linjc16/ctgov huggingface dataset:
Liver Transplantation for Unresectable GIST Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Liver Transplantation for Unresectable GIST Liver Metastases

Official Title
-----------------
Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases

Conditions
-----------------
Liver Diseases, Liver Cancer, Liver Metastases, Liver Neoplasms, Liver Mass, Liver Carcinoma, Liver Transplant; Complications, Liver Transplant Disorder, GIST, GIST, Malignant, Gastrointestinal Stromal Tumors, Gastrointestinal Stromal Tumor of Duodenum, Gastrointestinal Stromal Tumor of Rectum, Gastrointestinal Stromal Tumor of Other Sites, Gastrointestinal Stromal Tumor, Unspecified Site, Gastrointestinal Stromal Tumor of Stomach, Gastrointestinal Stromal Tumor of Esophagus (Disorder), Gastrointestinal Stromal Tumor by AJCC V8 Stage, Gastrointestinal Stromal Tumor, Malignant, Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract, Gastrointestinal Stromal Tumor of Small Intestine (Disorder), Gastrointestinal Stromal Tumor of Large Intestine (Disorder), Metastases to Liver, Metastatic Liver Cancer, Metastasis, Metastases, Liver Transplantation, Transplant Oncology

Intervention / Treatment
-----------------
* Procedure: Liver Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GIST diagnosis (c-Kit, CD34, DOG-1) Imatinib-sensitive mutation Non-resectable liver metastases Abscence of extrahepatic disease Period greater than two years between primary tumor and metastases diagnosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver Transplantation<br> | Procedure: Liver Transplantation<br>* Liver Transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Survival | Through study completion, an average of 2 years | 
| Graft Survival | Liver graft Survival | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse free survival |  | Through study completion, an average of 2 years | 
| Disease free survival |  | Through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplantation, gastrointestinal stromal tumor (GIST), Transplant Oncology, liver neoplasms, liver metastases
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation

Study Overview
=================
Brief Summary
-----------------
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.

Official Title
-----------------
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Device: PEB
* Device: POBA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years angiographic stenosis>50% or occlusion of one below-knee vessel Exclusion Criteria: allergy to Paclitaxel contraindication for combined antiplatelet treatment life expectancy <1 year hypersensitivity or contraindication to one of the study drugs lack of consent need for amputation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard PTA<br>conventional balloon angioplasty | Device: POBA<br>* conventional balloon angioplasty<br>|
| Experimental: Drug-eluting balloon angioplasty<br>paclitaxel-eluting balloon angioplasty | Device: PEB<br>* paclitaxel-eluting balloon angioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic binary restenosis | incidence of binary restenosis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major amputation | incidence of major amputation | 24 motnhs | 
| target lesion revascularization | incidence of target lesion revascularization | 24 months | 
| vessel reocclusion | incidence of vessel reocclusion | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical limb ischemia, drug-eluting balloon, restenosis
Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.

Official Title
-----------------
Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Dietary Supplement: follow on formula without probiotics
* Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy six months old children Exclusion Criteria: Lactose intolerance Cow's milk protein allergy Serious metabolic diseases Antibiotic treatment Serious gastrointestinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Children that consumed a follow on formula without Lactobacillus salivarius CECT5713 | Dietary Supplement: follow on formula without probiotics<br>* A follow on formula without probiotics<br>|
| Active Comparator: B<br>Children that consumed a follow on formula with Lactobacillus salivarius CECT5713 | Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713<br>* follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions |  | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth parameters (height, length, head circumference) |  | 3 months and 6 months | 
| Fecal microbiota |  | 3 months and 6 months | 
| Fecal short chain fatty acids |  | 3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
probiotics, safety, fecal microbiota, infections
Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts

Study Overview
=================
Brief Summary
-----------------
Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.

Detailed Description
-----------------
Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.

Official Title
-----------------
Österreichisches Register (Inklusive Biobank) für transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)

Conditions
-----------------
Portal Hypertension

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-99 years Portal hypertension Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS) Informed consent Exclusion Criteria: Retraction of consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|Not applicable (observational registry study)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant-free survival | Assessment of transplant-free survival after TIPS implantation | 0-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of portalhypertensive complications | Documenting the incidence of portalhypertensive complications | 0-10 years | 
| Assessment of hepatic encephalopathy | Documenting the incidence of hepatic encephalopathy | 0-10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, Advanced chronic liver disease, Ascites, Variceal hemorrhage, Transjugular intrahepatic portosystemic shunt
Stapled TransAnal Rectal Resection (STARR): Clinical and Radiological Outcome

Study Overview
=================
Brief Summary
-----------------
To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal Rectal Resection (STARR)

Official Title
-----------------
Stapled TransAnal Rectal Resection (STARR): Correlation Between Clinical and Radiological Outcome

Conditions
-----------------
Obstructed Defecation Syndrome (ODS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years clinical signs of ODS with prior not effective conservative treatment anterior rectoceles and/or intussusceptions in MR-defecography Exclusion Criteria: < 18 years fixed enteroceles severe fecal incontinence external rectal prolapse anismus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Clinical and radiological outcome as assessed by closed-configuration MR defecography |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and Mortality after STARR |  |  |
Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.

Detailed Description
-----------------
The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of invasive ductal or lobular breast cancer. Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer. no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive) Performance Status ECOG <2 Age > 18 years Tumor > 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky >50% Lab test : Absolute neutrophil count > 1,500/mm3 Total Bilirubin ≤ 2×ULN AST and ALT ≤ 2.5×ULN serum creatinine ≤ 1.5×ULN Exclusion Criteria: Pregnant or breast feeding patients are excluded stage Ⅳ breast cancer History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin uncontrolled cardiac disease Active infection or chronic infection requiring chronic suppressive antibiotics History of hypersensitivity reaction to investigating drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| AT<br>Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles | |
| AT-NP<br>docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response rate, safety |  | one year |
Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
A delay in the return of normal bowel function with the passage of flatus and feces is one of the most important factors affecting early recovery and discharge in patients undergoing open complete staging surgery for gynecological malignancies. A prolonged hospital stay increases the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and total hospital costs. The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel function in patients undergoing abdominal complete staging surgery for gynecological malignancies.

Conditions
-----------------
Ilues

Intervention / Treatment
-----------------
* Dietary Supplement: caffe
* Dietary Supplement: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients preparing for complete surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancerwere assessed for eligibility. Exclusion Criteria: Exclusion criteria for the study included thyroid diseases, inflammatory bowel disease, complaints of chronic constipation (defined as two or fewer bowel movements per week), a history of prior abdominal bowel surgery, abdominal radiation, neoadjuvant chemotherapy, need for intensive care more that 24 hpostoperatively, nasogastric tube drainage beyond the first postoperative morning, bowel anastomosis and upper abdominalmultivisceral surgical approaches in relation to the debulking surgery.
Sexes Eligible for Study
-----------------
Female

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: coffee<br>coffee | Dietary Supplement: caffe<br> <br> Dietary Supplement: Water<br> <br> |
| Placebo Comparator: water group<br>water | Dietary Supplement: caffe<br> <br> Dietary Supplement: Water<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first flatus | hours from end of operation to first flatus pass time | within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to tolerance diet | time to end of the surgery until the first solid diet intake without vomiting | within the first 30 days after surgery |
Rebound Pain Following Surgery With Regional Anesthesia Block

Study Overview
=================
Brief Summary
-----------------
For some kinds of surgery, Anesthesiologists provide nerve blocks (regional anesthesia) to reduce pain from surgery by injecting freezing medication around deep nerves with ultrasound. Nerve blocks help with pain control following surgery and reduce the amount of strong opioids needed but relatively little research has focused on the pain that occurs once the nerve block has worn off. This is called rebound or transition pain. This research study will prospectively collect data including pain scores before, during and after nerve blocks are given for surgery. We will look at the type of nerve blocks and other analgesia medications used with the aim of quantifying rebound pain to better understand how to limit it's impact on quality postoperative pain control.

Official Title
-----------------
Rebound Pain Following Surgery With Regional Anesthesia Block: A Prospective Cohort Study

Conditions
-----------------
Pain, Postoperative, Regional Anesthesia Morbidity

Intervention / Treatment
-----------------
* Other: Numerical Pain Scales


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years Receiving peripheral nerve block as part for anesthesia/analgesia as part of standard perioperative care for surgery performed at University of Alberta Hospital during a 6 month period Elective and emergency surgery Exclusion Criteria: Inability to consent to participate in the study (illiteracy, <7th grade education) Contraindication/history of hypersensitivity to local anesthetics

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regional Nerve Block Patients<br>Patients who receive regional nerve blocks as part of the anesthetic management prior to surgery. | Other: Numerical Pain Scales<br>* Patients who are about to receive regional nerve blocks will be administered a numerical pain scale (NRS) before, during and after the offset of the nerve block.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Scale |  | 2-3 times per patient over the course of a nerve block, up to 48 hours after the stop of the block (single shot or cessation of nerve catheter) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rebound Pain, Nerve Block