louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00108329: Weight Loss in Diabetic, Older Obese Adults
Official title: 5449 Genetics, Weight Loss and Glucose Metabolism in Older Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: aging
exercise
metabolic syndrome
insulin resistance
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study examines the effects of weight loss and aerobic exercise training on sugar metabolism and other risk factors for heart disease in obese older individuals.


Eligibility criteria: Inclusion Criteria:

* Age \> 50 years,
* Body mass index (BMI) \> 27kg/m(2),
* No prior history of diabetes or coronary disease,
* Sedentary

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References:
Clinical trial NCT06288529: EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY
Official title: PROTECTIVE EFFECT OF SGLT2 INHIBITORS ON POST-CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY IN DIABETIC AND CKD PATIENTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Type2diabetes
Keywords: Sodium-glucose co-transporter inhibitor
post-contrast acute kidney injury
contrast media
diabetes mellitus
chronic kidney disease
Lead sponsor: University of Health Sciences Balikesir Hospital Eduation and Research
Sponsor class: OTHER_GOV
First posted: 2024-03-01
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total of 975 patients are palanned to be included in our study who underwent coronary artery imaging or percutaneous coronary intervention procedures using CM in three tertiary hospitals. Patient ages between 18 and 75 years and estimated glomerular filtration rates (eGFRs) between 25 and 115 mL/(min•1.73 m2) are palanned to be included in our analyses.

Brief summary: Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.

In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent coronary artery imaging or percutaneous coronary intervention procedures using contrast media
* Patient ages were between 18 and 75 years
* Estimated glomerular filtration rates (eGFRs) between 25 and 115

Exclusion Criteria:

* Patients with acute myocardial infarction, acute renal injury, history of kidney transplantation, severe heart failure (HF, New York Heart Association IV), malignancy, also patients who received other PC-AKI preventive medications like as N-acetylcysteine, sodium bicarbonate, or incomplete medical records were excluded from the analyses.

Primary outcomes:
measure: Development of post-contrast acute kidney injury
timeFrame: Within 48-72 hours following intravenous contrast medium administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: University of Health Sciences Balikesir Education and Research Hospital
Study officials:
References:
Clinical trial NCT05270629: Supermicrosurgical Lymphvenous Bypass Intervention for Treatment
Official title: Supermicrosurgical Lymphvenous Bypass Intervention for Lymphedema Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphedema of Leg
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (age \> 18 years) with lower limb lymphedema patients were enrolled from March 2016 to December 2020.

Brief summary: Background: In addition to antegrade anastomosis, retrograde anastomosis has been thought to offer further improvements after lymphaticovenous anastomosis (LVA) by bypassing the retrograde lymphatic flow. However, this concept has yet to be validated. The aim of this study was to determine the impacts on outcomes of performing both retrograde and antegrade anastomosis, as compared to antegrade-only anastomosis for treating lower limb lymphedema.


Eligibility criteria: Inclusion Criteria:

* Lower limb lymphedema patients.

Exclusion Criteria:

* Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.

Primary outcomes:
measure: Magnetic resonance volumetry
timeFrame: 6 months after LVA
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT01019629: Fabry Screening Study
Official title: Expanded Screening for Fabry Trait
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fabry Disease
Keywords: Fabry, Fabry Disease, Alpha-galactosidase A deficiency, GLA gene, mutations
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 2724
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with any type of cardiac diagnosis

Brief summary: To determine if patients with a deficiency of alpha-galactosidase A are at-risk for cardiac complications that commonly occur in the general population

Detailed description: Fabry disease is an X-linked deficiency of alpha-galactosidase A resulting primarily in an accumulation of globotriaosylceramide (Gb3) in virtually all organs and systems. The main complications of Fabry disease are a 20-fold increased risk of ischemic stroke, cardiac disease including cardiomyopathy, atrio-ventricular conduction defects, a wide variety of arrhythmias, valvular dysfunction (insufficiency or stenosis) and cardiac vascular disease as well as progressive renal failure. Fabry disease cannot be easily diagnosed in patients with routine EKGs, echocardiograms or MRIs. Screening non-selected at-risk populations of patients with ischemic stroke or cardiac disease for urinary Gb3, alpha-galactosidase A activity and GLA gene mutations should enable the identification of patients previously undiagnosed with Fabry disease among the general population of patients with heart disease and stroke

Eligibility criteria: Inclusion Criteria:

* Any diagnosis of heart disease.
* Male or Female
* Able to donate 12 cc of whole blood and 10 cc of urine

Exclusion Criteria:

* No diagnosis of cardiac disease.
* Unable to donate 12 cc of whole blood and/or 10 cc of urine

Primary outcomes:
measure: Identify GLA gene variants
timeFrame: Once
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Institute of Metabolic Disease
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Raphael Schiffmann, M.D., M.H.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiffmann R, Forni S, Swift C, Brignol N, Wu X, Lockhart DJ, Blankenship D, Wang X, Grayburn PA, Taylor MR, Lowes BD, Fuller M, Benjamin ER, Sweetman L. Risk of death in heart disease is associated with elevated urinary globotriaosylceramide. J Am Heart Assoc. 2014 Feb 4;3(1):e000394. doi: 10.1161/JAHA.113.000394.
Clinical trial NCT06317129: Clinical Feasibility Study of the BariTon™ System in Obese Patients
Official title: Clinical Feasibility Study of the BariTon™ System in Obese Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: BariaTek Medical
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged between 25 and 60 years inclusive
2. A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program
3. Stable weight, i.e. \< 5% change in body weight for minimum of 3 months prior to enrolment
4. Willing and able to provide written informed consent
5. Willing and able to comply with the study procedures and follow-up schedule

Primary outcomes:
measure: Safety of the BariTon™
timeFrame: 3 months
measure: Safety of the BariTon™
timeFrame: 3 months
Secondary outcomes:
measure: Safety of the BariTon™
timeFrame: 1 year
measure: Safety of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov
Study officials:
References:
Clinical trial NCT05827029: Gastric Volume After Ingestion of Carbohydrate Drink vs Water in Obese Volunteers
Official title: Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obese Volunteers: A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Gastric Emptying
Keywords: gastric residual volume, obesity, carbohydrate drink
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: This randomized crossover study compares gastric residual volume after ingestion of carbohydrate drinks and water in obese volunteers. The main question\[s\] it aims to answer are:

* Is it safe for obese patients to shorten their fasting by allowing preoperative drinks?
* How long is the gastric emptying time in obese patients? Participants also will be evaluated the level of thirst/hungry and blood sugar.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 18 - 65 years old
* BMI ≥ 30 kg/m2
* NPO for at least 6 hours before the study

Exclusion Criteria:

* Diabetes Mellitus
* Chronic kidney disease or End-stage renal disease
* Use of any medication that affects gastric secretion or emptying (Histamine 2 receptor antagonist eg. Ranitidine/Proton pump inhibitor eg. Omeprazole/Acid neutralization eg. Aluminium hydroxide/Prokinetic eg. Domperidone) within the past 24 hours
* Gastroesophageal reflux disease
* Pregnancy
* History of upper gastrointestinal surgery
* In diet program or use appetite suppressant drug (eg. Liraglutide, Naltrexone, Phentermine, Diethylpropion) within the past 24 hours

Primary outcomes:
measure: gastric residual volume
timeFrame: baseline and every 30 minutes until 2 hours after drinking
Secondary outcomes:
measure: time to empty gastric antrum
timeFrame: baseline and 120 minutes after drinking
measure: POCT glucose
timeFrame: baseline and 120 minutes after drinking
measure: thirst and hunger level
timeFrame: baseline and 120 minutes after drinking
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Department of Anesthesiology, Faculty pf Medicine
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
name: Chanatthee Kitsiripant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06558929: Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With CRSWD
Official title: Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With Circadian Rhythm Sleep-Wake Disorders (CRSWD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Circadian Rhythm Sleep-Wake Disorder
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn the effectiveness of an intervention based on the Model of Occupational Harmony (MOHar) in treating patients with circadian rhythm sleep-wake disorders (CRSWD). The main questions it aims to answer are:

* Does intervention based on the MOHar can improve sleep quality in patients with CRSWD?
* Does intervention based on the MOHar can improve the quality of life in patients with CRSWD?

Researchers will compare intervention based on the MOHar to conventional treatment to see if the intervention works to treat CRSWD.

Participants will:

* Participate in an occupational therapy program for 6 weeks (including group therapy, individual treatment, and daily occupational tasks)
* Complete questionnaires at 1, 3, and 6 months after the program for follow-up


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* meet the diagnostic criteria for CRSWD
* able to participate in research independently or with the assistance of a caregiver
* participate voluntarily in the study and sign an informed consent form

Exclusion Criteria:

* unable to cooperate with the study process due to cognitive, sensory, and motor dysfunction
* unable to skillfully use wearable monitoring devices or smartphones
* diagnosed with mental disorders such as anxiety and depression
* diagnosed with severe cardiac, liver, and kidney dysfunction and nervous system diseases
* have cardiac pacemakers
* being pregnant
* participating in other clinical trials

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 months
measure: 36-Item Short Form Survey (SF-36)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03951129: Anxiety Levels Before Hemodialysis Catheter Insertion
Official title: Determination of Anxiety Levels After Verbal and Video Informing of Hemodialysis Patients Before Hemodialysis Catheter Insertion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety Levels
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was planned to receive 84 people. The people to be recruited will be divided into groups.

1. the group will only be informed verbally.
2. The group will be informed as both verbal and video. State-Trait Anxiety Inventory and VAS score will be made after informing all groups and after Hemodialysis Catheter Insertion

Brief summary: Determination of anxiety levels after verbal and video informing before hemodialysis catheter insertion

Detailed description: Treatment options for end-stage renal patients are renal transplantation, peritoneal dialysis, or hemodialysis, and the majority of these patients live on hemodialysis dependent. The venous access route required for hemodialysis is provided by dialysis catheters until arterio-venous shunts are performed. The aim of this study was to determine the difference between verbal or video-related anxiety levels of patients with hemodialysis and determine which one is better before the hemodialysis procedure is performed.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 -65
* Agree to participate ın the study
* No need for emergency hemodialysis
* No previously known psychiatric disorder
* No history of hemodialysis before
* No history of surgical procedures

Exclusion Criteria:

* Refusing to participate ın the study
* \<18 years of age and \>65 years
* Need emergency dialysis
* The presence of previously known psychiatric disorder
* Presence of dialysis and catheter
* Presence of a history of surgical procedure
* Lack of information and documents

Primary outcomes:
measure: The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) levels
timeFrame: 10 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray Universty
Study officials:
affiliation: Aksaray/Turkey
name: Hüseyin Mutlu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04852029: Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
Official title: Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.

Detailed description: The objective of this study is to conduct a double-blind prospective randomized control trial to determine if individualized hCG titration based on a patient's serum hCG level above or below the predetermined serum hCG level improves IVF outcomes, primarily sustained implantation rates. Patients who fall below the desired serum hCG threshold will be randomized to either maintaining their current dose of low dose hCG or being increased.

Eligibility criteria: Inclusion Criteria:

1. Patients whose physicians plan to prescribe low-dose hCG for ovarian stimulation
2. Age 18-46
3. Negative serum hCG prior to start of COH
4. BMI \>18 and \<35
5. Plan for ejaculated sperm use
6. Plan for PGT testing with euploid embryo transfer

Exclusion Criteria:

1. Administration of low-dose hCG during frozen embryo transfer cycle
2. Concomitant Menopur administration during ovarian stimulation or during frozen embryo transfer cycle
3. BMI \<18 or \>35
4. Age \<18 or \>46
5. Presence of hydrosalpinxes that communicate with the endometrial cavity
6. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), and persistent endometrial fluid
7. Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
8. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
9. Use of surgical procedures to obtain sperm
10. Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
11. Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
12. Declination of PGT testing

Primary outcomes:
measure: sustained implantation rate
timeFrame: 8 weeks gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT04714229: Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Official title: A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135 and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Meningococcal
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine


Eligibility criteria: Inclusion Criteria:

* Subjects 19 to 55 years of age
* Written informed consent
* Available for all visits and telephone calls scheduled for the study

Exclusion Criteria:

* Previous or suspected disease caused by N. meningitidis
* Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
* Serious acute, chronic or progressive disease as determined by investigator
* History of alcohol or substance abuse

Primary outcomes:
measure: Occurrence of solicited adverse events
timeFrame: within 7 days post vaccination
measure: Occurrence of unsolicited adverse events
timeFrame: within 28 days post vaccination
measure: Occurrence of serious adverse events
timeFrame: within 180 days post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: EuBiologics Co.,Ltd
name: YJ Lee
role: STUDY_DIRECTOR
References: