linjc16/ctgov huggingface dataset:
PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.

Official Title
-----------------
Longterm Efficacy and Safety of NVP-based HAART in HIV-1 Positive Patients in the Daily Clinical Practice.

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: The inclusion criteria follow the same criteria which are describe in the newest SPC. Exclusion criteria: The exclusion criteria follow the same criteria which are describe in the newest SPC.

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 |
| --- | --- |
| Patients HIV-1 positive<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Reporting Adverse Events | the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic Response (VR) | VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine. | 48 weeks | 
| Change in CD4+ Cell Count From Baseline to Week 48 | Calculated as CD4+ cell count at week 48 minus the baseline value | Baseline and week 48 |
The China Valvular Heart Disease Study

Study Overview
=================
Brief Summary
-----------------
This is a observational、multicenter, prospective cohort study for adults with significant VHD. The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with VHD；also to set up registration system of adult VHD in China, to build a database of Chinese adult VHD, to establish a web-based international standard data acquisition system for VHD and a multicenter clinical research platform. The results of the study will provide a basis for the future national health policy for prevention and treatment of adult VHD.

Official Title
-----------------
China Registry and Cohort Study of Valvular Heart Disease in Adults

Conditions
-----------------
Valvular Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 60 years old meet one of the following conditions. moderate or above valvular heart disease as defined by echocardiography: （1）aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, （2）aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （3）mitral stenosis, moderate or above, or valve area ≤1.5cm2, （4）mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （5）tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, （6）tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, （7）pulmonic stenosis, moderate or above, or maximal jet velocity >4m/sec, （8）pulmonic regurgitation, moderate or above, or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation), or diagnosis of endocarditis as assessed by Duke criteria. Exclusion Criteria: Patients cannot be followed up for any reasons. Patients have been enrolled in this study.

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 |
| --- | --- | --- |
| all-cause mortality |  | 2years |
Use of Morphine Gel Topically in Patients With Stage 2-3 Wounds

Study Overview
=================
Brief Summary
-----------------
Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of oral and intravenous pain medications, therefore reducing side effects.

Detailed Description
-----------------
Patients will be randomized to receive either placebo (versa base gel) or morphine gel to wound. Patients receiving morphine gel will have a decrease in pain score and use less oral/intravenous pain medications.

Official Title
-----------------
A Phase 3, Single-Centered, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Trial of Morphine Sulfate Gel 0.1% in Patients With Stage 2-3 Wounds

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Drug: morphine topical gel
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated consent form & HIPAA > 18 yo Single stage 2-3 wound No allergy to morphine Alert and oriented (thinking ability clear and intact, physician approval) English language proficiency Exclusion Criteria: Allergy to morphine, codeine, or versa base, pts taking medications for acute condition, other than for the wound pain Patients with neuropathies Patients with respiratory conditions

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>group to receive topical gel without morphine | Drug: placebo<br>* topical gel without morphine<br>|
| Experimental: 2<br>Morphine gel | Drug: morphine topical gel<br>* morphine gel 0.1%, applied every 12 hours to stage 2-3 wound, during their hospital stay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy with the use of morphine gel applied topically for pain control |  | 1 year |
Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.

Official Title
-----------------
Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study

Conditions
-----------------
Newly Diagnosed Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed multiple myeloma; age over 18 years, male or female; glomerular filtration rate (eGFR) < 40 mL/min Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process; patients who completed at least one course of treatment were included in the safety observation; Patients who completed at least 2 courses of treatment were included in the efficacy observation; Exclusion Criteria: acute and chronic renal insufficiency not caused by myeloma; are receiving any other investigational drug or investigational medical device; Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment; patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;

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

| Intervention/Treatment |
| --- |
|Drug: Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens|Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Very good partial response (VGPR) rate |  | 28 days after consolidation therapy |
A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.

Detailed Description
-----------------
100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir). Patients will be treated for 48 weeks.

Official Title
-----------------
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Lamivudine
* Drug: Stavudine
* Drug: Zidovudine
* Drug: Didanosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count of 200 - 700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|
|Drug: Zidovudine|nan|
|Drug: Didanosine|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
-----------------
Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Postoperative Pain in Orbital Disease and Ocular Tumor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the postoperative pain after general anesthesia of orbital diseases and ocular tumor patients.

Detailed Description
-----------------
The purpose of this study is to evaluate patients diagnosed of orbital diseases or ocular tumor over 16 years old of the postoperative pain after general anesthesia , and to analyze the related factors of pain after operation.

Official Title
-----------------
Postoperative Pain of General Anesthesia in Orbital Disease and Ocular Tumor

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: general anesthesia,orbital operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 16 years old diagnosed as orbital disease or ocular tumor surgery under general anesthesia Exclusion Criteria: any uncontrolled clinical problems

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: general anesthesia,orbital operation<br>diagnosed as orbital disease and ocular tumor over 16 years old orbital operation under general anesthesia | Procedure: general anesthesia,orbital operation<br>* to evaluate the pain under general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | numerical rating scale, NRS will be used to measure the pain | 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, general anesthesia
Oral Nutritional Supplementation of Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.

Official Title
-----------------
Oral Nutritional Supplementation of Hemodialysis Patients

Conditions
-----------------
Hemodialysis Complication

Intervention / Treatment
-----------------
* Dietary Supplement: Fresubin® Protein Energy DRINK
* Dietary Supplement: NEPRO® , Abbott


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-80 years Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least. Malnutrition patients. Definition of Malnutrition is serum albumin level<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW. Exclusion Criteria: BMI<18.5 and calorie intake unable to reach 50% of the recommended level BMI>30 kg/m2, abnormal liver function, malignant disease, scheduled surgery within a month or after surgery, infectious disease, suboptimal tolerance of nutritional supplements, inflammatory bowel disease, bowel obstruction, acute condition complicated with multiple organ failure or under palliative care.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NEPRO®<br> | Dietary Supplement: NEPRO® , Abbott<br>* 2-4 cans NEPRO® per day<br>|
| Experimental: Fresubin® Protein Energy DRINK<br> | Dietary Supplement: Fresubin® Protein Energy DRINK<br>* 1-2 bottles of Fresubin® Protein Energy DRINK per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Albumin level change |  | baseline, weerk 4 and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change |  | baseline, weerk 4 and week 8 |
Intervention for Resistant Pregnant Smokers

Study Overview
=================
Brief Summary
-----------------
This 31-month supplement to Sustaining Women's Smoking Cessation Postpartum (Project PANDA) designed, implemented, and evaluated an intensified intervention for pregnant women who were unable to stop smoking with minimal assistance.

Detailed Description
-----------------
DESIGN NARRATIVE: The substudy was a population-based experiment with White, Black, and Hispanic pregnant women whose continued smoking made them ineligible for randomization into the parent study. It was unique in focusing on heavier, more addicted pregnant smokers. PANDA research sites and protocols offered a special opportunity for a low cost test of a disseminable intervention which this project team was uniquely qualified to design and implement. The new intervention, One- to-One, used telephone counselors to assess the counselee's stage in the change process and give stage-appropriate messages, using established techniques of motivational interviewing. Between the two counselor calls spaced 10 days apart, counselees received personalized written feedback and suggestions. The primary aim, increasing quitting during pregnancy, was assessed by unobtrusive urine samples taken during prenatal visits in the ninth month and identified only by study group. A series of postpartum interviews with subsample cotinine validation was used to examine the second important aim, reduction of infant smoke exposure. A combination of messages, peer modeling, and support helped women sustain cessation after delivery and eliminate smoking around the baby. Project PANDA videotapes and newsletters already contained these messages and required only minimal supplementation to be used with the One-to-One experimental group, regardless of their success in quitting in pregnancy. As in Project PANDA, the assessments were separated from the experiment by enrolling subjects in a university-sponsored study of new mothers' health practices and baby care and by presenting the program as usual care by the health care site.

Conditions
-----------------
Cardiovascular Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Zilver® PTX™ Global Registry

Study Overview
=================
Brief Summary
-----------------
The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Official Title
-----------------
Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery

Conditions
-----------------
Peripheral Arterial Disease, Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: Zilver® PTX™ Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stenosis of the above-the-knee femoropopliteal artery appropriate size and location of the lesion Exclusion Criteria: pregnant or breast feeding failure or inability to give informed consent simultaneously participating in another drug or device study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent<br> | Device: Zilver® PTX™ Stent<br>* Stenting of the superfemoropopliteal artery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free Survival |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Aterial Disease (PAD), Peripheral Vascular Disease, Drug-Eluting Stent, Drug-Coated Stent, Vascular Diseases, Cardiovascular Diseases
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis

Study Overview
=================
Brief Summary
-----------------
Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the calcified component.

Official Title
-----------------
Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis

Conditions
-----------------
Carotid Disease, Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Vitamin K2 (Menaquinone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque Exclusion Criteria: renal and/or hepatic failure diseases with secondary calcifications dementia previous strokes concomitant use of anticoagulants concomitant infections pregnancy or breastfeeding reduced patient's compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin K2<br> | Drug: Vitamin K2 (Menaquinone)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in plaque calcification and carotid stenosis |  | One year |