louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02681978: Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease
Official title: Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of ivabradine on endothelial function in patients with coronary artery disease (CAD) after complete revascularization with percutaneous coronary angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive ivabradine 5 mg twice daily or to continue with standard medical therapy.


Eligibility criteria: Inclusion Criteria:

* history of stable coronary disease
* complete coronary revascularization with PCI at least 1 month prior to recruitment
* sinus rhythm
* absence of anginal symptoms

Exclusion Criteria:

* resting heart rate \<60 beats per minute
* severe reduction of left ventricle ejection fraction (\<40%)
* coronary artery by-pass surgery
* myocardial infarction, stroke or cerebral transient ischemic attack within the previous 6 months
* implanted pacemaker, cardioverter, or defibrillator
* sick sinus syndrome
* sinoatrial block
* congenital long QT
* complete atrioventricular block

Primary outcomes:
measure: Flow-mediated dilation of the brachial artery
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of patients with flow-mediated dilation of the brachial artery <7%
timeFrame: 8 weeks
measure: Endothelium-independent dilation of the brachial artery
timeFrame: 8 weeks
measure: Correlation between heart rate and flow-mediated dilation of the brachial artery
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Campus Bio-Medico University
state: RM
Study officials:
affiliation: Campus Bio-Medico University
name: Fabio Mangiacapra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mangiacapra F, Colaiori I, Ricottini E, Balducci F, Creta A, Demartini C, Minotti G, Di Sciascio G. Heart Rate reduction by IVabradine for improvement of ENDothELial function in patients with coronary artery disease: the RIVENDEL study. Clin Res Cardiol. 2017 Jan;106(1):69-75. doi: 10.1007/s00392-016-1024-7. Epub 2016 Aug 12.
Clinical trial NCT04927078: Analysis of Vital Signs in Patients With COVID-19
Official title: Analysis of Vital Signs in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disease
Keywords: Breathing rate
Pulse rate
COVID 19
Patient monitoring
Lead sponsor: Oxehealth Limited
Sponsor class: INDUSTRY
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2021-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants admitted to inpatient mental health wards.

Brief summary: This project will use data obtained from a proprietary vision-based patient monitoring and management system (OxeVision) for measuring heart rate and respiratory rate which is in clinical use at the Coventry and Warwickshire Partnership NHS Trust.

Detailed description: The investigators will analyse data from patients with known COVID 19 infection both during, and where possible before clinical COVID 19 infection and controls to determine whether changes can be detected in these parameters that precede overt clinical deterioration. The role of remote vision-based patient monitoring and management in supporting the care of patients with COVID-19 will be assessed through staff interviews.

Eligibility criteria: Inclusion Criteria:

* Patients age 18 and above. Patients on wards with a medical diagnosis of COVID 19 who are in rooms with the Vision based patient monitoring and management system.

Exclusion Criteria:

Children will be excluded. No data will be excluded unless specifically requested by the treating clinician.

Primary outcomes:
measure: Breathing rates
timeFrame: Data will be collected throughout study completion, an average of 7 months, to obtain breathing rate before and after the diagnosis of COVID 19.
Secondary outcomes:
measure: Pulse rates
timeFrame: Data will be collected throughout study completion, an average of 7 months, to obtain pulse rate before and after the diagnosis of COVID 19.
measure: BR and PR
timeFrame: Data will be collected throughout study completion, an average of 7 months, to obtain breathing and pulse rate before and after the diagnosis of COVID 19.
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Coventry and Warwickshire Partnership NHS
Study officials:
affiliation: The Royal Bromptom Hospital
name: Michael Polkey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04074278: Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease
Official title: Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lean Body Mass
Chronic Kidney Diseases
Keywords: mid-arm muscle circumference
handgrip strength
dual-energy x-ray absorptiometry
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The development and validation groups both included 150 non-dialyzed patients with CKD stage 3-5.

Brief summary: Simplified methods to estimate lean body mass (LBM), an important nutritional measure representing muscle mass and somatic protein, are lacking in non-dialyzed patients with chronic kidney disease (CKD).

Objective: We developed and tested a reliable equations for estimation of LBM in daily clinical practice.

Detailed description: Two cross-sectional data sets were derived from outpatients with CKD stage 3-5 in Peking University First Hospital.Two equations for estimating LBM based on midarm muscle circumference (MAMC) or hand grip strength (HGS)were developed and validated in CKD patients with dual-energy x-ray absorptiometry (DEXA) as referenced gold method. Demographic data, comorbidity, and other clinical variables were also recorded.

Eligibility criteria: Inclusion Criteria:

* non-dialyzed patients with CKD stage 3-5
* clinical stable
* a willingness to be examined with all measurements being taken simultaneously.

Exclusion Criteria:

* systemic infections, acute cardiovascular events, operations, trauma, active hepatitis or tumor
* severe edema within one month prior to the study
* chronic infections, connective tissue disease, hyper- or hypothyroidism, amputations or pregnancy,
* taking immunosuppressive agents and anti-inflammatory medication chronically

Primary outcomes:
measure: LBM_DEXA
timeFrame: between March 1st, 2014 and December 1st, 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renal Division and Institute of Nephrology, Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06122571: A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health
Official title: A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Health
Bowel Movements
Constipation
Bloating
Lead sponsor: Trace Minerals
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.


Eligibility criteria: Inclusion Criteria:

* Be male or female. Be aged over 18. Have a BMI less than 35. Have issues with digestion, heartburn, indigestion, gas, or constipation. Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.

Be generally healthy - must not live with any uncontrolled disease.

Exclusion Criteria:

* Any person with a pre-existing chronic condition that might prevent the participant from adhering to the protocol, including any oncological and psychiatric disorders.

Anyone taking any prescribed medication targeting the gut. Anyone taking any supplements targeting the gut within the past month. Anyone with any known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.

Primary outcomes:
measure: Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in bowel movement frequency. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT02109471: Observational Study of Corneal Opacities in Adults
Official title: Observational Study of Corneal Opacities in Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corneal Opacities (Scar and Stromal Dystrophy)
Keywords: corneal opacities
Optical coherence tomography
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2014-04-10
Enrollment: 150
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: PROBABILITY_SAMPLE
Study population: Adult patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

Brief summary: A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform 3-D corneal scans. These scans will be used to assess opacity depth and measure corneal thickness (pachymetry), corneal topography (anterior and posterior), and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imaging, will be performed for comparison.


Eligibility criteria: Inclusion Criteria:

• Adult (18 \& older) patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging.
* Inability to commit to required visits to complete the study.

Primary outcomes:
measure: Identification of suitable subjects
timeFrame: 2 years
Secondary outcomes:
measure: Validate OCT topography
timeFrame: 2 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Humberto Martinez
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03125278: Patient Knowledge of Medication Indication
Official title: Patient Knowledge of Medication Indication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Audit
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients recently discharged from the hospital with 1 or more new or changed medications.

Brief summary: This is a study to compare patient knowledge about the indications of their medications between two sites. Regions Hospital has a population of patients that receive the medication indication on the label for any new or changed medications at the time of patient discharge. Brigham Women's Health follows a standard policy of discharge medication labels including the name of the medication and instructions for use without any indication of what the medication is intended to treat. Consented patient will receive a phone call where researchers will ask about which medications they are taking and other questions about those medications.

The study population will be patients recently discharged from the hospital with 1 or more new or changed medications


Eligibility criteria: Inclusion Criteria

1. Hospital Medicine (HM) inpatient being discharged to home
2. Patient being discharged with ≥ 1 new or changed medications
3. English speaker

Exclusion Criteria

1. Inpatient being discharged to nursing home or TCU facility
2. Patient being discharged with no new or changed medications
3. Non-English speaker

Primary outcomes:
measure: Medication Knowledge Questionnaire
timeFrame: up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
References:
Clinical trial NCT01378078: Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
Official title: Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
negative syndrome
PANSS
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.


Eligibility criteria: Inclusion Criteria:

* schizophrenic patients with a negative syndrome. PANSS \> 40.

Exclusion Criteria:

* other psychiatric or neurologic diseases.

Primary outcomes:
measure: SANS reduction
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: neuropsychological tests
timeFrame: 4 weeks after baseline
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik fuer Psychiatrie
Study officials:
affiliation: Ludwig Maximilian University Munich
name: Ulrich Palm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328778: Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery
Official title: Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pharmacokinetics
Keywords: Sugammadex
Laparoscopic Surgery
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery

Detailed description: 48 patients undergoing laparoscopic surgery were divided into 3 groups according to body mass index (BMI), including normal weight group(A group,n=16,18.5kg/m² ≤ BMI ≤ 24.9kg/m²),obese group (B group, n=16, 25≤BMI≤39.9kg/m²) and morbidly obese group (C group, n=16, BMI≥40kg/m²).

Vecuronium was continuous infusing to maintain moderate neuromuscular blockade during the laparoscopic surgery and stopped infusing after the laparoscopic procedure. A single dose administration of sugammadex (Sug) 2.0mg/kg according to ideal body weight (IBW) was given at the reappearance of the second twitch of the train-of-four (TOF) response.

On one hand, venous blood samples were obtained before administration of Sug and at 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours after administration of Sug to determine plasma concentration of Sug using HPLC-MS. On the other hand, time from start of administration of Sug to recovery of TOF ratio to 0.9 and other clinical indicators were also recorded.

Eligibility criteria: Inclusion Criteria:

1. ASA: Ⅰ\~Ⅲ
2. BMI≥25kg/m²
3. Patients receiving bariatric surgery.

Exclusion Criteria:

1. Pregnant or lactating women
2. Neuromuscular diseases
3. Malignant hyperthermia or allergic history during general anesthesia
4. Drugs that react with rocuronium and vecuronium were taken

Primary outcomes:
measure: Plasma Concentration of Sugammadex
timeFrame: 0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours
measure: TOF ratio of Recovery Time
timeFrame: TOF ratio at 30, 60, 90, 120, 150 seconds after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
Clinical trial NCT05898971: Robotic Hand on Hand Functions in Strokes
Official title: Effect of Robotic Hand Versus Mirror Therapy on Hand Functions in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVA (Cerebrovascular Accident)
Keywords: Stroke
Hand Grip Strength
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Batterjee Medical College
First posted: 2023-06-12
Enrollment: 61
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Comparative trial
Primary purpose: TREATMENT

Brief summary: robotic glove training could be a useful aid for these patients. The aim of this study was to investigate the effect of Robotic gloves versus mirror therapy on Hand function in patients with cerebral vascular accident .

Detailed description: Post stroke patients aged over 40 years were randomly assigned into three groups (A and B ) Group . Maximum hand grip strength, Hand and Fugl-Meyer Assessment-Upper Extremity (FMA-UE), were assessed at baseline, post-intervention, and six-month follow-up.

Eligibility criteria: Inclusion Criteria:

Spasticity level 1 or 1+ according to modified Ashworth scale

Exclusion Criteria:

Uncontrolled seizures hand fractures or surgery

Primary outcomes:
measure: hand grip strength
timeFrame: 8 weeks, and six-month follow-up.
measure: Hand manual function
timeFrame: 8 weeks, and six-month follow-up.
Secondary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
timeFrame: 8 weeks, and six-month follow-up.
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Dr. Mariam Salem
Study officials:
affiliation: Professor of Physical Therapy , Batterjee Medical College.
name: Dr. Mariam Salem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06606171: Floor Sitting Study
Official title: Floor Sitting: an Exploration of Its Effects on Health and Sedentary Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-being/Quality of Life
Posture
Sedentary Behaviors
Keywords: sedentary behaviors
sitting behaviors
ergonomics
posture
floor sitting
accelerometry
movement
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to evaluate the impact of different sitting environments on general well-being and movement patterns in healthy young adults aged 18-35. The main questions it aims to answer are:

Does floor sitting lead to increased movement and postural changes compared to chair sitting? Over a month-long period, how does sustained floor sitting influence overall well-being, posture, and movement habits?

Researchers will compare the effects of chair sitting and floor sitting in a controlled lab environment (Aim 1) and observe the longer-term effects of habitual floor sitting in participants natural environments (Aim 2) to see if consistent floor sitting promotes more dynamic movement and comfort.

Participants will:

Undergo two 30-minute experimental sitting sessions, one in a chair and the other on the floor, while engaging in typical desk activities (Aim 1).

Participate in a month-long study where they integrate an hour of floor sitting into their daily routines, recording their experiences and any changes in sitting habits through daily diaries and in-depth interview (Aim 2).


Eligibility criteria: Inclusion Criteria:

* age 18-35 years
* English-speaking
* willing and able to complete study procedures.

Exclusion Criteria:

* Any injuries or conditions that would limit participants from sitting on the floor in a safe manner, mental states that would preclude the complete understanding of the protocol and compliance, and prior knowledge of the study hypotheses, as it may potentially influence participant behavior and compromise the integrity of the study.

Primary outcomes:
measure: Changes in Movement Patterns via Accelerometry
timeFrame: Recorded continuously during each 30-minute sitting session; analysis will compare aggregate data from the two sessions.
measure: Variations in Sitting Posture Captured by Video Analysis
timeFrame: Postural data will be collected throughout the two 30-minute experimental sitting sessions, with comparative analysis conducted post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Lifestyle Redesign for Chronic Conditions Lab
state: California
Study officials:
affiliation: University of Southern California
name: Elizabeth A Pyatak
role: STUDY_CHAIR
References: