linjc16/ctgov huggingface dataset:
Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

Study Overview
=================
Brief Summary
-----------------
Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.

Detailed Description
-----------------
The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.

Official Title
-----------------
Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis

Conditions
-----------------
Tuberculosis Infection

Intervention / Treatment
-----------------
* Diagnostic Test: TB-antigen responsive T cell markers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patients suspicious of TB infection TB culture and Xpert test required Chest X-ray required Exclusion Criteria: anti-TB therapy before the sample collection.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active TB<br>Subjects met the following: Either Pulmonary or Extra-pulmonary tuberculosis patients TB Bacteriological evidence obtained by culture or Xpert MTB/RIF from at least 1 specimen. | Diagnostic Test: TB-antigen responsive T cell markers<br>* A blood test including a series of T cell markers which are responsive to TB antigens<br>|
| Latent TB<br>Subjects met the following: TB Contact in history. Chest X-ray suggestive of non-TB. without any symptoms suggestive of TB. TST and/or IGRA positive. | Diagnostic Test: TB-antigen responsive T cell markers<br>* A blood test including a series of T cell markers which are responsive to TB antigens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive rate and negative rate | Evaluation of the positive rate and negative rate for each T cell marker | 2-3 month after sampling | 
| Receiver operating characteristic curve | The AUC of each T cell marker will be analyzed and compared | 2-3 month after sampling |
Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip.

Official Title
-----------------
A Multicenter, Open-Label, Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ [greater than or equal to] 40 years of age If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening Exclusion Criteria: Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease Has significant difficulties swallowing capsules or is unable to tolerate oral medication

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Diclofenac Capsules 35 mg bid or tid<br> | Drug: Diclofenac<br>* 35 mg bid or tid Capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events. | Baseline to Week 52/Early Termination |
Expanded Access to Venetoclax

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Venetoclax

Conditions
-----------------
Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma, Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia (ALL), Amyloidosis, Plasma Cell Leukemia

Intervention / Treatment
-----------------
* Drug: Venetoclax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant must not be eligible for a venetoclax clinical trial. Pediatric participants may be evaluated on a case by case basis.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Venetoclax|Venetoclax will be administered orally.|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration

Study Overview
=================
Brief Summary
-----------------
Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark. 200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.

Official Title
-----------------
Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration

Conditions
-----------------
Osteoarthritis, Knee, Joint Instability

Intervention / Treatment
-----------------
* Device: BPK-S Integration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital or acquired knee joint defects/deformation or Defects or malfunction of the knee joint or Arthrosis (degenerative, rheumatic) or Post-traumatic arthritis or Symptomatic knee instability or Reconstruction of flexibility or Patients with metal hypersensitivity (ceramic tibia/femur) Exclusion Criteria: Illnesses which can be treated without using a knee joint implant. Acute or chronic infections near the implantation Systemic diseases and metabolic disorders Serious osteoporosis Serious damage to the bone structures that impedes stable implantation of the implant components Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc. Bone tumors in the area of the implant anchoring Obesity or overweight of the patient Overload of the knee implant to be expected Abuse of medication, drug abuse, alcoholism or mental disease Lack of patient cooperation Sensitivity to foreign matter in the implant materials Patients under the age of 18 Patients participating in another 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

| Intervention/Treatment |
| --- |
|Device: BPK-S Integration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until revision |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of clinical situation based on Knee Society Score |  | 3 and 12 months, 2, 5, 10 years | 
| Documentation of incidents |  | Up to 10 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary TKR
Nutrition and Exercise Intervention Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study was to clarify the effects of increase in physical activity on incidence and surrogate marker of cardiovascular diseases. The working hypothesis of the present study was that the physical activity to satisfy the Japanese guideline of Ministry of Health, Labour and Welfare is effective for the primary prevention of the lifestyle-related disease.

Official Title
-----------------
Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People

Conditions
-----------------
Hypertension, Dyslipidemia, Diabetes, Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Ages 30-64 years old Exclusion Criteria: During treatment of any diseases Two or more metabolic risk factors

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Physically inactive participants receiving both physical activity and dietary counseling | Behavioral: physical activity<br>* The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.<br>|
| No Intervention: Active<br>Physically active participants receiving only dietary counseling | |
| No Intervention: Control<br>Physically inactive participants receiving only dietary counseling | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively measured amount of physical activity |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) |  | 5 years | 
| Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) |  | 10 years | 
| Incidence of musculoskeletal and joint pain |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity, nutrition, cardiovascular diseases, musculo-skeletal problems
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus for more than 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br> | Drug: Faster-acting insulin aspart<br>* A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.<br>* Other names: NN1218;|
| Experimental: Formulation B<br> | Drug: Faster-acting insulin aspart<br>* A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.<br>* Other names: NN1218;|
| Active Comparator: Insulin Aspart<br> | Drug: insulin aspart<br>* A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  | From 0 to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  | From 0 to 12 hours | 
| Maximum glucose infusion rate |  | Within 0 to 12 hours after dosing | 
| Time to maximum glucose infusion rate |  | Within 0 to 12 hours after dosing |
Sleep in Critically Ill Patients on Mechanical Ventilation in ICU

Study Overview
=================
Brief Summary
-----------------
15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep features within the groups

Detailed Description
-----------------
It is an observational study in order to define if there are common polysomnographic sleep features within the following three groups of wake critically ill patients on mechanical ventilation in ICU: the group of septical patients, the group of patients with chronic obstructive pulmonary disease in exacerbation and the group of surgical patients without sepsis. 15 patients will be included in each group. They will undergo polysomnographic sleep monitoring during up to 24 hours. Polysomnograms will be studies then in order to find out if there are common sleep characteristics within the homogeneous patient groups of critically ill.

Official Title
-----------------
Sleep Investigation in 3 Homogeneous Groups of Wake Mechanically Ventilated Patients in ICU: 1st Group - Septical Patients; 2nd Group - COPD Patients; 3rd Group - Surgical Patients, in Order to Define Common Sleep Features Within the Groups

Conditions
-----------------
Polysomnographic Sleep Characteristics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: wake non-sedated patients mechanical ventilation Exclusion Criteria: age < 18 years pregnant Glasgow Coma Scale < 11 sedated patients

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 |
| --- | --- |
| septic patients<br>wake septic patients on mechanical ventilation | |
| COPD patients<br>wake COPD patients on mechanical ventilation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polysomnographic sleep features |  | polysomnographic sleep assessment during up to 24 hours |
Role of Adipose Tissue in Pathogenesis of Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body composition and insulin resistance are measured before and during the diet.

Detailed Description
-----------------
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet without any medication and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. Adipose tissue samples are obtained using needle biopsy. In addition, before and during the diet,body composition is measured using multifrequency bioimpedance and insulin resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived indices.

Official Title
-----------------
Role of Adipose Tissue in Pathogenesis of Insulin Resistance

Conditions
-----------------
Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Behavioral: Hypocaloric diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity Exclusion Criteria: Diabetes Coronary heart disease Eating disorders Medication of beta blockers Medication of antiobesity drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Hypocaloric diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  |  | 
| Body fat |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance |  |  | 
| Adipocytokine plasma levels |  |  | 
| Adipocytokine adipose tissue expression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Insulin resistance, Hypocaloric diet, Adipose tissue, adipocytokine
NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers (BE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2

Detailed Description
-----------------
Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Official Title
-----------------
An Clinical Trial to Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: NVP-1805
* Drug: NVP-1805-R1 and NVP-1805-R2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult subjects who signed informed consent BMI of >18.0 kg/m2 and <30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman) Exclusion Criteria: Subjects participated in another clinical trial within 6 months prior to administration of the study drug Inadequate subject for the clinical trial by the investigator's decision Subjects participated in another clinical trial within 6 months prior to administration of the study drug

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1805<br>orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg) | Drug: NVP-1805<br>* NVP-1805 (80/10/20.8mg)<br>|
| Active Comparator: NVP-1805-R1 and NVP-1805-R2<br>orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg) | Drug: NVP-1805-R1 and NVP-1805-R2<br>* coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NVP-1805's Pharmacokinetics of plasma | AUCt | 0hours - 72hours | 
| Pharmacokinetics of plasma | Cmax | 0hours - 72hours |