linjc16/ctgov huggingface dataset:
Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two drugs (nelfinavir [NFV] and efavirenz [EFV]) used in start-up anti-HIV treatment. Doctors want to see if one is better than the other in extending the time that viral load (level of HIV in the blood) is kept low. The study will also look at the response of the immune system to each drug.

Detailed Description
-----------------
Patients are randomized to initiate therapy and receive either nelfinavir (NFV) or efavirenz (EFV) in the first regimen (R1). All patients also receive zidovudine (AZT) and lamivudine (3TC). Patients are further randomized in a factorial fashion and by stratification based on HIV RNA level (less than 10,000, 10,000-100,000, or greater than 100,000 copies/ml) to be administered a single injection of a neo-antigen (KLH) at Week 12, 24, or 48. Therapy continues until switch criteria are met either before or after Week 24. When switch criteria are met, patients advance to the next regimen (R2). R2 patients previously taking NFV switch to EFV; those randomized to EFV switch to NFV; the additional NRTIs change to stavudine (d4T) and didanosine (ddI). Therapy is continued for an additional 24 weeks.

Official Title
-----------------
A Randomized, Open-Label, Study of Nelfinavir or Efavirenz in HIV-1 Infected, Antiretroviral Naive Patients

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

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate
* Drug: Efavirenz
* Drug: Lamivudine
* Drug: Keyhole-Limpet Hemocyanin
* Drug: Stavudine
* Drug: Zidovudine
* Drug: Didanosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this trial if they: Are HIV-positive. Have a CD4 count of at least 100 cells/mm3. Have a viral load of at least 5,000 copies/ml. Exclusion Criteria Patients may not be eligible for this study if they: Have taken any antiretroviral (anti-HIV) agent.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|nan|
|Drug: Efavirenz|nan|
|Drug: Lamivudine|nan|
|Drug: Keyhole-Limpet Hemocyanin|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
-----------------
efavirenz, HIV-1, Drug Therapy, Combination, Lymphoid Tissue, HIV Protease Inhibitors, Genotype, Phenotype, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Adipose Tissue, Glucose, Lipids, Immunophenotyping
Evaluating the Hunger Project in Ghana

Study Overview
=================
Brief Summary
-----------------
The Hunger Project/Epicenter strategy is a community based development strategy that will positively affect health, education, empowerment, and consumption.

Detailed Description
-----------------
The investigators propose a randomized controlled design that will measure how The Hunger Projects' intervention affects the lives of Ghanaians. A pre-intervention baseline survey of approximately 4,000 households with over 20,000 individuals and two follow-up surveys of the same households will be conducted over the ten year experimental period.

Official Title
-----------------
Evaluating the Hunger Project's Scaling-up of Epicenter Strategy in Ghana

Conditions
-----------------
To Better Understand How Epicenter's (Which House Education, Health and Finance Centers in Ghana) Increase Individual's Sense of Empowerment.

Intervention / Treatment
-----------------
* Behavioral: Community Empowerment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject population will be individuals and households from communities in the Eastern Region of Ghana. Exclusion Criteria: Only exclusion criteria is that households outside of the Eastern region of Ghana will not be surveyed
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Community Empowerment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased sense of empowerment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased health, education, and consumption outcomes and increase in the number of public goods |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
empowerment, health, education
Prognostic Factors in Periampullary Tumors and Cysts

Study Overview
=================
Brief Summary
-----------------
The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.

Detailed Description
-----------------
From november 2021 an onward, study participants will be prospectively enrolled within the observational study. Before that, study participants are retrospectively enrolled. The study has a broad perspective including studies on clinical outcomes and prognostics based on patient and tumor characteristics.

Official Title
-----------------
Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region

Conditions
-----------------
Pancreas Cancer, Pancreas Neoplasm, Pancreas Cyst, Pancreatic Fistula, Pancreas Disease, Bile Duct Cancer, Periampullary Cancer, Surgery, Surgery--Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recommended surgery for tumor or cyst in the pancreas or periampullary region Information avalible in electronic journal files Informed consent (or deceased for retrospective part of the study) Exclusion Criteria: No informed consent (and still alive at study initiation)

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 survival | Overall survival | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Clavien-Dindo, Specific procedure related outcomes | 10 years | 
| Radical resection | Rates of R0 vs R1/2 resections | 10 years |
A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Detailed Description
-----------------
Study Design: Post Marketing study- Observational study

Official Title
-----------------
A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus(SELINA Study)

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

Intervention / Treatment
-----------------
* Drug: Trajenta tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form Exclusion criteria: Patients with previous exposure to Trajenta and current participation in clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 19 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 with Type 2 Diabetes Mellitus<br> | Drug: Trajenta tablet<br>* Linagliptin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta | Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta. | Up to 26 weeks (long-term surveillance) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) | Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c). | Baseline and Week 24 | 
| Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment | Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment. | 24 Weeks | 
| Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) | Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment). | 24 Weeks | 
| Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) | Change from baseline after 24 weeks in fasting plasma glucose (FPG). | Baseline and Week 24 |
Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates

Study Overview
=================
Brief Summary
-----------------
Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. It is however unknown if the application of deep NMB leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and ultimately lower readmission rates. In the leiden university medical center, deep NMB is routinely applied for a variety of procedures, most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro radiologic intervention surgery, since 2014. This retrospective study intends to investigate whether the application of deep NMB for these procedures affects patient outcome and readmission rates.

Official Title
-----------------
Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates: A Retrospective Analysis of Patient Chart Data

Conditions
-----------------
Pneumonia, Postoperative Complications, Postoperative Wound Infection

Intervention / Treatment
-----------------
* Drug: deep neuromuscular block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: deep neuromuscular block moderate neuromuscular block general anesthesia complete anesthesia chart Exclusion Criteria: incomplete anesthesia chart missing data regarding postoperative complications or readmission

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 |
| --- | --- |
| Deep neuromuscular block<br>patients received a continuous rocuronium dose to maintain a depth of neuromuscular block of 1-2 twitches post tetanic count | Drug: deep neuromuscular block<br>* a continuous dosing of rocuronium is used to achieve neuromuscular block of 1-2 twitches post tetanic count<br>|
| moderate neuromuscular block<br>patients received neuromuscular block aimed at > 0 twitches train of four | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | readmission to the hospital | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | The total cost, including sugammadex use and readmission cost | 30 days after surgery |
The Role of Steroids Following Selective Laser Trabeculoplasty

Study Overview
=================
Brief Summary
-----------------
To evaluate whether or not using topical steroids after selective laser trabeculoplasty affects intraocular pressure outcomes.

Detailed Description
-----------------
Subjects undergoing bilateral SLT will be randomly assigned to use prednisolone acetate 1% in one eye four times daily with no treatment in the fellow eye, for one week following SLT. Examinations will occur at baseline, and one week, one month and three months after SLT. IOP and anterior chamber inflammation will be noted at each visit.

Official Title
-----------------
The Role of Topical Prednisolone Acetate Following Selective Laser Trabeculoplasty

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: prednisolone acetate 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma or ocular hypertension need for bilateral SLT Exclusion Criteria: eye disease precluding accurate IOP measurement contraindication to topical prednisolone acetate

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: prednisolone acetate 1%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior chamber inflammation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, trabeculoplasty, steroids
Intervention of Air Pollution and Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
To determine the effect of intervention of ambient air pollution on acute coronary syndrome patients.

Detailed Description
-----------------
To investgate the effect of wearing facemasks to decreasing levels of exposure to ambient air on acute coronary syndrome patients.

Official Title
-----------------
Intervention of Air Pollution and Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Device: mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoker of any type during past six months and living in a non-smoking household. A diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent. Exclusion Criteria: Unstable CV disorders including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension. A history of infection with human immunodeficiency virus. History of malignancy including leukemia and lymphoma AND/OR any severe, life-threatening disease AND/OR history of drug abuse within the last 2 years. Pregnancy or intent to get pregnant during the study period.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: no masking<br>not wearing facemask | Device: mask<br>* facemask<br>|
| Active Comparator: masking<br>wearing facemask | Device: mask<br>* facemask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular function | Systolic blood pressure and diastolic blood pressure measured by omron HBP-1300 | six months | 
| autonomic nervous function | Twenty four-hour electrocardiograms and heart rate variability | six months |
Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.

Official Title
-----------------
Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA as defined by ACR/EULAR criteria Clinical indication to start abatacept therapy Exclusion Criteria: Treatment by rituximab in the previous year

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood B-cell phenotype changes | Measure of the proportion of the main B-cell subsets (transitional, naïve, memory, plasmablasts) by FACS analysis before abatacept initiation and 3 months later. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vitro B-cell function and regulatory properties | In vitro culture of B cells from the patients to assess B cell inhibition of T cell proliferation before abatacept initiation and 3 months later. | 3 months |
Prospective Randomised Study of a New an Uncemented Stem.

Study Overview
=================
Brief Summary
-----------------
Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.

Official Title
-----------------
Prospective Randomised Study of a New Anteverted Uncemented Stem. Randomised Study Between the SP-CL and the Corail Stem With the Use of a Delta Cup.

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Device: Hip Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoartritis Secondary osteoartritis Exclusion Criteria: Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Active Comparator: SP-CL<br> | Device: Hip Arthroplasty<br>* Patients are operated with hip replacement.<br>|
| Active Comparator: Corail<br> | Device: Hip Arthroplasty<br>* Patients are operated with hip replacement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford hip score | Patient reported outcome measure | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSA-examination | Migration of stem | two years | 
| Conventional X-rays | Detection of radiolucent lines | two years | 
| Harris hip score | Patient reported outcome | two years | 
| DXA | Change of bone mineral density | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip arthroplasty, Joint replacement, Uncemented stem, Anatomical stem
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy

Official Title
-----------------
A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Irbesartan/Amlodipine
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 19 years or older on screening Signed informed consent Patients with Essential Hypertension Other inclusion applied Exclusion Criteria: Orthostatic hypotension with symptom Other exclusion applied

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irbesartan/Amlodipine<br> | Drug: Irbesartan/Amlodipine<br>* Irbesartan/Amlodipine once daily for 8 weeks<br>|
| Active Comparator: Irbesartan<br> | Drug: Irbesartan<br>* Irbesartan once daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting systolic blood pressure (mmHg) |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form baseline in mean sitting systolic blood pressure (mmHg) |  | Week 4 | 
| Change form baseline in mean sitting diastolic blood pressure (mmHg) |  | Week 4, 8 | 
| Responder rate |  | Week 4, 8 | 
| Target blood pressure reach rate |  | Week 4, 8 |