louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03049085: Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Official title: Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Aspirin
Keywords: OPCAB
ASA
Aspirin
Lead sponsor: Medinet Heart Centre
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.


Eligibility criteria: Inclusion Criteria:

* Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB)
* Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB

Exclusion Criteria:

* Patients undergoing on-pump coronary artery bypass grafting
* Patients in whom antiplatelet therapy was not stopped 5-7 days prior to OPCAB
* Intraoperative conversion to on-pump coronary artery bypass grafting
* Patients with inherited blood-clotting disorders
* Patients undergoing other cardiac operations

Primary outcomes:
measure: Myocardial Injury
timeFrame: 6 hours following OPCAB
measure: Myocardial Injury
timeFrame: 12 hours following OPCAB
measure: Myocardial Injury
timeFrame: 24 hours following OPCAB
measure: Myocardial Injury
timeFrame: 72 hours following OPCAB
measure: Inflammation
timeFrame: 6 hours following OPCAB
measure: Inflammation
timeFrame: 12 hours following OPCAB
measure: Inflammation
timeFrame: 24 hours following OPCAB
measure: Inflammation
timeFrame: 72 hours following OPCAB
measure: Kidney Injury
timeFrame: 6 hours following OPCAB
measure: Kidney Injury
timeFrame: 12 hours following OPCAB
measure: Kidney Injury
timeFrame: 24 hours following OPCAB
measure: Kidney Injury
timeFrame: 72 hours following OPCAB
measure: All-cause mortality or MACE up to 30 days after surgery
timeFrame: 30 days after surgery
measure: Myocardial Injury
timeFrame: 6 hours following OPCAB
measure: Myocardial Injury
timeFrame: 12 hours following OPCAB
measure: Myocardial Injury
timeFrame: 24 hours following OPCAB
measure: Myocardial Injury
timeFrame: 72 hours following OPCAB
Secondary outcomes:
measure: Postoperative drainage (ml)
timeFrame: 12 hours and 24 hours following OPCAB
measure: Bleeding complication
timeFrame: < 30 days following OPCAB
measure: Blood transfusions (units)
timeFrame: < 30 days following OPCAB
Other outcomes:
Locations:
city: Nowa Sol
country: Poland
facility: Medinet Heart Centre
state: Lubuskie
Study officials:
References:
Clinical trial NCT02826785: Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease
Official title: Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates the feasibility of a cognitive strategy training intervention for people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire study duration per participant = 8 weeks). We will measure participant responsiveness and the overall efficiency of the intervention process.

Detailed description: Cognitive impairment is common in Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Existing rehabilitative interventions, which focus on cognitive process training, have not been successful in mitigating its negative functional consequences. We have developed a client-centered cognitive strategy training intervention to enable people with PD to work around their cognitive deficits and maintain their functional performance. This study is an exploratory case series to assess aspects of its feasibility. Specifically, we will assess participant responsiveness to the intervention (acceptance, engagement, adherence), and we will track logistical information (e.g., scheduling). We will also administer an exploratory outcome measure of treatment effect to gain preliminary evidence on the effect of the intervention on self-identified cognitive performance problems. This information will guide modifications and enhancements in preparation for future clinical trials.

Eligibility criteria: Inclusion Criteria:

* Males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn \& Yahr stage I-III (mild to moderate disease; Hoehn \& Yahr, 1967) and are treated with levodopa/carbidopa. For this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it.

Exclusion Criteria:

* Possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., STN DBS), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-English speaking). Participants taking benzos will be excluded.

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Erin R Foster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04176185: A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber
Official title: A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Allergic Rhinoconjunctivitis
Keywords: House Dust Mite
Allergic rhinitis
Allergic conjunctivitis
China
Environmental exposure chamber
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

Detailed description: This trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase III trial. Approximately 202 subjects will be randomised (1:1) to receive treatment with HDM SLIT-tablet or placebo. The trial will be conducted in China, with subjects recruited and treated in China. Two EEC assessments (baseline and end of treatment) will take place at a validated EEC facility in Austria.

The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet (12 SQ-HDM) once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24.

Eligibility criteria: Inclusion criteria

* Male or female Chinese subjects aged ≥18 years
* A clinical history of HDM AR/C with or without asthma
* Positive SPT and IgE to Der p or Der f at screening
* A TNSS of at least 6 of 12 within the first 2 hours of the screening EEC session prior to randomisation

Exclusion criteria

* Sensitised and regularly exposed perennial or seasonal allergens
* Asthma requiring treatment with high-dose ICS
* Reduced lung function
* Has a nasal condition that could confound the efficacy or safety assessment
* A relevant history of systemic allergic reaction

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: Last 4 hours of the EEC session at week 24
Secondary outcomes:
measure: Total Symptom Score (TSS)
timeFrame: Last 4 hours of the EEC session at week 24
Other outcomes:
measure: Frequency of adverse events
timeFrame: 26 weeks
measure: Assessment of lung function
timeFrame: 26 weeks
measure: Total Ocular Symptom Score (TOSS)
timeFrame: Last 4 hours of the EEC session at week 24
measure: Immunology
timeFrame: Baseline to 24 weeks
Locations:
city: Vienna
country: Austria
facility: Vienna Challenge Chamber
city: Beijing
country: China
facility: Tongren Hospital
Study officials:
affiliation: Beijing Tongren Hospital
name: Luo Zhang, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01447485: Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
Official title: A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Chronic Kidney Disease
Nephrotic Syndrome
Keywords: Hypertension, chronic kidney disease
nephrotic syndrome
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.


Eligibility criteria: Inclusion Criteria:

* Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome

Exclusion Criteria:

* GFR \< 30 mL/min/1.73 m2
* Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
* Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: AUC of valsartan in plasma
timeFrame: Up to 24 hours post-dose
measure: Cmax of valsartan in plasma
timeFrame: Up to 24 hours post-dose
measure: Tmax of valsartan in plasma
timeFrame: Up to 24 hours post-dose
measure: T1/2 of valsartan in plasma
timeFrame: Up to 24 hours post-dose
measure: CL/F of valsartan in plasma
timeFrame: Up to 24 hours post-dose
Secondary outcomes:
measure: ECG evaluations
timeFrame: 24 hours post-dose
measure: Standard clinical laboratory evaluations
timeFrame: 24 hours post-dose
measure: Vital signs
timeFrame: 2, 4, and 24 hours post-dose
measure: Physical examination
timeFrame: 24 hours post-dose
measure: Number and severity of adverse events
timeFrame: Up to 24 hours post-dose
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05740085: Osteoporosis Awareness in Rheumatoid Arthritis Patients
Official title: Knowledge and Awareness of Osteoporosis in Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Rheumatoid Arthritis
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 90 years with a diagnosis of rheumatoid arthritis who gave consent to participate in the study.

Brief summary: Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Rheumatoid arthritis patients are at increased risk for developing osteoporosis. It is crucial to identify whether rheumatoid arthritis patients know and know about this disease. This study investigates awareness and knowledge of osteoporosis in rheumatoid arthritis patients.

Detailed description: Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with rheumatoid arthritis are at high risk of developing osteoporosis due to chronic inflammation and the medications they use. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with rheumatoid arthritis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis
* Must be between the ages of 18 and 90
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent

Primary outcomes:
measure: Level of knowledge in osteoporosis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Üsküdar State Hospital
state: Üsküdar
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02358785: Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy
Official title: Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2015-02-09
Enrollment: 100
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: Individuals scheduled for laparoscopic sleeve gastrectomy

Brief summary: This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.


Eligibility criteria: Inclusion Criteria:

* Scheduled for laparoscopic sleeve gastrectomy;
* Subject meets NIH weight loss surgical criteria;
* BMI ≤ 60 kg/m2;
* Willing to give consent and comply with study-related evaluations; and
* At least 18 years of age

Exclusion Criteria:

* Previous bariatric procedures, including gastric banding;
* Prior gastric surgery;
* Scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy allowed);
* Pregnancy;
* Known or suspected uncontrolled bleeding disorders;
* History of chronic steroid use;
* Patients who have undergone significant upper GI surgery leading to adhesion; formation, as determined by the Principal Investigator;
* Physical or psychological condition which would impair study participation;
* The patient is judged unsuitable for study participation by the Investigator for any other reason; or
* Unable or unwilling to attend follow-up visits and examinations.

Primary outcomes:
measure: Surgical interventions (type, quantity, frequency, rationale) required during LSG
timeFrame: Intraoperative
Secondary outcomes:
measure: Procedure duration
timeFrame: Up to one day
measure: Length of stay
timeFrame: Up to 4 weeks
measure: Estimated blood loss
timeFrame: up to one day
Other outcomes:
Locations:
city: Metairie
country: United States
facility: Surgical Specialists of Louisiana
state: Louisiana
city: Charlotte
country: United States
facility: Carolinas Weight Management
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Adolfo Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177085: Substituting Mushrooms for Meat to Control Body Weight
Official title: Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
weight
weight-loss
mushroom
oxidative
stress
immune
function
inflammation
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Mushroom Council
First posted: 2010-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical parameters following a weight-control diet using either standard food guide pyramid alone, or standard food guide pyramid with substitution of mushrooms for meat.

Detailed description: This intervention study has a primary aim to assess omnivorous adult males and females' ability to control their weight over a period of 1 year. The control group will be required to use 90% lean ground beef a few times per week for one year while maintaining their personalized diet plans. The experimental group will have to follow their personalized diets as well, but will be required to substitute mushrooms for meat at least three times per week. Biochemical measures will also be assessed in response to the diet and weight loss.

Eligibility criteria: Inclusion Criteria:

* Male, female, \>=18 years old
* Omnivorous
* BMI 25-40
* Seeking weight-loss

Exclusion Criteria:

* \<18 years old
* Vegetarians
* Dislike mushroom
* Chronic disease
* HIV+
* Rheumatoid arthritis
* Pregnant or nursing child
* Must not self-report allergies to mushrooms

Primary outcomes:
measure: Weight-control efficacy
timeFrame: 1 year
measure: Weight-loss efficacy
timeFrame: 6 months
Secondary outcomes:
measure: Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence J Cheskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheskin LJ, Davis LM, Lipsky LM, Mitola AH, Lycan T, Mitchell V, Mickle B, Adkins E. Lack of energy compensation over 4 days when white button mushrooms are substituted for beef. Appetite. 2008 Jul;51(1):50-7. doi: 10.1016/j.appet.2007.11.007. Epub 2007 Dec 3.
Clinical trial NCT02070185: Effect of Energy Density on Liking and on Caloric Adjustment Conditioning
Official title: Effect of Energy Density on Liking and on Caloric Adjustment Conditioning After Sweet Beverage Exposure in Children Aged 8-11 y
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditioning of Caloric Adjustment and Liking in Children
Keywords: caloric adjustment,liking, flavour nutrient learning, children
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
Collaborators: name: European Community
name: Regional Council of Burgundy
First posted: 2014-02-25
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective is to study, in 8-11 year old children, the influence of energy density conditioning on liking for new flavored beverages and on caloric adjustment after the beverage consumption. The stability of the energy conditioning was evaluated after a period without exposure and after an extinction period during which the energy density of the beverages was changed.


Eligibility criteria: Inclusion Criteria:

* regularly ate at the school canteen
* returned signed consent from parents

Exclusion Criteria:

* present health problems, food restrictions or food allergies

Primary outcomes:
measure: Flavored beverages liking and preference before the conditioning period (T0)
timeFrame: Baseline
Secondary outcomes:
measure: Energy adjustment before the conditioning period (T0)
timeFrame: Baseline
Other outcomes:
measure: Energy adjustment after the conditioning period (T1)
timeFrame: T0 + 4 weeks
measure: Flavored beverages liking and preference after the conditioning period (T1)
timeFrame: T0 + 4 weeks
measure: Flavored beverages liking and preference after 3 weeks without exposure (T2)
timeFrame: T1 + 3 weeks
measure: Flavored beverages liking and preference before the extinction period (T3)
timeFrame: T2 +1 week
measure: Energy adjustment before an extinction period (T3)
timeFrame: T2 + 1 week
measure: Energy adjustment after 3 weeks without exposure (T2)
timeFrame: T1 + 3 weeks
measure: Energy adjustment after the extinction period (T4)
timeFrame: T3 + 4 weeks
measure: Flavored beverages liking and preference before the extinction period (T4)
timeFrame: T3 + 4 weeks
Locations:
city: Dijon
country: France
facility: Centre des Sciences du Goût et de l'Alimentation
state: Bourgogne
Study officials:
References:
citation: Remy E, Divert C, Rousselot J, Brondel L, Issanchou S, Nicklaus S. Impact of energy density on liking for sweet beverages and caloric-adjustment conditioning in children. Am J Clin Nutr. 2014 Oct;100(4):1052-8. doi: 10.3945/ajcn.114.087452. Epub 2014 Aug 13.