linjc16/ctgov huggingface dataset:
Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions

Study Overview
=================
Brief Summary
-----------------
Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.

Detailed Description
-----------------
observation indicator: recurrence rate after operation incidence rate of complications postoperative hospital stay hospitalization costs Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Official Title
-----------------
Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions

Conditions
-----------------
Incarcerated Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: ADM tension-free hernia reparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of incarcerated hernia randomly select patch agreed by patients and family members Exclusion Criteria: severe organ dysfunction No-tolerate anesthesia No-suitable for operation glucocorticoid with long-term use Sever intraperitoneal adhesion existed spirit disease patients automatically exit

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 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: ADM tension-free hernia reparation<br>Use ADM to repair incarcerated inguinal hernia by tension-free | Procedure: ADM tension-free hernia reparation<br>* Use ADM as opposed to nothing to repair incarcerated inguinal hernia<br>|
| Placebo Comparator: traditional tension hernia reparation<br>Just repair incarcerated inguinal hernia by nothing in tension condition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the recurrence rate after operation |  | ten years |
An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Detailed Description
-----------------
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Official Title
-----------------
An Observational Study to Evaluate AZD9291 Treatment in Patients With EGFR T790M Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Following Progression on at Least One Prior EGFR TKI Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 20 years of age Patients who were in the AZD9291 Early Access Program Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018 Patients agree to provide the written informed consent or the informed consent is waived by IRB. Exclusion Criteria: • Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC
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 |
| --- | --- | --- |
| Progression free survival (PFS) | PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression | Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause | Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months |
Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory factors among overweight and obese children.

Official Title
-----------------
High Protein Diet , Adiponectin and Inflammatory Factors

Conditions
-----------------
Body Mass Index Quantitative Trait Locus 5 Disorder, Tangier Disease

Intervention / Treatment
-----------------
* Other: nutrition intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 85th age of 6-11 years no history of chronic diseases taken medications Exclusion Criteria: do not prescribe their diet mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nutrition intervention<br>high protein diet | Other: nutrition intervention<br> <br> * Other names: high protein diet;|
| No Intervention: control diet<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adiponectin (mcg/ml) | amount of adiponectin | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interlukine 6 (mcg/ml) |  | 10 weeks | 
| tumor necrosis factor alpha (ng/ml) |  | 10 weeks | 
| C reactive protein (mcg/ml) |  | 10 weeks | 
| fibrinogen (mcg/ml) |  | 10 weeks |
A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry

Study Overview
=================
Brief Summary
-----------------
The study will include all newborns in Normandie region for 3 years (about 105,000 births) for whom signed consent by one (or two) parents will be collected. Based on our previous pilot study (2011) assessing MCAD and PKU using tandem mass spectrometry-based method in Normandie region in which informed consents have been signed for all newborns (43,000) but we are expecting a great willingness to participate to this project. Thus, we are aiming to include 100,000 newborns, and the study will be continued until we reach at least this target. The primary objective is to evaluate the epidemiology of MPS1 and Pompe disease using dried blood samples in the first cohort of neonates tested in France (Normandie region).

Official Title
-----------------
A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry

Conditions
-----------------
Neonatal Screening, Lysosomal Storage Diseases

Intervention / Treatment
-----------------
* Procedure: Additional blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn in a Normandy maternity hospital Newborn participating in the National Neonatal Screening Program Holder(s) of parental authority having read and understood the information letter and signed the informed consent form Exclusion Criteria: There are no criteria for non-inclusion in this study. Participation in the study, such as participation in the National Neonatal Screening Program, is not mandatory.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 4 Days

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

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

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 |
| --- | --- |
| Experimental: neonates tested in Normandie, France<br>All neonates will be tested in Normandie | Procedure: Additional blood sampling<br>* Additional blood sampling on blotting paper will be done in neonates in Normandy, France, compared to National neonatal screening program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of newborns in relation to the number of cases of blotting paper collected |  | From day 2 to day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of newborns with positive sample for Mucopolysaccharidosis type I |  | From day 2 to day 4 | 
| Number of newborns with positive sample for Pompe disease |  | From day 2 to day 4 |
Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine

Study Overview
=================
Brief Summary
-----------------
This is a cohort study performed in patients with cardiovascular diaeases who were treated with oral Chinese medicine and Western medicine. Collect indicators such as the incidence of cardiovascular events, all due to readmission, all due to death. To hospital using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of cardiovascular diseases, and provide reliable data support for its clinical application.

Official Title
-----------------
Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: Chinese patent medicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the Department of Cardiovascular Medicine at The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, The Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Hospital of ITCWM Nankai Hospital and Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital were considered for inclusion in this study, and all Western medical diagnoses were identified and classified according to the International Classification of Diseases, 11th Revision (ICD-11). Exclusion Criteria: No exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed group<br>Western medicine treatment with Chinese medicine treatmen | Drug: Chinese patent medicine<br>* Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill, etc.<br>|
| Non-exposed group<br>Western medicine treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Events Cardiovascular Events Cardiovascular Events | Non-fatal myocardial infarction, non-fatal ischemic stroke, unplanned hemodynamic reconstruction. | one year | 
| All due to readmission | Readmission for cardiovascular events and readmission for other reasons. | one year | 
| All due to death | Cardiac death and death from other causes. | one year |
Back and Neck Pain in Adolescence

Study Overview
=================
Brief Summary
-----------------
To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.

Detailed Description
-----------------
In two settings (school, clinics) back and neck pain of 10 to 16 years old adolescents will be assessed by the German Version of the Young Spine Questionnaire at 6 points in time during one year. Validity, reliability and responsiveness of the G-YSQ will be determined and the development of back and neck pain within a year will be described.

Official Title
-----------------
Back and Neck Pain in Adolescence: A Prospective Cohort Study Using a German Version of the Young Spine Questionnaire

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10 to 16 years old Exclusion Criteria: younger than 10, older than 16

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 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: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in a German Version of the Young Spine Questionnaire |  | change from baseline to 12 months |
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of erythropoietin administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Conditions
-----------------
HIV Infections, Cytopenias

Intervention / Treatment
-----------------
* Drug: Epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of any primary hematologic disease. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS. AIDS-related dementia. Uncontrolled hypertension (diastolic blood pressure 100 mmHg). Presence of concomitant iron deficiency. Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy. Acute opportunistic infection. History of seizures. Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded. Prior Medication: Excluded within 30 days of study entry: Experimental drug or experimental device. Cytotoxic chemotherapy. Excluded within 2 months of study entry: Androgen therapy. Clinical diagnosis of AIDS related anemia. Clinical diagnosis of AIDS. Clinically stable for 1 month preceding study entry. Substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|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
-----------------
Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine
Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders

Study Overview
=================
Brief Summary
-----------------
This study investigates in patients whose primary complaint is either neck pain and/or a voice disorder , if there are any correlations between subjective neck and voice symptoms according to Neck Disability Index (NDI) and Voice Handicap Index (VHI). NDI and VHI questionnaire results for voice disordered patients will be retrieved from the data base of the Department of Phoniatrics and Speech Pathology, University Hospital Zurich. Neck pain patient questionnaire data will be retrieved from an ongoing study. The agreement between subjective neck handicap (NDI) and voice handicap (VHI) will be statistically analysed.

Official Title
-----------------
Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders

Conditions
-----------------
Neck Pain and/or a Voice Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old primary diagnose of a functional disorder of the muscular structure in the neck area primary diagnose of a functional or secondary structural voice disorder Exclusion Criteria: systemic illness of the motion apparatus (i.e., polyarthritis rheumatica) acute cancer neurogenic voice and swallow disorder Intubation within the last 18 months lack of german knowledge, (not able to fill out a questionnaire independently)

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 |
| --- | --- | --- |
| Correlation between neck disability index and voice handicap index (questionnaire) |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional neck area handicap in patients with voice disorders (questionnaire) | Patients will fill out the questionnaire once, at the beginning of the study | 1 day | 
| Additional subjective voice disorder in patients with neck pain (questionnaire) | Patients will fill out the questionnaire once, at the beginning of the study | 1 day | 
| Difference in pain strength and quality in patients with functional voice disorder as compared to patients with benign organical vocal fold changes (questionnaire) | Patients will fill out the questionnaire once, at the beginning of the study | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neck pain, voice disorder
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).

Official Title
-----------------
A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease

Conditions
-----------------
Carcinoma, Non-small-cell Lung

Intervention / Treatment
-----------------
* Drug: Tarceva (erlotinib HCl, OSI-774 )


Participation Criteria
=================
Eligibility Criteria
-----------------
Clinical diagnosis of stage IIIB or IV non-small cell lung cancer. Must have evidence of disease (clinical or radiological). Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days. If the patient has had surgery, the surgery was at least 2 weeks ago. Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms. If the patient received radiation therapy, treatment was at least 4 weeks ago.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tarceva (erlotinib HCl, OSI-774 )|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
-----------------
Non-Small Cell Lung Cancer, Tarceva, EGFR, erlotinib