linjc16/ctgov huggingface dataset:
Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop simple diagnostic screeningtests and investigate potential biomarkers for identifying patients with abnormalities of mitochondrial function, which also can be used as outcome measures in future clinical trials. The study will investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with mitochondrial myopathy.

Official Title
-----------------
Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies

Conditions
-----------------
Mitochondrial Myopathies, Healthy Controls

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic screenings tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-75 verified mitochondrial myopathy or healthy control or disease control (another neuromuscular disease) Exclusion Criteria: Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements. Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments. Pregnancy or breastfeeding.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mitochondrial myopathy<br> | Diagnostic Test: Diagnostic screenings tests<br>* Handgrip test, 12-minute walk test and 6-minute walk test. Biomarkers: acyl-carnitine profile and GDF-15.<br>|
| Healthy controls<br> | Diagnostic Test: Diagnostic screenings tests<br>* Handgrip test, 12-minute walk test and 6-minute walk test. Biomarkers: acyl-carnitine profile and GDF-15.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lactate / pyruvate ratio | Changes between: before, during and after submaximal exercise | 1 hour | 
| Serum Acyl-carnitine levels | Changes between: before and after exercise, fasted and fed. | 1 hour | 
| Serum GDF-15 | Changes between: before and after exercise, fasted and fed. | 1 hour |
Assessment of Food Intake in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Food provision and consumption were assessed for all hospitalized patients over a 24h-period survey. This study is a part of a control quality programme and is performed every 4 years since 1999.

Detailed Description
-----------------
During one day, a team of dieticians assessed food provided, consumed and reasons for non-consumption in all hospitalized patients receiving 3 meals/day. Oral nutritional supplements, supplemental enteral and parenteral nutrition were taken into account. Nutritional needs were calculated according to the ESPEN recommendations. Amount of energy and proteins provided and consumed were calculated using the nutrient analysis software Winrest (FSI, Noisy-le-grand, France). In 2012, the presence of healthcare-associated infections was recorded during this study.

Official Title
-----------------
Assessment of Food Intake in Hospitalized Patients: A Prospective Hospital Survey

Conditions
-----------------
Undernutrition

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All hospitalized patients Exclusion Criteria: Exclusive enteral or parenteral nutrition Patients who do not receive three meals

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 |
| --- | --- |
| hospitalized patients<br> | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital food provided, consumed and wasted measured in energy (kcal) and gram of proteins |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of underfed patients |  | 24 hours | 
| Hospital meal quality assessed by questionnaire |  | 24 hours | 
| Presence of healthcare-associated infections |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutritional assessment, food survey, hospitalized patients, hospital food
EEG Motor Movement and Imagery Dataset for Stroke

Study Overview
=================
Brief Summary
-----------------
The investigators collect and analyze the alpha and beta wave of EEG activity at the motor cortices of the participants, When the motor task is being performed. The Brodmann area 10-20 method and portable EEG equipment was used in the single-center study.

Detailed Description
-----------------
To understand the motor mechanism of stroke patients with motor dysfunction, an EEG motor movement and imagery dataset for Stroke will be created. 120 subjects will be enrolled in the single-center study. The investigators collect and analyze the EEG activity at the motor cortices of the participants, When the motor movement or imagery task is being performed. The alpha and beta wave of EEGs were recorded from 32 electrodes as per the international 10-20 system with portable EEG equipment.

Official Title
-----------------
Construction of Non-invasive EEG Motor Movement and Imagery Dataset for Stroke

Conditions
-----------------
Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of cerebral infarction conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018, and the diagnosis of intracerebral hemorrhage conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of intracerebral hemorrhage 2019. First onset. Age ≥ 18 years old. Motor dysfunction of upper and / or lower limbs: muscle strength decreased by 0 to 5-grade and / or ataxia. Informed consent has been signed. Exclusion Criteria: Vital signs are unstable. Serious circulatory system, respiratory system, motor system and other diseases, such as atrial fibrillation, heart failure, pulmonary infection, severe liver and kidney insufficiency, lower extremity venous thrombosis and other serious diseases. Functional impairment of upper or lower limbs caused by other diseases of nervous system or other reasons, such as fracture, deformity, etc. Unable to cooperate to complete the examination, such as mental disorder, cognitive impairment, visual impairment, sitting balance disorder, etc Other reasons: alcoholism; Skull defect; Head skin defect, etc.

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 |
| --- | --- | --- |
| EEG characteristics of motor | EEG Characteristics for Motor Execution and Motor Imagery | 1-7day | 
| Action Research Arm Test | Use the assessment scale of Action Research Arm Test evaluation completes the limb function evaluation | 1-7days | 
| Fugl-meyer Assessment | Use the assessment scale of Fuel-meyer to evaluate completes the limb function evaluation | 1-7days |
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine

Study Overview
=================
Brief Summary
-----------------
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.

Official Title
-----------------
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Fluviral®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female adults, 18 years of age and older. Female subject of non-childbearing potential. Written informed consent obtained from subject. Exclusion Criteria: Acute disease at the time of enrollment. Blood pressure abnormalities. Any immunosuppressive condition, such as HIV or cancer. Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus. Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment. Any demyelinating disease, including Guillain-Barré syndrome. Alcohol consumption and/or drug abuse. Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment. Any known or suspected allergy to the Fluviral vaccine.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fluviral®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older |  | 21 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety & reactogenicity: Solicited AEs |  | 4 days | 
| Evaluate safety & reactogenicity: Unsolicited AEs |  | 21 days | 
| Evaluate safety & reactogenicity: SAEs |  | entire study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza
OPALS Cardiac Arrest Database (OCAD)

Study Overview
=================
Brief Summary
-----------------
To provide the infrastructure to answer prehospital research questions posed by scientists at academic health science centers and policy makers at multiple levels of government.

Detailed Description
-----------------
To provide the infrastructure to answer prehospital research questions posed by scientists at academic health science centers and policy makers at multiple levels of government

Official Title
-----------------
Ontario Prehospital Advanced Life Support (OPALS) Study Cardiac Arrest Database

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 16 years and above Exclusion Criteria: under 16 yrs

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Arrest
A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

Study Overview
=================
Brief Summary
-----------------
COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.

Official Title
-----------------
A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

Conditions
-----------------
COPD, Exacerbation

Intervention / Treatment
-----------------
* Drug: mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEV1 > 35% predicted COPD Exacerbation Inpatient Exclusion Criteria: Pneumonia CO2 retention

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: mannitol<br>* 400mg BD for 2 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 2 days |
Collection of Clinical Specimens From Volunteers for Assay Development

Study Overview
=================
Brief Summary
-----------------
This study will analyze gene expression data from various biological specimens collected from voluntary participants.

Detailed Description
-----------------
Primary objective is the collection of specimens from volunteers for the development and validation of HostDx tests. The study does only encompass specimen collection - Therefore, no traditional endpoint is defined but rather the successful collection of clinical specimens is defined as the endpoint.

Official Title
-----------------
Collection of Clinical Specimens From Volunteers for Assay Development

Conditions
-----------------
Acute Respiratory Infection

Intervention / Treatment
-----------------
* Diagnostic Test: HostDx Fever Test
* Diagnostic Test: HostDx Sepsis Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or greater Able to provide informed consent Exclusion Criteria: Known pregnancy Inability to understand instructions and comply with study related procedures

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HostDx Fever Test|HostDx Fever test to distinguish between viral and bacterial infections|
|Diagnostic Test: HostDx Sepsis Test|HostDx Fever test to determine the severity of a presented, suspected infection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests | Blood collection, upper respiratory specimens including. nasal swabs, nasal washes, nasopharyngeal swabs, buccal swabs, buccal washes), sputum, saliva, urine and a skin/soft-tissue specimen (dermal). | 1 Day |
A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center

Study Overview
=================
Brief Summary
-----------------
A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center

Official Title
-----------------
A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center(START-CHC)

Conditions
-----------------
Lipoprotein Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The informed consent form (ICF) should be signed before conducting any research-related operations Age ≥18 years Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded Exclusion Criteria: 1.Patients with well-diagnosed atherosclerotic cardiovascular disease (ASCVD) 2. Have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. The patient is currently participating in any other clinical trial except this study -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 diagnosed with hypertension or diabetes<br>Age ≥18 years; Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months; The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary outcome | To evaluate the blood lipid levels and current status of drug treatment in patients with CHC hypertension and/or type 2 diabetes Describe the characteristics of blood lipid treatment in patients with CHC with hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L | 2022.12.01 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary outcome | To evaluate the ASCVD risk stratification and the level of blood lipids in patients with CHC hypertension and/or type 2 diabetes. Evaluate the blood lipid level of patients with hypertension and/or type 2 diabetes in CHC with LDL-C between 2.6 and 4.1mmol/L (LDL-C/Non-HDL) To explore the compliance of patients with CHC hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L for lipid-lowering therapy. | 2022.12.01 |
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.

Official Title
-----------------
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: EPI-743 400mg
* Drug: EPI-743 200mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson's disease Age 40 - 75 Ambulatory with or without assistance Hoehn and Yahr Scale score of 1 - 3 Patient able to consent and comply with protocol requirements Abstention from use of Coenzyme Q10, vitamin E, Azilect and Idebenone two weeks prior to enrollment and during course of treatment with EPI-743 Exclusion Criteria: Allergy to EPI-743 or sesame oil Allergy to vitamin E Clinical history of bleeding or abnormal baseline PT/PTT Diagnosis of any other neurologic disease Malignancy within past two years Pregnant or plans to become pregnant Concomitant ophthalmologic disease History of stroke History of brain surgery Inability to undergo MRI scan or MRS Hepatic insufficiency with LFTs greater than two times upper limit of normal Renal insufficiency requiring dialysis End stage cardiac failure Fat malabsorption syndromes precluding drug absorption Use of anticoagulant medications, azilect

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EPI-743 400mg<br>EPI-743 at a dose of 400 mg three times daily | Drug: EPI-743 400mg<br> <br> |
| Active Comparator: EPI-743 200mg<br>EPI-743 at a dose of 200 mg three times daily | Drug: EPI-743 200mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual function | electroretinogram and color vision | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic function | UPDRS subscales | 3 months | 
| Motor function | UPDRS subscales | 3 months | 
| Brain metabolites | Magnetic Resonance spectroscopy (MRS) | 3 months | 
| Cognitive function | Montreal Cognitive Assessment (MoCA) | 3 months | 
| Mood | Beck Depression Inventory (BDI) | 3 months | 
| Disease biomarkers | Blood biomarker levels | 3 months | 
| Safety | Number of adverse events | 3 months |