linjc16/ctgov huggingface dataset:
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)

Study Overview
=================
Brief Summary
-----------------
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Chaetoglobosin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Chaetoglobosin A during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.

Official Title
-----------------
Chaetoglobosin A Supplementation to ICSI Handling Medium

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Medium Supplemented with Chaetoglobosin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ICSI participants agreed Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handling Medium Supplemented with Chaetoglobosin A<br> | Other: Medium Supplemented with Chaetoglobosin A<br>* A medium with in-house supplementation of Chaetoglobosin A to decrease oocyte degeneration after ICSI and improve the survival rate<br>|
| No Intervention: handling Medium as it is.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocyte Survival after ICSI | Survived oocytes per MII injected | two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate |  | 6 days of culture | 
| Rate of top-quality embryo | Rate of top-quality embryo per fertilized oocytes | 6 days of culture | 
| blastocyst formation and quality | Number of formed blastocyst and high-quality blastocyst per fertilized oocytes | 6 days of culture | 
| blastocyst utilization rate | Number of transferred and vitrified embryos per fertilized oocytes | 6 days of culture | 
| clinical pregnancy rate | Number of pregnant women per recruited cycles | 7 weeks | 
| Implantation rate | sacs with a heartbeat per embryo transferred | 7 weeks | 
| Ongoing pregnancy rate |  | 12 weeks |
Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Effect of Endotoxin on Inflammatory Markers in Exhaled Breath, Sputum, Saliva and Nasal Lavage in Healthy Non-Smokers and Current Smokers Including Patients With COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: Inhalation of LPS
* Procedure: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second [FEV1] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s) 0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production) I-II: Mild-moderate COPD FEV1 reversibility of < 15% after inhaled beta2-agonists FEV1/forced vital capacity (FVC) < 70% predicted FEV1 between greater than or equal to 50% and less than 80% With or without chronic symptoms (cough, sputum production) Able to comprehend and grant a written informed consent Exclusion Criteria: Concomitant use or pre-treatment within the last 4 weeks with oral steroids Respiratory infection within 4 weeks prior to entry into the trial Females who are pregnant or lactating History of current or past drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Inhalation of LPS | Procedure: Inhalation of LPS<br> <br> |
| Placebo Comparator: 2<br>PLacebo | Procedure: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum induced |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild to moderate Chronic Obstructive Pulmonary Disease (COPD), Volunteers (healthy non-smokers), Volunteers (current or ex-smokers)
Concurrent Electronic Order Entry Variation Reporting Impact on Ordering Behavior

Study Overview
=================
Brief Summary
-----------------
Display of information regarding utilization and quality to primary care physicians as they use our computer based system to order radiologic imaging (CT, MR, etc) will reduce unnecessary imaging.

Official Title
-----------------
Concurrent Electronic Order Entry Variation Reporting Impact on Ordering

Conditions
-----------------
Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCPs at MGH with patient panel > 99 loyal patients Exclusion Criteria: PCPs at MGH with patient panel < 99 loyal patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention<br>PCPs at MGH who receive display of utilization and quality during computer order entry | |
| control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status adjusted utilization of imaging by each PCP in the intervention group, compared to themselves before intervention, and as a group to the control group |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
this study does not look at patient conditions
Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. In these patients the investigators will measure the specific antibody production.

Detailed Description
-----------------
Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval. In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.

Official Title
-----------------
Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation

Conditions
-----------------
H1N1 Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Exclusion Criteria: Patients with unstable grafts.

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- |
| Stem cell and and heart transplant patients<br>Stem cell and and heart transplant patients | |

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
-----------------
Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: erlotinib [Tarceva]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >= 18 years of age; inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer; ECOG performance status of 0-3; previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy. Exclusion Criteria: prior systemic anti-tumor therapy with HER1/EGFR inhibitors; unstable systemic disease; any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer; any significant ophthalmologic abnormality.

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: 1<br> | Drug: erlotinib [Tarceva]<br>* 150mg po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Length of patient on study (length of time of patient on study determined by investigator) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response Rate per investigator assessment |  | Length of patient on study (length of time of patient on study determined by investigator) | 
| Time to Progression (TTP) |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first | 
| Overall survival |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first |
A Multiple-Ascending-Dose Study of the Safety and Tolerability of REGN421(SAR153192) in Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.

Official Title
-----------------
A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421 Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies

Conditions
-----------------
Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: REGN421(SAR153192)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older Histologically diagnosis of advanced solid malignancy, with no standard therapeutic options of proven benefit. Patients with measurable or non-measurable disease At least 6 weeks must have elapsed since the last dose of bevacizumab (AvastinTM) At least 4 weeks must have elapsed since the last major surgery For women of childbearing potential, a negative urine pregnancy test at the screening visit Willingness to use adequate contraception during the full course of the study. Systemic hormonal contraceptive agents are excluded Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures. Able to read, understand and willing to sign the informed consent form Exclusion Criteria: Medical history of myocardial infarction or cardiomyopathy Unstable angina NYHA class II - IV congestive heart failure Patients under treatment with more than 2 antihypertensive medications History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation, or clinically significant GI hemorrhage within 6 months of study drug administration Diabetic retinopathy Patients requiring anticoagulation Hypersensitivity to doxycycline or related compounds

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q2W<br>REGN421 (SAR153192) taken once every two weeks (Q2W) | Drug: REGN421(SAR153192)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary evidence of antitumor activity |  | 18 months |
The Effect of DPP4 Inhibitor on Vasclular Healing

Study Overview
=================
Brief Summary
-----------------
This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.

Official Title
-----------------
A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Effect of DiPeptidyl-Peptidase 4 Inhibitor on Vascular Healing After Biodegradable Polymer Based Sirolimus Eluting Stent Implantation in Diabetic Patients: OCT Study (DIAMOND-OCT)

Conditions
-----------------
Acute Coronary Syndrome, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Sitagliptin
* Drug: Non DPP-4 Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-ST segement elevation acute coronary syndrome Exclusion Criteria: Left main disease Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, sirolimus, siptagliptin and statin Congestive heart failure (patients with LVEF <30% or cardiogenic shock) Uncontrolled myocardial ischemia (repeated chest pain or dyspnea after revascularization) Uncontrolled ventricular arrhythmia History of malignancy with chemotherapy Serious hematologic disease (e.g. CML, MDS) Current infectious disease needs antibiotics therapy Creatinine level >1.5 mg/dL or dependence on dialysis Other severe concurrent illness (e.g. active infection, malignancy). Life expectancy of less than one year Pregnancy or women with potential childbearing Type I DM Treatment with insulin History of pancreatitis Who cannot read the informed consent form (e.g. illiteracy, foreigner)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPP-4 Inhibitor<br>Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication | Drug: Sitagliptin<br>* Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.<br>* Other names: Janiuvia;|
| Active Comparator: Non DPP-4 Inhibitor<br>Oral anti-diabetic medication except DPP-4 inhibitor | Drug: Non DPP-4 Inhibitor<br>* This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal coverage assessed by optical coherence tomography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malapposition, neointimal thickness or any optical coherence tomographic finding |  | 6 months | 
| Biomarkers | CD 34+ cell, hs CRP ect. | 6 months |
Cohort Study on Internet Game and Smart Phone Addiction

Study Overview
=================
Brief Summary
-----------------
The aim of this cohort study is to observe the prevalence, incidence, relapse, and remission rates of online and/or smartphone game addiction among elementary and secondary school students in Korea. In addition the investigators are going to identify risk and protective factors, to determine whether online and/or smart phone game addiction is a primary or secondary problem, and to identify outcomes for individuals who become or stop being online and smart phone game addiction.

Detailed Description
-----------------
Participants: Total 3,000 children will be enrolled the cohort and followed up for 4 years. Procedures: These students will be surveyed annually between 2015 and 2019. Surveys were conducted in classrooms by trained interviewer who had been trained by the research team assisted by the teachers. Measurements usage and frequency of internet, internet game, and smartphone game etc. interpersional relationship; with family members, peer group, and teacher etc. personal characteristics; self esteem, social support, depression, anxiety, hyperactivity etc. Socio-demographic factors

Official Title
-----------------
A Prospective Cohort Study to Identify Pathogenesis and Risk Factors on Internet Game and Smart Phone Addiction

Conditions
-----------------
Adolescent Problems, Addictive Behavior

Intervention / Treatment
-----------------
* Other: refer to mental health specialists


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3rd, 4th, and 7th grade students of selected 15 elementary and secondary schools who provide consent both the students and their parents Exclusion Criteria: does not provide consent

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: refer to mental health specialists|children who have diagnosed internet and/or smartphone disorder by psychiatrists referred to mental health specialists|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence, incidence, relapse, and remission of internet gaming addiction, internet addiction, and smartphone addiction |  | 2-year followup point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression, anxiety, attention deficit hyperactivity disorder, suicidality prevalence, incidence, relapse, and remission rate of internet gaming, internet, and smartphone addiction |  | 2-year follow-up point and 4-year followup point |
Analysis of Graft Function Following Autologous Islet Transplantation

Study Overview
=================
Brief Summary
-----------------
Analyze inflammatory markers and islet graft function through blood samples collected from subjects with chronic pancreatitis who undergo total pancreatectomy with auto islet transplantation.

Detailed Description
-----------------
A total of 100 subjects will be enrolled in this study; 85 subjects will be enrolled from patients who are scheduled for TP-AIT and 15 subjects will be for TP alone at Baylor University Medical Center at Dallas or Baylor All Saints Medical Center at Fort Worth. The patients who are enrolled in a clinical study, named 'A phase 2/3, multicenter, randomized, double-blind, placebo-controlled, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet auto-transplantation (REP0112, IND# 117390)', can be enrolled in this study.

Official Title
-----------------
Analysis of Graft Function Following Autologous Islet Transplantation

Conditions
-----------------
Chronic Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic pancreatitis and who are scheduled for TP alone or TP-AIT Patients aged 18 or older Patients are able and willing to attend required follow-up visits at Baylor Exclusion Criteria: Patients who are unable/unwilling to attend follow-up visits at Baylor For TP-AIT subjects: Patients who have advanced stage of chronic pancreatitis. The principal investigator or co-investigators carefully review the medical charts, laboratory results and radiology department reports and determine the suitability for this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Analysis of graft function following autologous islet transplantation |  | One year after transplant of islet cells. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatitis, islet cell