louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01371513: Korean Practice Patterns for Screening PCA(Prostate Cancer)
Official title: Korean's Practice Patterns for Screening PCA(Prostate Cancer) According to PSA(Prostate-specific Antigen) Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Prostate
Prostate Cancer
Benign Prostatic Hyperplasia
Keywords: Serum prostate specific antigen
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 1
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with PSA more than 2.5ng/ml in 2008 from urology department of clinic and general hospital

Brief summary: This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

Detailed description: This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

Eligibility criteria: Inclusion Criteria:

* Male with PSA more than 2.5ng/ml from 1 Jan 2008 to 31 Dec 2008

Exclusion Criteria:

* Age less than 40 at PSA screening
* History of drug use which can affect level of PSA within 6months before PSA screening
* Subject who participate any other clinical trial

Primary outcomes:
measure: Number of subjects with prostate biopsy
timeFrame: 1year
Secondary outcomes:
measure: Number of subjects with prostate cancer
timeFrame: 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00629213: Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial
Official title: Metabolic Syndrome and Its Single Traits as Risk Factors of Diabetes in People With Impaired Glucose Tolerance: The STOP-NIDDM Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Keywords: prevention,
type 2 diabetes,
metabolic syndrome,
acarbose treatment
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 1429
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose tolerance (IGT) and to assess the effect of acarbose by MetS status.

Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting glucose (IFG).


Eligibility criteria: Inclusion Criteria:

* High risk population
* Age 40 to 70 yrs.
* BMI \> 25 and \< 40; FPG \>5.5 mmol/l and \< 7.8 mmol/l; IGT in OGGT

Exclusion Criteria:

* Known type 2 diabetes
* Drug intake affecting glucose tolerance
* Any cardiovascular events within the last 6 months

Primary outcomes:
measure: Incidence of newly diagnosed type 2 diabetes
Secondary outcomes:
measure: newly diagnosed hypertension
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GWT-TUD GmbH
state: Saxony
Study officials:
References:
citation: Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trail Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002 Jun 15;359(9323):2072-7. doi: 10.1016/S0140-6736(02)08905-5.
citation: Hanefeld M, Karasik A, Koehler C, Westermeier T, Chiasson JL. Metabolic syndrome and its single traits as risk factors for diabetes in people with impaired glucose tolerance: the STOP-NIDDM trial. Diab Vasc Dis Res. 2009 Jan;6(1):32-7. doi: 10.3132/dvdr.2009.006.
Clinical trial NCT01574313: Effect of Stellate Ganglion Block on Meniere's Disease
Official title: Effect of Stellate Ganglion Block on Meniere's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vertigo
Meniere Disease
Keywords: stellate ganglion block.
Meniere's disease.
electrocochleography.
vertigo.
hearing impairment.
Lead sponsor: Chi Mei Medical Hospital
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for years. However, objective evidence of the effect of SGB was still lack. The investigators conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of electrocochleography (ECoG).

Detailed description: Ten patients were randomly assigned to receive stellate ganglion block. These ten patients made up the experimental group. Another ten patients in the control group were assigned to receiving one dosage of oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995)

Exclusion Criteria:

* patients with coagulopathy,
* arrhythmia,
* myocardial ischemia,
* glaucoma,
* pregnant,
* chronic otitis media or externa, and
* past history of middle or inner ear surgery were excluded.

Primary outcomes:
measure: SP/AP of Electrocochleography
timeFrame: ECoG was reorded 2 hours after SGB
Secondary outcomes:
measure: SP/AP recorded at 4 hours after SGB
timeFrame: 4 hours after SGB
measure: SP/AP recorded at 6 hours after SGB
timeFrame: 6 hours after SGB
measure: scores of verbal scale for vertigo recorded at 6 hours after SGB
timeFrame: 6 hours after SGB
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: i Mei Medical Center Tainan, Taiwan, Taiwan
Study officials:
affiliation: Chi Mei Medical Hospital
name: Yung-Song Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575913: Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Official title: ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Diseases
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-12-18
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.

Exclusion Criteria:

* Patients requiring BPH surgery immediately or within the 12 following months:

  * Acute renal obstruction
  * Chronic renal obstruction
  * Chronic renal failure from BPH
  * Bladder stone
  * Recurrent urinary tract infection
  * Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
  * Hematuria from BPH
* Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
* Patients previously not improved by an alpha1-blocker treatment
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Combination with other alpha1-blockers
* Hepatic enzyme (SGOT or/and SGPT ) \> 1.5 Upper Normal Limit
* Unstable angina pectoris
* Severe concomitant condition threatening life.
* Patients who had failed treatment with finasteride (Proscar)
* Patients with neuropathic bladder.
* Patients with history of previous surgery for BPH
* Patients with high risk for prostate cancer based on the clinical judgement of the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: improvements in urinary symptoms and quality of life index
timeFrame: During all the study conduct
Secondary outcomes:
measure: Improvement in sexual function
timeFrame: During all the study conduct
measure: Improvement in maximum flow rate (determined by uroflowmetry)
timeFrame: During all the study conduct
measure: Collection of spontaneously reported adverse events
timeFrame: At each visit
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Paibulsirijit Sompob
role: STUDY_DIRECTOR
References:
Clinical trial NCT02797613: Restricted Reporting for Positive Urine Cultures
Official title: Restricted Reporting for Positive Urine Cultures Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteriuria
Urinary Tract Infection
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 110
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: Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

Detailed description: Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.

Eligibility criteria: Inclusion Criteria:

* positive urine culture from inpatients at Health Sciences Centre or St. Clare's Mercy Hospital or outpatients during study period.

Exclusion Criteria:

* pregnancy,
* antibiotic treatment at the time of urine collection,
* collection from an indwelling catheter,
* admission to long term care facility.

Primary outcomes:
measure: The Number of Patients Receiving Appropriate Treatment
timeFrame: 72 hours from positive culture
Secondary outcomes:
Other outcomes:
Locations:
city: Saint John's
country: Canada
facility: Health Sciences Center
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University
name: Peter Daley, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daley P, Garcia D, Inayatullah R, Penney C, Boyd S. Modified Reporting of Positive Urine Cultures to Reduce Inappropriate Treatment of Asymptomatic Bacteriuria Among Nonpregnant, Noncatheterized Inpatients: A Randomized Controlled Trial. Infect Control Hosp Epidemiol. 2018 Jul;39(7):814-819. doi: 10.1017/ice.2018.100. Epub 2018 May 28.
Clinical trial NCT02590913: Acute Metabolic and Endocrine Responses of Glucose and Fructose in Healthy Young Subjects
Official title: Acute Metabolic and Endocrine Responses of Glucose and Fructose in Healthy Young Subjects: A Double-blinded, Randomized, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: fructose
metabolism
acute
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the metabolic and endocrine responses during 3 hour after taking 75g fructose or glucose in young Chinese.

Detailed description: The study was a double-blinded, randomized, crossover trial. Twenty healthy volunteers were randomized to two groups: group A (300ml of 22.5% glucose) and group B (300ml of 22.5% fructose).Volunteer was randomized into either group A or B, after an 8-h overnight fasting, took 300ml of solution at 0830 within 5 minutes. After one-week washout period, volunteer was crossed over for either group B or A. each intervention, venous blood was collected at 0h, 0.5h, 1h, 2h, and 3h and blood pressure was tested at 0h, 1h, 2h, and 3h.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were aged 19-39 years, with BMI between 18-24 kg/m 2.

Exclusion Criteria:

* Subjects pregnant or having a history of hepatic or renal disease, fructose intolerance, gout, hypoglycemia, or diabetes mellitus were excluded.
* Subjects taking any drugs, botanicals, or nutraceutical known to influence blood pressure also were rejected either.

Primary outcomes:
measure: serum uric acid
timeFrame: 3 hours
Secondary outcomes:
measure: blood pressure
timeFrame: 3 hours
Other outcomes:
measure: serum glucose
timeFrame: 3 hours
measure: nitric oxide
timeFrame: 3 hours
measure: aldose reductase
timeFrame: 3 hours
measure: phosphofructokinase
timeFrame: 3 hours
measure: insulin
timeFrame: 3 hours
measure: insulin-c
timeFrame: 3 hours
measure: triglyceride
timeFrame: 3 hours
measure: total cholesterol
timeFrame: 3 hours
measure: high-density cholesterol
timeFrame: 3 hours
measure: low-density cholesterol
timeFrame: 3 hours
measure: lactate dehydrogenase
timeFrame: 3 hours
Locations:
city: Hangzhou
country: China
facility: Zhejiang university
state: Zhejiang
Study officials:
affiliation: College of Biosystem Engineering & Food Science, Zhejiang University
name: Duo Li, Doctor
role: STUDY_DIRECTOR
References:
citation: Fulgoni V 3rd. High-fructose corn syrup: everything you wanted to know, but were afraid to ask. Am J Clin Nutr. 2008 Dec;88(6):1715S. doi: 10.3945/ajcn.2008.25825A.
citation: Le MT, Frye RF, Rivard CJ, Cheng J, McFann KK, Segal MS, Johnson RJ, Johnson JA. Effects of high-fructose corn syrup and sucrose on the pharmacokinetics of fructose and acute metabolic and hemodynamic responses in healthy subjects. Metabolism. 2012 May;61(5):641-51. doi: 10.1016/j.metabol.2011.09.013. Epub 2011 Dec 5.
Clinical trial NCT02854813: Overactive Bladder in Elderly Patients- An Early Warning of Coronary Artery Disease
Official title: Overactive Bladder in Elderly Patients- An Early Warning of Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder Syndrome
Coronary Artery Disease
Keywords: overactive bladder
coronary artery disease
gensini score
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients, whom were diagnosed to undergo coronary angiography in a center of cardiology between January 2016 and January 2017 were evaluated prospectively.

Brief summary: Investigators aimed to investigate the association between over active bladder and coronary artery disease as demonstrated on coronary angiography.

Detailed description: The close relationship has been demonstrated between pelvic ischemia and overactive bladder (OAB) in a study involving elderly patients. In this study, it has been found that pelvic ischemia has triggered OAB and it has been related with cardiac ischemia. The aim of this study was to delineate the correlation between OAB and the degree of coronary artery stenosis as demonstrated on coronary angiography.

Eligibility criteria: Inclusion Criteria:

* patients, whom were diagnosed to undergo coronary angiography in a center of cardiology

Exclusion Criteria:

* a maximum flow rate of 15 ml. per second or less,
* residual volume of 100 cc or more,
* diabetes mellitus,
* neurologic disease,
* prostate or bladder cancer,
* renal failure,
* urinary tract infection,
* nephrolithiasis or pelvic surgery,
* patients with a history of percutaneous coronary intervention or coronary artery bypass grafting

Primary outcomes:
measure: Over active bladder V8 questionnaire score
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
Study officials:
References:
citation: Tarcan T, Azadzoi KM, Siroky MB, Goldstein I, Krane RJ. Age-related erectile and voiding dysfunction: the role of arterial insufficiency. Br J Urol. 1998 Dec;82 Suppl 1:26-33. doi: 10.1046/j.1464-410x.1998.0820s1026.x. No abstract available.
citation: De EJ, Hou P, Estrera AL, Sdringola S, Kramer LA, Graves DE, Westney OL. Pelvic ischemia is measurable and symptomatic in patients with coronary artery disease: a novel application of dynamic contrast-enhanced magnetic resonance imaging. J Sex Med. 2008 Nov;5(11):2635-45. doi: 10.1111/j.1743-6109.2008.00969.x. Epub 2008 Aug 26.
Clinical trial NCT03402113: Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients
Official title: The Effect of Different Sedation Protocols on Skeletal Muscle Metabolism in Mechanical Ventilated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercatabolism
Sedative, Hypnotic, or Anxiolytic Use Disorders
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2018-01-18
Enrollment: 360
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: To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.


Eligibility criteria: Inclusion Criteria:

* mechanical ventilated for more than 48h
* 18-80 years
* stay in ICU for more than 5 days

Exclusion Criteria

* already participated in other clinical trials
* pregnancy or lactation
* lower limb amputation
* primary neuro-muscular disease
* disseminated tumor or accepted special therapy
* alcohol abuse
* severe liver dysfunction(Child-Push C)
* unstable angina/acute myocardial infarction
* heart rates\<50bpm
* all kinds dialysis
* severe burn
* epidural anesthesia
* severe neurological disease（acute stroke, uncontrollable epilepsy, severe dementia, etc）

Primary outcomes:
measure: acute muscle wasting
timeFrame: From date of randomization to extubation,up to 7 days
Secondary outcomes:
measure: 28-day mortality
timeFrame: From date of randomization to date of death from any cause,up to 28 days
measure: length of ICU stay
timeFrame: From date of randomization to date of to discharge or death,up to 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affliated Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01185613: Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Official title: Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial fibrillation.

This study is an observational clinical study which is not based on any specific endpoints.


Eligibility criteria: Inclusion Criteria:

* A signed written Informed Consent form
* 18 years of age or older
* Agrees to comply with follow-up visits and evaluation
* Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care.

Exclusion Criteria:

* Persistent or Long standing AF
* CABG procedure within the last 180 days (six months).
* Documented left atrial thrombus on imaging \[e.g. Transesophageal echocardiogram (TEE)\].
* History of blood clotting or bleeding abnormalities.
* Contraindication to anticoagulation (i.e. heparin or warfarin).
* Enrollment in another investigational study evaluating device or drug that might impact the results of this study.
* Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
* Acute illness or active systemic infection or sepsis.
* Life expectancy less than 12 months.
* Uncontrolled heart failure or NYHA class IV heart failure.
* Myocardial Infarction within 8 weeks of enrollment or unstable angina

Primary outcomes:
measure: Procedural parameters
timeFrame: 6 months
measure: AF Recurrence
timeFrame: 6 months
measure: Serious Adverse Events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Pessac
country: France
facility: Hopital du Haut Leveque
city: Leipzig
country: Germany
facility: Universitat Leipzig Herzzentrum
city: Mestre
country: Italy
facility: Ospendale dell'Angelo
city: Lisbon
country: Portugal
facility: Hospital Santa Cruz
city: London
country: United Kingdom
facility: Heart Hospital
Study officials:
References: