linjc16/ctgov huggingface dataset:
Effectiveness of Intracytoplasmic Sperm Injection and Laser Assisted Hatching on in Vitro Fertilization Outcomes of Patients With Different Causes of Infertility

Study Overview
=================
Brief Summary
-----------------
To determine the association of factors affecting the clinical pregnancy and live birth rates in patients undergoing in vitro fertilization (IVF) who received intracytoplasmic sperm injection (ICSI) and/or laser assisted hatching (LAH) or neither. After applying the inclusion and exclusion criteria, a total of 400 women who underwent IVF between January 2007 and December 2010 were included in the analysis. Patients were divided into 4 groups; 1) those that did not receive ICSI or LAH, 2) those that received ICSI only, 3) those that received LAH only, and 4) those that received both ICSI and LAH. Univariate and multivariate analyses were performed.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The present study was a retrospective review of the outcomes of women who underwent IVF with or without intracytoplasmic sperm injection (ICSI) at the Far Eastern Memorial Hospital, Taipei, Taiwan, between January 2007 and December 2010. Exclusion Criteria: Cases in which estradiol levels exceeded 50 pg/mL on the second day of the menstrual cycle were excluded. Female minors or disabled persons.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| those that did not receive ICSI or LAH<br> | |
| those that received ICSI only<br> | |
| those that received LAH only<br> | |
| those that received both ICSI and LAH<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate of intracytoplasmic sperm injection and laser assisted hatching on in vitro fertilization outcomes of patients with different causes of infertility |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate of intracytoplasmic sperm injection and laser assisted hatching on in vitro fertilization outcomes of patients with different causes of infertility |  | 1 year |
Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of healthy volunteers.

Official Title
-----------------
Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

Conditions
-----------------
Supersaturation and Precipitation in the Stomach

Intervention / Treatment
-----------------
* Drug: Diclofenac potassium 50 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age 20 - 35 years Exclusion Criteria: Illness Acute / Chronic gastric disorder Use of medicine (possible) pregnancy Frequent exposure to X-rays during the past year HIV / Hepatitis B Virus or Hepatitis C Virus infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional State<br>Fed vs. Fasted State Diclofenac potassium 50 mg | Drug: Diclofenac potassium 50 mg<br>* Diclofenac potassium 50 mg<br>* Other names: Cataflam;|
| Active Comparator: Use of a PPI<br>Nexiam (esomeprazole) 40 mg Diclofenac potassium 50 mg | Drug: Diclofenac potassium 50 mg<br>* Diclofenac potassium 50 mg<br>* Other names: Cataflam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Concentration - Time Curve |  | Every 10 minutes for 2 h |
Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).

Detailed Description
-----------------
The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC). This is a clinical quality improvement (CQI) initiative to evaluate outcomes within our institution. The data collected will be used to inform new innovative ways to improve EUS-guided liver biopsy with an ultimate goal of improving the quality of patient care. The clinical outcomes of this patient population have not been previously systematically reviewed in MDMC. Currently, the procedure in not being performed routinely at Methodist Dallas Medical Center (MDMC). However, with new technical and physician expertise, this option is now available at our institution. PI will evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients requiring histologic examination of their liver at MDMC.

Official Title
-----------------
Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy

Conditions
-----------------
Chronic Hepatic, Liver Diseases

Intervention / Treatment
-----------------
* Procedure: EUS-guided liver biopsy at MDMC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Undergone EUS-guided liver biopsy at MDMC Exclusion Criteria: Below 18 years of age Did not undergo EUS-guided liver biopsy at MDMC

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 |
| --- | --- |
| Undergone EUS-guided liver biopsy at MDMC<br>Undergone EUS-guided liver biopsy at MDMC | Procedure: EUS-guided liver biopsy at MDMC<br>* Endoscopic ultrasound (EUS) guided liver biopsy sampling is emerging as an alternative to the aforementioned approaches that offers several advantages, including decreased sampling variability and procedure-related complications.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of core biopsy |  | 9/1/2017 and 9/1/2019 | 
| Number of portal tracts |  | 9/1/2017 and 9/1/2019 | 
| Diagnostic yield | We will define an adequate specimen as one containing ≥11 portal tracts or measuring ≥20 mm cumulative core length. | 9/1/2017 and 9/1/2019 |
Prevalence of HbA1C in Women With PCOS

Study Overview
=================
Brief Summary
-----------------
Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.

Detailed Description
-----------------
In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS. Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests. Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.

Official Title
-----------------
Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study

Conditions
-----------------
Polycystic Ovarian Syndrome, Pelvic Endometriosis, Insulin Resistance, Non-insulin Dependent Diabetes Mellitus, Tubal Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of 25-35 Kg/Mt2 Atleast three of the Rotterdam criteria for diagnosis of PCOS. Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder. Exclusion Criteria: Subjects with documented diagnosis of Metabolic Syndrome. Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia. 4.Subjects with basal FSH >/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Arm<br>This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria) | |
| Control arm<br>This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HbA1C in both arms of the cohort of subjects | HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS | September 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, HOMA-B-cell, HbA1C, Insulin resistance, OGTT, HOMA-IR
Observational Study in Preterm Infants With Intracranial Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome. The investigators showed that preterm infants with severe ICH have decreased cerebral oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown. This longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ICH in comparison to infants without ICH.

Official Title
-----------------
Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function

Conditions
-----------------
Intracranial Hemorrhage, Intraventricular Hemorrhage, Cerebral Hypoxia

Intervention / Treatment
-----------------
* Other: No intervention/treatment is given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants born between 23 and 28 weeks of gestation Diagnosed with ICH grades II or higher during the first week after birth Matched control infants without ICH. Exclusion Criteria: Major congenital malformations Birth asphyxia Not expected to survive

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Matched group of control infants without diagnosis of intracranial hemorrhage | Other: No intervention/treatment is given<br> <br> |
| Intracranial Hemorrhage<br>Group of preterm infant with diagnosis of intracranial hemorrhage. | Other: No intervention/treatment is given<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral oxygenation | Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants. | postnatal weeks 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral perfusion and function | Comparisons of ultrasound measurements of superior vena cava flow and brain electrical activity by electroencephalography over time in infants with ICH and non-ICH infants. | post natal weeks 4 and 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature infants, Intracranial hemorrhage, Intraventricular hemorrhage, Cerebral oxygenation, Brain function, Cerebral perfusion
Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.

Detailed Description
-----------------
1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.

Official Title
-----------------
High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
EGFR-TKI Resistant Mutation

Intervention / Treatment
-----------------
* Other: history data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3. Exclusion Criteria: liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| weekly use erolotinib vs history data<br>Drug: erolotinib erolotinib 1050mg, oral, once a week, continues to disease progression or death or stop by physician | Other: history data<br>* history data of PFS after 1st line or second line theray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival Time (PFS) |  | an average 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate(ORR) |  | an average half year | 
| Overall Survival Time (OS) |  | an average 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Progression-Free Survival
A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Official Title
-----------------
A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently on drug therapy for type 2 diabetes Blood glucose criteria must be met Exclusion Criteria: History of type 1 diabetes Evidence of significant diabetic complications Serious cardiovascular events within the past 6 months Other protocol-defined exclusion criteria may apply

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vildagliptin<br> | Drug: vildagliptin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in disposition index at 52 weeks |  | 52 weeks | 
| Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks |  | 52 weeks | 
| Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks |  | 52 weeks | 
| Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks |  | 52 weeks | 
| Beta-cell function parameter derived from standard meal challenge |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
The Renin-Angiotensin System in Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. This study aims to compare the blood pressure and hormonal responses (plasma renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in individuals with mild essential hypertension.

Official Title
-----------------
The Renin-Angiotensin System in Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Enalapril 20 mg bd
* Drug: Candesartan 8 mg bd


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential Hypertension SBP 140-159 mmHg DBP 90-99 mmHg Exclusion Criteria: Intolerance of or allergy to ACE Inhibitors or ARBS Pregnant or Breastfeeding Pre-menopausal women Uncontrolled cardiac or renal failure Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enalapril 20 mg bd|nan|
|Drug: Candesartan 8 mg bd|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BP |  |  | 
| Change in PRA and aldosterone |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renin-angiotensin system, ACE Inhibitor, Angiotensin Receptor Blocker
A Registered Cohort Study of Immune-Mediated Neuropathies

Study Overview
=================
Brief Summary
-----------------
This study will provide further insights into the natural course of the disease about Immune-Mediated Neuropathies including clinical features，progression, related antibody spectrum and drug treatment effect.

Official Title
-----------------
A Registered Cohort Study of Immune-Mediated Neuropathies

Conditions
-----------------
Chronic Inflammatory Demyelinating Polyneuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 1. Outpatient or inpatient 2. Meet the diagnostic criteria of various inflammatory peripheral neuropathy. 3. Voluntary participation and informed consent signed by the applicant or his/her family. 4. Age 18 or above Exclusion Criteria: Severe complications Poor prognosis (<1 year survival) Severe mental disorder and inability to cooperate with the examination. Age less than 18

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between clinical phenotypes and Serum antibodies | Different clinical subtypes of GBS and CIDP have different course and prognosis.It may be related to different serum antibodies. | from date of enrollment until the date of death from any cause,assessed up to 20 years |