louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00990821: A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
Official title: A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy-Induced Nausea and Vomiting
Postoperative Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or 115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.


Eligibility criteria: Inclusion Criteria:

* Subject is neither grossly overweight nor underweight for his/her height and body build
* Subject is in good health -Subject is a nonsmoker
* Subject is willing to avoid excessive alcohol consumption for the duration of the study
* Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
* Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study

Exclusion Criteria:

* Subject has a history of multiple and/or severe allergies to drugs or food
* Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
* Subject has an infection, including Human immunodeficiency virus (HIV) infection
* Subject is a regular user of any illicit drug
* Subject consumes excessive amounts of alcohol
* Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages
* Subject currently uses on a regular basis, any prescription or non prescription medications

Primary outcomes:
measure: Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V
timeFrame: Up to 72 Hours Post Dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03984721: Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing
Official title: Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloidosis
Keywords: Mass spectrometry based proteomic analysis
NanoLC-MS/MS
Amyloidosis typing
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2019-06-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in \> 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling
* Immunolabeling Amyloidosis typing

  1. impossible (no frozen sample available)
  2. or inconclusive (doubtful)
  3. or inconsistent with clinical, biological, genetic and iconographic data
* Signature of the informed consent form

Exclusion Criteria:

* Insufficient tissue material to perform the new technique
* Person placed under judicial protection
* Pregnant and breastfeeding women

Primary outcomes:
measure: Amyloidosis typing
timeFrame: Day 0
Secondary outcomes:
measure: Time to return the result
timeFrame: Day 0
measure: Concordance
timeFrame: Day 0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University hospital of Toulouse
Study officials:
affiliation: CHU Rangueil
name: Dominique CHAUVEAU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vrana JA, Gamez JD, Madden BJ, Theis JD, Bergen HR 3rd, Dogan A. Classification of amyloidosis by laser microdissection and mass spectrometry-based proteomic analysis in clinical biopsy specimens. Blood. 2009 Dec 3;114(24):4957-9. doi: 10.1182/blood-2009-07-230722. Epub 2009 Oct 1.
citation: Theis JD, Dasari S, Vrana JA, Kurtin PJ, Dogan A. Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis. J Mass Spectrom. 2013 Oct;48(10):1067-77. doi: 10.1002/jms.3264.
Clinical trial NCT00569621: A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Official title: A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-12-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: It is known that several common eye diseases are associated with ocular perfusion abnormalities. Moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities because of its direct vasodilatory effects. The present study seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after intravenous administration.


Eligibility criteria: Inclusion Criteria:

* 6 healthy volunteers of either sex
* Age 18-35 yrs.
* Body mass index between 15th and 85th percentile, nonsmokers

Exclusion Criteria:

* Regular use of medication
* Abuse of alcoholic beverages or drugs
* Participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Ametropy less 3 dpt
* Acute gastric bleeding, massive cerebral hemorrhage related to stroke
* Women: pregnancy or lactation.

Primary outcomes:
measure: Retinal and Choroidal Blood flow
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Department of Clinical Pharmacology
name: Michael Wolzt, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04581421: The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
Official title: The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Overweight and Obesity
Metabolic Syndrome
Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Danish Research Centre for Magnetic Resonance
First posted: 2020-10-09
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized diet intervention study in a cross over design
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.

Detailed description: Overweight but otherwise healthy men will be included in the study which is a randomized diet intervention study in a cross over design.

The study involves 2 intervention periods of 5 days each, during which the participant ingests two different types of experimental diet. Participants will in randomized order (determined by block randomization) ingest a diet with low carbohydrate and high fat content, and a diet with high carbohydrate and low fat content.

Eligibility criteria: Inclusion Criteria:

* Healthy men being 18-50 years old.
* Overweight (BMI 25-35)
* Low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise.
* Non-smokers
* No use of medicine

Exclusion Criteria:

* Fasting blood glucose indicating overt diabetes (≥7 mmol/l)
* HbA1C \>48 mmol/mol
* Fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l)
* FIB-4 score \>1.45
* Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.

Primary outcomes:
measure: Liverfat
timeFrame: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
Secondary outcomes:
measure: Glycogen
timeFrame: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
measure: fasting hepatic glucose output
timeFrame: (Day 0 and Day 6 of the diet intervention)
measure: fasting blood triacylglycerol concentration
timeFrame: (Day 0 and Day 6 of the diet intervention)
measure: Insulin clearance determined during steady state insulin infusion
timeFrame: (Day 0 and Day 6 of the diet intervention)
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Amalie London
Study officials:
References:
Clinical trial NCT03547921: Primary Upper Limb Deep Vein Thrombosis. Is First Rib Resection Necessary?
Official title: Primary Upper Limb Deep Vein Thrombosis. Is First Rib Resection Necessary?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paget Schroetter Syndrome
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-06-06
Enrollment: 20
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: patients who were previously treated for upper extremity DVT ( anticoagulation- with or without 1st rib resection)

Brief summary: The purpose of the study is to compare outcome of patients with effort thrombosis who were treated operatively to those treated nonoperatively


Eligibility criteria: Inclusion Criteria:\\

\* patients treated for upper extremity DVT

Exclusion Criteria:

* none

Primary outcomes:
measure: clinical differences
timeFrame: 10years
Secondary outcomes:
measure: vein patency
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02955121: IU Health Krannert Personalized Medicine Study
Official title: IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Cytochrome P-450 CYP2C19
Pharmacogenetics
Platelet Aggregation Inhibitors
Percutaneous Coronary Intervention
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).

Detailed description: The study will randomize patients who have completed PCI and who are prescribed dual antiplatelet therapy to a genotype guided arm, in which CYP2C19 pharmacogenetic testing will be performed and a standard therapy arm without genetic testing. The study will examine the impact of pharmacogenetic testing on physician medication choice and clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with ischemic heart disease, who are prescribed dual antiplatelet therapy after percutaneous coronary intervention (PCI). Enrollment has to occur during index hospitalization or during outpatient visit for cath lab procedure.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Unwilling or unable, in the opinion of the investigator, to comply with instructions on prescribed medicines.
* Prior known allergy or intolerance to clopidogrel.

Primary outcomes:
measure: Change in prescription of antiplatelet therapy
timeFrame: one year
Secondary outcomes:
measure: Death, Myocardial Infarction, Stroke
timeFrame: one year
measure: Stent Thrombosis
timeFrame: one year
measure: Urgent target vessel revascularization
timeFrame: one year
measure: Major and Minor Bleeding
timeFrame: one year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Rolf Kreutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893321: Comparison of Inferior Oblique Muscle Recession and Myectomy
Official title: Comparison of Inferior Oblique Muscle Recession and Myectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Inferior Oblique Muscle Overactivity
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare muscle recession and myectomy on inferior oblique muscle overactivity.


Eligibility criteria: Inclusion Criteria:

* Overactivity of Inferior Oblique Muscle \>= 2

Exclusion Criteria:

* Nystagmus
* History of vertical muscle operation
* Mechanical limitation
* Eye disease
* Paralysis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05494021: China Lung Cancer Screening (CLUS) Study Version 3.0
Official title: Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 100000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take LDCT screening (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.


Eligibility criteria: Inclusion Criteria:

* Eligible participants were those aged 45-75 years, and with either of the following risk factors:

  1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  2. malignant tumors history in immediate family members;
  3. personal cancer history;
  4. professional exposure to carcinogens;
  5. long term exposure to second-hand smoke;
  6. long term exposure to cooking oil fumes.

Exclusion Criteria:

* Had a CT scan of chest within last 12 months
* History of any cancer within 5 years

Primary outcomes:
measure: The mortality rate of lung cancer
timeFrame: 5 years
measure: The attendance rate of high-risk individuals
timeFrame: 5 years
measure: The adherence rate of high-risk individuals
timeFrame: 5 years
Secondary outcomes:
measure: The mortality of all-cause
timeFrame: 5 years
measure: The detection rate of lung nodules
timeFrame: 5 years
measure: The incidence rate lung cancer
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00024921: The Genetics of Kidneys in Diabetes (GoKinD) Study
Official title: The Genetics of Kidneys in Diabetes (GoKinD) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Nephropathy
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2001-10-10
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Kidney disease in diabetes (diabetic nephropathy) tends to run in families. It is likely, therefore, that there are genes that predict or are associated with either getting or not getting diabetic nephropathy. The GoKinD Study will provide clinical information and DNA for investigators to look for these genes. Evaluation will be performed and DNA obtained from approximately 1100 diabetic persons with kidney disease and 1000 diabetic persons without kidney disease. In some cases, samples for DNA will also be obtained from the parents of these subjects. Clinical information and DNA will be coded so that individuals cannot be identified, but the DNA can be linked to the clinical data from the individual. Multiple investigators will be able to use this genetic material to test hypotheses about the genetics of kidney disease in diabetes.


Eligibility criteria: Inclusion criteria:

Type 1 diabetes mellitus with or without diabetic nephropathy; 19-54 years old; no other kidney disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT02285621: Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Keywords: Scoliosis
Spine deformity
Brace
3D
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application


Eligibility criteria: Inclusion Criteria:

* 10 years or older
* AIS diagnosis
* Risser 0-2
* Primary curve angles 20 degrees - 40 degrees
* If female, either premenarchal or less than 18 months postmenarchal.

Exclusion Criteria:

* Patients with a pre-existing cardiovascular condition
* Patients with symptom of a neurological disorder
* Patients with any other disorder of the musculoskeletal system affecting the lower limbs,

Primary outcomes:
measure: Change in Cobb angle
timeFrame: Baseline, 6 months, 1 year
Secondary outcomes:
measure: Change in Scoliosis Research Society questionnaire (SRS-22r) scores
timeFrame: Baseline, 6 months, 1 year
measure: Change in surface topography
timeFrame: Baseline, 6 months, 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Hubert Labelle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cobetto N, Aubin CE, Parent S, Barchi S, Turgeon I, Labelle H. 3D correction of AIS in braces designed using CAD/CAM and FEM: a randomized controlled trial. Scoliosis Spinal Disord. 2017 Jul 23;12:24. doi: 10.1186/s13013-017-0128-9. eCollection 2017.
citation: Cobetto N, Aubin CE, Parent S, Clin J, Barchi S, Turgeon I, Labelle H. Effectiveness of braces designed using computer-aided design and manufacturing (CAD/CAM) and finite element simulation compared to CAD/CAM only for the conservative treatment of adolescent idiopathic scoliosis: a prospective randomized controlled trial. Eur Spine J. 2016 Oct;25(10):3056-3064. doi: 10.1007/s00586-016-4434-3. Epub 2016 Feb 9.