linjc16/ctgov huggingface dataset:
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.

Detailed Description
-----------------
Branched-chain amino acids (BCAA; leucine, valine, isoleucine) are used to prevent hepatic encephalopathy in cirrhotic patients. The main effect of BCAAs is believed to take place in muscles where BCAAs provide carbon-skeletons for the TCA-cycle. This enhances the conversion of alfa-ketoglutarate to ammonia via glutamine. We intend to study the effect of oral administered BCAA on the metabolism of ammonia and amino acids across the leg-muscles by means of catheters inserted into the femoral artery (A) and vein (V). Muscle blood flow (F; L/min) will be determined by constant infusion of indocyanine green and indicator dilution principle. Arterial blood flow and A and V concentrations of ammonia and amino acids will be measured before an oral load of BCAA (0.45 g BCAA/kg body weight) and after 1 and 3 hours. The metabolism of ammonia will also be estimated by means of 13N-NH3 PET scans. Hypothesis: BCAA increases the uptake of ammonia in muscle tissue and lowers arterial ammonia.

Official Title
-----------------
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

Conditions
-----------------
Liver Diseases, Hepatic Encephalopathy, Hepatic Insufficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Branched chain amino acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 patients with liver cirrhosis 6 healthy subjects age and sex matched Exclusion Criteria: Non-treated diabetes Pregnancy/breast-feeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Branched chain amino acids<br>Patients with cirrhosis. Healthy subjects age and sex matched | Dietary Supplement: Branched chain amino acids<br>* Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial ammonia concentration |  | 1 and 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle ammonia metabolism |  | 1 hour and 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ammonia, Citric acid cycle, Branched Chain Amino Acids
CD Patients Immune Status Evaluation

Study Overview
=================
Brief Summary
-----------------
Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD.

Official Title
-----------------
Evaluating the Immune Status of Patients With Severe Crohn's Disease Using Single Cell Sequencing

Conditions
-----------------
Severe Crohn's Diease

Intervention / Treatment
-----------------
* Other: colonic tissue biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1, Patients with severe CD（CDAI>16,SES-CD>19） 2, Patients have no previous any drug therapy targeting CD or just received treatment of 5-ASA - Exclusion Criteria: 1, patients have previous treatment of prednisone, immunosuppressive agents such as azathioprine and biologic agents such as infliximab 2, patients were diagnozed as mild-moderate CD 3, patients have other immune disordered diseases such as SLE, PBC, AIH, PSC, sjogren syndrome, ulcerative colitis, and so on. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| CD<br>patients with severe crohn's disease | Other: colonic tissue biopsy<br>* colonic tissue biospy of patients with severe crohn's disease using colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| single cell analysis of the colonic tissue of patients with severe crohn's disease | single cell analysis of the colonic tissue of patients with severe crohn's disease: inflammed and non-inflammed area from right colon or the terminal ileum | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
singcel cell sequencing
Implications of the Human Microbiota for Health and Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to advance the understanding of human health and disease as it relates to environmental factors that may affect intestinal and non-intestinal microbiota.

Official Title
-----------------
Implications of the Human Microbiota for Health and Disease

Conditions
-----------------
Human Microbiota

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years of age or older Able to provide informed consent Exclusion Criteria: None

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 |
| --- | --- |
| Observational<br>Observational | Other: Observational<br>* Observational<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome Differences | compare the relative abundance of specific microorganism groups | 10 years |
Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy.

Detailed Description
-----------------
Post-operative pain in patients undergoing osteotomy can be severe. Current methods of treatment involve parenteral narcotics and regional anesthesia. Several studies have looked at the efficacy of regional anesthesia with various combinations of local anesthetic and additives in different populations. However, to our knowledge there have been none that directly compare bupivacaine/clonidine epidural with supplemental narcotics to parenteral narcotics alone. Many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia (1,2,3). Parenteral narcotic alone is associated with the possibility of significant side effects, overdose, and inadequate analgesia. Epidural analgesia has been shown to reduce postoperative pain scores more than parenteral narcotics (4). We believe that this study is important since the protocol allows additional parenteral narcotic in the epidural group if needed, and also allows for narcotic dosing prior to discontinuation of the epidural to compensate for rebound pain. Further, the prolongation of pain control shown with epidural clonidine may be beneficial during the transition (5,6).

Official Title
-----------------
Comparison of Epidural Bupivacaine-Clonidine With Intravenous Morphine Versus Intravenous Morphine Alone for Post-Operative Pain Relief in Pediatric Patients Undergoing Lower Extremity or Pelvic Osteotomy.

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

Intervention / Treatment
-----------------
* Drug: Bupivacaine, Clonidine, Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 4-16 English speaking Elective lower extremity osteotomy Expected length of stay greater than 24 hours Exclusion Criteria: History of previous spine surgery Current infection overlying catheter insertion site Coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 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: Bupivacaine, Clonidine, Morphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour recording of pain, sedation, narcotic usage, and satisfaction. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidural, Bupivacaine, Clonidine
Comparison of the Success Rate of Two Approaches for Obturator Nerve Block in TURB (Conventional Pubic Approach [Labat Technique] and Inguinal Approach)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the success rate of two approaches for obturator nerve block in TURB (conventional pubic approach [Labat technique] and inguinal approach.

Official Title
-----------------
Comparison of the Success Rate of Two Approaches for Obturator Nerve Block in TURB (Conventional Pubic Approach [Labat Technique] and Inguinal Approach)

Conditions
-----------------
Nerve Block

Intervention / Treatment
-----------------
* Procedure: obturator nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergoing transurethral resection of bladder tumor during combined spinal anesthesia and obturator nerve block were included in the clinical study Exclusion Criteria: Patients with advanced cardiac and respiratory insufficiency Allergy to local anesthetics Preexisting neurologic deficits Prior operation involving the hip and the inguinal region and bleeding tendency were excluded.

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

Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional pubic approach<br> | Procedure: obturator nerve block<br> <br> |
| Experimental: inguinal approach<br> | Procedure: obturator nerve block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of obturator sign during using nerve stimulator and operation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obturator nerve block in TURB
Preoperative PPI in Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy

Detailed Description
-----------------
In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not

Official Title
-----------------
Routine Preoperative PPI in Sleeve Gastrectomy

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Combination Product: sleeve + preoperative PPI
* Combination Product: sleeve + preoperative Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly obese patient with BMI more than 40 with or without co-morbidity Morbidly obese patient with BMI more than 35 with co-morbidity Exclusion Criteria: Unfit patients for laparoscopic sleeve gastrectomy patients refuse to share in the study patients that already on PPI due to any indications revisional surgery for obesity previous upper abdominal surgery

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPI group<br>take preoperative PPI for 10 days | Combination Product: sleeve + preoperative PPI<br>* sleeve + preoperative PPI<br>|
| Active Comparator: Control group<br>take placebo for for 10 days preoperative | Combination Product: sleeve + preoperative Placebo<br>* sleeve + preoperative Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early postoperative bleeding and leak | early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | time taken from skin incision to closure | 5 hours | 
| microscopic picture of the removed stomach | histological examination to detect the presence of inflammation in of the removed part of the stomach | 2 weeks |
Breathing Adapted Radiotherapy for Mediastinal Lymphoma

Study Overview
=================
Brief Summary
-----------------
In this study, radiation therapy plans will be made for 20 consecutive patients with mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphoma. One plan is done using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan and another plan is done using the standard procedure with pre-chemo PET-CT fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.

Detailed Description
-----------------
Radiotherapy using a breathing adapted therapy scan is a routine technique in breast cancer. Breathing adapted radiotherapy may also reduce radiation dose to organs at risk, e.g. heart and lung, in patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas. Optimal radiation therapy of these lymphoma patients includes radiotherapy planning using pre-chemotherapy PET-scanning, fused with a post-chemo planning CT-scan. This makes accurate treatment of pre-chemo involved volume possible and also accurate radiation of the post-chemo involved volume possible. Thus, the optimal breathing adapted radiation requires planning using a breathing adapted pre-chemo PET-CT scan fused with a breathing adapted post-chemo planning CT scan. In this study, 20 consecutive patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas will have combination therapy with chemotherapy and radiation therapy to involved nodes. Two radiation therapy plans will be made for each patient: one using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan, and one using the standard procedure of a pre-chemo PET-CT scan fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.

Official Title
-----------------
Breathing Adapted Radiotherapy for Mediastinal Lymphoma

Conditions
-----------------
Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I/II mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphomas Treatment plan includes radiotherapy Exclusion Criteria: Not able to comply to breathing adapted therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Estimated radiation dose levels to the lymphoma and to the organs of risk |  | Before day 1 of radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Radiotherapy, Positron-Emission Tomography, CT scan
Reversed TESS Shoulder Artroplasty

Study Overview
=================
Brief Summary
-----------------
Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. The radiologic phenomenom and clinical impact of scapular notching (SN) and arm length difference has been evaluated.

Official Title
-----------------
The TESS Reverse Shoulder Arthroplasty: Effect of Arm Lengthening and Early Scapular Notching at Three Years Follow-up

Conditions
-----------------
Humerus Fracture, Degenerative Shoulder Pain, Degenerative Supraspinatus Rupture

Intervention / Treatment
-----------------
* Procedure: Reversed shoulder arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operated with a reversed TESS total shoulder arthroplasty at Sundsvall hospital. Exclusion Criteria: Do not give informed consent Do not attend follow-up

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 88 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 |
| --- | --- |
| Reversed TESS<br>Patient undergone reversed shoulder arthroplasty | Procedure: Reversed shoulder arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome measurement Quick-DASH |  | 2007-2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of movement |  | 2007-2013 | 
| Quality of life EQ5-D |  | 2007-2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reversed shoulder arthroplasty, Treatment, TESS
A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers.

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

Intervention / Treatment
-----------------
* Drug: ABT-614


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between 18 and 40 years of age Exclusion Criteria: History of bleeding disorders or deep vein thrombosis (DVT) Previous gastrointestinal (GI) surgery or chronic GI disease History of spinal surgery History of significant, chronic low back pain History of frequent headaches

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose (Part 1)<br> | Drug: ABT-614<br>* Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.<br>|
| Experimental: Multiple Dose (Part 2)<br> | Drug: ABT-614<br>* Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination) |  | One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses | 
| ABT-614 levels in cerebral spinal fluid |  | 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen | 
| ABT-614 levels in blood (plasma) |  | 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen | 

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