louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05298384: Pathophysiologic Study to Understand and Possibly Treat Nocturia
Official title: Pathophysiologic Study to Understand and Possibly Treat Nocturia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nocturia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will mainly look at how well compression stockings decrease body weight between morning and night and the number of nocturia events, by preventing blood from pooling in your legs. Also, this research study is being done to collect the thoughts/reactions/opinions on how nocturia affects the life of one who suffers from nocturia.

Detailed description: This study intends to investigate the different causes nocturia. Patients with nocturia will be assigned to wearing knee high then thigh high compression stockings to assess the effect on weight gain during the day and the number of nocturia events. Renin and aldosterone levels will also be assessed. Furthermore, fluorescein dye will be used to to demonstrate vascular leakage of the fluorescent dye.

Eligibility criteria: Inclusion Criteria:

* Age above or equal to 18 years at the time of signing informed consent
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.

Exclusion Criteria:

* Suspected or proven peripheral arterial disease, including history of peripheral arterial bypass grafting
* Any sensory impairment such as severe peripheral neuropathy as evidenced by patient reported intermittent claudication and/or signs of ischemia such as "blue toes".
* Allergy to stocking textile material.
* Leg edema or pulmonary edema from congestive heart failure.
* Local skin or soft-tissue condition, including recent skin graft, gangrene, oozing dermatitis and severe cellulitis.
* Extreme deformity of the leg, or unusual leg shape or size that would prevent correct fit.
* Treatment with any diuretics such as furosemide or hydrochlorothiazide.

Primary outcomes:
measure: Change in the level of nocturia
timeFrame: Baseline, Day 11-20 visit, Day 21-30 visit
measure: Change in the quality of life for people with nocturia
timeFrame: Baseline visit, Day 20 visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: John Maesaka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06099184: Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)
Official title: A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: DME
EYP-1901
EyePoint
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

Detailed description: A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
* Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
* BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

Exclusion Criteria:

* Any current or history of ocular disease other than DME
* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
* Active ocular inflammation or active infection in either eye at Baseline (Day 1).

Primary outcomes:
measure: Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
timeFrame: Week 24
Secondary outcomes:
measure: Change in best corrected visual acuity (BCVA)
timeFrame: Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: EyePoint Investigative Site
state: Arizona
city: Lemont
country: United States
facility: EyePoint Investigative Site
state: Illinois
city: Hagerstown
country: United States
facility: EyePoint Investigative Site
state: Maryland
city: Reno
country: United States
facility: EyePoint Investigative Site
state: Nevada
city: Erie
country: United States
facility: EyePoint Investigative Site
state: Pennsylvania
city: Lynchburg
country: United States
facility: EyePoint Investigative Site
state: Virginia
Study officials:
affiliation: EyePoint Pharmaceuticals
name: Ramiro Ribeiro, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00648284: Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects
Official title: An Observational Study to Assess the Impact of Pharmacological Intervention and Life Style Changes in the Reduction of Cardiovascular Disease in Patients With Diabetes Type 2 in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
CV Risk
Keywords: Type 2 diabetes
CV risk
rosiglitazone
AVANDIA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 1100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The primary objective of this study is to assess the total CV risk in patients with type 2 diabetes and also to assess the impact of rosiglitazone in the total CV risk and the parameters of metabolic syndrome.


Eligibility criteria: Inclusion criteria:

* Patients with diabetes type 2 that their physician has decided to prescribe AVANDIA for better control of their condition
* Have signed informed consent

Exclusion Criteria:

* Patients with ALT \> 2.5x the normal value
* With heart failure symptoms
* With diagnosis of angina pectoris or stable angina demanding continuous treatment with nitrates
* With recent myocardial infarction (\<6 months)
* With severe renal disfunction
* Pregnant or lactating or planned to be pregnant during the study
* Under investigational drug treatment
* Alcoholic or drug abuser

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01348984: Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty
Official title: Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: postoperative
pain score
morphine consumption
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether transdermal fentanyl patch

Detailed description: Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of patient. The best standard analgesia regimen is patient-control analgesia (PCA) which requires a PCA pump that is expensive.

Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain.

If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much cheaper and more convenient.

Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled for TKA gave informed consent for inclusion

Exclusion Criteria:

* ASA class 3-4
* Known allergy to any of the drugs to be used, eg. TFPs ,MO
* History of substance or alcohol abuse, and tolerance or dependence on opioids
* Can not use PCA
* Contraindication for spinal anesthesia

Primary outcomes:
measure: intravenous morphine consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Pain score
timeFrame: 48 hours
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Faculty of Medicine, Khon Kaen University
name: Thepakorn Sathitkarnmanee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04740684: Microbiome Individuality and Stability Over Time
Official title: Microbiome Individuality and Stability Over Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will consume the exact same diet for one week. Samples will be collected before, during and after the intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: Microbial derived uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) are present in blood and excreted into the urine. Uremic solutes have high inter-individual variability of unclear etiology, that the investigators hypothesize is due to intestinal microbiome variation and/or dietary variation between people. In this study, the investigators will collect baseline samples on participant's habitual diet. The investigators will then administer a homogenous diet to all participants for 7 days and examine levels of uremic solutes in the urine via 24-hour urine collection during this period. In parallel, the investigators will monitor microbiome composition. The investigators predict that during the period subjects are consuming the same, homogenous diet, their excretion of uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) into the urine will have less inter-individual variation.

Detailed description: Participants will be asked to eat exactly the same meal for one week and to eat this same meal three times each day. Subjects will be allowed to eat as much of this meal as they want and to eat enough so that they do not lose weight. The food will provide a nutritionally adequate diet, designed by a registered dietitian. Participants will be asked not to eat anything else including candy, snacks, etc. and not to drink anything except water including coffee, tea, sodas, or alcoholic drinks.

Samples will be collected at 5 time points:

2 weeks prior to starting test diet, Baseline (day 1 on diet), day 4 on the diet, day 7 on the diet, 7 days after end of diet.

Samples collected include:

Blood sample Stool sample 24 hr urine collection Diet and Gastrointestinal questionnaires

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* pregnancy
* diabetes
* gastrointestinal disease
* use of medications thought by the investigators to have a significant effect on the microbiome

Primary outcomes:
measure: Uremic solute variability
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT05052684: The Leaflex™ Brazilian Standalone Study
Official title: The Leaflex™ Brazilian Standalone Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Pi-cardia
Sponsor class: INDUSTRY
First posted: 2021-09-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.

Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.


Eligibility criteria: Inclusion Criteria:

* Patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement.
* Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.

Exclusion Criteria:

* Severe aortic regurgitation.
* Anatomic contraindications.
* Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure.
* Aortic balloon valvuloplasty ≤ 3 months prior to index procedure.
* Stroke ≤ 12 months prior to index procedure.
* History of a myocardial infarction ≤ 6 weeks prior to index procedure.
* Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy.
* Hemodynamic instability.
* Hypertrophic cardiomyopathy with obstruction.
* Left ventricle ejection fraction \<30%.
* Ongoing severe infection, including endocarditis, or sepsis.
* Life expectancy ≤ 12 months.

Primary outcomes:
measure: Change in aortic valve area
timeFrame: Baseline and up to 3 days post procedure
Secondary outcomes:
measure: Rate of all-cause mortality and all-cause stroke (VARC 2)
timeFrame: 30 days post procedure
measure: Rate of worsening of aortic regurgitation
timeFrame: Baseline and 30 days post procedure
measure: Rate of device related adverse events
timeFrame: Up to 12 months post procedure
measure: Change in 6 minute walk test
timeFrame: Baseline, 1, 6 and 12 months post procedure
measure: Change in Quality of Life
timeFrame: Baseline, 1, 6 and 12 months post procedure
measure: Change in Quality of Life
timeFrame: Baseline, 1, 6 and 12 months post procedure
measure: Change in aortic valve area
timeFrame: Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure
measure: Change in pressure gradients
timeFrame: Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure
measure: Change in pressure gradients
timeFrame: Pre-treatment, immediately post treatment (during procedure)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração FMUSP Centro de Pesquisa
Study officials:
References:
Clinical trial NCT04617184: Registry and Biorepository for IBD in Central Texas
Official title: Registry and Biorepository for the Study of Inflammatory Bowel Diseases in Central Texas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Ulcerative Colitis
Inflammatory Bowel Diseases
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with a diagnosis or suspected diagnosis of IBD made by the treating medical team will be considered for recruitment and enrollment. No special populations are targeted for accrual to this study.

Brief summary: This is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. The biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, IV catheter placement, and/or endoscopy). Participants may choose to provide any or all of the aforementioned information and/or samples.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 years or older
* Willing and able to provide written consent for participation in the registry and biorepository
* Patients with known or suspected inflammatory bowel disease

Exclusion Criteria:

* Patient is unable to comprehend and/or cooperate with study activities
* Patient is too ill to provide consent
* Coagulopathy that precludes safe biopsy of the bowel
* Comorbidity that precludes safe participation in endoscopic procedures

Primary outcomes:
measure: Number of patients with inflammatory bowel disease
timeFrame: 10 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Medical School, UT Austin
state: Texas
Study officials:
References:
Clinical trial NCT05944484: Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence
Official title: Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence by EMG and Iciq Questionnaire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Visceral fat
total body fat
obese female
stress urinary incontinence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Visceral fat reduction vs total body fat reduction on obese female with stress urinary incontinence
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.

Detailed description: compare the effect of visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.

control group: consist of 20 obese women. They will receive Kegel exercises only 3 session/ week for 12 weeks.

Diet group: consist of 20 obese women. They will receive low caloric diet and Kegel exercises 3 session/week for 12 weeks.

Ultrasound cavitation group: consist of 20 obese women. They will receive Kegel exercises 3 session/week and ultrasound cavitation two sessions per week.

Eligibility criteria: Inclusion Criteria:

* They will be diagnosed with stress urinary incontinence grade≥ 1
* Their age will range from 35-48 years old.
* Their body mass index will exceed 29.9 kg/m².
* Their hip waist ratio will be more than 0.85 cm.
* They will be multipara \>1.

Exclusion Criteria:

* · Fecal incontinence, urge incontinence, overflow incontinence or functional incontinence or prolapse.

  * Diabetes, asthma, cardiovascular, or renal diseases
  * Taking medication for stress urinary incontinence or hormonal replacement therapy.
  * Gynecological surgeries, or surgeries for obesity.
  * Pregnant women.

Primary outcomes:
measure: stress urinary incontinence
timeFrame: 12 weeks
Secondary outcomes:
measure: waist circumference
timeFrame: 12 weeks
measure: Measure weight
timeFrame: 12 weeks
measure: Measure body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT02970084: Vitamin K2 for Reduction the Calcium at Carotid Bifurcation in Patients With Subcritical Lesions
Official title: Role of Vitamin K2 in the Reduction of the Calcium Content at the Level of the Carotid Bifurcation in Patients With Subcritical Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Plaques
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical study single center, prospective, randomized, controlled (vs. no supplement), open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12 months will not know the treatment given to the patient, because the diagnostic test in question is considered operator-dependent), a "parallel group", which aims is evaluate the reduction in the level of calcium in the carotid artery and the carotid atherosclerotic plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid bifurcation with a range of 40-60%.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Ability to provide written informed consent
3. subjects with calcified lesions subcritical from the carotid bifurcation. with a range of 40-60% calculated method with ECTS (European Carotid Surgery Trial)

Exclusion Criteria:

1. Patients with reduced life expectancy or age\> 80 years,
2. Patients already subjected to other clinical trial in the previous three months,
3. Patients with hypersensitivity or with known allergies to acetylsalicylic acid, patients with pre-existing mastocytosis, a history of asthma induced by salicylates, duodenal ulcer, bleeding diathesis, severe hepatic insufficiency, severe heart failure, concomitant treatment with methotrexate, last trimester of pregnancy.
4. Patients with known hypersensitivity to vitamin K2 and vitamin D, people with hemolytic diseases, concomitant anticoagulant therapy, people with cancer, MAV (arteriovenous malformations) and / or cerebral aneurysms, hypercalcemia, nephrolithiasis and renal failure.
5. Uncooperative patients , or allergies related to the substance under study or with any contra-indicated in the data sheet / Summary of Product Characteristics (SPC) of the substances in the studio.

Primary outcomes:
measure: Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References: