linjc16/ctgov huggingface dataset:
A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

Study Overview
=================
Brief Summary
-----------------
The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to: Comparison of total helper and suppressor T-cell number between the groups. Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups. Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.

Official Title
-----------------
A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

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

Intervention / Treatment
-----------------
* Drug: Inosine pranobex


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Opportunistic infections or Kaposi's sarcoma. Critical illness. History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Concurrent Medication: Excluded: Steroids. Cytotoxic immunosuppressive agents. Concurrent Treatment: Excluded: Radiotherapy. The following are excluded: Opportunistic infections or Kaposi's sarcoma. Critically ill patients. Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy. Patients who have received any other immunotherapy. Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Prior Medication: Excluded: Any other immunotherapy. Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inosine pranobex|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T-Lymphocytes, Suppressor-Effector, Neoplasms, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent gestational diabetes in their last pregnancy not longer than 9 months after birth. In this randomized, placebo-controlled, double-blinded clinical phase II study, 140 participants aged 18 years or older and an insulin dependent gestational diabetes in their last pregnancy should be included and treated with vildagliptin or placebo over 24 months, followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation as well as a clinical overt diabetes or islet autoimmunity. The null hypothesis is that there is no significant difference of diabetes incidence (according to ADA criteria 1997) in both groups. Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the improvement of beta cell function (evaluable by C-peptide measurement) and of insulin sensitivity by the treatment with vildagliptin.

Official Title
-----------------
A Phase II, Randomized, Double-blind, 2-arm Controlled Study to Evaluate Efficacy of the DPPIV-inhibitor Vildagliptin for Prevention of Type 2 Diabetes in Women With a Recent History of Insulin-requiring Gestational Diabetes

Conditions
-----------------
Insulin-dependent Gestational Diabetes

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: inactive pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with insulin-dependent gestational diabetes during the last pregnancy < 9 months after delivery age 18 years or older contraception during intervention period (at least 24 months) Exclusion Criteria: pregnancy or lactation GADA or IA-2A positivity clinical overt diabetes

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

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vildagliptin<br> | Drug: vildagliptin<br>* 100 mg per day over 24 months<br>|
| Placebo Comparator: inactive pill without active agent<br>participants receive an inactive pill without active agent, but undergo the same examinations, visits and tests as the group treated with vildagliptin. | Drug: inactive pill<br>* 1 pill per day over 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of type 2 diabetes mellitus by criteria of ADA 1997 |  | 3 years |
Cytomegalovirus (CMV) Infection in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if (recurrent) cytomegalovirus (CMV) infection of the mother results in pregnancy complications such as preterm delivery, severe preeclampsia, poor fetal growth, or stillbirth.

Detailed Description
-----------------
CMV infection in adults with a normal immune system is rarely a serious event. Once a person has been infected with CMV, they may have recurrences (relapses) of the infection. If a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk for infection. Unlike infection in adults, fetal infection may result in serious complications (congenital infection). The effects of fetal infection with CMV are well understood and many efforts have been made to potentially reduce the risk of congenital infection. However, the effect of CMV infection on the pregnancy itself (when the fetus is not affected by CMV) is less understood. In this study, we plan to determine if CMV recurrence in the mother results in pregnancy complications. The pregnancy complications listed above have been associated with poor placental function. We also plan to determine if (recurrent) CMV infection in the mother is associated with CMV infection of the placenta.

Official Title
-----------------
Cytomegalovirus Infection and Pregnancy Outcomes

Conditions
-----------------
Pregnancy Complications, Cytomegalovirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who deliver at term without pregnancy complications Women who deliver (preterm, less than 37 weeks gestation) as a result of spontaneous preterm labor Women whose pregnancies are complicated by severe preeclampsia Women whose pregnancies are complicated by unexplained poor fetal growth (less than the 10th percentile). Women whose pregnancies are complicated by unexplained stillbirth. Exclusion Criteria: Women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformation or chromosomal abnormality. Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease

Ages Eligible for Study
-----------------
Minimum Age: 15 Weeks

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

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
-----------------
cytomegalovirus, pregnancy, placenta
The Predictive Value of Hepatocyte Growth Factor and Soluble Receptor s-Met in Sepsis

Study Overview
=================
Brief Summary
-----------------
To observe the changes of plasma hepatocyte growth factor and soluble receptor s-Met levels in patients with sepsis, and to explore its clinical significance.

Detailed Description
-----------------
90 patients who diagnosed as sepsis were included in this study. Then keep blood samples from these patients in the first day, the third day, detect the hepatocyte growth factor and soluble receptor s-Met level in plasma byenzyme-linked immuno sorbent assay. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of hepatocyte growth factor and soluble receptor s-Met in plasma and the prognosis of the patients.

Official Title
-----------------
The Predictive Value of Hepatocyte Growth Factor and Soluble Receptor s-Met in Evaluating Sepsis Patient's Disease Severity and Prognosis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: taking peripheral blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to ICU diagnosed of sepsis(sepsis3.0 criteria) Patients signing informed consent Exclusion Criteria: Age is less than 18 years old or more than 80 years old Pregnant women Patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、HELLP syndrome Prothrombin time is extension in patients with after liver transplantation Patients with chronic renal failure Patients after kidney transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: taking peripheral blood|taking peripheral blood of no more than 3ml|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | 28-day mortality | 28-day |
Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Globally, cataract is the major cause of blindness accounting for 51% of total blindness and there are regional variations in it. Today, cataract surgery is a highly successful and cost-effective procedure, which enhances both the vision and quality of life of patients. Visual acuity alone should not be used as a criterion for planning cataract surgery, since visual acuity and function do not necessarily correlate. Therefore, there is a need to review our criteria for management. Based on recent studies, at least 90% of the patients undergoing cataract surgery obtain a postoperative visual acuity of 6/12 or better in the absence of coexisting ocular pathology. A number of previous studies have looked at the effect of risk factors on visual outcomes following cataract surgery. Risk factors commonly associated with worse visual outcomes include: age-related macular degeneration, diabetic retinopathy, corneal opacity/pathology, older age, female sex, previous vitrectomy, previous retinal detachment surgery, alpha-blockers, complex surgery, intraoperative complications and refractive surprise.

Official Title
-----------------
Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery: a Prospective Cohort Study

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with any type of cataract. Exclusion Criteria: Patients with diabetic retinopathy. Patients with previous ocular surgeries or pathologies. Patients with pre-operative visual acuity (no perception of light)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Lens Phacoemulsification Group<br>insertion of intra-ocular lens | Procedure: Phacoemulsification<br>* insertion of intra-ocular lens after emulsification of catractous lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visual acuity of patients after cataract surgery | measured by snellen's chart | 4 weeks |
Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects

Official Title
-----------------
A Randomized, Open-label, Multiple Dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Pitavastatin and Valsartan in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Multiple Oral Dose of
* Drug: Multiple Oral Dose of


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 50 years at screening. No significant congenital/chronic disease. No symptoms in physical examination. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion. History of known hypersensitivity to drugs including valsartan and pitavastatin.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Pitavastatin 4mg | Drug: Multiple Oral Dose of<br>* Pitavastatin 4mg<br>* Other names: Livalo®;|
| Experimental: B<br>Valsartan 320mg | Drug: Multiple Oral Dose of<br>* Valsartan 320mg<br>* Other names: Diovan®;|
| Experimental: C<br>Pitavastatin 4mg + Valsartan 320mg | Drug: Multiple Oral Dose of<br>* Pitavastatin 4mg<br>* Other names: Livalo®;Drug: Multiple Oral Dose of<br>* Valsartan 320mg<br>* Other names: Diovan®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (normal results for safety tests) | Adverse events Physical examination, vital signs | 39days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers
Affect of Dose Rate on UVR Induced Skin Erythema

Study Overview
=================
Brief Summary
-----------------
Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema. Study design: A single-center, prospective, randomized, crossover, open study. Number of patients: 20-40 Patient population: Healthy volunteers Control: Different sites on patients body Procedure duration: Total 3-5 hours (4 visits) Duration of follow up: 4 days Duration of study: Up to 6 months Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.

Official Title
-----------------
Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema

Conditions
-----------------
Erythema

Intervention / Treatment
-----------------
* Device: exposure to UVB radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin types I-III. Age 18-60. Absence of obvious sun damage on the volar side of the forearm or other exposure sites. Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment. Exclusion Criteria: History of skin cancer. Multiple nevi or atypical nevi on the forearm. Signs of sun damage on the volar side of the forearm or other exposure sites. Mentally incompetent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Device: exposure to UVB radiation|exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10 |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UVB induced skin erythema
Age-Related Changes in Stress Hormone Regulation

Study Overview
=================
Brief Summary
-----------------
Studies investigating physiological processes involved in aging-related deficits in regulation of stress hormone systems.

Official Title
-----------------
Mechanism of Aging-Related Changes in (HPA) Hydrocortisone Corticotropin Feedback Function

Conditions
-----------------
Physiological Processes, Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: History of major psychiatric disorders, Neurologic disorder affecting cognitive function, Unstable medical problems, Medications including antidepressants, neuroleptics, anxiolytics, CNS stimulants, narcotic analgesics, anti-convulsants, Drugs effecting HPA axis function, Vision and hearing deficits, Undergoing major life event within one month or Loss of family member within 6 months.

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
-----------------
Aging, Hydrocortisone Corticotropin Feedback
Weaning From Mechanical Ventilation in the ICU

Study Overview
=================
Brief Summary
-----------------
The investigators objective is to assess quality of life and functional outcome in patients requiring short-term mechanical ventilation. Additionally, the investigators plan to measure the recovery of peripheral muscle strength and respiratory muscle strength during recovery.

Official Title
-----------------
Weaning From Mechanical Ventilation in the ICU

Conditions
-----------------
Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients who require mechanical ventilation for at least 2 days the ability to speak English willing to participate Exclusion Criteria: patients who require mechanical ventilation at home before hospitalization patients previously requiring mechanical ventilation at an LTAC facility

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life scores | SF-36, Katz, respiratory muscle strength and handgrip strength will be measured | up to one year after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sf-36, Katz
Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy.

Official Title
-----------------
Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma After Radiation Therapy/Anthracycline Chemotherapy

Conditions
-----------------
Hodgkin Disease, Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with Hodgkin's Lymphoma and Non Hodgkin's lymphoma who underwent Radiation Therapy (RT) to either a mantle or modified mantle field with or without adriamycin at the Wilmot Cancer Center at the University of Rochester are eligible for the study. Exclusion Criteria: Any severe preexisting cardiac disease (e.g., arrhythmia, angina, coronary disease, myocardial infarction, or congestive heart failure) prior to diagnosis

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 |
| --- | --- |
| A<br>Individuals who have previously received radiation therapy and anthracycline chemotherapy for their Hodgkin's or non-Hodgkin's lymphoma. | Other: Survey<br>* Survey asking questions regarding the subjects cardiac and general health.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure changes in Cardiac ejection fraction score |  | Post Radiation Treatment | 
| Measure changes in perfusion imaging score on the radionuclide cardiac profusion scan |  | Post Radiation |