louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00157963: Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)
Official title: A 12 Week, Open, Randomized, Parallel, Multicenter Study of Efficacy, Tolerability & Safety of Hydrochlorothiazide (+) Losartan Potassium Versus Amlodipine in Essential Hypertensive Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to amlodipine at week 12 in Korean patients with essential hypertension


Eligibility criteria: Inclusion Criteria:

* Patients of age 20 70 75 with essential hypertension
* SiDBP 90 \~ 114mmHg at V1 \& V2

Exclusion Criteria:

* Patient has known or suspected secondary hypertension
* Patient has a history of malignant hypertension (SiSBP \> 210mmHg)
* Individuals has a known sensitivity or intolerance to HCTZ or any AIIAs, or any sulfonamide-derived drugs.
* Patient has shown significant abnormal laboratory evaluations

Primary outcomes:
measure: Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine
Secondary outcomes:
measure: Safety/Tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chung JW, Lee HY, Kim CH, Seung IW, Shin YW, Jeong MH, Cho MC, Oh BH. Losartan/Hydrochlorothiazide fixed combination versus amlodipine monotherapy in korean patients with mild to moderate hypertension. Korean Circ J. 2009 Apr;39(4):151-6. doi: 10.4070/kcj.2009.39.4.151. Epub 2009 Apr 28.
Clinical trial NCT03484663: Small Catheter Drainage With Chest Tube Versus Chest Tube Alone After Uniport Video-assisted Thoracoscopic Procedures
Official title: Small Catheter Drainage With Chest Tube After Uniport Video-assisted Thoracoscopic Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case of small catheter drainage with chest tube versus chest tube alone after uniport vats
Primary purpose: TREATMENT

Brief summary: Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures

Detailed description: Traditionally an Intercostal Tube is applied intraoperative following VATS procedures to drain the remaining pneumothorax and residual effusion , some of the residual effusion can't drain by intercostal tube which lead to prolonged hospital stay hypothesis that putting an additional small catheter drainage at the most depended part of hemithoracic early removal of chest tube without add more pain or hospital stay to the patient.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing uniport video-assisted thoracoscopic surgery at Assiut University Hospital who need intercostal drainage postoperative

Exclusion Criteria:

* Patients who do not need intercostal tube post operative

Primary outcomes:
measure: Number of participants with failure of initial intervention
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01634035: Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients
Official title: Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ESRD
Keywords: glycated hemoglobin
mean plasma glucose
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all hemodialysis and diabetic population

Brief summary: The investigators are studying the correlation between Hba1c and the mean plasma glucose in diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess glycemic control over a 3 months duration in hemodialysis patients

Detailed description: The Hb turnover in hemodialysis population is higher than the general population leading to a general believe that HbA1c tend to underestimate mean plasma glucose.

The investigators are trying to define the correlation between mean plasma glucose and HbA1c in the hemodialysis population and trying to study the factors that could affect this correlation (dose of erythropoetin, ret count..) We are trying to see if HbA1c is a better tool to assess glycemic control over 1 month than glycemic control over 3 month.

This clinicaly will translate in obtaining HbA1c more frequently in hemodialysis patients to assess their glycemic control.

Eligibility criteria: Inclusion Criteria:

* Age\>18
* Hemodialysis and diabetic
* Lab data are available for more than 6 months

Exclusion Criteria:

* Lab data not available

Primary outcomes:
measure: Measure levels of plasma blood glucose and HbA1c
timeFrame: 6 month intervals
Secondary outcomes:
measure: Measure ferritin, erythropoetin dose, reticulocytes count
timeFrame: 6 month intervals
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: statenisland university hospital
name: suzanne el-sayegh, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01955135: Anesthesia for Retinopathy of Prematurity
Official title: DECREASING THE NEED FOR MECHANICAL VENTILATION AFTER RETINOPATHY OF PREMATURITY SURGERY: Sedation vs General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinopathy
Keywords: Prematurity, Retinopathy, propofol, ketamine, sedation
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premature infants experience more respiratory problems after surgical procedures. The investigators aimed to compare general anesthesia with sedation on the need for post-operative mechanical ventilation in infants undergoing retinopathy of prematurity surgery.

Detailed description: 60 patients who underwent laser surgery due to retinopathy of prematurity (ROP) were included in the study. The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance. In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen. Our primary objective was to evaluate the need for post-operative mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP

Exclusion Criteria:

* The exclusion criteria were patients requiring inotropic support,
* the need for mechanical ventilation or intubation in the 3 days prior to the operation,
* known allergy or hypersensitivity reaction to ketamine and propofol,
* age ˃40 weeks.

Primary outcomes:
measure: Respiratory failure after retinopathy of prematurity surgery in premature infants.
timeFrame: 1 Day (From end of anaesthesia till discharge from the recovery room )
Secondary outcomes:
measure: Blood Pressure
timeFrame: 1 Day (From start of anaesthesia till discharge from the operation room)
measure: Heart rate
timeFrame: 1 Day (From start of anaesthesia till discharge from the recovery room )
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: AYŞE ÜLGEY, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00583635: Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia
Official title: Minimizing Early Pregnancy Oxidative Stress to Maximize Healthy Pregnancy Outcome: Reducing Preeclampsia and Reproductive Loss With Antioxidant-Rich Tablet Supplementation Initiated in the First Trimester
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Pregnancy Loss
Keywords: Preeclampsia
Prevention
Food Supplement
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 684
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients cared for in the University of Mississippi Medical Center

Brief summary: Use of Juice Plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. This is a prospective randomized and blinded placebo controlled study sponsored by NSA, LLC of Memphis, TN.

Detailed description: Not desired

Eligibility criteria: Inclusion Criteria:

* Pregnant Patients seen in first trimester with low or high risk pregnancy

Exclusion Criteria:

* Pregnant patients first seen after the first trimester
* Unlikely to continue care in our system
* Unwilling to comply with rigor of taking food supplements throughout gestation

Primary outcomes:
measure: Development of preeclampsia during pregnancy
timeFrame: Preeclampsia at any time during gestation
Secondary outcomes:
measure: The observed incidence of preterm labor, premature rupture of membranes, perinatal loss
timeFrame: First, second and third trimester
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: James N Martin, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356935: Effects of Heavy-load Resistance Training
Official title: Effects of Resistance Training on Lower Limb Mechanical Muscle Function and Sports Specific Performance in Elite Female Team Handball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Resistance training
Agility performance
Jump capacity
Knee extensor and flexor strength
Explosive muscle strength
Sprint ability
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Team Denmark
First posted: 2024-04-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON).

Detailed description: The study aims to examine how an eight-week heavy-load resistance training regimen affects both mechanical muscle function and functional performance in elite female team handball players. Given the sport's demands for rapid and forceful muscle actions, understanding the impact of such training on functional performance is crucial.

Players from four clubs in the Danish Women's Handball League, will be randomly block randomized (one block=one club) into two groups: the heavy-load resistance training group (RT), and the control group (CON). Each group contains players from 2 clubs. The study will conduct a battery of tests to evaluate various aspects of mechanical muscle function and performance, including isometric knee extensor and flexor peak torque, countermovement jump (CMJ) power/work, and functional measures like sprinting, jump height, and agility performance.

Eligibility criteria: Inclusion Criteria:

* Playing in the Danish Women's Handball League.

Exclusion Criteria:

* Absent from team handball training for more than two weeks due to injuries, within the six months preceding PRE-testing.

Primary outcomes:
measure: Explosive muscle strength
timeFrame: Eight week off-season
measure: Acceleration capacity
timeFrame: Eight week off-season
measure: Agility performance
timeFrame: Eight week off-season
measure: Jump ability
timeFrame: Eight week off-season
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Bjørn Fristrup, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05310435: A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
Official title: A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Edema Leg
Keywords: Lower leg edema
Equivalence study
Leg volume
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Ohmatex ApS
name: Aarhus University Hospital
First posted: 2022-04-05
Enrollment: 6
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women, 20-40 years, located to the Central Region of Denmark, admitted to Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.

Brief summary: The purpose of the study is to evaluate a prototype of an intelligent stocking (Edema Stocking Device \[ESD\]), consisting of two stretch sensitive sensors, as a new method for continuously lower leg volume monitoring. The study is a scientific evaluation of the ESD compared with water displacement volumetry and tape measure.

Detailed description: Background:

Balance of body fluids is strictly regulated within a narrow range and is controlled by water movement between the interstitial compartment and the capillaries. An unnatural balance between the two compartments can be seen in several diseases, leading to a net filtration out of the vascular space, resulting in the formation of edema. Monitoring of edema formation represents a unique way of evaluating the degree of the underlying disease and effect of treatment. Numerous different methods can be used to quantify leg volume. However, no current method provides continuous quantitative assessment. The feasibility of continuous lower leg measuring using an intelligent stocking was hypothesized.

The aim of the study was to evaluate the Edema Stocking device (ESD) as a tool for continuous quantification of edema compared with water displacement volumetry (WDV) and tape measure.

Materials and methods:

Study design: Non-randomized equivalence study. Experimental comparison study of new method compared to golden standard.

Eligibility criteria: Inclusion Criteria:

* Edema of the lower legs.
* Between 20-18 years.
* Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.

Exclusion Criteria:

* Length of lower leg of more than 34,0 cm (measured from floor to knee).

Primary outcomes:
measure: Leg volume measured with ESD (ml)
timeFrame: 1 minute
measure: Leg volume measured with WDV (ml)
timeFrame: 1 minute
measure: Leg circumference measured with tape measure (mm)
timeFrame: 1 minute
measure: Leg circumference measured with ESD (mm)
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department og Gynaecology and Obstetrics, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Olav B Petersen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02992535: Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity
Official title: Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Carones Ophthalmology Center
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.

Detailed description: Prospective study design among subjects with MGD and qualifying for IPL therapy.

Study testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).

Subjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements.

No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months

Eligibility criteria: Inclusion Criteria:

* Dry eye
* MGD

Exclusion Criteria:

* No history of ocular infection or corneal degeneration/dystrophy
* No history of corneal refractive surgery
* No change in ocular medications in the last 2 months

Primary outcomes:
measure: Tear film osmolarity change
timeFrame: Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04365335: Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic
Official title: Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Stress
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
Collaborators: name: Institut de Recherche Biomedicale des Armees
First posted: 2020-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of people who have been deployed to serve at the mobile intensive care unit in Mulhouse (France) during the Covid-19 crisis.

Brief summary: This study is aiming at investigating whether professional burnout in people involved in the mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by a dysregulation of stress pathways with a high level of perceived stress towards an emotional event (psychological index of allostatic load), i.e. an early and silent dysfunctional physiological response (measured by the electrophysiological and biological measurements of allostasis load and parasympathetic brake).

It is part of a global approach aiming at identifying levers to prevent the allostatic load of occupational stress related to large-scale health crises.


Eligibility criteria: Inclusion Criteria:

* Volunteer staff member of the Mulhouse mobile intensive care unit (in French: Elément mobile de réanimation, EMR), including military reservists.

Exclusion Criteria:

* Pregnant or breastfeeding woman,
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to a legal protection measure or unable of giving consent
* Intercurrent pathology with inability to work
* History of psychiatric disorder or cardiac pathology

Primary outcomes:
measure: Professional burnout
timeFrame: 21 days after enrollment (Day 21)
measure: Mindfulness level
timeFrame: Day 1
Secondary outcomes:
measure: Perceived stress level following the emotional stimulation
timeFrame: Day 1
measure: Parasympathetic flexibility evolution during emotional recall
timeFrame: Day 1
measure: Sympathetic tone at rest
timeFrame: Day 1
measure: Corticotropic activation at rest
timeFrame: Day 1
measure: Mood disorders (anxiety / depression)
timeFrame: Day 1
measure: Post-traumatic stress disorder
timeFrame: Day 1
measure: Sleep quality
timeFrame: Day 1
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Elément Militaire de Réanimation (EMR)
Study officials:
References:
Clinical trial NCT00839735: Trefoil Peptides in Lung Diseases
Official title: Trefoil Peptides in Lung Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Asthma
Keywords: COPD
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with chronic obstruction pulmonary disease (COPD) Subjects with asthma Healthy volunteers

Brief summary: The study focuses on trefoil family factor (TFF) peptides in sputum in lung diseases. The investigators hypothesize that TFF peptides are upregulated in lung diseases characterized by mucus hypersecretion.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Informed consent

Exclusion Criteria:

* Upper and lower airway infection 2 weeks prior to visit 1

Primary outcomes:
measure: TFF in sputum
timeFrame: Monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Respiratory and Allergy Research Unit, Department of Respiratory Medicine L, Bispebjerg Hospital
Study officials:
affiliation: Respiratory and Allergy Research Unit
name: Thomas K Lund, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: