louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01401413: Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
Official title: A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: REM Sleep Behavior Disorder
Lead sponsor: Sleep Medicine Centers of WNY
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

Detailed description: This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for RBD as determined by screening PSG's
* steady bed partner for completion of RBD questionnaire

Exclusion Criteria:

* Hepatic impairment
* RBD associated with narcolepsy
* use of fluvoxamine, rifampin, fluconazole or ketoconazole
* current alcohol or drug abuse

Primary outcomes:
measure: Change in polysomnographic scores
timeFrame: 30 days
Secondary outcomes:
measure: change in RBD symptom questionnaire and sleep diary
timeFrame: 30 days
Other outcomes:
Locations:
city: West Seneca
country: United States
facility: Sleep Medicine Centers of WNY
state: New York
Study officials:
affiliation: Sleep medicine Centers of Western New York
name: Daniel I Rifkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03987113: Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning
Official title: Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant
Lead sponsor: Hopital Foch
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale Rouen U1096
First posted: 2019-06-14
Enrollment: 20
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: Patient who requires a lung transplant, with ex-vivo reconditioning procedure. The objective is to create a plasma bank for all these patients with post analysis of sample.

Brief summary: The study population will be patients with planned double-lung transplant, with preoperative ex-vivo reconditioning procedure.

The ex-vivo procedure will be performed for lungs considered as limit to be directly implanted according to the national classification or in case of Maastrich 3 decision. They required a rehabilitation procedure like ex-vivo to determine their quality. Once the procedure initiated, the unused remaining liquid will be retrieved for the first gasometry usually performed. This will be the time T1 of sampling.

The unused remaining liquid will be retrieved for the gasometry of end of procedure usually performed, before the graft cooling. This will be the time T2.

The purge liquid of first lung at the declamping of the pulmonary artery will be retrieved at the time of unclamping (time T3 of sampling).

The purge liquid of the second lung at the declamping of the pulmonary artery will be retrieved with the same procedure (time T4 of sampling).

The samples will be analysed with ELISA technique. The endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS.


Eligibility criteria: Selection Criteria:

* patient aged \> 18 years old
* patient with healthcare insurance
* non-opposition of the patient
* patient with usual criteria for lung transplant and planned lung transplant after meeting of staff transplant

Non Selection Criteria:

* participation refusal
* patient under tutorship or guardianship
* protected adult

Inclusion Criteria:

* selected patient with Biomedecine Agency agreement for graft allocation off tour

Exclusion Criteria:

* selected patient with Biomedicine Agency agreement for standard allocation graft

Primary outcomes:
measure: Correlation between time of cold ischemia and endothelial dysfunction
timeFrame: 24 hours
Secondary outcomes:
measure: Correlation between time of cold ischemia and systemic inflammation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Anaesthesia department
name: Morgan LE GUEN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02733913: Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation
Official title: Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
pulmonary vein isolation
heart rate turbulence
baroreflex sensitivity
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo PVI for paroxysmal AF

Brief summary: Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF), however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA) reconnection, the cause of recurrence has been not yet fully clarified.

The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have been conducted. Some study showed the efficacy of GP ablation for AF patients.

According to the previous reports, heart rate (HR) increased, and heart rate variability (HRV) reduced after PVI. These are considered to be due to "autonomic denervation" caused by catheter ablation of GP.

For the best of investigators knowledge, there have been no data on heart rate turbulence (HRT) of baroreflex sensitivity (BRS) concerning PVI.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo PVI for paroxysmal atrial fibrillation
* Patients in sinus rhythm at baseline

Exclusion Criteria:

* prior left atrial Ablation
* left atrial diameter \>55mm
* frequent atrial extrasystole, frequent ventricular Extrasystole
* Diabetes Mellitus
* sleep apnea syndrome

Primary outcomes:
measure: recurrence of AF
timeFrame: 12 months
Secondary outcomes:
measure: effect of PVI on cardiac autonomic system utilizing HRT measurement
timeFrame: 12 months
measure: effect of PVI on cardiac autonomic system utilizing BRS measurement
timeFrame: 12 months
measure: association between measured parameters (HRT, BRS) and the recurrence of AF
timeFrame: 12 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Hisaki Makimoto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04084613: Mepolizumab: Real World Evidence Study for the Treatment of Severe Eosinophilic Asthma in Greece
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Eosinophilic Asthma
Keywords: Severe Eosinophilic Asthma
Mepolizumab
Anti-IL5 treatment
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 150
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: Patients with uncontrolled severe eosinophilic asthma

Brief summary: A prospective multi-centre, non-interventional observational study, that will be conducted in several centers in Greece for a 2-year time period (completion date December 2020), to describe patient characteristics, medical history, and the clinical benefit of mepolizumab in patients with severe eosinophilic asthma newly initiated to the drug.


Eligibility criteria: Inclusion Criteria:

* Patients with uncontrolled severe eosinophilic asthma placed under treatment with mepolizumab, i.e. in patients with peripheral blood eosinophils ≥300 cells/μL at any measurement in the previous year or ≥150 cells/μL in a recent measurement, with poor symptom control and increased number of exacerbations (2 or more) despite optimal treatment with high doses of inhaled corticosteroids and β2 stimulants

Exclusion Criteria:

* Patient refusal to participate in the study

Primary outcomes:
measure: Reduction of annual exacerbation rate in patients with severe eosinophilic asthma in treatment with mepolizumab
timeFrame: 2 years
measure: Quality of life improvement in patients with severe eosinophilic asthma receiving mepolizumab as it measured by Asthma Control Test (ACT)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01783613: Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis
Official title: Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 96
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosed of cystic fibrosis over than 2 months age
* Tolerance clinical supplementation with DHA
* Clinical situation stable

Exclusion Criteria:

* Changes in the routine treatment in the 2 weeks prior to baseline
* Admission to hospital or administration of oral or intravenous antibiotics within 2 weeks before inclusion

Primary outcomes:
measure: To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Madrid
country: Spain
facility: Ramón y Cajal Hospital
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La FE
Study officials:
References:
citation: Lopez-Neyra A, Suarez L, Munoz M, de Blas A, Ruiz de Valbuena M, Garriga M, Calvo J, Ribes C, Giron Moreno R, Maiz L, Gonzalez D, Bousono C, Manzanares J, Pastor O, Martinez-Botas J, Del Campo R, Canton R, Roy G, Menacho M, Arroyo D, Zamora J, Soriano JB, Lamas A. Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2020 Nov;162:102186. doi: 10.1016/j.plefa.2020.102186. Epub 2020 Oct 1.
Clinical trial NCT04313413: Yoga@Work for Reducing Musculoskeletal Pain in Neck and Shoulder
Official title: Effectiveness of Yoga@Work Program for Reducing Musculoskeletal Pain in Neck and Shoulder: Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Shoulder Pain
Musculoskeletal Pain
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: Brunel University
First posted: 2020-03-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Work-related musculoskeletal disorders (MSDs) are disorders of muscles, tendons, joints and nerves which can affect all body parts, although the neck, upper limb and back are the most common areas.

The peer-reviewed literature about workplace prevention describes a variety of interventions that have been implemented and evaluated.but only few studies show sustainable positive effects on symptom outcomes.

Yoga@Work program was developed to self manage pain around neck and shoulder areas among office workers.


Eligibility criteria: Inclusion Criteria:

* Office workers
* Willing to participate and give consent
* non specific neck and shoulder pain

Exclusion Criteria:

* neck injury
* Trauma
* Cancer related pain
* psychiatric disorder/ medication
* Pregnancy

Primary outcomes:
measure: Neck and Shoulder pain
timeFrame: From baseline to 4-week post intervention
Secondary outcomes:
measure: Global Outcome
timeFrame: from baseline to 5 week post intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Yog Kulam
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi, BAMS
role: STUDY_DIRECTOR
affiliation: Brunel University
name: Monomita Nandy
role: STUDY_CHAIR
References:
Clinical trial NCT00273013: Study With GW274150 In Patients With Mild Asthma
Official title: Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: asthma
allergen challenge
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.


Eligibility criteria: Inclusion criteria:

* Mild asthma: taking reliever medication (e.g. salbutamol) only.
* Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study.

Exclusion criteria:

* Recent steroid treatment.
* Significant illnesses or diseases other than asthma.

Primary outcomes:
measure: Effect on the late asthmatic reaction following an inhaled allergen challenge
timeFrame: Up to Day 115
Secondary outcomes:
measure: Measures of safety. Measures of lung function
timeFrame: Up to Day 115
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Singh D, Richards D, Knowles RG, Schwartz S, Woodcock A, Langley S, O'Connor BJ. Selective inducible nitric oxide synthase inhibition has no effect on allergen challenge in asthma. Am J Respir Crit Care Med. 2007 Nov 15;176(10):988-93. doi: 10.1164/rccm.200704-588OC. Epub 2007 Aug 23.
Clinical trial NCT04381013: Emergency Ventilator Splitting Between Two or More Patients (COVID-19)
Official title: Emergency Ventilator Splitting Between Two or More Patients Using a Single Ventilator to Address Critical Ventilator Shortages During a Pandemic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to develop a safe, easily scalable, and simple method to split a single ventilator for use amongst two or more patients, thus serving as a capacity bridge to save patient lives until manufacturers can produce enough ventilators.


Eligibility criteria: Inclusion Criteria:

* Phase I

  * Undergoing routine thoracic surgery which will include the use of a dual lumen endotracheal tube at Stanford.
* Phase II

  * Able to give consent
  * On venovenous extracorporeal membrane oxygenation for reason other than COVID-19
* Phase III

  * Able to give consent
  * Infected with COVID-19 and will likely require mechanical ventilation.

Exclusion Criteria:

* Phase I

  * Significant cardiac comorbidities
  * Liver disease
* Phase II

  * Significant cardiac comorbidities
  * Pre or Post-transplant patient
  * Infection with COVID-19
* Phase III

  * Co-infection with disease aside from COVID-19
  * Severely ill requiring high ventilator requirements and not stable for ventilator splitting

Primary outcomes:
measure: Completion of 1-minute test
timeFrame: Up to 1 minute
measure: Completion of 24-hour test
timeFrame: Up to 1 minute
measure: Completion of 24-hour test
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Joseph Woo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04630613: NOX4 and Related Biomarkers in ADPKD
Official title: NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Oxidative Stress
Mitochondria injury and function
NADPH oxidase 4
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Polycystic Kidney Disease Foundation
First posted: 2020-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with a previous diagnosis of ADPKD

Brief summary: To determine the value of NOX4, markers of mitochondria injury and function, and oxidative stress as real-time biomarkers to assess disease severity in patients with early autosomal dominant polycystic kidney disease (ADPKD).

Detailed description: This will be a cross sectional study and will include male and female, young (15-40-years) well characterized patients with early (eGFR\>70mL/min/1.73m2) ADPKD. Patients with different classes of disease severity will be selected using the ADPKD imaging classification. The study will include 60 class-1 (A-E) patients (N=12 per each sub-class).

Eligibility criteria: Inclusion Criteria:

* ADPKD (based on Ravine et al. criteria)
* Class 1 A-E according to imaging classification
* Male and female subjects 15 - 40 years of age
* Estimated GFR\> 70 mL/min/1.73 m2 (CKD-EPI)
* Ability to provide written, informed consent

Exclusion Criteria:

* Class 2 according to imaging classification
* Concomitant systemic disease affecting the kidney
* Diabetes mellitus
* Predicted urine protein excretion in \>1 g/24 hrs
* Use of antioxidants i.e. vitamins, Nrf2 activators
* Abnormal urinalysis

Primary outcomes:
measure: NOX4 levels
timeFrame: Baseline
measure: mtDNA copy number
timeFrame: Baseline
measure: Tricarboxylic Acid (TCA) cycle metabolites
timeFrame: Baseline
measure: REDOX status
timeFrame: Baseline
measure: Total kidney volume (TKV)
timeFrame: Baseline
Secondary outcomes:
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Maria V Irazabal, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01791413: Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Endometriosis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.


Eligibility criteria: Inclusion Criteria:

* Healthy women 18-40 years old
* A diagnosis of endometrioma with diameter of at least 3 cm.
* Candidates for laparoscopic cystectomy

Exclusion Criteria:

* Patients' refusal to participate
* Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
* Use of estrogen-suppressive drugs in the preceding 3 months, such as:

Oral contraceptives, GnRH analogues, Progestins, Danazol

* Pathology report present no endometriosis

Primary outcomes:
measure: Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation
timeFrame: Within the first 2 weeks and 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Department of Obstetrics and Gynecology
state: Bangkok
Study officials:
References: