louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02427412: Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty
Official title: Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss
Postoperative Blood Loss
Thromboembolic Complications
Keywords: Tranexamic Acid
Knee Arthroplasty
Blood loss
Blood transfusion
Thrombolic complication
Total blood loss 24 h after ended surgery.
Total blood loss 2 days after ended surgery.
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 60
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: A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.

Detailed description: Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.

In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Unilateral knee replacement
* Must be able to give oral and written consent

Exclusion Criteria:

* General Anesthetized
* Allergic to Tranexamic acid
* In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
* Use of oral anticonceptive.
* Reduced kidney function (S-creatinine \> 120 micromol/L)
* Medicine or alcohol abuse
* Females with menstruation within the last 12 mounts.
* Any kind of cancer disease
* Rheumatoid arthritis
* Have participated in a clinical trial within the last 30 days.

Primary outcomes:
measure: Total estimated blood loss
timeFrame: 24 hours surgery
Secondary outcomes:
measure: Total estimated blood loss
timeFrame: 2 days after surgery
measure: Thromboembolic complications
timeFrame: 90 days postoperative
measure: Blood transfusion
timeFrame: while hospitalized expected 3 days.
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Henrik Husted, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04563312: Lower Limb Performance, Balance and Coordination Differences Between the Muay Thai Athletes and Recreational Bodybuilders
Official title: Lower Limb Performance, Balance and Coordination Differences Between the Muay Thai Athletes and Recreational Bodybuilders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Martial Arts
Body Building
Functional Performance
Keywords: Muay Thai
Body Building
Balance
Coordination
Lower Extremity Functional Performance
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: Cyprus International University
First posted: 2020-09-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 35 participants, 17 athletes (14 men and 3 women) engaged in MT and 18 athletes (13 men and 5 women) engaged in BB were included in the study
Primary purpose: SCREENING

Brief summary: Purpose: The aim of this study was to compare balance, coordination and lower extremity functional performances of Muay Thai (MT) athletes and bodybuilders (BB).

Method: Seventeen athletes (14 men and 3 women; mean age: 20.65 + 2.34) engaged in MT and 18 (13 men and 5 women, mean age: 25.89 + 4.83) engaged in BB were included in the study. The Flamingo Balance Test and Y Balance Test were used to evaluate static and dynamic balance, respectively. Coordination was assessed using the Hexagon Test. Lower extremity functional performance was evaluated using the Single Leg Hop Test.


Eligibility criteria: Inclusion Criteria:

* age between 18-35 years
* Making MT and BB at least for 5 year as a professional athletes
* currently free of any lower limb injuries within the last three months
* no previous history of injury or surgery that may affect their lower limbs

Exclusion Criteria:

* trained less than 3 sessions per week
* having lower limb injury for more than 1 month
* having a history of surgery, or chronic and progressive disease in their lower limb
* having scoliosis or any other orthopaedic or neurological problems

Primary outcomes:
measure: The Flamingo Balance Test
timeFrame: 2 weeks
measure: Balance Assessment
timeFrame: 2 weeks
measure: Coordination Assessment
timeFrame: 2 weeks
measure: Lower Extremity Functional Performance Assessment
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Etlik
Study officials:
affiliation: Cyprus International University
name: Bünyamin Haksever, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01230112: The Role of ITGAM in Systemic Lupus Erythematosus
Official title: TAP0307.6: Sub-study of TAP 0307- Enrollment of Normal Controls to Study the Role of ITGAM in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal Control Subjects with genotype of interest registered in the Genotype and Phenotype Registry

Brief summary: Study to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene.


Eligibility criteria: Inclusion Criteria:

* males and females, age 18 or older, enrolled in Genotype and Phenotype Registry, in general good health
* Participants who carry the genotype of interest, based on a buccal or blood derived DNA sample

Exclusion Criteria:

* History of Systemic Lupus Erythematosus, rheumatoid arthritis, or other autoimmune disease
* History of cancer or lymphoma
* Current use of aspirin, prednisone, or NSAID or any immunosuppressant
* Self reported HIV

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
References:
Clinical trial NCT00613912: Advanced MRI in Major Depression
Official title: Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Keywords: Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Perfusion, brain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulant patients with major depression, selected from the Department of Psychatry, Aalborg hospital-Århus University Hospital.

Brief summary: Depression is the most common psychiatric disorder.

* 3-5% of a given population has major depression.
* Less than 50% of the depressed in Denmark are diagnosed with major depression.
* 25-50% of the depressed have a relative with major depression-underlying brain pathology?

The purpose of this study is to use MRI to evaluate cerebral morphology and function in ambulant patients with major depression

Detailed description: Previous studies within major depression, have often included hospitalized patients with severe symptoms and imaging have been performed with PET and SPECT, which uses ionizing radiation. This study focus on ambulant patients(with or without medication/ECT treatment), to find patients in an earlier stage. Cerebral perfusion with the MR sequence Arterial Spin Labelling, concentrations of different metabolites with MR spectroscopy and brain volumetry with BRAVO 3D T1 ax will be performed.

MR protocol: T2 sag, T2 FLAIR ax, ASL ax, MRS and 3D T1 ax. Scan time 45 min.

Eligibility criteria: Inclusion Criteria:

* Patients who fulfil ICD-10´s criteria for major depression, found within the ambulant psychiatric sector and who has a HAM-D ≥ 18

Exclusion Criteria:

* If the patient has pacemaker or other magnetic devices
* Pregnancy
* Has had an operation in the brain
* bipolar disorder

Primary outcomes:
measure: Differences in morphological and functional cerebral MRI findings in patients suffering from major depression
timeFrame: 6 months from first MRI in each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital / Aarhus University Hospital
state: Jutland
Study officials:
affiliation: Uppsala University Hospital
name: Elna-Marie B Larsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312312: Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide
Official title: Does Specific Immunotherapy Possess Immunomodulative Effects at the Bronchial Mucosa Level Among Adults With Atopic Diseases?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma, Bronchial
Allergic Rhinitis
Hypersensitivity, Immediate
Keywords: Asthma
Allergic rhinitis
Atopy
Exhaled nitric oxide
Specific immunotherapy
Atopic diseases
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2006-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years old
* Skin prick test or RAS test and physical examination conclude that the patient will have a beneficial effect from specific immunotherapy

Exclusion Criteria:

* Other diseases except atopic disease
* Pregnancy

Primary outcomes:
measure: Skin prick test
measure: Spirometry
measure: Methacholine provocation of the pulmonary system
measure: Exhaled nitric oxide
measure: Immunoglobulin E (IgE) status
measure: Sputum examination
measure: Condensation of exhaled air
Secondary outcomes:
measure: Questionnaire
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Lungeforskningsenheden v/Bispebjerg hospital
name: Vibeke Backer, M.D., M.D.Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03688412: Transvenous Lead Removal Post-Market Clinical Study
Official title: RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Electrophysiology
Keywords: Cardiac pacing, artificial
Cardiac Resynchronizaton Therapy Devices
Defibrillators, Implantable
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring percutaneous removal of Cardiovascular Implantable Electronic Device (CIED) leads

Brief summary: This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations


Eligibility criteria: Inclusion Criteria:

1. Patients must be 18 years of age or older
2. Lead indwell time greater than 1 year

Exclusion Criteria:

1. Patient is unable or unwilling to provide informed consent (per the IRB/EC requirements) to participate in the clinical study
2. Patient presents with an extracardiac lead

Primary outcomes:
measure: Rate of complete procedural success
timeFrame: Immediately following lead extraction
measure: Rate of clinical procedural success
timeFrame: Immediately following lead extraction
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Urbana
country: United States
facility: Carle Foundation
state: Illinois
city: Raleigh
country: United States
facility: NC Heart and Vascular Reseach
state: North Carolina
city: York
country: United States
facility: Wellspan York Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
city: Charlottesville
country: United States
facility: University of VA Medical Center
state: Virginia
city: Berlin
country: Germany
facility: German Heart Center Berlin
city: Zwolle
country: Netherlands
facility: Isala
city: London
country: United Kingdom
facility: St. George's University Hospital
Study officials:
References:
Clinical trial NCT06319612: Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea
Official title: Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-20
Enrollment: 80
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: The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Detailed description: Obstructive Sleep Apnea is of increasingly high prevalence.

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years diagnosed with Obstructive Sleep Apnea by polysomnography
* Patients with moderate to severe Obstructive Sleep Apnea.
* Patients who have undergone continuous positive airway pressure (CPAP) treatment for at least 3 months but have not achieved satisfactory therapeutic effects
* Patients who voluntarily agree to receive stellate ganglion block (SGB) treatment and sign the informed consent form

Exclusion Criteria:

* Patients with a history of allergy or contraindications to local anesthetics or corticosteroids
* Patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases
* Patients with a history of neck surgery or cervical spine disease
* Patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of SGB treatment
* Pregnant or lactating women
* Patients who have participated in other clinical trials within the past 3 months

Primary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: day 1 and day 10
Secondary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: day 1 and day 10
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01885546: Accuracy Study for Enhanced Meter Feature
Official title: Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
glucose
glucometer
Lead sponsor: AgaMatrix, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic control.

This study will evaluate a user's ability to obtain the enhanced meter feature.


Eligibility criteria: Inclusion Criteria:

* Type I or type II diabetes inclusive of the following populations:

  1. Mixed insulin therapies
  2. Basal insulin therapies
  3. Continuous subcutaneous insulin infusion therapies
  4. Multiple daily injection therapies
  5. Non-insulin diabetic treatments (oral and injectable)
  6. Life style (exercise and diet) diabetes management
  7. New diagnosis of diabetes
* Non diabetics
* Able to speak and read English proficiently
* Subjects must be willing to:

  1. once a month, perform a 7 point blood glucose profile over the course of one day
  2. perform fasting blood glucose tests every day
  3. complete baseline and follow-up questionnaires
  4. consent to baseline HbA1c assays

Exclusion Criteria:

* Pregnant
* Hct \<20 or \>60
* Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott)
* Homeless
* Incarcerated
* Mentally ill
* Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.
* Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.

Primary outcomes:
measure: User's ability to obtain the enhanced meter feature
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: MassResearch, LLC
state: Massachusetts
Study officials:
References:
citation: Sieber J, Flacke F, Dumais B, Peters CC, Mallery EB, Taylor L. Evaluation of a Methodology for Estimating HbA1c Value by a New Glucose Meter. J Diabetes Sci Technol. 2015 May 22;10(1):67-71. doi: 10.1177/1932296815587323.
Clinical trial NCT00389246: Evaluation of Consultation Including Genetic Aspects of Obesity
Official title: Evaluation of Consultation Including Genetic Aspects of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: obesity
genetic consultation
randomized controlled trial
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2006-10-18
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More than 1,000 obese people are screened for genetic mutations (MC4R). Those with positive screenings as well as 320 randomly selected people without MC4R mutations are randomized to 2 consultation types: one including recommendations for eating and physical activity behavior, the other with an additional part on genetic determinants and actions in obesity. It is hypothesized that obese people with obesity-specific genetic mutations, and obese people with a family history of obesity, benefit more if the consultation includes additional elements on genetic determinants.

Detailed description: More than 1,000 obese people are screened for genetic mutations (MC4R). Those with positive screenings as well as 320 randomly selected people without MC4R mutations are randomized to 2 consultation types: one including recommendations for eating and physical activity behavior, the other with an additional part on genetic determinants and actions in obesity. Their results are compared to a control group (n\>100). It is hypothesized that obese people with obesity-specific genetic mutations, and obese people with a family history of obesity, benefit more if the consultation includes additional elements on genetic determinants.

The following variables are used: BMI, SCID interview for mental disorders, Stunkard's body silhouttes for participants and their parents and siblings, Restraint Eating Scale, PANAS, Well-being scale, body acceptance, shame and guilt, coping with obesity, participant's satisfaction with consultation.

Assessment Points: before consultation, after consultation, 6 months later.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30

Exclusion Criteria:

* Brain damage

Primary outcomes:
measure: Feeling guilty for being overweight
measure: Negative affectivity
measure: Self-control
Secondary outcomes:
measure: weight
measure: body acceptance
measure: restraint eating
measure: qualityof life
measure: coping
Other outcomes:
Locations:
Study officials:
affiliation: Philipps University of Marburg, Marburg, Germany
name: Winfried Rief, PhD
role: PRINCIPAL_INVESTIGATOR
References: