louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02728986: Cost Evaluation of Venous Leg Ulcers Management
Official title: Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Ulcer
Keywords: Costs and Cost Analysis
Humans
Health Care Costs
varicose ulcer
Compression Bandages
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2016-04-06
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.

Detailed description: The purpose of this study is to evaluate direct costs of Venous Leg Ulcers management when two different compression systems are used. Micro-costing during the study will bring direct costs which include nurse and physician time, dressings and bandages.

Perspective of costs will be Public Health Insurance. Time horizon will be 16 weeks.

Eligibility criteria: Inclusion Criteria:

* consent to participate
* ambulatory management
* 1 to 3 leg ulcers
* leg ulcers below the knee and above ankle
* no contra-indication to wear compression bandage
* not currently treated by one of the investigational devices

Exclusion Criteria:

* cognitive impairment
* opposition to wear compression bandage
* bedridden
* pregnancy

Primary outcomes:
measure: Direct cost of leg ulcer management
timeFrame: 16 weeks
Secondary outcomes:
measure: Prevalence of adverse events related to compression
timeFrame: 16 weeks
measure: Patient's compression bandage acceptance score
timeFrame: 16 weeks
measure: Number of patients with fully healed ulcer
timeFrame: 16 weeks
measure: EuroQoL 5D-5L change between baseline and last visit
timeFrame: 16 weeks
measure: Average time to full healing
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Quimper
country: France
facility: Quimper Center
Study officials:
affiliation: AP-HP Hôpital Rothschild - Paris
name: Sylvie Meaume, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01513486: Electrical Stimulation During Immobilization
Official title: The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disuse Atrophy
Immobilization
Neuromuscular Electrical Stimulation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged from 18-35 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* Smoking
* Performing regular resistance training in the previous 6 months
* Hypertension (according to WHO criteria) \[46\] and/or cardiovascular disease
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Use of any prescribed medication
* Type 2 diabetes mellitus
* Any family history of thrombosis
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Myocardial infarction within the last 3 years
* Use of anti-coagulants

Primary outcomes:
measure: muscle mass, muscle fiber size
timeFrame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Secondary outcomes:
measure: muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
timeFrame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht UMC
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108886: Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth
Official title: Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Preterm Labor
Keywords: preterm labor
montelukast
uterine contractions
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preterm birth is a major public health problem, and actual treatments are not very efficient. The purpose of this study is to test the efficiency of a combined use of Montelukast and Nifedipine to treat preterm labor. Investigators aim to reduce uterine contractions more efficiently than with the use of Nifedipine only.

Detailed description: An inflammatory process is involved in 60% of preterm births. Moreover, investigators previously demonstrated that enzymes of lipoxygenase pathway are present in uterine smooth muscle, and that an additive tocolytic effect can be obtained from the combined use of Montelukast and Nifedipine.

Methods:

This is a double-blinded randomized controlled assay performed at the CHUS on two groups of 50 women. Women will be selected when admitted for preterm labor with a gestational age between 26 and 34 weeks.

The first group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to 10 mg of Montelukast per day, until delivery or 35 weeks of pregnancy.

The second group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to a placebo per day, until delivery or 35 weeks of pregnancy.

Cervical secretions and urine will be sample at the admission, after one week and every two weeks during treatment.

Eligibility criteria: Inclusion Criteria:

* women with 24-34 weeks of pregnancy
* indication for tocolysis

Exclusion Criteria:

* preterm labor before 26 or after 34 weeks of pregnancy
* minor patients
* patients with other obstetrical pathology
* twin pregnancies
* fetal distress
* severe congenital fetal malformation
* anti-phospholipid syndrome
* lupus
* gestational diabetes
* nephropathy
* congenital heart disease
* obvious causes of infection associated with prematurity
* patients with viral infections (HIV, hepatitis)
* patients already treated with Montelukast

Primary outcomes:
measure: Time between beginning of treatment and delivery
timeFrame: until delivery (max 17 weeks)
Secondary outcomes:
measure: preterm birth
timeFrame: until delivery (max 13 weeks)
measure: chorio decidual infection
timeFrame: between inclusion and delivery (max 17 weeks)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Charles Pasquier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001386: In Vitro Drug Sensitivity Testing of Fresh Human Samples
Official title: Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myeloproliferative Disorders
Lymphoproliferative Disorders
Keywords: Hematological malignancies
lymphoid
myeloid
multiple myeloma
anticancer drugs
sensitivity
new treatments
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) .

Over the last decade, the treatments have evolved significantly but the overall survival remains limited, especially for the AML and MM patients. There's an ongoing imperative to continue in-vitro and in-vivo studies to better evaluate the anti-cancer drugs sensitivity and therefore improving the response to treatments and open new fields of application. The healthy control group will be contributing to produce some pertinent and significant data for the results of the index cases group.

The investigators aim to analyze 10 differents drugs, common use in chemotherapy or immunotherapy and evaluate by 2 ways the sensitivity: first, Flow cytometry (cells apoptosis by Annexine V and propidium iodide) on fresh samples and in a second time, monitoring of the blasts in the mouse's blood after injection.


Eligibility criteria: Inclusion Criteria:

* Index cases: patients with myeloproliferative or lymphoproliferative disorders.
* Controls: patients without hematological disease, without chemotherapy ((≤ 5 years.) and without immunosuppressive treatment at the study time.
* Age ≥ 18 y.o for all the patients

Exclusion Criteria:

* Age \< 18 y.o
* Pregnant or breastfeeding woman
* Patients deprived of their liberty by judicial or administrative decision.

Primary outcomes:
measure: Evaluation of the sensitivity of 10 anti-cancer drugs
timeFrame: Through study completion, an average of 3 years
measure: Evaluation of the sensitivity of 10 anti-cancer drugs
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud -Service d'Hématologie
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud -Service de médecine du vieillissement
Study officials:
References:
Clinical trial NCT01652586: Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Keywords: cardiac ablation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are associated with respiratory depression and hypotension. The aim of this study was to compare the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect without serious respiratory depression, with conventional midazolam/remifentanil combination on sedative and analgesic levels in patients undergoing endocardial ablation.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective cardiac ablation for atrial fibrillation

Exclusion Criteria:

* ASA physical status class ≥ 3,
* respiratory disease,
* end stage renal disease,
* illiterate

Primary outcomes:
measure: change of sedation depth
timeFrame: 5 min after study drug adminstration, and every 10 min thereafter
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital
name: Young Lan Kwak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02037386: H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: Side branch stent
Coronary bifurcation lesion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intervention for coronary bifurcation lesion is about 10\~20% of entire percutaneous coronary intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore, occlusion of side branch frequently occurred during PCI. Several techniques to prevent occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side branch stent is developed to treat coronary side branch lesion and composed of proximal, connecting and distal parts. In vivo study performed in pigs showed effective H-side branch stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of coronary side branch lesion.


Eligibility criteria: Inclusion Criteria:

* Older than 20 years old
* Patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion
* Bifurcation lesion with 2.5\~4.0mm of main vessel diameter, \<30mm of main vessel length and ≥2.0mm of branched vessel diameter

Exclusion Criteria:

* Acute myocardial infarction
* Confirmed or suspicious presence of thrombus in target lesion
* In-stent restenosis lesion
* Visual angulation with ≥75°
* Lesion with severe calcification or severe tortuosity
* Left main lesion
* Chronic total occlusion lesion
* Graft lesion
* Contraindication to antiplatelet drugs
* Left ventricular dysfunction (LVEF ≤40%)
* Severe hepatic dysfunction (≥2.5 times than reference of AST or ALT)
* Renal dysfunction (serum Creatinine \> 2.0mg/dL)
* History of cerebral hemorrhage, pulmonary or gastrointestinal bleeding
* Hypersensitivity of aspirin, clopidogrel or contrast media
* Pregnant woman or possibility of pregnancy during clinical study period

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: During 6 months after implantation of H-side branch stent
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hong MK, Shim JM, Youn YJ, Lee KH, Kim JS, Ko YG, Lee SH, Choi D, Yoon J, Jang Y. A new stent design for the treatment of true bifurcation lesions: H-side branch stents. J Interv Cardiol. 2010 Feb;23(1):54-9. doi: 10.1111/j.1540-8183.2009.00519.x. Epub 2009 Dec 17.
Clinical trial NCT00174486: Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction
Official title: A Double Blind, Placebo Controlled, Parallel Group, Multicenter Study To Assess The Duration Of Action, Safety And Toleration Of Differing Doses and Combinations Of Immediate and Modified Release Formulations Of UK-369,003 and Cialis Compared To Placebo In Adult Male Subjects With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 300
Sex: MALE
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: Assessment of duration of action, safety \& toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Erectile Dysfunction

Exclusion Criteria:

* Alpha blockers and Nitrates of any preparation

Primary outcomes:
measure: Assessment of duration of action, safety & toleration of the investigational drug and Cialis
Secondary outcomes:
measure: Assess safety & toleration over 4 week treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04373486: Incidence of Acute Pulmonary Embolism in Covid-19 Patients on CT Angiography and Relationship to D-dimer Levels
Official title: Incidence of Acute Pulmonary Embolism in Covid-19 Patients on CT Angiography and Relationship to D-dimer Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19 With Positive RT-PCR
Keywords: Covid-19
Pulmonary Embolism
CT angiography
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with positive SARS-Cov-2 RT-PCR

Brief summary: Reports of acute pulmonary embolism (APE) associated with COVID-19 have emerged in the literature. For example, Chen et al. described 25 pulmonary CT angiograms examinations from 1008 COVID-19 patients; 10 were positive for pulmonary embolism mostly as segmental or sub-segmental APE. Case reports of APE in Covid-19 patients have been published. Cui et al. found an incidence of deep venous thrombosis in intensive care unit (ICU) patients with severe Covid-19 pneumonia near to 25% (20/81), however without any correlation with potential APE.

Despite these initial reports, it is not clear whether APE is more frequent in Covid-19 patients or if the association is just random. In favor of the former, D-dimer levels have been reported as elevated in patients with Covid-19 by two studies, and it has been suggested an independent association between the severity of the disease and the level of D-dimer. Finally, Tang et al. showed that anticoagulant therapy is associated with a decreased mortality at Day-28 in severe Covid-19 patients, in favor of a possible associated coagulopathy. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.

The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.


Eligibility criteria: Inclusion Criteria:

* Positive SARS-Cov-2 RT-PCR
* Chest CT angiography available
* Patient is aged 18yo or above

Exclusion Criteria:

* Expressed opposition to participate
* Adults under guardianship

Primary outcomes:
measure: Rate of positivity for Acute Pulmonary Embolism
timeFrame: March 1, 2020 - March 31, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Radiologie B - NHC
Study officials:
References:
Clinical trial NCT01609686: Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing Cardiac Surgery With the Use of Cardiopulmonary Bypass
Official title: Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing Cardiac Surgery With the Use of Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Renal Disease
Keywords: cardiac surgery
renal dysfunction
pharmacokinetics
tranexamic acid
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 49
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: Cardiac surgical patients with chronic renal dysfunction

Brief summary: Cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of patients. Tranexamic acid (TXA) is a routinely administered antifibrinolytic agent that reduces blood loss and blood transfusion requirement. However, standard dosing of TXA in patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may lead to higher blood concentration of TXA when compared to the patients with normal renal function. Solid phase microextraction (SPME) is a fast and simple method to measure TXA levels. This prospective study on cadiac surgical patients undergoing cardiopulmonary bypass aims to study the pharmacokinetics of TXA in patients with renal dysfunction. Two patient groups will be studied who will receive either TXA 50mg/kg bolus or BART regimen (30 mg/kg, 16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and bleeding risk.

Hypothesis: Standard dosing of TXA used in cardiac surgery result in higher blood concentration of TXA in patients with renal dysfunction when compared to patients with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgical patients above 18 years of age with renal dysfunction (stage 1, 2 ,3, 4 and 5 of the Kidney Disease Outcome Quality - Initiative classification of chronic kidney disease)

Exclusion Criteria:

* All patients under 18 years of age or unable to give consent
* Documented drug allergy to tranexamic acid
* Deep hypothermic circulatory arrest
* Pre-existing coagulopathy
* Pregnancy
* Advanced liver disease
* Renal transplant recipients
* Concomitant treatment with contraceptives, tretinonin

Primary outcomes:
measure: Tranexamic acid blood concentration
timeFrame: Baseline, intraoperatively, postoperatively up to 72 hourss
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
citation: Jerath A, Yang QJ, Pang KS, Looby N, Reyes-Garces N, Vasiljevic T, Bojko B, Pawliszyn J, Wijeysundera D, Beattie WS, Yau TM, Wasowicz M. Tranexamic Acid Dosing for Cardiac Surgical Patients With Chronic Renal Dysfunction: A New Dosing Regimen. Anesth Analg. 2018 Dec;127(6):1323-1332. doi: 10.1213/ANE.0000000000002724.