linjc16/ctgov huggingface dataset:
Risk of CV Events With EFV vs. EFV-free Regimens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.

Official Title
-----------------
The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

Conditions
-----------------
HIV/AIDS

Intervention / Treatment
-----------------
* Drug: Efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Aged 18 years or older on the index date Have at least one pharmacy claim for efavirenz or a drug in the comparison cohort during the period spanning January 1, 2007 through December 31,2013. Clinical Modification (ICD-9) diagnosis code for HIV infection including 042 (HIV disease), V08 (asymptomatic HIV infection status), 795.71 (nonspecific serologic evidence of HIV), and 079.53 (HIV, type 2) any time prior to the index claim. Have at least 6 months (180 days) of continuous enrollment prior to the index claim Exclusion Criteria: Patients who have been dispensed any antiretroviral medications anytime before the index date including the 180-day baseline period Patients with evidence of a cardiovascular outcome of interest during the 180-day baseline period

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


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with Efavirenz exposure<br>Patient with Efavirenz exposure | Drug: Efavirenz<br> <br> |
| Patient without Efavirenz exposure<br>Patient without Efavirenz exposure | Drug: Efavirenz<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events specifically based on incidence rate and compare the hazard between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen | cardiovascular events specifically based on incidence rate and compare the hazard (myocardial infarction, stroke,percutaneous coronary intervention, coronary artery bypass graft, and composite of aforementioned events) between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen | upto 1 to 5 years |
Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD).

Detailed Description
-----------------
Alzheimer's disease (AD) is characterized by a progressive decline of memory and intellectual abilities, interfering activity in daily living, the overall quality of life, and ultimately leads to death. Although pharmacologic treatments are currently approved for treating mild- to moderate AD using acetylcholinesterase inhibitors (ACEI) or memantine, the NMDA antagonist, for the advanced stage of AD, the therapeutic efficacies need to be further improved. For millennia, ginseng or its components have been used to treat medical conditions, and the pharmacologic effects have been demonstrated in cardiovascular, endocrine and immune system (Attele et al., 1999). In means of memory and learning, a number of studies suggested that ginseng can attenuate learning deficits of damaged or ageing brains in rodent models (Kennedy et al., 2003; Zhao and McDaniel, 1998; Nitta et al., 1995). In studies with human healthy participants, correspondently, both acute and chronic dosage of ginseng increased the cognitive performance (Kennedy et al., 2001; Kennedy et al., 2003; D'Angelo et al., 1986; Sorensen and Sonne, 1996). In this study, we we will investigate the contribution of ginseng treatment in increasing the cognitive improvement of AD patients. In addition, we will test various bio-markers and hematopoietic progenitor cell count in those included patients using their blood samples. Patients with AD as well as memory decline will be included

Conditions
-----------------
Alzheimer's Disease, Memory Decline

Intervention / Treatment
-----------------
* Drug: Panax Ginseng


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's disease Exclusion Criteria: other neurologic disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 83 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Panax Ginseng|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performances monitored by MMSE and Alzheimer's disease assessment scales. |  |  | 
| Biomarkers including hematopoietic progenitor cell count. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Ginseng, CD34
Pharmacological Study on Absorption of WE 941 OD Tablets in Japanese Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE 941 OD tablets are administered in Japanese healthy male volunteers.

Official Title
-----------------
Clinical Pharmacological Study on Absorption From Mucous Membrane of Oral Cavity of WE 941 OD Tablets

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

Intervention / Treatment
-----------------
* Drug: WE 941 OD tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers age 20 - 35 years body weight 50 - 80 kg Body Mass Index (BMI) +/- 20%

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WE 941 OD under deglutition<br> | Drug: WE 941 OD tablets<br> <br> |
| Experimental: WE 941 OD under non-deglutition<br> | Drug: WE 941 OD tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from zero to 24hours (AUC0-24 ) |  | up to 24 hours post dose | 
| Maximum concentration of the analyte in plasma (Cmax) |  | up to 24 hours | 
| Cmax ratio for non-deglutition to deglutition |  | up to 24 hours |
Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

Study Overview
=================
Brief Summary
-----------------
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included.

Official Title
-----------------
Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

Conditions
-----------------
Gastrointestinal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole. Exclusion Criteria: limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists |  | proportion of treated subjects without any specific acid associated symptoms at the end of the study; change in intensity of specific acid associated symptoms; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of a diagnosis tool |  | evaluation of the predictive value of a two items questionnaire on acid associated symptoms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal disorder, acid associated gastrointestinal symptoms., esomeprazole therapy in patients with gastrointestinal disorders, patients with acid associated gastrointestinal symptoms
Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

Study Overview
=================
Brief Summary
-----------------
Recently, it was reported that when vancomycin levels are determined after port sampling, levels can be falsely increased potentially leading to wrong dose adjustments. The investigators conducted an in vitro experiment using several central venous port devices, in which different flushing techniques were evaluated yielding residual vancomycin levels of less than 0.5 mg/L. In this study, the investigators want to evaluate this flushing technique in vivo in 15 patients admitted with catheter-related infection and treated with systemic vancomycin and vancomycin antibiotic lock. The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained via port sampling.

Official Title
-----------------
Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

Conditions
-----------------
Catheter-related Infection

Intervention / Treatment
-----------------
* Procedure: blood levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, having central venous port device, treated with systemic vancomycin in combination with vancomycin antibiotic lock Exclusion Criteria: pregnant women, children, patients with 'do not resuscitate' (DNR) code

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 |
| --- | --- |
| vancomycin cohort<br> | Procedure: blood levels<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L |  | central and peripheral vancomycin levels will be obtained during steady state: this means starting from the 4th dose (= day 2) of vancomycin treatment. Vancomycin is usually given during 14 days after the last positive blood culture. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vancomycin, levels, central venous port device, peripherally obtained levels, dose adjustments, TDM
Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.

Official Title
-----------------
A Multicenter, Randomized, Parallel, Double-blind, Clinical Trial Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in Patients With Otic Eczema

Conditions
-----------------
Otic Eczema

Intervention / Treatment
-----------------
* Drug: DF277
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 years or older Clinical diagnosis of otic eczema suitable for local treatment Exclusion Criteria: Other diseases.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: DF277<br>Two administrations daily for 7 days | Drug: DF277<br>* Two administrations daily for 7 days<br>|
| Placebo Comparator: Placebo<br>Two administrations daily for 7 days | Drug: Placebo<br>* Two administrations daily for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the Itching Change at the End of Treatment. | The analysis of the itching change at the end of treatment (mean itching on days 4-8 compared to baseline). Itching was assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe | Baseline and days 4-8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Signs/ Symptoms | - Change in itching at follow-up (mean itching on days 9-15 compared to baseline). | Baseline and days 9-15 | 
| Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1). | Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 8 compared to baseline). Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe. | Baseline and day 8 | 
| Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1). | Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 15 compared to baseline). Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe. | Baseline and day 15 |
Juvenile Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.

Official Title
-----------------
A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis

Conditions
-----------------
Juvenile Chronic Arthritis

Intervention / Treatment
-----------------
* Drug: Anakinra
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* placebo<br>|
| Experimental: anakinra<br> | Drug: Anakinra<br>* anakinra<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the study was to evaluate the safety of anakinra |  | 28 weeks |
Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Drug: Thymoglobulin Induction
* Drug: Basiliximab Induction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old Recipient of a renal allograft Patient receiving either basiliximab or thymoglobulin as in induction therapy for renal transplant Patient presenting a low immunologic risk Patient not opposed to his (her) study participation Exclusion Criteria: Patient participating in a clinical trial

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 |
| --- | --- |
| Thymoglobulin Induction<br>Patient receiving thymoglobulin as an induction therapy for renal transplant | Drug: Thymoglobulin Induction<br>* The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Thymoglobulin treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.<br>|
| Basiliximab Induction<br>Patient receiving basiliximab as an induction therapy for renal transplant | Drug: Basiliximab Induction<br>* The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Basiliximab treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distribution of mature blood B cells subpopulations will be compared between the 2 groups |  | one year after renal transplant | 
| Proliferation of freshly isolated cells T in presence of autologous B cells will be compared between the 2 groups. |  | one year after renal transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum B-cell activating factor (BAFF) concentration comparison between the two groups |  | one year after renal transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Transplant, Immunology
Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia

Study Overview
=================
Brief Summary
-----------------
This is a registry study that aims to collect patients' data with advanced-stage rare cancer in Asia-Pacific region. Data includes clinical information, details of treatment, prognosis, pathological diagnosis and genetic biomarkers by next-generation sequencing. The relationship between cancer types and prognosis, the effect of treatments, and the cancer type-specific incidence of genomic alterations will be investigated to discover more specific and effective treatment.

Official Title
-----------------
A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA

Conditions
-----------------
Rare Malignant Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a histological diagnosis of rare cancer, cancer of unknown primary origin, or cancer of rare tissue subtypes of common cancers. (Defined in protocol.) Patients with Advanced stage cancer. Exclusion Criteria: 1. Patients with complications of cognitive impairment.

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 |
| --- | --- | --- |
| Overall incidence of any genomic alteration in overall population | Overall incidence of any genomic alteration in overall population | 1 year | 
| Overall incidence of any genomic alteration in patients with a certain cancer type | Overall incidence of any genomic alteration in patients with a certain cancer type | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of individual genomic alteration in overall population | The incidence of individual genomic alterations in overall population | 1 year | 
| Incidence of individual genomic alteration in patients with a certain cancer type | The incidence of individual genomic alterations in patients with a certain cancer type | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rare cancer, Rare subtype, Registry, Asia, Next-generation sequencing