linjc16/ctgov huggingface dataset:
Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy

Study Overview
=================
Brief Summary
-----------------
We intend to use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or suppression visible with functional MRI, and will not cause tissue damage.

Official Title
-----------------
LIFUP for Treatment of Temporal Lobe Epilepsy

Conditions
-----------------
Epilepsy, Temporal Lobe

Intervention / Treatment
-----------------
* Device: LIFUP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity. Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs. Subjects with epilepsy who would clearly benefit from surgical intervention. Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy. Exclusion Criteria: Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing. Subjects with dementia, delirium and psychotic symptoms. - Subjects with ferromagnetic materials in the head. Subjects with severe cardiac disease, increased intracranial pressure, or a TENS unit. Subjects who exhibit primary generalized seizures or pseudoseizures. Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease. Subjects who have experienced status epilepticus during the 3-week baseline period prior to the operation. Subjects (females) who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIFUP<br> | Device: LIFUP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of histological changes |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Symptom Inventory changes |  | 1 day | 
| Beck Depression Inventory changes |  | 1 day | 
| Neuropsychiatric changes |  | 1 day | 
| Neurological changes |  | 1 day | 
| Seizure frequency changes |  | 6 days |
Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus caused acute lung injury.

Detailed Description
-----------------
recruiting volunteers of H7N9 infection: age > 18; patients signed with the informed consent; APACHE II > 20 score patients infused with menstrual blood progenitor cells infusion dose: 1 10×10*7 cells/kg infusion frequency: 2 times a week, 2 weeks for infusion test items and standard spirits lifted; pulmonary function improved; lung image injury improved

Official Title
-----------------
Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients

Conditions
-----------------
Acute Lung Injury, Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure

Intervention / Treatment
-----------------
* Drug: Menstrual blood stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of H7N9 infection must be critical injured for lung tissues Exclusion Criteria: cancer diseases pregnancy mental disorder allergic constitution severe inflammation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menstrual blood stem cells<br>1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks. | Drug: Menstrual blood stem cells<br>* 10*7 cells/kg, intravenous injection for 4 times during two weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of lung injury |  | 14 days |
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.

Official Title
-----------------
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation (tDCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of tinnitus > 6 months Maximum loudness of tinnitus on the VAS ≥ 4 TFI score ≥ 25 Exclusion Criteria: Pregnancy Psychiatric disorders Pace maker or defibrillator Pulsatile tinnitus Acoustic Neurinoma CVA

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

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

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: TRT and real tDCS<br> | Device: transcranial direct current stimulation (tDCS)<br> <br> |
| Sham Comparator: TRT and sham tDCS<br> | Device: transcranial direct current stimulation (tDCS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index (TFI) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperacusis Questionnaire |  | 3 months | 
| Hospital Anxiety and depression Scale |  | 3 months | 
| Patient Global Impression of Change |  | 3 months | 
| Psychoacoustic measurements |  | 3 months | 
| Late Latency Evoked Potentials |  | 3 months | 
| Visual Analogue Scale of Loudness |  | 3 months |
Pharmacodynamic and Pharmacokinetic Study of PL-ASA

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose

Detailed Description
-----------------
This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.

Official Title
-----------------
A Randomized, Open-label, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of a Novel Pharmaceutical Lipid-aspirin Complex Formulation (PL-ASA) at an 81 mg Dose

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: PL-ASA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female non-smoking subjects between the ages of 18 to 75 years inclusive, without known medical conditions requiring treatment Consumes on average no more than 2 alcoholic drinks per day for 30 days prior to study Exclusion Criteria: Abnormal baseline laboratory results Current prescribed use of aspirin, warfarin or other anticoagulants Use of other specific medications within 2 weeks of study start History of certain medical conditions Subject's platelets are unresponsive to arachidonic acid, as defined as <60% of aggregation as measured by light transmittance aggregometry

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PL-ASA capsule, then EC-ASA tablet<br>PL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg | Drug: PL-ASA<br>* Pharmacologic profile of different aspirin formulations<br>* Other names: Enteric-coated Aspirin (EC-ASA);|
| Active Comparator: EC-ASA tablet, then PL-ASA capsule<br>EC-ASA tablet 81 mg, then crossover to PL-ASA capsule 81 mg | Drug: PL-ASA<br>* Pharmacologic profile of different aspirin formulations<br>* Other names: Enteric-coated Aspirin (EC-ASA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetylsalicylic acid and salicylic acid | Presence of serum acetylsalicylic acid and salicylic acid | 24 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light transmittance aggregometry | Effects on platelet function by light transmittance aggregometry | 24 hours after dosing |
A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population

Official Title
-----------------
A Single-centre, Open Label, Single-dose, Four Parallel Cohorts Study to Investigate the Pharmacokinetics, Safety and Tolerability of SB-649868 10mg in Healthy Female Non-childbearing Potential, Healthy Male and in Healthy Elderly Subjects

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: SB-649868


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Healthy adult and elderly female and male Female must be of non-childbearing potential Body weight =50 kg EXCLUSION CRITERIA: Abuse of alcohol or drugs Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication Smoking history of = 10 cigarettes a day in the last three months History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases Participation in clinical trial during the previous 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB649868<br>10 mg | Drug: SB-649868<br>* 10 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours |  | single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868 |  | within 7-14 days from a single dose of SB-649868 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
4 Parallel cohorts, Healthy Female, Healthy Elderly, Pharmacokinetic, Safety and Tolerability
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test

Study Overview
=================
Brief Summary
-----------------
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.

Detailed Description
-----------------
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.

Official Title
-----------------
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test

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

Intervention / Treatment
-----------------
* Diagnostic Test: Covid-19 test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process. Exclusion Criteria: Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 125 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 |
| --- | --- |
| Patients<br>Patients presenting to clinical sites for Covid-19 testing who are 2 years of age or older. | Diagnostic Test: Covid-19 test<br>* PCR Covid-19 test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covid-19 PCR test result | Molecular Covid-19 testing | 90 minutes |
Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to demonstrate that a continuous infusion of intravenous (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic levels of heparin in high-risk critically ill medical patients as compared with guideline recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used to demonstrate that Intravenous administration is more effective.

Official Title
-----------------
Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: intravenous continuous infusion of heparin (IV UFH)
* Drug: Subcutaneous Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to the medical ICU (MICU) High-risk for Venous Thromboembolism (VTE) ≥ 1 of the following: Body Mass Index (BMI) ≥ 30 kg/m2 Personal or family history of VTE Receiving vasopressors Exclusion Criteria: Indication for therapeutic anticoagulation Evidence of deep vein thrombosis (DVT) on ultrasonography at admission Indwelling intrathecal, epidural, or other indwelling deep catheters Recent (< 3 months) International Society of Thrombosis and Haemostasis (ISTH) major bleeding13 Recent (< 3 months) major trauma Recent (< 3 months) neurosurgery or orthopedic surgery Pregnancy Contraindication to heparin or heparin products

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous continuous infusion of heparin (IV UFH)<br>Heparin will be administered intravenously. | Drug: intravenous continuous infusion of heparin (IV UFH)<br> <br> |
| Active Comparator: Subcutaneous heparin<br>Heparin will be subcutaneously administered. | Drug: Subcutaneous Heparin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin |  | 3 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heparin
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

Study Overview
=================
Brief Summary
-----------------
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Official Title
-----------------
A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.

Conditions
-----------------
Epilepsy, Tonic-clonic

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a confirmed diagnosis of epilepsy. Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]). Male/female subjects (>= 16 years). Exclusion Criteria: - Need for an additional Antiepileptic Drug (AED).

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam<br>Subjects received open-label Levetiracetam. | Drug: Levetiracetam<br>* Pharmaceutical form: oral tablets Route of administration: Oral use<br>* Other names: Keppra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Participants With Treatment Emergent Adverse Events | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monotherapy, Epilepsy, Keppra, Levetiracetam
CAP Pilot Study for Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.

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

Intervention / Treatment
-----------------
* Other: CAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 21 to 75 years of age Diagnosed with OSA (AHI >5 events/hour) and eligible for Continuous Positive Airway Pressure (CPAP) treatment under local requirements Must be initiated on program (i.e. received their device) within 12 weeks of CPAP titration study Naïve to CPAP therapy, i.e have not been prescribed CPAP in the past Access to a cellphone Exclusion Criteria: Contraindicated for CPAP therapy Medically unstable condition/diagnosis that is not yet under control Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study) Periodic Leg MOvement Arousal Index greater than 15/hr Home titration of longer than 5 days

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Naive cohort<br> | Other: CAP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of delivery of SMS messages to participant | Cross check recieved messages logged in a diary by the participant to those sent by CAP | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant CPAP Adherence | Assess the adherence of participants to CPAP therapy while enrolled in CAP | 30 nights |