louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02708329: T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)
Official title: Results of T-provisional and Mini Crush Stenting in Patients With Bifurcation Lesions After Chronic Coronary Arteries Occlusions Recanalization: A Prospective Randomized Single-center Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Coronary Atherosclerosis
Coronary Artery Disease
Coronary Artery Stenosis
Keywords: Coronary stenosis
Drug-eluting stent
Coronary angioplasty with stenting
Ischemic Heart Disease
Chronic total occlusion
Bifurcational lesion
Bifurcational stenting
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-03-15
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment.


Eligibility criteria: Inclusion Criteria:

* Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
* Bifurcation side branch diameter \>2 mm in CTO segment, verified by coronary angiography
* Successful CTO recanalization
* Signed, documented informed consent prior to admission to the study

Exclusion Criteria:

* Age \<18 years or \>75 years
* Left main artery bifurcation lesion
* Reocclusion CTOs
* Renal insufficiency (GFR/MDRD \<30 ml/min)
* Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
* Known non-adherence to double anti-platelet therapy (DAPT)
* LVEF \<30%
* Continuing bleeding
* Acute coronary syndrome (ST-elevation Myocardial infarction)
* Anamnesis of previous CABG
* Pregnancy

Primary outcomes:
measure: Target lesion failure
timeFrame: During 1 year after procedure
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: During 1 year after procedure
measure: Restenosis of main vessel/side branch
timeFrame: At 12-month follow-up
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References:
Clinical trial NCT02586129: Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
Official title: Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Type II Diabetes
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 249
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.

Detailed description: This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.

In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks.

In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks.

In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Subjects with Dyslipidemia and Type II Diabetes
* 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening
* BMI ≤ 45kg/m2
* Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit.
* 19 years later, men and women under the age of 75

Exclusion Criteria:

* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
* Subject with type I Diabetes
* Subject with hypertension which does not controlled by treatment(have blood pressure \> 160/110mmHg)
* Have a known allergy to drugs
* Have administered Cyclosporine
* Have administered Obesity treatment within 12 weeks prior to screening visit
* Participated in any other clinical trials within 30 days prior to the first administration
* Subject who is judged to be ineligible by investigator

Primary outcomes:
measure: Change in LDL Cholesterol
timeFrame: Change from baseline at 16 weeks
measure: Change in HbA1c
timeFrame: Change from baseline at 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul National Universitiy Bundang Hospital
state: Gyeonggi-Do
Study officials:
affiliation: Department of Internal Medicine, SNU Bundang Hospital
name: Hakcheol Jang, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00844129: Spinal Abnormalities in Neurofibromatosis Type 1 (NF1)
Official title: Spinal Abnormalities in Neurofibromatosis Type 1 (NF1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurofibromatosis Type 1
Keywords: neurofibromatosis type 1
spinal abnormalities
scoliosis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-02-13
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be recruited from a primary care clinic.

Brief summary: The purpose of this study is to determine the incidence and clinical history of neurofibromatosis type 1-related spinal abnormalities.

Detailed description: Neurofibromatosis type 1 (NF1) is a common genetic disorder that is associated with spinal abnormalities which are varied and may include scoliosis, neurofibromas, meningoceles, and vertebral defects. Skeletal abnormalities occur in more than one third of individuals with the disorder. These abnormalities are unpredictable and the pathogenesis, natural history, and clinical outcome remain relatively unclear.

The primary objective of this study is to determine the incidence and clinical history of NF1-related spinal abnormalities in children with NF1, over a 3-year period.

In the study, researchers will enroll children between ages 6 and 9 years who have been diagnosed with NF1 to look at changes in the spine. Participants in the study will be followed yearly for a total of 4 evaluations. Evaluations may include bone scans, spinal x-rays, magnetic resonance imaging (MRI), computed tomography (CT) scans, and urine samples.

Information gained from this study may lead to a better understanding of the causes of bone disease in NF1, and improved treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of NF1
* Age greater than 6 years at time of enrollment
* Age less than 9 year and 1 day at time of enrollment
* Tanner Stage not greater than 1

Exclusion Criteria:

* Prior surgical repair of spine
* Short-segment (4-6 vertebrae) curve with a Cobb angle of 45°or more
* Hormone replacement therapy
* Chronic steroid use
* Tibial pseudarthrosis
* Other chronic medical problems known to influence bone health (i.e. diabetes mellitus, cerebral palsy, etc.)

Primary outcomes:
measure: Scoliosis and it's progression
timeFrame: 4 years
Secondary outcomes:
measure: Differences in other bone health variables as measured by thoracic MRIs, Dexa (xray measuring bone density), pQCT (a cross sectional picture of the tibia), urine analysis, and scoli series (xrays to look for scoliosis).
timeFrame: 4 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University Health Care, 50 North Medical Drive
state: Utah
Study officials:
affiliation: Division of Medical Genetics, Department of Pediatrics, University of Utah
name: David Viskochil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03410329: Effect of Different Frequencies Weekly Training in Overweight/Obese Women
Official title: Comparison of the Effect of Different Frequencies Weekly Training on Body Composition, Cardiometabolic Risk Factors and Handgrip Strength in Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensitivity Training Groups
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to evaluate the effects of a resistance training programme of one or three times a week on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women

Detailed description: This study aimed to determine the effects of supervised structured 6 months resistance training and a restricted caloric diet on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women. 45 women were randomly assigned to one of two groups: a group with a high-weekly frequency of three times a week (HIGH) and a group that performed only one weekly session (LOW).HbA1c, percentage of fat mass and handgrip strength were taken before and after the intervention period.

Eligibility criteria: Inclusion Criteria:

overweight or obese

Exclusion Criteria:

-

Primary outcomes:
measure: Fat mass
timeFrame: 24 weeks
Secondary outcomes:
measure: Handgrip strength
timeFrame: 24 weeks
Other outcomes:
measure: HbA1c
timeFrame: 24 weeks
Locations:
Study officials:
References:
Clinical trial NCT00347529: Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
Official title: A Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza (Pandemic)
Keywords: DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
Lead sponsor: PowderMed
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu

Detailed description: Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28

Eligibility criteria: Inclusion Criteria:

Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent

-

Exclusion Criteria:

No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment

Primary outcomes:
measure: Safety, tolerability and local reactogenicity-AEs and laboratory parameters.
Secondary outcomes:
measure: Immunogenicity of the vaccine
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys Research Drug Unit, Quintiles Ltd.
Study officials:
affiliation: Guys Research Drug Unit, Quintiles UK Ltd.
name: Tim Mant, BSc, FRCP, FFPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566729: MRD in High-risk EBC
Official title: Application of Molecular Residual Disease in the Recurrence Monitoring and Response Predicting of High-risk Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: MRD
breast cancer
adjuvant therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
2. HER2-positive breast cancer, lymph node metastasis≥4;
3. Triple negative breast cancer, the number of lymph node metastases ≥ 1;

Brief summary: This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed
* Age ≥18 years old
* Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions:

  1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
  2. HER2-positive breast cancer, lymph node metastasis≥4;
  3. Triple negative breast cancer, the number of lymph node metastases ≥ 1;
* ECOG 0-1
* Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance

Exclusion Criteria:

* Confirmed distant metastases site
* History of other malignancy
* Psychopaths or other reasons unable to comply with treatment
* Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments
* HIV carrier or HBC/HCV infected
* Current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug

Primary outcomes:
measure: Relapse-free survival
timeFrame: 5 years after surgery
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years after surgery
measure: Lead time
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02879929: Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction
Official title: Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Nasal Polyps
Keywords: chronic nasal dysfunction
Quality of life
measurement
self-reporting questionnaire
development
validation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 759
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 were consecutively recruited in 16 centers in rhinology outpatient clinics all over France.

Brief summary: Nasal symptoms are the main elements that lead to a therapeutic decision and allow for evaluating treatment effects or natural evolution. Despite availability of several questionnaires with good measurement qualities, no systematic assessment takes into account the specific physical and psychosocial consequences of each of the six main nasal symptoms, independently of the disease. The study proposed to measure these symptoms with the use of a selfreport questionnaire and to test the validity of the questionnaire in a large representative sample of patients attending outpatient rhinologic clinics.

Detailed description: The study was conducted in two parts: (1) expert-based development and testing of the face validity of a questionnaire in French; and (2) validity testing, including construct validity by factor analysis, reproducibility by intraclass correlation coefficient (ICC) and Bland and Altman plots, and sensitivity to change by standardized response means, on a large sample of patients in a prospective multicenter study. DyNaChron, a questionnaire with 78 items divided into six domains and exploring both the physical and psychosocial repercussions of CND, was developed. In total, 759 patients completed the questionnaire at a first visit to a clinic, and 539 again 19.5 days later, on average.

Eligibility criteria: Inclusion Criteria:Patients had to

* be older than 18 years
* have nasal or sinus dysfunction for more than 3 months
* be able to understand and read theFrench language.

Exclusion Criteria:

* nasal or sinus tumor or Rendu-Osler disease,
* patients were under immediate post-operative care

Primary outcomes:
measure: Development of the DyNaChron questionnaire for chronic nasal dysfunction
timeFrame: 6 months
Secondary outcomes:
measure: Validation of the DyNaChron questionnaire for chronic nasal dysfunction
timeFrame: 10 months
Other outcomes:
Locations:
Study officials:
References:
citation: Kacha S, Guillemin F, Jankowski R. Development and validity of the DyNaChron questionnaire for chronic nasal dysfunction. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):143-53. doi: 10.1007/s00405-011-1690-z. Epub 2011 Jul 8.
Clinical trial NCT01971229: Gastric Emptying and Insulin Response to Test Drink
Official title: Assessment of Insulin Response Following Ingestion of a Carbohydrate/Whey Protein Drink. A Cross-over Randomized Double Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Surgery is a stress on the body and recovering well after surgery is very important to patients and their doctors. It is therefore important to prepare patient's bodies for the stress of surgery, and one way to do this is to provide proper nutrition. In the past, patients were asked to prepare for surgery by fasting from midnight before surgery. Today, it is known that this practice is not beneficial to patient's recovery. In fact, it has been recognized that drinking a sugary beverage (e.g., juice) before surgery stimulates the production of insulin, which is a hormone that helps make the proteins needed for wound healing after surgery. This is currently practiced at the MUHC. It might also be beneficial, however, to drink a beverage that contains sugar and whey proteins (a protein isolated from milk) before surgery. In fact, whey proteins stimulate insulin and may also have the added benefit of improving muscular strength. In this study, investigators will measure the level of insulin produced after drinking a carbohydrate (i.e., sugar)-whey protein beverage to determine how it compares to the level of insulin produced after drinking the sugary beverage used at the MUHC.

Detailed description: It is hypothesized that the increase in plasma insulin following a mixed carbohydrate whey protein drink is significantly greater than that elicited by a carbohydrate drink.

Eligibility criteria: Inclusion Criteria:

- Healthy volunteer

Exclusion Criteria:

* diabetes,
* neurological disorders
* chronic kidney failure
* chronic liver disease
* disorders of gastric motility
* gastro-esophageal reflux
* achalasia
* gastroparesis
* intestinal obstruction
* previous abdominal surgery
* lactose intolerance
* body mass index below 17 or above 29
* allergy to acetaminophen.

Primary outcomes:
measure: Insulin response to a test meal
timeFrame: Change over 3 hours
Secondary outcomes:
measure: Gastric emptying
timeFrame: Change over 3 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: Montreal General Hospital
name: Franco Carli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01530529: A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
Official title: A Phase 1, Cross-Over, Single-Dose, Open-Label Study to Estimate the Relative Bioavailability of a Modified-Release Formulation of PF-05180999 Under Fed and Fasted Conditions in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-05180999
safety
pharmacokinetics
relative bioavailability
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.


Eligibility criteria: Inclusion Criteria:

* Male or female of non-childbearing potential

Exclusion Criteria:

* Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: