linjc16/ctgov huggingface dataset:
Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (DMARDs).

Official Title
-----------------
A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints; must also have DAS of 3.2 or greater at study entry, normal laboratory parameters and ESR >20, satisfactory response or intolerance to one or more prior DMARDs and be willing and able to give informed consent. Exclusion: Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia, history of acute inflammatory joint disease other than RA, prior treatment with cyclophosphamide or chlorambucil, prior treatment with intravenous immunoglobulin within 70 days, history of malignant lymphoma, history of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease or stroke, positive HIV status, positive serology for Hepatitis B or C, no previous history of tuberculosis or listeria infection, no previous history of cancer other than successfully treated skin cancer; women can not be pregnant or be breastfeeding

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity score at visit week 12 as compared to baseline |  |  |
Bioequivalence of Alprazolam Sublingual vs Oral Tablets

Study Overview
=================
Brief Summary
-----------------
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.

Official Title
-----------------
Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)

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

Intervention / Treatment
-----------------
* Drug: alprazolam sublingual tablet
* Drug: alprazolam oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects BMI 17.5 - 30.5 Must provide informed consent Exclusion Criteria: Clinically significant disease Narrow angle glaucoma Positive drug screen

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual tablet<br>Test treatment | Drug: alprazolam sublingual tablet<br>* 1 mg alprazolam sublingual tablet, given as a single dose to each subject<br>|
| Experimental: Oral tablet<br>Reference treatment | Drug: alprazolam oral tablet<br>* 1 mg alprazolam immediate release oral tablet, given as a single dose to each subject<br>* Other names: Xanax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) |  | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam time of maximum concentration (Tmax) and half life |  | 11 days | 
| Adverse events, clinical laboratory tests, vital signs |  | 11 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual
Frailty Assessment in Elderly Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients . It is an important factor on the cardiologist decision between conservative and invasive treatment in older patient with acute coronary syndrome, and is usually made subjectively by the cardiologist known in the literature as eyeball testing. in this study the investigators will compare the cardiologists eye ball testing to objective frailty assessment based on Fried score and Edmonton frailty scale.

Detailed Description
-----------------
elderly patients admitted to Meir hospital with acute coronary syndrome will be assessed for frailty twice: the first frailty assessment will be a subjective eye ball testing made by the cardiologist, the second assessment will be an objective one based on Fried frailty score and Edmonton frail scale. The cardiologist will not be aware of the objective frailty assessment result. The eye ball testing will be compared to the objective frailty assessment (Fried score and Edmonton frailty scale).

Official Title
-----------------
Frailty Assessment in Elderly Patients With Acute Coronary Syndrome

Conditions
-----------------
Frail Elderly Syndrome, Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient admitted to Meir hospital with acute coronary syndrome Age: 80 years old and older eligible for signing an informed concent Exclusion Criteria: uncontrolled heart failure ( pulmonary edema or the use of iv diuretics) cardiogenic shock fever st elevation myocardial infarction

Ages Eligible for Study
-----------------
Minimum Age: 80 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| A subjective eye ball frailty assessment will be compared to an objective frailty assessment based on Fried score and Edmonton frailty scale | Subjective frailty assessment made by a cardiologist during hospitalization with acute coronary syndrome- eye ball testing | Through hospitalization , an average of 1 week | 
| An objective frailty assessment using Fried score and Edmonton frailty scale will be compared to a subjective eye ball frailty assessment | An objective frailty assessment based on Fried score and Edmonton frailty scale | Through hospitalization , an average of 1 week |
Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Introduction: Diabetes mellitus a chronic diseases, is the most common and important metabolic disease in human. Increased free radicals production due to hyperglycemia produces oxidative stress which worsens the disease and its complications. Pomegranate juice has antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure and oxidative stress in patients with type 2 diabetes

Official Title
-----------------
Effects of Pomegranate Juice Consumption on Glycemic Control, Lipid Profile, Oxidative Stress and Blood Pressure in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Dietary Supplement: pomegranate juice
* Behavioral: lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 40-65 years Body Mass Index 18.5-30 Fasting blood glucose ≥ 126 mg/dl Exclusion Criteria: Smoking insulin for blood glucose control taking estrogen or progesterone (if female) Taking antioxidant supplements suffering from any other chronic diseases Participants are also excluded if they missed more than 10% of their pomegranate juice packs

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pomegranate juice<br>200 ml pomegranate juice + lifestyle modification | Dietary Supplement: pomegranate juice<br> <br> |
| Active Comparator: control<br>lifestyle modification including dietary recommendations | Behavioral: lifestyle modification<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total antioxidant capacity |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pomegranate, diabetes, oxidative stress
Early Chemotherapy Intensification in Interim-Positron Emission Tomography (PET) Positive Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2 positive patients is only 12%, but the optimal treatment for this patient subset is still unknown. From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.

Official Title
-----------------
Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study

Conditions
-----------------
Hodgkin Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced Hodgkin's lymphoma according to the World Health Organization classification Age 16-80 Not previously treated Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion) Written informed consent Exclusion Criteria: Patients aged more than 80 Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma Psychiatric disorders Uncontrolled infectious disease Impaired cardiac (EF < 50%) or renal (creatinine clearance < 60 ml/m)function Pregnancy and lactation Uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- |
| PET2 negative<br>Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD | |
| PET2 positive<br>Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of progression/relapse |  | 2 years | 
| Interim PET positive and negative predictive value |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET
Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects

Detailed Description
-----------------
This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.

Official Title
-----------------
A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: SR-exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 20   45 years old Healthy Male Body weight : ≥50kg and Ideal body weight ± 20% Informed consent Exclusion Criteria: Clinically significant medical history Acute or Chronic pancreatitis Clinically significant hypersensitivity of Drugs Clinically significant cutaneous disorder History of administration of exenatide Disorder of blood pressure History of drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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: DA-3091<br>SR-exenatide | Drug: SR-exenatide<br>* Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection<br>* Other names: DA-3091;|
| Placebo Comparator: Placebo of DA-3091<br>Placebo | Drug: SR-exenatide<br>* Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection<br>* Other names: DA-3091;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety | Adverse Events Laboratory Results Vital sign, Physical Examination, EKG | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and Pharmacodynamics | PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample | PK : 84 days / PD : 42days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SR-Exenatide
Placental Pathology and Inflammatory Factor Analysis of OAPS

Study Overview
=================
Brief Summary
-----------------
This investigation is on placental pathological changes and inflammatory factors associated with obstetric antiphospholipid syndrome.

Detailed Description
-----------------
1. To clarify the correlation between antiphospholipid antibody, ACC1 expression level, Treg cell and placental pathological changes associated with antiphospholipid syndrome. 2. Reveal that antiphospholipid antibodies affect Treg cell differentiation through the key enzyme of lipid metabolism ACC1.

Official Title
-----------------
Placental Pathology and Inflammatory Factor Analysis of Obstetric Antiphospholipid Syndrome Patients

Conditions
-----------------
Antiphospholipid Syndrome in Pregnancy

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group consent to join this study and finish the informed consents Exclusion Criteria: pregnant women with other autoimmune diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| obstetric antiphospholipid syndrome<br>obstetric antiphospholipid syndrome 20 cases and normal pregnant women 20 cases | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of ACC1 in placenta in pregnancy with/without antiphospholipid syndrome |  | in two years |
An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium

Study Overview
=================
Brief Summary
-----------------
This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.

Official Title
-----------------
An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours

Conditions
-----------------
Gastric Ulcer

Intervention / Treatment
-----------------
* Drug: Esomeprazole Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill male or female subjects 18 years or older who have a baseline gastric aspirate pH less then or equal to 4 Subjects admitted to an ICU requiring mechanically ventilated Subjects will have at least one additional stress ulcer risk factor Exclusion Criteria: Anticipated use of pre-pyloric enteral feeding after screening until the end of study Physician estimated survival of less then 96 hours Anticipation of major surgery within 96 hours of study enrollment

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole Sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress ulcer, critically ill, gastric acid, gastric aspirates, esomeprazole
Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. This study is to investigate the relationship between the inflammatory gene polymorphism, known for acute lung injury, and the duration of mechanical ventilatory care for such liver transplantation recipients.

Conditions
-----------------
Patients With Postoperative Mechanical Ventilation After Liver Transplantation

Intervention / Treatment
-----------------
* Other: Mechanical ventilatory lung care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-65 years old scheduled for liver transplantation Exclusion Criteria: Patients under mechanical ventilation prior to surgery patients with muscular skeletal disorder, probable cause for respiratory depression patients not able to read, or understand the consent form ethnicity, other than asian patients refusal

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Mechanical ventilatory lung care<br>liver transplantation recipients under mechanical ventilatory lung care | Other: Mechanical ventilatory lung care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total duration of postoperative ventilator care | Time for successful weaning from ventilator could correlate with the inflammtory gene polymorphism, especially those related to acute lung injury. | an expected average of 2-3 days |