linjc16/ctgov huggingface dataset:
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate neutralization of keratometric astigmatism in patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the implantation of a toric intraocular lens.

Detailed Description
-----------------
Patients with Cataract are treated with phacoemulsification of the lens with an implantation of an intraocular lens. Besides cataract, almost 25% of these patients have some degree of Astigmatism; when it is higher than 1 diopter, it is possible to neutralize it with an implantation of a toric intraocular lens.

Official Title
-----------------
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

Conditions
-----------------
Cataract, Astigmatism

Intervention / Treatment
-----------------
* Procedure: Acrysof Toric one-piece intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symmetrical keratometric astigmatism ≥ 1.0 D and cataract. Exclusion Criteria: Irregular astigmatism, Keratoconus, Previous Refractive Surgery.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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: Acrysof Toric intraocular lens<br>A One piece, acrylic intraocular lens is implanted in the lens bag. | Procedure: Acrysof Toric one-piece intraocular lens<br>* Cataract Surgery with a intraocular lens implantation<br>* Other names: Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralization of Astigmatism |  | 3 months after cataract surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Astigmatism, Cataract
MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks
* Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks
* Drug: Comparator : niacin / Duraton of Treatment: 4 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be between the ages of 18 and 70 years Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant Exclusion Criteria: Patient has a history of peptic ulcer or gout Patient is sensitive to niacin or products containing niacin Patient drinks more than 2 alcoholic drinks per day Patient has certain heart disease, cancer, or is HIV positive

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: Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks|nan|
|Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks|nan|
|Drug: Comparator : niacin / Duraton of Treatment: 4 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo. |  | After 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo. |  | After 4 weeks |
National Survey on Infiltrative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.

Official Title
-----------------
National Prospective Survey on Women With a Diagnosis of Infiltrative Breast Cancer

Conditions
-----------------
Infiltrative Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women> or = 18 years old Women with newly diagnosis of infiltrative breast cancer Agree to take part in this study Exclusion Criteria: Women with other malignant tumor (except in situ cervical carcinoma or treated basal cell carcinoma) Women with in situ ductal carcinoma or in situ lobular carcinoma

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological, Clinical and Histological characteristics |  | Once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatments: Surgery, radiotherapy, chemotherapy, hormonotherapy. |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infiltrative breast cancer-Clinical practice, Women with infiltrative breast cancer
A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients

Study Overview
=================
Brief Summary
-----------------
Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.

Official Title
-----------------
A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients

Conditions
-----------------
Asthma, Mild Asthma

Intervention / Treatment
-----------------
* Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Diagnosed history of asthma Non smoker last two years < 5 pack years FEV1 >70% of predicted Mild and stable asthma Only using short acting b2-agonist as rescue for the last 4 weeks Have a history of atopy. Exclusion: Any significant respiratory disease, other than asthma Subjects with seasonal asthma may not be included if they are in their season Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks Upper or lower RTI within 6 weeks Evidence of any disease that in the investigators mind would affect the results of the study Participating in another study within 4 weeks Females who are pregnant, intend to be or who are lactating Methacholine PD20 > 454mcg Negative scin prick test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LTD4 PC20 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shift in methacholine PD20 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild asthma, FLIXOTIDE, methacholine, bronchial challenge, leukotriene D4
Understanding Family Refusal

Study Overview
=================
Brief Summary
-----------------
The investigators plan a secondary data analysis of an existing dataset to examine how individual decision-making differs from family decision-making in organ donation.

Official Title
-----------------
Exploring Family vs. Individual Decision-making in Organ Donation

Conditions
-----------------
Brain Death, Renal Failure

Intervention / Treatment
-----------------
* Other: Health sciences survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Citizens or permanent residents of Singapore Above 21 Exclusion Criteria: - Below 21

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Community sample<br>Representative sample of the Singapore population | Other: Health sciences survey<br>* Large scale demographic survey evaluating attitudes of population towards organ donation for the self vs. family<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to donate | Participants indicated their willingness to donate their own organs and those of a close family member | Single measurement (time of taking the survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confidence in family decision-making | Participants rated how confident they were that - upon their family member's death - they would respect their family member's views regarding donation rated using 5-point scales anchored on one end with 1=Not confident at all and 5=Absolutely confident). | Single measurement (time of taking the survey) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Organ donation, Transplantation, Intensive care
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

Official Title
-----------------
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Drug: Psilocybin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of at least moderate Major Depressive Disorder (MDD) Exclusion Criteria: Comorbidities Note for CA sites: Only Veterans are Eligible

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: Psilocybin<br>25mg of Psilocybin | Drug: Psilocybin<br>* open-label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) | MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score. | From Baseline (Day -1) to three weeks post-dose. |
Botswana Pediatric Respiratory Disease and Bloodstream Infection Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about lower respiratory tract and bloodstream diseases among infants born to HIV positive mothers in Botswana. Study factors include how commonly infants get these diseases, the causes, and outcomes. The study will also try to measure the protective effect, if any, of breast feeding on respiratory disease illness and deaths.

Official Title
-----------------
Botswana Pediatric Respiratory Disease and Bloodstream Infection

Conditions
-----------------
HIV Infections, Respiratory Tract Diseases, Sepsis

Intervention / Treatment
-----------------
* Procedure: blood draws, etc.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in parent study, Mashi HIV vertical transmission prevention study for pregnant Botswana women and their infants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood draws, etc.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE | MORTALITY; EPISODES OF SUSPECTED PNEUMONIA; BACTEREMIA; PRESENCE OF NASOPHARYNGEAL VIRAL PATHOGENS; OROPHARYNGEAL COLONIZATION WITH BACTERIAL PATHOGENS | Between birth and 2 years of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV infected mothers, Infants at risk of HIV-infection, Infant lower respiratory tract disease, Infant bloodstream infection
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

Study Overview
=================
Brief Summary
-----------------
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.

Official Title
-----------------
Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

Conditions
-----------------
Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed the core CZOL446H2202 study Males or females between 1-17 years of age Exclusion Criteria: Deformity or abnormality which would prevent spine bone density from being done Any surgical bone-lengthening procedure Any kidney diseases or abnormalities Low calcium or vitamin D levels in the blood Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Zoledronic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children
Follow-up Pilot Study After a First Stroke

Study Overview
=================
Brief Summary
-----------------
This is a randomized follow-up study after discharge from a stroke unit after a first stroke. The patients are randomized either to follow-up at a special out-patient stroke unit or with their general practitioners. The hypothesis is that follow-up with specialists is superior to follow-up with general practitioners. Endpoints are mortality, recurrent stroke and handicap measured with different scales.

Official Title
-----------------
Open, Randomized Follow-up Pilot Study After a First Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Information, further rehabilitation, additional drugs to prevent recurrent stroke
* Other: As the general practitioner wants to do


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first stroke (ischemic or hemorrhagic) age below 85 years living at home before the stroke Exclusion Criteria: modified Rankin scale 5 points other severe disease expected survival less than one year severe dementia drug or alcohol abuse

Ages Eligible for Study
-----------------
Maximum Age: 84 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Follow-up at an out-patient stroke unit<br>Information, measurement of handicap, further rehabilitation efforts, drug therapy for secondary prevention of stroke. | Other: Information, further rehabilitation, additional drugs to prevent recurrent stroke<br> <br> |
| Other: Follow-up with the general practitioner<br> | Other: As the general practitioner wants to do<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mortality |  | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke |  | 3.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Follow-up after stroke
Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

Official Title
-----------------
A Double-blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Primary Hypercholesterolemia

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

Intervention / Treatment
-----------------
* Drug: BMS-770767
* Drug: BMS-770767
* Drug: BMS-770767
* Drug: BMS-770767
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypercholesterolemia Currently taking a stable daily dose of statin therapy Serum triglyceride level < 500mg/dl Exclusion Criteria History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study Congestive heart failure Diabetes mellitus Active liver disease Impaired renal function Hepatitis C, B and HIV This list is not inclusive additional information is provided in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: BMS-770767 (Treatment A)<br> | Drug: BMS-770767<br>* Active, Oral, 15 mg, Daily, 28 days<br>|
| Experimental: BMS-770767 (Treatment B)<br> | Drug: BMS-770767<br>* Active, Oral, 50 mg, Daily, 28 days<br>|
| Experimental: BMS-770767 (Treatment C)<br> | Drug: BMS-770767<br>* Active, Oral, 150 mg, Daily, 28 days<br>|
| Experimental: BMS-770767 (Treatment D)<br> | Drug: BMS-770767<br>* Active, Oral, 50 mg BID, Daily, 28 days<br>|
| Placebo Comparator: Placebo (Treatment E)<br> | Drug: Placebo<br>* Placebo, Oral, 0 mg, daily, 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of LDL-C |  | Within 28 days following dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Blood Level) of BMS-770767 |  | Within 28 days following dosing | 
| Pharmacodynamic effects of BMS-770767 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, non-esterified free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG) |  | Within 28 days following dosing |