louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04530760: Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Official title: Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Cirrhosis, Liver
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cirrhotic patients receiving invasive mechanical ventilation

Brief summary: The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.

Detailed description: Intra-abdominal pressure monitoring will be performed using intra-vesical pressure every 8 hour in the first 2 days of mechanical ventilation.

Micro aspiration is defined by pepsin or amylase positivity in trachea suction. Two groups will be compared : one with IAH , one without IAH.

Eligibility criteria: Inclusion Criteria:

* adult patients
* Cirrhosis
* intubation and mechanical ventilation

Exclusion Criteria:

* pregnancy
* oliguric patients
* impossibility to measure intravesical pressure

Primary outcomes:
measure: abundant microaspiration
timeFrame: 48 hours after inclusion
Secondary outcomes:
measure: Mortality
timeFrame: from ICU admission until day 28
measure: Incidence of ventilator associated pneumonia (VAP)
timeFrame: from intubation until day 28 or extubation
measure: duration of mechanical ventilation
timeFrame: from intubation until day 28 or extubation
measure: incidence of patients requiring renal replacement therapy
timeFrame: from ICU admission until Day 28 or ICu discharge, whichever came first
measure: incidence of cirrhosis related complications
timeFrame: from ICU admission until Day 28 or ICU discharge, whichever came first
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
city: Lille
country: France
facility: Hop Salengro - Hopital B
Study officials:
affiliation: University Hospital, Lille
name: Saad Nseir, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00411060: Clinical Orthopaedic Data Bank (Acute and Chronic)
Official title: Orthopaedic Data Bank; Collection and Storage of Data Relating to Orthopaedic Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Osteosarcoma
Scoliosis
Cerebral Palsy
Keywords: Rotator Cuff Tear
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2006-12-13
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic clinic

Brief summary: Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and neuromuscular disorders will be collected and stored as part of the normal clinical care of patients seen in the University of Florida (UF) and Shands Orthopaedics and Sports Medicine Institute.

Detailed description: All patients seen the Orthopaedic clinic will be informed of the data collection and asked to participate. If the patient is agreeable to participation, informed consent will then be obtained.

Eligibility criteria: Inclusion Criteria:

* All patients seen in the UF\&Shands Orthopaedics and Sports Medicine Institute will be asked to sign an informed consent.

Exclusion Criteria:

* No exclusions, all patients interested in participation will be asked to sign an informed consent.

Primary outcomes:
measure: Retrospective data
timeFrame: 2007 to present, until 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: UF Department of Orthopaedics and Rehabilitation
name: Parker Gibbs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097560: The Effect of HFNC on Exercise Capacity Compared to VM in COPD Patients Recovering From Acute Evacerbation
Official title: The Effect of High Flow Nasal Cannula on Exercise Capacity Compared to Venturi Mask in COPD Patients Recovering From Acute Evacerbation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: HFNC
PR
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Early PR is thought to be effective in COPD patients recovering from acute exacerbation, while the effect of HFNC during exercise training in these patients remains unclear. The study may provide evidence of early PR in COPD patients recovering from acute exacerbation.

Detailed description: We hypothesize that HFNC may increases exercise time in COPD patients recovering from acute exacerbation compare to VM. A randomized, cross-over clinical trial in which either HFNC or VM may be used as an adjunct in 10-MST in random order, respectively, will be performed to compare the endurance time. The physiological effect of HFNC and VM during exercise will also be measured to explore the mechanism.

Eligibility criteria: Inclusion Criteria:

* hospitalized AECOPD patients
* be ambulatory by 48h after admission for AECOPD
* requires oxygen by screening exercise test

Exclusion Criteria:

* active coronary ischemia
* respiratory diseases other than COPD
* unstable vital signs
* unstable psychological status

Primary outcomes:
measure: Endurance time
timeFrame: 10 minute
Secondary outcomes:
measure: Respiratory pattern
timeFrame: 10 minute
measure: Work of breathing
timeFrame: 10 minute
measure: Neural respiratory drive
timeFrame: 10 minute
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Shiying
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Rongchang Chen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03564860: HBP Device EGM Data Collection
Official title: His Bundle Pacing Device Electrogram Data Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sick Sinus Syndrome
AV Block
Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended population for this clinical investigation consists of patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device.

Brief summary: This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.

Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.

The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.


Eligibility criteria: Inclusion Criteria:

* Has previously implanted with Abbott device and any pacing lead at HB
* Age ≥ 18 years
* Ability to provide informed consent for study participation
* Willing to comply with study evaluation requirements

Exclusion Criteria:

* Suspected pacing system failure
* Lead impedance out of range
* Ventricular sensing amplitude lower than 0.5 mV

Primary outcomes:
measure: Amplitude of device electrogram
timeFrame: through study completion, an average of 1 year
measure: Duration of device electrogram
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: *Heart Center Research, LLC.
state: Alabama
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education & Research
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
References:
Clinical trial NCT00117260: Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a 91-Day Extended-Cycle Combination Oral Contraceptive (Seasonale) for the Treatment of Low Bone Mineral Density in Adolescent Females With Secondary Amenorrhea and Osteopenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Osteopenia
Keywords: osteopenia
bone mineral density
amenorrhea
adolescents
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. The duration of the study for each patient will be approximately two years.


Eligibility criteria: Inclusion Criteria:

* Not sexually active and agree to remain sexually inactive throughout the course of the study
* First menstrual period at least one year ago
* No menstrual period in the last 6 months

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding
* Known or suspected pregnancy
* Medical history of any disorder that contraindicates the use of oral contraceptives

Primary outcomes:
measure: Mean percent change in the lumbar spine bone mineral density at month 12
Secondary outcomes:
measure: Interim and 24 month mean percent change in lumbar spine bone mineral density
measure: Mean percent change in the proximal femur (hip) bone mineral density
measure: Mean percent change in total body bone mineral density
measure: Mean change in biochemical markers of bone resorption and bone formation
measure: Change in body weight
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01116960: How do Attitude About Pay for Performance Differ Among Different Anesthesia Care Provider and Over Time
Official title: How do Attitute About Pay for Performance Differ Among Different Anesthesia Care Provider and Over Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attitude
Keywords: P4P
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anesthesia care providers

Brief summary: The investigators hypothesize that common objections to P4P relate to potential loss of autonomy or concerns about adverse effects on patient care.

Detailed description: We seek to establish baseline attitudes about Pay for Performance (P4P) in the OUHSC Dept of Anesthesiology and determine what differences exist between faculty, CRNAs and residents. We plan to resurvey annually to determine if attitudes change as the department implements a P4P program. We hope that by understanding the attitudes of anesthesia care providers, we can alleviate their concerns. We hope to account for their concerns as we develop and modify our P4P program. We believe that acceptance of the general idea of P4P is important if individuals are to maintain job satisfaction.

Eligibility criteria: Inclusion Criteria:

* All anesthesia care providers in the department

Exclusion Criteria:

* locum faculty members and CRNAs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology
state: Oklahoma
city: Oklahoma City
country: United States
facility: Univeristy of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Pamela Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06687460: Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation
Official title: Brief Electrical Stimulation for Promoting Peripheral Nerve Regeneration After Primary Neurorrhaphy of Upper Extremities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Electrical Stimulation
Peripheral Nerve Regeneration
Keywords: electrical stimulation
peripheral nerve regeneration
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the process of nerve microsurgical reconstruction, 30 minutes of electrical stimulation is applied to the distal end of the damaged nerve to assess its potential benefits for nerve regeneration, functional recovery, slowing down the degeneration at the neuromuscular junction, and preventing muscle atrophy.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and older
* Acute peripheral nerve rupture between the elbow and wrist
* Acute rupture of the median or ulnar nerve
* Patients who have signed a valid written consent for surgery and trials

Exclusion Criteria:

* History of injury or other causes leading to muscle and joint dysfunction in the affected area
* Patients with radial nerve damage
* Diabetes
* History of arrhythmia
* Stroke
* Multiple sclerosis
* Hereditary peripheral neuropathy
* Amyotrophic lateral sclerosis (ALS)
* Patients with a pacemaker
* Presence of local infection at the wound site
* Pregnant or breastfeeding women
* Patients deemed unsuitable for enrollment by a physician

Primary outcomes:
measure: NCV/EMG(CMAP,latency)
timeFrame: The third month after surgery.
Secondary outcomes:
measure: DASH questionnaire
timeFrame: The first, third, and sixth months after surgery.
measure: Muscle power
timeFrame: The third and sixth months after surgery.
measure: Purdue Pegboard test
timeFrame: The third and sixth months after surgery.
measure: MMDT
timeFrame: The third and sixth months after surgery
measure: NCV/EMG(CMAP,latency)
timeFrame: The sixth month after surgery.
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT02376660: Effect of Oats on Lipid Profile
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of 3 g of Soluble Fiber From Oats on the Lipid Profile of Men and Women With Elevated Lipid Levels Aged Between 20 and 50 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mildly Hypercholesterolemic Subjects
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized control trial to assess the effect of oats on lipid profile of mildly hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In total 3 assessment visits of the subjects planned for the study period.


Eligibility criteria: Inclusion Criteria:

* Men and women between 20 and 50 years old
* Total Cholesterol: ≥ 200 mg/dL and \< 240mg/dL
* Availability and willingness to follow study protocol
* Stable body weight for previous 3 months (not more than 5% weight change)

Exclusion Criteria:

* Subjects already on lipid lowering drugs
* LDL-c \> 190 mg/dL
* Total cholesterol \<200 mg/dL and \>240 mg/dL
* Subjects with serum creatinine levels \> 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse
* Baseline Triglycerides: \> 300 mg/dL
* Diabetes (Type 1 or Type 2) as diagnosed by a physician
* Uncontrolled hyperthyroidism (as per physician's discretion)
* Uncontrolled hypertension (as per physician's discretion)
* Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs by history
* Irritable bowel syndrome by history
* Unwillingness to give written informed consent for participation in the study.
* Pregnancy \& lactation (by history)
* Severe end organ damage
* Subjects with allergy to oats
* Heavy smokers (smoking more than 5 cigarettes per day)

Primary outcomes:
measure: reduction of total cholesterol
timeFrame: 4 weeks
Secondary outcomes:
measure: LDL-c
timeFrame: 4 weeks
measure: Triglycerides
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fortis Clinical Research Limited
name: Anoop Misra, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gulati S, Misra A, Pandey RM. Effects of 3 g of soluble fiber from oats on lipid levels of Asian Indians - a randomized controlled, parallel arm study. Lipids Health Dis. 2017 Apr 4;16(1):71. doi: 10.1186/s12944-017-0460-3.
Clinical trial NCT03109860: Can the Perception of a Treatment Influence Pain Processing - an Examination of Psychological and Neurobiological Mechanisms
Official title: Can the Perception of a Treatment Influence Pain Processing - an Examination of Psychological and Neurobiological Mechanisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: Chronic neuropathic pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Augustinus Foundation, Denmark.
name: The (Danish) Foundation for Neurological Research
First posted: 2017-04-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic neuropathic pain after thoracic surgery.

Brief summary: The study investigates the effect of an open (in full view of the patient) vs hidden treatment (without the patient's knowledge).


Eligibility criteria: Inclusion Criteria:

- Neuropathic pain \> 3 on a 0-10 NRS.

Exclusion Criteria:

* Psychiatric or competing neurological disorders.
* Known allergies to any medications, including local anesthetics.

Primary outcomes:
measure: Mechanical visual analogue scale
timeFrame: 10 minutes after treatment administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01122160: Gastric pH and Anthocyanin Absorption
Official title: Gastric pH as a Possible Determinant of Anthocyanin Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anthocyanin Metabolism
Keywords: anthocyanin
omeprazole
Prilosec
gastric pH
proton pump inhibitor
PPI
nutrition
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2010-05-13
Enrollment: 13
Sex: ALL
Minimum age (years): 22
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.


Eligibility criteria: Inclusion Criteria:

* BMI 18.5 kg/m2 to 30 kg/m2
* Age 22 to 59 years

Exclusion Criteria:

* Plans to have MRI analysis or other contact with MRI equipment during the study
* Has implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
* Suspected strictures, fistulas or physiological GI obstruction
* Allergy to omeprazole
* Current use of clopidogrel (Plavix) or use within the past 3 months
* Use of warfarin, prescription antifungals/anti-yeast drugs, diazepam, and digoxin
* Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)
* History of bariatric or other gastric surgery
* Frequent use of antacids
* Use of proton pump inhibitors in past 3 months
* History of acid reflux
* History of gastrointestinal disorders or gastrointestinal surgery
* History of bezoars (packed collection of partially digested or undigested material that is unable to exit the stomach)
* Crohn's disease, diverticulitis or inflammatory bowel disease
* Inability to swallow large pills
* Dysphagia (Trouble or pain with swallowing food or pills)
* Allergy to strawberries or blackberries
* Pregnant women
* Lactating women
* Pregnancy in last 12 months
* History of kidney disease
* History of liver disease
* History of metabolic disorder
* History of some cancers
* Tobacco use in past 6 months
* Use of oral or IV antibiotics in past month
* Use of herbal supplement in past month

Primary outcomes:
measure: Gastric pH
timeFrame: 1 hour prior to gastric emptying on Day 7 of the given intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA's Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: USDA Beltsville Human Nutrition Research Center
name: Beverly Clevidence, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: