louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01301742: Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers
Official title: Relative Bioavailability of Single Dose BI 10773 Co-administered With Multiple Doses of 600 mg Gemfibrozil Bid Compared to Single Dose Treatment of BI 10773 Alone in Healthy Volunteers - a Phase I, Open-label, Randomised, 2-way Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.


Eligibility criteria: Inclusion criteria:

- Healthy male and female subjects

Exclusion criteria:

- Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance

Primary outcomes:
measure: Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
measure: Total Empa: Maximum Measured Concentration (Cmax)
timeFrame: 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Secondary outcomes:
measure: Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
timeFrame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1245.58.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Macha S, Koenen R, Sennewald R, Schone K, Hummel N, Riedmaier S, Woerle HJ, Salsali A, Broedl UC. Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther. 2014 Feb 1;36(2):280-90.e1. doi: 10.1016/j.clinthera.2014.01.003. Epub 2014 Feb 1.
Clinical trial NCT02045342: The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
Official title: The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.


Eligibility criteria: Inclusion Criteria:

* healthy, 18 to 35 year old man or woman.

Exclusion Criteria:

* smoker
* pregnancy
* taking part in other research.
* followed a weight loss diet in the previous 6 months.
* history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
* neurological or psychiatric condition that may cause cognitive dysfunction.

Primary outcomes:
measure: Oxygen Consumption
timeFrame: Four 10 minute measures throughout 90 min protocol (1 day).
Secondary outcomes:
measure: Appetite ratings
timeFrame: Four appetite ratings throughout 90 min protocol (1 day).
measure: Cognitive function
timeFrame: 2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise Nutrition Research Laboratory, Western University
state: Ontario
Study officials:
References:
Clinical trial NCT04969042: Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury
Official title: Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Stimulation
Closed-Loop
Lead sponsor: Tsinghua University
Sponsor class: OTHER
Collaborators: name: Beijing Tsinghua Changgeng Hospital
First posted: 2021-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this experiment is to evaluate the efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients after Spinal Cord Injury

Detailed description: The whole course will last around 12 months, during which there will be: Pre-implant evaluations and standard rehabilitation (6-10 weeks), Stimulator implantation and stimulation optimization (4-8 weeks), Rehabilitation training with stimulation (6 months). At the end of the protocol, the study aims to make the patients walk better and faster.

Eligibility criteria: Inclusion Criteria:

* Age 18\~70
* Spinal cord injury staging(AIS) A,B,C or D
* Level of lesion is T10 and above
* Distance between lesion and conus \>60mm
* Injured Time \> 3 months
* Capable of participating rehabilitation program
* Agree to comply with all conditions of the study and to attend all required study training and visits

Exclusion Criteria:

* With Obvious psychiatric disorder that cannot complete relevant questionaires
* Cognitive impairment
* Severe autonomic reflex disorder
* Severe muscle atrophy and joint contracture
* Cannot participate in spinal cord stimulation surgery or follow-up visits
* Life expectancy less than 12 months
* Abnormal blood or other physiological examinations that cannot conduct surgery, such as blood coagulation disorder or kidney/liver abnormalities
* Uncontrollable hypertension, heart diseases, respiratory diseases or took related medicine in last 3 months
* Unsuitable candidates in PI's perspective

Primary outcomes:
measure: WISCI III
timeFrame: Change from Baseline to the 8 month after implantation.
measure: 10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking
timeFrame: Change from Baseline to the 8 month after implantation.
measure: Weight Bearing Capacity
timeFrame: Change from Baseline to the 8 month after implantation.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Engineering Laboratory for Neuromodulation
state: Beijing
Study officials:
affiliation: National Engineering Laboratory for Neuromodulation
name: Luming Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305342: Sensitivity of Antibiotics for Urinary Tract Infections Patients Attending Family Physicians
Official title: Antibiotic Susceptibility of Bacterial Uro-Pathogens In Patients Attending Family Physicians" (In Vitro Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections (UTIs)
Keywords: Uncomplicated UTI
Enoxacin
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinics

Brief summary: This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary objective is to study the spectrum of uropathogens responsible for community acquired UTI in local population

Detailed description: Mid stream , clean catch urine specimens of patients with uncomplicated community acquired UTI sent to microbiology labs by treating consultants from filter clinics for evaluation of pathogens will be utilized for sensitivity analysis.

Only the first positive urine culture obtained per sample will be included in the analysis to eliminate any possibility of recurrence and nosocomial infection. The polymicrobial cultures and cultures with multidrug-resistant uropathogens will not be included in the analysis. Cultures with common contaminants, including coagulase-negative staphylococci and hemolytic streptococci, and cultures with Candida growth will be excluded. .

Data points to be collected will be date of collection, computer generated Lab #, age, gender,list of cultured organisms, sensitivity of organisms with antibiotics.

Eligibility criteria: Inclusion Criteria:

* Samples from primary care clinics from patients who reports UTI symptoms and in which uropathogens are isolated will be included.

Exclusion Criteria:

* Samples from specialized, hospitalized or catheterized patients.

Primary outcomes:
measure: Sensitivity of Uropathogens
timeFrame: 3 months
Secondary outcomes:
measure: Common UTI pathogens
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Research facility ID ORG-001126
Study officials:
affiliation: Abbott
name: Raeefuddin Ahmed, MBBS, FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02852642: Plyometric Training for Elderly Women
Official title: Structure and Musculoskeletal Function, Functional Capacity and Quality of Life of Elderly Women in Response to a Plyometric Training Model Based on the Stretch-shortening Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: power training
plyometric training
functional capacity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 37
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction: the physiological aging process induces several structural changes in the musculoskeletal system. These, in turn, result in functional changes that are reflected in the senescent dependency, determining the reduction in their quality of life. Power training has been identified as ideal to mitigate the effects of aging. However, there are indications that an intervention based on the potentiation of the stretch-shortening cycle action is a better choice.

Detailed description: Study hypotheses: the participants of the proposed intervention will increase their bone mineral density, muscle volume, functional capacity and will show some improvement in their gait, as well as in their quality of life. Purposes: the main objective of this study was to propose a training model based in the potentiation of the stretch-shortening cycle action and assess its effects on selected parameters of musculoskeletal morphology, functional capacity and quality of life of elderly women.

Eligibility criteria: Inclusion Criteria:

* sedentary women, not using bone alteration medication physically able

Exclusion Criteria:

* attending less than 80% of the intervention sessions and not attending the final evaluation

Primary outcomes:
measure: Bone microstructure
timeFrame: through study completion, an average of 6 months
measure: body composition
timeFrame: through study completion, an average of 6 months
measure: gait kinematics
timeFrame: through study completion, an average of 6 months
measure: balance
timeFrame: through study completion, an average of 6 months
measure: function capacity assessment
timeFrame: through study completion, an average of 6 months
measure: electromyography gait analysis
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Alberto C Amadio, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01170442: Does Vitamin D Improve Glycemic Control in Type II DM?
Official title: Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus
Vitamin D Deficiency
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.


Eligibility criteria: Inclusion Criteria:

* Type II diabetics living in Riyadh area who consume no more than one serving of milk/day
* Do not take vitamin supplement
* Habitually have less than 10 hour of sun exposure per week
* Don't suffer from granulomatous conditions, liver disease, or kidney disease
* Don't take anticonvulsants, barbiturates, or steroids.
* Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)
* Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.

Primary outcomes:
measure: Area under the curve of HA1C.
timeFrame: 6 months
Secondary outcomes:
measure: Area under the curve for BP
timeFrame: 6 months
measure: area under the curve of weight
timeFrame: 6 months
measure: area under the curve for 25 OH vitamin D level
timeFrame: 6 months
measure: area under the curve of fasting blood glucose
timeFrame: 6 months
measure: area under the curve of 2 hour post breakfast glucose
timeFrame: 6 months
measure: fasting insulin to glucose ratio
timeFrame: 6 months
measure: incidence of hypercalcemia
timeFrame: 6 months
measure: incidence of hypercalciuria
timeFrame: 6 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Muhammad M Hammami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02391142: Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure
Official title: Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
cardiac sympathetic nerve block
sympathetic nervous system
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac structure, systolic function, electrical activities and concentration of B - type natriuretic peptide precursor in patients with Chronic Heart Failure.


Eligibility criteria: Inclusion Criteria:

* 20-70 years old
* more than 3 months of chronic heart failure history or clinical symptoms of heart failure last for more than 3 months (including acute episode of chronic heart failure), chronic heart failure diagnostic criteria refer to 2012ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
* NYHA functional class III-IV, ejection fraction ≤45%
* NT-proBNP\>400ng/L

Exclusion Criteria:

* first episode of acute heart failure
* unrepaired valvular heart disease accompanied with Hemodynamic changes
* hypertrophic cardiomyopathy, pericardial disease, congenital heart disease, severe pulmonary hypertension
* Second-degree type 2 or worse sinoatrial or atrioventricular block without pacemaker therapy
* right heart failure caused by various diseases, respiratory failure or right heart failure induced by chronic obstructive pulmonary disease
* overt renal decompensation: serum creatinine\>2.1mg/dl(186umol/L)
* severe hepatic dysfunction, transaminase or alkaline phosphatase \> 3 times the upper limit of normal
* Cerebral vascular accident in three months( cerebral infarction, cerebral embolism, cerebral hemorrhage,etc)
* life expectancy shorter than 6 months
* patients with a previous or present history of tumour or precancerous lesions confirmed by pathological examination
* Spine Deformity or skin infection at puncture site
* participate in any clinical drug trials in the three months
* the patients who do not sign the informed consent, unable or unwilling to comply with the requirements of the protocol or unsuitable for the study

Primary outcomes:
measure: All cause mortality
timeFrame: one year
Secondary outcomes:
measure: Rehospitalization rate
timeFrame: one year
Other outcomes:
Locations:
city: Harbin
country: China
facility: the First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References:
Clinical trial NCT04620642: Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy
Official title: Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
revascularisation therapy
registry
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 4500
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 over 18 years old, hospitalized in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon), for an ischemic stroke treated by thrombolysis and / or mechanical thrombectomy and not opposed to this research.

Brief summary: This observational study as an objective of characterizing the population of patients treated within the neurovascular unit of the Pierre Wertheimer hospital (Hospices Civils de Lyon) in order to determine their phenotype (age, sex, risk factors, etc.) and its evolution over time. It also aims to assess the management of ischemic stroke (IS) in the neurovascular unit of Pierre Wertheimer Hospital. We will assess in particular the pre-hospital and hospital care times, the type of medical care (thrombolysis and / or thrombectomy) as well as the efficiency of this care (effective recanalization, outcome of patient, etc.).

Detailed description: All patient who has had an IS with an indication of thrombolysis and / or thrombectomy, hospitalized in the neurovascular unit of Pierre Wertheimer Hospital (HCL) since January 2013 and until December 2030 will be contacted for this study

Eligibility criteria: Inclusion Criteria:

* - Patients over 18 years old,
* Hospitalization in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon),
* Ischemic stroke treated by thrombolysis and / or mechanical thrombectomy.

Exclusion Criteria:

* - Opposition to this research.

Primary outcomes:
measure: Phenotype of the population
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Pierre Wertheimer, GHE, HCL
Study officials:
References:
citation: Rascle L, Bani Sadr A, Amaz C, Mewton N, Buisson M, Hermier M, Ong E, Fontaine J, Derex L, Berthezene Y, Eker OF, Cho TH, Nighoghossian N, Mechtouff L. Does the Brush-Sign Reflect Collateral Status and DWI-ASPECTS in Large Vessel Occlusion? Front Neurol. 2022 Mar 2;13:828256. doi: 10.3389/fneur.2022.828256. eCollection 2022.
Clinical trial NCT04793542: Hot Water Immersion Therapy for Mental Health
Official title: Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Depression
Post-traumatic Stress Disorder
Heat
Water Immersion
Lead sponsor: Lakehead University
Sponsor class: OTHER
Collaborators: name: Northern Ontario School of Medicine
First posted: 2021-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In 2016, it was estimated that nearly 1 billion people worldwide were affected by a mental or addictive disorder, and were associated with considerable excess mortality. Acute heat therapy sessions (e.g. whole-body heating or foot immersions) have been shown to improve symptoms in individuals diagnosed with common mental health illness such as major depressive disorders and reduce anxiety.

This study will assess the impact of an at-home 8-week lower-limb immersion in hot water on symptom severity in patients diagnosed with major depressive disorder, generalized anxiety disorder, and PTSD.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Diagnosed with depression, anxiety, or post-traumatic stress disorder
* Internet access (e.g. via smartphone, computer)
* Currently engaging in mental health treatment

Exclusion Criteria:

* Free of any mental health disorder
* Not engaging in regular mental health treatment
* Diagnosed with other psychiatric disorders (e.g. schizophrenia, bipolar disorder, panic disorder)

Primary outcomes:
measure: Change in Patient Health Questionnaire - 9 Item
timeFrame: Change from baseline at 8 weeks
measure: Change in General Anxiety Disorder - 7 Item
timeFrame: Change from baseline at 8 weeks
measure: Change in Post-Traumatic Stress Disorder Checklist - 20 Item
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Post-water immersion thermal sensation
timeFrame: throughout study completion, 8 weeks in duration
measure: Post-water immersion thermal comfort
timeFrame: throughout study completion, 8 weeks in duration
measure: Post-water immersion thermal preference
timeFrame: throughout study completion, 8 weeks in duration
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead University
state: Ontario
Study officials:
References: