linjc16/ctgov huggingface dataset:
The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery

Study Overview
=================
Brief Summary
-----------------
The effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery.

Official Title
-----------------
The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery

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

Intervention / Treatment
-----------------
* Drug: propofol, fentanyl, atracurium
* Drug: bupivacaine
* Drug: bupivacaine, Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patients (ASA physical status I and II) aged over 65 yrs and scheduled elective transurethral surgery Exclusion Criteria: cardiovascular, renal, liver disease, or cerebrovascular disorder

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: propofol, fentanyl, atracurium|general anesthesia|
|Drug: bupivacaine|spinal anesthesia|
|Drug: bupivacaine, Midazolam|spinal anesthesia & sedation|

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
-----------------
transurethral surgery
Perceived Barriers of Cervical Cancer Screening in Reunion Island and Key Levers for Improvment

Study Overview
=================
Brief Summary
-----------------
FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.

Detailed Description
-----------------
FOSFORE is a cross sectional KABP (Knowledge, Attitudes, Beliefs and Practices) telephone survey on cervical cancer screening from a sounding board of women aged between 25 and 65 years and living in Reunion Island. Sample size was estimated from local datas on cervical cancer screening.

Official Title
-----------------
Identification Des barrières au dépistage du Cancer du Col utérin à la Réunion et Des Leviers d'amélioration

Conditions
-----------------
Uterine Cervical Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged between 25 and 65 yo living in Reunion Island speaking French, Creole or Shimaore language able to answer phone Exclusion Criteria: history of hysterectomy history of incomplete or total conisation

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Type of barriers in cervical cancer screening | Telephone survey with a KABP-like questionnaire | 6 months | 
| Proportion of barriers in cervical cancer screening | Telephone survey with a KABP-like questionnaire | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of levers in cervical cancer screening | Telephone survey with a KABP-like questionnaire | 6 months | 
| Proportion of levers in cervical cancer screening | Telephone survey with a KABP-like questionnaire | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical cancer, Screening, Barriers
Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.

Study Overview
=================
Brief Summary
-----------------
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate

Official Title
-----------------
Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial

Conditions
-----------------
Hyaluronan-EnRiched Medium, Randomized Controlled Trial

Intervention / Treatment
-----------------
* Other: use of hyaluronan-enriched transfer medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with own oocytes/embryos; Patients with female age at 1st OR in the study <40 year; Patients planned for a 2nd oocyte retrieval, with no clinical ongoing pregnancy after the previous oocyte retrieval Patients planned for a 3rd oocyte retrieval with no clinical ongoing pregnancy after previous oocyte retrievals Patients with female age at 1st OR in the study <40 year; Patients with BMI ≤32; Patients with written informed consent; Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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 |
| --- | --- |
| Active Comparator: study group<br>Patients receiving an embryo transfer in hyaluronan-enriched transfer medium | Other: use of hyaluronan-enriched transfer medium<br>* In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium<br>|
| No Intervention: control group<br>Patients receiving an embryo transfer in conventional culture medium | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of transfers needed to reach ongoing pregnancy | The primary outcome parameter is the number of transfers needed to reach ongoing pregnancy (ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy), as a time-to-event outcome variable. Patients that do not reach pregnancy, are censored at their last transfer. | ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy | clinical pregnancy is defined as a pregnancy with at least one intrauterine (IU) or extrauterine (EU) fetal sac at 6-7 weeks of pregnancy) | until Live birth: 9 months after ET |
Glioblastoma and Individualized Therapies

Study Overview
=================
Brief Summary
-----------------
The treatment of patients with World Health Organization (WHO) grade 4 malignant glioma has not seen any significant breakthrough the past years. Following surgery and radio / chemotherapy patients still experience a very high recurrence risk and the prognosis is dismal. The investigators observed patients with grade IV malignant glioma receiving individualized treatment based on their molecular profile including fully personalized vaccines.

Official Title
-----------------
Retrospective Analysis of Glioblastoma Patients With Immune Therapies

Conditions
-----------------
Glioma, Malignant

Intervention / Treatment
-----------------
* Biological: Vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: malignant glioma, IDH WT Exclusion Criteria: na
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Vaccination|Personalized neoantigen vaccination|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Alpha MSH in Ocular Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is gain a better understanding of a molecule called alpha melanocyte stimulating hormone (alpha MSH) and its potential role in your retinal disease. Alpha MSH has been shown to have an important role in the regulation of ocular immunity in animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a protective effect of alpha MSH. By studying the levels of alpha MSH in your eye we may better understand its role in advanced dry macular degeneration. By studying the levels of this molecule we hope to better understand if it may be a good target for future treatment.

Detailed Description
-----------------
A small amount (0.1 mL) of aqueous humor would be removed from the study eye in the clinic setting. This sample will be processed and then sent off for measurement of alpha MSH levels.

Official Title
-----------------
The Role of Alpha Melanocyte Stimulating Hormone in Ocular Disease

Conditions
-----------------
Advanced Dry Macular Degeneration

Intervention / Treatment
-----------------
* Device: Alpha MSH assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 years or older diagnosis of advanced dry macular degeneration with foveal geographic atrophy limited vision or blindness (20/100 or worse) in that eye pseudophakia (prior cataract surgery in that eye) Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Advanced Dry macular degeneration<br> | Device: Alpha MSH assay<br>* Assay to detect levels of alpha MSH in intraocular fluid.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular degeneration, blindness
A Study of LY317615 in Patients With Brain Tumors

Study Overview
=================
Brief Summary
-----------------
The safety of LY317615 and any side effects that might be associated with the drug. Whether LY317615, can help patients with brain tumors.

Official Title
-----------------
A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas

Conditions
-----------------
Malignant Glioma

Intervention / Treatment
-----------------
* Drug: Enzastaurin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must be at least 18 years old You must have been diagnosed with a recurrent brain tumor by MRI or CT scan You must be able to swallow the LY317615 tablets Exclusion Criteria: You are a woman who is pregnant or breastfeeding In view of your doctor, you have significant heart, liver, kidney, or psychiatric 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas |  |  |
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.

Official Title
-----------------
A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Tenofovir DF
* Drug: lopinavir/ritonavir with 2 Nucleoside RTIs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive >18 years of age HIV RNA> 400 copies/mL Any CD 4 cell count Antiretroviral naïve No acute illness Exclusion Criteria: -

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>2 drug arm | Drug: Tenofovir DF<br>* TDF 300mg QD for 72 wks<br>Drug: lopinavir/ritonavir with 2 Nucleoside RTIs<br>* LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks<br>* Other names: lopinavir/ritonavir;|
| Active Comparator: B<br>3 drug arm, SOC | Drug: lopinavir/ritonavir with 2 Nucleoside RTIs<br>* LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks<br>* Other names: lopinavir/ritonavir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral efficacy by HIV RNA |  | 72 wks | 
| Incidence of adverse events |  | 72 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence and quality of life |  | 72 wks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lopinavir, Ritonavir, Kaletra, Tenofovir, HIV infection, Treatment Naive
Telehealth Autism Assessment for Adults

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the reliability and validity of an adapted Autism Spectrum Disorder assessment measure for use in a telehealth visit.

Official Title
-----------------
Telehealth Autism Assessment for Adults

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: ADOS-2 Module 4
* Behavioral: Adapted Telehealth ADOS-2 Module 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60 years old Access to personal computer with video, microphone, and speaker English literate Fluent English speaker Exclusion Criteria: Non-fluent English speaker Not English literate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standardized assessment<br> | Behavioral: ADOS-2 Module 4<br>* Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4.<br>|
| Experimental: Telehealth assessment<br> | Behavioral: Adapted Telehealth ADOS-2 Module 4<br>* Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concurrent validity | Concurrent validity will be assessed through correlations between the domain, Overall Total, and calculated Comparison scores of the two ADOS-2 versions, as well as through comparison of total scores on the Social Communication Questionnaire (SCQ) and the Social Responsiveness Scale, Second Edition (SRS-2). | Immediately after intervention |
Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH

Study Overview
=================
Brief Summary
-----------------
This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).

Detailed Description
-----------------
Pulmonary arterial Hypertension is characterized by a progressive incerease in pulmonary vascular resistance(PVR) leading to right ventricualar failure. Udenafil inhibits PDE 5, an enzyme that metabolizes cGMP, enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells, including those in the lung.

Official Title
-----------------
A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Udenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Udenafil<br>Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks) | Drug: Udenafil<br>* Udenafil 50mg tablet<br>* Other names: Zydena;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc) | Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc | during 48-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-MWD |  | 24, 48-week | 
| BORG dyspnea score |  | 24, 48-week | 
| WHO class |  | 12, 24, 36, 48-week | 
| Time to clinical worsening(TTCW) |  | during 48-weeks | 
| NT-pro BNP |  | 24, 48-week | 
| Echocardiography |  | 48-week |
VTE Incidence in Severe Sepsis and Septic Shock

Study Overview
=================
Brief Summary
-----------------
Prospective studies on the incidence of VTE during severe sepsis and septic shock remain absent, hindering efficacy assessments regarding current VTE prevention strategies in septic patients. The investigators will prospectively study consecutively enrolled ICU patients with severe sepsis and septic shock admitted at three hospitals. All patients will provide informed consent and the study will be IRB approved. VTE thromboprophylaxis, provided per standard of care and according to the patients' primary team, will be recorded for all patients. Patients will undergo bilateral lower (and upper, if a central venous catheter [CVC] was present) comprehensive compression ultrasonography (CUS) and will be followed for symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. The investigators will perform multivariate regression analyses to identify predictors of VTE.

Official Title
-----------------
VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock

Conditions
-----------------
Severe Sepsis With Septic Shock

Intervention / Treatment
-----------------
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients with severe sepsis and septic shock Exclusion Criteria: Admission diagnosis of acute VTE, age < 13 years, pregnancy, severe chronic respiratory disease, severe chronic liver disease (Child-Pugh Score of 11-15), moribund patients not expected to survive 24 hours, and acute myocardial infarction within 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of VTE |  | 28 days |