linjc16/ctgov huggingface dataset:
Validation of the SD-ICU. A Risk Assessment Tool of Unplanned ICU Readmission

Study Overview
=================
Brief Summary
-----------------
In a recent study, which included 845 patients that at the time of ICU discharge had at least one risk factor for readmission, the investigators' group developed a new readmission risk score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the investigators found that patients with a score above 14.5 had a high probability of readmission. The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a tool to predict unplanned readmissions to the intensive care unit. All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be included in the study. The SD-ICU score is routinely calculated at the time of discharge from the ICU. Patients will be divided into two groups: those with SD-ICU score> 14.5 (group 1) and those with a score equal to or less than 14.5 (group 2). The two groups will be compared with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic regression will be used to investigate the association between the risk factors for readmission used in SD-ICU score and ICU readmission as outcome.

Official Title
-----------------
Assessment of the Risk of Unplanned Readmission to the Intensive Care Unit Using the Safe Discharge From ICU (SD-ICU) Score: A Validation Study.

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients discharged from a general ICU Exclusion Criteria: Patients under 18 years old Those that were not candidates for ICU readmission (interhospital and home care transfer)

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 |
| --- | --- | --- |
| Readmission to the ICU |  | After ICU discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk, score, readmission, ICU
Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

Study Overview
=================
Brief Summary
-----------------
Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents Study Design: Single center, double-blind, randomized-control trial study Study drug: Repamipide vs. placebo Assessment criteria The patients will be discharged from the study when one of the followings occurred, Peptic ulcer from upper endoscopy at 3 and 6 month follow up Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy Evidence of recurrent myocardial infarction from stent thrombosis

Official Title
-----------------
Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study

Conditions
-----------------
Gastric Ulcer Induced by Anti-platelet Agent, Duodenal Ulcer Induced by Anti-platelet Agent

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 year-old Had cardiovascular disease which needed clopidogrel and aspirin Stable enough for gastroscopy Exclusion Criteria: Gastroscopy revealed peptic ulcer Had contraindication for gastroscopy Not allowed for gastroscopy by cardiologist

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Repamipide<br>Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred | Drug: Repamipide<br> <br> |
| Placebo Comparator: placebo<br>A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide. | Drug: Placebo<br> <br> * Other names: Placebo will be made in the same configuration of rabamipide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of peptic ulcer by end0scopy |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Repamipide, Dual antiplatelet, Peptic ulcer
L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function

Study Overview
=================
Brief Summary
-----------------
exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by L-arginine supplementation to determine the potential beneficial effect of L-arginine supplementation on exercise capacity and renal function of heart transplant recipients

Official Title
-----------------
Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Drug: 12 g of L-arginine glutamate during 6 weeks twice a day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male (> 18 years old) stable heart transplant recipient for at least 6 weeks Stable treatment for at least 3 months Sedentary people Exclusion Criteria: Unstable cardiac pathology Obesity (IMC > 40) Participation in another study in the last month Chronic renal failure (creatinine clearance < 20 ml/min) Renal transplantation Diabetes Impossibility to practice exercise test Nitrate 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 12 g of L-arginine glutamate during 6 weeks twice a day|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal and sub maximal exercise capacity at the end of the 6 weeks L-arginine supplementation. Renal function at the end of the 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
L-arginine, exercise capacity, renal function, nitric oxide, exercise capacity using a maximal exercise test, urinary elimination of a saline load using blood and urinary samples
Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.

Official Title
-----------------
A Phase 3, Randomized,Double-Blind, Comparative Study of Micafungin (FK463) Versus Placebo as Preemptive Prophylactic Antifungal Therapy in Patients in the Intensive Care Unit

Conditions
-----------------
Invasive Fungal Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Meets entry criteria for high risk Exclusion Criteria Evidence of active invasive fungal infection Received more than one dose of systemic antifungal agent within 72 hours prior to first dose of study drug Known to be HIV positive who have CD4 count less than 500 cells/mm3 Has life-expectancy of less than 72 hours or moribund

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Micafungin<br>* IV<br>* Other names: FK463;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study |  | Baseline through one week post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection |  | Baseline through one week post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-Fungal Therapy, Preemptive Anti-Fungal Therapy, Invasive Fungal Infection, Micafungin, ICU
Incidence of Recurrent Caries Next to Tooth Restorations

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration.

Detailed Description
-----------------
The data will be collected from patients who are visiting the dental clinic for a check-up. These data will be retrieved in the patient records. In particular the clinical (mouth) exam and the radiographic images ('RX-bite-wings'), which are routinely taken during these check-up consultations, will be used for the evaluation of recurrent caries. Information regarding medical background, oral hygiene, sugar eating habits and possible parafunctional activities will also be gathered from the patient files. In addition, caries risk of the patients will be assessed using commercial kits for analysis of their saliva (Saliva-Check Buffer, GC, Tokyo, Japan) and dental plaque (Tri Plaque ID Gel, GC, Tokyo, Japan), which are a part of the routine care of the patients at the clinic.

Official Title
-----------------
Epidemiological Study on the Incidence and Characteristics of Secondary Caries Next to Tooth Restorations

Conditions
-----------------
Recurrent Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up Exclusion Criteria: Patients for who not all necessary data could be registered (incomplete mouth exam records, missing RX-bite wings, etc)
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 |
| --- | --- | --- |
| Incidence of recurrent caries | Number of recurrent caries lesions (new caries lesion next to restoration) within a specified time period divided by the total number of restorations. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries risk of the patient | Caries risk of each patient will be assessed based on scoring of several parameters such as: number of new caries lesions in the last 3 years (from patients' files), presence of relevant systemic disease (from patients' files), sugar consumption (from patients' files), oral hygiene (from patients' files) and results of the Saliva-check test and Tri plaque ID test. | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent caries, Secondary caries, Dental composite, Dental amalgam
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

Study Overview
=================
Brief Summary
-----------------
This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.

Official Title
-----------------
An Open-label, Two Period Study to Determine the Excretion Balance and Pharmacokinetics of [14C]-GSK221149A, Administered as Single Doses of an Oral Solution and an Intravenous Infusion to Healthy Female Volunteers

Conditions
-----------------
Obstetric Labour, Premature, Premature Labor

Intervention / Treatment
-----------------
* Drug: GSK221149A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy adult, non-smoking females Aged between 30 - 55 years old, and BMI of between 19 and 32 Not of child-bearing potential Exclusion criteria: No clinically significant findings on clinical examination, medical examination and blood tests. Radiation exposure over previous 3 years is greater than 10mSv History of bleeding or gastric problems

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK221149A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary and fecal cumulative excretion as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and fecal samples for assessment of metabolites. Samples are collected for approximately 7 days (or longer). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Safety data. PK parameters of GSK221149A and drug-related material (radioactivity) in plasma following oral and intravenous dosing. Samples are collected for approximately seven days (or longer) following dosing. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
absorption,, metabolism,, excretion, distribution,
A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients

Official Title
-----------------
A Randomized, Double Blind, Placebo and Active Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Potential Efficacy of a 12-Week Treatment With YM543 in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: YM543
* Drug: Metformin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment-naive subjects diagnosed with T2DM Stable diet and exercise program for at least 6 weeks Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1 Exclusion Criteria: Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders Use of insulin or oral blood glucose lowering drugs in the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose 1 | Drug: YM543<br>* Oral<br>|
| Experimental: 2<br>Dose 2 | Drug: YM543<br>* Oral<br>|
| Experimental: 3<br>Dose 3 | Drug: YM543<br>* Oral<br>|
| Experimental: 4<br>Dose 4 | Drug: YM543<br>* Oral<br>|
| Active Comparator: 5<br> | Drug: Metformin<br>* Oral<br>|
| Placebo Comparator: 6<br> | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination) |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel) |  | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus Type 2, YM543, Treatment, Safety, efficacy
The Use of Barbed Sutures in Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the role of new barbed suture for closure of wound during total hip arthroplasty in reducing the risk for wound healing problems.

Official Title
-----------------
The Use of Barbed Sutures in Total Hip Arthroplasty: A Prospective, Randomized, and Controlled Clinical Trial

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Device: Interrupted Knotted Sutures
* Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All patients receiving elective primary THA through the direct anterior approach, treated by the primary investigator (JP) at the Thomas Jefferson University Hospital or Rothman Specialty Hospital. Exclusion Criteria: Prior surgical incision or scar in close proximity of the proposed incision (<2 cm). Local skin conditions such as dermatitis, eczema, or psoriasis. Active or previous infection in the skin or the hip. Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical cortico-steroid use

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inturrupted Knotte Sutures<br> | Device: Interrupted Knotted Sutures<br> <br> |
| Active Comparator: Barbed Sutures<br> | Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of suture abscess or other wound related compilation |  | Within 30 days of surgery |
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects

Study Overview
=================
Brief Summary
-----------------
A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.

Official Title
-----------------
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: laparoscopic (TEP) inguinal hernia repair
* Device: lightweight TiMesh
* Device: lightweight VyproII
* Device: Heavyweight Marlex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary, unilateral or bilateral, inguinal hernia patients Informed consent Exclusion Criteria: Sterilized patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- |
| Experimental: lightweight TiMesh<br> | Procedure: laparoscopic (TEP) inguinal hernia repair<br>* laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)<br>Device: lightweight TiMesh<br> <br> |
| Experimental: lightweight VyproII<br> | Procedure: laparoscopic (TEP) inguinal hernia repair<br>* laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)<br>Device: lightweight VyproII<br> <br> |
| Experimental: Heavyweight Marlex<br> | Procedure: laparoscopic (TEP) inguinal hernia repair<br>* laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)<br>Device: Heavyweight Marlex<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Male fertility aspects |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, pain development, recurrence |  | 1, 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Laparoscopic repair, Prostheses, Male fertility