linjc16/ctgov huggingface dataset:
Influence of Pomegranate Juice Consumption on the Level of Antioxidants in Breast Milk

Study Overview
=================
Brief Summary
-----------------
Many medicinal effects of Pomegranate juices are already known. Mainly known for its anti-viral, anti-bacterial and anti-oxide tendency of pomegranate juice. Many studies which have demonstrated antioxidant activity of pomegranate juice in the blood and blood cells were published. In addition, published studies have demonstrated the anti-oxidant activity which inhibit the development of atherosclerosis and stroke, even in patients with diabetes, and its effect of decreasing systolic blood pressure in patients with systemic hypertension. The purpose of the work is to examine the effect of drinking pomegranate juice on the level of anti-oxidants in human breast milk.

Detailed Description
-----------------
the effect of pomegranate juice consumption on breast milk anti oxidants level.

Official Title
-----------------
Influence of Pomegranate Juice Consumption on the Level of Antioxidants in Breast Milk

Conditions
-----------------
Breast Milk

Intervention / Treatment
-----------------
* Dietary Supplement: pomegranate juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lactating woman Exclusion Criteria: pomegranate allergy diabetes mellitus use of other Dietary Supplement

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>label I- 200 cc pomegranate juice once daily for 6 weeks post partum. label II- control group, no placebo is givening. | Dietary Supplement: pomegranate juice<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti oxidant level in human breast milk |  | at least one year |
Comparative Results of Conservatively and Surgically Treated Adolescents With Triplane and Juvenile Tillaux Ankle Fractures After Skeletal Maturity

Study Overview
=================
Brief Summary
-----------------
Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric population. It is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be healed without any sequences. Until now, no evidence of ankle function and pain after skeletal maturity or long follow-up was published. More than that, no comparative study between operative and no operative treatment of mild and borderline displaced fractures were published. The purpose of this study is to evaluate functional and radiographic results of operatively and conservatively treated patients after they reach skeletal maturity.

Conditions
-----------------
Ankle Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent. Exclusion Criteria: Pregnancy Unwillingness to sign the informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in Cmax. Therefore, the sensitivity of CP-945,598 pharmacokinetics (PK) to less potent CYP3A inhibitors needs to be characterized to support labeling and registration. Diltiazem is a known substrate and moderate mechanism-based inhibitor of the CYP3A enzyme system and was chosen as the moderate CYP3A inhibitor for this study as it is a clinically relevant medication likely to be prescribed concomitantly with CP-945,598 given the increased risk of hypertension and cardiovascular disease in the obese patient population.

Official Title
-----------------
A Phase 1, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Modified Release Diltiazem On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: CP-945,598
* Drug: CP-945,598


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically relevant abnormalities based upon medical history, physical exam, 12-lead ECG, and clinical lab tests Body Mass Index (BMI)   27-40 kg/m2, inclusive Personally signed inform consent document Exclusion Criteria: Evidence or history of significant acute or chronic disease Pregnant or nursing females Screening PR interval > 220 msec Sitting blood pressure <= 90 mmHg systolic or <= 60 mmHg diastolic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Drug: CP-945,598<br>* 20 mg CP-945,598 + 240 mg MR Diltiazem<br>|
| Experimental: Group B<br> | Drug: CP-945,598<br>* 20 mg CP-945,598 alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax) |  | Days 7 and 28 | 
| Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests. |  | 28 days |
A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.

Official Title
-----------------
A Six-month, Multicenter, Double-blind, Parallel, Placebo-controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Donepezil (Aricept)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Probable or possible Alzheimer's disease Living in skilled nursing home Exclusion Criteria: Other types of dementia or psychiatric or neurologic disorders Musculoskeletal disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Donepezil (Aricept)<br>* Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching placebo tablets orally once daily for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score |  | Month 6 | 
| Change from baseline in Severe Impairment Battery (SIB) total score |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in SIB total score |  | Month 3 | 
| Change from baseline in Neuropsychiatric Inventory (NPI) total score |  | Months 3 and 6 | 
| Change from inclusion in Mini Mental State Examination (MMSE) total score |  | Month 6 | 
| Change from baseline in Clinical Global Impression of Improvement (CGI-I) score |  | Months 3 and 6 | 
| Adverse events and laboratory value changes |  | Months 3 and 6 | 
| Change from baseline in modified ADCS-ADL-severe total score |  | Month 3 |
Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II

Study Overview
=================
Brief Summary
-----------------
Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Detailed Description
-----------------
Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification. Specular microscopy photos will be taken pre-. and 3 month postoperatively. Cellular parameters will be compared between the two groups prior and post surgery. Clinical significant difference is defined as 1 SD (300 cell/mm2)

Official Title
-----------------
Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes

Conditions
-----------------
Diabetes, Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract, diabetes Exclusion Criteria: Corneal disease Uveitis Previous intraocular surgery and diabetes type I

Ages Eligible for Study
-----------------
Minimum 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
-----------------
Diabetes Mellitus, cornea endothelium, cell loss, cataract surgery
Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Study Overview
=================
Brief Summary
-----------------
Investigators will collect serum and urine specimens from pregnant patients along the full pregnancy continuum, assay each specimen for selected placental proteins, and examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

Detailed Description
-----------------
Investigators will collect serum and urine specimens from pregnant patients along with ultrasound results and information about factors that may affect the concentrations of proteins or the estimation of gestational age. Investigators will obtain data across the full pregnancy continuum but we will over sample patients within five gestational weeks before and after the 10 week mark. Investigators will assay each specimen for selected placental proteins (Human placental lactogen (HPL), Schwangerschaftsprotein 1 (SP1), Pregnancy-associated plasma protein A (PAPP-A), A Disintegrin and Metalloproteinase 12 (ADAM12), and Human chorionic gonadotropin (HGC)) and any other proteins of interest identified prior to running assays and will examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound. The goal is to identify at least one compound and a concentration threshold for that compound that can be used for differentiating pregnancies of less than 10 weeks in duration from later pregnancies.

Official Title
-----------------
Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Conditions
-----------------
Gestational Age

Intervention / Treatment
-----------------
* Other: Non-interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has an intrauterine pregnancy confirmed by ultrasound Not known to have pregnancy-induced hypertension (preeclampsia) or diabetes Not known to have a nonviable pregnancy, a multiple pregnancy, a pregnancy with a chromosomal or fetal abnormality, or a pregnancy with growth restriction Not currently taking anticoagulants Not currently having clinically significant vaginal bleeding, unusual pelvic pain, or other symptom suggestive of a pregnancy complication No use of assisted reproductive technology to conceive the current pregnancy Not previously enrolled in this study Exclusion Criteria: Does not meet inclusion criteria
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-interventional Study|no interventions in this study, just specimen collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| protein concentration | Concentration of placental proteins in blood and urine | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
placental proteins
Follicle Stimulating Hormone (FSH) Receptor Polymorphisms in In-Vitro Fertilization Cycles.

Study Overview
=================
Brief Summary
-----------------
This study is being done to identify if certain sequences (patterns) of key genes (called polymorphisms) may predict a response to fertility medications. The investigators will also determine if the individual response to fertility medications affects pregnancy rates in in-vitro fertilization.

Detailed Description
-----------------
All IVF patients who meet inclusion criteria and not exclusion criteria will be asked to participate in this study. Upon consent, a blood sample will be obtained in 2 EDTA containing lavender topped tubes before, during or within 3 months after their IVF cycle. Genomic DNA will be extracted and saved for genotyping. The Investigators will collect data on each individual's age, ethnic background, and estradiol levels on the day of hCG administration, total gonadotropin amount, clinical pregnancy rates, basal FSH levels, and occurrence of OHSS. The Investigators will then analyze all samples from all patients for their FSH receptor genotypes. Patients will be compensated $75 via a check within 6-8 weeks of their blood drawn.

Official Title
-----------------
The Use of FSH Receptor Polymorphisms To Improve Pregnancy Rates In In-Vitro Fertilization

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 100 women less than 35 years old at time of signing the Informed Consent Form. Day 3 FSH level less than or equal to 10 mIU/ml with an estradiol < 70 pg/ml Day 3 antral follicle count of greater than 10 follicles total. Couples who have male factor infertility, tubal factor infertility, and unexplained infertility. Exclusion Criteria patients who have: Endometriosis Polycystic ovarian syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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 |
| --- | --- | --- |
| The primary outcome measure is to evaluate the frequency of FSH receptor polymorphisms in our population. | The investigators are looking to quantify how often certain FSH receptor Polymorphisms occur in the population and cetain racial groups. We will be looking at patient's race along with the laboratory results. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome is to further clarify the variation in response to FSH due to FSH receptor polymorphisms using the protocols largely used in the United States, including our center. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, FSH Receptor Polymorphisms
A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome

Conditions
-----------------
Dry Eye With Sjögren's Syndrome

Intervention / Treatment
-----------------
* Drug: KCT-0809 ophthalmic solution
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry eye patients with Sjögren's syndrome Corneal and conjunctival damage Exclusion Criteria: Severe ophthalmic disorder Punctal plugs or surgery for occlusion of the lacrimal puncta

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KCT-0809<br> | Drug: KCT-0809 ophthalmic solution<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the corneal staining |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the conjunctival staining |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye syndromes, Corneal diseases, Conjunctival diseases
A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect medical information about HIV-positive pregnant women and their babies who have been (or are being) seen at study sites. This information will be used to help design future research studies for these patients. The population of HIV-positive pregnant women and their babies who are seen at study sites has not been officially examined. In order to design future studies to research the best care for these patients, this study will examine important characteristics and the general number of women in these trials.

Detailed Description
-----------------
The population served at affiliated ACTG sites has not been officially described. Anecdotal evidence, however, has surfaced regarding the characteristics of HIV-infected pregnant women and the current standard of care during pregnancy. This chart abstraction study is designed to define, more accurately, the pertinent characteristics and general numbers of women in these trials. In this medical chart abstraction study, pertinent information is collected on all HIV-infected pregnant women and their infants who receive primary or consultative care at PACTG 367 study sites. Part A profiles all HIV-infected women who received care or consultation at study sites and who had a pregnancy outcome between January 1, 1998 through July 1, 1998. [AS PER AMENDMENT 04/12/02: Part A is closed to enrollment.] Part B profiles HIV-infected pregnant women who receive primary or consultative care and a pregnancy outcome following July 1, 1998.

Official Title
-----------------
Medical Chart Abstraction of HIV-Infected Pregnant Women and Their Infants Receiving Care or Consultation at Study Sites

Conditions
-----------------
HIV Infections, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria A patient may be eligible for this study if she: Is an HIV-positive woman. Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available. Had a baby on or after January 1, 1998.
Sexes Eligible for Study
-----------------
Female

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
-----------------
Pregnancy, Anti-HIV Agents