louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00659581: J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation
Official title: Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 21471
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese hypertension patients

Brief summary: The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following:

1. Adverse events and adverse drug reactions under long-term use
2. Blood pressure measurements during the survey period
3. Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
4. Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events


Eligibility criteria: Inclusion criteria:

Hypertension patients unadministered Micardis.

Exclusion criteria:

1. Patients with a history of hypersensitivity to any ingredient of this product.
2. Pregnant woman or possibly pregnant woman
3. Patients with extremely poor bile secretion or patients with serious hepatic disorder

Primary outcomes:
measure: Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events
timeFrame: 3 years after initiation of treatment
Secondary outcomes:
measure: Change From Baseline in Systolic Blood Pressure at 6 Months
timeFrame: initiation and 6 months
measure: Change From Baseline in Diastolic Blood Pressure at 6 Months
timeFrame: initiation and 6 months
measure: Change From Baseline in Systolic Blood Pressure at 12 Months
timeFrame: initiation and 12 months
measure: Change From Baseline in Diastolic Blood Pressure at 12 Months
timeFrame: initiation and 12 months
measure: Change From Baseline in Systolic Blood Pressure at 24 Months
timeFrame: initiation and 24 months
measure: Change From Baseline in Diastolic Blood Pressure at 24 Months
timeFrame: initiation and 24 months
measure: Change From Baseline in Systolic Blood Pressure at 36 Months
timeFrame: initiation and 36 months
measure: Change From Baseline in Diastolic Blood Pressure at 36 Months
timeFrame: initiation and 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03003481: Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Paravalvular Leaks (PVL)
Aortic Paravalvular Leaks (PVL)
Lead sponsor: Occlutech International AB
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aortic or mitral PVL

Brief summary: Collect patient data and to monitor the clinical use (safety and efficacy) of the device


Eligibility criteria: Inclusion criteria:

- Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure

Exclusion criteria

The device is contraindicated for patients known to have any of the following:

* Known coagulation dysfunction
* Leak reversal with separate or significant residual or recurrent leak
* Acute infection
* Known intra-cardiac thrombi
* Recent pelvic venous thrombosis
* Recent myocardial infarction or a surgical bypass operation in the last 30 days
* If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally
* Intolerance of contrast agent

Primary outcomes:
measure: Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.
timeFrame: 6 month following implantation
measure: Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.
timeFrame: 6 month following implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Cardiovascular Department
Study officials:
References:
Clinical trial NCT02882581: Metformin in Breast Cancer, Visualized With Positron Emission Tomography
Official title: Metformin in Breast Cancer, Visualized With Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Metformin
Pharmacokinetics
Organic cation transporter
Multidrug and toxin extrusion
Pharmacogenetics
positron emission tomography
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 11C-metformin uptake in breast cancer. Single center, single dose, open-label.
Primary purpose: OTHER

Brief summary: The general purpose of the trial is to investigate whether metformin is taken up into the breast tumor. Studies in the last few years have shown an effect of metformin on cell proliferation on breast cancer. It is though unclear whether the effect on tumor is direct, indirect or a combination of the two. The investigators plan to:

* investigate if metformin is taken up in breast cancer using our novel 11C-metformin tracer and positron emission tomography (PET)
* investigate whether the uptake is correlated to the amounts of organic cation transporters (OCT1-3, MATE 1 \&2 and PMAT) using quantitive polymerase chain reaction (qPCR).


Eligibility criteria: Inclusion Criteria:

* over 50 years
* C. mammae
* Tumor size: \> 10 mm in diameter
* Unilateral cancer
* WHO performance status 0-1

Exclusion Criteria:

* Severe heart- or kidney failure
* Pregnant or breast feeding
* If the patient is found not eligible for participation in the study på principal investigator

Primary outcomes:
measure: Metformin uptake in breast cancer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Nuclear Medicine & PET-center, Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Department of Surgery, Aarhus University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology, Aarhus University Hospital
name: Niels Jessen, Prof,MD,PhD
role: STUDY_DIRECTOR
affiliation: Department of Clinical Medicine, Aarhus University Hospital
name: Elias IO Sundelin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04359381: Kinesiotaping Versus Pilate Exercises
Official title: Kinesiotaping Versus Pilate Exercises on Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea
Exercise
Keywords: kinesiotaping
pilate exercises
primary dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Amira Hassan Abdelaziz
name: Soheir Mahmoud El-Kosery
First posted: 2020-04-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups.

Detailed description: Group (A) (30 girls) treated by kinesiotaping during menstruation for 3 successive menstruation. Group (B) (30 girls) treated by pilate exercises, 3 sessions per week for 3 months except the days of menstruation. Visual analogue scale to assess pain intensity, Quality of life enjoyment and satisfaction questionnaire, Menstrual Distress Questionnaire, WALIDD score, Spielberger questionnaire and blood sample analysis to estimate plasma prostaglandin level were applied for each girl in both groups before and after the treatment course.

Eligibility criteria: Inclusion Criteria:

* Their ages ranged from 14 to 20 years old
* their body mass index (BMI) would be less than 25 Kg/m2
* having primary dysmenorrhoea

Exclusion Criteria:

* skin diseases or cardiac diseases
* irregular or infrequent menstrual cycles
* previous abdominal or back operations

Primary outcomes:
measure: Weight and height scale
timeFrame: three months
Secondary outcomes:
measure: Visual analog scale
timeFrame: three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ghada Elrefaye
Study officials:
affiliation: Assistant Professor of Physical Therapy for Woman's Health, Cairo University
name: ghada eb elrefaye, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00404781: Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention
Official title: Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Heart Disease
Acute Coronary Syndromes
Keywords: ischemic heart disease
acute coronary syndromes
percutaneous transluminal coronary angioplasty
platelet function
aspirin
clopidogrel
cilostazol
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2006-11-29
Enrollment: 305
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.


Eligibility criteria: Inclusion Criteria:

* non-ST-segment elevated acute coronary syndromes
* patients undergoing selective or emergent PCI

Exclusion Criteria:

* administration of clopidogrel or ticlopidine within 2 weeks
* ST-segment elevated myocardial infarction
* contraindications of antiplatelet therapy
* history of intracranial bleeding
* known bleeding disorders
* severe liver or kidney disease

Primary outcomes:
measure: Major adverse cardiac and cerebral events at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Hemorrhage events at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Northern Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06185881: Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)
Official title: Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations Versus Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Caries
Keywords: fiber reinforced glass ionomer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: split mouth
Primary purpose: TREATMENT

Brief summary: This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.


Eligibility criteria: Inclusion Criteria:

* Patients with untreated cervical carious lesions
* Patients with normal occlusion
* Vital teeth with carious cervical lesion with asymptomatic vital pulp.
* Teeth with no or minimum mobility.
* Teeth with normal occlusion.
* Teeth with surrounding healthy gingiva and supporting-structures.

Exclusion Criteria:

* Patients who are unable to return for recall appointments
* Presence of abnormal oral, medical or mental conditions.
* Patients with severe medical diseases.
* Patients with xerostomia
* Patients with parafunctional habits.
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.

  * Severe periodontal problems.
  * Non carious cervical lesions.

Primary outcomes:
measure: Change in Marginal integrity score
timeFrame: [Time Frame: Baseline, 6 months, 12 months]
Secondary outcomes:
measure: Change in Marginal discoloration, Color match, Gross fracture scores
timeFrame: [Time Frame: Baseline, 6 months, 12 months]
measure: Change in Secondary caries scores
timeFrame: [Time Frame: Baseline, 6 months, 12 months]
measure: Change in Post operative Hypersensitivity
timeFrame: [Time Frame: Baseline, 7 days, 6 months]
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01307995: The Incretin Effect in Patients With Gestational Diabetes Mellitus
Official title: Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: GDM
incretin effect
gestation
reversibility
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2011-03-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age of 18 years with NGT)

Brief summary: The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.


Eligibility criteria: Inclusion Criteria:

* age above 18 years old
* GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)

Exclusion Criteria:

* Previous diagnosis of DM
* Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
* Affected biochemical liver parameters (ALAT \> 2 times normal upper range)
* Affected biochemical kidney parameters (se-creatinine \> 130 µM)
* Treatment with medicine interacting with insulin secretion (e.g. steroids)
* Treatment with medicine that can not be paused for 16 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital
Study officials:
affiliation: Medical University Lodz
name: Katarzyna Cypryk, MD, PhD, Asoc. Prof.
role: STUDY_DIRECTOR
affiliation: University of Copenhagen
name: Tina Vilsbøll, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Medical University Lodz
name: Marcin Kosiński, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02087995: Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
Official title: Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.

Detailed description: A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.

Eligibility criteria: Inclusion Criteria:

* Ages 18 years or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)
* Willing to participate in a clinic session

Exclusion Criteria:

* Use of Acetaminophen during study period
* Pregnancy
* Hematocrit (HCT) \<35% (females) and 38% (males)
* Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.

Primary outcomes:
measure: The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.
timeFrame: 7-day wear period
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
Study officials:
affiliation: DexCom, Inc.
name: Andy Balo
role: STUDY_CHAIR
References:
citation: Peyser TA, Nakamura K, Price D, Bohnett LC, Hirsch IB, Balo A. Hypoglycemic Accuracy and Improved Low Glucose Alerts of the Latest Dexcom G4 Platinum Continuous Glucose Monitoring System. Diabetes Technol Ther. 2015 Aug;17(8):548-54. doi: 10.1089/dia.2014.0415. Epub 2015 May 11.
Clinical trial NCT01774695: Physical Activity in IBS - a Long Term Follow up
Official title: An Intervention to Improve Physical Activity in IBS Patients Has Long Term Positive Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: IBS
physical activity
exercise
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Increased physical activity has in the investigators recent study been shown to improve symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long term effects of the investigators previous intervention in IBS patients to improve physical activity. The investigators aimed to assess the long term effects on IBS symptoms as well as quality of life, fatigue, depression and anxiety.

Detailed description: 86 patients who had been included in the investigators previous study "Physical Activity Improves Symptoms in Irritable Bowel Syndrome: A Randomized Controlled Trial" were contacted and asked to participate in a long term follow up 5 years after the previous study. The subjects attended one visit at which they underwent a bicycle ergometer test to calculate the oxygen uptake and filled out questionnaires.

Eligibility criteria: Inclusion Criteria:

* Baseline data from the previous study

Exclusion Criteria:

* pregnancy
* organic gastrointestinal disorders
* cardiac disease
* respiratory disease

Primary outcomes:
measure: IBS Severity Scoring System (IBS-SSS)
timeFrame: Change between baseline and follow up after five years
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change between baseline and follow up after 5 years
measure: IBS Quality of Life (IBS-QoL)
timeFrame: Change between baseline and follow up after 5 years
measure: Short Form 36 (SF-36)
timeFrame: Change between baseline and follow up after 5 years
measure: Fatigue Impacts Scale(FIS)
timeFrame: Change between baseline and follow up after 5 years
Other outcomes:
measure: Oxygen uptake
timeFrame: Change between baseline and at follow up after 5 years
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Internal Medicine, Sahlgrenska University Hospital
Study officials:
References:
citation: Johannesson E, Simren M, Strid H, Bajor A, Sadik R. Physical activity improves symptoms in irritable bowel syndrome: a randomized controlled trial. Am J Gastroenterol. 2011 May;106(5):915-22. doi: 10.1038/ajg.2010.480. Epub 2011 Jan 4.