linjc16/ctgov huggingface dataset:
Impairment-Specific and Augmented Intervention on Turning

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke.

Official Title
-----------------
Effects of Impairment-Specific and Augmented Intervention on Turning Performance in Individuals With Chronic Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Impairment-specific and augmented intervention
* Other: Conventional physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≧ 6 months post first-ever stroke with unilateral motor deficits ≧20 years of age The ability to walk independently for at least 7 m with or without using walking aids Score ≧ 24 of 30 on the Mini-Mental State Examination Exclusion Criteria: Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis) History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Other: Impairment-specific and augmented intervention<br>* Balance and lower extremities strength training<br>|
| Active Comparator: control group<br> | Other: Conventional physical therapy<br>* Trunk and upper extremity training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turning performance | Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning | Change from baseline at 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR) | Change from baseline at 4 week | 
| Strength | Using handheld dynamometer | Change from baseline at 4 week | 
| Straight walking performance | Using GAITRite system (CIR system, Inc, Havertown, PS) calculate walking speed, cadence, swing time, stance time, and step length | Change from baseline at 4 week | 
| Timed up and go test |  | Change from baseline at 4 week | 
| Falls Efficacy Scale International (Chinese) |  | Change from baseline at 4 week | 
| Stroke Impact Scale (SIS) Taiwan version |  | Change from baseline at 4 week |
Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the efficacy of combined intraocular injection of gentamycin and clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (APBE) following penetrating eye injuries. Design: Multicenter, randomized, double masked, controlled trial. Participants: Three hundred forty six eyes of 346 patients with penetrating eye injury. Method: Following primary repair, eyes were randomized to receive a 0.1 ml intracameral or intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral or intravitreal injection of 0.1ml balanced saline solution (controls). All patients received standard prophylactic antibiotic therapy (systemic, subconjunctival and topical). Main outcome measures: Occurrence of endophthalmitis within two weeks after primary repair.

Conditions
-----------------
Endophthalmitis, Prophylaxy of Post Traumatic Endophthalmitis, Bacterial Endophthalmitis

Intervention / Treatment
-----------------
* Drug: gentamycin and clindamycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with penetrating eye injuries referred to collaborating institutes for primary repair Exclusion Criteria: Absence of light perception presence of endophthalmitis at the time of initial evaluation total corneal opacity age under 3 years severe intracameral hemorrhage history of intraocular surgery and presence of a corneal ulcer Monocular patients the better eye in simultaneous bilateral injuries

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gentamycin and clindamycin|nan|

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
-----------------
Endophthalmitis, Post-traumatic Endophthalmitis, Bacterial Endophthalmitis, Prophylaxis of Endophthalmitis, Intra Ocular Injection of antibiotics
Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)

Study Overview
=================
Brief Summary
-----------------
Registration study

Official Title
-----------------
A Non-Comparative, Multicenter, Open-Label, Study to Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia

Conditions
-----------------
Fungal Infection

Intervention / Treatment
-----------------
* Drug: MK0991, caspofungin acetate / Duration of Treatment:


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has had an absolute neutrophil count < 500/mm3 for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding study entry, and patient has fever >38.0 Degrees Centigrade within the last 24 hours prior to study entry Appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage Exclusion Criteria: Patient has an inadequately managed bacterial infection at the time of enrollment

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0991, caspofungin acetate / Duration of Treatment:|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of caspofungin-treated patients with SAE |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy |  |  |
NeoChord TACT Post-Market Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

Official Title
-----------------
Post-Market Surveillance Registry for the NeoChord DS1000

Conditions
-----------------
Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grade 3+ or 4+ mitral valve regurgitation Exclusion Criteria: Heavily calcified valves Valvular retraction with severely reduced mobility Active bacterial endocarditis Complex mechanism of MR (leaflet perforation, etc.) Significant tethering of leaflets Inflammatory valve disease
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 |
| --- | --- | --- |
| Procedure Success | To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure | The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DS1000, NeoChord, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae
Diagnostic and Prognostic Value of Combination Biomarkers in the Critically Ill Patient With Sepsis.

Study Overview
=================
Brief Summary
-----------------
Sepsis is a common cause for morbidity and mortality in critically ill patients. With the development of medical skills, the mortality is still remain very high. Inappropriateness of initial antibiotic treatment is an important risk factor for mortality and effective antimicrobial administration within the first hour of documented hypotension was associated with increased survival to hospital discharge in adult patients with septic shock. However, the early treatment based on early diagnosis.But it is very difficult to diagnosis because of lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore, combine several biomarkers could enhance the diagnostic value.

Conditions
-----------------
Diagnostic and Predictive Value

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill patients admitted into ICU Exclusion Criteria: Age younger than 18 years Refuse to participate in this 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?
-----------------
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
-----------------
CRP, PCT, IL-6, Diagnosis, Prediction
Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients. Effetti Del Temperamento, Dell'Ansia e Della Depressione Sulla Sopravvivenza Globale e Sulla Risposta Immunitaria Del Paziente Affetto da Adenocarcinoma Colo-Rettale.

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity and influence Survival in Colorectal Cancer Patients

Detailed Description
-----------------
120 prospective patients, with non-metastatic colorectal cancer, will be evaluated with questionnaires and auto-questionnaires in order to assess temperament, anxiety and depression. The immunity status will be assessed by a blood sample with the aim to evaluate cell-mediated immunity. Survivall will be related to level of anxiety/temperament/depression and cell-mediated immunity. Univariate and multivariate model analisys will be performed in order to evaluate if anxiety/temperament/depression and cell-mediated immunity can be considered as prognostic factors.

Official Title
-----------------
Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients.

Conditions
-----------------
Anxiety, Temperament, Depression, Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of non-metastatic colorectal cancer Exclusion Criteria: previous other primary malignancies immunodepression diagnosis of major deppression diagnosis of anxiety/depression syndrome

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Temperament in non-metastatic colorectal cancer patients | Evaluation if Temperament can be considered as dependent or indipendent prognostic factor for survival in non-metastatic colorectal cancer patients | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temperament, Anxiety, Depression, Colorectal Cancer
Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush and Manual Toothbrush

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.

Detailed Description
-----------------
This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved research study evaluating the single-use plaque removal efficacy of a new children's battery-operated toothbrush and a marketed children's manual toothbrush. This study will accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups. After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.

Official Title
-----------------
Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush

Conditions
-----------------
Plaque, Dental

Intervention / Treatment
-----------------
* Device: Battery operated toothbrush
* Device: Manual toothbrush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5 to 8 years Be a regular manual toothbrush user. Exclusion Criteria: Have any physical limitations or restrictions which might preclude normal tooth brushing. Have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments. Have fixed or removable orthodontic appliances.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 8 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Battery operated toothbrush<br>battery operated toothbrush | Device: Battery operated toothbrush<br>* Device on plaque removal efficacy<br>|
| Active Comparator: Manual toothbrush<br>Manual toothbrush | Device: Manual toothbrush<br>* Device on plaque removal efficacy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal | Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured. | up to 2 weeks |
Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy over the short and long term (2, 3). Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar clamping, which creates the desired bloodless operative field, allowing for more precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic kidney injury which can compromise the functional outcomes of the remaining kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving partial renal arterial clamping, with the goal of completely eliminating surgical ischemia to the renal remnant.

Official Title
-----------------
A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

Conditions
-----------------
Partial Nephrectomy, Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Hypoperfusion of renal artery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be at least 18 years old scheduled for open partial nephrectomy Exclusion Criteria: No prior diagnosis of renal artery disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypoperfusion<br>Hypoperfusion of the renal artery | Procedure: Hypoperfusion of renal artery<br>* The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow | renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury | up to 2 weeks prior to surgery and up to 24 hrs post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partial nephrectomy, hypoperfusion, renal function
Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male Chinese subjects.

Official Title
-----------------
A Randomized, Open-Label, Single-Dose Administration, Parallel-Group, Multisite Study of the Pharmacokinetics of Etanercept, 25 or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Chinese subjects, ages 18 to 45. BMI in the range of 18 to 30 kg/m2 and weight greater than or equal to 50 kg. Exclusion Criteria: Active tuberculosis (TB) or history of TB. Serious infection (associated with hospitalization and/or antibiotics) within 1 month before study drug administration. History of protein drug hypersensitivity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>25 mg | Drug: Etanercept<br> <br> |
| Experimental: B<br>50 mg | Drug: Etanercept<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| etanercept levels in the blood |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single doses of etanercept administered to healthy Chinese subjects |  | 21 days |
Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

Study Overview
=================
Brief Summary
-----------------
Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.

Official Title
-----------------
Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy/Uncinectomy

Conditions
-----------------
Nasal Blockage, Nasal Obstruction, Septum; Deviation

Intervention / Treatment
-----------------
* Procedure: Infundibultomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral breathing impairment due to septal deviation

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infundibulotomy<br>Infundibulotomy on one side of sinuses | Procedure: Infundibultomy<br>* Infundibultomy on one side of patient<br>|
| Sham Comparator: No Infundibultomty<br>No Intervention on other side of sinuses | Procedure: Infundibultomy<br>* Infundibultomy on one side of patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single sided VAS Scores for breathing impairment | Rating of nasal breating on a 0-10 scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT Score | Quality of Life Measure from 0-110 | 3 months | 
| NOSE Score | Nasal symptom questionnaire | 3 months | 
| PNIF | Peak Nasal Inspiratory Flow measured in ml/sec | 3 months |