linjc16/ctgov huggingface dataset:
Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

Study Overview
=================
Brief Summary
-----------------
lupus nephritis accounts for the most morbidity and mortality in patients with SLE. Glucocorticoids combined with cyclophosphamide (CYC) are effective for the treatment of patients with proliferative lupus nephritis and have been the immunosuppressive regimen of choice for many years. However, some patients do not respond well to the regimen, and adverse effects of cyclophosphamide limit its use in certain patients. Leflunomide is a novel immunosuppressive agent currently used in the treatment of rheumatoid arthritis.There were a few pilot observational studies and reports suggesting leflunomide was also safe, well-tolerated and may be effective in SLE patients without important organ involvement. It has not been shown if leflunomide can be used in the treatment of patients with lupus nephritis. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of patients with biopsy proven proliferative lupus nephritis.

Official Title
-----------------
Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy

Conditions
-----------------
Nephritis, Lupus

Intervention / Treatment
-----------------
* Drug: leflunomide combined with prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients were diagnosed as SLE according to the updated criteria of American College of Rheumatology in 1997, had a systemic lupus erythematosus disease activity index (SLEDAI)equal or greater than 8; had evident renal diseases and biopsy-documented diffuse proliferative or focal proliferative lupus nephritis, with or without coincident membranous nephropathy, and pathological activity index (AI)equal or greater than 4 Exclusion Criteria: Patients who had received cyclophosphamide within the previous 3 months, cerebral lupus, severe infection, liver disease, pregnancy, and anticipated poor compliance with the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leflunomide combined with prednisone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission of renal disease at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial remission at 6 months and adverse events |  |  |
Endoscopic Scoring System Utilization in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Inflammatory bowel diseases comprise two distinctive entities: Crohn's disease and ulcerative colitis. During the last decade, endoscopic assessment of inflammation has become relevant since it is a prognostic factor. As a consequence, therapeutic targets now contemplate mucosal healing as part of the goals to be achieved. Endoscopic scores for Crohn's disease and ulcerative colitis have been developed to objectively assess the mucosal inflammatory activity. Although they may have some limitations, these scores have been widely accepted in referral centers, especially since they have been adopted as standard evaluation in inflammatory bowel disease clinical trials . However, their use in the setting of endoscopic practice outside centers with a high volume or with less experience in clinical trials is not known.

Official Title
-----------------
Endoscopic Scoring System Utilization for Inflammatory Bowel Disease Activity Assessment

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Procedure: colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who underwent colonoscopy for the evaluation of mucosal inflammatory activity Patients with an established diagnosis of either Crohn's disease or ulcerative colitis Exclusion Criteria: Sigmoidoscopies performed in ulcerative colitis for the assessment of mucosal inflammatory activity

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 |
| --- |
|Procedure: colonoscopy|endoscopic exploration of colonic mucosa to evaluate inflammatory activity in patients with either Crohn's disease or ulcerative colitis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic score report | Proportion of colonoscopy reports among inflammatory bowel disease patients which include an endoscopic score to assess inflammatory activity | January 2018-October 2022 |
Impact of Maternal COVID-19 Vaccines on Breast Milk

Study Overview
=================
Brief Summary
-----------------
prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.

Official Title
-----------------
Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health

Conditions
-----------------
COVID-19 Vaccines

Intervention / Treatment
-----------------
* Biological: Covid vaccines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines. Exclusion Criteria: cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.

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 |
| --- | --- |
| Vaccinations<br>SARS-CoV-2 vaccination | Biological: Covid vaccines<br>* women within Priority groups for coronavirus (COVID-19) vaccination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibodies | presence and levels of antibodies | 1st year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast milk bioactive composition | immune profile (cytokines and growth factors, immunoglobulins) | 1st year | 
| breast milk bioactive composition | microbiota profile | 1st year | 
| breast milk bioactive composition | metabolite profile | 1st year | 
| infant microbiota | infant microbiota composition and diversity | 1st year | 
| infant growth and development | z-scores growth curves | 1st year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth and development, breast milk, microbiota, metabolites, immune compounds
Association Between Cytokines and Severity of Respiratory Syncytial Virus (RSV)-Induced Illness in the Elderly

Study Overview
=================
Brief Summary
-----------------
This research study involves studying the genes that may affect how ill you become during respiratory infection with respiratory syncytial virus (RSV). RSV is a virus that often causes common colds. Cytokines are chemicals that are naturally made by your body. Cytokine levels are increased in some people when they have common colds or wheezing caused by respiratory syncytial virus (RSV). The purpose of this study is to study the genes that may control cytokine levels during infection with RSV in the elderly population.

Official Title
-----------------
The Association Between Cytokine Genotype Polymorphisms and Severity of RSV-Induced Illness in the Elderly

Conditions
-----------------
Respiratory Syncytial Virus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects > 65 years of age diagnosed with RSV-induced respiratory illness Diagnosis (based upon ICD-9-CM codes) for pneumonia, upper respiratory illness, bronchitis, COPD, asthma, viral illness, or congestive heart failure (CHF) Willing to sign informed consent. Exclusion Criteria: Not willing to sign informed consent. Subjects less that 65 years of age Subjects not diagnosed with a respiratory illness

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory, RSV-induced respiratory illness
An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.

Official Title
-----------------
An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics

Conditions
-----------------
Shoulder Injury, Insulin-dependent Diabetics

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Insulin-dependent diabetic Age 18+ Shoulder pain for over 4 weeks duration that is uncontrolled with activity modification or nonsteroidal anti-inflammatory drugs Use of glucometer for blood sugar monitoring Well controlled blood glucose levels Hemoglobin A1c less than or equal to 7.5 Exclusion Criteria Previous corticosteroid injection within the past 6 months Active infection Pregnant or plan on becoming pregnant Previous adverse event with corticosteroid or lidocaine use

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Group 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine. | Drug: Dexamethasone<br>* The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.<br>* Other names: Corticosteroid;|
| Placebo Comparator: Placebo<br>Group 2 will receive an injection of 5 mL of 1% lidocaine (placebo). | Other: Placebo<br>* the placebo group will not receive the corticosteroid medication in their injection to treat the inflammation and pain in their shoulder. Instead, they will receive an injection of 5 mL lidocaine only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can diabetic patients maintain their blood glucose in a normal range after receiving a corticosteroid injection? | The main outcome variable in this study is to determine what effects, if any, a corticosteroid injection has on the ability of diabetic patients to maintain their blood glucose in a normal range. This will allow for better patient education when discussing the risks of corticosteroid injections and allow for improved post-injection care of patients. | 4 weeks |
Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention

Study Overview
=================
Brief Summary
-----------------
The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov) and to evaluate study Brief Intervention impact on reduction exposure, and its effect on newborn outcomes.

Detailed Description
-----------------
All pregnant women who will arrive to Poria (and third of pregnant who will arrive to Ichilov) ER, high risk, and follow-up clinic will be asked for alcohol exposure, smoking and psychoactive substance usage. Relevant women will be asked to participate in a brief intervention treatment for about 30 min by expert personal, and a follow-up by phone every 3 months during pregnancy and post deliver. In addition, through all the year, questionnaires about exposure will be given to all women who will have labor (about 3000 labors), and third of 10,000 expecting in Ichilov. We expect in the second half of the year, to have those who enrolled to the BI. New-born outcome of the BI group as compared to the non-BI group will be compared, as well as rate of alcohol/substance/nicotine abstinence and reduction.

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: brief intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women who smoke cigarets, drink alcohol and or abuse any drugs Exclusion Criteria: pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: brief intervention|limit time giving information, motivation, empathy, responsibility, self control|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nicotine, alcohol and drug abstinence | nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor | during pregnancy until labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| newborn weight of birth | data about newborn at labor and it relation to brief intervention of mother will be deternined | at labor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brief intervention, alcohol, nicotine, drug abuse
Chemically Assisted Capsulectomy-A New Clinical Approach

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Detailed Description
-----------------
Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.

Official Title
-----------------
Chemically Assisted Capsulectomy-A New Clinical Approach

Conditions
-----------------
Implant Capsular Contracture

Intervention / Treatment
-----------------
* Drug: Mesna


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All females undergoing capsulectomy Exclusion Criteria: All pregnant women and nursing mothers will be exclued

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment<br>Standard treatment | |
| Experimental: Use of Mesna<br>Standard surgical procedure with Mesna | Drug: Mesna<br>* B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsular contracture, capsulectomy, mesna, Capsular contracture after breast implant placement
Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Study Overview
=================
Brief Summary
-----------------
Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition. Hypothesis: Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.

Official Title
-----------------
The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Conditions
-----------------
Dysthymic Disorder

Intervention / Treatment
-----------------
* Drug: Testoviron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, age 40-80 years. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated. Diagnosis of Dysthymic disorder with onset after age 40. PSA < 4.0. Normal digital exam of the prostate in the preceding 1 year. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12). Able to give informed consent. Exclusion Criteria: Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism. Currently being treated with testosterone. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years. Current suicidal risk. Current (past year) substance abuse or dependence.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-d) |  |  | 
| Clinical Global Impression- Change (CGI-C) |  |  | 
| Profile of Mood States (POMS) |  |  | 
| Beck Depression Inventory (BDI) |  |  | 
| Sheehan Disability Scale |  |  | 
| Self Anchoring Scale (SAS) |  |  | 
| Affective Balance Scale (ABS) |  |  | 
| International Index of Erectile Function (IIEF) |  |  | 
| Aging Male Symptom rating (AMS) |  |  | 
| Clinical Global Impression (CGI) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysthymic Disorder, HPG hypofunctioning, Testosterone replacement
Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such phenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.

Official Title
-----------------
Study of Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy

Conditions
-----------------
Heart Failure, Patients Undergoing CRT-D Device Implantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing implantation of a CRT-D Exclusion Criteria: age < 18 y pregnancy or planned pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| CRT<br>Patients with implanted cardiac resynchronization therapy defibrillator | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between electrical and mechanical remodeling | correlation between electrical and mechanical measures of dyssynchrony | 6 months after CRT implantation |