linjc16/ctgov huggingface dataset:
Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit in adult patients undergoing general anesthesia.

Detailed Description
-----------------
Assessment of the performance of ANI to predict immediate postoperative pain on a 0-10 numerical rating scale (NRS) >3 by building a receiver operating characteristic curve.

Official Title
-----------------
Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI): an Observational Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult ear-nose-throat or orthopedic surgical procedures halogenated and remifentanil-based general anesthesia Exclusion Criteria: age <18 yrs or >75 yrs arrythmia administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes psychiatric diseases autonomic nervous system disorders (epilepsy) inability to understand the verbal rating pain scale

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia/Nociception Index (ANI) receiver operating characteristic (ROC) curve area under the curve (AUC) for the prediction of immediate postoperative pain | ROC curve AUC | At day 0 at the end of surgery immediately before extubation for ANI and at arrival in postoperative care unit within 10 minutes after arrival | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia Nociception Index, ANI
A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin efficacy after injection into these different areas is still unclear. The results from this study may expand the knowledge on the severity of this issue and may provide evidence for future treatment recommendations regarding injection sites for insulin administration.

Official Title
-----------------
A Trial to Compare the Pharmacokinetics and Pharmacodynamics of Insulin Lispro Administered s.c. Into Lipohypertrophic or Normal Abdominal Adipose Tissue in Subjects With Diabetes Mellitus Type 1

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin LISPRO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AUCINS.0-4h and AUCGIR.0-4h during treatment period 1 Exclusion Criteria: AUCINS.0-4h and AUCBG.0-4h during treatment period 2, intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin lispro<br> | Drug: Insulin LISPRO<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCINS.0-4h and AUCGIR.0-4h | Compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c. administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination. | up to 4 hours |
A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements

Study Overview
=================
Brief Summary
-----------------
Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.

Official Title
-----------------
A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements

Conditions
-----------------
Total Hip Replacement

Intervention / Treatment
-----------------
* Other: Metal Ion Levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One total hip replacement, either a large metal head (>40) or a small metal head (<30) on a polyethylene bearing surface. 2 to 5 years s/p surgery minimum. No symptoms Exclusion Criteria: Any other bearing surface besides metal on poly, no other joint replacements, symptomatic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Metal Ion<br> | Other: Metal Ion Levels<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metal Ion levels | We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Replacement, Metal Ion, 2-5 years after surgery, Asymptomatic
Catechin Mouth-washing for Removal of Intraoral Bacteria

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal of intraoral bacteria in the elderly

Detailed Description
-----------------
Catechins are the major components of tea flavonoids and recent in vitro experimental studies have revealed that tea catechin extracts induce bactericidal effects. However, a limited number of studies have been conducted on the clinical effects of tea catechin against bacterial infection and also the effects in the elderly is unclear. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of catechin mouth washing on oral pathogenic bacterial detected in the elderly.

Official Title
-----------------
A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Dietary Supplement: catechin extracts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged over 65 years detected oral pathogenic bacterium and revalidated during the wash-out period without antibacterial medicine, other mouth-washing remedies during the study Obtained written informed consent before participation Exclusion Criteria: possessing some infectious diseases in need of therapy possessing tea or catechin allergy diagnosed as inadequate for other reasons to participate the study by principal investigator

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 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: catechin<br>mask containing catechins | Dietary Supplement: catechin extracts<br>* catechin extracts solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of intraoral pathogenic bacteria identified before the study |  | After intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of intraoral bacteria after the study |  | After intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catechin, elderly, mouth washing, disabled, colonized
Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.

Official Title
-----------------
A 12-week Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of Biphasic Remogliflozin Etabonate When Administered to Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: Biphasic Remogliflozin Etabonate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide written informed consent Subject with clinical diagnosis of type 2 diabetes HbA1c 7.0 - 10.5% inclusive at Visit 1. Exclusion Criteria: History of metabolic acidosis or ketoacidosis. Current active renal disease that is not related to hypertension or type 2 diabetes (e.g. non-diabetic glomerulonephritis, interstitial nephritis, symptomatic nephrolithiasis, etc.) Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Placebo | Other: Placebo<br>* Placebo Comparator<br>|
| Experimental: Arm 2<br>Biphasic remogliflozin etabonate | Drug: Biphasic Remogliflozin Etabonate<br>* Experimental Drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated haemoglobin A1c (HbA1c) at Week 12 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | at weeks 4, 8 and 12 | 
| Fasting plasma glucose (FPG) |  | at Weeks 4, 8 and 12 | 
| Insulin |  | at Weeks 4, 8 and 12 | 
| C-peptide |  | at Weeks 4, 8 and 12 | 
| Total Cholesterol |  | at Weeks 4, 8 and 12 | 
| LDL-c |  | at Weeks 4, 8 and 12 | 
| HDL-c |  | at Weeks 4, 8 and 12 | 
| Serum Triglycerides |  | at Weeks 4, 8 and 12 | 
| Body Weight |  | at Weeks 4, 8 and 12 | 
| Waist Circumference |  | at Weeks 4, 8 and 12 | 
| Adverse Events (AE) |  | Over 12 weeks | 
| Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests |  | 12 weeks |
A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Study Overview
=================
Brief Summary
-----------------
This is an observational study and will evaluate IOP reduction in newly diagnosed patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with primary open angle glaucoma or ocular hypertension Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POAG or OHT<br>Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care. | Other: Standard of Care<br>* Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline | Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit. | Baseline, 14 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With an IOP Reduction ≥10% From Baseline | Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit. | Baseline, 14 Weeks | 
| Percentage of Patients With an IOP Reduction ≥20% From Baseline | Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit. | Baseline, 14 Weeks |
Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib

Study Overview
=================
Brief Summary
-----------------
Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

Detailed Description
-----------------
This is a non-interventional trial. No active patients will participate in this study. Only data generated from the A6181036 study will be utilized for correlational purposes. The A6181036 study data in addition to mutational status data previously analyzed but not collected as part of the A6181036 study in the same patient population

Official Title
-----------------
A Non-Interventional Retrospective Correlation Of Tumor Mutation Status To Clinical Benefit From The SU011248, A6181036 Treatment Protocol Titled: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

Conditions
-----------------
GIST

Intervention / Treatment
-----------------
* Other: non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GIST subjects that participated in the A6181036 study that had mutational status data analyzed. Exclusion Criteria: Subjects not participating in the A6181036 study

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 |
| --- | --- |
| Data generated from the past sunitinib A6181036 GIST study<br> | Other: non-interventional<br>* Non-interventional; Mutational status data analyzed previously but not collected in the A6181036 study, will be correlated wth A6181036 clinical outcomes data collected during the A6181036 study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retrospective, GIST, sunitinib, mutational
A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems

Official Title
-----------------
A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

Conditions
-----------------
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Humeral Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid Arthritis Correction of functional deformity Exclusion Criteria: Absolute contraindications: - Infection, Sepsis, and Osteomyelitis Relative contraindications: Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions Osteoporosis Metabolic disorders which may impair bone function Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biomet Humeral Stems<br>Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCLA End Result Score |  | 3 months, 6 months, 1 year, 3 years, 5 years | 
| X-rays |  | 3 month, 1 year, 3 years, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revisions and removals |  | Any time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder Arthritis, Total Shoulder Arthroplasty, Total Shoulder Replacement
Point of Care Device Use in the Pediatric Emergency Department

Study Overview
=================
Brief Summary
-----------------
To compare the effect of point-of-care (POC) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (PED).

Detailed Description
-----------------
This study was a prospective, randomized controlled study of patients requiring blood work that a POC device was capable of performing. Length of time spent at various timepoints were prospectively recorded by a dedicated research assistant after randomization.

Official Title
-----------------
A Randomized Trial to Assess the Efficacy of Point-of-Care Testing in Decreasing Length of Stay in a Pediatric Emergency Department

Conditions
-----------------
Dehydration, Seizure, Gastroenteritis, Hyperglycemia

Intervention / Treatment
-----------------
* Device: Point of Care Device; i-Stat Analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically requiring bloodwork capable by the POC device Exclusion Criteria: Requiring other bloodwork such as medication levels, WBC

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Point of Care Device; i-Stat Analyzer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Length of Stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time length for results return, disposition decision, time in ED proper |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Point-of-care Testing, Pediatric Emergency Department, Length of Stay, Efficiency