linjc16/ctgov huggingface dataset:
The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk factors for neuropathic pain development and chronification in painless and chronic pain patients.

Official Title
-----------------
DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain

Conditions
-----------------
Neuropathic Pain, Polyneuropathy, Peripheral Nerve Injury

Intervention / Treatment
-----------------
* Other: QST, Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic peripheral neuropathic pain or Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced) Exclusion Criteria: Minors

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 |
| --- | --- |
| Cross-sectional cohort<br>Patients with chronic peripheral neuropathic pain | Other: QST, Questionnaires<br>* Assessment of sensory phenotype by QST and questionnaires<br>|
| Longitudinal cohort<br>Painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, Operation) | Other: QST, Questionnaires<br>* Assessment of sensory phenotype by QST and questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Somatosensory phenotype detected by quantitative sensory testing (QST) | The somatosensory phenotype will be assessed by quantitative sensory testing (QST) once at baseline | Single assessment at baseline (cross-sectional study). Report of complete cohort data at study completion | 
| Change of neuropathic pain: Development and chronification of neuropathic pain detected by DN4 questionnaire | Assessment with DN4 pain questionnaire | Assessment of change of neuropathic pain from baseline and 6 months after study enrollment (longitudinal study). Report of complete cohort data at study completion. |
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if pyridostigmine bromide improves heart rate variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.

Detailed Description
-----------------
The reduced heart rate variability is associated with increased risk of death in patients with diabetes mellitus. Cholinesterase inhibition with pyridostigmine bromide increases heart rate variability in normal individuals and congestive heart failure subjects but its effects on patients with diabetes mellitus is unknown. Based on those evidences, we will test if the short-term administration of pyridostigmine bromide increases heart rate variability in patients with diabetes mellitus.

Official Title
-----------------
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy

Conditions
-----------------
Diabetes Complications

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus Exclusion Criteria: myocardial infarction acute ischemic syndromes second or third degree atrioventricular block active alcoholism thyroid dysfunction chronic obstructive pulmonary disease history of intolerance to pyridostigmine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pyridostigmine<br> | Drug: Pyridostigmine<br>* Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.<br>|
| Placebo Comparator: Placebo<br>If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day. | Drug: Placebo<br>* If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autonomic modulation assessed by heart rate variability |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pyridostigmine, autonomic modulation, diabetes mellitus, heart rate variability
eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation (AF) is the most common arrhythmia in western countries and causes of up to one quarter of ischemic strokes. The randomized eHealth-based Bavarian Alternative Detection of Atrial Fibrillation study (eBRAVE-AF) tests the efficacy of an e-health based strategy for the detection of AF. The e-health-based strategy consists of a smartphone-based photophlethysmographic (PPG) screening and an ECG-based validation.

Official Title
-----------------
eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Diagnostic Test: e-Health based strategy: PPG-based screening using a smartphone and ECG patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: policy holders of a large health insurance company age ≥50 years CHA2DS2-VASc ≥1 (females ≥2) Exclusion Criteria: atrial fibrillation oral anticoagulation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>e-health-based strategy | Diagnostic Test: e-Health based strategy: PPG-based screening using a smartphone and ECG patch<br>* PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch<br>|
| No Intervention: control group<br>symptom based AF-screening | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with newly diagnosed atrial fibrillation |  | 6 months | 
| Number of participants with newly prescribed oral anticoagulation |  | 6 months | 
| Number of participants with stroke |  | 6 months | 
| Number of participants with thromboembolic events |  | 6 months |
Effects of Early Exercise in Patients With Moderate to Severe Stroke.

Study Overview
=================
Brief Summary
-----------------
Purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability. Methods: Patients with medium to severe stroke (NHISS >7) were recruited 24 - 48 hours after stroke onset from two stroke units in Sweden. Both groups received usual care. The intervention group received even 20 minutes bed-cycling 5 days per week with a maximum of 15 sessions. Functional outcome was measured with modified Rankin Scale (mRS) and Barthel index and walking with the 6-minute walking test (6MWT). Measurements were performed pre- and post-intervention (3 weeks), and at 3-months follow-up.

Official Title
-----------------
Effects of Early Exercise in Patients With Moderate to Severe Stroke - a Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age over 18 years. Diagnose stroke with The National Institutes of Health Stroke Scale (NIHSS) 7-42 points. Ability to understand the Swedish language. Approval of medical responsible physician to participate in the study. Exclusion criteria: • Medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.

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
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Usual care and bedcycling. | Other: Exercise<br>* Bedcycling<br>|
| No Intervention: Control group<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Rankin Scale (mRS) | Functional Outcome | Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Barthel ADL-Index | ADL | Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline. | 
| Change in 6-Minutes Walking test (6MWT) | Walking Ability | Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Rehabilitation, Exercise, Bedcycling
Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation

Study Overview
=================
Brief Summary
-----------------
To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group

Official Title
-----------------
Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation

Conditions
-----------------
Frozen Shoulder,, Shoulder Pain

Intervention / Treatment
-----------------
* Other: evaluations
* Procedure: Protocol of physiotherapy exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be diagnosed with unilateral breast cancer; be submitted to surgical and radiation treatment as part of the treatment for breast cancer. Exclusion Criteria: patients with neurological or orthopedic diseases that could impair the upper limb movements bilateral breast cancer; prior thoracic radiotherapy; presence of distant metastasis.

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

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

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 |
| --- | --- |
| Other: Control Group (CG)<br>Control Group, which were subjected only to evaluations and to no exercise | Other: evaluations<br>* Only evaluations<br>|
| Experimental: Study Group (SG)<br>Study group (SG), was oriented to perform domiciliary exercises for the upper limbs. | Procedure: Protocol of physiotherapy exercises<br>* Oriented domiciliary physiotherapeutic exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer,, radiotherapy,, physical therapy,, upper limb
The Dynamics of Human Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.

Official Title
-----------------
The Dynamics of Human Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Atrial Tachyarrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (AF) after having failed >or= 1 anti-arrhythmic drug.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Survival Free of Atrial Fibrillation | Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds. | 6 -12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Termination or Slowing of Atrial Fibrillation During Ablation | Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus. | acute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ablation, Atrial Fibrillation
Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.

Official Title
-----------------
Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery

Conditions
-----------------
Vitrectomy

Intervention / Treatment
-----------------
* Drug: Triamcinolone Acetonide Injectable Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patients under 18. Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease. Other protocol-defined exclusion criteria may apply.

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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triamcinolone<br>Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal. | Drug: Triamcinolone Acetonide Injectable Suspension<br>* Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Visualization Score at Post-Instillation from Pre-Instillation | A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by Not Visible (0) and Clearly Delineated (4). The mean difference was calculated, and a higher number indicated increased visibility. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitrectomy, Visualization
Functional Prognosis in Patients With Ischemic Stroke According to the Therapeutic Strategy Used

Study Overview
=================
Brief Summary
-----------------
The current management of ischemic stroke is based on different strategies that may be combined: intravenous thrombolysis in a stroke ICU, intravenous thrombolysis in a telemedicine procedure, endovascular thrombectomy. Given this now rich therapeutic arsenal, it seems necessary to evaluate practices in local care in the field and the impact of these on the prognosis of ischemic stroke victims. The aim of this observational study is to compare these different care practices without interfering with the choice of strategy. A blood sample will also be taken at different times to study the value of growth differentiation factors (GDF) 8, 11 and 15, and Brain-derived Neurotrophic Factor as prognostic biomarkers

Official Title
-----------------
Prognosis After Revascularization Therapy in the Dijon Ischemic Stroke Evaluation Study

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Biological: prise de sang
* Other: quality of life questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic ischemic stroke defined according to WHO criteria and treated by intravenous thrombolysis at the stroke ICU at Dijon CHU, intravenous thrombolysis by telemedicine with subsequent transfer to the Dijon stroke ICU, and/or endovascular thrombectomy at Dijon CHU) Patients aged over 18 years. Patients who have provided written informed consent to take part in the study. Exclusion Criteria: Patients who refuse to take part in the study. Subjects in custody. Patients (or a person of trust) who cannot be contacted by telephone during the follow-up.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ischemic stroke patients<br> | Biological: prise de sang<br> <br> Other: quality of life questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of handicap |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of biomarkers of stress |  | Changes compared with baseline levels at Day 1, Day 3, Day 7 |
Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.

Official Title
-----------------
A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Bicalutamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate gland Patients with advanced prostate cancer Adult male over the age of 18 years old Normal liver function (AST < 2 x Upper Limit Normal) Exclusion Criteria: ECOG performance status of 4. Previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg Casodex<br> | Drug: Bicalutamide<br>* 200mg daily<br>* Other names: Casodex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of patients treated with a 200 mg daily dose of CASODEX |  | every three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety