louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00250432: A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of Caspofungin in the Treatment of Invasive Candidiasis in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Invasive Candidiasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 204
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: Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3 times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or systemic yeast infections)


Eligibility criteria: Inclusion Criteria:

* Clinical and Laboratory evidence of blood stream \&/or systemic candida infections

Exclusion Criteria:

* Possible candida contamination
* Candida colonization (non invasive infection), urine, cardiac, bone or brain and prosthetic device infections
* Acute or moderately severe liver disease
* Abnormal liver function tests
* Abnormal blood clotting for patients on blood thinners

Primary outcomes:
measure: Number of Patients Who Develop Significant Drug-related Adverse Events.
timeFrame: 90 Days
Secondary outcomes:
measure: Number of Patients With a Favorable Overall Response.
timeFrame: 90 Days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Betts RF, Nucci M, Talwar D, Gareca M, Queiroz-Telles F, Bedimo RJ, Herbrecht R, Ruiz-Palacios G, Young JA, Baddley JW, Strohmaier KM, Tucker KA, Taylor AF, Kartsonis NA; Caspofungin High-Dose Study Group. A Multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis. Clin Infect Dis. 2009 Jun 15;48(12):1676-84. doi: 10.1086/598933.
Clinical trial NCT01446432: Validation of Two New Questionnaires for Dupuytren's Disease
Official title: A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dupuytren's Disease
Keywords: Dupuytren's Contracture
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Auxilium Pharmaceuticals, Inc.
First posted: 2011-10-05
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment with XIAFLEX for Dupuytren's Disease

Brief summary: A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are standard and validated questionnaire instruments used to measure health related quality of life and function, they do not address patient specific issues. The investigators will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's Disease.


Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of Dupuytren's Disease in at least one finger
* Patients will be 35 years of age or older
* Patients will be able to read, speak, and understand English
* Patients will be able to provide voluntary written consent to participate

Exclusion Criteria:

* Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
* Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
* Patient has a known allergy to collagenase or any other excipient of XIAFLEX.
* Patient has received any collagenase treatments before the first dose of XIAFLEX.
* Any history of or current medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study

Primary outcomes:
measure: QuickDASH (Disability of the Arm, Shoulder, and Hand)
timeFrame: 30 day follow up
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital For Special Surgery
state: New York
Study officials:
affiliation: Hosptial for Special Surgery
name: Robert N Hotchkiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05739032: Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome
Official title: Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: post-COVID-19
Lung function
Fatigue
Aerobic exercise
Strength training
Lead sponsor: Nuh Naci Yazgan University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 50
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 study investigate the effects of 12-week exercise training on pulmonary function, symptoms, functional capacity, and quality of life (QoL) in patients with severe COVID 6 months after intensive care discharge. The main question it aims to answer are:

1-Does exercise training given in post-COVID-19 syndrome have an effect on pulmonary function, symptoms, functional capacity, muscle strength and quality of life?

25 severe post-COVID patients (35 M) were in exercise group (EG) (age=52.9±11 years, 18M), and 25 (age=53.6±11.9 years, 17M) were in the control group (CG). EG received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. CG continued only routine follow-up.


Eligibility criteria: Inclusion Criteria:

* COVID-19 pneumonia patients were followed up for at least 24 h in the ICU. Those post-COVID six months who could cooperate with the tests and volunteered to participate were included.

Exclusion Criteria:

* Individuals with pulmonary, orthopedic, neurological, vestibular, and psychological problems diagnosed before COVID-19 infection; myocarditis developed after COVID-19 infection; and those pregnant and those having any other acute diseases (such as infection and trauma) that would prevent performing the tests and/or interfering with the test results were excluded.

Primary outcomes:
measure: Six Minute Walk Test Distance
timeFrame: six minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Nuh Naci Yazgan University
Study officials:
References:
Clinical trial NCT01740232: Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?
Official title: A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rupture; Meniscus, Bucket Handle
Lead sponsor: Amager Hospital
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.

Detailed description: RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.

Eligibility criteria: Inclusion Criteria:

* Adults who have a meniscus repaired.

Exclusion Criteria:

* Meniscus not fit for repair.
* Patients not fit for the repair regime.
* Arthrosis \> stadie 2 (ICRS).
* Prior attempt of repair of the meniscus.

Primary outcomes:
measure: KOOS Questionnaire
timeFrame: 4 month
measure: KOOS Questionnaire
timeFrame: 12 month
Secondary outcomes:
measure: Clinical meniscus healing
timeFrame: 4 month
Other outcomes:
measure: Lysholm
timeFrame: 4 month
measure: rearthroscopy
timeFrame: 6 month
measure: KOOS
timeFrame: 12 month
measure: Lysholm
timeFrame: 12 month
measure: IKDC
timeFrame: 12 month
measure: IKDC
timeFrame: 4 month
measure: KOOS
timeFrame: 4 month
Locations:
city: Copenhagen S
country: Denmark
facility: Artroskopisk Center Amager
state: Copenhagen
city: Copenhagen
country: Denmark
facility: Artroskopisk Center Amager
Study officials:
affiliation: Artroscopic Center Amager
name: Mikkel Attrup
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964652: Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson´s Disease
Keywords: treadmill
body load
Parkinson's disease
gait
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 9
Sex: ALL
Minimum age (years): 51
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Studies about the effects of walking training with additional body load in Parkinson's disease (PD) are lacking. There is evidence that the increase of body load during treadmill walking improves reflex activity and leg extensor muscle activity, which are impaired in subjects with PD.

Purpose: The purpose of this study was to assess the effects of treadmill walking training with additional body load on the ground reaction forces, spatiotemporal, and kinematic variables of the gait of subjects with moderate PD.

Design: This study was an A1-B-A2 single-case. Setting: The evaluation and the training were conducted in a movement analysis laboratory, and at the rehabilitation unit of the University, respectively.

Participants: Nine patients with PD (Hoehn and Yahr 2 through 3) and gait disturbances.

Interventions: Phases A1 and A2 included 6 weeks of gait training on a treadmill with 10% increase of normal body mass. Phase B included 6 weeks of conventional physical therapy.

Measurements: Measures included the ground reaction forces, spatiotemporal, and kinematic variables during overground walking, at baseline and after each phase.


Eligibility criteria: Inclusion Criteria:

* Idiopathic PD (previously diagnosed by one specialist physician,)
* Hoehn and Yahr (H-Y) stages 2 through 3,
* Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level) and,
* Capacity to ambulate independently for at least 10 meters.

Exclusion Criteria:

* Change medication (dopaminergic) during the study period,
* Use treadmill for at least six months prior to the study, and
* Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the performance of the training.

Primary outcomes:
measure: Significant increase in propulsive forces, stride length, speed, maximum hip extension during stance were observed after the training program.
timeFrame: 4 times, once before treatment, and 3 after each treatment phase.
Secondary outcomes:
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Universidade Federal de São Carlos
state: SP
Study officials:
References:
Clinical trial NCT01524952: The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Obesity
Official title: The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Cardiorespiratory Fitness and Adipose Tissue in Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2012-02-02
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective:

It is unclear whether prolonged electrical muscle stimulation can improve cardiorespiratory fitness and reduce body fat in obese subjects. The purpose of this study is to investigate the effect of prolonged combined thermal and electrical muscle stimulation (cTEMS) on peak oxygen consumption (VO2 peak) and body composition. We will also investigate the biochemical effects and the resultant lipolysis-related gene expression changes in adipocytes.

Methods:Eleven obese (BMI≥30) individuals will receive cTEMS in three 60-minute sessions per week for 8 weeks. Activity levels and dietary habits will be kept unchanged and controlled with an accelerometer and nutritional questionnaire. Before and after the stimulation period, functional capacity are assessed by VO2 peak, and body composition was assessed by dual-energy X-ray absorptiometry and bioelectrical impedance analyses. Lipolytic activity will be determined in abdominal adipose tissue by 24 hours of microdialysis on a sedentary day, and adipose tissue biopsies will be taken for the gene expression analysis.


Eligibility criteria: Inclusion Criteria:

* Obese (Body mass index; BMI ≥ 30 kg/m2),
* sedentary subjects (\< 20 minutes of exercise \< 3 days per week).
* Other inclusion criteria were age between 30 and 70 years and
* the ability to undergo exercise testing.

Exclusion Criteria:

* Pacemaker or implanted defibrillator,
* regular medication,
* cardiovascular disease,
* pulmonary disease,
* extensive dermatological disease or other primary diseases;
* pregnant women;
* and individuals who abuse alcohol or drugs were excluded from the study

Primary outcomes:
measure: Oxygen uptake
timeFrame: Baseline and after 10 weeks
Secondary outcomes:
measure: Lipolytic activity
timeFrame: Baseline and after 10 weeks
measure: Gene expression in adipose tissue
timeFrame: Baseline and after 10 weeks
measure: Body composition
timeFrame: Baseline and after 10 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: University of Bergen
name: Jan Erik Nordrehaug, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02035852: High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
Official title: High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-01-14
Enrollment: 184
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 at the Simmons Cancer Center at UTSW

Brief summary: The study will compare two different size MRI's of a brain tumor.

Detailed description: The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRI in approximately 150 patients followed serially with MR imaging to evaluate for tumor progression.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 years or older
* Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
* Histological diagnosis of a brain tumor
* Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
* Pre-operative brain MR imaging suggestive of a brain tumor
* Radiographic diagnosis of brain tumor in an inoperable location (e.g., brainstem)
* Patient able and willing to provide informed consent
* Karnofsky Performance status \> 70%
* Life expectancy greater than 3 months
* Negative serum or urine pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
* Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T \* Spanish speaking participants will be enrolled for this study

Exclusion Criteria:

* Body weight \>137 Kg (300 lbs)
* Patient unable to provide informed consent
* Karnofsky Performance status \< 70%
* Patients who are claustrophobic or have other contraindications to MRI, such as implanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
* NYHA class III and IV congestive heart failure
* Psychiatric or addictive disorders that preclude obtaining informed consent
* Unstable angina
* Sexually active patients of childbearing potential not using a reliable contraceptive method
* Pregnant or lactating women
* Women of childbearing potential who refuse a pregnancy test (performed during screening)

Primary outcomes:
measure: Benefit of 7T MR imaging
timeFrame: Baseline and 6 month intervals after baseline
Secondary outcomes:
measure: Vascular Integrity
timeFrame: Every 6 months, up to 12 months.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Elizabeth Maher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04219852: Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Official title: Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 50 years, pre-menopausal, who undergone bariatric surgery at Reims University Hospital

Brief summary: Obesity is a public health phenomenon affecting more than 17% of women in France, and more than 20% of men and women in Champagne-Ardenne.

Obese women are more likely to have an unplanned pregnancy, whereas these pregnancies are more at risk than women of normal weight and should be planned or considered after weight loss. These women are also often less well followed in terms of gynecology and especially on contraception.

More and more patients are opting for bariatric surgery. However, bariatric surgery is not trivial. Indeed, the important loss of weight expected is at risk of nutritional deficiencies. In addition, a large number of patients are still obese during the months following surgery. This is why pregnancy is theoretically contraindicated within 12 or 18 months postoperatively.

Women with bariatric surgery must have been properly informed of these risks so that they can choose a contraceptive method, and that can be adapted to both their risk factors and the surgical technique performed.

Detailed description: The purpose of this study is to describe contraception in obese women who have undergone bariatric surgery in Champagne-Ardenne.

Eligibility criteria: Inclusion Criteria:

* Women between 18 and 50 years old
* Followed at Reims University Hospital after bariatric surgery
* Pre-menopausal status
* Accepting to participate in the study

Exclusion Criteria:

* Women less than 18 or more than 50 years old
* Women with postmenopausal status
* Women refusing to participate

Primary outcomes:
measure: contraception method
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT05723952: Effect of Barcelona School and Schroth for Adolescent Idiopathic Scoliosis.
Official title: Effect of Barcelona Scoliosis Physical Therapy Versus International Scoliosis Schroth Therapy in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis, Thoracic Region
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: for adolescent idiopathic scoliosis child, investigator will use Barcelona scoliosis physical therapy school and International scoliosis schroth therapy to see which school is better in dealing with scoliosis.


Eligibility criteria: Inclusion Criteria:

scoliosis with angle \< 25 participant has Risser sign of П-V participant is not receiving other treatment during study participant not using braces or muscle relaxants

Exclusion Criteria:

scoliosis due to congenital, neuro-muscular, or syndromic etiology, participant who has true leg length discrepancy participant who has cardiac anomalies participant who has kyphosis.

Primary outcomes:
measure: Cobb's Angle
timeFrame: 3 month
measure: Angle Trunk Rotation (ATR):
timeFrame: 3 month
Secondary outcomes:
measure: SRS-22 patient questionnaire
timeFrame: 3 month
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Physical Therapy
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT02182752: The Effect of Tramadol on Interscalene Brachial Plexus Block
Official title: The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Fracture
Shoulder Dislocation
Rotator Cuff Injury
Shoulder Arthritis
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Aretaieion University Hospital
First posted: 2014-07-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.


Eligibility criteria: Inclusion Criteria:

* Shoulder surgery

Exclusion Criteria:

* patients on opioids
* diabetes mellitus
* interscalene block contraindicated
* patient refusing regional anesthesia techniques

Primary outcomes:
measure: Postoperative analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Persistent postoperative pain
timeFrame: 1 month postoperatively, 3 months postoperatively
measure: Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement
timeFrame: 24 hours postoperatively
measure: Evidence of sensory blockade resolution, confirmed by pin-prick test
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
state: Attica
Study officials:
References:
citation: Lin E, Choi J, Hadzic A. Peripheral nerve blocks for outpatient surgery: evidence-based indications. Curr Opin Anaesthesiol. 2013 Aug;26(4):467-74. doi: 10.1097/ACO.0b013e328362baa4.
citation: Bishop JY, Sprague M, Gelber J, Krol M, Rosenblatt MA, Gladstone JN, Flatow EL. Interscalene regional anesthesia for arthroscopic shoulder surgery: a safe and effective technique. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):567-70. doi: 10.1016/j.jse.2006.01.009.