linjc16/ctgov huggingface dataset:
Shanghai Mild Cognitive Impairment Cohort Study

Study Overview
=================
Brief Summary
-----------------
This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion.

Official Title
-----------------
Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease

Conditions
-----------------
Mild Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive) Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5 Objective memory loss* as evidenced by Auditory Verbal Learning test (AVLT-HS) Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Not-demented, as defined by 'All-cause Dementia (see 3.4. All-cause Dementia) Willing to and able to undergo all test procedures including neuroimaging, and agree to longitudinal follow up Written informed consent for the participation of this study including repeated neuropsychological tests and MRI scans

Ages Eligible for Study
-----------------
Maximum Age: 90 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 |
| --- | --- |
| single-group MCI patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Conversion from MCI to Probable AD Dementia |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Conversion from MCI to Possible AD Dementia or Probable AD Dementia |  | 3 years | 
| Time to Conversion from MCI to All-cause Dementia |  | 3 years | 
| Overall survival |  | 3 years | 
| Changes in Neuropsychological examinations |  | baseline, annual and 3 years | 
| Changes in MRI |  | baseline, annual and 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild Cognitive Impairment, Alzheimer's Disease
Safety Study of JTT-302 in Subjects With Low HDL-C Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or 12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid parameters and CETP activity and mass.

Official Title
-----------------
An Eight Week, Open-label Extension Study Evaluating the Safety of JTT-302 Administered Once Daily in Subjects With Low HDL-C Levels Who Have Completed the Treatment Phase of Study AT302-U-06-003

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

Intervention / Treatment
-----------------
* Drug: JTT-302


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have successfully completed the 4-week treatment period of study AT302-U-06-003 Exclusion Criteria: Females who are pregnant or lactating, and females of child bearing potential who are not using an effective method of contraception Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol Subjects who cannot follow the prescription and OTC medication restrictions defined in the protocol Flu-shots not permitted during the study, including the follow-up period.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>JTT-302, 400 mg | Drug: JTT-302<br>* JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters |  | 4, 8 or 12 weeks |
Three-Year Clinical Evaluation of Bonded Posterior Restorations: Amalgam vs Resin Composite

Study Overview
=================
Brief Summary
-----------------
Background: This 3-year clinical trial compared the performance and post-operative sensitivity of a posterior resin composite with that of bonded-amalgam in large sized cavities. Additionally, it was evaluated whether resin composite could be an alternative for bonded amalgam. Methods: This was a randomized clinical trial. Patients in need of at least two posterior restorations were recruited. Authors randomly assigned one half of the restorations to receive bonded-amalgam and the other half to composite restorations. Forty bonded-amalgams and composites were evaluated for their performance on modified Ryge criteria and post-operative sensitivity using VAS for 36-months.

Official Title
-----------------
Three-Year Clinical Evaluation of Bonded Posterior Restorations: Amalgam vs Resin Composite

Conditions
-----------------
Class II Lesions

Intervention / Treatment
-----------------
* Procedure: posterior restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included, the teeth to be restored had to: be asymptomatic have occlusal and adjacent teeth in contact have cavity sizes exceeding the one-third of the bucco-lingual distance between cusp tips - Exclusion Criteria: Patients with periodontitis, poor oral hygiene, bruxism or a history of allergic reactions to any of the materials

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active comparator<br>posterior restorations | Procedure: posterior restoration<br>* restorations for caries effected teeth<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ryge Criteria |  | 3 years |
Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?

Study Overview
=================
Brief Summary
-----------------
Many cases of male infertility are poorly understood and regarded as unexplained. Therefore, a etiological treatment for this condition can not be offered in most cases. A beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. However, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc Tablets.

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Dietary Supplement: Porimore - A Carnitine based food supplement
* Dietary Supplement: Zinc and Folate Supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertility at least one abnormal sperm quality parameter female age < 35 normal ovarian reserve Exclusion Criteria: known allergy to one of the food additives planned for treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Porimore arm<br>Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed. | Dietary Supplement: Porimore - A Carnitine based food supplement<br>* A daily dose of 2 grams L-carnitine, 1 gr acetyl L-carnitine, 500mg Vitamin C, 400 IU vitamin E, 60 mg Q10, 30mg Zinc Picolinate, 500mcg Folic Acid, 200 Mcg Selenium, 100 MCG Vitamin B12.<br>|
| Active Comparator: Folate and Zinc<br> | Dietary Supplement: Zinc and Folate Supplementation<br>* 500 Mcg Folic acid, 30-60 mg Zinc tablets/ day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | proportion of women becoming pregnancy following treatment with intrauterine insemination | 3 Insemination cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm quality parameters |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sperm, male infertility, Carnitine, food supplementation, insemination
Vision In Preschoolers Study (VIP Study)

Study Overview
=================
Brief Summary
-----------------
To identify vision-screening tests that can accurately predict those three- and four-year old preschoolers who would benefit from a comprehensive vision examination because of signs of amblyopia, strabismus, and/or significant refractive error.

Detailed Description
-----------------
The Vision In Preschoolers (VIP) Study is a multi-center, multidisciplinary, prospective clinical study to evaluate screening tests for identifying preschool children in need of comprehensive eye examinations. The primary goal of the VIP Study is to identify an effective and efficient battery of screening tests that has high sensitivity and specificity in identifying preschoolers in need of further evaluation for amblyopia, strabismus and/or significant refractive error. The VIP Study is designed in three-phases. Phase I activities will establish which screening tests perform well when administered by licensed eye care professionals (pediatric optometrists and pediatric ophthalmologists) in a population of 1000 Head Start preschoolers at high risk for the targeted vision disorders. Phase II activities will provide evaluation of the tests' performance when administered by pediatric nurses and lay people on a high risk population of 1000 Head Start preschoolers. Each child will be tested twice with each screening test - once by a pediatric nurse and once by a lay screener. Tests selected for Phase II will be determined by the outcome of Phase I. Phase III activities will evaluate the performance of the tests in identifying individuals with specific vision disorders in a general population of (6400) Head Start preschoolers. The category of screening personnel and the specific screening tests used in Phase III will be determined by the outcome of Phases I and II.

Conditions
-----------------
Amblyopia, Strabismus, Refractive Error

Intervention / Treatment
-----------------
* Procedure: Vision Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 59 Months

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Vision Screening|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
-----------------
vision screening
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).

Official Title
-----------------
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

Conditions
-----------------
Parathyroid Carcinoma, Hypercalcemia, Primary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: Cinacalcet HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium > 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is > 12.5 mg/dL at the screening test). Patients who provided their voluntary written informed consent to participate in the study. Exclusion Criteria: Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment. Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma. Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma. Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRN1493<br> | Drug: Cinacalcet HCl<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected serum calcium |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum intact parathyroid hormone |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT
The Effects of Inositol on Glucose Metabolism in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis

Official Title
-----------------
The Action of Inositols and Alpha-lactalbumin on Glucose Metabolism, Arterial Stiffness and Vascular Damage in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis

Conditions
-----------------
Metabolic Syndrome, Cardiac Fibrosis

Intervention / Treatment
-----------------
* Dietary Supplement: Inositol and alpha-lactalbumin


Participation Criteria
=================
Eligibility Criteria
-----------------
At least 3 of the following inclusion criteria: triglycerides levels ≥ 150 mg/dL HDL ≤ 40 mg/dL Fasting glycemia > 100 mg/dL <126 mg/dl Systolic Pressure ≥ 130 mmHg or Diastolic pressure ≥ 85 mmHg Hip circumference > 102 cm in men or 88 cm in women
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br> | |
| Experimental: Experimental<br>Dietary Supplement with inositols and alpha-lactalbumin | Dietary Supplement: Inositol and alpha-lactalbumin<br>* The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tryglicerides | Plasmatic levels of tryglicerides | Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days | 
| Hypertension | sphygmomanometer | Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days |
Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost

Study Overview
=================
Brief Summary
-----------------
Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy

Official Title
-----------------
Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age Diagnosis of open-angle glaucoma or ocular hypertension IOP > 16 mm Hg in each eye at the latanoprost -treated baseline evaluation Presently on latanoprost monotherapy for at least 6 weeks Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: · Known contraindication or allergy to brimonidine or any of its components Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2% Uncontrolled systemic disease Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator. Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed). Corneal abnormalities History of intraocular surgery within the last 3 months Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sun Protection Factor Assay (341/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517
* Drug: SFP Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987517<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-094)<br>Drug: SFP Control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |