secondary Outcome Measures: SF-36 questionnaire, The SF-36 questionnaire is used to assess the participant's health status of participants. It consists of 36 items that assess physical functioning, physical performance, physical pain, emotional functioning, vitality, mental health, social functioning, and general health. The higher the score, the better the participant's health., The assessment will be conducted at baseline and at week 13 after the intervention end.
Research on Clinical Safety and Effectiveness of Wearable Assistive Devices With Flexible Structure for Daily Life Support of Stroke Patients
NCT Number: NCT06549127
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Hemiplegia
Interventions: DEVICE: Soft Wearable Robot
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-05-15
Completion Date: 2024-05-29
Locations: Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of

Summary:
Gait independence is a critical goal for stroke patients and significantly impacts their return to society. Due to hemiplegia, stroke patients often face walking difficulties. Compensatory approaches using lower limb assistive devices have shown promise in improving independent walking. Wearable assistive devices, which minimize daily life restrictions, are gaining attention globally. Despite the availability of many imported rehabilitation assistive devices, their high cost and poor fit for East Asian patients highlight the need for domestic alternatives. In light of the global interest in robotics, there is a shortage of domestic research on advanced wearable robots. This study aims to clinically test and verify the effectiveness of a flexible, wearable robotic assistive device developed by Angel Robotics for stroke patients.

Primary Outcome Measures: 10-meter walking test, The 10 Meter Walk Test (10MWT) is a simple and commonly used assessment to evaluate walking speed. During the test, participants are instructed to walk a distance of 10 meters. The time is measured for the middle 6 meters, allowing the first and last 2 meters for acceleration and deceleration. This approach ensures a more accurate assessment of the participant's steady-state walking speed., Initial Assessment|10-meter walking test, The 10 Meter Walk Test (10MWT) is a simple and commonly used assessment to evaluate walking speed. During the test, participants are instructed to walk a distance of 10 meters. The time is measured for the middle 6 meters, allowing the first and last 2 meters for acceleration and deceleration. This approach ensures a more accurate assessment of the participant's steady-state walking speed., After 2 weeks of hip assistive device adaptation training|10-meter walking test, The 10 Meter Walk Test (10MWT) is a simple and commonly used assessment to evaluate walking speed. During the test, participants are instructed to walk a distance of 10 meters. The time is measured for the middle 6 meters, allowing the first and last 2 meters for acceleration and deceleration. This approach ensures a more accurate assessment of the participant's steady-state walking speed., After 2 weeks of knee assistive device adaptation training
NLR and Emergency Surgery
NCT Number: NCT06549101
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Emergency Surgery
Sponsor: University of Chile
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 851
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-23
Completion Date: 2023-12-30
Locations: Hospital Clínico de la Universidad de Chile, Santiago, 8380456, Chile

Summary:
In the immune system, it has been observed that the preoperative neutrophil-to-lymphocyte ratio (NLR) is an index that reflects the state of inflammation and oxidative stress. In the perioperative period, NLR has been described as a predictor for patients who will develop renal injury, ischemic stroke, and myocardial injury. Since preoperative inflammation is a predictor of morbidity and mortality in patients undergoing non-cardiac surgery, we propose conducting a retrospective analysis of the inflammatory status of patients undergoing surgery at our center.

Primary Outcome Measures: NLR, Preoperative neutrophil-to-lymphocyte ratio, Day of surgery|Mortality, 30 and 180 days mortality, 6 months after surgery