linjc16/ctgov huggingface dataset:
Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones

Study Overview
=================
Brief Summary
-----------------
ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP. 210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients). The total hospital stay were significantly shorter in the group of LC/IOES

Official Title
-----------------
Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis

Conditions
-----------------
Common Bile Duct Stones.

Intervention / Treatment
-----------------
* Procedure: preoperative ERCP and LC
* Procedure: Intraoperative ERCP and LC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gallstones and common bile duct stones Exclusion Criteria: contraindications to ercp contraindication to laparoscopy biliary pancreatitis refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PES/LC<br>preoperative ES followed by LC within the same hospital admission | Procedure: preoperative ERCP and LC<br>* preoperative ERCP followed by LC<br>|
| Active Comparator: LC/IOES<br>laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia | Procedure: Intraoperative ERCP and LC<br>* LC and intraoperative ERCP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance of stones from the common bile duct |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Choledocholithias, Common bile duct stones, Endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy, Preoperative, intraoperative, Laparoscopic common bile duct exploration
PD-L1 Expression in Advanced Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.

Official Title
-----------------
The Expression of Programmed Death Ligand-1 (PD-L1) on Advanced Osteosarcoma Tissue and Its Influence on Prognosis

Conditions
-----------------
Progression, Survival

Intervention / Treatment
-----------------
* Other: all study participants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis confirmed histologically and reviewed centrally; received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining; progressing upon prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD); having measurable lesion according to RECIST 1.1; Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months; intend to receive anti-PD-1/anti-PD-L1 antibody for therapy. Exclusion Criteria: fail to be followed up regularly. sample disqualification.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observation group<br>All these patients who have been tested will be observed for further treatment and been recorded for toxicity. | Other: all study participants<br>* patients will receive anti-PD-1/anti-PD-L1 antibody for further treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 expression level | all those specimens will be tested for expression level,Tumors with ≥50% cells showing positive membrane staining were considered to have high expression of PD-L1 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | from the timing of testing to disease progression/death whichever comes first | 2 years | 
| overall survival | from the timing of testing to death/last follow-up | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteosarcoma, refractory to chemotherapy, unresectable, PD-L1, VENTANA PD-L1 (SP263)
Connect for Health Pediatric Weight Management Program

Study Overview
=================
Brief Summary
-----------------
The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.

Official Title
-----------------
Dissemination and Implementation of Effective Childhood Obesity Treatment Innovations

Conditions
-----------------
Overweight and Obesity, Severe Obesity

Intervention / Treatment
-----------------
* Behavioral: Connect for Health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children receiving primary care at the participating health centers across the three health systems

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connect for Health Program<br> | Behavioral: Connect for Health<br>* The program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child Body Mass Index | Age- and sex-specific Body Mass Index z-score | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, Pediatric, Implementation, Dissemination
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.

Official Title
-----------------
Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.

Conditions
-----------------
Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

Intervention / Treatment
-----------------
* Drug: PUVA (8MOP + UVA) + IFN
* Drug: PUVA (8-MOP + UVA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mycosis fungoides Stage Ia Ib IIa Written informed consent 18-70 y.o., both sex No concomitant systemic disease Exclusion Criteria: Pregnant or lactating women Fertile women not accepting contraception Medical history of melanoma or non melanoma skin cancer Concomitant infections Immunodeficiency states Previous Heart disease Respiratory insufficiency Chronic RRenal insufficiency Chronic hepatopathy Epilepsy Depression Leucocytes <3000 or neutrophiles <1000 or thrombocytes <100000 or hemoglobin <12 gr/dL or ANA <1/80 Treatment with systemic steroids Altered thyroid hormones Previous resistance to PUVA and/or IFN Hypersensitivity to IFN Patients under treatment with teophiline and/or dicumarol Previous total skin electron beam Wash up period less than 3 month for IFN and /or PUVA Wash up period less than 1 month for topical treatments

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>8-MOP + UVA x 24 weeks | Drug: PUVA (8-MOP + UVA)<br>* Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)<br>|
| Active Comparator: B<br>IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks | Drug: PUVA (8MOP + UVA) + IFN<br>* Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PUVA vs PUVA + IFN |  | Weeks 4, 8, 12, 16 and 24 |
A Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy.

Official Title
-----------------
A Randomised, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Finding Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Conditions
-----------------
Anemia, Cancer

Intervention / Treatment
-----------------
* Drug: AMG 114


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part A: - Non-myeloid malignancy receiving multicycle chemotherapy - Receiving non-platinum containing chemotherapy - At least 6 additional weeks of cyclic cytotoxic chemotherapy planned Part B and Part C: - Non-myeloid malignancy receiving multicycle chemotherapy - At least 12 additional weeks of cyclic cytotoxic chemotherapy planned All Parts: - Chemotherapy induced anemia - Greater than 6 month life expectancy - ECOG 0-2 - Adequate renal and liver function Exclusion Criteria: - Chronic myeloid leukemia, AML, ALL, Burkitt's lymphoma or lymphoblastic lymphoma - History of seizure disorder - Primary hematologic disorder which could cause anemia, other than a non-myeloid malignancy - Unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia - Uncontrolled hypertension - History of pure red cell aplasia - Clinically significant inflammatory disease or active infection - Iron deficiency - ANC less than 0.8 x 10^9 cells/L

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: AMG 114|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  |  | 
| Change in hemoglobin concentration |  |  | 
| Maximum observed concentration (Cmax) |  |  | 
| Time Cmax is observed (Tmax) |  |  | 
| AUC |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FACT-fatigue sub-scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-myeloid malignancy, Clinical Trial
Total Energy Expenditure and Fat Oxidation in 2 Year Old Children

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old children.

Official Title
-----------------
Total Energy Expenditure and Fat Oxidation in 2 Year Old Children

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.5-2.5 years of age Mother is a participant of the Glowing study (NCT01131117) Healthy without taking medication that can affect study outcomes, as determined by the PI Exclusion Criteria: None listed

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 2 Years

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 |
| --- | --- |
| 1<br>Normal weight mothers | |
| 2<br>Overweight/Obese mothers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine total energy expenditure in 2 year old children | Doubly labeled water is administered to 2 year old children and urine is collected at different time points. | 15 days | 
| To determine fat oxidation in 2 year old children | Deuterated palmitate is administered and urine is collected at different time points. | 2-6 hours |
Factors Associated With Success of NIPPV in ALS Patients

Study Overview
=================
Brief Summary
-----------------
This is a retrospective cohort study to assess the factor associated with success of non-invasive positive ventilation in ALS patients.

Detailed Description
-----------------
Patients with ALS who were admitted to a tertiary hospital for initially applying non-invasive positive pressure ventilation (NIPPV). The objective of this study was to investigate factors associated with optimal NIPPV initiation and adherence, and to assess the long-term effects of NIPPV adherence in ALS patients.

Official Title
-----------------
Factors Associated With Success of Non-invasive Positive Pressure Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Retrospective Cohort Study

Conditions
-----------------
ALS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fulfilling the El Escorial World Federation criteria for probable, or definite ALS Aged ≥ 19 years Patients who performed blood gas analysis including venous blood gas and arterial blood gas before NIPPV application. Exclusion Criteria: Patients who had experience in applying the NIPPV or currently using NIPPV Patients who applied in outpatient settings Patients who did not perform blood gas analysis before NIPPV application Patietns who had a history of asthma or COPD, Patients who didn't have any record of NIPPV application time

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Success of NIPPV | The success of NIPPV application was defined empirically as use of ≥ 2 hours per day and the failure as use of < 2 hours for a day or conversion to invasive positive pressure ventilation via tracheostomy or refuse to apply NIPPV during hospitalization. | through intervention completion, with an average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lenght of stay | The length of stay (LOS) was defined as the interval between admission and hospital discharge, and calculated as the number of midnights between admission and discharge from the hospital. | through intervention completion, with an average of 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence, Noninvasive positive pressure ventilation, Amyotrophic lateral sclerosis
Manual Therapy Effects on Upper and Lower Esophageal Sphincter Pressures

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test the influence of manual cervical traction and chest stabilization maneuvers on pressures in upper and lower esophageal sphincters.

Detailed Description
-----------------
High Resolution Manometry (HRM) will be used to measure pressure changes in upper esophageal sphincter (UES) and lower esophageal sphincter (LES) during manual cervical traction and trunk stabilization maneuvers. 50-55 gastroesophageal reflux disease (GERD) subjects will participate in the study. UES and pressures will first be measured in relaxed supine position then, during manual cervical traction and finally, the subjects will undergo manual positioning of the trunk into neutral position and LES and UES pressures will be measured again.

Official Title
-----------------
Manual Cervical Traction and Trunk Stabilization Causes Significant Changes in Lower and Upper Esophageal Sphincter

Conditions
-----------------
Gastroesophageal Reflux Disease, Globus Pharyngeus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroesophageal reflux disease Exclusion Criteria: Previous gastro- esophageal surgery Concomitant other chronic disease that would affect esophageal motility Esophageal structural pathology Massive hiatus hernia

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: manual therapy|Manual Cervical Traction, Trunk Stabilization Maneuver|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure in upper and lower esophageal sphincter | Pressure in upper and lower esophageal sphincter at rest, during cervical manual traction, and during trunk stabilization maneuver | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High resolution manometry, globus pharyngeus, gastroesophageal reflux disease, manual cervical traction, trunk stabilization maneuver
Gut Microbiota in Obesity and Diabetes

Study Overview
=================
Brief Summary
-----------------
An altered gut microbiota composition has recently been linked to obesity and diabetes. The principal aim of this study was to investigate and compare the gut microbiota composition of obese, diabetic and control individuals. Then, associations between analyzed gut microbial concentrations and clinical-biochemical blood parameters were assessed.

Official Title
-----------------
Comparison of Gut Microbiota in Obese, Diabetic and Healthy Control Individuals

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

Intervention / Treatment
-----------------
* Other: Comparison of the gut microbiota composition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with obesity or newly diagnosed type 2 diabetes 18 years to 65 years of age Exclusion Criteria: Any chronic disease (other than obesity and diabetes) Alcohol consumption/smoking Pregnancy/breastfeeding The use of antibiotics, pro-prebiotics within 3 months <18 years or >65 years History of intestinal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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 |
| --- | --- |
| Obesity<br>27 obese individuals (20 men and 7 women with mean BMI: 39.98±5.56 kg/m2) | Other: Comparison of the gut microbiota composition<br> <br> |
| Diabetes<br>26 patients with newly diagnosed type 2 diabetes (18 men and 8 women with mean BMI: 28.63±5.08 kg/m2) | Other: Comparison of the gut microbiota composition<br> <br> |
| Control<br>Healthy control subjects (22 men and 6 women with mean BMI: 23.02±1.70 kg/m2) | Other: Comparison of the gut microbiota composition<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of the gut microbiota composition | The gut microbiota composition of obese, diabetic and control individuals was analyzed by quantitative real-time PCR (qRT-PCR) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between metabolic parameters and the gut microbiota composition | A multivariate linear regression analysis was performed in order to test associations between the gut microbiota composition and metabolic variables of participants | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut microbiota