louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00861497: Bifeprunox Extension to Extension Study in Patients With Schizophrenia
Official title: An Open-label Safety Study of Bifeprunox Investigating Flexible Doses of 20, 30, or 40mg/Day in Patients With Schizophrenia Who Have Completed Studies 10206 or 10265
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Open-label
Flexible-dose
Extension
Safety study
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2009-03-13
Enrollment: 11
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: The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.

Detailed description: This is a non-controlled, open-label, flexible-dose, international multi-centre extension study. The patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.

Eligibility criteria: Inclusion Criteria:

* Patients, suffering from schizophrenia, having completed studies 10206 or 10265
* Otherwise healthy
* Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception
* The patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible)

Exclusion Criteria:

* Current Axis I primary psychiatric diagnosis other than schizophrenia
* Significant risk of suicide and/or violent behaviour
* Other psychiatric, neurological or behavioural disorders that may interfere with study conduct
* Substance or alcohol abuse, current cannabis dependence
* Clinically significant physical illness

Primary outcomes:
measure: Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)
timeFrame: Assessments every 4 to 8 weeks
Secondary outcomes:
measure: CGI-S
timeFrame: Assessments every 4 to 8 weeks
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IT001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT00099697: Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans
Official title: Biologic Effects of DHEA in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Obesity
Insulin Resistance
Keywords: abdominal fat
dehydroepiandrosterone
Insulin sensitivity
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
First posted: 2004-12-20
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Maximum age (years): 78
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity.

Detailed description: Studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (DHEA) reduces abdominal visceral fat and protects against insulin resistance. This study was done to learn if DHEA replacement therapy decreases abdominal obesity and improves insulin action in humans.

Participants were randomly assigned to receive 50 mg per day of DHEA or a placebo at bedtime for 6 months. Participants underwent magnetic resonance imaging (MRI) and oral glucose tolerance tests at the beginning and conclusion of the study. Other tests included measurements of hormones and lipids.

Eligibility criteria: Inclusion Criteria:

* 65 to 78 years old
* Physically healthy
* Non-smoker
* On stable medications for at least 6 months
* Stable body weight for the past year

Exclusion Criteria:

* Serious active medical problems
* Hormone therapy
* Abnormal PSA (prostate specific antigen) in men

Primary outcomes:
measure: 6-month change in visceral and subcutaneous abdominal fat
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: John O. Holloszy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Dennis T. Villareal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen PA, Han DH, Nolte LA, Chen M, Holloszy JO. DHEA protects against visceral obesity and muscle insulin resistance in rats fed a high-fat diet. Am J Physiol. 1997 Nov;273(5):R1704-8. doi: 10.1152/ajpregu.1997.273.5.R1704.
citation: Han DH, Hansen PA, Chen MM, Holloszy JO. DHEA treatment reduces fat accumulation and protects against insulin resistance in male rats. J Gerontol A Biol Sci Med Sci. 1998 Jan;53(1):B19-24. doi: 10.1093/gerona/53a.1.b19.
citation: Villareal DT, Holloszy JO, Kohrt WM. Effects of DHEA replacement on bone mineral density and body composition in elderly women and men. Clin Endocrinol (Oxf). 2000 Nov;53(5):561-8. doi: 10.1046/j.1365-2265.2000.01131.x.
citation: Villareal DT, Holloszy JO. Effect of DHEA on abdominal fat and insulin action in elderly women and men: a randomized controlled trial. JAMA. 2004 Nov 10;292(18):2243-8. doi: 10.1001/jama.292.18.2243.
Clinical trial NCT05083897: Effect of Hip Adductors Isometric Contraction on Knee Extensors Isokinetic Torque in Patellofemoral Pain Syndrome
Official title: Effect of Hip Adductors Isometric Contraction on Knee Extensors Isokinetic Torque in Patellofemoral Pain Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patellofemoral Pain Syndrome
Keywords: PFPS
Lead sponsor: Badr University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients suffering from unilateral patellofemoral pain syndrome

Brief summary: the study will be done to investigate the effect of hip adduction isometric contraction on the pain level by VAS and knee extensors peak torque by using the isokinetic dynamometer in patients with unilateral patellofemoral pain syndrome

Detailed description: the study will be done to investigate the effect of isometric hip adduction that will be measured by the hand held dynamometer (the manual muscle tester) to measure the produced adduction torque and its effect on the peak torque of knee extension by the knee extensors which will be measured by the isokinetic dynamometer in addition to measuring the pain intensity before and through the assessment by using the visual analogue scale

Eligibility criteria: Inclusion Criteria:

* Anterior or retro-patellar knee pain from at least 2 of the following Activities: (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping (Tyler et al., 2006).
* Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks (subacute or chronic pain).
* They will be diagnosed as a PFPS case by a physician
* The patient's age will be ranged from 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the patients should have closed epiphyseal growth plates (Robinson and Nee, 2007).

Exclusion Criteria:

* A history of any of the following condition: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.
* A history of traumatic patellar subluxation or dislocation.
* Previous surgery in the knee and hip joints.
* Any lower limb bony/congenital deformity.
* Ankle, Knee and hip joints osteoarthritis.
* A history of any conditions affects muscle strength: diabetes mellitus, rheumatoid arthritis.
* Pregnancy.

Primary outcomes:
measure: peak torque of knee extensors
timeFrame: 2 months
measure: pain level at the patellofemoral area
timeFrame: 2 months
measure: hip adduction peak torque
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03250897: Phenotypic Characterization of Alveolar Macrophages 2016 (Caract-Aires-2016)
Official title: Phenotypic Characterization of Alveolar Macrophages 2016
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases
Keywords: Alveolar macrophages
Blood monocyte-derived macrophages
FACS analysis
Broncho-alveolar lavage fluids
Non-infectious lung diseases
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 18
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 affected by non-infectious lung diseases older than 18 years

Brief summary: The aim of the study is to investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from patients with non-infectious lung diseases.

Detailed description: Although alveolar macrophages (AMs) represent the main immune cell population in the human lungs, consensus on their phenotypic characterization is still missing.

Current translational protocols use human AMs obtained by invasive methods (broncho-alveolar lavage and lung biopsy) or differentiate macrophages from blood monocytes cultured in the presence of growth factors such as macrophage colony-stimulating factor (M-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF). The group has already published the phenotypic and functional comparison of human blood monocyte-derived macrophages differentiated with M-CSF or GM-CSF. Aim of this study is to use a multi-staining flow cytometry (FACS analysis) to better characterize the phenotype of AMs isolated from broncho-alveolar lavage fluids of patients affected by non-infectious lung diseases. The FACS profiles of AMs will be further compared to the phenotypic profile of blood monocyte-derived macrophages differentiated in the presence of GM-CSF or M-CSF. The results of this study will allow to define the most valid in vitro model of AMs in a non-infectious setting.

Eligibility criteria: Inclusion Criteria:

* Patients affected by non-infectious lung diseases and for whom a broncho-alveolar lavage is scheduled for their medical care in the pulmonary division
* Patient Information leaflet provided
* Written informed consent of the patient

Exclusion Criteria:

* A suspected respiratory infection

Primary outcomes:
measure: To investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from broncho-alveolar lavage fluids of patients with non-infectious lung diseases.
timeFrame: 1 year
Secondary outcomes:
measure: To compare the phenotypic profile of AMs from broncho-alveolar lavage fluids of patients with non-infectious lung diseases to that of blood monocyte-derived macrophages differentiated in the presence of GM-CSF or M-CSF and obtained from healthy donors
timeFrame: 1 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pneumology Division
Study officials:
affiliation: Rennes University Hospital
name: Stéphane Jouneau, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05087797: The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion
Official title: The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 61
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: Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack.

Objective To determine whether nicorandil can improve left ventricular myocardial strain in patients with CTO.

Methods Patients with CTO were included and were randomized to the nicorandil group and the control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire (SAQ) survey were performed at baseline and at 3 months. Participants were randomized according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter)

Exclusion Criteria:

* successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases

Primary outcomes:
measure: total area strain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: ming cui, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen S, Ma C, Feng X, Cui M. Nicorandil Improves Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion. Front Cardiovasc Med. 2022 May 12;9:864223. doi: 10.3389/fcvm.2022.864223. eCollection 2022.
Clinical trial NCT00507897: Hemodynamic Parameters in Euthyroid Patients With Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thyroid Nodules
Keywords: thyroid nodules, blood pressure, thyroid hormones
Lead sponsor: Yaroslavl State Medical Academy
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine the relationship of hemodynamic parameters with the level of thyroid hormones and the histological structure of thyroid nodules in euthyroid patients.

Detailed description: As opposed to widely investigated condition of cardiovascular system in patients with functional disorders of thyroid gland, the relationship between thyroid hormones and hemodynamic parameters in euthyroid patients remains not enough clear.

We detect the parameters of blood pressure and thyroid hormones in euthyroid patients with thyroid nodules directly before planned operation on the thyroid gland.

As the study is carries out directly before operation, that assumes presence of preoperative stress in patients, activity of the sympatho - adrenal system is estimated in addition.

On the one hand, the design of our research will allow to estimate relationship of thyroid hormones with the parameters of blood pressure in conditions of euthyroidism, on the other hand - to investigate features of blood pressure in patients with thyroid nodules.

The research of the patients in the preoperative period will enable to select the group of patients without pathology of cardiovascular system whose increased blood pressure is connected with preoperative stress, that in turn will allow to exclude influence of the pathology of the cardiovascular system on studied correlation.

Eligibility criteria: Inclusion Criteria:

* Euthyroid patients with thyroid nodules before operation on the thyroid gland

Exclusion Criteria:

* Hyperthyroidism
* Hypothyroidism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical Academy
Study officials:
affiliation: Yaroslavl State Medical Academy
name: Yuriy Alexandrov, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05358197: Effect of Laughter Yoga on Sleep Quality and Happiness
Official title: Investigation of the Effect of Laughter Yoga on Sleep Quality and Happiness in Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Quality
Keywords: sleep quality,
laughter yoga,
happiness,
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the effect of laughter yoga on sleep quality and happiness level in individuals with sleep problems will be investigated. Yoga exercises will be done for about 30 minutes with a laughter yoga instructor 3 days a week for a month.


Eligibility criteria: Inclusion Criteria:

individuals with sleep problems individuals without mental illness

Exclusion Criteria:

those who use sleeping pills those with mental disabilities

Primary outcomes:
measure: Laughter yoga improves sleep quality
timeFrame: 1-15. day
measure: Laughter yoga improves happiness
timeFrame: 1-15. day
measure: Laughter yoga improves sleep quality
timeFrame: 30. DAY
measure: Laughter yoga improves happiness
timeFrame: 30. day
Secondary outcomes:
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University
Study officials:
affiliation: OSMANİYE KORKUT ATA UNİVERSİTY
name: Kevser Sevgi ÜNAL ASLAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257997: Quantification of Human Adipogenesis
Official title: Quantification of Human Adipogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: No specific experimental conditions
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers. Aged 18-49 years. Free of significant chronic medical illness. Free of illicit substance abuse.

Brief summary: This pilot study is using a novel technology to measure the rate of turnover of new fat cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling new volunteers.


Eligibility criteria: Inclusion Criteria:

* Aged 18-49 years.
* Healthy.

Exclusion Criteria:

* Significant chronic medical illness.
* Illicit substance or alcohol abuse.
* Body mass index \> 27 kg/meters squared.
* Underweight (BMI \< 20 kg/m2).
* History of keloid formation (excessive scarring).
* Pregnant.

Primary outcomes:
measure: Quantifying human adipogenesis-counting the number of new fat cells.
timeFrame: 4 weeks-7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Matthew L Steinhauser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinhauser ML, Bailey AP, Senyo SE, Guillermier C, Perlstein TS, Gould AP, Lee RT, Lechene CP. Multi-isotope imaging mass spectrometry quantifies stem cell division and metabolism. Nature. 2012 Jan 15;481(7382):516-9. doi: 10.1038/nature10734.
Clinical trial NCT02509897: Normobaric Hypoxic Training and Multiple Sclerosis
Official title: Cardiorespiratory, Metabolic and Immunoregulatory Response to Hypoxia in Multiple Sclerosis Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Hypoxia training
Activity energy expenditure
Immunoregulation
Energy Metabolism
Exercise
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To study the effects of normobaric hypoxic training on cardiorespiratory fitness, resting, postprandial and exercise activity energy expenditure, immunoregulatory functions and serum erythropoietin levels in relapsing-remitting multiple sclerosis patients.


Eligibility criteria: Inclusion Criteria:

* stable immunomodulatory therapy
* expanded disability status scale score \< 4.5
* body mass index 18.5 - 29.9 kg/m2

Exclusion Criteria:

* clinically relevant heart, lung, liver, and kidney diseases

Primary outcomes:
measure: Activity energy expenditure measured by indirect calorimetry (respiratory chamber)
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental & Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Friedemann Paul, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahler A, Balogh A, Csizmadia I, Klug L, Kleinewietfeld M, Steiniger J, Susnjar U, Muller DN, Boschmann M, Paul F. Metabolic, Mental and Immunological Effects of Normoxic and Hypoxic Training in Multiple Sclerosis Patients: A Pilot Study. Front Immunol. 2018 Nov 29;9:2819. doi: 10.3389/fimmu.2018.02819. eCollection 2018.