linjc16/ctgov huggingface dataset:
Natural History Study of Patients With X-linked Retinal Dystrophy Associated With Mutations in Retinitis Pigmentosa GTPase Regulator (RPGR)

Study Overview
=================
Brief Summary
-----------------
The rod-cone dystrophies (often referred to as retinitis pigmentosa (RP)) are a clinically and genetically heterogeneous group of disorders in which there is progressive loss of rod and later cone photoreceptor function leading to severe visual impairment. RP usually occurs as an isolated retinal disorder, but it may also be seen in association with systemic abnormalities.

Detailed Description
-----------------
X-linked Retinitis Pigmentosa (XLRP) is a severe form of RP with early onset of nyctalopia and progression to legal blindness by the 3rd to 4th decade. Most affected males show symptomatic night blindness before the age of 10 years, are often myopic and show fundus abnormalities and ERG changes in early childhood. Examination of close female relatives is helpful in the absence of a family history, as the recognition of the XL carrier state will confirm the diagnosis.

Official Title
-----------------
Natural History Study of Patients With X-linked Retinal Dystrophy Associated With Mutations in Retinitis Pigmentosa GTPase Regulator (RPGR)

Conditions
-----------------
Retinitis Pigmentosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males & Females aged 5 years or older Have RPGR-associated retinal dystrophy Are able to give informed consent or assent, with the guidance of their parent/guardian where appropriate Are able to undertake age-appropriate clinical assessments as specified in the protocol Have genetic mutation within the RPGR gene confirmed by an accredited lab or research lab. Exclusion Criteria: Are unable or unwilling to undertake consent or clinical testing

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- | --- |
| Analysis of retinal structure and function to assess disease progression | Retinal structure will be measured using Adaptive optics and SD-OCT and Fundal autofluorescence. | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Sensitivity | To be assessed by Microperimetry | 6 years | 
| Retinal Structural detailed phenotyping | Retinal Structure measured by Adaptive Optics ( | 6 years | 
| Fundus Autofluorescence | Presence or Absence | 6 years | 
| Visual Fields testing | Assessment of Visual Fields with analysis of hill vision by perimetry | 6 years |
A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Multiple Oral Doses of 2000 mg of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity in Subjects With Hypercholesterolemia

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Niaspan
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate methods of contraception throughout the study Subject is in good health (other than history of high cholesterol) Subject is a non-smoker Exclusion Criteria: Subject has a history of stroke, seizures or major neurological disorder Subject has a history of cancer Subject is unable to refrain from or anticipates the use any prescription or non-prescription drugs Subjects consumes excessive amounts of alcohol or caffeine

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Niaspan - Placebo | Drug: Niaspan<br>* Oral doses of 2000 mg of Niaspan once daily for 7 days.<br>Drug: Comparator: Placebo<br>* Oral doses of placebo once daily for 7 days.<br>|
| Experimental: 2<br>Placebo - Niaspan | Drug: Niaspan<br>* Oral doses of 2000 mg of Niaspan once daily for 7 days.<br>Drug: Comparator: Placebo<br>* Oral doses of placebo once daily for 7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation (FMD) of brachial artery |  | predose, 4 hours post dose and 24 and hours post dose | 
| Nitroglycerin (GTN) induced dilation of brachial artery |  | predose, 4 hours post dose and 24 hours post dose |
Participant Database for Autism Research Studies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a subject database to recruit for current and future studies in research on autism and other neurodevelopmental disabilities.

Detailed Description
-----------------
Aim 1: to recruit people interested in research on autism and other neurodevelopmental disabilities Aim 2: to complete a diagnostic assessment, to confirm the diagnosis of autism spectrum disorder or other developmental disability (e.g., developmental language delay) in our patient population and rule out a diagnosis of autism spectrum disorder and other comorbid conditions in our control group Aim 3: to maintain subject information in a database, from which we can recruit for our studies

Official Title
-----------------
Database for Persons Interested in Research Studies of Developmental Disorders

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Typically-developing, healthy adolescents and adults (ages 14-32) Adolescents and adults with autism spectrum disorder (ages 14-32) Exclusion Criteria: Extreme premature birth (<34 weeks) Known genetic disorders related to autism (e.g. Fragile X) Recent diagnosis of psychosis (within 6 months) Some other psychiatric diagnoses may be excluded following screening (e.g. Tourette's syndrome). Metal implants / permanent retainers / hair dyes with metallic components

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 32 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 |
| --- | --- |
| Healthy individuals<br>No intervention Healthy participants ages 14-32 for a neuroimaging study. | |
| Individuals with Autism Spectrum Disorder<br>No intervention ASD participants ages 14-32 for a neuroimaging study. | |

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
-----------------
autism, autistic, language, development, developmental, assessment
Bleb Vascularity and the Outcomes After Trabeculectomy

Study Overview
=================
Brief Summary
-----------------
Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.

Detailed Description
-----------------
Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a >30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.

Official Title
-----------------
Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy

Conditions
-----------------
Glaucoma, Filtering Bleb

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP) pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP) Exclusion Criteria: primary angle closure glaucoma (PACG) secondary glaucoma except PEXG previous eye surgery subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| patients after primary MMC-augmented trabeculectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of surgical success | The successful bleb group consisted of eyes with IOP below 18 mmHg and a >30% reduction in IOP at 1 year after surgery without antiglaucoma medications or additional surgical interventions. Failed blebs were defined when IOP was over 18 mmHg, below 18 mmHg with antiglaucoma medications or if any additional surgical intervention was necessary | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Bleb vascularity with IOP | Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
filtering bleb, trabeculectomy, glaucoma
The Effects of Smoking on Mortality in Patients With Acute Respiratory Syndrome Coronavirus 2 Infection

Study Overview
=================
Brief Summary
-----------------
This is a retrospective single centered study that was done in the ICU on patients with Covid-19 between 16th of March -16th of May in 2020 Retrospective records will be examined by examining the electronic data files of the patients. There were two groups as smoker and non-smoker.

Detailed Description
-----------------
The aims of the present study is to see the effects of smoking prevalence, the length of stay regarding the usage of cigarettes, and the effects on the mortality of COVID-19 in our intensive care unit(ICU). This is a retrospective single centered study that was done in the ICU on patients with Covid-19 between 16th of March -16th of May in 2020. The demographic data, comorbidity status, the units they were accepted from, clinical symptoms , respiratory support, prevalence of smoking, length of stay in the ICU and mortalities of the patients weill be recorded. There are two groups as smoker and non-smoker.

Official Title
-----------------
The Effects of Smoking on Mortality in Intensive Care Unit in Patients With Acute Respiratory Syndrome Coronavirus 2 Infection

Conditions
-----------------
Covid19, Smoking

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patient's data are diagnosed with acute respiratory syndrome Covid-19 over 18 years old Exclusion Criteria: Patients under 18 years of age

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| smoker<br>active smokers | Other: no intervention<br>* no intervention<br>|
| non-smoker<br>Patients who have never smoked | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality rates of patients | 3 months |
Regulatory Post Marketing Surveillance Study in Korea

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.

Official Title
-----------------
Visanne® (Dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Dienogest (Visanne, BAY86-5258)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent Women diagnosed by a physician as having endometriosis Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period Exclusion Criteria: - All contraindications according to the local marketing authorization have to be considered.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Dienogest (Visanne, BAY86-5258)<br>* Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population |  | 6 months and 1 year | 
| Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit). |  | 6 months and 1 year |
Acute Cardiovascular Adverse Events Occuring in Children Treated by Anticancer Drugs for Malignancies

Study Overview
=================
Brief Summary
-----------------
Little is known about acute cardiovascular adverse events occuring in children treated by anticancer drugs for malignancies. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of acute cardiovascular adverse events associated with anticancer drugs.

Official Title
-----------------
Description of Acute Cardiovascular Adverse Events Occuring in Children Treated by Anticancer Drugs for Malignancies Using the World Health Organization (WHO) Database VigiBase

Conditions
-----------------
Malignancies, Cardiovascular Diseases, Children, Only

Intervention / Treatment
-----------------
* Drug: use of anticancer drugs in monotherapy or in combination therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to children and reported, or not, acute cardiovascular adverse events Exclusion Criteria: cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients cases related to long-term and delayed cardiovascular adverse events

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: use of anticancer drugs in monotherapy or in combination therapy|Cases of acute cardiovascular events associated with anticancer drugs will be identify and describe|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute cardiovascular adverse events associated with anticancer drugs | identification and description of cases of acute cardiovascular adverse events associated with anticancer drugs in the World Health Organization (WHO) database of individual safety case reports (vigibase) | from inception to the octobre 31, 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between acute cardiovascular adverse events and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase) | Disproportionnality analyses in Vigibase (IC025 and/or ROR) perfomed on cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) | from inception to the octobre 31, 2022 | 
| Description of the malignancies for which the incriminated drugs have been prescribed | Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) | from inception to the octobre 31, 2022 |
Predictive Value of a SNP Signature and Liquid Biopsy in Natural Killer T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the Predictive value of a SNP signature and liquid biopsy in patients with natural killer T-cell lymphoma.

Official Title
-----------------
Predictive Value of a SNP Signature and Liquid Biopsy in Natural Killer T-cell Lymphoma

Conditions
-----------------
Natural Killer T-cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved Natural Killer T-cell Lymphoma newly diagnosed patients Exclusion Criteria: patients with biopsy samples unavailable

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 |
| --- | --- |
| tested group<br> | |
| controlled group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5-years |
Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal, observational, prospective, multicentre study conducted in metropolitan France, among a representative sample of office-based or mixed practice rheumatology doctors. The aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.

Official Title
-----------------
Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, ambulatory, seen in a rheumatology consultation. With a confirmed diagnosis of RA (ACR 1987 or ACR/EULAR 2010 criteria) receiving a disease-modifying treatment with methotrexate as a monotherapy. With clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA . Informed about the computer processing of their medical data and their right of access and correction. Exclusion Criteria: Patient not treated with methotrexate for their RA. Already treated with a biotherapy or receiving other synthetic DMARDs (disease-modifying antirheumatic drugs) in combination with methotrexate . Participating in a clinical trial in rheumatology.

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 |
| --- | --- | --- |
| Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28) | The distribution of the various therapeutic options will be described overall. Their impact on the progression of the RA will be assessed at 6 months according to the EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28) score during the study) | Patients are included at the time of the change in the treatment of the RA and followed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction using a 4-point verbal scale | Satisfaction will be assessed using a 4-point verbal scale. | 6 months after inclusion | 
| Medical economic aspect (cost/benefit ratio) | The cost/benefit ratio of each therapeutic strategy will be described. | 6 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methotrexate, Therapeutic strategy