louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01972139: Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Official title: Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Keywords: Uncontrolled hypertension
blood pressure
renal denervation
HTN-4
SYMPLICITY
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2013-10-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.

Detailed description: After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.

Eligibility criteria: Inclusion Criteria:

* Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
* Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg
* Individual has ABPM average SBP greater than or equal to 135 mmHg

Exclusion Criteria:

* Individual lacks appropriate renal artery anatomy
* Individual has eGFR of less than 30
* Individual has Type I diabetes mellitus
* Individual has had one or more episodes of orthostatic hypotension
* Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
* Individual has primary pulmonary hypertension
* Individual has other concomitant conditions that may adversely affect the patient or the study outcomes
* Individual is pregnant, nursing or planning to be pregnant
* Individual has had a previous organ transplant

Primary outcomes:
measure: Reaching BP Goal
timeFrame: 6 months post-randomization
measure: Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Piedmont Heart Institute
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Downstate College of Medicine
name: Michael Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651339: The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Balance
Gait
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 children suffer from Cerbral Palsy

Brief summary: Children suffer from Cerebral Palsy that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 2 month after BOTOX injection in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). Participants will be required to stand on the platform 5 times for 30 s For each trial, they will be instructed to sway as little as possible. In addition Gait analysis will be also examined.


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy
* BOTOX injection

Exclusion Criteria:

* Not able to stand independently 60 seconds
* Not able to walk independently

Primary outcomes:
measure: SDF parameters
timeFrame: before and 2 months after the BOTOX injection
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
References:
Clinical trial NCT01521039: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
Official title: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Graft-versus-Host Disease
Allogeneic Stem Cell Transplant
Keywords: aGVHD
Acute Graft-versus-Host Disease
allogeneic stem cell transplantation
Hematopoietic stem cell transplantation
MicroRNA Expression
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 259
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 who are receiving allogeneic stem cell transplantation at the Ohio State University are eligible and will be consented for the study.

Brief summary: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).

Detailed description: The purpose of this study is to examine whether the expression levels of a novel class of molecules, called microRNAs, are associated with acute graft-versus-host disease frequency and severity. Acute graft-versus-host disease is a Acute GVHD is a medical condition that can become very serious. It happens when the donor cells attack and damage your tissues after transplant.

Eligibility criteria: Inclusion Criteria:

* Patients who are receiving allogeneic stem cell transplantation at the Ohio State University Blood and Marrow Transplantation program are eligible and will be consented for the study.

Primary outcomes:
measure: Measure miR-155 expression levels over time in the serum from patients receiving allogeneic stem cell transplant, and evaluate if miR-155 expression can predict development of aGVHD (Acute Graft-versus-Host Disease)
timeFrame: up to 14 weeks
Secondary outcomes:
measure: Compare miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with aGVHD diagnosis with matched allogeneic recipients without aGVHD.
timeFrame: up to 14 weeks
measure: Correlate miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with the severity of aGVHD.
timeFrame: up to 15 weeks
measure: Perform serum global microRNA analysis in allogeneic recipients at the time of clinical suspicion of aGVHD to identify other miRNAs that are associated with aGVHD diagnosis and severity.
timeFrame: up to 15 weeks
measure: Collect and store serum/plasma and mononuclear cells from patients receiving allogeneic blood and marrow stem cell transplantation.
timeFrame: up to 14 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Hannah Choe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02053025: Appetite Regulation and Mycoprotein
Official title: Appetite Regulation and Mycoprotein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Energy Intake
Keywords: appetite
overweight
energy intake
obesity
gut hormones
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effect of eating various levels of mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in overweight volunteers.

Detailed description: Owing to its relatively high protein and fibre content, mycoprotein presents an attractive food product to improve appetite regulation and postprandial glycaemic and insulin responses in overweight and obese individuals at risk of developing T2DM

Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 18 and 65
* body mass index (BMI) 25-32kg/m2
* Weight stable over the past 6 months
* No known major illness or eating disorder nor on any medication that may impact on appetite or hormone levels.
* No paracetamol or other analgesic in the previous 48 hours
* A score of \<2.5 in the Dutch Eating Behaviour Questionnaire (DEBQ)
* A score of \<2 in the SCOFF questionnaire

Exclusion Criteria:

* Persons outside the age and BMI ranges stated above
* Pregnant and lactating women
* Weight variation of greater than 5% in the last 6 months
* Any diagnosed major illness
* Any paracetamol or analgesic intake in the last 48 hours
* Diagnosed eating disorder
* Allergy to mycoprotein or mushrooms
* Regular consumption of Quorn products
* Dislike of any of the test foods or drinks
* A score of \>2.5 in the Dutch Eating Behaviour questionnaire
* A score of 2 or more in the SCOFF questionaire

Primary outcomes:
measure: Energy intake at ad-libitum meal
timeFrame: upon completion of all participants, expected timeframe: 2 years
Secondary outcomes:
measure: Glucagon-like peptide-1 (GLP-1)
timeFrame: upon completion of all participants, expected at 2 years
measure: peptide tyrosine-tyrosine (PYY) levels
timeFrame: upon completion of all participants, expected at 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NIHR CRF
Study officials:
affiliation: Imperial College London
name: Gary Frost
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bottin JH, Swann JR, Cropp E, Chambers ES, Ford HE, Ghatei MA, Frost GS. Mycoprotein reduces energy intake and postprandial insulin release without altering glucagon-like peptide-1 and peptide tyrosine-tyrosine concentrations in healthy overweight and obese adults: a randomised-controlled trial. Br J Nutr. 2016 Jul;116(2):360-74. doi: 10.1017/S0007114516001872. Epub 2016 May 20.
Clinical trial NCT02062125: Calcinosis in a Single-Center Scleroderma Population
Official title: A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma
Calcinosis
Keywords: scleroderma
calcinosis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult scleroderma subjects with and without calcinosis will be enrolled

Brief summary: This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis

2) to identify common complications associated with scleroderma-related calcinosis.

.

Detailed description: This is a prospective study of scleroderma- spectrum patients focused on soft tissue calcinosis in order 1) to better understand the risk factors (including clinical/laboratory characteristics, and serology) of calcinosis in the scleroderma-spectrum disorders (limited or diffuse systemic sclerosis with or without overlap of inflammatory arthritis and/or myositis).

2) view common complications associated with calcinosis.

Better understanding of scleroderma calcinosis would lead to other studies that eventually will define better treatment options for this incurable and often disabling complication.

Eligibility criteria: Inclusion Criteria:

* Adult scleroderma subjects with and without calcinosis

Exclusion Criteria:

* Subjects unwilling to participate

Primary outcomes:
measure: risk factors and outcomes in scleroderma calcinosis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: RWJ Medical School
state: New Jersey
Study officials:
References:
Clinical trial NCT01561625: Signaling Pathway Activation After Exercise in Patients With Chronic Obstructive Pulmonary Disease
Official title: Signaling Pathway Activation in the Quadriceps of Patients With COPD After an Acute Bout of Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
exercise training
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-03-23
Enrollment: 21
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD). Although resistance exercises increase strength and muscle mass in patients with COPD, the response to training appears to be suboptimal in these individuals. A dysregulation in the signaling pathways involved in the regulation of muscle mass could play an important role in this phenomenon.

Hypothesis: Proteins involved in muscle mass regulation will be less activated in the quadriceps of patients with COPD following the acute bout of resistance training exercise compared to healthy age-matched controls.

Detailed description: Our objective is to investigate the impact of an acute bout of resistance training on key signaling pathways involved in the regulation of muscle mass in moderate to severe COPD (FEV1 under 60% of predicted). Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured before after 72 contractions of the quadriceps. The exercise protocol was designed to match the actual exercise prescription model use in the context of pulmonary rehabilitation. A squat, leg press and leg extension will be done at 80% of max with one minute rest between sets. A biopsy of the quadriceps will be done before and after exercise in order to measure phosphorylated kinases, total protein content and mRNA expressions. All our patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition.

Eligibility criteria: Inclusion Criteria:

* Male
* COPD with an FEV1 of under 60% of predicted
* non-smoker
* Between 50 and 75 years old

Exclusion Criteria:

* All inflammatory disease (HIV, Cancer, renal and cardiac deficiency)
* Hormonal dysregulation
* Inferior limb pathology
* Neuromuscular pathology
* History of tabacco or alcool abuse
* Oxygen dependent
* Recent exacerbation (2 months) of the symptoms of COPD

Primary outcomes:
measure: Post-exercise signaling proteins phosphorylation level in the quadriceps of COPD patients and age-matched healthy controls
timeFrame: 2 hours post-exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: IUCPQ
state: Quebec
Study officials:
affiliation: Laval University
name: François Maltais, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03316625: Reference Curve on Bone Mineral Density in Young Adult: French Multicenter Study
Official title: Reference Curve on Bone Mineral Density in Young Adult: French Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Mineral Density
Grip Strength
Physical Performance
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 151
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are three factors that explain the lower incidence of osteoporosis in men. Epidemiological data indicate a prevalence of 15% among men aged over 50 years (Szulc et al. 2000). According to global analyzes, the number of fractures of the upper end of the femur in humans will increase from 400 000 to 800 000 per year between 2000 and 2025 (Kanis et al. 2004). Furthermore the mortality due to major osteoporotic fractures when they occur in humans than that seen in women (Johnell and al.2001).The main goal of this study is to establish reference curves in elderly male volunteers from 20 to 30 years through the assessment of bone mineral density of the spine, hip, and the measurement of body composition (fat mass, lean mass). This study will allow us to establish the mean and standard deviation of the value of the young adults of the same sex, which will eventually be applied in the calculation of the "T-score" for older people.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged between 20 and 30 years
* Caucasians

Exclusion Criteria:

* Lack of informed consent
* Pieces of metal or plastic parts in the field
* Diseases which cause technical difficulties for the correct evaluation of the hip and spine (severe dysplasia, hip surgery or lumbar spine)

Primary outcomes:
measure: bone mineral density of the spine
timeFrame: Day 0
measure: bone mineral density of the hip
timeFrame: Day 0
measure: body composition (fat mass, lean mass)
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Chru Lille
city: Lyon
country: France
facility: CHRU Lyon
city: Orléans
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR Orléans
name: Eric LESPESSAILLES, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abrahamsen B, Hansen TB, Jensen LB, Hermann AP, Eiken P. Site of osteodensitometry in perimenopausal women: correlation and limits of agreement between anatomic regions. J Bone Miner Res. 1997 Sep;12(9):1471-9. doi: 10.1359/jbmr.1997.12.9.1471.
citation: Ahmed AI, Blake GM, Rymer JM, Fogelman I. Screening for osteopenia and osteoporosis: do the accepted normal ranges lead to overdiagnosis? Osteoporos Int. 1997;7(5):432-8. doi: 10.1007/s001980050029.
citation: Baumgartner RN. Body composition in elderly persons: a critical review of needs and methods. Prog Food Nutr Sci. 1993 Jul-Sep;17(3):223-60.
Clinical trial NCT01393925: Effect of Parecoxib on Postoperative Shoulder Pain After Gynecological Laparoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-Inflammatory Agents, Non-Steroidal
Pain, Postoperative
Laparoscopy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 126
Sex: FEMALE
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: This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, the sample size was estimated to be 120 subjects. All eligible patients will be randomly assigned to one of three groups: Group A (single parecoxib) receiving parecoxib 40mg at 30min before the end of surgery; Group B (multiple parecoxib) receiving parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, respectively, and Group C (Control group) receiving normal saline. All patients will be managed by a standard propofol-remifentanil based total intravenous anesthesia protocol. The incidence and intensity of shoulder pain at rest and with motion will be evaluated by an independent doctor blinding to medication and grouping using visual analog scale (VAS) at 6h, 24h and 48h postoperatively. Other types of pain (e.g. trocar wound and visceral pain), side effects (such as postoperative nausea and vomiting, itching, dizziness, and oversedation) will be assessed as well. At the end of the observation, the intensity of the maximum pain will be recorded, and the effect of shoulder pain on the four variables regarding to quality of life (activity, mood, walking and sleep) will be assessed using modified Brief Pain Inventory(BPI) questionnaire.


Eligibility criteria: Inclusion Criteria:

* females age 18-65yr
* American Society of Anesthesiologists (ASA) physical status classification I-II
* Body Mass Index(BMI) 18-25kg/m2
* scheduled for elective gynecologic laparoscopic surgery

Exclusion Criteria:

* patients with a history of severe cardiac, pulmonary, hepatic, renal disease, chronic drug or alcohol abuse;
* the presence of preoperative shoulder pain or any chronic pain syndrome, long-term use of analgesics;
* allergy or contraindications to nonsteroidal anti-inflammatory drugs (allergy, peptic ulcer disease, gastroesophageal reflux disease, renal insufficiency, coagulopathy) and any other drugs used in the study;
* those whose pain evaluation was judged unreliable

Primary outcomes:
measure: The incidence of shoulder pain
timeFrame: up to 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology,,The first affiliated hospital of Sun Yat-Sen university
state: Guangdong
Study officials:
References: