linjc16/ctgov huggingface dataset:
A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.

Official Title
-----------------
An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Formulation E1 of L-PPDS
* Drug: Formulation E2 of L-PPDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over 18 years of age diagnosed with ocular hypertension or open-angle glaucoma Subjects who have a best corrected visual acuity of 20/100 or better Exclusion Criteria: Subjects who wear contact lenses Subjects who have uncontrolled medical conditions Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular topical medications Subjects who have a history of chronic or recurrent inflammatory eye disease

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: 1. Formulation E1<br>Formulation E1 of Latanoprost-PPDS | Drug: Formulation E1 of L-PPDS<br>* Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.<br>|
| Experimental: 2. Formulation E2<br>Formulation E2 of Latanoprost-PPDS | Drug: Formulation E2 of L-PPDS<br>* Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline |  | 12 weeks |
Randomized Study of Hormonal Regulation of Infantile Hemangioma

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the clinical efficacy of leuprolide, a gonadotropin-releasing hormone agonist (GnRHa), in treating infants with vision-endangering or large, disfiguring hemangiomas. II. Assess the impact of GnRHa on growth and development during infancy. III. Assess the safety of GnHRa in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified according to gender and by position of the lesion (periorbital vs nonperiorbital). All patients receive oral prednisone daily for 3 weeks. Patients are then randomized to receive either placebo or leuprolide IM every 3 weeks, while continuing oral prednisone. Tumors are assessed at 1, 3, and 6 weeks. If the tumor is not responding, the leuprolide will be administered every 2 weeks. Tumors are reassessed at 3 and 6 months, at which point the treatment is stopped. Responding patients are observed every 3 weeks for 3 months. If the tumor begins to grow again, leuprolide may be administered for another 3 months. Patients whose tumors grow rapidly during treatment may crossover to the alternate therapy, repeat the leuprolide or prednisone therapy, or undergo surgical excision.

Conditions
-----------------
Hemangioma

Intervention / Treatment
-----------------
* Drug: leuprolide
* Drug: prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Presence of hemangioma meeting at least one of the following criteria: Vision-threatening because of induced astigmatism or occlusion of the visual axis or proptosis Severe anatomic distortion compromising function of an organ or creating an unacceptable cosmetic outcome Other complications, e.g., Kasabach-Merritt consumptive coagulopathy, high-output heart failure, etc. No lesions that are clearly regressing before therapy No vascular malformations other than juvenile hemangiomas

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 8 Months

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leuprolide|nan|
|Drug: prednisone|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
-----------------
cardiovascular and respiratory diseases, hemangioma, rare disease
Dexamethasone for Preterm Labour

Study Overview
=================
Brief Summary
-----------------
The investigators sought to determine whether the incidence of neonatal respiratory distress syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of dexamethasone.

Detailed Description
-----------------
The administration of glucocorticoids to accelerate fetal lung maturity in patients with preterm delivery plays an important role for obstetrics and neonatal care. Many studies have shown that maternal administration of glucocorticoids has a significant beneficial effect in decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34 weeks of gestation.

Official Title
-----------------
Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Drug: Dexamethasone 24 hours
* Drug: Dexamethasone 12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient with threatened or established preterm labor between 28 - 34 weeks attended to our emergency unit Exclusion Criteria: emergent obstetric conditions like: Antepartum hemorrhage in severe attack Antepartum eclampsia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 hours Dexamethasone<br>Those patient will be given 12 hours dexamethasone after randomization | Drug: Dexamethasone 12<br> <br> * Other names: glucocorticoids;|
| Experimental: 24 hours Dexamethasone<br>Those patient will be give 24 hours dexamethasone after randomization | Drug: Dexamethasone 24 hours<br> <br> * Other names: glucocorticoids;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory distress syndrome (RDS) | determine whether the incidence of neonatal respiratory distress syndrome (RDS) is similar with 12- vs 24-hour dosing interval of dexamethasone. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal mortality | Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone. | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexamethasone, preterm labour, respiratory distress
HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.

Study Overview
=================
Brief Summary
-----------------
Observational, single-center, prospective case-control study, in which each patient is his own control. It focuses on the study of tubal patency and establishing the agreement of results between HyFoSy and HSG.

Detailed Description
-----------------
Observational, single-center, case-control study in which tubal pathology is studied in the context of a Basic Sterility Study. The main objective of this study is to demonstrate the concordance of this new diagnostic test (HyFoSy) with HSG, which is the common technique to visualize tubal patency. Once demonstrated concordance, we also want to carry out a cost-effectiveness study and demonstrate through different scales the greater ease of the test, less time to perform and less pain for the patient. It is a study in which the patients are women between 18-39 years old, undergoing study for primary sterility, with a BMI <30, AMH> 0.6 (good ovarian reserve).

Official Title
-----------------
HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency: a Prospective Case-control Study.

Conditions
-----------------
Tubal Patency, Sterility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 18-39 years, under study for primary sterility, with BMI <30, AMH> 0.6 (good ovarian reserve), subsidiaries of Conjugal or Donor IA, according to the 2019 SAS Reproduction Guide. Exclusion Criteria: Women <19 or> 39 years old, BMI> 30, secondary sterility, previous tubal sterilization, that is, the ART exclusion criteria according to the 2019 SAS Reproduction Guide.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| Cases-Control<br>Women aged 18-39 years, with BMI <30 and good ovarian reserve, undergoing study for primary sterility, subsidiary of conducting tubal patency studies to rule out pathology of the same and thus be able to perform Spousal or Donor IA. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of tubal patency and establish the concordance of results between HyFoSy and HSG. | Concordance study between HyFoSy and HSG. It is a qualitative study (yes / no). | Up to 48 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurrence of complications in the patients included in the study. | Expand the knowledge of the complications in the clinical practice of HyFoSy, confirming the lower perception of pain and the therapeutic effect of HyFoSy. | Up to 48 weeks. | 
| Time costs of performing HyFoSy versus HSG. | Compare the time it takes to see the effect of the study drug compared to HSG. | Up to 48 weeks. |
Cognitive Remediation and Functional Skills Training in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.

Official Title
-----------------
Specificity and Generalizability of Cognitive Remediation and Functional Skills Training in Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive Remediation
* Behavioral: FAST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Enrolled in outpatient mental health care Reading level of 6th grade or higher English speaking Exclusion Criteria: Medical conditions known to affect cognition

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive remediation<br>Cognitive remediation | Behavioral: Cognitive Remediation<br>* Computer-based, therapist-lead cognitive remediation<br>|
| Active Comparator: Functional Adaptive Skills Training<br>Functional and social skills group treatment | Behavioral: FAST<br>* Functional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills<br>|
| Active Comparator: Combined Treatment<br>Combined cognitive remediation and functional adaptive skills training | Behavioral: Cognitive Remediation<br>* Computer-based, therapist-lead cognitive remediation<br>Behavioral: FAST<br>* Functional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurocognition |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional competence | performance-based measures of functional and social competence | 12 weeks | 
| neurocognition |  | 24 weeks | 
| neurocognition |  | 36 weeks | 
| functional competence |  | 24 weeks | 
| functional competence |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Psychosis, Schizoaffective Disorder
Effect of Rifampin on the Pharmacokinetics of BAY73-4506

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.

Official Title
-----------------
A Phase 1, Non-Randomized, Open Label Study to Determine the Effect of Rifampin on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Regorafenib (BAY73-4506) + rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subject Age: 18 to 45 years (inclusive) at the first screening examination / visit Body mass index (BMI): 18 to 32 kg/m² (inclusive) Ability to understand and follow study-related instructions Subjects enrolled in this study must use adequate barrier birth control measures prior to, during the course of the study, and 3 months after the last administration of regorafenib. An adequate contraception includes the use of condoms or a vasectomy. In addition, adequate birth control measures for the subject's partner is required, such as a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, or hysterectomy. Exclusion Criteria: Clinically significant disease or condition Recent serious infection

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Regorafenib (BAY73-4506) + rifampin<br>* Drug: BAY73-4506 A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 1 as four 40 mg tablets. Drug: BAY73-4506 and rifampin 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 15 to Day 23. A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 21 as four 40 mg tablets.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile |  | after 1 month | 
| Proportion of subjects with adverse event collection |  | after 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers, rifampin, pharmacokinetics, single dose
Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

Study Overview
=================
Brief Summary
-----------------
Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. The rate of development of choroidal neovascularization postoperatively is noted.

Official Title
-----------------
To Peel or Not to Peel: Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

Conditions
-----------------
Epiretinal Membrane, Macular Holes, Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: pars plana vitrectomy with membrane peeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants diagnosed with ERM or FTMH and co-existing macular drusen; undergone pars plana vitrectomy with ILM and epiretinale membrane peeling; SD-OCT at the initial visit and at last follow up visit with image quality score >30; no evidence of CNV on initial fluorescein angiography (FA). Exclusion Criteria: history of other macular disease, severe non-proliferative or proliferative diabetic retinopathy, other retinal vascular diseases, glaucoma, myopic retinopathy, or other diseases interfering with OCT images in any one of the eyes; active CNV or history of CNV

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pars plana vitrectomy with membrane peeling|23-gauge pars plana vitrectomy with peeling of the epiretinal and internal limiting membrane as well as air- or gastamponade|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with CNV | number of patients with CNV (choroidal neovascularization) development | last visit, in common 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | best corrected visual acuity | last visit, in common 6 months postoperatively | 
| incidence of central retinal atrophy | development of central retinal atrophy on OCT | last visit, in common 6 months postoperatively |
Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.

Official Title
-----------------
Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: simvastatin
* Drug: atorvastatin
* Drug: pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers in good health according to their medical history, a physical examination and standard laboratory tests Exclusion Criteria: Subjects who have been using any continuous medication or herbal supplements.
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 |
| --- | --- |
| Active Comparator: statin-1<br>simvastatin | Drug: simvastatin<br>* 10mg, 2 weeks<br>* Other names: Lipovas tablets;|
| Active Comparator: statin-2<br>atorvastatin | Drug: atorvastatin<br>* 10mg<br>* Other names: Lipitor tablets;|
| Active Comparator: statin-3<br>pitavastatin | Drug: pitavastatin<br>* 2mg<br>* Other names: Livalo tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the pharmacokinetics of oral midazolam |  | after 14-days treatment with statins |
Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment

Study Overview
=================
Brief Summary
-----------------
The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches. Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical treatment. Determination of genetic polymorphisms will reduce the number of postoperative complications by predicting of possible complications in the long term period.

Official Title
-----------------
Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment

Conditions
-----------------
Aortic Aneurysm, Abdominal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infrarenal Aortic Aneurysm Exclusion Criteria: Other Aneurysms

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Mortality | 1-60 Month |