linjc16/ctgov huggingface dataset:
Vitamin K2 and Muscle Weakness in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to determine the effects of vitamin K2 supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.

Official Title
-----------------
Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes

Conditions
-----------------
Diabete Type 2

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Vitamin K2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician confirmed type 2 diabetes. Age >/= 40 years No changes in anti-diabetic medication in the last 3 months. Muscle weakness (grip strength <27kg and females <16kg) Exclusion Criteria: BMI of 45 or higher BP of 160/100mmHg or higher Cancer or cancer that has been in remission <5 years Any medical condition that prevents participants from exercising safely On anticoagulant therapy Currently consuming vitamin K2 supplements Current smoker

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Group Randomised Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>micro-crystalline cellulose placebo (one 380 mg tablet per day) | Dietary Supplement: Placebo<br>* Placebo<br>|
| Active Comparator: Vitamin K2<br>micro-crystalline cellulose (one 380 mg tablet per day) where vitamin K2 (K2VITAL® 0.2% DELTA powder) is mixed into the formulation to a final vitamin K2 concentration of 240 μg/tablet | Dietary Supplement: Vitamin K2<br>* Vitamin K2<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Strength | Change in Grip Strength | Baseline to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPPB | Change in Short Performance Physical Battery Test | Baseline to one year | 
| HbA1c | Change in glycated haemoglobin | Baseline to one year | 
| Blood Pressure | Change in blood pressure | Baseline to one year | 
| Body Mass | Change in body mass | Baseline to one year | 
| Lean Mass | Change in lean mass | Baseline to one year | 
| Body Fat | Change in body fat | Baseline to one year | 
| BMC | Change in bone mineral content | Baseline to one year | 
| BMD | Change in bone mineral density | Baseline to one year | 
| Vitamin K status | Change in vitamin K status | Baseline to one year |
Familial Aortopathies and Cellular Exploration

Study Overview
=================
Brief Summary
-----------------
The prevalence of hereditary aortic disease (HTAD), responsible for aneurysm or dissection, is estimated at 25%. Mutations in the ACTA2 gene represent the main cause of non-syndromic forms (10-21%). ACTA2 is expressed in vascular wall smooth muscle cells (VSMC) and encodes alpha actin (α-SMA). This actin isoform is in the majority in VSMCs and plays a key role in their contractile properties. The mutations are dominant-negative and lead, in a fibroblast model, to defects in the organisation of the actin cytoskeleton and to an increase in the migratory and proliferative potential of the cells. In vivo, VSCMs exist in a phenotypic continuum ranging from a quiescent differentiated contractile state to a so-called synthetic state in which cells are proliferative, synthesise extracellular matrix elements and exhibit enhanced migratory capabilities. To understand how ACTA2 mutations deregulate VSMC functions and steer them towards a synthetic phenotype, it is necessary to have a cellular model as close as possible to the affected tissue..

Official Title
-----------------
ACTA2 and Familial Aortopathies: Creation and Validation of an Exploratory Cellular Model

Conditions
-----------------
Familial Aortopathies

Intervention / Treatment
-----------------
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with a mutation in the ACTA2 gene Exclusion Criteria: patient under 18 years of age at the time of inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: familial aortopathy<br> | Biological: blood sample<br>* blood sampling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis of the impact of ACTA2 mutations on the morphology of the actin cytoskeleton | use of a model of IPS cells reprogrammed into VSMCs from patients with ACTA2 mutations, compared to a healthy control | baseline |
Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)

Study Overview
=================
Brief Summary
-----------------
To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences.

Detailed Description
-----------------
This is a multi-center, observational, single arm, post-approval study enrolling the following study population: Subjects with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate), or Subjects without neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate) The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI). For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).

Official Title
-----------------
Emboshield and Xact Post Approval Carotid Stent Trial Using the Emboshield® BareWire™ Rapid Exchange Embolic Protection System and Xact® Rapid Exchange Carotid Stent System

Conditions
-----------------
Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis

Intervention / Treatment
-----------------
* Device: Carotid artery stenting with filter (interventional)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who agree to participate in this study and have signed the IRB approved informed consent form. Subjects who are willing to have the Emboshield and/or the Xact inserted into the their vasculature. Exclusion Criteria: There are no exclusion criteria for this study.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Carotid artery stenting with filter (interventional)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI). |  |  | 
| For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotid stenting, Carotid endarterectomy, Carotid artery disease with severe narrowing of the artery, Stroke prevention, cerebral infarction
Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures

Study Overview
=================
Brief Summary
-----------------
The proposed project will be a multi-centre, prospective observational study to determine the prognosis and determinants of functional outcomes of patients with proximal humerus fractures. Approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.

Official Title
-----------------
The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort

Conditions
-----------------
Humeral Fractures, Proximal

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture Exclusion Criteria: pathologic fractures patients likely to be lost before completing follow-up patients who do not provide consent patients who do not speak English and who do not have a translator that will be available during consent discussion and at each follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Population<br>We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma | Other: Observational<br>* observational cohort of proximal humerus fractures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder, and Hand (DASH) | The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | Clinical outcomes will include range of motion measurements, standardized radiographic evaluation, assessment of complications, rate of re-operation, infections, osteonecrosis. | 2 years |
Study of Aripiprazole in Patients With Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

Official Title
-----------------
Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of bipolar I disorder, manic or mixed episode Exclusion Criteria: First manic or mixed episode Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aripiprazole|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in a mania rating scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate and Clinical Global Impression Scale at endpoint |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Mania
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.

Official Title
-----------------
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Biaxin ( clarithromycin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of CF ability to reliably perform spirometry FEV1 of 30% predicted at the time of screening Exclusion Criteria: Mycobacterium in a sputum culture ever recorded a respiratory exacerbation requiring IV antibiotics in the 60 days prior used a investigational drug or device in the 60 days prior significant (>30ml) of hemoptysis in the past year require oxygen or have significant liver or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Biaxin ( clarithromycin)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function Testing - FEV1 |  |  | 
| Quality of Life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in neutrophil-dominated airway inflammation |  |  | 
| decrease in Pseudomonas alginate production in vitro and in the airway |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis (CF), Macrolide antiobiotics, airway inflammation
Impact of Follicular and Blood G-CSF During a Natural Cycle of IVF

Study Overview
=================
Brief Summary
-----------------
Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of this molecule is increasing in reproduction pathology. High level of follicular and blood G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation rates.

Official Title
-----------------
Impact of Follicular and Blood G-CSF on Pregnangcy and Implantation Rate During Modified Natural in Vitro Fertility Cycle

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 18 and 43 years old Women natural In Vitro Fecondation Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G-CSF FIV nat<br>Patient following a natural In Vitro Fecondation cycle | Procedure: Blood test<br>* Taking blood sample of the patient during the day 3, triggering day, oocyte collection day and pregnancy test day. Taking the follicular fluid during the oocyte collection day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum and / or follicular minimum level of G-CSF predictive of pregnancy |  | 6 months |
SSVEP and Distractor Processing During Visual Search

Study Overview
=================
Brief Summary
-----------------
In this line of research, the researchers are utilizing an EEG measure of repeated visual stimulation, the Steady-State Visually Evoked Potential (SSVEP) to examine processing of target and distractor information during visual search. This is a basic science study.

Detailed Description
-----------------
The researchers are interested in how the brain responds to target and distractor information during visual search. The researchers will manipulate the information available to the research participants, and measure research participants brain responses to information matching target or distractor features utilizing an EEG measure of repeated visual stimulation, the Steady-State Visually Evoked Potential (SSVEP).

Official Title
-----------------
SSVEP and Distractor Processing During Visual Search in Healthy Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Visual Search Information Type (target or distractor information)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal or corrected to normal visual acuity, normal color vision Exclusion Criteria: history of neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: All participants receive each level of visual information (target or distractor)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Within-Subjects Attentional Information<br>Within-Subjects, all participants receive all interventions | Behavioral: Visual Search Information Type (target or distractor information)<br>* Participants will have information about targets, distractors, or neither in different blocks of the intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady-State Visually Evoked Response (SSVEP) | Brain response to visual stimuli flashing at a pre-defined frequency | One day (during testing) | 
| Button Press Reaction Time | Speed to respond correctly to the target- after participant finds the target shape on a computer screen, they press a button to indicate what shape they see | One day (during testing) | 
| Button Press Accuracy | Accuracy of responses to target item (% correct)- the researchers will measure whether the participants presses the correct button which corresponds to the target shape presented on the computer screen or the incorrect button | One day (during testing) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attention, visual search
Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury

Study Overview
=================
Brief Summary
-----------------
A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury

Conditions
-----------------
Acute Traumatic Injury

Intervention / Treatment
-----------------
* Drug: pelubiprofen 45mg
* Drug: pelubiprofen placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, ages over 19 years Patients with post traumatic acute pain within 48 hr(sprain/strain) Patient whose pain scale is over 50 mm(VAS score) Exclusion Criteria: Patients with chronic pain Presence of a fracture or more than one injury Previous adverse reaction or known allergy to NSAIDs

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelubiprofen<br> | Drug: pelubiprofen 45mg<br>* bid for 3 days after meal<br>|
| Placebo Comparator: Pelubiprofen placebo<br> | Drug: pelubiprofen placebo<br>* bid for 3 days after meal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID-D3 | Sum of Pain Intensity Differences(100 mm pain VAS) | Day 3 |