linjc16/ctgov huggingface dataset:
HIV Diversity and Pathogenesis in Donor-Recipient Clusters

Study Overview
=================
Brief Summary
-----------------
To assess, in donor-recipient clusters, current models of HIV-1 genetic evolution and pathogenesis, based on the sequence diversity displayed by this lentivirus.

Detailed Description
-----------------
DESIGN NARRATIVE: Based on anti-HIV-1 screening of a repository of 200,000 blood donor sera collected in late 1984, the Transfusion Safety Study identified and enrolled into ongoing followup 133 seropositive donors and 111 HIV-1-infected transfusion recipients. Included among these were 38 'transmission clusters' composed of a donor and from one to six linked, infected recipient(s), and, in four cases, infected recipients' sexual partners. Frozen cells and sera collected at six-month intervals over a six-year period from members of these clusters were available for study. Specimens were accessed such that sub-repositories of cellular DNA, PCR-amplified HIV-1 sequences, and viral isolates were generated for future investigations of these unique clusters. The studies included analysis of sequence diversity in envelope (env) V3, V4, and V5 hypervariable regions both within each infected individual over time, and between different members of each cluster and different clusters. Sequence diversity profiles from PBMC and serum were analyzed separately to discern differences in these different blood components at each sampling and over time. The pattern of turnover of specific sequence variants over time (evolution of viral genotypes) was correlated with clinical and immunological progression. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Acquired Immunodeficiency Syndrome, Blood Transfusion, Blood Donors, HIV Infections

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

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.

Official Title
-----------------
A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn's Disease Subjects Who Have Previously Participated in Antegren Crohn's Disease Studies

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: natalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and Female Subjects 18 years and older with Crohn's Disease who have participated in studies CD251, CD301, CD303, CD306, or CD307 per protocol

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: natalizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs. |  |  |
The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Study Overview
=================
Brief Summary
-----------------
More recent studies have shown that the HBV-infected population has a greater risk of development of hepatocellular carcinoma. Nevertheless, there are still a significant number of people chronically infected by HBV who do not develop the complication. Hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.

Official Title
-----------------
Strategic Alliance for The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Conditions
-----------------
Hepatitis B,Chronic, Carcinoma,Hepatocellular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of at least 21 years old on day of giving consent for study Patients must be able and wiling to give an informed consent Patient with chronic HBV infection Patient with active hepatocellular carcinoma and chronic hepatitis B Healthy subjects Exclusion Criteria: Patients who have co-infection with HIV or chronic hepatitis C Subjects with other types of cancer

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
hepatocellular carcinoma, microarray, gene expression profiling, biomarkers
Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia

Study Overview
=================
Brief Summary
-----------------
breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer.

Detailed Description
-----------------
thrity patients participated in this randomized, single-blined study. Before and at the postoperative day 1, the bowel function (orocecal transmit time) were measured. Before induction of general anesthesia, patients recieved a bolus of intravenous Tenoxicam or an equal volume of saline (control group). Pain score and opioid consumption were recorded in the postoperative period and then daily for 1 week.

Official Title
-----------------
Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia in Patients Receiving Abdominal and Non-abdominal Surgeries.

Conditions
-----------------
Gastrointestinal Recovery

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I to II Breast cancer patients Mastectomy or wide local excision + axillary note dissection Exclusion Criteria: Preexisting malignancy Chronic infection Previous pain condition Diabetes Thyroid disorder Severe cardiac, renal or hepatic disease Previous breast surgery Psychiatric illness Neurological disease Contraindication for tenoxicam or morphine use

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: treatment: Tenoxicam; control: placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tenoxicam<br>nonsteroidal anti-inflammatory drug (NSAID) | Drug: Tenoxicam<br>* nonsteroidal anti-inflammatory drug (NSAID)<br>|
| Placebo Comparator: placebo<br>equal volume of normal saline | Drug: Placebo<br>* equal volume of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | morphine consumption after breast cancer surgery | until postoperative day7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| orocecal transmit time, | smal intestinal function | preoperative and postoperative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orocecal transmit time, flatus
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of metformin.

Official Title
-----------------
A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Metformin

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

Intervention / Treatment
-----------------
* Drug: AZD1656
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female (with non child-bearing potential) Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t HbA1c <11 % at screening (HbA1c value according to international DCCT standard) Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1656 | Drug: AZD1656<br>* Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG) |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions | 
| Pharmacodynamic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes
Obstetric Anesthesia and Analgesia Month Attributes in Czech Republic

Study Overview
=================
Brief Summary
-----------------
A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic.

Detailed Description
-----------------
A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic. Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.

Official Title
-----------------
A National Survey on Obstetric Anesthesia and Analgesia Care in Czech Republic

Conditions
-----------------
Obstetric Anesthesia Care

Intervention / Treatment
-----------------
* Procedure: Obstetric anesthesia and analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in labor undergoing anesthesia care
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstetric anesthesia and analgesia<br>Women in labor undergoing anesthesia care | Procedure: Obstetric anesthesia and analgesia<br>* All anesthesia procedures during labor: labor analgesia, anesthesia for Cesarean section, anesthesia for procedures in third stage of labor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A national survey of current practice of obstetric anesthesia and analgesia in Czech Republic | Monitoring of all obstetric anesthesia procedures in peripartal period and anesthesia complications: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor. | Parturition period, up to 24 hours after labor |
Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
This study is to determine if subjects with .systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening

Detailed Description
-----------------
Pilot study to assess whether patients with systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening

Official Title
-----------------
Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis

Conditions
-----------------
Systemic Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfill the American College of Rheumatology criteria for systemic sclerosis or: Have no diseases that result in primary fibrosis of an organ system, including the skin and do not have an autoimmune disease Exclusion Criteria: If the subject has systemic sclerosis resulting from an environmental exposure If the subject has an autoimmune disease excluding scleroderma If the subject has an active infection (including, but not limited to hepatitis B, hepatitis C and HIV) If the subject has been treated with cyclophosphamide in the past 8 weeks. If the subject is prone to bleeding because they are on medications that thin the blood or have a low platelet count.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Subjects with diffuse scleroderma | |
| 2<br>Subjects with limited scleroderma | |
| 3<br>Subjects without a fibrosing or autoimmune disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulatory autoantibodies to the PDGF receptor |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phosphorylation of the PDGF receptor in patients with systemic sclerosis |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
systemic sclerosis autoantibodies
Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

Detailed Description
-----------------
To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese. The investigation will be conducted as the addtional pharmacovigilance activitiy specified in the Japan Risk Management Plan (J-RMP) of Evusheld in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).

Official Title
-----------------
General Drug Use-Result Study of Evusheld Intramuscular Injection Set (Treatment and Prevention of Symptomatic Disease Caused by SARS-CoV-2 Infection)

Conditions
-----------------
SARS-CoV-2 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For treatment of symptomatic disease caused by SARS-CoV-2 infection; Patients with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen. For prevention of symptomatic disease caused by SARS-CoV-2 infection; Individuals for whom SARS-CoV-2 vaccination is not recommended OR those who are considered to have an inadequate response to a COVID-19 vaccine due to immunodeficiencies AND who is not close contacts such as family members or other people living in the same dwelling as patients infected with SARS-CoV-2. Exclusion Criteria: None
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 |
| --- | --- | --- |
| Incidence of ADRs | The incidence of ADRs related to Evusheld Safety Specification; anaphylaxis and other serious allergic reactions, cardiovascular events | 24weeks(6 months) |
Efficacy and Safety Study of MK0359 in Patients With Arthritis (0359-017)

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety Study of MK0359 in Patients with Arthritis

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

Intervention / Treatment
-----------------
* Drug: MK0359


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You are 18-65 years of age and have Rheumatoid Arthritis You must be able to read and understand patient questionnaires Exclusion Criteria: You have had certain types of surgery, certain types of cancer or history of Tuberculosis (TB) or HIV.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: MK0359|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Psychiatric Rehabilitation Approach to Weight Loss

Study Overview
=================
Brief Summary
-----------------
The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation Weight Loss program in reduction of weight and body mass index (BMI.

Detailed Description
-----------------
The study involves 144 individuals who will be randomly assigned to the intervention group or treatment as usual group(control group). All Participants will undergo baseline assessment, assessment at week 12, week 24 and in year from baseline.

Official Title
-----------------
The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.

Conditions
-----------------
Schizophrenic Disorders

Intervention / Treatment
-----------------
* Behavioral: Psychiatric Rehabilitation Approach to Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of serious mental illness, Age 18 - 65 BMI > 25 Medication stable (there have been no changes in antipsychotic medications or mood stabilizers for the last 3 months). Exclusion Criteria: Current or history of eating disorder Pregnant or breast feeding Uncontrolled HTN Severe coronary artery disease Severe valvular disease Uncontrolled diabetes Sustained arrhythmia Insulin using severe physical limitations Severe Lung Disorders Diagnosis of MR or dementia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Behavioral | Behavioral: Psychiatric Rehabilitation Approach to Weight Loss<br>* The use of psychiatric rehabilitation as a way to lose weight<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction of weight and Body Mass Index (BMI) |  | Week 12, Week 24, 1 Year from Baseline Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity |  | Baseline, 12 Weeks, 24 weeks, 1 year |