louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00131404: A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)
Official title: A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-18
Enrollment: 2400
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: A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.


Eligibility criteria: Inclusion Criteria:

* Obese patients with a body mass index between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia, and sleep apnea

Exclusion Criteria:

* Patients with serious or unstable current or past medical conditions

Primary outcomes:
measure: Decreases body weight; safety and tolerability
timeFrame: 156 Weeks
Secondary outcomes:
measure: Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity
timeFrame: 156 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obes (Lond). 2010 May;34(5):919-35. doi: 10.1038/ijo.2010.21. Epub 2010 Feb 16.
Clinical trial NCT01064804: To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing
Official title: An Open Randomised 4-Way Crossover Single Dose And A Parallel Group Multiple Dose Comparative Pharmacokinetic Study Of The PF-04191834 Phase 2 Tablet And The Phase 1 Dispersion Formulations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young, healthy male volunteers

Brief summary: To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet compared with solution following single and multiple dosing.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of approximately 17.5 kg/m2 to 30.5 kg/m2 and a total body weight \> 50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects who have urinary LTE4 levels greater than or equal to 30 pg/mg Creatinine at screening following spot urinary collection for Cohort 2.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.

Primary outcomes:
measure: pharmacokinetic parameters of PF-04191834
timeFrame: hours
Secondary outcomes:
measure: maximum concentration
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00630604: Quantitative Ultrasonography (US) Evaluation on Femoral Condyle Cartilage
Official title: Quantitative Evaluation by Ultrasonography for Severity of Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: ultrasonography
knee
early degeneration
cartilage
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2008-03-07
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: patients with knee OA who were going to receive total knee arthroplasty

Brief summary: The purpose of this study is to investigate the feasibility of using quantitative ultrasonography (US) evaluation to determine the severity of osteoarthritic femoral condyle cartilage erosion.


Eligibility criteria: Inclusion Criteria:

* Patients with knee OA who were going to receive total knee arthroplasty

Exclusion Criteria:

* Patients with inflammatory arthritis (e.g. rheumatic arthritis) and infectious disease (e.g. hepatitis B)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MD
name: Chia-Ling Lee, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219804: Efficacy and Safety of Tetrabenazine in Chorea
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Huntington's Disease
Lead sponsor: Prestwick Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study was to establish the absolute reduction of chorea in participants with Huntington's disease(HD) treated with tetrabenazine or placebo


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* suffer from manifest HD as confirmed by genetic testing
* Meet chorea and total functional capacity scores on Unified Huntington's Disease Rating Scale
* Meet criteria on Hamilton Depression Rating Scale, Unified Parkinson's Disease Rating Scale dysphagia and dysarthria scale
* Independently ambulatory

Exclusion Criteria

* previous treatment with tetrabenazine
* unstable or serious medical or psychiatric illness
* concomitant use identified drugs
* untreated depression
* lack of caregiver

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Huntington's Study Group
name: Fred Marshall, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claassen DO, Carroll B, De Boer LM, Wu E, Ayyagari R, Gandhi S, Stamler D. Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease. J Clin Mov Disord. 2017 Mar 1;4:3. doi: 10.1186/s40734-017-0051-5. eCollection 2017.
citation: Frank S. Tetrabenazine as anti-chorea therapy in Huntington disease: an open-label continuation study. Huntington Study Group/TETRA-HD Investigators. BMC Neurol. 2009 Dec 18;9:62. doi: 10.1186/1471-2377-9-62.
Clinical trial NCT02112604: Predictors of Upper Airway Function and Sleep-disordered Breathing in the Critically Ill
Official title: Determining Predictors of Adequate Upper Airway Function in Ventilated Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Obstructive Sleep Apnea
Keywords: critically ill, OSA, mechanical ventilation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 50
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: Ventilated patients in the surgical intensive unit (SICU)

Brief summary: This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary objective of this study is to examine factors that are related to sleep-disordered breathing and upper airway patency in critically ill patients who have been recently mechanically ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given in the ICU prior to extubation and during the first night following extubation are associated with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during the night after extubation.

The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be predicted by standard pulmonary function testing in the ICU.


Eligibility criteria: Inclusion Criteria:

1. Patients admitted to the SICU
2. Age over 18 years.
3. Ventilated patients with an endotracheal tube for at least 24 hours.

Exclusion Criteria:

1. Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
2. Non-cooperative patient, CAM score positive for risk of delirium.
3. For women: pregnancy.

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: 1 Night after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthias Eikermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.
citation: Timm FP, Zaremba S, Grabitz SD, Farhan HN, Zaremba S, Siliski E, Shin CH, Muse S, Friedrich S, Mojica JE, Kurth T, Ramachandran SK, Eikermann M. Effects of Opioids Given to Facilitate Mechanical Ventilation on Sleep Apnea After Extubation in the Intensive Care Unit. Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx191.
Clinical trial NCT04425304: Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
Official title: The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes.

Two different group counseling methods (intensive and standard) with or without internet support will be compared. Thus, the patients will be randomized into four arms. Patients will be recruited from local general practice teams. The intensive lifestyle counseling consists of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling consists of 4 group sessions. The internet-based counseling contains aspects of cognitive behavior therapy and persuasive design system and consists of weekly reminders, tasks, self-monitoring, and reflection.

The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk and adiposity.


Eligibility criteria: Inclusion Criteria:

* Body mass index 30 to 40 kg/m2
* + 2 risk factors of cardiovascular diseases:

  * Elevated blood pressure or hypertension
  * High LDL or hypocholesterolemic drug
  * Low HDL or hypocholesterolemic drug
  * Elevated triglyceride value or hypolipidemic drug
  * Elevated glucose value or diabetes medication
  * Smoking
* Access to email and internet

Exclusion Criteria:

* Untreated hypothyroidism
* Oral corticosteroid treatment
* Pregnancy and lactation
* Angina pectoris
* Cardiac insufficiency
* Coronary Heart Disease
* Inability to speak Finnish
* Anticipated lack of compliance

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu, Oulu University Hospital
name: Janne Hukkanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06793904: Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS
Official title: Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovarian Syndrome (PCOS)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation \[glucose (mmol/L) × insulin (µU/L)\]/22.5 while homeostatic model assessment for insulin resistance 2 was calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations will be introduced as needed.


Eligibility criteria: Inclusion Criteria:

* Age 18-35 years
* duration of infertility 1-4 years
* PCOS

Exclusion Criteria:

women with other causes of infertility (tubal factor assessed by laparoscopy or hysterosalpingogram, uterine cavity abnormality assessed by ultrasound or hysteroscopy or male factor assessed by seme analysis),

* endometriosis,
* ovarian cysts,
* endocrinological abnormalities (Diabetes mellitus, hypothalamic, pituitary or thyroid disorders, or hyperprolactinemia),
* women with history of poor ovarian response or ovarian hyperstimulation
* women with chronic diseases, chromosomal, autoimmune or coagulation defects, abnormal leucocytic count or other inflammatory markers
* Women with contraindications to pregnancy.

Primary outcomes:
measure: Number of participants with successful ovulation
timeFrame: 5 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06007404: Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Official title: The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Insulin Resistance
Obesity
Metabolic Disease
PreDiabetes
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-08-23
Enrollment: 175
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants may be recruited from a variety of sites including University of Michigan clinical sites, non-University of Michigan clinical sites, local communities and schools throughout Southeast Michigan, and the University of Michigan campus.

Brief summary: This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Between 14 and 18 years of age
* Tanner stage 4 or 5 (mature adult stage of puberty)
* Normal weight (BMI ≥ 5th percentile \& \< 85th percentile), overweight (BMI \> 86th percentile) \& \< 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c \> 5.7%)
* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes

Exclusion Criteria:

* Currently pregnant
* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management
* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff
* Allergies or intolerance to milk, soy, or palm oil

Primary outcomes:
measure: Glucose (OGTT)
timeFrame: 120 minutes
measure: Insulin (OGTT)
timeFrame: 120 minutes
measure: Glucose (MMTT)
timeFrame: 180 minutes
measure: Insulin (MMTT)
timeFrame: 180 minutes
measure: Monocyte /macrophage populations by flow cytometry
timeFrame: 180 minutes
Secondary outcomes:
measure: Free fatty acids (MMTT)
timeFrame: 180 minutes
measure: Triglycerides (MMTT)
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kanakadurga Singer, MA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00612404: Symptoms and Endoscopic Results in Consideration of Pretreatment
Official title: Symptoms and Endoscopic Results in Consideration of Pretreatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Keywords: gastrointestinal disorder
endoscopy
patient with gastrointestinal disorders for whom an endoscopy is performed and who is treated with esomeprazole afterwards.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 16255
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: gastroenterologists; specialists

Brief summary: Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. gastroenterologists) are asked to document relevant data in patients with gastrointestinal disorders.


Eligibility criteria: Inclusion Criteria:

* patients with gastrointestinal disorders who need an endoscopy.

Exclusion Criteria:

* limitiations; possible risks; warnings; contraindications mentioned in the SPC.

Primary outcomes:
measure: to gain insight into the relationship between subjective gastrointestinal symptoms and findings of a laryngopharyngeal-esophagogastric endoscopy with respect to the medicinal pre-therapy;
Secondary outcomes:
measure: to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings.
Other outcomes:
Locations:
Study officials:
affiliation: Medical Department AstraZeneca Germany
name: Kai Richter, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02921204: Dietary Intake and Vitamin D Level in Adult Women
Official title: Study is to Assess the Effect of Dietary Intake of Nutrients and Level of Vitamin D in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deficiency of Vitamin D3
Keywords: Vitamin D
Calcium
Phytic Acid
body weight
Lead sponsor: Princess Nourah Bint Abdulrahman University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2016-10-03
Enrollment: 168
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre and post-menopausal women 35-55 years of age who were able to provide a 24 hour dietary record.

Brief summary: Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia. Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are thought to be at greater risk for vitamin D deficiency because of their darker skin type and the likelihood of reduced ultraviolet exposure . The present study entitled, "Dietary Intake and Vitamin D Level in adult Women," was formulated as there is paucity of data on the etiologic importance of dietary intake in Vitamin D level on blood on women. The major objective of the proposed study is to assess the effect of dietary intake of nutrients and level of vitamin D in women .

Detailed description: For this study, the investigators enrolled 168 women 35-55 years old to evaluate Vitamin D status and to determined whether status was correlated with Vitamin D deficiency.

All women completed a self-administered questionnaire about personal socio-demographic characteristics; They all had anthropometric measurements of body mass index and waist circumference. A 24-hour dietary recall was administered to all women.

The proximate analysis of 25 types of food was conducted according to the American Association of Organic Chemists (AOAC) methods. The following parameters were measured: serum calcium. Vitamin D, levels of parathyroid hormone.

Eligibility criteria: Inclusion Criteria:

* Women 35- 55 years old,
* Women who spoke Arabic language fluently, and
* Women who were willing to fill a 24-hour questionnaire and provide a serum sample for measurements.

Exclusion Criteria:

* Women \< 35 years old or \> 55 years old.

Primary outcomes:
measure: Vitamin D serum levels
timeFrame: 1 year
Secondary outcomes:
measure: Calcium serum levels
timeFrame: 1 year
measure: Vitamin D and Calcium Intake
timeFrame: 1 year
Other outcomes:
measure: Exposure to sun
timeFrame: 1 year
Locations:
Study officials:
affiliation: Princess Nourah Bint Abdulrahman University
name: Amani Aljajani, PhD
role: STUDY_CHAIR
References: