linjc16/ctgov huggingface dataset:
Fatty Liver and Ectopic Fat in Overweight and Obese Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Detailed Description
-----------------
Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases. The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients. Fatty liver and ectopic fat accumulation will be particularly assessed.

Official Title
-----------------
Fatty Liver and Ectopic Fat in Overweight and Obese Patients

Conditions
-----------------
Steatohepatitis

Intervention / Treatment
-----------------
* Procedure: liver biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25 and 40 ALAT level superior to normal level even after 3 months of diet alcohol consumption < 20 g/j for women and < 30 g/j for men Exclusion Criteria: HIV, hepatitis B virus, hepatitis C virus positive known hemochromatosis glycemia > 1.26 g/L or under anti-diabetic treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>obese or overweight patients with fatty liver or ectopic fat | Procedure: liver biopsy<br>* liver biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients. |  | at inclusion and at year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients. |  | at year 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, obesity, steatohepatitis, ectopic fat
Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention and validate Nassar Scale.

Detailed Description
-----------------
Laparoscopic cholecystectomy is the commonly performed procedure in our institute. Laparosopic cholecystectomy is high variable surgery ranging from simple routine operation to difficult surgery leading to increased morbidity and mortality. The majority of previous scores use a combination of pre-operative and operative data and were produced in studies that were limited by retrospective data, small sample sizes and lack of external validation. Very few intraoperative difficulty grading scale was published and none are widely used in clinical practice. So operative grading scale will have advantages of assisting in intra-operative strategy and planning, allowing comparison across different research studies, facilitating risk adjustment for surgical outcomes and providing an aid in training surgeons and monitoring of training progression. The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention.

Official Title
-----------------
Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

Conditions
-----------------
Laparoscopic Cholecystectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing laparoscopic cholecystectomy Exclusion Criteria: CBD Stone Malignancy of Extrahepatic biliary tree Cholecystectomy as a part of other surgery

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Laproscopic cholecystectomy Conversion to open with Nassar Grade | Laproscopic cholecystectomy converted to open with Nassar grade ie chance of conversion to open in higher Nassar grade(difficult laparoscopic cholecystectomy) | 30 day | 
| Duration of Surgery |  | 30 day | 
| Introperative Complication with Nassar Grade | Complication like biliary spillage, stone spillage and bleeding with higher Nassar grade (difficult laparoscopic cholecystectomy) | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total length of stay |  | 30 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Laparoscopic, Cholecystectomy, Cholecystitis
The Clinical Outcomes of the Percutaneous Cholecystostomy, Supportive Care Versus Cholecystectomy.

Study Overview
=================
Brief Summary
-----------------
Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in surgical high risk patients. However, there has been no definite agreement of the additional cholecystectomy in these patients. The investigators surveyed the clinical outcomes of the PC in surgical high risk patients. And the investigators tried to prove the PC can be appropriate and ultimate treatment for acute cholecystitis patients with critical illness through this study.

Detailed Description
-----------------
Between 2007 and 2012, all patients admitted for acute cholecystitis, and then underwent ultrasonography guided percutaneous cholecystostomy in Cheju Halla General Hospital were consecutively enrolled. Among 82 patients, 35 were performed laparoscopic cholecystectomy after recovery (Cholecystectomy group) and 47 treated by best supportive care without additional surgery (BSC group). The investigators analyzed their surgical risks and clinical outcomes of both patients retrospectively.

Official Title
-----------------
The Percutaneous Cholecystostomy is Appropriate as the Ultimate Treatment of Acute Cholecystitis in Critically Ill Patients: a Cross-sectional Study at Single Center.

Conditions
-----------------
Acute Calculous Cholecystitis, Acute Acalculous Cholecystitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute cholecystitis Underwent the ultrasound-guided percutaneous cholecystostomy Exclusion Criteria: Transferred patients from other institute after cholecystostomy procedure.
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 |
| --- | --- | --- |
| All cause mortality |  | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of recurrent cholecystitis or biliary complication | Acute cholecysitits : fever, abdominal pain, abnormal chemistry results Biliary complication : Gallstone pancreatitis, gallstone ileus or cholangitis | Within 30 days | 
| Evidence of recurrent cholecystitis or biliary complication | Acute cholecystits : fever, abdominal pain, abnormal chemistry results Biliary complication : Gallstone pancreatitis, gallstone ileus or cholangitis | Within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute cholecystitis, Elderly, Critically ill patients, Surgical high risk, Percutaneous cholecystostomy, Cholecystectomy
The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women

Study Overview
=================
Brief Summary
-----------------
Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age women. According to Rotterdam 2003 criteria: at least two of three criteria are met, hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes that may increase risk of cardiovascular disease. Hyperprolactinaemia is also a common problem in reproductive aged women. Both hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle. Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison. Investigators at the same time would like to understand more about other similarities and differences between these two endocrinological dysfunction for future study.

Official Title
-----------------
Relationship of Metabolic Parameters, Endocrine and Prolactin Levels in Taiwan's Women With Polycystic Ovary Syndrome and Hyperprolactinemia.

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOM by ultrasound Diagnosis Anovulation, Oligo menses Hyperandrogenism Exclusion Criteria: Women who had been diagnosed with other etiology that should be excluded in PCOS diagnosis, such as hyperprolactinemia, hypogonadotropic hypogonadism, premature ovarian failure, congenital adrenal hyperplastic, androgen-secreting tumor, Cushing's syndrome, disorders of uterus( such as Asherman's syndrome, Mullerian agenesis), chromosomal anomalies( such as Turner syndrome). Women who did not have sufficient clinical or biochemical records. Girls who had menarche at <3 years of age and women who were >40 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS group<br>Who met the 2003 Rotterdam criteria. | |
| Mild hyperprolactinaemia group<br>Who were diagnosed with prolactin levels above the upper limit of normal (24.29 ng/ml) and under 100 ng/ml. | |
| Control group<br>Without PCOS and with normal prolactin levels. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hyperprolactin |  | Who visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center from April 2004 to June 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, hyperprolactinemia, obesity, hyperandrogenic
Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ottawa, Ontario.

Detailed Description
-----------------
The investigators will use a coarsened exact matching algorithm prior to the analysis to minimize bias in this observational study. A multivariate logistic regression model will be used to compare the effect of anesthesia interventions on the primary outcome within matched cohorts. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Official Title
-----------------
Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Other: Peripheral nerve blockade
* Other: No peripheral nerve blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ontario residents Aged 18 years and older Elective ambulatory shoulder surgery Exclusion Criteria: Emergency Surgery

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peripheral nerve block<br>Peripheral nerve block | Other: Peripheral nerve blockade<br>* Participants who receive a peripheral nerve block identified through the medical chart.<br>|
| No peripheral nerve block<br>No peripheral nerve block | Other: No peripheral nerve blockade<br>* Participants who did not receive a peripheral nerve block identified through the medical chart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication | Composite outcome: 1) unplanned admissions on the day of surgery, 2) post-discharge ED visits within 30 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause. | From day of surgery to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health system costs in the 30 days after surgery | Calculated using validated algorithms | From day of surgery to 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Death, Unplanned admissions, Visits to the ED, Readmissions
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.

Official Title
-----------------
A Randomized, Open Label Parallel Group Mechanical Prophylaxis Controlled Comparison Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: YM150
* Procedure: mechanical prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients after a major abdominal surgery Written informed consent obtained Exclusion Criteria: Subject has history of symptomatic deep vein thrombosis and/or pulmonary embolism Subject has a hemorrhagic disorder and/or coagulation disorder Subject has had clinically important bleeding occurred within 90 days prior to the screening visit Subject has an active bacterial endocarditis Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke Subject is receiving anticoagulants/antiplatelet agents Subject has a thrombocytopenia Body weight less than 40 kg at the screening

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM150 group<br> | Drug: YM150<br>* oral<br>|
| Active Comparator: mechanical prophylaxis group<br> | Procedure: mechanical prophylaxis<br>* The investigator will determine the method of mechanical prophylaxis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite assessment of venous thromboembolism events and all causes of death |  | Until day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of venous thromboembolism |  | Until day 28 | 
| Incidence of bleeding events |  | Until day 28 | 
| All cause mortality |  | Until day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, Bleeding, VTE, FXa inhibitor, Deep Vein Thrombosis, Venous thromboembolism
A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh

Study Overview
=================
Brief Summary
-----------------
Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial. THis protocol will review the one year outcome of patients who underwent this pocedure using a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.

Conditions
-----------------
Pelvic Organ Prolapse, Urinary Incontinence, Mesh Erosion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient receiving Robotic assisted laparoscopic sacral copopexy with polypropylene mesh >21 y.o Exclusion Criteria: Graft material other than polypropylene mesh Enrollment in another study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vaginal mesh placement<br> | |

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
-----------------
Uterine prolapse, vaginal prolapse, mesh erosion, urinary incontinence, bowel symptoms
Study of NMS-1116354 in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced solid tumors.

Official Title
-----------------
A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: NMS-1116354


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available Maximum of 4 regimens of prior cancer therapy allowed Prior radiotherapy allowed if no more than 25% of BM reserve irradiated Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy ECOG performance status (PS) 0 or 1 Adult (age >/= 18 and </= 80 years) patients Adequate renal, liver and BM reserve Capability to swallow capsules intact Exclusion Criteria: Current enrollment in another therapeutic clinical trial Known brain metastases Currently active second malignancy Major surgery within 4 weeks prior to treatment Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis Pregnancy or breast-feeding women Known active infections Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption Adrenal insufficiency Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: NMS-1116354<br>* Oral daily administration for 7 consecutive days every 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD) |  | Cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½) |  | Cycles 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I study, Advanced Solid Tumors, Cdc7 kinase inhibitor