linjc16/ctgov huggingface dataset:
Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
With this randomised intervention study, the investigators want to investigate the training effect of an 8 week training regime, using a robot-assisted training system in persons with MS. Besides conventional therapy, study participants in the experimental group will train 3 times per week during 30 minutes, using the haptic master. Research questions focus on the effects of additional robot assisted training on range of motion, movement quality and clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16 weeks of follow-

Official Title
-----------------
Robot-assisted Training on the Upper Limb in Persons With MS: an RCT

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: I-TRAVLE training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index <80), age > 18 years Exclusion Criteria: MS relapse or glucocorticosteroid treatment in the last month before the start of the study, upper limb paralysis (Motricity Index < 18), other sever limitations, influencing participation (cognitive, visual)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group (persons with MS)<br>no training | |
| Experimental: Experimental group (persons with MS)<br>Robot-assisted training | Other: I-TRAVLE training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motricity index | Random motor activity | 2.5 min (pre-post) | 
| Fugl-Meyer | Assessment of recovery of motor function | 30 min (pre-post) | 
| Action Research arm test | Grasp, grip, pinch, gross movement | 15-20 min (pre-post) | 
| Motor Activity log | perceived activities of daily life | 45 min (pre-post) | 
| Jamar handgrip strength | Handgrip strength | 2.5 min (pre-post) |
Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.

Official Title
-----------------
A Single Dose, Two-Treatment, Two-Period, Two Sequence Crossover Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fed Conditions

Conditions
-----------------
Dry Mouth

Intervention / Treatment
-----------------
* Drug: Pilocarpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Pilocarpine or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.

Study Overview
=================
Brief Summary
-----------------
Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year Study design:Prospective,Interventional (single arm study) Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis

Official Title
-----------------
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: Peg IFN 2b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU Exclusion Criteria: - HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peg IFN 2b<br>Peg IFN 2b 1.5mcg/kg once every week for 48 weeks. | Drug: Peg IFN 2b<br>* Peg IFN 2b 1.5mcg/kg once every week for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of HBsAg after 48 weeks of PEG IFN alpha |  | 48 weeks | 
| End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN |  | 48 weeks | 
| Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy |  | 1 year |
Impact of Early Renal Involvement on the Development of Severe In-hospital Renal Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes.

Official Title
-----------------
Impact of EArly Renal Involvement on the Developement of Severe In-hospital Renal Failure

Conditions
-----------------
Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure, Renal Insufficiency

Intervention / Treatment
-----------------
* Other: Early Renal Involvement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized, elevation in creatinine meeting definition Exclusion Criteria: CDK5, ESRD,solid organ transplant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Early renal involvement | Other: Early Renal Involvement<br>* Renal Consultation<br>|
| No Intervention: 2<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe renal Failure |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome morbidity mortality |  | hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Failure, Acute, Renal Insufficiency, Acute, Kidney Failure, Renal Insufficiency
General Surgery Training Outcomes Project

Study Overview
=================
Brief Summary
-----------------
The purpose of the General Surgery Training Outcomes Project: Evaluating the Impact of the Curriculum on General Surgery Resident Training and Evaluation is to analyze data collected as a normal course of the general surgery curriculum. The information collected is data readily available and routinely collected on all participants in the general surgery curriculum at NewYork Presbyterian Hospital/Columbia Campus. This information may lead to improvement in the general surgery curriculum.

Official Title
-----------------
General Surgery Training Outcomes Project: Evaluating the Impact of the Curriculum on General Surgery Resident Training and Evaluation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Participation in laparoscopic training curriculum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All general surgery interns and PGY2-5's at NewYork Hospital/Columbia

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Participation in laparoscopic training curriculum|General Surgery Training Outcome|

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
-----------------
laparoscopy, surgery, technical skills, outcomes, resident training
NTX-001 to Repair Peripheral Nerve Transection(s)

Study Overview
=================
Brief Summary
-----------------
The proposed use of NTX-001 for transections of peripheral nerves in the upper extremity for subjects that don't qualify for study NTx20201.

Detailed Description
-----------------
The proposed procedure would employ NTX-001 as a free functional muscle transfer to the upper extremity. This procedure is meant to restore the function of one or two joints in the upper extremity by bringing the gracilis muscle from the leg with its associated obturator nerve and its vascular pedicle. Most commonly, and in this case, as well, elbow flexion is the main function that is targeted for improvement. This is for a brachial plexus injury, and therefore we would be using an extraplexal nerve as a donor nerve to reinnervate the gracilis muscle. Most commonly, this is the spinal accessory nerve. The only proposed direct tension-free coaptation that would be subject to NTX-001 is the spinal accessory nerve to the obturator nerve. The benefit of this would be immediate reinnervation of the gracilis in the arm without a period of muscle atrophy that traditionally occurs with this operation. Usually, the first signs of any muscle contraction occur around 6 months when the patient tries to flex their elbow. With NTX-001, this may be significantly expedited with early return of function and result in greater muscle strength due to the prevention of muscle atrophy.

Official Title
-----------------
An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)

Conditions
-----------------
Peripheral Nerve Injury Upper Limb

Intervention / Treatment
-----------------
* Combination Product: NTX-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: The subject is between 16 and 80 years of age. The subject has clinical evidence of an acute peripheral nerve transection from conditions or interventions that have or may result in motor or sensory impairment amendable to surgical repair. Exclusion: Subjects whose nerve repair will occur greater than 48 hours after nerve transection. Subjects on chronic corticosteroid therapy within 14 days of repair. The subject is pregnant and/or is breastfeeding. The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: NTX-001|One-time use surgical product of three solutions and a device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?

Study Overview
=================
Brief Summary
-----------------
Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.

Detailed Description
-----------------
Bacteremia and thrombosis are the major complications of TCC used for hemodialysis.Instilation of CLS containing antibiotic-anticoagulant solution in the end of each dialysis session till the next dialysis ,can prevent Catheter related bacteremia (CRB).In previous study in our department, Taurolock-TM decreased the rate of CRB but increased the incidence of catheter malfunction. The aim of the study is to investigate the influence of of Heparin addition to CLS-Taurolock- TM ( Taurolidine &citrate 4%) in prevention of catheter patency problems in HD patients with TCC, in addition to CRB prevention. Methods : Patients with newly inserted TCC for HD enrolled and randomized to receive one of three CLS types : group 1- Taurolock-TM, Group 2 - Taurolock-TM and Heparin , Group 3- Heparin .Patients were followed for 6 monthes. The objective of the study is to investigate the effect of Taurolock TM with heparin on the rate of CRB and vascular patency.

Conditions
-----------------
End Stage Renal Disease, Hemodialysis

Intervention / Treatment
-----------------
* Other: Catheter Lock Solution Taurolidine and Citrate
* Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin
* Other: Catheter Lock Solution : Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis patients with new TCC Informed Consent
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Other: Catheter Lock Solution Taurolidine and Citrate<br> <br> |
| Experimental: B<br> | Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin<br> <br> |
| No Intervention: C<br> | Other: Catheter Lock Solution : Heparin<br> <br> |

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
-----------------
Tunneled Cuffed Catheter, Catheter Lock Solution, Catheter Related Bacteremia
Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study

Study Overview
=================
Brief Summary
-----------------
Introduction. Comprehensive data on infective endocarditis in developing countries are scarce. Objectives: Description of the characteristics (clinical and microbiological) and assessment of the outcomes of infective endocarditis in low-income countries. Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged over 1 year fulfilling the modified Duke criteria for infective endocarditis. Exclusion criteria: patient included during a previous infective endocarditis episode. Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access to antibiotic treatment (modalities and duration), hospital length of stay and reason for discharge, and cardiac surgery when indicated. Duration: One year (June 2014- June 2015)

Official Title
-----------------
Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study

Conditions
-----------------
Infective Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 1 year diagnosed with infective endocarditis according to the modified Duke criteria Exclusion Criteria: Already included for a previous episode of infective endocarditis (i.e., relapse or reinfection)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Mortality at 1 month follow-up |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 6 months follow-up |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infective endocarditis, Developing country, Global health, Cardiac surgery, Heart valve disease, Bacteremia
Needlescopic-assisted Uniportal vs Uniportal VATS

Study Overview
=================
Brief Summary
-----------------
The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.

Official Title
-----------------
Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study

Conditions
-----------------
Lung Cancer, Lung Cancer Metastatic, Bullous Disease Lung, Nodule Solitary Pulmonary, Mediastinal Tumor

Intervention / Treatment
-----------------
* Procedure: Thoracoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung or mediastinal disease requiring thoracoscopic surgery Exclusion Criteria: Thoracoscopic esophagectomy Decortication for empyema

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needlescopic-assisted<br>Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports. | Procedure: Thoracoscopic surgery<br>* Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.<br>|
| Active Comparator: Uniportal<br>Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision | Procedure: Thoracoscopic surgery<br>* Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale POD 3 | Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS) | 3 days | 
| Pain scale POD 5 | Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS) | 5 days | 
| Hospital stay | Post-operative hospital stay | 14 days | 
| Post-operative 3 month neuralgia | Out patient documented using PainDETECT questionnaire (PD-Q) | 3 months | 
| Post-operative 6 month neuralgia | Out patient documented using PainDETECT questionnaire (PD-Q) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | Total hospital cost | 14 days | 
| Surgical time | Time spend in surgery | 1 day | 
| Surgical bleeding | Blood loss during operation | 1 day | 
| Opioid using dosage | Total opioid equivalent dose used during post-operative course | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracoscopy, VATS, Needlescopy, Uniportal