linjc16/ctgov huggingface dataset:
Influences of Cane Use on Voluntary Forward Stepping Movement and Associated Attentional Demands in Hemiplegic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to examine the influence of cane use on the movement, kinetics, and associated attentional demands of performing a voluntary forward stepping movement in patients with stroke and age-matched healthy adults.

Official Title
-----------------
Influences of Cane Use on Voluntary Forward Stepping Movement and Associated Attentional Demands in Hemiplegic Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Age ang Sex are correspond with the stroke subjects(between 30 and 75 years old) being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital Stroke subjects between 30 and 75 years old stroke confirmed by ICD-10-CM (including I60, I61, I62, I63, I67, and I63.9) first stroke with single side hemiplegia and received acute treatment at NTUH being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital able to stand independently for 10 minutes and to forward step without ankle-foot orthosis Mini-Mental State Examination (MMSE) score at least 24 Excursion criteria: Healthy subjects having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those would influence the belance or motor ability Stroke subjects having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases those will influence standing ability other than stroke having hemi-neglect or hemi-anopia

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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
-----------------
Hemiplegia, Regular cane, Volitional stepping, Dynamic equilibrium, Attention, Dual task
Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula

Study Overview
=================
Brief Summary
-----------------
Comparison of automatic CPAP with fixed CPAP in patients with OSAS

Detailed Description
-----------------
The polysomnography is divided into two parts, randomly assigned: in one part, the patient uses the automatic CPAP device in titration mode in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula

Official Title
-----------------
Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: Comparison of automatic CPAP versus fixed CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with proven Obstructive Sleep Apnea Syndrome Apnea-hypopnea-index > 20/h Awaking index > 30/h Exclusion Criteria: Severe nasal obstruction Hypoventilation Excessive sleep fragmentation caused by non-respiratory factors COPD (FEV1/FVC < 65%) CPAP compliance < 3h per night Insufficient sleep time (< 2h TST) during one of both parts of the split night CPAP-titration Patients needing > 16 mbar CPAP pressures

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Comparison of automatic CPAP versus fixed CPAP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring |  |  | 
| Arousal index |  |  | 
| Pressure profile Auto-CPAP (P50, P95 en Pmax) |  |  | 
| All outcomes are measured during polysomnography |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability |  |  | 
| Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography |  |  |
Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

Study Overview
=================
Brief Summary
-----------------
In this study we aim to investigate whether a 3-month life-style intervention would reduce oxidative stress (OS) in semen in men of infertile couples attending IVF-treatment. Men with a DFI above 15% (SCSA method) are recruited for intervention with a 3-month follow-up. It is hypothesized that men who also have a OS above 1.34 using a novel OS diagnostic method (MiOXSYS) respond better to antioxidant treatment with a change in OS and DFI. The primary outcome is the change in OS following the intervention. Secondary outcomes are morphological semen parameters and DNA fragmentation index.

Official Title
-----------------
Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

Conditions
-----------------
Oligospermia

Intervention / Treatment
-----------------
* Dietary Supplement: Omega 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DFI>15 Attending IVF treatment for unknown or male factor infertility. Exclusion Criteria: Genetic diseases Azospermia

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All men with DFI >15 (SCSA method) are assigned to life-style intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>Diet, omega-3 fish oil (1g daily), CoQ10 (100 mg/day) and a normal Multi-vitamin, Smoking cessation, weight loss, exercise, | Dietary Supplement: Omega 3<br>* Omega 3: 1g daily for 3 months CoQ10: 100 mg daily for 3 months Multivitamin: 1 normal multivitamin tablet daily for 3 months<br>* Other names: Multi-vitamin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress | Oxidative stress as measured with MiOxysis (Ayto Bioscience inc). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen quality | Morphological semen parameters using WHO recommendation for semen analysis. | 3 months | 
| DNA fragmentation index | DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method) | 3 months |
Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal tolerated dose: MTD) that can be used in women with breast cancer.

Detailed Description
-----------------
3+3 step up design method will be used in this study.

Official Title
-----------------
Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Dietary Supplement: Tocotrienol-rich Fraction (TRF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with operable breast cancer Life expectancy of at least 3 months Adequate organ function No allergy to Vitamin E and TRF Provides consent to participate in trial and adhere to the study protocol Exclusion Criteria: Receiving concomitant chemotherapy, radiotherapy, hormonal, immune therapy or other investigational drugs Uncontrolled concurrent illness Pregnant / breast feeding women Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm intervention study 3+3 step up design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tocotrienol-rich Fraction (TRF)<br>Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level. | Dietary Supplement: Tocotrienol-rich Fraction (TRF)<br>* TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol<br>* Other names: Tocovid Suprabio;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Assessment | Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 | For 2 to 4 weeks during supplementation | 
| Liver Function Test | Liver enzymes with units of U/L | For 2 to 4 weeks during supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of TRF | Blood pharmacokinetic parameters | For 2 to 4 weeks during supplementation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MTD, TRF, Pharmacology
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.

Detailed Description
-----------------
Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.

Official Title
-----------------
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study

Conditions
-----------------
Crohn Disease, Fistula Perianal

Intervention / Treatment
-----------------
* Drug: Darvadstrocel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas Exclusion Criteria: rectovaginal fistulas rectal and/or anal stenosis active proctitis diverting stomas an abscess (<2cm) that was not drained at the fistula preperation visit

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with Crohn's disease and complex perianal fistula<br>14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study. | Drug: Darvadstrocel<br>* Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract<br>* Other names: Alofisel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula Closure | The study's primary endpoint was established at week 52 with clinically assessed fistula closure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of perianal disease | At every follow up visit the perianal disease was evaluated using the PDAI (Perianal disease activity index) | 1 year | 
| Evaluation of Crohn's disease | Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index) | 1 year |
Predictive Character Analysis of Ganglionic Echography for the Diagnostic of Benin or Malignant Superficial Adenopathy

Study Overview
=================
Brief Summary
-----------------
Investigators need to establish a formal diagnostic of superficial adenopathy through complementary investigations to find etiologic diagnostic ( Echography, adenogram). Echography examination should be a guide to take in charge the adenopathy and to predict presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of this study is to codify the management of adenopathic patient with a diagnostic in 48 hours after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting time in case of a serious pathology.

Official Title
-----------------
Analyse du caractère prédictif de l'échographie Ganglionnaire Pour le Diagnostic de bégninité ou malignité d'Une adénopathie Superficielle

Conditions
-----------------
Superficial Adenopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - superficial adenopathy Exclusion Criteria: - obvious adenopathy

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 |
| --- | --- | --- |
| Parameter of echography | The benign or malignant nature of adenopathy (or lymphadenopathy) confirmed by adenogram results +/- lymph node biopsy (as the gold standard) | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
superficial adenopathy - echography
Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.

Detailed Description
-----------------
Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.

Official Title
-----------------
Supplementation Efficacy Comparing the Oral Nano and Conventional Vitamin D in Inflammatory Bowel Disease

Conditions
-----------------
Vitamin D Substitution

Intervention / Treatment
-----------------
* Drug: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inflammatory bowel disease patients Exclusion Criteria: Liver and renal disease Hypercalcemia Hyperparathyreoidism Chronic pancreatitis Concomitant vitamin D medication Pregnancy Sarcoidosis Malignancy Inability to obtain valid data from subject

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NanoVitD<br>Oral nano form of the calciferol | Drug: Vitamin D<br>* cholecalciferol<br>|
| Active Comparator: ConvVitD<br>Conventional oral calciferol | Drug: Vitamin D<br>* cholecalciferol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D (25OHD) blood level | Change of the D vitamin level after follow-up interval | 4 months |
A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.

Detailed Description
-----------------
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.

Official Title
-----------------
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia

Conditions
-----------------
Dystonia

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation (DBS) of Gpi
* Device: Deep Brain Stimulation (DBS) of STN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is aged 18 to 75 years old, male or female. Diagnosed with cervical dystonia by a movement disorders neurologist. Has cervical dystonia alone, not generalized or multifocal. Has had adequate trials of medical therapy. Exclusion Criteria: Cognitive impairment. Abnormalities on pre-operative magnetic resonance imaging (MRI). Medical conditions precluding general anaesthetic or surgery. Unstable psychiatric disease. Previous brain lesions to treat cervical dystonia. Attended some other trials within three month.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep Brain Stimulation<br>Stimulation is on | Device: Deep Brain Stimulation (DBS) of Gpi<br> <br> * Other names: Rechargeable Neurostimulator;Device: Deep Brain Stimulation (DBS) of STN<br> <br> * Other names: Rechargeable Neurostimulator;|
| Sham Comparator: Placebo<br>Stimulation is off | Device: Deep Brain Stimulation (DBS) of Gpi<br> <br> * Other names: Rechargeable Neurostimulator;Device: Deep Brain Stimulation (DBS) of STN<br> <br> * Other names: Rechargeable Neurostimulator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burke-Fahn-Marsden Scale (BFM) |  | Change from baseline in BMF at 1, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (SF-36) |  | Change from baseline in SF-36 at 1, 3 months and 6 months | 
| Psychiatric assessment (HADS-D and PANSS) |  | Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months |
Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to see if the heart-lung machine involved in cardiac surgery increases the movement of activated white blood cells from the bloodstream into the patient's tissues and also to see if aprotinin usage during surgery reduces this effect.

Detailed Description
-----------------
It has long been known that exposure of blood to the heart-lung bypass machine can trigger a whole-body inflammatory response in cardiac surgery patients that is linked to activation of circulating white blood cells. The investigators propose to use a technique to track the movement of white blood cells into the skin of patients during bypass surgery. The skin blisters will be elicited by application of the blistering agent cantharidin to the forearm of volunteer patients. This will allow the investigators to study the activation state of white blood cells that enter tissues during bypass surgery and to determine whether aprotinin has any beneficial effect with regards to inflammatory status of these cells. The investigators propose that white blood cell trafficking into the blisters will increase following the use of the heart-lung machine and that the effect of aprotinin will be to ablate this.

Official Title
-----------------
Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Conditions
-----------------
Ischemic Heart Disease, Angina Pectoris

Intervention / Treatment
-----------------
* Drug: Aprotinin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary elective coronary artery bypass surgery Exclusion Criteria: Emergent, urgent or re-do surgery Patients on oral corticosteroid medication Patients on aspirin therapy < 7 days prior to operation

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary, Surgery, leukocyte, inflammation, Coronary Artery Bypass Grafting