louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05729009: The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients
Official title: The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Transplantation
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2023-02-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adult individuals from the cohort of heart failure patients under evaluation for heart transplantation, at the National Institute of Cardiology, Rio de Janeiro, Brazil

Brief summary: The evolution of systemic microvascular reactivity may aid in the comprehension of cardiovascular physiology in heart transplantation patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.

Detailed description: Introduction: Systemic microvascular reactivity (MR) is an essential component of cardiovascular physiology, being studied through non-invasive techniques in readily accessible body regions, such as the skin surface. Heart transplant (HT) is a treatment considered to selected patients, with advanced heart failure. The main cause of long-term mortality after HT is graft vascular disease (GVD), a condition which starts with endothelial dysfunction. To know the evolution of systemic MR in patients subjected to HT can help to find prognostic factors. Objective: The present study aims to perform the prospective evaluation of systemic MR in adult patients, before and two years after HT, at a quaternary hospital, correlating the findings with clinical variables. Methods: Systemic MR will be evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis, followed by postocclusive reactive hyperemia (PORH), before and after HT. Measurements will be correlated to patient clinical profile, hemodynamic and echocardiographic data. Expected results: The evolution of systemic MR may aid in the comprehension of cardiovascular physiology in HT patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.

Eligibility criteria: Inclusion Criteria:

* capability to understand the objectives of the research and to fulfill the Term of Consent

Exclusion Criteria:

* Pregnancy, acute infection diagnosis, use of circulatory assistance devices

Primary outcomes:
measure: Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity
timeFrame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Eduardo Tibiriçá
Study officials:
References:
Clinical trial NCT01857609: Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin
Official title: The Cross-Over Study to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Korean Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Metformin
Proton pump inhibitor
Drug interaction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men.


Eligibility criteria: Inclusion Criteria:

* healthy male subject aged 20 to 45 at screening
* A body weight in the range of 50 kg (inclusive) - 100 kg (inclusive) with ideal body weight range of +- 25%
* subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator.

Primary outcomes:
measure: AUC(area under the plasma concentration-time curve)
timeFrame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose
Secondary outcomes:
measure: AUG(total area under the serum concentration-time curve for glucose)
timeFrame: predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test
Other outcomes:
Locations:
city: Seoul,
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea
name: Jae-Yong Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587009: Application of Shock Wave Technique in Conservative Treatment of Rotator Cuff Tear
Official title: Director of Rehabilitation Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Shock wave technique
Conservative treatment
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 22
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective cohort study and is a single-center clinical trial. Sample: This study will enroll about 22 patients from the Department of Sports Medicine and rehabilitation outpatient department of Beijing Third Hospital who are diagnosed with rotator cuff tear and choose conservative treatment.

Detailed description: A single-center randomized controlled clinical trial was conducted to compare the effect of ESWT combined with conventional rehabilitation training on patients with rotator cuff tear. To explore the effect of ESWT on the clinical efficacy of patients with rotator cuff tear, and to explore the application of shockwave technology in the conservative treatment of rotator cuff tear. It provides a new treatment idea for patients with rotator cuff tear who choose conservative treatment, promotes tendon healing for patients with partial rotator cuff tear, improves shoulder joint function, and provides a new treatment plan for patients to accelerate their return to life and exercise, and provides a theoretical basis for the clinical application of ESWT.

Eligibility criteria: Inclusion Criteria:

* Identify patients with rotator cuff tears and choose conservative treatment
* Able to complete cardiopulmonary exercise tests
* Able to cooperate with rehabilitation training and complete questionnaire survey

Exclusion Criteria:

* Previous shoulder surgery history
* Irreparable rotator cuff damage
* Retear after ARCR

Primary outcomes:
measure: pain VAS score
timeFrame: 6 weeks, 3 months, and 6 months after surgery
measure: ASES score
timeFrame: 6 weeks, 3 months, and 6 months after surgery
measure: MRI evaluation
timeFrame: 3 months and 6 month after surgery
measure: UCLA score
timeFrame: 6 weeks, 3 months and 6 months after surgery
Secondary outcomes:
measure: Active shoulder ranges of motion
timeFrame: 6 weeks, 3 months, and 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: PekingUTH
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Guoqing Cui
role: STUDY_CHAIR
References:
Clinical trial NCT00912509: Cross Linking for Treatment of Corneal Infection
Official title: A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infectious Keratitis
Keywords: infectious keratitis
cross linking
corneal ulcer
corneal infection
collagen cross linking
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
Collaborators: name: Cornea Research Foundation of America
First posted: 2009-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.


Eligibility criteria: Inclusion Criteria:

* diagnosis of infectious keratitis

Exclusion Criteria:

* corneal ulcer that has perforated
* corneal ulcer that has produced a descemetocele
* women who are pregnant or breastfeeding
* patients who are immunocompromised or unwilling or unable to comply with a medication regimen

Primary outcomes:
measure: Time to Re-epithelialization
timeFrame: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete
Secondary outcomes:
measure: Time to Resolution of Stromal Infiltration
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis W Price, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iseli HP, Thiel MA, Hafezi F, Kampmeier J, Seiler T. Ultraviolet A/riboflavin corneal cross-linking for infectious keratitis associated with corneal melts. Cornea. 2008 Jun;27(5):590-4. doi: 10.1097/ICO.0b013e318169d698.
citation: Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06.
citation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Clinical trial NCT05410509: "Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Official title: "Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma (RCC)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Varian, a Siemens Healthineers Company
First posted: 2022-06-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma. Continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.


Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years
2. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
3. Longest tumor diameter measures 4.1-7cm
4. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation
6. Provision of signed and dated informed consent form
7. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Pregnancy
2. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) \<30
3. Renal cell carcinoma as part of a syndrome
4. Horseshoe kidney
5. Patient unable to undergo renal mass protocol CT or MRI
6. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
7. Uncorrectable coagulopathy, including a platelet count of \<30,000/μL and/or an international normalized ratio (INR) \>2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
8. Performance status precludes enrollment as determined by the investigators

Primary outcomes:
measure: The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
timeFrame: 30-90days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Thomas Jefferson Health
state: Pennsylvania
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrew Gunn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05769309: Efficacy of Erector Spinae Plane Block Analgesia After Off Pump Cardiac Surgery
Official title: Efficacy of Erector Spinae Plane Block on Postoperative Analgesia and Recovery After Off Pump Cardiac Surgery: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.

Detailed description: General anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of Atracurium. After induction, bilateral erector spinae plane block will be performed in the block group. Intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. Postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.

Eligibility criteria: Inclusion Criteria:

* age 18-70 years
* ejection fraction of \> 45%
* undergoing elective off-pump cardiopulmonary bypass surgery

Exclusion Criteria:

* vertebral anomalies
* intra-aortic balloon pump in the preoperative period
* acute myocardial infarction
* local infection at the site of block
* allergy to the local anesthetic used
* morbid obesity, psychiatric disorders, neurologic deficits, alcohol and chronic opioid abuse, and patients with bleeding diathesis.

Primary outcomes:
measure: Total intraoperative and postoperative opioid consumption
timeFrame: 48 hours
Secondary outcomes:
measure: pain intensity at rest and movement
timeFrame: 48 hours
measure: time to first rescue analgesia
timeFrame: 24hous
measure: Duration of mechanical ventilation
timeFrame: 24 hours
measure: time to extubation
timeFrame: 24hours
measure: time to ambulation
timeFrame: 24hours
measure: time to oral intake
timeFrame: 48 hours
measure: time of chest drain removal
timeFrame: 5 days
measure: time of intensive care unit stay
timeFrame: one week
measure: The heart rate
timeFrame: 48 hours
measure: mean arterial blood pressure
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: Islam M ElDesoky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University
name: AMAL G SAFAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University
name: Abd-Elazeem A Elbakry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402309: A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
Official title: Phase II Study of the Safety, Pharmacokinetics, and Exploratory Activity of Once Daily (QD) Topical Application of NS2 Cream to Treat Ichthyosis in Subjects With Sjögren-Larsson Syndrome (SLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sjögren-Larsson Syndrome
Keywords: Sjögren-Larsson Syndrome
SLS
FALDH Deficiency
Neuro-ichthyosis
Fatty Alcohol:NAD+ Oxidoreductase Deficiency
Fatty Aldehyde Dehydrogenase Deficiency Disease
Congenital Icthyosis Mental Retardation Spasticity Syndrome
Spastic Neurologic Disorder
Oligophrenia
Ichthyosis
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of topically-applied NS2 dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to Sjögren- Larsson Syndrome (SLS).

NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.


Eligibility criteria: Inclusion Criteria:

* Genetically-confirmed diagnosis of SLS
* Active ichthyosis on the lower extremities that is determined to be at least moderate severity

Exclusion Criteria:

* Evidence of an active infection
* Currently receiving immunosuppressive therapy, including intermittent or low-dose corticosteroids and is not able or willing to suspend from 2 weeks before and during the study
* Currently receiving systemic or topical retinoids, other topically applied drugs, or other supplements that could interfere with dermatologic examination findings
* Received an investigational systemic or topically administered drug within 30 days before screening

Primary outcomes:
measure: Number of Participants Experiencing a Serious Adverse Event (SAE).
timeFrame: The safety assessment period is approximately 9 weeks.
measure: Number of Participants Experiencing an Adverse Event Leading to Discontinuation.
timeFrame: The safety assessment period is approximately 9 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hershey
country: United States
facility: Penn State Hershey Medical Center - Department of Dermatology
state: Pennsylvania
city: Fairfax
country: United States
facility: Pediatric and General Dermatology
state: Virginia
Study officials:
affiliation: University of Nebraska
name: William B. Rizzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02229409: Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population
Official title: Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: adults
Lead sponsor: MeYou Health, LLC
Sponsor class: INDUSTRY
First posted: 2014-09-01
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the product Walkadoo to determine whether it effectively increases walking behavior in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years or older;
* Healthways employees based in Franklin, TN with an email account with the company;
* Provide informed consent and complete eligibility questionnaires

Exclusion Criteria:

* Current or prior use of the intervention Walkadoo
* Presence of a chronic condition that affects walking
* Projected inability to access the internet for 4 consecutive days or longer during the study
* Non-adherence to device wear during baseline

Primary outcomes:
measure: Average steps per day
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MeYou Health
state: Massachusetts
Study officials:
affiliation: Georgetown University
name: Nathan K Cobb, MD
role: STUDY_DIRECTOR
References:
citation: Poirier J, Bennett WL, Jerome GJ, Shah NG, Lazo M, Yeh HC, Clark JM, Cobb NK. Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial. J Med Internet Res. 2016 Feb 9;18(2):e34. doi: 10.2196/jmir.5295.
Clinical trial NCT01072409: Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
Official title: Clinical Evaluation of the Nucleus 5 Cochlear Implant System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Speech perception ability in the CI alone condition
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Detailed description: Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.

Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older at the time of the study.
* Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
* Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (\<50% open-set sentence recognition in quiet scores in the ear to be implanted and \<60% in the best-aided condition)
* English spoken as the primary language.
* Willingness to participate in and to comply with all requirements of the study
* Subject may receive bilateral simultaneous cochlear implants.

Exclusion Criteria:

* Previous cochlear implant experience
* Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
* Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
* Normal hearing in one or both ears.
* Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
* Active middle-ear infection.
* Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.

Primary outcomes:
measure: CNC Monosyllabic Word Performance - Treated Ear
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Teresa Zwolan, PhD
role: PRINCIPAL_INVESTIGATOR
References: