louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03865368: Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive People With Obesity
Official title: Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive Patients With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Blood Pressure
Whole Body Vibration
Exercise
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2019-03-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active Whole Body Vibration (aWBVT) group, performed ten dynamic standard exercises on a vibration platform. The vibration protocol lasted for 15 minutes, in a frequency of 30 Hz and amplitude of 2 mm. Control group performed only ten dynamic standard exercises with no vibration application. Blood Pressure, heart rate, saturated oxygen were measured for the hemodynamic response. Modified Borg Dyspnoea Scale (MBDS) and The Borg Rating of Perceived Exertion (BRPE) Scale were used in order to evaluate fatigue level. All evaluations were performed at the beginning of the study, at the end of the session and at the recovery period
Primary purpose: DIAGNOSTIC

Brief summary: Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate effect on hemodynamic response and fatigue parameters in patients with obesity.


Eligibility criteria: Inclusion Criteria:

* Individuals between age 18-65 with Body Mass Index (BMI) of \>29.9 kg/m2

Exclusion Criteria:

* Unstable hypertensive patients
* History of cardiovascular, neurologic, or orthopedic diseases,
* Presence of knee prosthesis, hip replacement
* Chronic inflammatory disease,
* Anti-inflammatory treatment
* Cognitive impairments
* Pregnancy.

Primary outcomes:
measure: Heart rate
timeFrame: "20 minute"
measure: Blood pressure
timeFrame: "20 minute"
Secondary outcomes:
measure: Fatigue
timeFrame: "20 minute"
Other outcomes:
measure: Change in Dyspnea
timeFrame: "20 minute"
Locations:
city: Istanbul
country: Turkey
facility: Okan University Sports Laboratory
Study officials:
References:
Clinical trial NCT04020068: Diabetes Cohort in French Amazonia
Official title: Diabetes Cohort in French Amazonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Adults
Keywords: Diabete
French Guiana
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients living in French Guiana

Brief summary: CoDiAm aims to collect clinical, biological and social data of diabetic patients in French Guiana.

Detailed description: Diabetes is a very common disease in French Guiana. This disease is caused by the body's inability to metabolise sugar properly. A diet and treatment with tablets are enough for some patients, while others may need insulin injections. In the long term, high blood sugar levels may cause problems to the small and large blood vessels in the body. This is complicated by nerve, renal and retinal damage, as well as increased risks of cardiac and vascular events (such as strokes or heart attacks.) It appears that diabetes is more common and more severe in French Guiana than in other parts of France. It seems that the types of diabetes found here are more variable than those found in France, and that patients tend to be diagnosed at a later stage. We would this like to better understand diabetes and its evolution in French Guiana.

This research is aimed at diabetic patients and it is being carried out in the Andrée Rosemon Hospital Centre, the Ouest Guyanais Hospital Centre as well as in other Primary Healthcare Centres. At some point in the future, some private health centres may also invite their patients to take part in this study.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetes
* At least 18 years old

Exclusion Criteria:

* Less than 18 years old
* Patients under legal guardianship
* Patients' refusal to participate
* Patients living outside French Guiana

Primary outcomes:
measure: Improvement of patient care
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cayenne
country: France
facility: Centre Hospitalier de Cayenne
state: French Guiana
Study officials:
References:
Clinical trial NCT06757868: Amobarbital and Cardiopulmonary Bypass
Official title: The Effect of Amobarbital on Myocardial Protection and Prognosis in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiopulmonary Bypass
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 80
Sex: ALL
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: Explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

Detailed description: AMO is a short acting complex I blocker that blocks mitochondrial complex I between flavoprotein and ubiquitin, and its blocking effect can be rapidly reversed. Our study is to explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

Eligibility criteria: Inclusion Criteria:

* Age range: 18-65 years old, undergo elective cardiac surgery with extracorporeal circulation.
* ASA II-III;
* surgical duration is 3-6 hours;
* Sign the informed consent form

Exclusion Criteria:

* BMI less than 18 kg/m2 or greater than 30 kg/m2;
* Individuals with a history or potential history of drug abuse or alcohol dependence;
* Preoperative use of sedatives or analgesics;
* Individuals with severe liver and kidney dysfunction;
* Individuals who are allergic or potentially allergic to barbiturates;
* Patients with coagulation dysfunction, endocrine disorders, or other conditions that affect hemodynamic status;
* Participated in other clinical studies in the past 3 months;
* The researchers believe that participants who are not suitable to participate in this study.

Primary outcomes:
measure: Cardiac recurrence time
timeFrame: 1 hour after heart beat recurrence
Secondary outcomes:
measure: extubation time
timeFrame: 1day
measure: cTnI
timeFrame: 2 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Aihua Du, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT00463268: Osteoporosis Prevention With Low Dose Alendronate
Official title: Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteopenia
Keywords: osteopenia
osteoporosis prevention
alendronate
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 83
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.


Eligibility criteria: Inclusion Criteria:

* 45 to 60 year-old women
* Menopausal since at least 6 months
* Baseline lumbar BMD from -1 till -2.5

Exclusion Criteria:

* Bone disease other than osteopenia
* Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
* Former or current treatment with any bisphosphonate or bone forming agents
* Chronic use of oral or iv corticosteroids
* Any diagnosis of malignancy less than 12 months

Primary outcomes:
measure: percentage of lumbar BMD modification after 2 years
timeFrame: 2 years
Secondary outcomes:
measure: percentage of hip BMD modification (total hip and sub-regions)
timeFrame: 2 years
measure: percentage of modification of bone remodeling markers
timeFrame: 2 years
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: University (UCL) Louvain Hospital in Mont-Godinne
state: Namur
Study officials:
name: Yves R Boutsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03783468: LIght Sedation Pressure Support
Official title: Early LIght Sedation Pressure Support in ARDS Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: ARDS, Human
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.

Light sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure.

The goal of the study is to measure transpulmonary pressure before sedation decrease and after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.


Eligibility criteria: Inclusion Criteria:

* ARDS (Berlin definition)
* social insurance

Exclusion Criteria:

* neuromuscular disorders
* pregnancy
* need for muscular paralysis
* need for deep neurosedation
* more than 24hrs of artificial ventilation
* cystic fibrosis

Primary outcomes:
measure: transpulmonary pressure at early stabilization of patient
timeFrame: when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours
Secondary outcomes:
measure: oxygenation modification
timeFrame: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
measure: arterial pressure modification
timeFrame: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
measure: Heart rate modification
timeFrame: stabilization of ventilator settings;1hour after stabilization of ventilator settings
measure: vasopressor dose modification
timeFrame: stabilization of ventilator settings ; 1hour after stabilization of ventilator settings
measure: acquired neuromyopathy
timeFrame: ICU discharge, an average 16 days
measure: muscular volume decrease
timeFrame: at 24 hours; at day of extubation; ICU discharge, an average 16 days
measure: ventilator free days
timeFrame: during the first 28 days
measure: delirium in ICU
timeFrame: ICU discharge, an average 16 days
measure: change of the functional respiratory parameters from baseline at 6 months
timeFrame: at 6 months
measure: PTSD
timeFrame: at 6 months
measure: number of auto extubation
timeFrame: whatever until ICU discharge, an average 16 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Geoffrey Ledoux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01323868: Endogenous Endophthalmitis in the Inpatient Setting
Official title: Endogenous Endophthalmitis Rates, Clinical Course, and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endophthalmitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-03-28
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients at Stanford Hospital with positive blood cultures who receive an Ophthalmology consultation and eye examination.

Brief summary: The purpose of this study is to determine the rate of endogenous endophthalmitis in patients admitted to Stanford Hospital with a systemic infection and positive blood cultures, as this may improve the clinical care of this population of patients.

Detailed description: Some patients admitted to the hospital have blood-borne infections. Occasionally, these blood infections can end up inside the eye and cause an infection inside the eye (called endogenous endophthalmitis).

Prior to modern and rapid treatment of systemic infections, the rate of endogenous endophthalmitis was reported to be 37% in 1982. By 1997, the rate was reported to be 2.8%. This study aims to determine the rate of endogenous endophthalmitis at Stanford Hospital in the modern medical era in that our rates may be different as those reported in the literature. This potential difference may be a reflection of treatment protocols and antibiotics currently in use at Stanford Hospital.

Eligibility criteria: Inclusion Criteria:All patients admitted to Stanford Hospital that have a systemic blood-borne infection and on which an Ophthalmology consult to rule out endogenous endophthalmitis is performed will be included in the study. Exclusion Criteria:None

Primary outcomes:
measure: Positive intraocular infection
timeFrame: 1 day
Secondary outcomes:
measure: Visual acuity
timeFrame: 2 wk
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Theodore Leng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377168: Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Official title: Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Alcohol Use Disorder
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Yale University
name: Asociación Civil Impacta Salud y Educación, Peru
First posted: 2011-06-21
Enrollment: 159
Sex: MALE
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 will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.


Eligibility criteria: Inclusion Criteria:

* Meets DSM-IV criteria for alcohol dependence or problem drinking.
* Age 18 years and older
* Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
* No participation in pharmacotherapy trial in the previous 30 days
* Not pregnant

Exclusion Criteria:

* Unable to provide informed consent
* Verbally or physically threatening to research staff
* Unable to communicate in Spanish
* Pending trials for a felony
* Childs-Pugh Class C Cirrhosis
* Grade 3 Hepatitis (LFTs \> 5X normal)
* Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.

Primary outcomes:
measure: HIV Viral Load Suppression
timeFrame: 6 months
Secondary outcomes:
measure: ART Compliance and Alcohol Use Behavior
timeFrame: 6 months
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Asociación Civil Impacta Salud y Educación
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Ann Duerr, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Frederick Altice, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01538368: Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease
Official title: Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease: Should the Endoscopist Take a Second Look?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suspected Bilio-pancreatic Disease
Keywords: MRCP
ERCP
EUS
Image interpretation
MRCP findings
endoscopic intervention(s)
Lead sponsor: Deutsche Klinik fuer Diagnostik
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 155
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: During 1/2007 until 12/2009 consecutive patients who were referred for dedicated endoscopic procedures regarding suspected alterations of the pancreato-biliary ductal system (nearly exclusively for EUS and/or ERCP) to our unit based on actual MRCP-findings were enrolled.

Brief summary: The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is primarily performed by radiologists who only in some cases have experience with the interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images. It is unclear if MRCP-interpretation by the radiologist is sufficient to decide which additional endoscopic procedures might be necessary in an individual case or if an additional MRCP-interpretation by the endoscopist renders any clinical impact.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older who were referred for pancreato-biliary endoscopy to our unit based on actual MRCP-findings. In all cases MRCP should have been performed within 4 weeks prior admittance and a written radiological report as well as the digital images must be available.

Exclusion Criteria:

* Patients who had any endoscopic interventions in our institution before and also patients who underwent MRCP at our hospital were excluded.

Primary outcomes:
measure: Endoscopic management
timeFrame: 1 day
Secondary outcomes:
measure: MRCP-interpretation
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02766868: Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL
Official title: Sequential Intensive Chemotherapy With Reduced Intensity Conditioning Regimen in Adult Patients With Refractory and Relapse Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoblastic Leukemia, Acute, Adult
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with refractory and relapse lymphoblastic leukemia had poor outcome even with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. In this study, we focus on a new treatment strategy with high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.

Detailed description: All patients with refractory and relapse lymphoblastic leukemia will receive a high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+ cyclophosphamide+etoposide. At day 7 after chemo, a bone marrow aspiration and MRD study by flow-cytometry is planned. For those patients with no residual blasts will undergo allogeneic stem cell transplantation with reduced intensity condiotning regimen consisting of 5-day fludarabine and 3-day busulfan and post-infusion cyclophophamide (D+3 and +4) as GVHD prophylaxis.

Eligibility criteria: Inclusion Criteria:

* adult patients with refractory or relapse acute lymphoblastic leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse
* age 16-60 years with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA matched related (6/6), unrelated donors (8\~10/10) or haplo

Exclusion Criteria:

* liver function/renal function damage (over 2 X upper normal range)
* mental disease

Primary outcomes:
measure: disease-free survival
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
Study officials:
affiliation: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
name: Jiong Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199368: An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018
Official title: A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
levodopa
end of dose wearing off
OFF time
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin UK, Ltd.
First posted: 2005-09-20
Enrollment: 1100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

Detailed description: Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.

Eligibility criteria: Inclusion Criteria:

* Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018
* Non-pregnant and either not of childbearing potential or using specified contraception

Exclusion Criteria:

* History of psychotic illness
* Variant/atypical Parkinson's disease
* Cancer within 5 years of enrollment
* ALT/AST levels \> 1.5 times ULN
* Seizure disorder
* Neuroleptic malignant syndrome

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Kyowa Pharmaceutical Inc.
state: New Jersey
Study officials:
affiliation: Kyowa Kirin, Inc.
name: Neil Sussman, MD
role: STUDY_DIRECTOR
References: