linjc16/ctgov huggingface dataset:
The Effect of Hypertrophic Pyloric Stenosis (HPS) on Sodium Intake in Childhood

Study Overview
=================
Brief Summary
-----------------
The loss of sodium during infancy causes long term changes in sodium intake. Human research shows that the loss of maternal sodium during pregnancy and neonatal after birth causes an increase sodium intake during childhood. A study that examined sodium intake among infants that were treated with diuretics during the post-natal period found changes in sodium intake compared to controls. In this study we will test sodium intake in young children who have suffered from vomiting due to Hypertrophic Pyloric stenosis during early infancy.

Conditions
-----------------
Healthy, Hypertrophic Pyloric Stenosis

Intervention / Treatment
-----------------
* Behavioral: sodium taste tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 7-13 years Status post HPS in infancy Exclusion Criteria: Children with chronic diseases Hospitalization due to dehydration after HPS hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 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 |
| --- | --- |
| Infants ages -13 years that had HPS in infancy<br> | Behavioral: sodium taste tests<br>* The cohort group will had sodium taste tests and an interview regarding diat habits.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased sodium intake |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertrophic pyloric stenosis, sodium intake, Healthy children with no chronic diseases, Status post HPS
Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects

Study Overview
=================
Brief Summary
-----------------
The use of autogenous graft materials has been recorded to be a gold standard in regenerative therapy. This study directed toward evaluation of two autogenous regenerative materials, marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers for treating intrabony defects. In spite of its reported significant clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate other autogenous alternatives such as PRF that could offer predictable outcomes.

Detailed Description
-----------------
Material and methods: 10 patients with sever chronic periodontitis and at least single ≥4 mm intrabony defect had participated in this randomized clinical study. Subjects were randomly divided into2 groups, Group 1(MPP) defect coverage with xenograft defect fill(10 patients),Group 2(PRF) defect coverage with xenograft defect fill(10 patients).Clinical and radiographic measurements were carried out at 3,6 and 9 months postoperatively.

Official Title
-----------------
Marginal Periosteal Pedicle Flap and Platelet Rich Fibrin Barriers for the Treatment of Periodontal Intrabony Defects -Randomized Clinical Trial

Conditions
-----------------
Periodontal Pocket

Intervention / Treatment
-----------------
* Procedure: Regenerative therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No systemic diseases that could influence the outcome of therapy Good compliance for plaque control instructions after initial therapy Vital teeth Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs, Exclusion Criteria: Pregnant females and patients presented with opened interproximal contact

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: PRF<br>Platelets rich fibrin, | Procedure: Regenerative therapy<br>* Periosteal pedicle, Platelets rich fibrin<br>* Other names: Guided tissue regeneration;|
| Experimental: MPP<br>Marginal periosteal pedicle | Procedure: Regenerative therapy<br>* Periosteal pedicle, Platelets rich fibrin<br>* Other names: Guided tissue regeneration;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrabony defect | measurements of intrabony gain from CEJ to base of defect | 9 month after surgery |
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

Study Overview
=================
Brief Summary
-----------------
To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy.

Official Title
-----------------
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Tumor Necrosis Factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions. Minimum life expectancy of 3 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Clinically significant cardiac disease. Known hemorrhagic diathesis or active bleeding disorder. Clinically apparent vascular disease. Known lipoprotein disorders. History of seizure disorder or central nervous system (CNS) metastasis. Additional malignancy. Concurrent Medication: Excluded: Cardiac agents. Anticoagulants. Thrombolytic agents. Nonsteroidal anti-inflammatory drugs. Corticosteroids. Aspirin. Vasodilators. Patients with the following are excluded: Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions. Prior Treatment: Excluded within 4 weeks of study entry: Chemotherapy. Radiotherapy. Immunotherapy.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tumor Necrosis Factor|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
-----------------
Skin Neoplasms, Tumor Necrosis Factor, Acquired Immunodeficiency Syndrome
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.

Official Title
-----------------
A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Drug: Delayed and extended release mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed or diagnosis of relapsing (relapsed <= 6 weeks to baseline) mild to moderate ulcerative colitis women not of childbearing potential or WOCP who agreed to use an effective contraceptive method Exclusion Criteria: severe ulcerative colitis or relapsed for > 6 weeks prior to baseline subjects who had relapsed on maintenance therapy with doses of mesalazine > 2.0 g/day subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease subjects with asthma if they were known to be mesalazine-sensitive subjects who were at immediate or significant risk of toxic megacolon subjects who had previous resective colonic surgery subjects who had moderate or severe renal impairment

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: Delayed and extended release mesalazine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score |  | 8 weeks | 
| Change in the UC-DAI score |  | 8 weeks | 
| Change in symptoms (rectal bleeding and stool frequency) |  | 2, 4 and 8 weeks | 
| Change in sigmoidoscopic (mucosal) appearance |  | 8 weeks | 
| Time to withdrawal from the start of study medication |  | Throughout the study period of 8 weeks |
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).

Official Title
-----------------
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: TS-152


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself. At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit. etc. Exclusion Criteria: Subjects who had serious adverse drug reactions in the previous study. At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events. etc.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TS-152 30mg SC<br>TS-152 30mg subcutaneously (SC) every 4 weeks | Drug: TS-152<br>* 30mg,80mg<br>* Other names: ozoralizumab;|
| Experimental: TS-152 80mg SC<br>TS-152 80mg subcutaneously (SC) every 4 weeks | Drug: TS-152<br>* 30mg,80mg<br>* Other names: ozoralizumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | To evaluate the Long-term safety of TS-152 in RA patients by incidence of adverse events which include vital signs, and clinical laboratory parameters. | through study completion, an average of 3 year | 
| ACR20 | Percentage of Subjects who meet the American College of Rheumatology 20% (ACR20) Criteria from baseline of previous study (TS152-3001-JA or TS152-3001-JA). | through study completion, an average of 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RA
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.

Official Title
-----------------
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose criteria must be met On a stable dose of insulin as defined by the protocol Body mass inde (BMI) in the range 22-45 Exclusion Criteria: Type 1 diabetes Pregnancy or lactation Evidence of serious diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 24 weeks |  |  | 
| Adverse event profile after 24 weeks of treatment |  |  | 
| Change from baseline in mean daily insulin dose at 24 weeks |  |  | 
| Change from baseline in mean daily number of insulin injections at 24 weeks |  |  | 
| Patients with endpoint <7% after 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Clinical Studies of the Effects of Extracorporeal Membrane Oxygenation for Severe ARDS Mortality

Study Overview
=================
Brief Summary
-----------------
Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians have more choices in the face of hypoxemia, and with the deepening understanding of ECMO, ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO indications and standardizing the implementation of treatment can significantly improve the prognosis, shorter hospital stays, lower hospitalization costs.

Conditions
-----------------
ECMO Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) age 18-70 years; (2) severe respiratory dysfunction (Murry score ≥ 3 points or clinical optimized ventilation conditions pH remains <7.2 patients); (3) PaCO2/FiO2 <100mmHg; (4) plateau pressure >30cmH2O more than 6h，duration of no more than seven days; (5) with severe respiratory dysfunction etiology reversible. Exclusion Criteria: (1) high levels pressure mechanical ventilation (PEEP> 15-20cmH2O and / or Pplat> 35-40cmH2O) over 7 days; (2) continued to receive high concentrations of oxygen (FiO2> 80%) is more than 7 days; (3) severe active bleeding; (4) within 24 hours of the surgery or head injury with intracranial bleeding; (5) a variety of serious irreversible state; (6) malignancy; (7) progressive pulmonary fibrosis; (8) can not surgical problems; (9) due to cardiac dysfunction leading to ARDS.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis

Study Overview
=================
Brief Summary
-----------------
Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Detailed Description
-----------------
Breast cancer has become the most common malignancy in women. Improving the early diagnosis of breast cancer can reduce mortality. Mammography is recommended as the main tool for screening and early diagnosis of breast cancer in the guidelines of European and American countries. However, the characteristics of dense breast and young onset of disease in Chinese women make the screening and early diagnosis strategies of Western countries, which are mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Official Title
-----------------
A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis

Conditions
-----------------
Breast Cancer Diagnosis, Breast Cancer Screening

Intervention / Treatment
-----------------
* Diagnostic Test: mammography and ultrasound screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray Exclusion Criteria: Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mammography and ultrasound<br>mammography and ultrasound screening | Diagnostic Test: mammography and ultrasound screening<br>* Patients screened by both mammography and ultrasound.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening yield | The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness | The cost-effectiveness of each screening modality to detect one case of breast cancer | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammography, ultrasound, breast cancer screening, early diagnosis
An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.

Official Title
-----------------
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: CPT-11 based regimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic colorectal cancer (adenocarcinoma) UGT1A1 genotyped patients Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents) Exclusion Criteria: Contraindication of CPT-11 Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4 Patients to receiving CPT-11 as adjuvant chemotherapy History of pelvic irradiation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UGT1A1 genotyped patients<br>UGT1A1 genotyped patients receive CPT-11 based regimens | Drug: CPT-11 based regimens<br> <br> * Other names: FOLFIRI, CPT-11+S-1, CPT-11;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Percentage of participants alive without disease progression | Within 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Percentage of participants alive at end of study | At 3 years | 
| Time to treatment failure | Duration of time (in months) from treatment to failure | Within 3 years | 
| Response rate | Percentage of participants with an objective response | from Day 1 (treatment) through disease progression (within 3 years) | 
| Disease control rate | Percentage of participants with controlled disease | Within 3 years | 
| Safety events | Adverse events will be collected during treatment | Within 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UGT1A1, irinotecan