linjc16/ctgov huggingface dataset:
Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

Study Overview
=================
Brief Summary
-----------------
An expanded access trial of belimumab for named patients who participated in LBRA99.

Detailed Description
-----------------
An expanded access trial of belimumab for named patients with Rheumatoid Arthritis (RA) who have experienced continued benefit under HGS Protocol LBRA99.

Official Title
-----------------
An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99

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

Intervention / Treatment
-----------------
* Drug: belimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the HGS Protocol LBRA99. Over the course of the study and for 60 days after the last dose of study agent, any woman with an intact uterus who is not post-menopausal must agree to practice a medically accepted method of contraception. Over the course of the study and for 60 days after the last dose of study agent, all men must agree to practice a medically accepted method of contraception. Have the ability to understand the requirements of this study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the required study visits. Exclusion Criteria: Had not been previously treated with belimumab in LBRA99 or were discontinued from treatment prior to HGS' decision to terminate LBRA99. Had clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to RA (ie, cardiovascular, pulmonary, anemia, gastrointestinal, hepatic, renal, neurological, cancer or infectious diseases) that could, in the opinion of the principal investigator, put the patient at undue risk. Are a pregnant female or nursing mother.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: belimumab|IV 10mg/kg q28days|

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
-----------------
Rheumatoid Arthritis, RA
The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia

Study Overview
=================
Brief Summary
-----------------
The effects of 12 hours of prolonged standing will be compared to prolonged standing on a high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be measured in a crossover study design.

Official Title
-----------------
The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia

Conditions
-----------------
Metabolic Syndrome, Atherosclerosis

Intervention / Treatment
-----------------
* Behavioral: Prolonged Standing
* Behavioral: Prolonged Sitting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: heart problems coronary artery disease hypertension respiratory problems musculoskeletal problems that prevent prolonged standing or sitting obesity susceptibility to fainting

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Standing<br>Subject stand for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions. | Behavioral: Prolonged Standing<br>* Subject will stand for 12 hours and undergo a high fat tolerance test the subsequent day<br>|
| Experimental: Prolonged Sitting<br>Subject sit for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions. | Behavioral: Prolonged Sitting<br>* Subject will sit for 12 hours and undergo a high fat tolerance test the subsequent day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Triglycerides | The area under the curve for plasma triglycerides from hourly samples during a 6 hour high fat tolerance test | 6 hours | 
| Plasma Insulin | The area under the curve for plasma insulin from hourly samples during a 6 hour high fat tolerance test | 6 hours | 
| Plasma Glucose | The area under the curve for plasma glucose from hourly samples during a 6 hour high fat tolerance test | 6 hours |
Antibiotic Irrigation for Pancreatoduodenectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the routine use of antibiotic irrigation during pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.

Detailed Description
-----------------
The primary aim of this study is to test the efficacy of routine antibiotic irrigation in reducing superficial and organ space infections among patients undergoing pancreatoduodenectomy.

Official Title
-----------------
Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates

Conditions
-----------------
Surgery, Infection

Intervention / Treatment
-----------------
* Drug: Polymyxin B in Normal Saline
* Other: Placebo: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age and older; Open pancreatoduodenectomy for any diagnosis Exclusion Criteria: Pregnant; Prisoners; Patients undergoing concomitant colectomy; Antibiotic allergy to study medication; Serum creatinine > 2.0; Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polymyxin B in Normal Saline<br>Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline | Drug: Polymyxin B in Normal Saline<br>* Antibiotic irrigation via peritoneal lavage<br>* Other names: Antibiotic;|
| Placebo Comparator: Placebo: Normal Saline<br>0.9 % Normal Saline | Other: Placebo: Normal Saline<br>* Placebo irrigation via peritoneal lavage<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With Infections |  | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With Fistulas |  | 5 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatoduodenectomy, Whipple
OLGA and OLGIM Stage System for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification in South Korea. Also attempted to estimate synergistic interaction among the several risk factors to help establish surveillance strategy.

Detailed Description
-----------------
To validated the OLGA and OLGIM staging system with serum pepsinogen to estimate gastric cancer risk according to Lauren's histologic classification in South Korea, where the incidence rate of GC is high. In addition, the investigators attempted to investigate the interaction among the several risk factors including OLGA or OLGIM staging system for the risk of GC to help establish surveillance strategy.

Official Title
-----------------
The Evaluation of OLGA and OLGIM Stage Systems for Prediction of Gastric Cancer Risk and Interaction With Other Risk Factors According to Lauren's Classification

Conditions
-----------------
Stomach Neoplasms, Atrophic Gastritis, Intestinal Metaplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Control group those who were between 25 and 80 years old and did not have any evidence of gastric cancer and gastric dysplasia, esophageal tumor and MALToma in upper gastrointestinal endoscopy Gastric cancer group Patients diagnosed as gastric cancer in the upper gastrointestinal endoscopy at the time of participating in the study between 25 and 80 years old. Exclusion Criteria: history of previous gastrointestinal surgery, any other malignancy cardia cancer who do not perform endoscopic biopsy pathologically proven gastric dysplasia

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 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 |
| --- | --- |
| Gastric cancer<br>Patients who were diagnosed with gastric cancer | |
| Control<br>Healthy participants or benign disease patients such as benign gastric ulcers, duodenal ulcers, reflux esophagitis, or non-erosive reflux disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of OLGA and OLGIM stage systems with serum pepsinogen for prediction of gastric cancer risk | To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification | per 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OLGA, OLGIM, Helicobacter pylori, Gastric cancer, pepsinogen
Photographic Assessment of Eyebrow Position and Range of Motion

Study Overview
=================
Brief Summary
-----------------
Forehead and eyebrow surgery is a frequently performed cosmetic surgical procedure in which the eyebrows are raised to a more aesthetically pleasing position. Typically, this position is judged by the surgeon pre-operatively based on traditional aesthetic concepts, some of which date to the Classical era. This study is designed to assess the variance of the eyebrow from the desired aesthetic position (as determined by the subject), as wel as to assess the distance of normal excursion of the brow from maximum voluntary depression to maximum voluntary elevation.

Detailed Description
-----------------
A set of 5 digital photographs will be taken of 100 (30 male, 70 female) adult study participants. Prior to photography, water soluble ink will be used to mark the inferior aspect of the superior orbital rim above the medial and lateral canthi and in the mid pupillary line. Photographs taken will image patients from crown to chin and will be taken with eyes open and closed, brows raised, maximally contracted and at rest. A final photograph will be taken with the subject manually holding both brows in the position he/she finds most aesthetically pleasing as seen in a mirror. During all photography, a ruler will be held against the face for later calibration, all photographs will be taken with a camera mounted flash and with the patient in a Frankfort horizontal plane. All photographs will be analyzed with proprietary computer software.

Official Title
-----------------
Photographic Assessment of Eyebrow Position and Range of Motion

Conditions
-----------------
Brow Ptosis

Intervention / Treatment
-----------------
* Behavioral: Eyebrow Position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults, aged 18-85 years Exclusion Criteria: prior forehead, eyebrow or eyelid surgery, neurotoxin treatment to the forehead or eyes within the past 6 months, injectable soft tissue filler used within the last 12 months, photosensitivity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Eyebrow Position|Photography of brow positions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyebrow Position | Position of eyebrow at the medial canthus relative to orbital rim | At time of evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brow ptosis, facial aesthetics, browlift, facelift
Novel Biomarkers of Thrombotic Risk

Study Overview
=================
Brief Summary
-----------------
Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. Because new drugs have increased treatment options, the development of tests that can guide treatment should improve treatment selection and further reduce the risk of cardiovascular events as well as bleeding. This study is designed to assess the value of new tests. It is a prospective study that will enroll patients who have had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day after their heart attack) and a second time 6 months later during an ambulatory clinical visit. Investigators will perform biochemical tests on the blood that assess the likelihood of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount of blood poses no risk to the participant. Investigators will ask the participant whether they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their 1 year of participation, investigators will review medical records and record information in a manner that protects the identity of all participants. We hypothesize that the biochemical test results will be similar at baseline and 6 month follow-up and that these biochemical tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment of participants will not be altered by their participation in this study.

Official Title
-----------------
Novel Biomarkers of Thrombotic Risk

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myocardial infarction demonstrated by elevated markers of cardiac injury (troponin I (TNI) or creatine kinase (CK) MB fraction) the presence of coronary artery disease demonstrated by cardiac catheterization or perfusion imaging Exclusion Criteria: Treatment with long term anticoagulants active infection malignancy
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 |
| --- | --- | --- |
| Cardiovascular Event - Myocardial Infarction, Stroke, Death | number of participants with myocardial infarction, stroke, and/or death | average duration of follow-up 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | number of participants with the occurrence of a bleeding event leading the participant to seek medical attention | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet reactivity, thrombin generation
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans

Study Overview
=================
Brief Summary
-----------------
We hypothesized that short-term treatment with haloperidol induces insulin resistance through a mechanistic route that is independent of weight gain. We therefore treated healthy non-obese men with haloperidol for 8 days, and studied the impact of these intervention on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.

Official Title
-----------------
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans

Conditions
-----------------
Insulin Resistance, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Haloperidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men 20 kg/m2 < BMI < 26 kg/m2 Age 20-40 years FPG < 6 mmol/L Exclusion Criteria: FPG > 6 mmol/L BMI > 26 kg/m2 Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past. A positive family history of schizophrenia Any significant chronic disease Renal, hepatic or endocrine disease Use of medication known to influence lipolysis and/or glucose metabolism Total cholesterol > 7mmol/L and/or triglycerides > 2 mmol/L Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months) Difficulties to insert an intravenous catheter Smoking (current) Severe claustrophobia (ventilated hood) Recent blood donation (within the last 2 months) Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year Extensive sporting activities (more than 10 hours of exercise per week)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Healthy men | Drug: Haloperidol<br>* Haloperidol 3 mg/day for 8 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of subchronic haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation. |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin resistance, Dyslipidemia, Haloperidol
Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to detect the evidence on the immune response following acute SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after infection for both symptomatic and asymptomatic patients.

Detailed Description
-----------------
A total of 30 COVID-19 patients for the study will be enrolled. All the patients enrolled were confirmed to be infected with SARS-CoV-2 by RT-PCR assay for nasal and pharyngeal swab specimens. For the study, serum samples of the 30 patients will be collected and will be investigated for the detection rate for immunoglobulin G (IgG). The first sample will be collected 2 weeks after the second negative RT-PCR assay for nasal and pharyngeal swab specimens and 6 samples will be collected after that for 6 months later; one serum sample tested every month for 6 months after. The following questions will be addressed:- What proportion of confirmed cases develops specific IgG antibodies to SARS-CoV-2? How long is the duration of detection of serum IgG antibodies and antibody titres over time following infection with SARS-CoV-2?

Official Title
-----------------
Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with recent COVID- 19 infection(2 weeks after the second negative RT-PCR assay) Exclusion Criteria: patients on immune-suppressive therapy patients with immunological disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| rising titre of IGg antibodies | it's expected to have COVID-19 antibodies within 1month of infection the antibody titre expected to rise the fall to a lower levels | first month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID19 IGg