linjc16/ctgov huggingface dataset:
Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Official Title
-----------------
Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently on drug therapy for type 2 diabetes Blood glucose criteria must be met Body mass index (BMI) in the range 22-45 Exclusion Criteria: History of type 1 diabetes Evidence of significant diabetic complications Serious cardiovascular events within the past 6 months Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 24 weeks of treatment |  |  | 
| Change from baseline in fasting plasma glucose at 24 weeks |  |  | 
| Patients with endpoint HbA1c < 7% after 24 weeks |  |  | 
| Patients with reduction in HbA1c >/= 0.7% after 24 weeks |  |  | 
| Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients

Study Overview
=================
Brief Summary
-----------------
This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result. The hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin B12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.

Official Title
-----------------
Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients : an Observational Study.

Conditions
-----------------
Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥18 years old) Infection, confirmed by a positive culture result Signed informed consent. Exclusion Criteria: Pregnancy and/or breast feeding Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Holotranscobalamin (HTC) levels | HTC levels in patients with infection and sepsis compared to patients with infection without sepsis. | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin B12 levels | Levels of vitamin B12 in patients with infection and sepsis compared to patients with infection without sepsis | 6 days | 
| Methylmalonic acid (MMA) levels | Levels of ethylmalonic acid (MMA) in patients with infection and sepsis compared to patients with infection without sepsis | 6 days |
Florbetaben PET Imaging in PPA

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to better understand how dementia affects activity in different parts of the brain.

Detailed Description
-----------------
This study will examine Positron Emission Tomography (PET) imaging with Florbetaben F18. Florbetaben F18 is a radioactive tracer that binds to particles in your brain. This process displays activity in the brain. Florbetaben F18 is a PET amyloid imaging agent approved by the United States Food and Drug Administration (FDA) to estimate the amount of beta-amyloid plaque in adult patients who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The purpose of this research is to better understand how dementia affects activity in different parts of the brain. Currently, the scientific community is limited by how well it can see inside the brain. The use of a PET scan better helps us understand what the brain looks like in a diseased state. Participation in the study will help to understand what brain activity looks like, especially around language regions.

Official Title
-----------------
Florbetaben PET Imaging in Primary Progressive Aphasia

Conditions
-----------------
Primary Progressive Aphasia, Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Florbetaben F18
* Device: PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have a diagnosis of PPA or a related dementia syndrome Exclusion Criteria: Pregnant Breastfeeding Receiving radiation clinically

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Experimental: Florbetaben F18 recipients<br>Participants in this arm of the study will receive 8.1mCi of florbetaben F18 and then be scanned in a PET scanner for brain imaging. | Drug: Florbetaben F18<br>* A single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection<br>* Other names: trade name NeuraCeq;Device: PET<br>* PET Scan for brain imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyloid plaque levels in PPA participants | Amyloid plaque aggregation as measured by florbetaben F18 standard uptake value ratio cerebral and cerebellar regions of interest. | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease, Dementia, Primary Progressive Aphasia, Neurocognitive Disorders, Speech Disorders
Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

Study Overview
=================
Brief Summary
-----------------
This single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections.

Detailed Description
-----------------
Objective: To investigate whether injection of botulinum toxin type A is less painful if performed through follicular openings versus traditional non-specific approach. Design: Prospective, randomized, single-blinded study. Setting: Academic dermatology department. Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection. Intervention: Each patient received six randomized injections of botulinum toxin type A (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator muscle. Three of the injections were performed through follicular openings and three were performed traditionally. Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.

Official Title
-----------------
Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: botulinum type a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female No prior history of botulinum toxin Age 25-55 Exclusion Criteria: Male Prior history of botulinum toxin Neuromuscular disorders Aminoglycoside therapy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: botulinum type a|12 Units total were injected into 6 sites in the glabellar complex to determine if injecting through the follicle versus a traditional approach would decrease patient discomfort|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease pain on injection for treatment intervention assessed on a 10 point scale |  | At time of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
botulinum toxin a, botox, Decreasing botox injection pain, injections
Treatment of Bulimia Nervosa in a Primary Care Setting

Study Overview
=================
Brief Summary
-----------------
Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this disorder cannot be treated effectively in a primary care setting. This assumption has never been tested empirically, and is probably incorrect. In the last 15 years, effective treatment interventions for Bulimia Nervosa have been developed and validated in specialized treatment centers. The broad aim of this proposal is to examine whether these treatments, suitably adapted, can be usefully transferred to general health care settings. Specifically, the proposed study will determine the relative and combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care setting. The two major interventions are treatment with an antidepressant medication, fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for use in primary care.

Conditions
-----------------
Bulimia Nervosa

Intervention / Treatment
-----------------
* Drug: Fluoxetine
* Behavioral: Guided Self-Help


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for bulimia nervosa with a modified frequency criterion of at least once a week Exclusion Criteria: Physical disorder requiring hospitalization or ongoing treatment likely to affect eating and/or weight Significant suicidal ideation or behavior Subjects judged unable to tolerate four-month treatments available in the study because of comorbid psychiatric conditions Current drug or alcohol dependence Current anorexia nervosa Pregnancy or any physical condition or treatments known to influence eating and weight Current psychiatric treatment or medication known to affect eating or weight Previous course of fluoxetine at a dose of 60 mg. per day for at least four weeks Allergy to fluoxetine Previous course of cognitive behavioral therapy for Bulimia Nervosa at a qualified center

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: Fluoxetine|nan|
|Behavioral: Guided Self-Help|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Care, Fluoxetine
Dexmedetomedine Infusion Versus Fentanyl Infusion for Donor Anlgesia During Living Donor Hepatectomy

Study Overview
=================
Brief Summary
-----------------
To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion during donor hepatectomy.

Conditions
-----------------
Donor Hepatectomy

Intervention / Treatment
-----------------
* Drug: dexmedetomedine
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: donors of living donor liver transplantation Exclusion Criteria: patient refusal Known allergy to dexmedetomedine

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D group<br>intraoperative dexmedetomedine infusion | Drug: dexmedetomedine<br>* intraoperative infusion<br>|
| Sham Comparator: F group<br>Intraoperative fentanyl infusion | Drug: Fentanyl<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative VAS scale |  | 3 days |
Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)

Study Overview
=================
Brief Summary
-----------------
GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.

Official Title
-----------------
A Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Denagliptin in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: denagliptin (GW823093)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment Body mass index between 20 and 40 Females of childbearing potential must use adequate birth control. Exclusion criteria: Subjects with previous use of insulin Type 1 diabetes Uncontrolled thyroid disease History of drug or alcohol abuse in the past year Any other clinically significant disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: denagliptin (GW823093)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood glucose regulation after 26 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus (T2DM), glycosylated hemoglobin (HbA1c), denagliptin, diabetes treatment, glycemic control
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.

Official Title
-----------------
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)

Conditions
-----------------
Anticoagulation, Left Ventricular Assist Device

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HeartMate II Left Ventricular Assist Device (LVAD) patient Patient has signed an informed consent for data collection. Patient was discharged, or is being discharged, from the hospital after their initial LVAD implant surgery. Patient: at time of enrolling in study, is currently on, with the intention of being maintained on reduced anti-thrombotic therapy (RT) for chronic long-term management. OR -- On or after January 1, 2011 patient was being maintained on, or had been initiated with the intention of being maintained on, reduced anti-thrombotic therapy (RT) for chronic long-term management; but where RT was subsequently discontinued due to an adverse event or transplant, explant, or death. Exclusion Criteria: Patients under acute management of anti-thrombotic agents before a final decision on long term antithrombotic strategy. Patients requiring a legal representative to sign consent form, rather than themselves. Patient is being managed on other anti-thrombotic agents
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of thromboembolic events and hemorrhagic events |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoratec Corporation, HeartMate II, Anticoagulation
Formula for Children With Cow's Milk Allergy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.

Official Title
-----------------
A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein

Conditions
-----------------
Milk Allergy

Intervention / Treatment
-----------------
* Other: Experimental Extensively Hydrolyzed Formula
* Other: Active Comparator Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health Parent/guardian must be willing to provide informed consent Parent/guardian agrees to feed study formula provided Confirmation of Cow's Milk Allergy Exclusion Criteria: No clinically significant abnormal findings on medical history, laboratory results, and physical exam. No medications that may interfere with or impact evaluation of the study assessments Allergy to extensively hydrolyzed casein formula Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention

Ages Eligible for Study
-----------------
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Extensively Hydrolyzed Formula<br>Administered in context of oral food challenge and then for 16 weeks. | Other: Experimental Extensively Hydrolyzed Formula<br> <br> |
| Active Comparator: Comparator Formula<br>Administered in context of oral food challenge and then for 16 weeks. | Other: Active Comparator Formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Allergic Reaction |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Anthropometric measurements of weight in all enrolled subjects. | 16 weeks | 
| Growth | Anthropometric measurements of length/height in all enrolled subjects. | 16 weeks |