louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00396110: Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)
Official title: Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Coronary Heart Disease
Keywords: cholesterol
coronary heart disease
rosuvastatin
LDL-C goal
hypercholesterolemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 3889
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Primary end points analysis was the percentage of patients reaching the target of LDL-C \< 3.2 mmol/l. Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.


Eligibility criteria: Inclusion Criteria:

* High-risk patients with and without evident CHD who had LDL-C \> 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin.
* Patients were aged \>18 years and \<70 years (men) and \< 75 years (women).

Exclusion Criteria:

* Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg
* Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Ingrid van Geel, MD
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Ingeborg Vosjan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01909310: Head Positions to Open the Airway IV
Official title: Head Positions to Open the Upper Airway IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac or Respiratory Arrest, Anaesthesia
Keywords: anesthesia, cardiac arrest, resuscitation, ventilation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After routine induction of general anaesthesia peak airway pressure (= P max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on different head positions;


Eligibility criteria: Inclusion Criteria:

* male and female patients ≥ 18 years
* elective operations in general anaesthesia
* patient´s written informed consent
* American Society of Anesthesiology scale I-III

Exclusion Criteria:

* non fasting patient
* body mass index \> 35 kg/m2
* anamnestic cervical spine pathologies or other peripheral neurological deficiences due to pathologies of the cervical spine
* malformations of the head or upper airway
* history of perforation of stomach or esophagus
* anamnestic hiatus hernia or reflux
* acute respiratory infection or obstructive airway disease

Primary outcomes:
measure: Peak airway pressure
timeFrame: peak airway pressure is measured over one minute
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Klinik für Anästhesie und Allgemeine Intensivmedizin, Medizinische Universität Innsbruck, Anichstraße 35
Study officials:
References:
Clinical trial NCT01995110: Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal
Official title: Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Nutritional Intervention
Lead sponsor: Agroscope Liebefeld-Posieux Research Station ALP
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 14
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.


Eligibility criteria: Inclusion Criteria for normal weight subjects:

* age 25-50
* 20\<BMI\>25
* waist circumference \<94cm

Inclusion Criteria for obese subjects:

* age 25-50
* 30\<BMI\>40
* waist circumference \>102cm

Exclusion Criteria for both groups:

* physiological or psychological diseases
* allergies to food or intolerance to high-fat meal
* vegetarians, vegans
* chronic intake of drugs
* smokers
* diabetes mellitus type I and II
* debiliating kidney disease
* debiliating liver disease
* clinically established coronary heart diseases
* ingestion of vitamins or dietary supplements during the course of the study

Primary outcomes:
measure: blood cell transkriptome/ gene-expression
timeFrame: 0h, 2h, 4h, 6h
Secondary outcomes:
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Agroscope
city: Berne
country: Switzerland
facility: University Hospital Inselspital Berne
Study officials:
affiliation: Agroscope Liebefeld-Posieux Research Station ALP
name: Guy Vergeres, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Agroscope Liebefeld-Posieux Research Station ALP
name: Doreen Gille, M.Sc.
role: STUDY_DIRECTOR
affiliation: Inselspital University of Berne
name: Kurt Laederach, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01055210: Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
Official title: Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cardiac Resynchronisation Pacemakers
Keywords: Heart Failure
Pacemakers
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.


Eligibility criteria: Inclusion Criteria:

* Cardiac Resynchronization Device in situ for Heart Failure

Exclusion Criteria:

* Unable to cope with mouthpiece
* Estimated life expectancy \< 6 months

Primary outcomes:
measure: 6 minute hall walk test
timeFrame: 4 months
Secondary outcomes:
measure: Echocardiographic measures of desynchrony
timeFrame: 3 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
Study officials:
affiliation: University of Dundee
name: Anna- Maria Choy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06723210: Parkinson and the Males Body Composition
Official title: Parkinson´s Disease: Correlation Analysis Between the Cardinal Motor Symptoms of the Illness and the Male Patients´ Body Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodegenerative Disease
Keywords: Movement Disorders
Components of the Human Body
Lead sponsor: University of Oviedo
Sponsor class: OTHER
Collaborators: name: University of Leon
First posted: 2024-12-09
Enrollment: 15
Sex: MALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A group of fifteen male patients with idiopathic Parkinson´s disease participated in the project.

Brief summary: The main aim of the present study was to ascertain the type of relationship (dependency or independency) among some of the cardinal motor symptoms of the Parkinson´s disease (PD) and the body composition (BC) variables of a group of the male PD´s patients, using the bioelectrical impedance analysis.


Eligibility criteria: Inclusion Criteria:

(I) Males with diagnosis of idiopathic PD and rated 1-3 on the Hoehn and Yahr Scale.

(II) No type of dementia as assessed by the mini-mental state examination. (III) Between 50 and 69 years old (a specific range of ages of the illness´s onset).

(IV) Between one and five years diagnosed with the illness. (V) Able to stand for two min without assistance. (VI) Able to walk teen m without assistance.

Exclusion Criteria:

(I) Do not meet the eligibility criteria. (II) Suffer a neurological disease other than Parkinson´s disease.

Primary outcomes:
measure: The body composition variables or the bioelectrical impedance variables
timeFrame: From February 2025 to February 2025
measure: The Movement Disorder Society-Unified Parkinson´s Disease Rating Scale (MDS-UPDRS))
timeFrame: From February 2025 to February 2025
measure: The Ten-Meter Walk Test
timeFrame: From February 2025 to February 2025
measure: Step length
timeFrame: From February 2025 to February 2025
measure: : Spanish validated version of the Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: From February 2025 to February 2025
measure: The Timed up and Go Test (TUG)
timeFrame: From February 2025 to February 2025
measure: Handgrip Strength of both hands.
timeFrame: From February 2025 to February 2025
measure: Static posturography
timeFrame: From February 2025 to February 2025
measure: The nine holes peg test (9-HPT)
timeFrame: From February 2025 to February 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
Study officials:
References:
Clinical trial NCT02260310: The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of acupuncture protocol involving in Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.


Eligibility criteria: Inclusion Criteria:

* Eligible adult (≥18 years of age) patients
* had a diagnosis of AS for at least 3 months defined as definite by the 1984 modified New York criteria
* Eligible patients also had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of ≥4 (0-10 cm scale)
* A visual analogue scale (VAS) score for total back pain of ≥4 (0-10 cm scale)

Exclusion Criteria:

* Had received prior Acupuncture therapy
* With complete ankylosis of the spine, defined as the presence of bridging syndesmophytes at all intervertebral levels of the cervical and lumbar spine on lateral view spinal radiographs

Primary outcomes:
measure: Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks
timeFrame: At 0 week, 6 weeks, 12 weeks
measure: Change from Baseline in Visual Analog Scale at 12 weeks
timeFrame: At 0 week, 6 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu city
country: China
facility: 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，
state: Sichuan
Study officials:
References:
Clinical trial NCT01913210: Effect of Ginseng on Blood Pressure
Official title: Effect of Ginseng on Blood Pressure: A Systematic Review and Meta-Analysis of Controlled Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertensive Healthy

Brief summary: To determine the effect of ginseng on blood pressure control.

Detailed description: The effect of ginseng on blood pressure control is controversial, originating from an early 1970s observational study, suggesting that ginseng may adversely effect blood pressure. Despite these early findings, extensive research has since suggested that ginseng may have a positive effect on blood pressure. The current study will help clarify present uncertainty on the effect of ginseng on blood pressure control.

This systematic review and meta-analysis will follow The Cochrane Handbook for Systematic Reviews of Interventions. MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Intervention trials that investigate the effect of ginseng on blood pressure in humans will be included.

Eligibility criteria: Inclusion Criteria:

* clinical trials in humans
* randomized treatment allocation
* ≥ 1 month
* suitable control
* viable endpoint data

Exclusion Criteria:

* non-human studies
* non-randomized treatment allocation
* \< 1 month
* lack of a suitable control
* no viable endpoint data
* trials where ginseng is part of a multi-herbal treatment

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 1 month
Secondary outcomes:
measure: Diastolic Blood Pressure
timeFrame: 1 month
measure: Mean Arterial Pressure
timeFrame: 1 month
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: John Sievenpiper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Allison Komishon, MSc(c)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05273710: Effects of Dietary Folate and Phytate Zinc Absorption: Zinc Amino Acid Complexes vs. Zinc-chloride
Official title: Comparison of the Effects of Dietary Folate and Phytate on the Absorption of Zinc From Either Zinc-amino Acids (ZnAA) or Zinc-chloride (ZnCl2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Zinc Absorption
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of consuming a small breakfast of juice and toast with added phytate or with taking a folic acid supplement on the absorption of a small amount of zinc that is either bound to amino acids or to chloride or picolinate. The results of this study will provide new information on how components of diet (e.g., phytate, and folic acid) affect the absorption of different forms of dietary zinc (e.g., zinc bound to amino acids, zinc chloride, and zinc picolinate).


Eligibility criteria: Inclusion Criteria:

* Apparently healthy men (i.e., have no current health issues requiring medications or a specific diet), 19 to 50 years of age, with a body mass index between 18 and 30 kg/m2, and willing to eat only the foods provided by the study for 17 days

Exclusion Criteria:

* Those reporting current chronic or acute diseases or HIV diagnosis, food allergies, smoking tobacco or marijuana, alcohol abuse, any contraindication to venipuncture such as bleeding disorders or use of blood thinners; use of illicit drugs; regular consumption of medications, micronutrient supplements, or both. Vegetarians, or those unable to eat meat, are also excluded since the foods for the study contain meat.

Primary outcomes:
measure: Fractional zinc absorption
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Berkeley
name: Janet C King, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01778010: Modafinil for Smoked Cocaine Self-Administration
Official title: Modafinil in a Human Laboratory Model of Cocaine Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: cocaine
modafinil
self-administration
DRD4
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-01-29
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).


Eligibility criteria: Inclusion Criteria:

1. Smokes cocaine
2. Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
3. Age 21-50.
4. Able to give informed consent, and comply with study procedures.
5. Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Exclusion Criteria:

1. Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
2. Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
3. Request for drug treatment
4. Judged to be noncompliant with study protocol.
5. Current use of any psychotropic medication.
6. Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP \> 140/90; BUN, creatinine, LFTs \> 3x ULN; hematocrit \< 34 for women, \< 36 for men; pseudocholinesterase deficiency)
7. History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
8. Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
9. Current parole or probation Self-report during interview -

Primary outcomes:
measure: Cocaine Self-administration
timeFrame: 48 days
Secondary outcomes:
measure: Drug Quality Cluster
timeFrame: 48 days
measure: Heart Rate
timeFrame: 48 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: NYS Psychiatric Institute
name: Margaret Haney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00853710: Test Semiquantitative Prostate Specific Antigen (PSA)
Official title: Validation of a Semiquantitative Screening Assay for PSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostatic Neoplasms
Prostatic Diseases
Keywords: Prostate-Specific Antigen
Prostate Cancer
Cancer
Assay
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2009-03-02
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

Detailed description: Screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (PSA). In this study, we determine the sensitivity and specificity of a simple test strip based PSA assay using only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples will be taken from hundred patients who are followed for a prostatic disease needing PSA surveillance. Before decantation of the samples, a few drops of blood will serve for the rapid test on strips. Plasma PSA levels will be determined with the TRACE ("Time Resolved Amplified Cryptate Emission") technology in homogeneous liquid phase. The results from the rapid test can then be compared to the plasma levels obtained by TRACE.

Eligibility criteria: Inclusion Criteria:

* Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
* Patients must have given informed consent.

Exclusion Criteria:

* Patients followed for a disease other than prostatic.

Primary outcomes:
measure: Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay.
timeFrame: day of test
Secondary outcomes:
measure: Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.
timeFrame: at the last inclusion
Other outcomes:
Locations:
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
Study officials:
affiliation: Institut Curie
name: Dominique BELLET, Pr
role: PRINCIPAL_INVESTIGATOR
References: