linjc16/ctgov huggingface dataset:
Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery

Study Overview
=================
Brief Summary
-----------------
This will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.

Official Title
-----------------
Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery

Conditions
-----------------
Shoulder Pain

Intervention / Treatment
-----------------
* Other: ibuprofen 600 mg
* Other: Oxycodone/acetaminophen (Percocet) 5 mg/325


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-II Patients scheduled for arthroscopic shoulder instability surgery Exclusion Criteria: Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder) Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.) Younger than 18 years of age or older than 65 Any patient considered a vulnerable subject Patients on pain medication prior to 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ibuprofen + Percocet<br> | Other: ibuprofen 600 mg<br>* MRN ending in an EVEN # will receive ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN) and oxycodone/acetaminophen (Percocet) 5 mg/325 mg for pain that is not adequately controlled by the ibuprofen.<br>Other: Oxycodone/acetaminophen (Percocet) 5 mg/325<br>* MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.<br>|
| Percocet<br> | Other: Oxycodone/acetaminophen (Percocet) 5 mg/325<br>* MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) Score | Scale consisting of a drawn line from 0 to 100 - the patient will be asked to mark where they believe their pain is (100 being worse pain). | 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery | 
| Change in Verbal Rating Scale (VRS) | Consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe) | 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery |
Special Drug Use Investigation for LAMICTAL Bipolar

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice. (LAMICTAL is a trademark of the GlaxoSmithKline group of companies.)

Official Title
-----------------
Special Drug Use Investigation for LAMICTAL Bipolar

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Lamotrigine tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bipolar disorder Patients treated with lamotrigine tablets for the first time Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with bipolar disorder<br>Patients with bipolar disorder prescribed lamotrigine tablets for the first time | Drug: Lamotrigine tablets<br>* Administered according to the prescribing information in the locally approved label by the authorities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with any adverse drug reaction |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of skin disorder |  | 1 year | 
| Occurrence of suicide-related event and self injurious behaviour |  | 1 year | 
| Occurrence of harming others |  | 1 year | 
| Occurrence of withdrawal symptoms after treatment |  | 1 year |
Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

Study Overview
=================
Brief Summary
-----------------
In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Elevation of the anterior abdominal wall is recommended for the access to peritoneal cavity in literatures however the benefit exactly has not proved. This study aimed to determine the distance from anterior abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to represent this distance -on the average- generate the safe range whether or not and compare with this distance and patient's age, BMI and parity.

Detailed Description
-----------------
40 patients who undergoing laparoscopic surgery for various indications are enrolled in the study. The telescope is inserted at second trocar place and the distances between anterior abdominal wall and visceral organs are measured with plastic hysterometry during maximal elevation of the abdominal wall.

Official Title
-----------------
Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

Conditions
-----------------
Other Surgical Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients who performed laparoscopic surgery Exclusion Criteria: the patients who suspected pregnancy large scale intrabdominal mass

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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 |
| --- | --- | --- |
| The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry. |  | 2-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic access, Abdominal wall lifting, Direct trocar insertion, Safety endoscopy
Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively and replace renal function partly. It is widely used in intensive care units (ICUs), especially for patients with acute kidney injury/failure in an unstable hemodynamic status. Lactate is a molecule smaller than glucose, which can pass through filtration membrane freely in CVVH. Therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status in patients with unstable hemodynamic status. However, there is no prospective study evaluated the effect of CVVH on lactate removal in critically ill patients. The influence of different dose of CVVH on lactate elimination is not clear in patients with different level of serum lactate. Our study aimed to find out how the dose of CVVH effects on lactate clearance, and then re-estimate the prognostic value of lactate in critically ill patients with CVVH.

Conditions
-----------------
Kidney Injury, Acute

Intervention / Treatment
-----------------
* Other: Plasma lactate were measured


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The critical ill patients with acute kidney injury Patients requiring continuous veno-venous hemofiltration APACHE II scores more than 12 Arterial lactate is higher than 0.5mmol/L but lower than 15mmol/L (due to the sensitivity and optimal measuring range of the equipment) Continuous veno-venous hemofiltration for at least 12 hrs Hemo-filter age of <24 hrs Exclusion Criteria: APACHE II scores lower than 12 patients' age are more than 75Y or lower than 18Y

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Plasma lactate were measured|Three different doses (20 ml/kg/h, 35 ml/kg/h and 45 ml/kg/h) of CVVH were applied to critically ill patients who experiencing CVVH. Each dose of CVVH was sequentially gave to each patient and lasted for 30 minutes separately|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lactate | Each dose of CVVH was lasted for 30 minutes separately. Blood samples were draw pre-(A) and post-dialyzer (V) site after each dosage of CVVH was carried out for 30 minutes and then plasma lactates were measured immediately | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous veno-venoous haemofiltration, Plasma lactate, Critical illness, Acute kidney injurytissue perfusion, Multiple organ dysfunction syndrome
MGB/OAGB Versus RYGB After Failed Sleeve

Study Overview
=================
Brief Summary
-----------------
Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number of data documents that some patients have to be surgical revised due to weight regain or gastro-esophageal reflux disease. This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.

Detailed Description
-----------------
All patients who underwent RYGB or MGB/OAGB between October 2014 and December 2016 after failed sleeve gastrectomy will be recorded and analyzed in relation to weight loss, intra- and postoperative complications (Clavien-Dindo) and postoperative morbidity up to one year follow-up.

Official Title
-----------------
A Comparison of the Mini/One Anastomosis-Gastric Bypass and Roux-en-Y Gastric Bypass for Conversion of Failed Sleeve Gastrectomy

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Roux en Y gastric bypass
* Procedure: Mini/One anastomosis gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with failed sleeve due to weight regain weight loss failure gastro-esophageal reflux disease Grade B Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Failed sleeve gastrectomy - RNYGB<br>Intervention: Roux en Y gasric bypass (RNYGB) | Procedure: Roux en Y gastric bypass<br>* Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)<br>* Other names: RNYGB;|
| Other: Failed sleeve gastrectomy - MGB/OAGB<br>Inervention: Mini/One anastomosis gasic bypass (MGB/OAGB) | Procedure: Mini/One anastomosis gastric bypass<br>* Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)<br>* Other names: MGB/OAGB;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Total Body Weight Loss in % | 1 year follow-up | 
| Weight Loss | Excess Weight Loss in % | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Complications | Perioperative Complications (Clavin-Dindo) | up to 30 days postsurgery | 
| Postoperative Morbidity | Postoperative Morbidity | 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity Surgery, Failed Sleeve Gastrectomy, Roux-en-Y gastric bypass, Mini/One anastomosis gastric bypass
fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the organization of memory and develop future methods for early detection of AD. Using functional magnetic resonance imaging (fMRI), we examine the responsiveness of the brain to memory tasks, specifically focusing on regions of the brain (the mesial temporal lobe and posterior cingulate) that are known to be involved in early stages of Alzheimer's disease (AD). Of interest are differences in brain activation between people with and without a family history of AD and other risk factors.

Official Title
-----------------
fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease

Conditions
-----------------
Magnetic Resonance Imaging, Alzheimer's Disease, Dementia, Adult Children, Risk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MCI Group: Diagnosis of mild cognitive impairment AD Family History Group: Confirmed family history of Alzheimer's and concurrent enrollment in the Wisconsin Registry for Alzheimer's Prevention (WRAP) Control Groups: Cognitively healthy and both parents survived past age 70 with no memory problems Exclusion Criteria: Claustrophobia Metallic or electronic implants or devices that are not MRI-safe

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| 1<br>Persons with a parent with Alzheimer's disease | |
| 2<br>Persons whose parents survived to old age without memory problems | |
| 3<br>Persons with diagnosed mild cognitive impairment | |
| 4<br>Persons without memory problems | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.

Official Title
-----------------
the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: transarterial infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent Exclusion Criteria: cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: low dose<br>low oxaliplatin (85mg/m2) | Procedure: transarterial infusion<br>* transarterial infusion<br>|
| Active Comparator: high dose<br>high oxaliplatin (135mg/m2) | Procedure: transarterial infusion<br>* transarterial infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | From date of randomization until the date of death from any cause, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | object response rate | From date of randomization until the date of death from any cause, assessed up to 60 months | 
| PFS | progression-free survival | From date of randomization until the date of progress from any cause, assessed up to 60 months |
Potential Nosocomial Infection Prevention Via Modification of Anesthesia Intraoperative Aseptic Practice

Study Overview
=================
Brief Summary
-----------------
We hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients.

Detailed Description
-----------------
We performed an observational study evaluating provider adherence to these techniques. We then sought to increase hand hygiene compliance through the use of a point of care alcohol based hand hygiene device. We hypothesized that increased hand hygiene compliance would reduce bacterial contamination of the anesthesia workspace and peripheral intravenous tubing, and ultimately reducing overall morbidity and mortality secondary to a reduction in nosocomial infection rates.

Official Title
-----------------
Before and After Study Evaluating Deployment of the Sprixx GJ Personal Hand Hygiene Device in the Intra-Operative Environment

Conditions
-----------------
Nosocomial Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients present in operating rooms randomized to study. Exclusion Criteria: Patients that were already enrolled in study and return to the operating room.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before (Control)<br>Study group representative of standard practice | |
| After(Treatment)<br>After treatment group with the personal hand hygiene device ie. Device Group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of a positive culture on the previously sterile patient stopcock set, and the presence of multidrug resistant bacteria |  | Beginning and end of surgical case | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bacterial contamination on predetermined sites on the anesthesia machine |  | Beginning and End of Surgical Case | 
| Decreased length of stay |  | Postoperatively | 
| Nosocomial infection rates |  | within 30 days postoperatively | 
| Mortality |  | Within 30 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia Workspace, Hospital Acquired Infections, Hand Hygiene, Alcohol Based Cleanser, Bacterial Contamination
Rifaximin Therapy in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Rifaximin decreases serum and urine levels of bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to evaluate changes in the bacterial content of the stool from these individuals.

Official Title
-----------------
Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Rifaximin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2 Exclusion Criteria: Patients with normal renal function or those with less advanced kidney disease Inability or unwillingness to provide consent Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant Patients who may be pregnant Hemodynamically unstable patients Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease Patients with ongoing or recent infection and those with history of C-diff infection Patients with abnormal bowel structure secondary to surgical or anatomic variations Patients on certain medications including immunosuppressants, antidiarrheal agents, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin<br>Participants will receive a 10-day course of Rifaximin. | Drug: Rifaximin<br>* 550mg pills<br>* Other names: XIFAXAN®;|
| Placebo Comparator: Placebo<br>Participants will receive a 10-day course of placebo. | Drug: Placebo<br>* Placebo pill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Trimethylamine N-oxide (TMAO) |  | Change from baseline to Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive Protein |  | Change from baseline to Day 11 | 
| Change in Serum Interleukin-6 (IL-6) | post- minus pre-treatment values | Change from baseline to day 11 |