linjc16/ctgov huggingface dataset:
Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis (ALS) pathophysiology and its impact on disease progression and survival is unclear. The investigators analyzed the correlation between lipid levels with disease progression and survival in ALS patients and the association of LLT with these outcomes.

Official Title
-----------------
Cohort Study of the Relationship of Hyperlipidemia and Statin Therapy on Survival and Disease Progresssion in Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of laboratory-supported probable, probable, or definite familial, sporadic ALS, according to a modified El Escorial criteria (ref), by the study investigators Time from disease onset is less than three years 18 years of age Subjects with diagnosis of hyperlipidemia and/or taking lipid lowering medications will not be excluded from study. Exclusion Criteria: Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc) A clinically significant history of significant medical illness (advanced cancer, chronic inflammatory/infectious conditions, etc) within six months of baseline Use of progestins, anabolic steroids, and corticosteroids within 45 days of baseline visit. Therapy is allowed as medically indicated after baseline visit.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lipid lowering therapy<br>those with lipid lowering therapy those without lipid lowering therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survial(tracheostomy free,<23 hours on NIPPV, from enrollment) | Death was confirmed from Social Security Death Index or newspaper obituaries. Tracheostomy- ventilation was also considered as an end of the life time point. | 3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALSFRS(measure of disability) | DeltaFS = (48-ALSFRS at first evaluation )/duration from onset to diagnosis (month) changeFS=(ALSFRS at six months-ALSFRS at first evaluation)/6 | at first evaluation(time 0-T0) to six months (T6) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lipid lowering therapy, survival, ALSFRS, age, BMI, weight
A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome

Study Overview
=================
Brief Summary
-----------------
The investigators plan to retrospectively analyze clinical data from 14,189 fresh ICSI cycles in Reproductive and Genetic Hospital of CITIC-Xiangya from January 2016 to December 2017.The investigators will regard total progressive sperm number of 2 x 10^6 after pretreatment as the boundary value, and will divide total progressive sperm number of 2 x 10^6 after pretreatment into 2 x 10^6 or higher and < 2 x 10^6 groups, and will further divide < 2 x 10^6 group into: = 0, (0,10^6], (10^6, 2 x 10^6) three groups. Propensity score matching will be used to balance the baseline data between four groups. The matching variables are age, female BMI, AFC, AMH and ICSI.

Official Title
-----------------
A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome

Conditions
-----------------
Sperm Count, Low, Reproductive Sterility

Intervention / Treatment
-----------------
* Other: semen pretreatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertility female and sterility male for reproductive treatment Exclusion Criteria: chromosomal abnormalities none retrieval oocyte none oocyte for ICSI Recurrent abortion female age≥37 years Assisted hatching abnormal oocyte zona pellucida In Vitro Maturation AZF microdeletion
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group1<br>A+B grade sperm count after treatment=0 | Other: semen pretreatment<br>* semen pretreatment<br>|
| group2<br>0<A+B grade sperm count after treatment≤10^6 | Other: semen pretreatment<br>* semen pretreatment<br>|
| group3<br>10^6<A+B grade sperm count after treatment<2*10^6 | Other: semen pretreatment<br>* semen pretreatment<br>|
| group4<br>A+B grade sperm count after treatment≥2*10^6 | Other: semen pretreatment<br>* semen pretreatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high quality embryo rate for ICSI | rate of embryo grade above 6CI on the third day after fertilization | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate of ICSI | number of fertilized oocytes/ number of metaphase II oocytes | two years | 
| normal fertilization rate of ICSI | number of 2PN fertilized oocytes/ number of metaphase II oocytes | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICSI, progressive sperm count, embryo
Buckberg vs Del Nido in Isolated Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures. Half the patients will receive the Del Nido solutions while the other half will receive the Buckberg solution.

Official Title
-----------------
Randomized Multicentric Trial to Compare Efficacy and Security of Bucberg vs Del Nido Cardioplegic Solutions in Isolated Aortic Valve Replacement.

Conditions
-----------------
Cardiac Surgical Procedures

Intervention / Treatment
-----------------
* Drug: Del Nido
* Drug: Buckberg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old Patients listed for elective aortic valve replacement Patients that have signed informed consent Exclusion Criteria: Emergent surgery Patients that do not accept blood transfusion

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bukcberg<br>Buckberg cardioplegical solution administered antegrade and/or retrograde at 1-2ml/Kg for cardiac arrest induction. Arrest manteinance with antegrade and/or retrograde administration at 1-2ml/Kg every 15 to 20 minutes. Reperfusion dose with antegrade or retrograde administration at 15-20 ml/Kg before removing the aortic crossclamp. | Drug: Buckberg<br>* Buckberg cardioplegical solution administered antegrade and/or retrograde at 1-2ml/Kg for cardiac arrest induction. Arrest manteinance with antegrade and/or retrograde administration at 1-2ml/Kg every 15 to 20 minutes. Reperfusion dose with antegrade or retrograde administration at 15-20 ml/Kg before removing the aortic crossclamp.<br>|
| Experimental: Del Nido<br>Del Nido cardioplegic solution administered in a single dose at 15-20mg/Kg with a maximum dose of 1L of solution, administered antegrade or retrograde. In those patients in wich the crossclamping time exceed 90 to 120 minutes a manteinance dose of 500ml will be administered. | Drug: Del Nido<br>* Del Nido cardioplegic solution administered in a single dose at 15-20mg/Kg with a maximum dose of 1L of solution, administered antegrade or retrograde. In those patients in wich the crossclamping time exceed 90 to 120 minutes a manteinance dose of 500ml will be administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All cause mortality | 30 days | 
| Troponin T | Troponin T blood levels | 5 days | 
| CK | CK blood levels | 5 days |
Healthy Lifestyle Program: A Novel Group-based Training

Study Overview
=================
Brief Summary
-----------------
The Healthy Lifestyle Program involves twelve, 2-hour seminars during which participants will learn how to build healthy behaviors through a combination of individual and group exercises. Participants will use lessons from the seminars to pursue health goals and learn the basics of physical fitness, nutrition, sleep & recovery, stress management, and weight management for optimal health. Throughout the program, participants will be supported by a behavior coach along with dedicated fitness training, dietary strategy, and stress management support. As part of this next installment of the program, we are conducting a study of the Healthy Lifestyle Program to capture outcome data, including weight/BMI, blood pressure, hemoglobin A1c, and lipid profile.

Official Title
-----------------
Healthy Lifestyle Program: A Novel Group-based Training

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

Intervention / Treatment
-----------------
* Behavioral: Healthy Lifestyle Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preferential access to the HLP is provided folks who live in the neighborhoods of Roxbury, Dorchester, and Mattapan. However, this is certainly not exclusive and we continue to have participants from all around the greater Boston area, especially now that the program is being delivered virtually. Exclusion Criteria: There are no groups of people who are excluded from participating in the program, except for the specified by the age cut offs.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Lifestyle Program Intervention Arm<br> | Behavioral: Healthy Lifestyle Program<br>* An intensive behavior change curriculum designed to help create and sustain healthy habits<br>|
| No Intervention: Waitlist Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 1 year |
Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.

Official Title
-----------------
Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

Conditions
-----------------
Fungal Infection

Intervention / Treatment
-----------------
* Drug: Voriconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers 18-55 years of age Exclusion Criteria: Subjects with any condition affecting drug absorption Subjects with a positive urine drug screen

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess brain levels of voriconazole in the brain using a non-evasive technique of MRS |  |  |
Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)

Study Overview
=================
Brief Summary
-----------------
A phase IIR cmRCT trial companion to PERa registry, investigating the merit of SABR consolidation in men with metastatic prostate cancer. 80 patients will be randomly selected to be offered experimental SABR based on PSMA-PET detected disease after maximal systemic response. The primary endpoint is the rate of FFS at 1 year. Patients will be stratified according to hormone sensitive vs resistant disease prior to randomisation.

Official Title
-----------------
Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)

Conditions
-----------------
Prostate Cancer Metastatic

Intervention / Treatment
-----------------
* Radiation: SABR
* Other: no RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3.1.1 Enrolled in PERa (CHUM CER 17.032) and randomly selected for AnChoR-Prostate. 3.1.2 Diagnosis of metastatic prostate cancer having achieved maximum PSA response to SOC systemic therapy defined as two consecutive stable PSA within 6 months of regimen start. Stable PSA is defined as non- progressing (<25% rise from nadir, per PCWG3 guidelines). 3.1.3 ECOG 0-2 3.1.4 PSA > 0.2 ng/mL 3.1.5 1-5 sites of PSMA-PET avid disease amenable to SABR. Exclusion Criteria: none
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SABR consolidation<br> | Radiation: SABR<br>* SBAR to PSMA-PET visible disease at maximal systemic therapy response.<br>|
| Active Comparator: Control - no SABR consolidation<br> | Other: no RT<br>* no SABR, continued systemic therapy per SOC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FFS | FFS is defined as time from randomization to the first of the following events: PSA progression, radiographic or clinical progression. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQoL |  | 5 years | 
| Toxicity | CTCAEv5, incidence rate | 5 years | 
| Time to progression |  | 5 years |
Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.

Study Overview
=================
Brief Summary
-----------------
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug

Official Title
-----------------
9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug.

Conditions
-----------------
Epilepsy, Partial

Intervention / Treatment
-----------------
* Drug: levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment Exclusion Criteria: Subjects dosing with LEV two weeks prior to the selection visit Subjects using more than one AED Subjects with specific and non-specific sleep disorders

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints are based on the changes from Baseline to visit 7 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, adult, partial-onset epilepsy, antiepileptic
Outcomes in CF Patients Accessing Their Registry Health Records

Study Overview
=================
Brief Summary
-----------------
A multifactorial, parallel group, randomised control study in cystic fibrosis (CF) patients aged 13-30 years over an 18 month period. Patients will be offered read-only access to their CF registry electronic health record (CF View), or educational videos on CF (videos), or videos and CF View, or usual standard of care. The study aims are to examine the effect of patient access to C View on a range of clinical outcomes, health service usage, health literacy and patient reported outcomes.

Official Title
-----------------
Evaluating Outcomes in European Cystic Fibrosis Patients With Access to Their Health Records: a Randomised Control Trial of a Registry Patient Portal

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: CFView
* Other: CF educational videos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with CF registered with their national CF patient registry FEV1pp ≥40 aged 13-30 years Exclusion Criteria: organ transplantation FEV1pp <40

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 30 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CF View<br> | Other: CFView<br>* Registry patient portal<br>|
| Active Comparator: CF Educational videos<br> | Other: CF educational videos<br>* CF educational videos<br>|
| Active Comparator: CF View and videos<br> | Other: CFView<br>* Registry patient portal<br>Other: CF educational videos<br>* CF educational videos<br>|
| No Intervention: Usual standard of care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1pp | forced expiratory volume in 1 second percentage predicted | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health literacy | Health Literacy Survey - HLS- EU - Q16 score | 12 months | 
| Health-related quality of life | CFQr score - (Cystic Fibrosis questionnaire revised) | 12 months | 
| BMI | kg/m^2 | 18 months | 
| Pulmonary exacerbations | pulmonary exacerbation requiring IV antibiotics | 18 months | 
| Hospitalisations | hospitalisation for treatment of pulmonary exacerbation | 18 months |
Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

Study Overview
=================
Brief Summary
-----------------
Authors compared incidence of Hemolysis on Cardiopulmonary Bypass surgery for repair of congenital heart disease in Pediatric Patients between patients with thalassemia major and control group

Official Title
-----------------
Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major : Analysis of Hemolysis During Cardiopulmonary Bypass

Conditions
-----------------
Hemolysis

Intervention / Treatment
-----------------
* Diagnostic Test: Hemolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric Patients with thalassemia major. Pediatric Patients with congenital heart disease undergoing surgical repair. Exclusion Criteria: known hepatic or renal disease uncontrolled active hemolytic reaction emergency surgery redo surgery

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thalassemia group<br>16 pediatric patients with thalassemia major undergoing surgery for repair of congenital heart disease. Authors measure hemolysis by free plasma hemoglobin concentration. | Diagnostic Test: Hemolysis<br>* Authors measured free plasma hemoglobin concentration in gram<br>|
| Control group<br>25 pediatric patients with demographic data related to those in thalassemia group, undergoing surgery for repair of congenital heart disease. Authors measure hemolysis by free plasma hemoglobin concentration | Diagnostic Test: Hemolysis<br>* Authors measured free plasma hemoglobin concentration in gram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemolysis | Authors measure hemolysis by free plasma hemoglobin concentration | 3 hours |