linjc16/ctgov huggingface dataset:
Cerliponase Alfa Observational Study in the US

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, observational study for patients with a confirmed diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as TPP1 deficiency, who intend to be or are currently being treated with cerliponase alfa. Patients receiving or expected to receive cerliponase alfa within 60 days of signing the informed consent form (ICF) may be eligible to enroll in the study, assuming all regulatory requirements for sites that have agreed to participate and protocol inclusion criteria are met. Data may be collected for all or some of the assessments as outlined in the protocol, dependent upon the clinic's and/or individual patient's standard of care.

Official Title
-----------------
Cerliponase Alfa Observational Study

Conditions
-----------------
Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2

Intervention / Treatment
-----------------
* Drug: Cerliponase Alfa
* Device: Administration Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with CLN2 disease. Currently receiving or plan to begin treatment with cerliponase alfa. Written informed consent/assent obtained. Exclusion Criteria: 1. Currently receiving treatment in another investigational device or drug study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cerliponase alfa patients<br>Patients who are currently on or plan to start taking cerliponase alfa within 60 days of signing the study informed consent form. | Drug: Cerliponase Alfa<br>* Commercially available product provided to patient by participating clinic site.<br>* Other names: Brineura;Device: Administration Kit<br>* Commercially available administration kit provided to the patient by participating clinic site.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety surveillance of cerliponase alfa | To evaluate the long-term safety of cerliponase alfa in patients with neuronal ceroid lipofuscinosis Type 2 (CLN2 disease). | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity | To further assess the occurrence of serious hypersensitivity reactions (including anaphylaxis), serious cardiovascular adverse events, and serious device-related complications. | 10 years | 
| Severe SAE impact on patient's motor and language functions | To evaluate the effects of Grade III or higher serious adverse events (SAEs) on patient performance on the CLN2 clinical rating scale (motor and language domains). | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Batten's Disease, CLN2, TPP1 enzyme
Nicotinic Receptors and Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

Detailed Description
-----------------
3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.

Official Title
-----------------
Nicotinic Receptors and Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Pharmacokinetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers: males and females who are incapable of pregnancy Exclusion Criteria: Medical illnesses requiring acute treatment History of seizures Substance abuse including nicotine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Other: Pharmacokinetic<br>This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation. | Drug: Pharmacokinetic<br>* Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined<br>* Other names: GTS-21;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Levels of Drug | This is the plasma level of the drug as determined by high performance liquid chromatography. | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
receptors nicotinic
Biomechanical Parameters of Gait in Patients With Parkinson's Disease and Parkinsonian Syndromes

Study Overview
=================
Brief Summary
-----------------
Gait disorders and falls are frequent in patients with parkinsonian syndromes. In patients with Parkinson's disease (PD), these signs occurred later during the course of the disease in comparison to patients with other degenerative parkinsonian disorders. The pathophysiology of these symptoms are still not fully understood. Gait initiation challenges the balance control system as the body moves from an upright stable static posture to a continuously unstable gait. The aim of this study is to analyse the gait initiation process in patients with parkinsonian disorders.

Official Title
-----------------
Biomechanical Parameters of Gait in Patients With Parkinson's Disease and Parkinsonian Syndromes

Conditions
-----------------
Gait Disorders, Neurologic

Intervention / Treatment
-----------------
* Device: Force platform and electromyography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients able to walk without assistance Patients with Parkinson's disease or other degenerative parkinsonian syndromes (progressive supranuclear palsy [PSP], multiple system atrophy [MSA], corticobasal degeneration [CBD], etc.) Exclusion Criteria: Other parkinsonian syndromes Dementia Neuroleptic treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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: Force platform and electromyography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomechanical gait initiation parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adults, Gait disorders, Postural instability, parkinsonian syndrome, Gait initiation, Parkinson's disease
Treatment of Patients With Takayasu Arteritis Complicated With Pulmonary Artery Involvement

Study Overview
=================
Brief Summary
-----------------
Evaluate the effect of medical treatment and percutaneous transluminal pulmonary angioplasty on takayasu arteritis with pulmonary artery involvement evaluate the efficacy of FAPI in predicting the activity and treatment efficacy of takayasu arteritis with pulmonary artery involvement

Detailed Description
-----------------
At baseline, FAPI and FDG are performed to evaluate the activity of takayasu arteritis with pulmonary artery involvement. FAPI is also used to predict the treatment efficacy and prognosis of takayasu arteritis with pulmonary artery involvement.

Official Title
-----------------
Observation of Long Term Effect of Medical and PTPA Treatment on Patients With Takayasu Arteritis Complicated With Pulmonary Artery Involvement

Conditions
-----------------
Takayasu Arteritis With Pulmonary Artery Involvement, Percutaneous Transluminal Pulmonary Angioplasty, PAH Targeted Medication

Intervention / Treatment
-----------------
* Device: Percutaneous transluminal pulmonary angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with Takayasu arteries with pulmonary arteries involvement Exclusion Criteria: Patients had pulmonary artery stenosis arising from CTEPH, fibrosing mediastinitis and congenital pulmonary artery stenosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Percutaneous transluminal pulmonary angioplasty|Percutaneous transluminal pulmonary angioplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death | all cause death | 2014/1/1-2042/12/31 | 
| mean pulmonary arterial pressure change | change of mean pulmonary arterial pressure after treatment | 2014/1/1-2042/12/31 | 
| pulmonary vascular resistance change | chagne of pulmonary vascular resistance after treatment | 2014/1/1-2042/12/31 | 
| 6MWD change | change of six minute walk distance after treatment | 2014/1/1-2042/12/31 | 
| peak VO2 change | change of peak oxygen consumption after treatment | 2014/1/1-2042/12/31 | 
| NT-proBNP change | change of NT-proBNP after treatment | 2014/1/1-2042/12/31 | 
| RV/LV change | change of right ventricular end-diastolic diameter versus laboratory left ventricular end-diastolic diameterafter treatment | 2014/1/1-2042/12/31 | 
| CI change | change of cardiac index after treatment | 2014/1/1-2042/12/31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous transluminal pulmonary angioplasty, Takayasu Arteritis with Pulmonary Artery Involvement
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo control in the respiratory syncytial virus challenge model.

Official Title
-----------------
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered ALS-008176 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model

Conditions
-----------------
Respiratory Syncytial Virus Infections

Intervention / Treatment
-----------------
* Drug: ALS-008176
* Drug: vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 45 years, inclusive. In good health with no history of major medical conditions A total body weight ≥ 50 kg and a body mass index (BMI) of > 18kg/m2. Exclusion Criteria: Acute or chronic medical illness Positive for Human Immunodeficiency Virus, Hepatitis B or C Nose or nasopharynx abnormalities Abnormal lung function

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALS-008176<br>ALS-008176 drug substance for oral suspension | Drug: ALS-008176<br> <br> |
| Placebo Comparator: vehicle alone<br>Vehicle alone | Drug: vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load measurements. |  | Baseline to day 12 |
Continued Early Intervention for Recent-onset Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine whether outreach integrated treatment of first episode schizophrenia was more effecive than standard outpatient treatment.

Detailed Description
-----------------
Early intervention for schizophrenia has spawned considerable enthusiasm among clinicians without solid research evidence to suport its benefits and costs. The present study is a random-controlled study of integrated biomedical and psychosocial treatment on a population of recent-onset cases. Comparison(s): 50 consecutive referrals with schizophrenic disorders of less than two years duration were allocated randomly to a comprehensive model of integrated treatment or standard care for two years. Main outcome measures was psychopathology, psychosocial functioning and hospital admissions.

Official Title
-----------------
Continued Early Intervention for Recent-onset Schizophrenia. A Randomized Controlled Study.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: integrated psychosocial treatment (behavior)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first-episode schizophrenia Exclusion Criteria: acute psychosis

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

| Intervention/Treatment |
| --- |
|Behavioral: integrated psychosocial treatment (behavior)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalizations and psychotic relapse at two years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychopathology, psychosocial changes, functioning, antipsychotic medication |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, psychosocial treatment, outcome
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.

Official Title
-----------------
Evaluation of the H-Coil (TMS) Device - Safety and Feasibility in Bipolar Depression

Conditions
-----------------
Bipolar Depression

Intervention / Treatment
-----------------
* Device: H1 -coil TMS device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bipolar depression Exclusion Criteria: No other axis I disorder Risk factors for convulsions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Device: H1 -coil TMS device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults

Official Title
-----------------
An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults

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

Intervention / Treatment
-----------------
* Drug: Aricept 5mg Tablet
* Drug: Aricept 10mg Tablet
* Drug: DA-5207 150mg
* Drug: DA-5207 170mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health Voulunterrs (Age : 19 55 years) Body Weight : Male≥55kg, Female≥50kg 18.5 ≤BMI≤ 25.0 Exclusion Criteria: Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption Allergy or Drug hypersensitivity Clinically significant Medical History AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m² Heavy alcohol intake (more than 210g/week) Heavy smoker (more than 10 cigarettes/day) Heavy caffeine intake

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg | Drug: Aricept 5mg Tablet<br>* 1 tablet once daily<br>Drug: Aricept 10mg Tablet<br>* 1 tablet once daily<br>Drug: DA-5207 150mg<br>* 1 patch once weekly<br>|
| Experimental: Sequence 2<br>Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg | Drug: Aricept 5mg Tablet<br>* 1 tablet once daily<br>Drug: Aricept 10mg Tablet<br>* 1 tablet once daily<br>Drug: DA-5207 150mg<br>* 1 patch once weekly<br>|
| Experimental: Sequence 3<br>Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg | Drug: Aricept 5mg Tablet<br>* 1 tablet once daily<br>Drug: Aricept 10mg Tablet<br>* 1 tablet once daily<br>Drug: DA-5207 170mg<br>* 1 patch once weekly<br>|
| Experimental: Sequence 4<br>Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg | Drug: Aricept 5mg Tablet<br>* 1 tablet once daily<br>Drug: Aricept 10mg Tablet<br>* 1 tablet once daily<br>Drug: DA-5207 170mg<br>* 1 patch once weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | area under the concentration-time curve | 29-36 days | 
| Css,max | maximum serum concentration at steady state | 0-36 days |
Mucin in Sputum of CF During Pulmonary Exacerbation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether mucin is increased during pulmonay exacerbations in adult patients with cystic fibrosis (CF).

Detailed Description
-----------------
CF is typically associated with mucus hypersecretion in the airways. In health, mucin is the major macromolecular component and is responsible for the protective and clearance properties of the mucus gel. In a recent study we found that mucins are decreased in the sputum of adult CF patients. In this study we want to investigate the differences on the mucin and DNA quantity and quality of airway secretions in during pulmoanry exacerbation.We hypothesize that during an exacerbation the mucin and DNA amount is increasing. The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-DNA-network) of the airway secretions in CF related to the severity of the disease. We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis and dot-blot with specific antibodies we will analyze MUC5AC and MUC5B mucins. DNA amount will be measured by microfluorimetry. With the laser scanning confocal microscopy the mucin-DNA-network will be evaluated. The significance of these studies is that they will give us novel information about the pathogenesis of chronic inflammatory airway diseases, provide tools for assessing the progression of lung disease, and most critically, will identify novel opportunities and targets for therapeutic intervention.

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cystic fibrosis chronic pseudomonas aeruginosa inflammation pulmonary exacerbation Exclusion Criteria: -

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung, airway, pulmonary exacerbation, mucus
A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD.

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: AD 237


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea. Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value. Pre-bronchodilator FEV1/FVC ratio of less than 70%. Current or ex-smokers with a smoking history of at least 10 pack years. Exclusion Criteria: History of asthma, atopy or allergic rhinitis. Other serious respiratory or other medical conditions which may interfere with the outcome of the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Drug: AD 237|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, COAD, Chronic obstructive pulmonary disease, emphysema, chronic bronchitis