linjc16/ctgov huggingface dataset:
Establishment and Characterization of Meningioma Patient-derived Organoids

Study Overview
=================
Brief Summary
-----------------
In this study, meningioma organoids will be established from patients' tissues and the characterization of the organoid will be performed.

Detailed Description
-----------------
Aims and Hypothesis to be tested: The investigators hypothesized that the derived organoid should have a similar morphological and genetic mutation signatures to the patient primary tissue. Study period: 1 year for patient recruitment and organoid generation from patient tumor Study population: 30 Study samples: Patient's meningioma tumor sample are collected from patients with surgical needs. Sample collected are used for organoid culture. Morphological and genetic characteristics will be compared between the patient tumor sample and the corresponding derived organoids Primary outcome measures: Whole exome sequencing data of patient tumor tissue and patients-derived organoids

Official Title
-----------------
Establishment and Characterization of Meningioma Patient-derived Organoids

Conditions
-----------------
Meningioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (aged >18 years) with meningioma Admission into Prince Wales hospitals neurosurgical services Patients with surgical needs of meningioma removal Exclusion Criteria: 1. Patients (or next-of-kin as appropriate) refuse to participate into the study

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole exome sequencing data | DNA extracted from patient tumor tissue and patients-derived organoids will be perform whole exome sequencing for genetic characterization. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunostaining | H&E staining and meningioma markers immunostaining | 7 days |
Long-term Follow-up of Sanfilippo Type A Patients Treated by Intracerebral SAF-301 Gene Therapy

Study Overview
=================
Brief Summary
-----------------
P2-SAF-301 is an open-label interventional study without administration of investigational product, evaluating the long-term safety and tolerability of intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome. The primary objective is to collect additional safety and tolerability data on intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome. The secondary objective is to further collect data to assess the effects of SAF-301 on neurological and psychological status, and potential biological markers.

Official Title
-----------------
Long-term Follow-up of Patients With Sanfilippo Type A Syndrome Who Have Previously Been Treated in the P1-SAF-301 Clinical Study Evaluating the Tolerability and Safety of the Intracerebral Administration of SAF-301.

Conditions
-----------------
Mucopolysaccharidosis Type III A, Sanfilippo Disease Type A

Intervention / Treatment
-----------------
* Genetic: SAF-301


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having completed the previous phase I/II study (P1-SAF-301), Family understanding the follow-up procedures and the informed consent, Patient's parents having signed the informed consent form. Exclusion Criteria: Participation in any other clinical trial.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAF-301<br> | Genetic: SAF-301<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Checking of adverse events |  | until 60 months after SAF-301 administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information on neurological and cognitive changes based on clinical status, standardized neurocognitive and behavioral assessments |  | 5 years after the injection of SAF-301 | 
| Information on changes in potential biomarkers of the disease |  | 5 years after the injection of SAF-301 | 
| Information to further evaluation of immune response |  | 5 years after the injection of SAF-301 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurodegenerative diseases, Nervous systems diseases, Genetic diseases, Inborn, Metabolic diseases, Gene therapy, Adeno Associated Virus (AAV)
A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

Detailed Description
-----------------
Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.

Official Title
-----------------
A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Conditions
-----------------
Cataract in Inflammatory Ocular Disorders

Intervention / Treatment
-----------------
* Drug: Dexamethasone Dose 1
* Drug: Dexamethasone Dose 2
* Drug: Placebo Dose 1
* Drug: Placebo Dose 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing traditional cataract surgery. Exclusion Criteria: Patients with unusual ocular conditions.

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
Interventional Model Description: Randomized to 2 active dosing groups and 2 corresponding dosing groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone Dose 1<br> | Drug: Dexamethasone Dose 1<br>* Dexamethasone ophthalmic suspension dose 1<br>|
| Active Comparator: Dexamethasone Dose 2<br> | Drug: Dexamethasone Dose 2<br>* Dexamethasone ophthalmic suspension dose 2<br>|
| Placebo Comparator: Placebo Dose 1<br> | Drug: Placebo Dose 1<br>* Placebo suspension dose 1<br>|
| Placebo Comparator: Placebo Dose 2<br> | Drug: Placebo Dose 2<br>* Placebo suspension dose 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular inflammation | Measuring Anterior Cell Count | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Pain | Measuring patient ocular pain using an 11-point visual scale | Day 8 |
Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.

Detailed Description
-----------------
The duration of treatment is 12 weeks.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patients With Combined Hyperlipidemia-Simvastatin and Fenofibrate Efficacy Trial (SAFARI)

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0733, simvastatin
* Drug: Comparator: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated cholesterol level Exclusion Criteria: Liver disease Known allergies to study drugs

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0733, simvastatin|nan|
|Drug: Comparator: simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting triglyceride levels at 12 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High cholesterol
Healthy Kids Pilot

Study Overview
=================
Brief Summary
-----------------
Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.

Official Title
-----------------
Healthy Kids Pilot

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: m-Health Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Child: Have at least one participating parent Have a BMI percentile > 85 Be physically capable of exercise Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer Inclusion Criteria for Parent: Have a smartphone Be willing to use the smartphone for the mHealth intervention Exclusion Criteria for Child: Significant cardiovascular disease or disorders via self-report from parent Other significant medical problems that would prevent them from engaging in regular physical activity.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 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: m-health approach<br>See intervention description | Behavioral: m-Health Intervention<br>* Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability/feasibility of the mHealth approach | Acceptability/feasibility of the mHealth approach will be evaluated by a survey on treatment satisfaction. | Week 0 to Week 14-16 |
Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers

Official Title
-----------------
A Single-Centre, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD3241 Following Administration of Single Ascending (Part A) and Fractionated Ascending (Part B) Oral Doses to Young Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: AZD3241
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Body Mass Index (BMI) 19 to 30 kg/m2 inclusive Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator Exclusion Criteria: Clinically significant illness within the 2 weeks prior to the administration of the investigational product Heart rate (resting, recumbent) <50 bmp or >85 bmp History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD3241<br>* single oral dose<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General tolerability and safety variables |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pk |  | approximately 48 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single dose, Phase 1, Safety of AZD3241, tolerability of AZD3241
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

Study Overview
=================
Brief Summary
-----------------
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.

Official Title
-----------------
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions

Conditions
-----------------
Therapeutic Equivalency

Intervention / Treatment
-----------------
* Drug: methylprednisolone
* Drug: methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 45 kg (99 lbs). Exclusion Criteria: Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylprednisolone suspension<br> | Drug: methylprednisolone<br>* constituted powder for oral suspension 4 mg/mL single dose at 32 mg<br>|
| Active Comparator: methylprednisolone tablets<br> | Drug: methylprednisolone<br>* tablets 32 mg single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf (area under the concentration curve to infinity) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Cmax (maximum concentration) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC last (area under the concentration curve to last time point) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Tmax (time at maximum concentration) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Half-life |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioequivalence study, methylprednisolone, suspension, tablets
Pulmonary Hypertension Institutional Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a registry of patients with Pulmonary Hypertension who received medical care in the Hospital Italiano of Buenos Aires.

Detailed Description
-----------------
The Institutional Registry of Pulmonary Hypertension includes patients prospectively with incident pulmonary hypertension, and excludes type II Pulmonary Hypertension. It also includes prevalent cases from our HMO who had diagnosis prior the beginning of the registry.

Official Title
-----------------
Pulmonary Hypertension Institutional Registry at Hospital Italiano de Buenos Aires

Conditions
-----------------
Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More 17 Pulmonary Hypertension Systolic Pulmonary Pressure >40 mmhg measured in a doppler echocardiogram, Systolic artery pressure <25 in a pulmonary angiography Exclusion Criteria: Non accept to participate Pulmonary Hypertension type II (Left cardiac disease)

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- | --- |
| Pulmonary hypertension prevalence and incidence | The main goal is to describe Pulmonary hypertension prevalence and incidence in our community as well as depict its risk factors, symptoms, prognosis and treatment response. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | 1 year |
MTX Hold During Covid-19 Booster

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.

Official Title
-----------------
Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MTX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females ≥ 19 years of age at time of consent Have a diagnosis of RA per ACR criteria Require methotrexate for RA treatment Subject to a Covid-19 booster vaccination Must understand and voluntarily sign an informed consent form including writing consent for data protection Exclusion Criteria: Pregnant or lactating females Previous anaphylactic response to the vaccine components Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease Any condition including laboratory abnormality which places the subject at unacceptable risk Subjects who decline to participate

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MTX continue<br>Group will continue MTX after vaccination | Drug: MTX<br>* MTX continuation<br>|
| Experimental: MTX 1 week hold<br>Group will continue MTX for 1 week after vaccination | Drug: MTX<br>* MTX continuation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covid-19 antibody titer before and after Covid-19 vacciation | Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell activation after vaccination | Percentage of activated T cells after vaccination | 2, 4, 16 weeks | 
| B cell activation after vaccination | Percentage of activated b cells after vaccination | 2, 4, 16 weeks |