louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04857567: The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents
Official title: The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Out (Psychology)
Keywords: resident
surgery
ego resilience
mindfulness
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Mind Works Clinical Psychologist Group
First posted: 2021-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: There are few systematic studies on the working environment and mental health of residents who are at the forefront of Korean medical care. In particular, there is no scientific research on burnout prevention. Since preventing burnout of surgical residents is directly related not only to personal well-being but the health of the patients, it is necessary to care for the individual's psychological state at a social level. This psychological intervention program that is expected to improve recovery resilience in stressful situations of residents and prevent burnout is implemented, and its effectiveness is to be verified.


Eligibility criteria: Inclusion Criteria:

* Surgical trainees (residents and clinical fellows) at Bundang Seoul National University Hospital, who is 20 years of age or older, regardless of sex or race.

Exclusion Criteria:

* Subjects who do not consent to the study
* Subjects with meditation experience

Primary outcomes:
measure: TCI, Temperament and Character Inventory
timeFrame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
measure: MBI, Maslach Burnout Inventory
timeFrame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
measure: ER89, Ego Resilience Scale
timeFrame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
measure: DASS-21, Depression Anxiety StressScale
timeFrame: In this study, changes in participant's psychological pain are measured at each session during the program (6 cycles of TSC program, 3-4 weeks interval, up to 24 weeks from baseline).
measure: Subjective Well-being
timeFrame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
measure: SCS, Self-Compassion Scale
timeFrame: Change from baseline at right after 6 cycles of TSC program at the end of Cycle 6 (each cycle is 4 weeks, up to 24 weeks from baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Heung-Kwon Oh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205567: Bergamot and Cardio-Metabolic Risk Factors
Official title: The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult subjects with dyslipidemia

Brief summary: Bergamot-derived products have shown significant effects on plasma lipids. We aim in the present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.

Detailed description: The research hypothesis is to assess whether bergamot reduces plasma lipids (total cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.

The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic lipoproteins in patients with dyslipidemia.

Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.

Secondary endpoint: Reduction in IMT and and liver steatosis.

Clinical diagnostic tools will include the measurement of:

1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed angles of insonation;
2. liver steatosis, that will be assessed by by abdominal ultrasound.

Biochemical analyses will include the analysis of:

1. Routine testing of plasma lipids;
2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses and 7 low density lipoprotein (LDL) subclasses.

Eligibility criteria: Inclusion Criteria:

* elevated LDL-cholesterolemia

Exclusion Criteria:

* severe hepatic or renal diseases

Primary outcomes:
measure: Change from baseline in plasma lipids
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University Hospital of Palermo
state: PA
Study officials:
affiliation: University of Palermo, Italy
name: Giuseppe Montalto, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01135667: Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI
Official title: Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Acute Coronary Syndromes
Keywords: clopidogrel
prasugrel
low responder
multiplate
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Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 106
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: All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.

A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age \> 75 og bodyweight \< 60 kg 5 mg)once daily for 30 days after the procedure.

Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.

Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy.

Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)


Eligibility criteria: Inclusion Criteria:

* PCI with stenting and Multiplate hep-ADP \> 70 U despite clopidogrel loading

Exclusion Criteria:

* need for vit K antagonist
* women with childbearing potential
* breastfeeding women
* Planned surgery within 6 months
* Intolerance to clopidogrel, prasugrel or aspirin
* previous stroke

Primary outcomes:
measure: Heparin ADP by Multiplate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen O
country: Denmark
facility: Rigshospitalet, Department of Cardiology, 2013
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Holmvang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03384667: Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer
Official title: Efficacy and Safety Evaluation of Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer -Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Postoperative Cough
Lung Cancer
Keywords: Maekmoondong-tang
Mai-men-dong-tang
Bakumondo-to
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, placebo-controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the efficacy and safety of Maekmoondong-tang on post-operative cough in patients with lung cancer. A randomized, double-blind, placebo-controlled trial will be conducted.


Eligibility criteria: Inclusion Criteria:

* Adults over 20 years old.
* Patients undergone segmentectomy or lobectomy for lung cancer within 1 month
* Patients who do not or poorly respond to one week administration of common antitussive agents.
* Eastern Cooperative Oncology Group(ECOG) 0 to 2
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Patients undergoing adjuvant chemotherapy.
* Patients who have been diagnosed with acute respiratory disease within 1 month.
* Patients who have been diagnosed with bronchial asthma or bronchiectasis within 1 year
* Patients taking Angiotensin Converting Enzyme Inhibitor
* Patients with pseudoaldosteronism.
* Participants who have known prior hypersensitivity to any investigational product component
* Patient with acute or chronic infections requiring treatment (active HAV, HBV, HCV, HIV, TB)
* Pregnant or lactating females
* Women of childbearing potential
* Patient who do not agrees to use effective means of contraception and not to donate sperm during the trial and up to 1 month after final administration
* Patient who participated other clinical trials of medicine or medical devices within 1 month
* Individuals who are judged inappropriate for the study by investigator

Primary outcomes:
measure: Leicester Cough Questionnaire (LCQ)
timeFrame: Day 0 to Day 28
Secondary outcomes:
measure: Cough VAS
timeFrame: Day 0 to Day 28
measure: Yin deficiency scale
timeFrame: Day 0 to Day 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
Clinical trial NCT00969267: The Effect of Auricular Point Stimulation on Obese Women
Official title: The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: ear acupuncture
obese
obese women
women
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2009-09-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine whether the ear acupoint stimulation is effective on obese women.

Detailed description: % change body weight, BMI, lipid profile, glucose and obese hormone.

Eligibility criteria: Inclusion Criteria:

* Age 16-65 years women
* BMI\>27 kg/mm
* Signed informed consent

Exclusion Criteria:

* Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
* Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
* Allergy and Immunology disease.
* High aminotransferases ( Alanine, Aspartate \> 80 IU/L) or high serum creatinine (\> 2.5 mg/dL)
* Pregnant or lactating women.
* Childbirth within 6 months.
* Stroke or otherwise unable to exercise
* Management for weight control within 3 months.
* Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.
* Endocrine disease

Primary outcomes:
measure: % reducting of body mass index (BMI)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Branch of Chinese Medicine, Taipei City Hospital
Study officials:
affiliation: Insitute of Traditional Medicine, National Yang Ming University
name: Chung-Hua Hsu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu CH, Wang CJ, Hwang KC, Lee TY, Chou P, Chang HH. The effect of auricular acupuncture in obese women: a randomized controlled trial. J Womens Health (Larchmt). 2009 Jun;18(6):813-8. doi: 10.1089/jwh.2008.1005.
citation: Hsu CH, Hwang KC, Chao CL, Lin JG, Kao ST, Chou P. Effects of electroacupuncture in reducing weight and waist circumference in obese women: a randomized crossover trial. Int J Obes (Lond). 2005 Nov;29(11):1379-84. doi: 10.1038/sj.ijo.0802997.
citation: Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
Clinical trial NCT06092840: Effect of Transform Burn on Weight Loss
Official title: Effect of a Thermogenic Composition on Healthy Adult Women and Men in a 12-week Weight Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: 4Life Research, LLC
Sponsor class: INDUSTRY
Collaborators: name: Brigham Young University
First posted: 2023-10-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was undertaken to explore the effects of a Thermogenic Composition (TC) composed of dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel extract, coleus (Coleus forskholi) root extract, and african mango (Irvingia gabonensis) seed extract to support body composition, weight management, and improve parameters related to energy, hunger, and satiety on healthy adult women and men over a 12-week interval.


Eligibility criteria: Inclusion Criteria:

* Individuals could participate who were at least 18 years old and not smokers.
* Not currently taking a dietary supplement or prescription for weight loss.
* Exercising volunteers were asked to maintain their regimen consistently throughout the course of the 12-week study and caffeine drinking volunteers maintained their caffeine intake consistently throughout the course of the 12-week study.

Exclusion Criteria:

* Participants were not allowed to participate if they were pregnant or planning to become pregnant in the following 12 weeks, or lactating.
* Individuals were not allowed to participate if they were taking any stimulant medications.

Primary outcomes:
measure: Satiety Score
timeFrame: 12 weeks
measure: Resting Metabolic Rate
timeFrame: 12 weeks
measure: Blood Pressures
timeFrame: 12 weeks
measure: Heart Rates
timeFrame: 12 weeks
measure: Glucose Levels
timeFrame: 12 weeks
measure: Cholesterol Levels
timeFrame: 12 weeks
measure: Body Fat
timeFrame: 12 weeks
measure: Body Weight
timeFrame: 12 weeks
measure: Waist and Hip Ratio (WHR)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sandy
country: United States
facility: 4Life Research
state: Utah
Study officials:
affiliation: 4LIFE
name: David Vollmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05628467: Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database
Official title: Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antidepressants Causing Adverse Effects in Therapeutic Use
Fall
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 100000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 years and over who presented fall on antidepressants

Brief summary: The incidence of fall in older adults aged 65 and over is estimated at 30%, and 50% of the people aged 80 and over with at least one fall a year. Falls are associated with significant morbidity and mortality.

The origin falls is often multifactorial, involving intrinsic and extrinsic factors. Few studies have investigated the association with all antidepressants. Potential adverse effects of antidepressants such as hyponatremia, sedation, orthostatic hypotension, extrapyramidal symptoms are known risk factors for falls. Due to multimorbidity, polypharmacy including interaction risks, and aging-related changes in pharmacokinetic and pharmacodynamic of drugs, antidepressants may further increase this risk in older patients.

Based on the World Health Organization global database, the main objective of this study is to investigate the association between antidepressants classes and the occurrence of falls reported in the database.

A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of falls.

A mediation analysis will also be performed. It will aim to examine some of the mediators involved in the association between antidepressants classes and falls.


Eligibility criteria: Inclusion Criteria:

* be over 65 years old
* take antidepressants
* have already presented falls

Exclusion Criteria:

-

Primary outcomes:
measure: Descriptive analysis of the studied population
timeFrame: 01/07/2022
measure: Analysis of the association between antidepressant classes and falls reporting, among subjects aged 65 or older
timeFrame: 01/07/2022
Secondary outcomes:
measure: Analysis by age group
timeFrame: 01/07/2022
measure: Analysis of the most frequent antidepressants
timeFrame: 01/07/2022
measure: Mediation analysis
timeFrame: 01/07/2022
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital, Department of Pharmacology
state: Normandie
Study officials:
References:
Clinical trial NCT00168467: The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
Official title: The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Lead sponsor: Baker Heart Research Institute
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One important clinical challenge in older individuals is maintaining mobility in the absence of pain. Peripheral arterial disease affects up to 12% of adults over 50 and impairs quality of life due to intermittent claudication causing pain and limiting mobility.

Conventional therapies have only modest effect in improving symptoms. The investigators hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial disease.


Eligibility criteria: Inclusion Criteria:

* Ankle-brachial index of \<0.9 at rest in at least one leg
* History of intermittent claudication (unilateral or bilateral) which was stable for 6 months
* Evidence of superficial femoral artery stenosis or occlusion on duplex scan
* Blood pressure \<=160/90 mmHg
* Stable medication regimen for at least 6 months and not previously treated with ACE inhibitors

Exclusion Criteria:

* Limiting coronary artery disease
* Renal Failure
* History of hypertension
* History of type 2 diabetes mellitus

Primary outcomes:
measure: Time to onset of claudication
measure: Total exercise time during a standard treadmill test
measure: Walking ability measured using the standard Walking Impairment Questionnaire
Secondary outcomes:
measure: Leg Blood Flow using Duplex Ultrasound
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Baker Heart Research Institute
name: Bronwyn A Kingwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahimastos AA, Lawler A, Reid CM, Blombery PA, Kingwell BA. Brief communication: ramipril markedly improves walking ability in patients with peripheral arterial disease: a randomized trial. Ann Intern Med. 2006 May 2;144(9):660-4. doi: 10.7326/0003-4819-144-9-200605020-00009.
Clinical trial NCT02027740: Almond Intervention in Type 2 Diabetes Mellitus
Official title: Effect of Almond Supplementation on Glycemic and Cardiovascular Risk Factors in Asian Indians in North India With Type 2 Diabetes Mellitus: A 24-week Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This prospective cohort study of an almond-enriched diet (within the overall context of Asian Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM almond-enriched balanced diet improves glycemic measures and CVD risk factors.


Eligibility criteria: Inclusion Criteria:

* Patients in the age range of 25-65 years
* on stable doses of metformin from past 3 months
* having HbA1C less than 9%
* LDL-c ≥100 mg/dl were recruited

Exclusion Criteria:

* Patients on insulin therapy, plioglitazone, insulin secretagogues, beta blockers or steroids or suffering from diabetes for more than 10 years
* having high uric acid levels (≥ 8 mg/dl),
* with accelerated hypertension (stage 2 hypertension according to JNC guidelines) , hypothyroidism, suffering from acute infection or any debilitating disease or with renal failure,
* appreciable weight loss (more than 10%) during past 6 months
* Patients with known food allergy, lipid altering medication or extraneous factors that can affect glycemic or lipid parameters

Primary outcomes:
measure: Change in LDL-c
timeFrame: baseline, after six months
Secondary outcomes:
measure: HbA1C
timeFrame: baseline, after six months of intervention
Other outcomes:
Locations:
city: Delhi
country: India
facility: Fortis Flt Lt Hospital
Study officials:
References: