linjc16/ctgov huggingface dataset:
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Study Overview
=================
Brief Summary
-----------------
The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

Official Title
-----------------
Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis

Conditions
-----------------
Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Spinal Cord Injuries, Stroke, Lacunar, Stroke Brainstem, Cervical Spinal Cord Injury, Spinal Muscular Atrophy, Tetraplegic; Paralysis, Quadriplegia/Tetraplegia

Intervention / Treatment
-----------------
* Device: Motor Neuroprosthesis (MNP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe quadriparesis Able to give consent Appropriate candidate for neurointerventional procedure Able and willing to access all clinical testing and not impeded by geographical location Proficient in English Have a study partner Exclusion Criteria: Active condition resulting in immunosuppression Unsuitable for general anesthesia Anaphylactic allergy to contrast media Allergy to nickel History of pulmonary embolism History of recent deep vein thrombosis Psychiatric or psychological disorder No study partner or caregiver Unable to provide evidence of COVID vaccination

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single<br>Implantation of the motor neuroprosthesis medical device. | Device: Motor Neuroprosthesis (MNP)<br>* Type of implantable brain computer interface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Related Serious Adverse Events | Number of subjects with treatment-related adverse events | 12 months post implant |
Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cognitive function in patients undergoing cardiac surgery compared to control intervention.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: Remote Ischemic Preconditioning
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing heart surgery on cardiopulmonary bypass Exclusion Criteria: Emergency cases Myocardial infarction up to 7 days prior to enrollment Stroke up to 2 months prior to enrollment Ejection fraction less than 30% Previous psychiatric and neurological illness Inability to give informed consent

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIPC<br>Remote Ischemic Preconditioning | Procedure: Remote Ischemic Preconditioning<br>* RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to 200 mmHg (at least a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line).<br>|
| Placebo Comparator: CONTROL<br>Control | Other: Control<br>* Sham intervention with four 5-min cycles of inflation of the blood pressure cuff at 20 mmHg and 5 min deflation without any upper leg ischaemia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is postoperative neurocognitive dysfunction. |  | Preoperative, 1 week and 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study). |  | Within 24-48 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic Preconditioning, Cognitive function
Colchicine for Acute Coronary Syndromes

Study Overview
=================
Brief Summary
-----------------
Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.

Detailed Description
-----------------
Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.

Official Title
-----------------
Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.

Conditions
-----------------
Acute Coronary Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18years Acute coronary syndrome (unstable angina or acute myocardial infarction) Life expectancy> 2 years Absence of contraindications to colchicine Exclusion Criteria: Colchicine treatment for any cause Severe liver disease Renal insufficiency with creatinine>150mmol/l or creatinine clearance<30ml/min/1.73m2 Known cancer Chronic inflammatory bowel disease treatment with cyclosporine allergy or hypersensitivity to colchicine pregnancy or lactating woman or woman with childbearing potential without valid contraception

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: Colchicine<br>Colchicine 0.5mg once daily for 24 months | Drug: Colchicine<br>* 0.5mg once daily orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality, new acute coronary syndrome, and ischemic stroke. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome. | 24 months | 
| New acute coronary syndrome (unstable angina and myocardial infarction) |  | 24 months | 
| Ischemic Stroke |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, Colchicine
Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service?

Study Overview
=================
Brief Summary
-----------------
Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation

Official Title
-----------------
Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? Randomized Controlled Trial

Conditions
-----------------
Respiratory Physiotherapy, Resuscitation

Intervention / Treatment
-----------------
* Other: Study on patients with respiratory resuscitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult Major Patient over 18 years of age Patient affiliated to social security Exclusion Criteria: Sedate With restrictive or tracheotomized syndrome With rib fractures Not able to benefit from physiotherapy within 3 hours after the start of the weaning protocol Refusal of patient or family Physiotherapy contraindications Patient under tutorship or curatorship Pregnant women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient receiving respiratory physiotherapy<br> | Other: Study on patients with respiratory resuscitation<br>* Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult<br>|
| Other: Patient not receiving respiratory physiotherapy<br> | Other: Study on patients with respiratory resuscitation<br>* Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between initiation of weaning protocol and extubation. |  | 8 months |
Normal Ventilatory and Perfusion Pulmonary Function in TEMP

Study Overview
=================
Brief Summary
-----------------
Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity. In that context, it would be of interest to build statistical maps from registrered normal studies and propose a new methodology for normal SPECT delineation

Detailed Description
-----------------
Patients with normal VQ SPECT-CT will be analysed. After a image proccesing workflow including rigid registration, non rigid registration and normalization, a voxelized mean and standard deviation map will be created. Those maps will be analyzed in regards of physiology and litterature.

Official Title
-----------------
Normal Ventilatory and Perfusion Pulmonary Function in TEMP: Generation of 3D Statistical Maps From Normal Examinations

Conditions
-----------------
Patents With Normal VQ/SPECT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal perfusion and ventilation scans, and no parenchyma or pleural abnormality on low dose CT confirmation by a second senior physician Exclusion Criteria: Patients with history of pulmonary disease: chronic obstruction pulmonary disease, previous pulmonary embolism, surgery of the lungs radiotherapy of the lungs

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 |
| --- | --- | --- |
| Posterior to Anterior and Inferior to Superior uptake relative difference on parametric mean registered SPECT map versus non registered SPECT | parametric mean and standard deviation maps are build from elastic registration of normal lung V/Q SPECT-CT. A ROI based quantitative regional uptake comparison is performed to verify the influence of elastic registration on radiotracer distribution | through study completion, an average of 3 months |
Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.

Detailed Description
-----------------
In this study we will try to improve the outcome for children with stage II disease. It is hoped that we will be able to show that with early intervention correct early diagnosis the survival of these children is greatly improved. The collection of data in this observational study will allow us to show this improvement, by analysis of stage, treatment and outcome.

Official Title
-----------------
Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Other: OBSERVATIONAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral intraocular Retinoblastoma (RB) Unilateral extraocular intraorbital (RB) Bilateral intraocular (RB) bilateral intraocular (RB) on one side and extraocular but intraorbital on the other side. Exclusion Criteria: Externalized tumor mass massive extension to optic nerve up to optical channeltumor intracranial extension leptomeninges cerebral parenchyma extension to regional lymph nodes and/or remote metastases. cerebrospinal fluid involvement. Trilateral RB Incapacity to followed the whole treatement.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: OBSERVATIONAL|We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases with retinoblastoma in each participating hospital. | Evaluation of the number of cases registered . | 10 years | 
| Number of cases with stage 2 disease | Evaluation of the number of cases registered with stage 2 disease. | 10 years | 
| Feasibility of these therapeutic recommendations in an African setting | Evaluate the application of these therapeutic recommendations | 10 years | 
| Evaluating the treatment given. | Comparison of treatment given and recommended treatment. | 10 years | 
| follow up | analysis of the number of children alive or dead after treatment | 10 years |
Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of lofexidine in the treatment of opiate-dependent individuals.

Official Title
-----------------
Evaluation of Lofexidine for Treatment of Opiate Withdrawal

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Lofexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate withdrawal |  |  | 
| Adverse effect measures |  |  | 
| Craving of opiates |  |  | 
| Liking of opiates |  |  | 
| Efficacy of lofexidine |  |  | 
| Euphoria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid dependence
Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations. Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia

Official Title
-----------------
Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Iron Sucrose Injection
* Drug: Ferrous Bisglycinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age >38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study Exclusion Criteria: Severe anemia < 7 gm/dl. Women received iron therapy during pregnancy. Intolerance to iron preparations Anemia due to other causes Peripartum blood transfusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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 |
| --- | --- |
| Experimental: Intravenous iron<br>Women will receive iron sucrose (sacrofer ampules 100 mg/5ml) A patient's total body iron deficit will be calculated using the Ganzoni formula (total iron dose = [body weight (kilogram)× (15-actual Hemoglobin)] × 2.4 + 500 mg) then the total dose will be divided on 3 settings | Drug: Iron Sucrose Injection<br>* iron Intramuscular injections<br>|
| Active Comparator: Oral ferrous bis-glycinate<br>Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets | Drug: Ferrous Bisglycinate<br>* oral iron tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of patients achieving Hb rise 3 gm or more |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean rise of Hb from baseline to 6 weeks. |  | 6 weeks |
Non-Interventional F-Two Isoprostane Trial (NIFTI)

Study Overview
=================
Brief Summary
-----------------
Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do survive do not fully recover and are left with a varying degree of permanent disability. It is therefore imperative that new methods of early interventions be explored. One possible road to effective therapy is to examine the timing of secondary injury via a biological marker, to help guide the timing of treatment directed specifically at early oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention, possibly peaking within the first two hours after the initial injury. Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood, urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected over the first 5 days post-injury. Clinically-relevant patient progress, clinically required interventions, neuro-imaging results, and demographics will be tracked while the patient is hospitalized, with final neurological outcome measured at 3 months.

Official Title
-----------------
Non-Interventional F-Two Isoprostane Trial

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated age of 18 - 50 years Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation. Systolic blood pressure of >90 mm Hg Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center in Dallas, Texas Exclusion Criteria: Those in whom the time of injury is unknown Those with any 2 readings of systolic blood pressure of <90 prior to enrollment Those who are known to have legal Do Not Resuscitate (DNR) orders in place prior to enrollment. Those receiving CPR prior to enrollment Known incarcerated individuals Pulse ox reading of < 90 prior to enrollment Status epilepticus prior to enrollment Penetrating head trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Levels of oxidant injury in cerebrospinal fluid following severe traumatic brain injury | F2 Isoprostane levels in cerebrospinal fluid following severe traumatic brain injury | Up to 5 days |