linjc16/ctgov huggingface dataset:
Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.

Detailed Description
-----------------
This is an open-labeled, randomized clinical trial. Group A will receive one dose of NALDEBAIN before surgery. Group B will receive morphine as needed. Pain will be assessed for PACU, 4, 24, 48, 72 hours after surgery.

Official Title
-----------------
Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Naldebain
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female with 20 years old or older. Scheduled to electively undergo laparoscopic cholecystectomy. Ability and willingness to provide informed consent. Exclusion Criteria: Not willing to adhere to the study visit schedule and complete all study assessments. History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil. Any clinically significant condition that may interfere with study assessments or compliance. Pregnant or breastfeeding. Medical history may cause abnormal intracranial pressure. History of dependency, addiction, and withdrawal for narcotic drugs.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naldebain<br>Subjects will receive one dose of Naldebain before surgery. | Drug: Naldebain<br>* 150 mg Nalbuphine sebacate<br>|
| Active Comparator: Morphine<br>Subjects will receive morphine after surgery. | Drug: Morphine<br>* Morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain) | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of supplemental analgesics | Sum of supplemental analgesics | From Day 0 to Day 3 |
The Effect of Arginine on Classic Galactosemia

Study Overview
=================
Brief Summary
-----------------
Rationale: Classic galactosemia is a rare inherited metabolic disease that presents in neonatal patients with a life-threatening multi-organ toxic syndrome. Although the current standard of care - a galactose-restricted diet - quickly relieves the severe neonatal clinical picture, it fails to prevent brain and gonadal sequelae. There is a need for new therapeutic strategies. As arginine is an amino acid that is therapeutically widely used with no side effects described, we propose to use it in a pilot-clinical study. We aim to evaluate the effects of arginine in classic galactosemia patients, in order to determine its potential therapeutic role in this disease. Objective: To evaluate the possible effect of arginine on the whole body galactose oxidative capacity in classic galactosemia patients. Study design: Interventional pilot-clinical study with pre-post single arm design. Study population: We aim to include 5 classic galactosemia adult patients homozygous for the p.Q188R mutation. Intervention: All participants will receive arginine in the form of Asparten ® (arginine aspartate) during 1 month, by oral administration. The main study parameter is whole body galactose galactose oxidative capacity.

Official Title
-----------------
Does Arginine Enhance Galactose Oxidative Capacity in Classic Galactosemia: A Pilot Study

Conditions
-----------------
Classic Galactosemia

Intervention / Treatment
-----------------
* Drug: Arginine Aspartate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Classic galactosemia patient homozygous for the p.Q188R mutation, diagnosed by GALT enzyme activity assay and GALT gene mutation analysis Eighteen years of age or older Capable of giving informed consent Exclusion Criteria: Urea cycle disorders (assessed by post prandial amino acid profile in blood) Increased level of plasma uric acid Patients experiencing acute illness of classic galactosemia Pregnant women (or considering getting pregnant) or breastfeeding women

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: Asparten<br>Asparten (arginine aspartate) 5000mg/10mL 3x/day | Drug: Arginine Aspartate<br>* Asparten<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body galactose oxidative capacity | Whole body galactose oxidative capacity is breathing test that quantifies [1-13C]-galactose conversion into 13CO2, thus allowing to delineate the exact extent of impaired galactose metabolism, providing clear information on a patient's ability to oxidize galactose. | 6 hours |
Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients

Study Overview
=================
Brief Summary
-----------------
Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000

Official Title
-----------------
Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients: Analysis of Intraoperative Cardiac Output, Systemic Vascular Resistant and Stroke Volume Variation

Conditions
-----------------
Hemodynamic Monitoring

Intervention / Treatment
-----------------
* Device: Transthoracic Electrical Bioimpedance
* Device: Pulse Contour Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18.5 - 35 kg/m^2 Exclusion Criteria: Heart function abnormalities (arrhythmia, AV block, using pacemaker, severe aorta stenosis) Morbid obesity Bradycardia (< 50 bpm) Tachycardia (> 110 bpm) refuse to participate

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

| Intervention/Treatment |
| --- |
|Device: Transthoracic Electrical Bioimpedance|Non-invasive hemodynamic monitor|
|Device: Pulse Contour Analysis|Invasive hemodynamic monitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic correlation | Correlation between hemodynamic measured between devices: cardiac index, stroke volume index, systemic vascular resistance index, stroke volume index | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemodynamic profiles: Cardiac Index | The trends of perioperative hemodynamic profiles during and after surgery: cardiac index in L/minutes/m^2 | Intraoperative | 
| Changes in hemodynamic profiles: Stroke Volume Index | The trends of perioperative haemodynamic profiles during and after surgery: stroke volume index in mL/beat/m^2 | Intraoperative | 
| Changes in hemodynamic profiles: Systemic Vascular Resistance Index | The trends of perioperative haemodynamic profiles during and after surgery: systemic vascular resistance index in dynes-second-m^2/cm^5 | Intraoperative | 
| Changes in hemodynamic profiles: Stroke Volume Variation | The trends of perioperative haemodynamic profiles during and after surgery: stroke volume variation in % | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bio-impedance, Haemodynamic monitoring, Pulse contour analysis, kidney transplantation
Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males

Detailed Description
-----------------
Background: Glucagon like peptide-1 (GLP-1) promotes satiety and reduces food intake. GLP-1 is secreted from intestinal L-cells into the splanchnic circulation, it is (i) subject to rapid breakdown and (ii) submitted to a high liver extraction. Highest concentrations of GLP-1 are therefore found in the splanchnic blood rather than in the systemic circulation. An oral delivery system would mimick the physiological path of endogenous secretion. Objective: We aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males.

Official Title
-----------------
Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile Following an Oral Glucose Tolerance Test in Healthy Male Subjects

Conditions
-----------------
Glucose Homeostasis

Intervention / Treatment
-----------------
* Drug: Oral GLP-1
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male subjects no gastrointestinal or endocrine disorder Exclusion Criteria: females alcohol or drug abuse active virus hepatitis

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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Human GLP-1 | Drug: Oral GLP-1<br>* GLP-1 tablet (2mg)<br>|
| Placebo Comparator: 2<br>Placebo tablet | Drug: Placebo<br>* Control tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon secretion GH release adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLP-1, insulin, glucose
Safety and Efficiency Study of Valproic Acid In HAM/TSP

Study Overview
=================
Brief Summary
-----------------
Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19 HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained decrease was expected). Secondary end-point was the neurological status before and after one-year treatment.

Official Title
-----------------
Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP

Conditions
-----------------
HTLV-I-Associated Myelopathy

Intervention / Treatment
-----------------
* Drug: Valproic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HAM/TSP patients diagnosed on WHO criteria Obtained informed consent. Exclusion Criteria: Patients with hepatic or nephrologic disease Valproic Acid allergy Pregnancy.

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

| Intervention/Treatment |
| --- |
|Drug: Valproic Acid|Valproic acid by oral route (20mg/Kg/day) during one year.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTLV, HAM/TSP, VALPROIC ACID, PROVIRAL LOAD
Expanded Access of Sotorasib

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.

Official Title
-----------------
A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation

Conditions
-----------------
Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC

Intervention / Treatment
-----------------
* Drug: AMG 510


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age ≥ 18 years Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated) Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 Exclusion Criteria Mixed small-cell lung cancer or mixed NSCLC histology Active brain metastases Active hepatitis B or hepatitis C virus Current active malignancy other than NSCLC Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AMG 510|Administered as an oral tablet.|

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
-----------------
KRAS p.G12C Mutation, NSCLC
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery. Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.

Official Title
-----------------
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?

Conditions
-----------------
Ankle Fracture

Intervention / Treatment
-----------------
* Procedure: Early Weight bearing + Cam Boot
* Procedure: Non-Weight Bearing + Cam Boot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operative unstable ankle fractures Exclusion Criteria: Requirement of syndesmotic fixation Pilon fractures Open fractures Patients with diabetic neuropathy BMI>40 Polytrauma patients Patients who are unable to comply with non-weight bearing Patients who are unable to follow up

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Weight Bearing + Cam boot<br> | Procedure: Early Weight bearing + Cam Boot<br>* Patients will be transitioned to weight bearing as tolerated in a cam boot.<br>|
| Active Comparator: Standard Treatment Cam boot<br> | Procedure: Non-Weight Bearing + Cam Boot<br>* Subject will be transitioned to non weight bearing cam boot, standard treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olerud Molander Ankle Score | The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedic, Post-operative, Weight bearing, Range of motion
Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

Study Overview
=================
Brief Summary
-----------------
Contrast ultrasound is a technique that can quantify blood flow in the tissues of the body by ultrasound detection of microbubble contrast agents that behave in the circulation similar to red blood cells. In this study, the investigators hypothesize that contrast ultrasound of blood flow in the leg (thigh and calf) at rest and during stress produced by medications that mimic exercise (vasodilator stress) can provide information on the location and severity of peripheral vascular disease (blockages of the blood vessels in the leg). The investigators will also determine whether symptom improvement after revascularization (procedures to open up or bypass the blockages) is directly related to the improvement in blood flow.

Official Title
-----------------
Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease

Conditions
-----------------
Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known or suspected PAD Lower extremity angiography or MRA planned or performed within 6 months Exclusion Criteria: Age <19 y.o. Pregnant or lactating females Hypersensitivity to ultrasound contrast agent, dipyridamole, or regadenoson Severe reactive airways disease Evidence right-to-left shunt (identified on screening echo) NYHA Class III or IV heart failure. Planned amputation Unstable coronary artery disease or severe aortic stenosis

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Control<br>Age matched control subjects without PAD | |
| Patients with PAD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitation of Perfusion | Correlation of skeletal muscle perfusion with symptom status | Immediate |
Chronic Low Back Pain - Epiduroscopy Treatment

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of patients with low back pain after epiduroscopic procedure

Detailed Description
-----------------
Retrospective analysis of patients with low back pain after epiduroscopic procedure Retrospective analysis of ambulatory data and next phone survey

Official Title
-----------------
Chronic Low Back Pain - Epiduroscopy Treatment

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Procedure: Epiduroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients after epiduroscopy Exclusion Criteria: patients disagreement

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Epiduroscopy|Endoscopic intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of back pain after epiduroscopic procedure |  | 1 year | 
| Incidence of leg pain after epiduroscopic procedure |  | 1 year |