linjc16/ctgov huggingface dataset:
Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

Study Overview
=================
Brief Summary
-----------------
Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.

Conditions
-----------------
Vaginal Candidiasis

Intervention / Treatment
-----------------
* Dietary Supplement: Lactibiane candisis 5M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 18-65 years suffering from 4 or more episodes of VVC during the 1 year prior to the survey all participants must be symptomatic with a microbiological proof of infection with candida albicans Exclusion Criteria: Pregnancy, lactation being HIV infection, chemotherapy or illness serious enough to induce an immune deficiency. A diabetic patient will not be systematically excluded; Vulvo-vaginitis and / or cervicitis specific, defined in a bacteriological examination by the presence of herpes virus, gonorrhea or chlamydia; Bacterial Vaginosis or Trichomonas; Use of vaginal probiotics in the months before inclusion; Cure of probiotics in the months preceding the inclusion; Contraindication to Gynopévaryl LP

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Dietary supplement | Dietary Supplement: Lactibiane candisis 5M<br>* 2 gelules per day for 2 months then 1 gelule per day for 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo. |  | 2, 3, 6 and 9 months |
Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals.

Study Overview
=================
Brief Summary
-----------------
Drug drug interactions is frequent in critically ill patients due to polypharmacy, different drug groups and prolonged ICU or hospital stay

Detailed Description
-----------------
This cross sectional study was conducted in Surgical ICU, zagazig University Hospital for 6months period. Demographic data (age, gender),clinical history data (main diagnosis, ICU stay in days, transfer from emergency room or other departments, on mechanical ventilation or not, state of consciousness

Official Title
-----------------
Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals

Conditions
-----------------
Drug Interaction

Intervention / Treatment
-----------------
* Diagnostic Test: Survey for drug drug interactions on medscape and lexicomp applications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to Surgical ICUs for six months period Exclusion Criteria: less than one day admission to ICU,not completed data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Survey for drug drug interactions on medscape and lexicomp applications|Survey for drug drug interactions on Medscape and Lexicomp interaction checker applications|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Drug interactions by Lexicomp interactions application | Lexicomp interactions classified As: A(no known interactions) B(no action needed) C(monitor therapy) D(consider therapy modification) X (avoid combination) | 6months period | 
| Severity of Drug interactions by Medescape interactions checker: | Interactions classified with Medescape interactions checker as :(contraindicated, serious use alternative, monitor closely,minor) | 6months period |
Presbyopia in Breast Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process called accommodation. It is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. Currently, there are no known treatments that can be used to prevent or delay presbyopia. As a result, the risk, in later life, of having this condition is essentially 100%. The purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

Detailed Description
-----------------
Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process called accommodation. It is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. Currently, there are no known treatments that can be used to prevent or delay presbyopia. As a result, the risk, in later life, of having this condition is essentially 100%. The purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

Official Title
-----------------
Presbyopia in Breast Cancer Survivors

Conditions
-----------------
Presbyopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 45-60 ability to understand and provide written consent in English Exclusion Criteria: blindness visual defects leading to accommodative failure severe myopia recurrent breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 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
-----------------
presbyopia; breast cancer survivors
A Phase I/II Study of GX15-070MS in Untreated CLL

Study Overview
=================
Brief Summary
-----------------
This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

Detailed Description
-----------------
Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Official Title
-----------------
A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: GX15-070MS
* Drug: GX15-070MS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed B-CLL Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1 Age ≥18 years ECOG Performance Status ≤1 Life expectancy of >8 weeks Exclusion Criteria: Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy Patients with history of seizure disorders Pregnant women and women who are breast feeding HIV-positive patients receiving combination anti-retroviral therapy

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX15-070MS<br>GX15-070MS at various doses and schedules | Drug: GX15-070MS<br>* A 60-minute or 3-hour IV infusion every 2-3 weeks.<br>* Other names: Obatoclax;Drug: GX15-070MS<br>* GX15-070MS at various doses and schedules<br>* Other names: Obatoclax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, obatoclax
Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia.

Official Title
-----------------
A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Trial to Determine the Lipid-Lowering Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Muraglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-diabetics Serum TG >150 mg/dL and < or = 600 mg/dL Serum LDL-C >130 mg/dL Exclusion Criteria: Type 1 or type 2 diabetics Fasting plasma glucose >126 mg/dL Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2): Niacin or bile-acid binding agents and HMG CoA reductase inhibitors: 8 weeks Fibrates: 8 weeks Probucol: 1 year History of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes from baseline to average at week 5-6 of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, apolipoprotein A1 (ApoA1), and free fatty acid (FFA) levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixed Dyslipidemia
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies

Study Overview
=================
Brief Summary
-----------------
This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).

Official Title
-----------------
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies

Conditions
-----------------
Clostridium Difficile-Associated Diarrhea

Intervention / Treatment
-----------------
* Drug: Colostrum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Written informed consent At least 3 unformed or watery stools in each of the 2 previous 24 hour periods. Confirmed diagnosis of C. difficile associated diarrhea Exclusion Criteria: Pregnant or breast feeding women Known allergy to milk or milk products Other etiology of diarrhea Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus Pseudomembranous colitis White blood count > 50,000 Blood in stools Laxatives or motility drugs within 12 hours Inability to participate in adequate follow up Clinically unstable Investigator deems unsuitable Immune suppression (disease or treatment) GI surgery Past intestinal parasites

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Hospitalized patients with Clostridium difficile associated diarrhea. | Drug: Colostrum<br>* Daily administration of Colostrum derived antibodies against C. difficile.<br>|
| Experimental: 2<br>Close hospital contacts of each index case | Drug: Colostrum<br>* Daily administration of Colostrum derived antibodies against C. difficile.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of active Clostridium difficile associated diarrhea in index cases |  | 60 days | 
| New cases of Clostridium difficile associated diarrhea in close hospital contacts. |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease severity - duration, maximal intensity (number of stools) in index cases. |  | 60 days | 
| Eradication of Clostridium difficile from stools |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clostridium difficile, diarrhea, colostrum
Staging Procedures to Diagnose Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the accuracy of participants imaging versus staging procedures. The investigators will consent subjects that are scheduled to undergo staging procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy, endobronchial ultrasound and laparoscopy) as part of their standard of care.

Official Title
-----------------
Staging Procedures to Diagnose Malignant Pleural Mesothelioma

Conditions
-----------------
Mesothelioma, Solitary Fibrous Tumor of the Pleura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides informed consent Subject is >18 years of age Subject is deemed competent for making medical decisions Subject is scheduled to undergo a staging pleuroscopy Subject is a surgical candidate A negative pregnancy test is required in women of child-bearing potential, as standard of care. Exclusion Criteria: Subject is <18 years old.

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 |
| --- | --- | --- |
| Accuracy of surgical staging versus imaging procedures based on surgical findings. | The staging imaging will be compared with the actual surgical staging procedure to evaluate the accuracy of the imaging. | 2 years |
Device to Reduce Surgery Site Contamination - Spine

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.

Detailed Description
-----------------
The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.

Official Title
-----------------
Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Air Barrier System Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for instrumented posterior lumbar interbody fusion Exclusion Criteria: Prior history of infection Revision surgery Screens positive for MRSA
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No device<br> | |
| Experimental: Device deployed<br> | Device: Air Barrier System Device<br>* Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Site CFU Density | CFU culture counts for samples taken in surgery. | Ten-minute intervals throughout procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CFU, surgery site
Diet, Exercise and Body Fat in 3-5 Year Olds

Study Overview
=================
Brief Summary
-----------------
To determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children.

Official Title
-----------------
Relationship of Dietary Factors and Physical Activity to Body Fat in 3-5 Year Old Children

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3-5 year old children Full term at birth English as primary language Weighed at least 5.5# at birth Parent or guardian is at least 18 years of age Exclusion Criteria: Child has any chronic condition, metabolic disorder, pulmonary disorder, bone disorder, condition that may affect growth, ADD or ADHD Child on any medication thought to interfere with study parameters as determined by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 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 |
| --- | --- |
| 1<br>3 year old children | |
| 2<br>4 year old children | |
| 3<br>5 year old children | |

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
-----------------
Children, Nutrition, Body Fat, Physical Activity, Diet, Childhood Obesity, Healthy Children