louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00947921: Plasty or Prosthesis to Treat Functional Mitral Regurgitation
Official title: POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Mitral Regurgitation
Keywords: Functional MItral regurgitation
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis remains controversial in terms of mid and long term benefit for the patient. The investigators propose a randomized controlled study to compare the efficacy of both technique in terms of mortality and freedom from reintervention.


Eligibility criteria: Inclusion Criteria:

* All patients presenting for surgery due to functional mitral regurgitation

Exclusion Criteria:

* Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction

Primary outcomes:
measure: Mortality
timeFrame: 1 year of follow up after discharge from hospital
Secondary outcomes:
measure: Freedom from reintervention
timeFrame: 1 year of follow-up after discharge from hospital
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Divisione di Cardiochirurgia, E.H.
Study officials:
affiliation: Cardiochirurgia E.H.
name: Luca Weltert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04795921: Investigating the Sleeping Habits of Patients With Haemophilia
Official title: Investigating the Sleeping Habits of Patients With Haemophilia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disorder
Psychological
Activity, Motor
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: University of Wuppertal
First posted: 2021-03-12
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to include 104 patients with haemophilia as well as 104 age-matched healthy controls.

Brief summary: This investigation aims to explore sleeping habits in patients with haemophilia.

These patients often suffer from joint pain, which leads to restricted physical activity. Further, many of the patients suffer from psychological strains, such as depression. Both depression and restricted physical activity can result in sleeping disorders. Thus it is aimed to find out which factors and comorbidities do play a role within sleeping habits in patients with haemophilia.


Eligibility criteria: Inclusion Criteria:

* adult (≥ 18 years) patients with haemophilia (all severities) or Von-Willebrand-Disease (Typ III)
* female carriers
* signed informed consent

Exclusion Criteria:

* patients with other bleeding disorders
* patients with acute injuries, psychological disorders or Prior surgeries (in the last 6 weeks)
* no signed informed consent

Primary outcomes:
measure: Sleeping habits
timeFrame: 15 Minutes
Secondary outcomes:
measure: Physical activity
timeFrame: 10 Minutes
measure: Psychological distress
timeFrame: 10 Minutes
measure: Kinesiophobia
timeFrame: 5 Minutes
measure: Subjective pain perception
timeFrame: 5 Minutes
measure: Adherence to prophylactic treatment
timeFrame: 5 Minutes
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital of Bonn
state: Northrhine Westfalia
Study officials:
References:
Clinical trial NCT00206921: Pulsed Dye Laser and Intense Pulsed Light (IPL) for the Treatment of Telangiectasia and Skin Redness
Official title: Pulsed Dye Laser and Intense Pulsed Light for the Treatment of Telangiectasia and Skin Redness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telangiectasis
Erythema
Keywords: Telangiectasia
Skin redness
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with skin telangiectasia and redness.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Skin types I, II, III
* No previous laser or IPL treatment for the condition

Exclusion Criteria:

* Younger than 18 years old
* Skin types IV, V, or VI
* Pregnant or lactating women
* Previous laser or IPL treatment for the condition
* Recent exposure to sun or sun-beds
* Treatment with oral retinoid within 6 months
* Tendency to produce hypertrophic scars or keloids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Hædersdal, MD, PhD, DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652521: Effects of Pleural Effusion Drainage on Respiratory System Mechanics
Official title: Effects of Pleural Effusion Drainage on Respiratory System Mechanics in Mechanically Ventilated Patients, as Measured by Esophageal Balloon.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pleural Effusion
Keywords: lung compliance
pleural effusion
esophageal pressure
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.

Brief summary: The effects of pleural drainage on lung mechanics are unknown. Insertion of esophageal balloon will allow us to measure and assess pleural pressure, and thus assess any possible effects of pleural fluid drainage may have on lung mechanics.

Detailed description: Esophageal balloon will be inserted prior to pleural fluid drainage.

Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.who are candidates for pleural fluid drainage.

Exclusion Criteria:

* Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.

Primary outcomes:
measure: chest wall and lung compliance
timeFrame: 1 year
Secondary outcomes:
measure: oxygenation
timeFrame: 1 year
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson MC
Study officials:
affiliation: Wolfson MC
name: Arie Soroksky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown NE, Zamel N, Aberman A. Changes in pulmonary mechanics and gas exchange following thoracocentesis. Chest. 1978 Nov;74(5):540-2. doi: 10.1378/chest.74.5.540.
Clinical trial NCT02696421: Ramadan and Energy Expenditure Study
Official title: Ramadan and Energy (RAMEE) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Energy Expenditure During Ramadan Fasting
Lead sponsor: Imperial College London Diabetes Centre
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 50 healthy non-obese (BMI: 20-30) subjects (age: 18-70) will be recruited. We will aim for equal representation of men and women.

Physically and mentally healthy. Consent form signed.

Brief summary: Ramadan fasting entails abstinence from eating and drinking between dawn and sunset. During this month major changes in meal times and patterns, sleeping times and activity occur. Starvation is known to lead to a compensatory reduction in energy expenditure. However, the Ramadan fast is not synonymous with starvation as it involves intermittent periods of fasting followed by gorging. People who fast during Ramadan feel less energetic. However, little is known about the effects of this religious practice on energy metabolism. .

The aim of this study is to assess energy dynamics before and/or after and during Ramadan fasting in non-obese participants. Resting metabolic rate (RMR), thermic effect of food (TEF), active energy expenditure (AEE) and total energy expenditure (TEE) in free-living conditions will be measured . Indirect calorimetry will be used to assess RMR and TEF, doubly labeled water will be used to measure TEE and activity monitors will measure physical activity. In addition, body composition analysis will be performed by bio-electrical impedance. Blood sample will be taken to exclude medical factors affecting energy metabolism.


Eligibility criteria: Inclusion Criteria:

* Willing to participate.
* Age (18-70) years.
* BMI (20-30 kg/m2).
* Physically and mentally healthy.
* Consent form signed.

Exclusion Criteria:

* Any patients with significant health problem.
* Pregnant and lactating females.
* Smokers.
* Consumption of caffeine before tests.
* Patients who have had vigorous exercise for the last 12 hours before visit.
* Patients with diabetes treated with drugs known to alter the metabolic rate.
* Patients who had bariatric surgery.
* Patients with eating disorders.
* Patients with conditions known to affect energy expenditure
* Patients on medication know to alter EE (Thyroxine, anti-thyroid drugs, certain cold remedies)

Primary outcomes:
measure: Resting metabolic rate
timeFrame: 3 months
measure: 24 hour energy expenditure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
Study officials:
References:
citation: Lessan N, Saadane I, Alkaf B, Hambly C, Buckley AJ, Finer N, Speakman JR, Barakat MT. The effects of Ramadan fasting on activity and energy expenditure. Am J Clin Nutr. 2018 Jan 1;107(1):54-61. doi: 10.1093/ajcn/nqx016.
Clinical trial NCT00000521: Sodium-Potassium Blood Pressure Trial in Children
Official title: Sodium-Potassium Blood Pressure Trial in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 1999-10-28
Enrollment: 285
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the effects of nutritional intervention on the rate of rise of blood pressure in late childhood and early adolescence.

Detailed description: BACKGROUND:

Since 1970, children and adolescents with hypertension have been detected with increasing frequency. Many of them were thought to have primary or essential hypertension and it remained unclear how they should be managed. Additionally, since tracking of blood pressure occurred even in early life, it was believed that youngsters with blood pressures persistently in the upper deciles for age were at increased risk for later hypertension. No clinical trials had been performed in this age group to examine the effects of non-pharmacologic or drug therapy in lowering blood pressure. The trial was one of the first attempts to examine the effects of a nutritional intervention on the rate of rise of blood pressure in late childhood and early adolescence.

DESIGN NARRATIVE:

Randomized, partial-blind. After 19,542 fifth to eighth grade students were screened, 210 (105 boys and 105 girls) from the upper 15 percentiles of blood pressure distribution were randomly assigned to one of three groups: low sodium diet (70 mmol sodium intake per day), potassium chloride supplementation (normal diet plus 1 mmol/kg potassium chloride per day), and placebo (normal diet plus placebo capsule). Capsules for the potassium chloride and placebo groups were administered in a double blind protocol. Blood pressure was measured every three months for three years. The effect of the intervention was determined by comparing the rate of rise (slope) of blood pressure among the groups using a random-coefficient growth curve model.

Eligibility criteria: Children in grades 5 through 8 whose systolic blood pressure was greater than or equal to 120 mm Hg on two visits.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gomez-Marin O, Prineas RJ, Sinaiko AR. The Sodium-Potassium Blood Pressure Trial in Children. Design, recruitment, and randomization: the children and adolescent blood pressure program. Control Clin Trials. 1991 Jun;12(3):408-23. doi: 10.1016/0197-2456(91)90020-m.
citation: Sinaiko AR, Gomez-Marin O, Prineas RJ. Effect of low sodium diet or potassium supplementation on adolescent blood pressure. Hypertension. 1993 Jun;21(6 Pt 2):989-94. doi: 10.1161/01.hyp.21.6.989.
Clinical trial NCT01880021: Synthetic Mesh Explant Study
Official title: Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herniorrhaphy
Humans
Polypropylene
Polytetrafluoroethylene
Histology
Materials Testing
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 111
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: Subjects will be recruited from study investigators' patient population.

Brief summary: The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 yrs
* Previous placement of hernia mesh material
* Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure

Exclusion criteria:

* Age \< 18 yrs
* No retained mesh prosthetic.
* Non surgical candidate
* Prisoner

Primary outcomes:
measure: Fibrosis level of explanted mesh
timeFrame: Within 2 weeks
Secondary outcomes:
measure: Tensile strength of explanted mesh
timeFrame: Within 2 weeks
measure: Collagen protein levels of explanted mesh.
timeFrame: Within 2 weeks
measure: Number of subjects with history of radiation to abdomen/pelvis
timeFrame: Within 2 weeks
measure: Number of subjects with history of chemotherapy
timeFrame: Within 2 weeks
measure: Number of subjects with corticosteroid/immunosuppression therapy
timeFrame: Within 2 weeks
measure: Number of subjects with history of tobacco use
timeFrame: Within 2 weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael Brunt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04305821: Medico-economic Interest of the Protein S100b in Mild Head Trauma Under Anti-thrombotics
Official title: Intérêt de la protéine S100β Dans Les Traumatismes Crâniens légers Sous Anti-Thrombotiques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Head Injury
Anticoagulant
Antiplatelet
Keywords: Mild head injury, traumatic brain injury, traumatic intracranial hemorrhage
Anticoagulant, antiplatelet, anticoagulant, antithrombotic
S100β protein
health care cost
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2020-03-12
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient taking antithrombotic medication with mild head trauma and trauma occured ≤ 6 hours

Brief summary: Head trauma is a common injury in emergency department. Investigation to search for complication is guided by the clinical examination and the case history, such as taking anti-thrombotics. Cranial computed tomography (CCT) is the gold standard to investigate, and is mandatory in case of antithrombotic drugs.

Recently, some biomarkers have proven their utility to rule-out mild head trauma without CCT in the general population. Among these biomarkers, S100β protein has been added in guidelines for mild head trauma. Some studies have found similar data in population taking anticoagulant or antiplatelet drugs.

The investigators aim to prove medical utility of S100β protein in population under antithrombotics, by the reduction of CCT use. Then, The investigators hypothesize that the add of S100β protein reduces cost of health care in the management of head injury in that population.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old
* Taking antithrombotic medication (antiplatelet drugs, K vitamin antagonist, direct oral anticoagulants, heparins)
* Mild head trauma with Glasgow coma scale ≥ 13
* Trauma occured ≤ 6 hours
* Agreeing the participation in the study

Exclusion Criteria:

* Head injury occured \> 6 hours
* Patient \< 18 years old or under juridic protection
* pregnant women
* polytrauma
* Glasgow coma scale ≤ 12
* ancient or actual cerebral ou cutaneous neoplasia

Primary outcomes:
measure: Diagnostic performances are evaluated by AUC
timeFrame: 1 day
measure: Diagnostic performances are evaluated by sensibility, specificity
timeFrame: 1 day
measure: Diagnostic performances of S100β protein in case of mild head trauma for detection of traumatic intracranial lesion in patients under antithrombotic medication compare to cranial computed tomography.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Centre Hospitalier Univesitaire de Rennes
name: Cédric GANGLOFF, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01803321: Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Official title: A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Juvenile Idiopathic Arthritis
Keywords: SJIA
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.


Eligibility criteria: Inclusion Criteria include, but are not limited to, the following:

* Patients aged 4 to less than 21 years who meet the criteria for active SJIA
* Must have been on a stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks prior to the screening visit

Exclusion Criteria include, but are not limited to, the following:

* Use of certain medications prior to the baseline visit
* History of recurrent infections

Primary outcomes:
measure: Frequency of treatment emergent adverse events (TEAEs)
timeFrame: Baseline to Week 123
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Chicago
country: United States
state: Illinois
city: Hackensack
country: United States
state: New Jersey
city: Long Island
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Lovell DJ, Giannini EH, Reiff AO, Kimura Y, Li S, Hashkes PJ, Wallace CA, Onel KB, Foell D, Wu R, Biedermann S, Hamilton JD, Radin AR. Long-term safety and efficacy of rilonacept in patients with systemic juvenile idiopathic arthritis. Arthritis Rheum. 2013 Sep;65(9):2486-96. doi: 10.1002/art.38042.