louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00299624: Effect of Aging on Haemostasis Parameters
Official title: Identifying Morphological and Biological Biomarkers of the Venous Thromboembolic Risk Risk Related to Aging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: venous thromboembolism risk,
elderly,
hypercoagulability
fibrinolysis
microparticles
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2006-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stable patients without overt acute clinical event, not receiving antiplatelet or anticoagulant treatment

Brief summary: Aging is an independent risk factor, without any clear explanation. The primary aim of the study is to depict the effect of aging on the coagulation fibrinolysis parameters and microparticles.

Detailed description: Patients older than 40, without any acute disease and not receiving any antiaggregant and anticoagulant therapy will be included in the study. Blood tests will be performed for coagulation, fibrinolysis and microparticles measurement.

Eligibility criteria: Inclusion Criteria:

* age \<40 2 groups : 1 : no history of VTE 2 : history of VTE

Exclusion Criteria:

* antiaggregant or anticoagulant therapy at curative dose
* arterial or thrombotic event in the last month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Lariboisière
Study officials:
affiliation: MCU-PH
name: isabelle mahé, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00545324: First Step With Singulair® Therapy (0476-323)
Official title: A 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma "To Low Dose" Inhaled Corticosteroid Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.


Eligibility criteria: Inclusion Criteria:

* First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
* Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
* Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
* Patient's forced expiratory volume in one second (fev1) is \< 80% of predicted value

Exclusion Criteria:

* Patient on combination therapy
* Patient on long acting beta2 agonists
* Patient on using moderate to high doses of ICS. (ICS \>250 \&micro g/day flovent\&reg; or equivalent per day)

Primary outcomes:
measure: Canadian asthma guidelines criteria
Secondary outcomes:
measure: Asthma control questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00616824: The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
Official title: The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Mastectomy
Postoperative Pain
Complications
Keywords: Acellular dermal matrix
breast reconstruction
tissue expander
postoperative pain
complication
pain
patient satisfaction
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 36
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: This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.

The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.

Exclusion Criteria:

* Preoperative radiation therapy
* Autoimmune disease
* Fever
* Uncontrolled diabetes mellitus
* Inability to comprehend or cooperate with postoperative instructions
* Local or systemic infection
* Have any allergies to the excipient ingredients found in the matrix
* Pregnancy
* Low vascularity of the surrounding tissue
* Mechanical trauma
* Poor nutrition
* Poor general medical condition

Primary outcomes:
measure: postoperative pain
timeFrame: perioperative up to 1 year
Secondary outcomes:
measure: aesthetic outcome
timeFrame: 1 year
measure: complications (infection, hematoma, capsular contracture)
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Jason J. Wendel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00791024: Development of a New Method for Analgesia
Official title: Phase One Study and Two of a New Method for Local Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Analgesia
Keywords: Analgesia Tests
Analog Pain Scale
Pain Measurement
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2008-11-14
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: To examine a new method to perform local anesthesia in order to diminish the inconvenience by the procedure in patients before performing intubation or oesophagogastroduodenoscopy.

Detailed description: A phase one and two study. part one is performed as a single arm unblinded uncontrolled study in 16 obese patients undergoing awake intubation (investigational pill). The second part is a phase two study randomized single blinded study in 100 patient attending a day case endoscopy unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).

Eligibility criteria: Inclusion Criteria:

* Patients admitted for adipositas surgery
* Patients who attend for oesophagogastroduodenoscopy.

Exclusion Criteria:

* Severe psychiatric diseases
* Alcohol abuse

Primary outcomes:
measure: VAS score
timeFrame: at day O and 3
Secondary outcomes:
measure: Questionnaire( examiner and patient)
timeFrame: performed at day 0 and 3
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University, Hvidovre Hospital
Study officials:
References:
citation: Mogensen S, Pulis S, Kristensen BB, Ravn L, Treldal C, Rasmussen M, Mogensen T, Andersen O. A new method to facilitate oro-tracheal intubation of awake patients: a pilot study. Eur J Anaesthesiol. 2012 Nov;29(11):546-7. doi: 10.1097/EJA.0b013e328357e4e5. No abstract available.
Clinical trial NCT00848224: Improving Adherence to Pharmacological Treatment
Official title: Improving Adherence to Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: coronary heart disease
lipid lowering medication
NCEP guidelines
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-02-20
Enrollment: 689
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall goal of this study was to implement and evaluate the effects of a systems-based and pharmacist-mediated program designed to improve adherence for patients with known coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their physicians/nurse practitioners to the National Cholesterol Education Program Guidelines.

Detailed description: Patients were randomly assigned to a usual care condition which consisted of patients provided with usual care only, or to the Special Intervention (SI) condition. The intervention was implemented and coordinated by pharmacists, who utilized for tracking and communication the Lotus Notes®-based system that was developed for the project.

Eligibility criteria: Inclusion Criteria:

* was between 30 and 85 years of age;
* had known CHD, defined as the presence of at least one coronary lesion at coronary angiography of \>50%.

Exclusion Criteria:

* was unable or unwilling to give informed consent;
* had a history of intolerance to two or more statin drugs;
* planned to move out of the area within one year of recruitment;
* had a poor prognosis such that life expectancy was thought to be \<5 years;
* had a psychiatric illness which limited ability to participate; or
* had no telephone.

Primary outcomes:
measure: The primary outcome evaluated is the percentage of patients with a serum low-density lipoprotein cholesterol (LDL-C) level <70 mg/dl.
timeFrame: One year
Secondary outcomes:
measure: Proportion of prescribed lipid-lowering medication taken by patients as measured by a continuous multiple-interval (CMA) measure of medication availability based on pharmacy records.
timeFrame: One year
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Ira S Ockene, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441724: Mechanocardiography in Patients With STEMI
Official title: Mechanocardiographic Detection of Acute ST-Segment Elevation Myocardial Infarction - the MECHANO-STEMI Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Infarction, Acute
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Consecutive patients presenting with ST-segment elevation

Brief summary: The study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving ST-segment elevation infarction.

Detailed description: Subsequent patients with ST-segment elevation assigned to the Turku University Hospital Heart Center cathlab for primary percutaneous coronary intervention are enrolled in the study. A 2 to 15 minutes mechanocardiographic recording is acquired before the intervention. A control recording is collected after the coronary intervention, within 24 hours. These recordings are compared and the results analyzed to determine the ability of this novel modality to discriminate between the two circumstances.

Eligibility criteria: Inclusion Criteria:

* Myocardial ischemia with ST-segment elevation in ECG
* Primary PCI procedure

Exclusion Criteria:

* Age \>17 years
* No informed consent

Primary outcomes:
measure: Observed difference in mechanocardiographic signal
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
Clinical trial NCT04736524: Immune Response Following COVID-19 Vaccination
Official title: Immune Response Following COVID-19 Vaccination (IFVAC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IgM and IgG in Blood
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals receiving COVID-19 vaccines

Brief summary: Few trials have reported the safety and efficacy of the COVID-19 vaccines. However, these trials were mostly focused on post-vaccination adverse events and short-term antibody detection with none monitoring the presence of immunoglobulin G (IgG) in blood at long-term follow-up after the vaccination. This study aims to evaluate the immune response in post-vaccinated individuals across a follow-up period of one year.

Detailed description: The COVID-19 pandemic started in December 2019 and since then has spread globally claiming over 550, 000 deaths, \>12 million infections and an economic toll in the trillions of dollars to date. The urgent need for a global vaccination program to control this pandemic has prompted the development of several vaccines.

Preliminary reports from few trials evaluating the safety and efficacy of the vaccines have been published (2-4).

However, no trials have yet reported the long-term post-vaccination immune response that would potentially determine the necessity and timing for booster doses of the vaccine.

Therefore, this study is designed to assess the presence of immunoglobulin (Ig) M and G at several time points after the first and the second dose of the vaccine.

Eligibility criteria: Inclusion Criteria:

• Individuals that have received first dose of COVID-19 vaccine

Exclusion Criteria:

* Unwilling to provide informed consent
* Unwilling for the follow-up serological test during the 1-year enrollment

Primary outcomes:
measure: Post-vaccination immune response
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Cardiac arrhythmia Institute, St. David's Hospital
state: Texas
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Sanghamitra Mohanty
role: STUDY_DIRECTOR
References:
Clinical trial NCT02404324: Conservative Treatment of Esotropia in Children up to 3 Years Old
Official title: Prescription of Full Optical Correction in Refractive Errors to Treat Esotropia in Children up to 3 Years Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esotropia
Lead sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva
Sponsor class: OTHER_GOV
First posted: 2015-03-31
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this prospective study is the treatment of esotropia by prescribing the full precise optical correction of refractive errors in children up to 3 years old.

Detailed description: This investigation includes children with esotropia associated with hyperopia, hypermetropic astigmatism, myopia, myopic astigmatism and minor ametropias. All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dpt to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization were administered to the children. The investigators suggest that this approach will give good results in the treatment of esotropia.

Eligibility criteria: Inclusion Criteria:

* Within the age of 3 months to 3 years (inclusive infantile esotropia)
* Patients with constant or periodic esotropia and with revealed angle of deviation 5 degrees or over by Hirschberg test
* Patients with refractive errors (inclusive minor ametropias from 0.5 Dptr)

Exclusion Criteria:

* Age above 3 years
* Patients with neurological diseases and paralytic strabismus

Primary outcomes:
measure: The angle of deviation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Centre of Ophthalmology named after academician Zarifa Aliyeva
name: Elmar Kasimov, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05890924: Intimate Partner Violence as a Risk Factor for Venous Thromboembolism in Women
Official title: (WAST-VTE) Intimate Partner Violence as a Risk Factor for Venous Thromboembolism in Women on Combined Oral Contraceptives: a Matched Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 997
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women managed and followed by their respective departments dedicated to the evaluation of the vascular risk in women (Gynecology-Obstetrics + Haematology)

Brief summary: The frequency of violence against women, or intimate partner violence (IPV) is more and more underlined and recognized as a cofactor favoring certain somatic and psychic pathologies. However, its incidence in patients with venous thromboembolism (VTE) is unknown and its status as a risk factor is still elusive and ambiguous.

Investigators therefore conducted a matched case-control study consisting of women taking combined oral contraceptives (COC) who were investigated and followed up between 2010 and 2020.

The cases are the patients investigated for their first venous thromboembolic event, The controls were women free of thrombosis who had regular gynecological checkups. Case-control pairs were matched on region of residence, age (+/- 2 years), duration of COC intake (+/- 4 months), COC type (2nd, 3rd or 4th generation).


Eligibility criteria: * Patients: first venous thromboembolic event associated with the intake of combined oral contraceptives
* Controls: regular follow-up of their combined oral contraception
* Patient-Control pairs matched on region of residence, age, duration of COC intake, type of COC.

Primary outcomes:
measure: Woman Abuse Screening Tool (WAST)
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémea
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Jean-Christophe GRIS, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05116124: Inflammatory Parameters as Predictive Factors for Complicated Appendicitis
Official title: Inflammatory Parameters as Predictive Factors for Complicated Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Lead sponsor: Centro Hospitalar do Tâmega e Sousa
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 841
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted for acute appendicitis

Brief summary: Acute appendicitis is a major cause of acute abdomen. Although its diagnosis is clinical, it is often supported by complementary diagnostic tests. Sometimes, delay in diagnosis can lead to worsening of the clinical picture, resulting in a complicated acute appendicitis. Some series have studied some clinical and analytical parameters as possible predictors of complicated acute appendicitis.

A retrospective analysis of patients admitted for acute appendicitis and undergoing appendectomy between January 2014 and December 2017 was performed in order to assess the possible existence of preoperative analytical predictive factors for complicated acute appendicitis (such as leukocytosis, C-reactive protein and ratio between neutrophils and lymphocytes).


Eligibility criteria: Inclusion Criteria:

* all patients admitted for acute appendicitis

Exclusion Criteria:

* excluded if no existence of dosing of all the inflammatory parameters cited above

Primary outcomes:
measure: C-reactive protein dosage
timeFrame: 4 years
measure: Leukocytosis dosage
timeFrame: 4 years
measure: Ratio between neutrophils and lymphocytes dosage
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04874324: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349
Official title: Phase-I Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 Under Fasting Conditions in Adult Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.


Eligibility criteria: Inclusion Criteria:

* Must be healthy males or non-pregnant females
* Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg / height in m2
* Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings.
* Should test negative for drugs of abuse and urine alcohol test.

Exclusion Criteria:

* Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
* Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

Primary outcomes:
measure: To evaluate the safety & tolerability of multiple doses of WCK 2349
timeFrame: 12 days
measure: To evaluate the pharmacokinetics of multiple doses of WCK 2349
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wockhardt Ltd
name: Ashima Bhatia, MD
role: STUDY_DIRECTOR
References: