louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03396900: Periodontally Accelerated Osteogenic Orthodontics With BMP2
Official title: Periodontally Accelerated Osteogenic Orthodontics Combined With Recombinant Human Bone Morphogenetic Protein-2: An Outcome Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malocclusion
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled clinical trial where systemically healthy individuals undergoing orthodontic therapy and willing to participate in the study were referred from the Department of Orthodontics and were followed up over a 6 month period after treatment.
Primary purpose: TREATMENT

Brief summary: rhBMP-2 has the potential to function as a regenerative material in periodontally accelerated osteogenic orthodontics (PAOO). This study aimed to assess the effects of PAOO with BMP-2 on outcomes such as treatment period, bone density, healing and pain.

Detailed description: Subjects were randomly assigned into each of the following experimental groups; C+BMP: corticotomy with 0.5 μg/mL rhBMP-2 and C: corticotomy only. Clinical parameters included recording the duration of treatment period, visual analogue scale (VAS) scores and early healing index (EHI) scores. The evaluation of bone density was performed at baseline, 3 months and 6 months by using RVG.

Eligibility criteria: Inclusion Criteria:

* 30 subjects with moderate crowding of lower incisors based upon Little's index and willing to undergo undergoing orthodontic treatment with extraction therapy of lower 1st premolars and PAOO were included in the study.

Exclusion Criteria:

* Smokers and subjects with severe crowding of anterior teeth, periodontitis and systemic diseases were excluded from the study.

Primary outcomes:
measure: Orthodontic treatment duration
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Andhra Pradesh
Study officials:
affiliation: SVS Institute of Dental Sciences
name: Madhukar R Rachala, MDS
role: STUDY_CHAIR
References:
Clinical trial NCT00917800: Comparison of the HyperQ Versus Conventional Electrocardiogram (ECG) to Detect Ischemia
Official title: Diagnostic Benefits of HyperQ™ vs. Conventional ECG During Stress Test. A Comparison Study in Patients Referred for Angiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: angiography
exercise testing
high frequency ECG
coronary artery disease
Lead sponsor: West German Heart Center Essen
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to the West German Heart Center in Essen for coronary angiography

Brief summary: The purpose of the investigation is to verify the efficiency of the HyperQ™ system in detecting exercise induced ischemia, with higher specificity and sensitivity than conventional ECG Stress testing. The study will be carried out by applying the HyperQ™ system during cycle ergometer stress testing in patients who are referred for angiography at the Department of Cardiology, Essen University Hospital, Essen, Germany. The HyperQ™ results will then be compared to the standard ECG stress test results using the angiography results as the gold standard. The study will be considered successful if analysis of the HyperQ provides a statistically significant improvement over the diagnostic accuracy of conventional ECG stress testing analysis.


Eligibility criteria: Inclusion Criteria:

* A patient who was referred to angiography.
* A patient who is able (i.e., no contraindications) to perform an exercise stress test
* A patient who signed an informed consent form.

Exclusion Criteria:

* Contraindications for an exercise test.
* Wolff-Parkinson-White (pre-excitation) syndrome.
* Left Bundle branch block, Complete Right bundle branch block or QRS duration \> 120 ms, change in QRS morphology during exercise.
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin.
* Pacemaker.
* Having taken beta blockers within 24 hours before the exercise test.
* Pregnancy or suspected pregnancy.

Primary outcomes:
measure: The primary objective of this study is to determine the incremental diagnostic value of HyperQ data over exercise stress testing parameters to detect significant coronary artery disease (CAD) in patients referred for coronary angiography.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: West German Heart Center
Study officials:
affiliation: Director, West German Heart Center
name: Raimund Erbel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406900: Melanoma Inhibitory Activity (MIA): A Serological Marker for Metastatic Uveal Melanoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Radiotherapy
Metastatic Disease
Keywords: uveal melanoma
metastatic disease
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 560
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Uveal Melanoma is the most common primary intraocular tumor in adults. Most tumors metastasize to the liver. So far no sensitive or specific serological tumor marker is routinely used. The marker "Melanoma inhibitory activity" is a promising marker. Study hypothesis is to detect metastatic lesions in an early stage. This would increase life expectance of our patients

Detailed description: Serum is taken from each melanoma patient at every follow up after signed concent. With ELISA the marker MIA is evaluated. An increase of MIA serum level will lead to search for metastasis by oncologists.

Eligibility criteria: Inclusion Criteria:

* uveal melanoma (With/without overt metastatic disease)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dept of Ophthalmology, University of Munich
Study officials:
affiliation: University of Munich, Germany
name: Ulrich C Schaller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schaller UC, Bosserhoff AK, Neubauer AS, Buettner R, Kampik A, Mueller AJ. Melanoma inhibitory activity: a novel serum marker for uveal melanoma. Melanoma Res. 2002 Dec;12(6):593-9. doi: 10.1097/01.cmr.0000043146.28051.b8.
Clinical trial NCT00798200: Community Based Exercise Program for Well Cancer Survivors
Official title: CanWell: YMCA Based Exercise Program for Well Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Cancer
Oncology
Rehabilitation
Endurance
Strength
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2008-11-26
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project will create a community based exercise program for well cancer survivors. The goal is that the YMCA will gain the competence to work with this unique population in a safe and productive manner.

Detailed description: All well, adult, cancer survivors are eligible to participate.

Eligibility criteria: Inclusion Criteria:

* All well cancer survivors who are medically stable.

Exclusion Criteria:

* Children are not eligible for this project.

Primary outcomes:
measure: Endurance measure (STEEP treadmill test)
timeFrame: Within one week before initiating the exercise program
measure: Endurance measure (STEEP treadmill test)
timeFrame: Administered at 6 weeks of the exercise program
measure: Endurance measure (STEEP treadmill test)
timeFrame: Administered at 12 weeks (end of) the exercise program
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
References:
citation: Cheifetz O, Dorsay JP, MacDermid JC. Exercise facilitators and barriers following participation in a community-based exercise and education program for cancer survivors. J Exerc Rehabil. 2015 Feb 28;11(1):20-9. doi: 10.12965/jer.150183. eCollection 2015 Feb.
citation: Cheifetz O, Park Dorsay J, Hladysh G, Macdermid J, Serediuk F, Woodhouse LJ. CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Psychooncology. 2014 Feb;23(2):204-15. doi: 10.1002/pon.3389. Epub 2013 Sep 6.
Clinical trial NCT01478100: Virtual Coronary Intervention and Non-invasive Fractional Flow Reserve (FFR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
CT
Computational flow dynamics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From the DISCOVER-FLOW study 20 patients with available post-intervention FFR were included in this study.

Brief summary: The investigators examined the feasibility of treatment planning using virtual coronary revascularization and fractional flow reserve (FFR) CT before the invasive procedures.


Eligibility criteria: Inclusion Criteria:

* Significant stenosis at CT angiography
* Normal ejection fraction on echocardiography
* Informed consented patient

Exclusion Criteria:

* Total occlusion and collateral flow to target vessel
* AV conduction abnormality
* Left ventricular hypertrophy
* Significant valvular heart or primary myocardial disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim KH, Doh JH, Koo BK, Min JK, Erglis A, Yang HM, Park KW, Lee HY, Kang HJ, Kim YJ, Lee SY, Kim HS. A novel noninvasive technology for treatment planning using virtual coronary stenting and computed tomography-derived computed fractional flow reserve. JACC Cardiovasc Interv. 2014 Jan;7(1):72-8. doi: 10.1016/j.jcin.2013.05.024. Epub 2013 Dec 11.
Clinical trial NCT01402700: VISIBILITY™ Iliac Study
Official title: Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Claudication
Keywords: Peripheral arterial disease
claudication
stent
VISI-Pro
Iliac artery
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2011-07-26
Enrollment: 75
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: The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.


Eligibility criteria: Inclusion Criteria:

* Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
* Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
* Willing to comply with all follow-up evaluations at the specified times.
* Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

* Previous implantation of stent(s) in the target vessel.
* Received endovascular treatment of the target lesion within six months prior to the index procedure.
* Known hypersensitivity to contrast material that cannot be adequately pretreated.
* Known hypersensitivity to 316L stainless Steel.
* Life expectancy of less than 12 months

Primary outcomes:
measure: Major Adverse Event Rate at 9 Months
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Peter L. Faries, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Holy Name Medical Center
name: John H. Rundback, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rundback JH, Peeters P, George JC, Jaff MR, Faries PL. Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months. J Endovasc Ther. 2017 Jun;24(3):342-348. doi: 10.1177/1526602817692960. Epub 2017 Feb 1.
Clinical trial NCT01925300: Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin
Official title: A Randomized, Open-label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Bisoprolol and Rosuvastatin in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Pharmacodynamics
Safety
Tolerability
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-19
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and rosuvastatin in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Male volunteers in the age between 20 and 55 years old(inclusive)
* Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
* Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 150 mmHg, 60 mmHg ≤ diastolic blood pressure ≤ 100 mmHg, 50 beats per minute ≤ pulse rate ≤ 100 beats per minute)
* Available for the entire study period
* Understand the requirements of the study and voluntarily consent to participate in the study

Exclusion Criteria:

* Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
* History of clinically significant arrhythmic, peripheral vascular,thyroid, bronchospasm, asthma disease
* Subjects with anaphylaxis to bisoprolol and/or rosuvastatin
* History of drug abuse
* History of caffeine, alcohol, smoking abuse

  * caffeine(coffee,tea,coke) or grapefruit juice \> 4cups/day
  * smoking \> 20 cigarettes/day
  * alcohol \> 140g/week
* Clinical laboratory test values are outside the accepted normal range

  * AST(Aspartate Transaminase), ALT(ALanine Transaminase)( \> 1.5 times to normal range
  * CK(Creatine Kinase) \> 1.5 times to normal range
  * Estimated GFR(Glomerular Filtration Rate) \< 60 mL/min
* Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
* Subjects considered as unsuitable based on medical judgement by investigators

Primary outcomes:
measure: Assessment of the drug-drug interactions of bisoprolol and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
timeFrame: 6 days
Secondary outcomes:
measure: Assessment of the bisoprolol and rosuvastatin:tmax,ss(Time to reach Cmax,ss), t1/2, Cmin,ss(Minimum steady-state plasma drug concentration during a dosage interval ), CL/Fss(Oral Clearance), Vd/Fss(Apparent Volume of Distribution)
timeFrame: 6 days
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Conter
name: Jae-wook Ko, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03194100: Serum METRNL Concentration in Type 2 Diabetes
Official title: Comparison of Serum METRNL Concentration Between Type 2 Diabetes and Normal Glucose Tolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 125
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oral glucose tolerance test (OGTT) was performed in all of the included participants. The participants were divided into three groups according to the American Diabetes Association criteria; normal glucose tolerance, prediabetes and diabetes mellitus.

Brief summary: The investigators measured serum METRNL levels in newly diagnosed patients with type 2 diabetes (T2DM) compared with normal glucose tolerance or prediabetes and explored the correlations between its serum levels and various metabolic parameters


Eligibility criteria: Inclusion Criteria:

* Subjects who have not been diagnosed diabetes mellitus

Exclusion Criteria:

* Person with diabetes who were treated with oral hypoglycemic agent or insulin
* Individuals with type 1 diabetes, gestational diabetes, active hepatitis/liver cirrhosis, chronic renal failure on hemodialysis, congestive heart failure, or other known major disease

Primary outcomes:
measure: serum METRNL concentration
timeFrame: on the 1 day of oral glucose tolerance test
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03465800: Understanding Mechanisms of Exercise Behavior Change
Official title: Understanding Mechanisms of Exercise Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Physical Activity
Incentives
Keywords: overweight
obesity
physical activity
exercise
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically physical activity. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with an active self-monitoring intervention condition in which no rewards are offered. Study participants will provide reports of their physical activity each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their physical activity. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards. The study will also examine how cognitive and anthropomorphic factors may contribute to intervention response and the effects on psychological constructs.


Eligibility criteria: Inclusion Criteria:

* Complete less than 150 minutes of moderate-vigorous physical activity weekly
* Daily access to the internet for 3 weeks following baseline research visit
* Have or are willing to create an account on PayPal
* Willing to wear a heart rate monitor watch during physical activity for 3 weeks
* BMI greater than or equal to 25, from self-reported height and weight

Exclusion Criteria:

* Diagnosis of cardiovascular, metabolic, or renal disease

Primary outcomes:
measure: Moderate-vigorous physical activity minutes
timeFrame: Week 3
measure: Self-Efficacy for physical activity
timeFrame: Week 3
measure: Moderate-vigorous physical activity minutes
timeFrame: Week 5
measure: Self-Efficacy for physical activity
timeFrame: Week 5
measure: Attitudes toward physical activity
timeFrame: Week 3
measure: Attitudes toward physical activity
timeFrame: Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References:
Clinical trial NCT01151800: Using Automated Calls To Improve Compliance With Acute Coronary Syndrome Best Practice Guidelines
Official title: Using Interactive Voice Response To Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Medication Adherence
Keywords: ACS
Interactive Voice Response Technology
Best Practice Guidelines
Health Care Utilization
Outcome Assessment
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: The Change Foundation
First posted: 2010-06-28
Enrollment: 1608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs).

The study hypothesis is that ACS patients who are contacted by IVR technology will be more likely to receive care as recommended in the BPGs than those followed by usual care.

Detailed description: Acute coronary syndrome (ACS) is a significant public-health problem in Canada and worldwide with 20,000 Canadians dying of myocardial infarction and 42,000 dying of coronary artery disease in 1999. Large clinical trials have provided evidence for the development of standardized best practice guidelines (BPG) and compliance with these guidelines have significantly improved survival. Despite the development and dissemination of BPG, their application in patients with ACS is suboptimal. This randomized control trial will use 2 groups: IVR and usual care. Patients in the IVR group will receive 5 automated calls at 1,3,6,9 and 12 months consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Responses are captured in a database allowing for interventions to maintain patients on BPG as needed.

Eligibility criteria: Inclusion Criteria:

* Patients discharged from the UOHI with ACS (acute myocardial infarction, STEMI or NSTEMI)
* Patients who have a land line telephone service at home
* Patients who speak English or French

Exclusion Criteria:

* Patients discharged to a care facility or transferred to another health care institution

Primary outcomes:
measure: Compliance with BPGs
timeFrame: 1 year
Secondary outcomes:
measure: Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
References: