linjc16/ctgov huggingface dataset:
Effect of Pulse Width With Spinal Cord Stimulation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.

Detailed Description
-----------------
This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data. Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.

Official Title
-----------------
The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation

Conditions
-----------------
Pain, Chronic Pain, Back Pain

Intervention / Treatment
-----------------
* Device: Precision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain. Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment. Be 18 years of age or older. Be willing and able to comply with all study related procedures and visits. Be capable of reading and understanding patient information materials and giving written informed consent. Exclusion Criteria: Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. Have any other chronic pain condition likely to confound evaluation of study endpoints.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Precision|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) | Pain severity as measured by NRS quantifies pain, where 0 is no pain and 10 is worst pain imaginable | Within 6 months post-implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Neurostimulation, Back pain, Chronic Pain
Characteristic of Play: Comparison Between Children With Development Coordination Disorder ( DCD) and Children With Typical Development

Study Overview
=================
Brief Summary
-----------------
There will be found differences in the issue of characteristic of play between Children with Development Coordination Disorder and Children with Typical Development.

Conditions
-----------------
Development Coordination Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with proper( age expected) intelligence and IQ level Study in regular education system The DCD diagnosis must be confirmed by a pediatrician Exclusion Criteria: Score above 9 in the Movement Assessment Battery test for Children Score below 3.83 in Children Activity Scale for Parents routinely take medication any physical limitations neurologic and/or muscle disease any significant hearing and/ or vision limitations

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with DCD and Typical Development<br> | |
| Children with DCD<br>2 groups Children with DCD and Typical Development | |

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
-----------------
Characteristic of play, DCD, children, Typical Development, Whether there are any differences in the issue of Characteristic of play between Children with DCD and Children with Typical Development
Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Official Title
-----------------
Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL

Conditions
-----------------
Chronic Lymphocytic Leukemia, Richter Syndrome

Intervention / Treatment
-----------------
* Drug: Umbralisib
* Biological: ublituximab
* Biological: TG-1501


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation Refractory to or relapsed after at least 1 prior treatment regimen Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: Any major surgery, chemotherapy or immunotherapy within the last 14 days Known hepatitis B virus, hepatitis C virus or HIV infection Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TG-1501 + Ublituximab + Umbralisib<br>Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals | Drug: Umbralisib<br>* A once daily oral agent<br>* Other names: TGR-1202;Biological: ublituximab<br>* IV anti-CD20 monoclonal antibody<br>* Other names: TG-1101;Biological: TG-1501<br>* IV immunotherapy for cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Acceptable Adverse Events That Are Related to Treatment | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities | 6 months of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy | Up to 1 year |
Noninvasive Brain Stimulation for Stroke

Study Overview
=================
Brief Summary
-----------------
Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.

Detailed Description
-----------------
Noninvasive brain stimulations (NIBS) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ... NIBS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after NIBS, as well as brain functional imaging data.

Official Title
-----------------
Noninvasive Brain Stimulation for Stroke Improvement

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

Intervention / Treatment
-----------------
* Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke with at least slight deficit Exclusion Criteria: epilepsy contraindication to tDCS and/or to fMRI presence of metal in the head unability to understand / complete behavioural tasks chronic intake of alcohol or recreative drugs major health condition presence of pacemaker pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real stimulation<br>real NIBS | Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)<br>* transcranial direct current stimulation<br>|
| Sham Comparator: Sham stimulation<br>sham NIBS | Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)<br>* transcranial direct current stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in function before/after tDCS | any brain function impaired by stroke | Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in neuroimaging and neurophysiological before/after tDCS | noninvasive neuroimaging : brain activity studied by means of fMRI noninvasive neurophysiological measure : TMS, EEG,evoked potentials, EMG | Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke
Honey and Nigella Sativa in COVID-19 Prophylaxis

Study Overview
=================
Brief Summary
-----------------
Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis

Official Title
-----------------
Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Honey
* Drug: Nigella sativa seed
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care professionals Post-exposure COVID-19 Exclusion Criteria: Multi-organ failure active COVID-19

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Honey and Nigella sativa Arm<br>0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds | Drug: Honey<br>* 0.5 gm/Kg/day honey<br>Drug: Nigella sativa seed<br>* 40 mg/Kg/day<br>|
| Placebo Comparator: Placebo Arm<br>empty capsule with sugar water | Other: Placebo<br>* empty capsule with sugar water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 infection rate | RT-PCR SARS-CoV-2 | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Honey, Nigella sativa, Prophylaxis, COVID-19, Prophetic Medicine
European Postgraduate Training in Geriatric Medicine

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to give a structured update on geriatric postgraduate education throughout Europe. The study will be performed as a cross-sectional structured quantitative online survey with qualitative comments. The survey content covers structural items, content and educational aspects of geriatric specialty training in European countries.

Detailed Description
-----------------
The study is performed as a cross-sectional structured quantitative survey leaving space for qualitative comments. The survey content covers structural items, content and educational aspects of geriatric specialty training in European countries. To prove feasibility in the questionnaire setting and time management the survey will be piloted in five international experts in geriatric medicine. Questions in the survey are closed with the possibility to give a free comment.Validity of individual data collection will be controlled by repeated hidden content within different questions. Experts in the field of geriatric medicine and members of one of the organizations European Union of Medical Specialists (UEMS), European Academy for the Medicine of Ageing (EAMA) or European Union Geriatric Medicine Society (EUGMS) and a strong personal focus of interest in postgraduate training are contacted by the survey coordinator and invited to participate in the survey personally and via E-mail. The survey will be performed online using the following software (http://www.surveyxact.com/) . To reassure data quality, the survey will be sent for double checks within nations.

Official Title
-----------------
European Postgraduate Training in Geriatric Medicine

Conditions
-----------------
Education, Geriatrics

Intervention / Treatment
-----------------
* Other: Online Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experts in geriatric medicine and member of one of the organizations European Union of Medical Specialists (UEMS), European Academy for the Medicine of Ageing (EAMA) or European Union Geriatric Medicine Society (EUGMS). Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Online Survey|Online questionaire submitted to experts in geriatrics in different European countries. 12-item survey.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| situation of geriatric postgraduate education | Evaluate a structured update on geriatric postgraduate education throughout Europe in order to assess the need for further developments in geriatric postgraduate education. | until June 2014 |
Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

Study Overview
=================
Brief Summary
-----------------
Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

Detailed Description
-----------------
Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

Official Title
-----------------
Randomized Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

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

Intervention / Treatment
-----------------
* Biological: Pandemrix® (H1N1 pandemic influenza)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-64 Both genders Healthy Exclusion Criteria: Under 18 or above 64 Not healthy

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

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

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

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

| Intervention/Treatment |
| --- |
|Biological: Pandemrix® (H1N1 pandemic influenza)|vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody levels |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation

Study Overview
=================
Brief Summary
-----------------
The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is 4 to 22% failure. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. Some risk factors are well defined in the literature as the duration of intubation, ENT and neurological history, the persistence of a respiratory disease, a high level of sedation. Other factors are more controversial as age, ventilatory parameters just before extubation before extubation blood gases, the interest of a leak test. Also pediatric populations are extremely heterogeneous, so the investigators would like to highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support these high-risk children.

Conditions
-----------------
Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened. Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes. Exclusion Criteria: Refusal to participate in the study

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Failure of extubation |  | need for a new intubation within the first 48 hours after extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extubation, pediatric resuscitation, reintubation, failures of extubation., Respiratory Insufficiency
Gastric Cancer Metastasized to the Central Nervous System (CNS)

Study Overview
=================
Brief Summary
-----------------
Descriptive registry to investigate frequency of HER-2 positive gastric cancer involving CNS. Exploration of additional prognostic factors for brain involvement from gastric cancer.

Detailed Description
-----------------
HER2 Status E-Cadherin Status

Official Title
-----------------
Registry of Gastric Cancer and Brain Metastases

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: in order to be eligible for the study, the diagnosis of gastric cancer and/or lower esophageal cancer must be confirmed histologically. CNS involvement must be confirmed either via independent neuroradiological and/or positive CSF cytology. Exclusion criteria: Patients whose diagnosis is not confirmed upon pathological review or where the CNS involvement cannot be confirmed after neuroradiological review will be excluded from 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 |
| --- | --- | --- |
| HER2 Status | Determination of HER2 Status on Tumor Tissue | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome according to HER2 Status |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central nervous system, pathological markers