louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02254824: Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients
Official title: Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: Xuezhikang
atorvastatin
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking Union Medical College Hospital
name: Beijing Hospital of Traditional Chinese Medicine
First posted: 2014-10-02
Enrollment: 300
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: The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.

Detailed description: EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.

Eligibility criteria: Inclusion Criteria:

* All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China

Exclusion Criteria:

* Secondary Hypertension
* Women who are pregnant or lactating
* History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy
* Type 2 Diabetes
* Active liver disease or impaired liver function tests
* Impaired renal function
* Uncontrolled cardiac arrhythmia
* Patient who is unable to give informed consent
* Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study

Primary outcomes:
measure: The primary endpoint is the Flow Mediated Dilatation (FMD)
timeFrame: 1 year
Secondary outcomes:
measure: the carotid - femoral Pulse Wave Velocity (cf-PWV),
timeFrame: 1 year
measure: inflammatory markers
timeFrame: 1 year
measure: lipid profiles
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital & Cardiovascular Institute
name: Aimin Dang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00209924: A Study of Gaboxadol in Primary Insomnia
Official title: A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Insomnia
Keywords: Primary insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 505
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia.

Detailed description: To compare hypnotic efficacy of gaboxadol with placebo in elderly outpatients with primary insomnia

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of primary insomnia

Primary outcomes:
measure: Efficacy
measure: Safety
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Non-US study, principal location:
Study officials:
affiliation: H. Lundbeck A/S
name: Please contact: Annelies van der Hammen Legters
role: STUDY_DIRECTOR
References:
Clinical trial NCT01684124: An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients
Official title: A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critical Illness
Keywords: oxygen
critical illness
mechanical ventilation
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
First posted: 2012-09-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that it is feasible and safe to deliver a conservative approach to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on average,10 days).

Detailed description: 1. Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
2. Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
3. Target an oxygen saturation between 90 and 92%
4. Adjust FiO2 to achieve target SaO2 at all times
5. Assess percentage of time patient is within target
6. Assess for safety of this approach

Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation
* expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours)

Exclusion Criteria:

* expected to be off mechanical ventilation today or tomorrow
* carbon monoxide poisoning
* necrotizing fasciitis

Primary outcomes:
measure: Difference in PaO2/FiO2 ratio from baseline to worst value
timeFrame: 10 days
Secondary outcomes:
measure: Lactate
timeFrame: 10 days
Other outcomes:
measure: arrhythmias
timeFrame: 10 days
Locations:
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
Study officials:
References:
citation: Eastwood GM, Tanaka A, Espinoza ED, Peck L, Young H, Martensson J, Zhang L, Glassford NJ, Hsiao YF, Suzuki S, Bellomo R. Conservative oxygen therapy in mechanically ventilated patients following cardiac arrest: A retrospective nested cohort study. Resuscitation. 2016 Apr;101:108-14. doi: 10.1016/j.resuscitation.2015.11.026. Epub 2015 Dec 21.
Clinical trial NCT03766724: Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg After Oral Administration in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults


Eligibility criteria: Inclusion Criteria:

* Health Male Volunteers (Age : 19\~55 years)
* Body Weight≥55kg, 18.5≤BMI\<25.0

Exclusion Criteria:

* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT \> Upper Normal Range\*1.25, eGFR\<60mL/min/1.73㎡
* Drink during clinical trial period
* Smoking during clinical trial period
* Grapefruit/Caffeine intake during clinical trial period
* No Contraception

Primary outcomes:
measure: AUCτ,ss
timeFrame: 4 weeks
measure: Cmax,ss
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Severance Hospital
Study officials:
affiliation: Clinical Trial Center, Severance Hospital
name: Min soo Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871424: Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy
Official title: Transdermal Buprenorphine Patch for Postoperative Pain Control in Laparoscopic Cholecystectomy: a Prospective Randomized, Placebo-controlled, Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preliminary studies of the transdermal buprenorphine patch target chronic pain patients, and the pain relief effect and safety have been proven. There are previous reports that the transdermal buprenorphine patch is effective in acute postoperative pain control. However, no clinical studies have yet been reported on its application during laparoscopic cholecystectomy. Therefore, we designed this study to see if the use of a transdermal buprenorphine patch resulted in a better pain profile.


Eligibility criteria: Inclusion Criteria:

* 1) Patients 19 years of age or older who are expected to undergo laparoscopic cholecystectomy 2) ASA PS 1-3

Exclusion Criteria:

* (1) Patients with known hypersensitivity to buprenorphine, including patients with previous allergic contact dermatitis (2) Patients with drug resistance, opioid dependence, and treatment for drug withdrawal symptoms (3) Patients with severe respiratory dysfunction or respiratory depression (4) Patients currently taking other central nervous system depressants or muscle relaxants that may cause respiratory depression, hypotension, severe sedation, or lead to coma (5) If you are unable to read or understand the consent form (e.g. cognitive impairment, illiteracy, foreigners, etc.) (6) Other vulnerable subjects

Primary outcomes:
measure: Numeric rating scale pain score at movement
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Numeric rating scale pain score at rest
timeFrame: up to 2 weeks after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT03046524: Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior
Official title: Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parathyroid Carcinoma
Parathyroid Neoplasm
Keywords: Parathyroid Carcinoma
Parathyroid Neoplasm
Chart Review
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center between the years of 1/1/2002 and 12/31/2013.

Brief summary: Objectives:

1. Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical neoplasms
2. Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and have a different impact on the health of the patients

Detailed description: Data between the years of 1/1/2002 and 12/31/2013 will be analyzed. The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center will be screened in order to identify patients that had a histopathological diagnosis of parathyroid carcinoma or atypical parathyroid neoplasm.

Eligibility criteria: Inclusion Criteria:

* All patients from MDACC diagnosed with PHPT that have a histopathological diagnosis of PTH carcinoma or atypical parathyroid neoplasm between the years 1/1/2002 and 12/31/2013

Exclusion Criteria:

* Pediatric patients
* Cases with incomplete records
* Patients where the follow-up will be less than six months

Primary outcomes:
measure: Information Collected on Clinical Characteristics of Parathyroid (PTH) Cancer and PTH Atypical Neoplasms by Conducting a Retrospective Chart Review
timeFrame: 5 years
measure: Information Collected on PTH Carcinoma's Biological Behaviour and Impact on the Health of the Patients by Conducting a Retrospective Chart Review
timeFrame: 5 years
measure: Information Collected on Atypical Neoplasm's Biological Behaviour and Impact on the Health of the Patients \by Conducting a Retrospective Chart Review
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nancy D. Perrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802424: FRIENDS as an Indicative Prevention Program in Norway
Official title: The FRIENDS-program as Indicative Prevention for Children and Adolescents With Symptoms of Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Open trial
Indicative prevention
Youth anxiety
Cognitive behavioral therapy
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot-study is to evaluate a cognitive behavioral program, the Friends-program, as indicated prevention for anxious youth. The youths are recruited by school nurses who will also lead the intervention groups applying the Friends-manual.


Eligibility criteria: Inclusion Criteria:

* subclinical to clinical symptoms of anxiety with or without comorbid symptoms of depression

Exclusion Criteria:

* previously diagnosed with conduct disorder, major life-crises that needs to be attended to, serious school refusal, Obsessive Compulsive Disorder, mental retardation or autism.

Primary outcomes:
measure: Change in anxiety symptoms from baseline to 12 months after completing the FRIENDS program, measured by the Spence Children Anxiety Scale (SCAS)
timeFrame: When completing the intervention and 3months and 12 months after having completed the intervention
Secondary outcomes:
measure: Changes in life-quality (measured by KINDL)from baseline to 12 months after completing the FRIENDS program
timeFrame: When completing the intervention and 3months and 12 months after having completed the intervention
measure: Changes in depressive symptoms (measured by the Short Mood and Feeling questionnaire)from baseline to 12 months after completing the FRIENDS program
timeFrame: When completing the intervention and 3months and 12 months after having completed the intervention
measure: Changes in psychosocial functioning (measured by the Strengths and difficulties questionnaire)from baseline until 12 months after having completed the FRIENDS program
timeFrame: When completing the intervention and 3months and 12 months after having completed the intervention
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Fjell municipality
Study officials:
affiliation: Uni Research Health
name: Bente SM Haugland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01207024: Assessment of Knee Arthrosis After Bariatric Surgery
Official title: Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Keywords: knee arthrosis
obesity
MRI
bariatric surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* bariatric surgery
* IMC \>= 35

Exclusion Criteria:

* those of bariatric surgery
* contra-indication to MRI
* pregnancy

Brief summary: Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.

Knee MRI is not currently part of the investigations preceding bariatric surgery.

Detailed description: Assessment of knee arthrosis in severely obese patients after bariatric surgery.

Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* bariatric surgery
* IMC \>= 35

Exclusion Criteria:

* those of bariatric surgery
* contra-indication to MRI
* pregnancy

Primary outcomes:
measure: variation of knee joint space thickness
timeFrame: 24 hours, one year
measure: proportion of patients with pain
timeFrame: 1 year
Secondary outcomes:
measure: prevalence of atherosis
timeFrame: 24 hours
measure: mean pain and disability
timeFrame: 24 hours
measure: evolution of KOOS score after surgery
timeFrame: 6 months, 1 year and two years
measure: evolution of pain scores after surgery
timeFrame: 6 months, 1 year, 2 years
measure: evolution of the proportion of patients in pain
timeFrame: 6 months, 1 year and two years
measure: evolution of knee MRI parameters after surgery
timeFrame: 6 months, 1 year and two years
Other outcomes:
Locations:
city: Colombes
country: France
facility: Louis Mourier hospital (AP-HP)
Study officials:
affiliation: Louis Mourier University Hospital (AP-HP)
name: Elisabeth Dion, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317524: The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
Official title: The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Inflammation
Atherosclerosis
Keywords: Milk
Homogenization
Postprandial hyperlipidemia
Postprandial inflammation
Overweight
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Dairy Association (NZO)
First posted: 2011-03-17
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men


Eligibility criteria: Inclusion Criteria:

* men
* aged between 18 and 70 years
* Quetelet index between 25 - 30 kg/m2
* mean serum triacylglycerol (≤1.7 mmol/L (31))

Exclusion Criteria:

* women
* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (32)
* lactose intolerance
* current smoker
* familial hypercholesterolemia
* abuse of drugs
* more than 21 alcoholic consumptions per week
* no stable body weight (weight gain or loss \< 3 kg in the past three months)
* use of medication or a diet known to affect serum lipid or glucose metabolism
* severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis.
* active cardiovascular disease like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebro vascular accident)
* use of an investigational product within the previous 1 month
* not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
* not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
* difficult venipuncture as evidenced during the screening visits

Primary outcomes:
measure: Incremental Area Under the triacylglycerol Curve
timeFrame: during 8 hours after meal consumption
Secondary outcomes:
measure: Plasma inflammatory markers
timeFrame: during 8 hours after meal consumption
measure: Markers of endothelial activation
timeFrame: during 8 hours after meal consumption
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Ronald P Mensink, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00546624: GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment of patients with generalized anxiety disorder.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with Generalized Anxiety Disorder
* Women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study

Exclusion Criteria:

* History of drug or alcohol abuse
* Have previously participated in another study using MK0777

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: