linjc16/ctgov huggingface dataset:
Hypoglycemia: Physician and Patient Perspectives

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.

Official Title
-----------------
Hypoglycemia: Physician and Patient Perspectives

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug at least 1 HbA1c test recorded during the identification period continuous enrollment in the health plan for at least 12 months prior to survey date Exclusion Criteria: Type 1 Diabetes Mellitus pregnancy or gestational diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| SU<br>T2DM patients with a prescription for a sulfonylurea but no insulin | |
| Antidiabetic without SU<br>T2DM patients with an oral antidiabetic drug other than an SU, and no insulin | |
| Insulin<br>T2DM patients using insulin, with or without other oral antidiabetics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of hypoglycemia and impact of hypoglycemia |  | October 2009-October 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia) |  | October 2009-October 2010 | 
| Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization |  | October 2009-October 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, Hypoglycemia
Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.

Official Title
-----------------
A Study to Evaluate the Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of Multiple Doses of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease, Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Drug: ABT-957
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female participants must have negative results for pregnancy test performed on a serum sample obtained at Screening Body Mass Index is 18.0 to 35.0 at Screening Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease (AD). Meets the NIA-AA core clinical criteria for Mild Cognitive Impairment due to AD Exclusion Criteria: Use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration Consumption of alcohol within 24 hours prior to study drug administration Positive screen for non-prescribed drugs of abuse or alcohol The participant has clinically significant abnormal laboratory values at Screening as determined by the investigator History of a drug or alcohol abuse within 6 months prior to study drug administration Current diagnosis of major depression or other major psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-957<br>ABT-957 given twice a day for 84 days | Drug: ABT-957<br> <br> |
| Placebo Comparator: Placebo<br>Placebo given twice a day for 84 days | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants reporting treatment-emergent adverse events |  | For approximately 84 days | 
| Level of spectrin breakdown product-145 (SBDP-145) |  | 84 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild Cognitive Impairment, Alzheimer's Disease
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial. Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.

Official Title
-----------------
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Drug: Granulocyte Colony Stimulating Factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years to75 years Patients of decompensated cirrhosis with CTP ≥6 and ≤ 13 Liver transplantation not feasible soon (due to financial reasons or unavailability of donors). Exclusion Criteria: Hepatocellular Carcinoma Sepsis (Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP): Patients were included after sepsis is controlled. Any organ failure Grade 3 or 4 Hepatic Encephalopathy, Active Variceal bleed, Hepatorenal Syndrome: Patients might be included after clinical improvement HIV seropositivity Pregnancy Refusal to participate in the study Previous known hypersensitivity to G-CSF

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GCSF+SMT<br>5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months | Drug: Granulocyte Colony Stimulating Factor<br> <br> |
| No Intervention: SMT<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants alive at 6 months |  | 6 months |
Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area and Insula

Study Overview
=================
Brief Summary
-----------------
The implication of the second somatosensory area (SII) and the insular cortex in the processing of somatosensory inputs is now well established. However the functional anatomy of these areas hidden in the depth of the sylvian scissure remain mostly unknown. The aim of this fMRI study is to determine the functional cartography of SII and insula. The localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.

Detailed Description
-----------------
Aims : Demonstrate that localization of the several types of somatosensory stimuli is different into SII and into insula. If possible, we'll determine a functional cartography of these areas.

Official Title
-----------------
Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area (SII) and Insula : an fMRI Study

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

Intervention / Treatment
-----------------
* Other: localization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 25 healthy volunteers will be included ranging in age from 18 to 50 years contraception needed for women right handed All the subjects have to give their written informed consent. Exclusion Criteria: pregnancy neurological or psychiatric disease drugs taken <12h before fMRI contra-indications to fMRI : pacemaker, clip, metallic device Refusing to be informed of the presence of a cerebral abnormality, detected during MRI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>healthy volunteers | Other: localization<br>* localization of the several types of somatosensory stimuli<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of euclidian distances between the centroids of clusters activations for the different types of stimulations into SII and insula. |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Talairach coordinates of the centroids of clusters of activations for the different types of somatosensory stimuli into SII and insula |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers, Somatosensory stimuli, fMRI, second somatosensory area, insular cortex, functional anatomy
Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.

Detailed Description
-----------------
The duration of treatment is 12 months.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib
* Drug: Comparator: Diclofenac sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 50 years or older with rheumatoid arthritis. Exclusion Criteria: History of gastrointestinal malabsorption or inflammatory bowel disease History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.

Ages Eligible for Study
-----------------
Minimum 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, etoricoxib|nan|
|Drug: Comparator: Diclofenac sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuations due to clinical and laboratory gastrointestinal adverse experiences |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

Detailed Description
-----------------
Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.

Official Title
-----------------
An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

Conditions
-----------------
Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: solithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic evidence of NASH based on liver biopsy obtained within 180 days NAS> or = 5 Able to swallow capsules intact Exclusion Criteria: Symptoms of acute liver disease Cirrhosis on liver biopsy Positive HIV or Hepatitis tests Primary Biliary Cirrhosis Poorly controlled diabetes with HgA1C >8.5% ALT >4-fold upper limit of normal QTcF >450 msec CrCl <40 mL/min

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solithromycin<br>Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks | Drug: solithromycin<br> <br> * Other names: CEM-101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate effects on hepatic histology in patients with NASH | Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Steatosis on liver biopsy | Graded from 0 to 3 | 13 weeks | 
| Changes in hepatocellular ballooning score on liver biopsy | Graded from 0 to 2 | 13 weeks | 
| Changes in inflammation on liver biopsy | Graded from 0 to 3 | 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NASH, Liver disease
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

Study Overview
=================
Brief Summary
-----------------
Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.

Detailed Description
-----------------
Inpatient Infants younger than 2 years of age with first episode of RSV bronchiolitis will be randomly assigned to treatment with nebulized epinephrine (1 mg diluted with 3 ml of 0.9% saline) or nebulized albuterol (2.5 mg diluted with 3.5 ml of 0.9% saline). Both solutions will be provided in identical containers. Clinical assessment and clinical score will be done before treatment, 10 and 30 minutes after treatment. The following parameters were recorded at each time point, wheezing, respiratory distress, O2 saturation, respiratory rate and heart rate. Computerized lung sounds as well, will be recorded before treatment, 10 and 30 minutes after treatment via 4 contact sensors attached to the chest.

Official Title
-----------------
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

Conditions
-----------------
Rsv Bronchiolitis

Intervention / Treatment
-----------------
* Drug: nebulized epinephrine and nebulized albuterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under one year of age first episode of wheezing and dyspnea RSV antigen detected by ELISA parents signed informed consent. Exclusion Criteria: infants with chronic lung disease cardiac disease other chronic conditions.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 1 Year

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: nebulized epinephrine and nebulized albuterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory clinical score |  |  | 
| computerized quantification of wheezing and crackles |  |  |
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.

Official Title
-----------------
A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers

Conditions
-----------------
Heart Rate, Blood Pressure, Arrhythmias

Intervention / Treatment
-----------------
* Drug: Phenylephrine HCL
* Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between 18 and 50 years; Clinical examination without abnormal findings Ability to understand the nature and purpose of the study, including the risks and adverse effects Exclusion Criteria: Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia History of serious adverse reactions or hypersensitivity any drug Hypersensitivity to the drug study drugs or chemically related compounds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate<br>Phenylephrine HCL/Acetaminophen/Dimethindene Maleate | Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate<br>* Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg<br>|
| Active Comparator: Phenylephrine hydrochloride<br>Phenylephrine hydrochloride 10mg | Drug: Phenylephrine HCL<br>* Phenylephrine HCL 10mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing |  | 15 days | 
| To report and evaluate adverse events |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, heart rate, systolic and diastolic blood pressure, arrhythmias