linjc16/ctgov huggingface dataset:
Bile Leaks After Biliary Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.

Detailed Description
-----------------
The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.

Official Title
-----------------
Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery

Conditions
-----------------
Bile Leak, Anastomotic Leak Biliary, Biliary Tract Fistula

Intervention / Treatment
-----------------
* Other: bilioenteric anastomosis i


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who has undergone a surgical bilioenteric anastomosis for any etiology. Exclusion Criteria: Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis. Subjects under the age of 18. Years. Subjects who refused to participate in this study. Cases of biliary and pancreatic anastomoses performed during the same surgery.

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient in whom a bilioenteric anastomosis is performed for any etiology.<br>Patient in whom a bilioenteric anastomosis is performed for any etiology.. | Other: bilioenteric anastomosis i<br>* The creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract,<br>* Other names: hepaticojejunostomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of a bile leak in the postoperative period (Day 0 to Day 90). | Occurrence of a bile leak visible through a drain, through the wound, visible on the control radiology, or after the occurrence of a peritoneal collection or biliary peritonitis. | From (day 0) of surgery to (day 90) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hospital stay | length of postoperative hospital stay | From (day 0) of surgery to (day 90) | 
| Mortality | Mortality after surgery | From day 0 to day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatobiliary surgery, Morbidity, leak, anastomosis
Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

Study Overview
=================
Brief Summary
-----------------
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.

Official Title
-----------------
Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature

Conditions
-----------------
Idiopathic Short Stature

Intervention / Treatment
-----------------
* Drug: DA-3002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronological Age ≥ 4 Bone Age <11 (for girls) and <13 (for boys) Height <3rd percentile for age normal thyroid function Exclusion Criteria: endocrine and/or metabolic disorders growth failure caused by other disorders previous use of drugs that could interfere with Growth Hormone treatment

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 13 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: DA-3002 Treatment group<br>1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week) | Drug: DA-3002<br> <br> * Other names: Recombinant Human Growth Hormone;|
| No Intervention: Non-treatment control group<br>Height be measured with no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Height Velocity(cm/Year) After 26 Weeks | Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Height Standard Deviation Score After 26 Weeks | The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height. | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth hormone
Research Into the Molecular Bases of a New Phenotype Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia

Study Overview
=================
Brief Summary
-----------------
This study involves a single family, including 1 patient, father, mother and sister. The patient presented with a new phenotype associating premature white hair, renal polycystosis, aortic dilation/dissection and lymphopenia. Samples were taken in order to identify the origin of the symptomatology highlighted in the index case. In addition, it was observed that mice invalidated for bcl-2, normal at birth and indistinguishable from control mice, showed, after one week, a phenotype similar to that observed in this patient. The overlap between the patient's main clinical signs (lymphopenia, white hair and polycystic renal disease) and the manifestations presented by the invalidated murine model for BCL2 suggests that its phenotype may be secondary to a Bcl-2 expression defect.

Official Title
-----------------
Research Into the Molecular Bases of a New Phenotype Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia

Conditions
-----------------
New Phenotype (Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia)

Participation Criteria
=================
Eligibility Criteria
-----------------
This study involves a single family, including 1 patient, father, mother and sister.
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 |
| --- | --- |
| Patient<br>Patient with a new phenotype combining premature white hair, renal polycystosis, aortic dilation/dissection and lymphopenia | |
| Related parties of the 1st degree<br>1st degree related family of Group A patient | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole genome sequencing of BCL2 |  | Through study completion, an average of 2 years. | 
| Bcl-2-regulating miRNA sequencing |  | Through study completion, an average of 2 years. | 
| Study of the methylation of the BCL2 promoter |  | Through study completion, an average of 2 years. |
Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

Study Overview
=================
Brief Summary
-----------------
This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: YM060


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients satisfying the Rome II Diagnostic Criteria. Patients in whom no organic changes were observed in large intestine. Exclusion Criteria: Patients have diseases which interfere with evaluation of the efficacy and safety in this study. Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: YM060|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
-----------------
Irritable Bowel Syndrome, Diarrhea
Measuring Skin Elasticity in Lymphedema Patients

Study Overview
=================
Brief Summary
-----------------
This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity), to better characterize disease progression in patients with lymphedema. Beth Israel Deaconess Medical Center patients who undergo treatment of lymphedema will be candidates for this noninvasive test. This device and the data it generates will help understand the incidence of lymphedema at Beth Israel Deaconess Medical Center compared to national data and the outcomes of surgical treatment of lymphedema.

Official Title
-----------------
Measuring Skin Elasticity in Lymphedema Patients

Conditions
-----------------
Diagnoses Disease, Lymphedema

Intervention / Treatment
-----------------
* Device: Lymphedema Indentometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients evaluated by the Beth Israel Deaconess Medical Center Lymphedema team with a diagnosis of lymphedema OR determined to be at risk of developing Lymphedema in any of their extremities Patients must be over 18 years of age Patients must be willing and capable to provide informed consent Patients must speak English Exclusion Criteria: None

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Durometer Measurement<br>All patients participating in the study will receive standard of care treatment for their lymphedema. As part of the study they will be measured by the durometer in addition to other, standard diagnostics to further characterize their lymphedema progression. | Device: Lymphedema Indentometer<br>* The subject will sit down. The machine will be placed over their extremity/affected region. They will then be told the machine will be activated. They may or may not feel the machine touch them. A small pressure will be applied to the skin surface for 4 seconds. The computer will record the skin elasticity as change in resistance to compression over time during these 4 seconds. The entire procedure will take about a minute or less, after which the standard of care visit with the physical therapist will continue.<br>* Other names: Durometer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durometer Measurement | Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep. | Enrollment (3 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphedema indentometer, Durometer
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

Study Overview
=================
Brief Summary
-----------------
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.

Detailed Description
-----------------
open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study

Official Title
-----------------
An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between the Altana Formulation of Pantoprazole Delayed-Release Granules and the Wyeth Formulation of Pantoprazole Delayed-Release Granules in Healthy Subjects.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men or women aged 18 to 50 years. Healthy as determined by the investigator. Exclusion Criteria History or active presence of clinically important medical disease. History of drug or alcohol abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pantoprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy
Development of a Computerized Adaptive Test (CAT) for Evaluation of Sleep, Fatigue and Quality of Life in Patients With Chronic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an Item-Response Theory methodology and also generating a Computer Adaptive Testing System

Official Title
-----------------
Desenvolvimento de Teste Adaptativo Computadorizado (CAT) Para avaliação do Sono, Fadiga e Qualidade de Vida em Pacientes Com Dor crônica

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Sinlge arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be able to read Portuguese be able to write Portuguese being in treatment for chronic pain Exclusion Criteria: hearing impairment that impairs ability to respond to tests visual impairment that impairs ability to respond to tests physical impairment that impairs ability to respond to tests cognitive impairment that impairs ability to respond to tests

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 |
| --- | --- |
| Single arm<br> | Other: Sinlge arm<br>* application of scales for evaluation of sleep, fatigue and quality of life - Observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep disorders | score in Pittsburgh Sleep Quality | Within 1 month before the study start | 
| fatigue | score of Multidimensional Fatigue Inventory | Within 7 days before the study start | 
| measurement quality of live | measurement quality of live will be score the using SF-12 | Within 1 month before the study start | 
| sleep disorders | score Index and Insomnia Severity Index (ISI) | Within 1 month before the study start | 
| measurement quality of live | measurement quality of live will be WHOQOL-bref | Within 1 month before the study start |
Chronic Pediatric Pain

Study Overview
=================
Brief Summary
-----------------
The purpose will be to study the functional impact of pediatric chronic pain on children, and their families. Focus will be on the impact of pain on school functioning, social functioning, psychological functioning and family functioning of pediatric chronic pain.

Official Title
-----------------
Functional Impact of Chronic Pediatric Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have completed parent surveys before coming to the multidisciplinary pain management clinic evaluations. Exclusion Criteria: If the patient's surveys are missing or incomplete (i.e. more than half of the survey was not completed, they will be excluded from entry into the data base.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.

Official Title
-----------------
Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: Tetracaine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: early labor (>=2cm but =<6cm cervical dilation) at least 12 years of age have an assigned ASA physical status 1 or 2 singleton pregnancy Exclusion Criteria: contraindications to neuraxial anesthesia with allergies to drugs used in the study have an assigned ASA status 3 or 4 advanced labor (> 6cm cervical dilation) less than 12 years of age Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.

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

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

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 |
| --- | --- |
| Active Comparator: tetracaine 2mg<br> | Drug: Tetracaine<br>* Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.<br>|
| Active Comparator: Bupivacaine 2 mg<br> | Drug: Bupivacaine<br>* Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Analgesic Duration | duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete | 1-2 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor pain, combined spinal epidural labor analgesia, CSE analgesia, labor analgesia