linjc16/ctgov huggingface dataset:
Pegcetacoplan Early Access Program for PNH

Study Overview
=================
Brief Summary
-----------------
This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with paroxysmal nocturnal hemoglobinuria (PNH).

Official Title
-----------------
Early Access Program (EAP) For The Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) With Pegcetacoplan

Conditions
-----------------
Paroxysmal Nocturnal Hemoglobinuria (PNH)

Intervention / Treatment
-----------------
* Drug: Pegcetacoplan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a confirmed diagnosis of PNH, who are transfusion dependent and are not responding to C5 treatment Exclusion Criteria: N/A

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegcetacoplan|Complement (C3) Inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Anterior Chamber Paracentesis and Conventional Mannitol Infusion in Patients With Primary Acute Angle-closure Glaucoma

Study Overview
=================
Brief Summary
-----------------
The investigators wanted to reported the results of immediate anterior chamber paracentesis (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma (PACG). In this study, the investigators first divided patients into three sub-groups according to their initial intraocular pressure (IOP) for analyzing the differences of IOP control, severity of corneal edema, waiting time for laser peripheral iridotomy (LPI), and visual outcome between ACP and Mannitol infusion.

Detailed Description
-----------------
The investigators demonstrated that ACP could be first considered in patients with initial IOP between 45 to 60 mmHg because it provided better visual outcome than Mannitol infusion through the rapid stabilization of the anterior segment, which was achieved by rapid IOP control, better corneal edema regression, shortening waiting time for LPI. However, ACP should be considered in patients with the initial IOP of 60mmHg and higher only when Mannitol was contraindicated.

Official Title
-----------------
Comparison of Anterior Chamber Paracentesis and Conventional Mannitol Infusion in Patients With Primary Acute Angle-closure Glaucoma

Conditions
-----------------
Glaucoma, Acute Primary Angle-closure Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first attack of acute PACG; initial presenting IOP was higher than 45 mmHg; diagnosis confirmed by gonioscopic examination; patients within 48 hours of symptom onset. Exclusion Criteria: been incompletely followed up within 2 weeks; been using anti-glaucomatous medication before ACP or Mannitol infusion; previous intraocular surgeries on the same eye; contraindication for Mannitol; history of other vision-threatening ocular diseases.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental Group<br> | |
| Control Group<br> | |

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
-----------------
Glaucoma, anterior chamber paracentesis, conventional Mannitol infusion
Study on Hemodialysis: Illumination Effects

Study Overview
=================
Brief Summary
-----------------
Previous research has shown that sleep quality in hemodialysis patients is disturbed. One of the possible explanations is an insufficient or disturbed melatonin rhythm. Melatonin rhythm is regulated by exposure to light. In this feasibility study, the investigators examine the effects of light therapy during dialysis on sleep, melatonin rhythm and mood.

Official Title
-----------------
Effects of Light Therapy on Sleep, Melatonin Rhythm and Mood in Hemodialysis Patients

Conditions
-----------------
Sleep Problems

Intervention / Treatment
-----------------
* Procedure: light therapy with the device: EnergyLight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent men/women aged 18-85 years knowledge of the dutch language hemodialysis patient subjective sleep problems (Epworth sleepiness score >9) Exclusion Criteria: known major illness, which interferes with patient's participation use of melatonin/hypnotics use of photosensitizing medication jet lag or travel > 1 time zone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Starting with light therapy<br>Starts with 3 weeks of light therapy, followed by a control period | Procedure: light therapy with the device: EnergyLight<br>* 2 hr of light therapy during each hemodialysis session<br>* Other names: Philips Energylight;|
| Experimental: Ending with light therapy<br>Ends with 3 weeks of light therapy after a control period. | Procedure: light therapy with the device: EnergyLight<br>* 2 hr of light therapy during each hemodialysis session<br>* Other names: Philips Energylight;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of sleep parameters |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective sleep parameters |  | 3 weeks | 
| Change in mood |  | 3 weeks | 
| change in melatonin concentrations |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep problems, melatonin, mood, Hemodialysis
Antipsychotics and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life.

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender male Age 18-45 Debut drug-naive schizophrenics, Caucasians Consent given to take part in the project Exclusion Criteria: Compliance-problems Major lung-/kidney/hart/lever disorders Abuse of alcohol/drugs Diabetes 1 and 2 Antihypertensive Anticholesterol-reducing medication Patients under duress

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>schizophrenic patients | |
| 2<br>controls | |

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
-----------------
Metabolic and endocrine changes in schizophrenic patients by antipsychotics treatment.
Dining With Diabetes in Pennsylvania

Study Overview
=================
Brief Summary
-----------------
Penn State Extension's Dining with Diabetes program is an evidence-based community education program for people with or at risk for type 2 diabetes. The program teaches participants how to prevent or manage their disease by providing practical knowledge and strategies to make the necessary lifestyle changes that will lead to healthier living and reduction in the risk of complications. The overall goals and objectives of the program are as follows: Increasing knowledge of healthy food choices for families with or at risk for diabetes Promoting behavior changes by offering demonstrations and tasting of healthy food. Increasing knowledge of essential medical tests associated with diabetes management. Promoting physical activity as a component of diabetes control. Encouraging self-management and self-efficacy skill. Connecting participants to their healthcare providers for long-term follow-up. The program is designed to meet 4 consecutive weeks and then a 3 month follow-up. Participants A1c and blood pressure are taking at the first and follow-up classes. Classes consist of a nutrition lesson, physical activity, cooking demonstration and food tasting.

Official Title
-----------------
Dining With Diabetes in Pennsylvania

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Lifestyle modification education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with type 2 diabetes individuals with pre-diabetes individuals at risk of developing type 2 diabetes healthy family members/caretakers healthy volunteers Exclusion Criteria: under age 18

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

| Intervention/Treatment |
| --- |
|Behavioral: Lifestyle modification education|Lifestyle modification education and goal setting|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin A1C | participants can choose to have their hemoglobin A1C taken at the first and follow-up class, 3 months later | 3 months |
Parkinson's Research: The Organized Genetics Initiative

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study genetic and other risk factors that may be important in the development of Parkinson's disease.

Detailed Description
-----------------
The The Parkinson's Research: The Organized Genetics Initiative, also known as PROGENI, is a multi-center study involving 2000 people throughout North America who are affected, or possibly affected, with Parkinson's disease (PD). The goal of the initiative is to study the genetic and other risk factors which may be important in the development of PD. In order to better understand the genetic factors leading to PD, researchers will study families having 2 or more members diagnosed with PD. Using DNA samples from each participant, researchers hope to identify genes that may cause a person to be at higher risk for developing PD. Each participant in the study will be asked to complete a family history questionnaire, providing information about the history of PD in the family. Participants also will be asked to discuss the symptoms they have experienced and their responses to PD medications. This information will be used by study personnel to determine further eligibility for the study. Those eligible for further participation will be asked to undergo a study visit at the site closest to their residence, during which they will be asked to complete questionnaires regarding PD symptoms, medical history, places of residence, occupations, mood, mental status, and activity level. A blood sample will be drawn for DNA extraction. The study visit will take about 2 hours.

Official Title
-----------------
Parkinson's Disease Collaborative Study of Genetic Linkage

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible to participate in this study participants must be diagnosed with or have symptoms of PD. In addition, they must also have a family history of PD in other relatives. Exclusion Criteria: Subjects cannot have participated in any other genetic research project for Parkinson's disease.
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
-----------------
Parkinson disease, Parkinson's disease, PD, genetics, genes, siblings, family
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.

Official Title
-----------------
An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum

Conditions
-----------------
Pyoderma Gangrenosum

Intervention / Treatment
-----------------
* Drug: gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An established diagnosis of pyoderma gangrenosum Currently experiencing an inflammatory episode of pyoderma gangrenosum Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: Clinical evidence of acutely infected pyoderma gangrenosum History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent or chronic systemic infections Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gevokizumab<br>Solution for subcutaneous injection | Drug: gevokizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer |  | Day 1 through Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum, Atypical Pyoderma Gangrenosum, Peristomal Pyoderma Gangrenosum
Evolution of Swallowing in Patients Undergoing Lateral Pharyngoplasty With Preservation Stylopharyngeal Muscle

Study Overview
=================
Brief Summary
-----------------
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle.

Detailed Description
-----------------
refer patients to the side pharyngoplasty with total preservation of stylopharyngeal muscle and evaluate the total recovery time of swallowing, making a daily assessment.

Official Title
-----------------
Evolution of Swallowing in Patients Undergoing Lateral Pharyngoplasty With Preservation Stylopharyngeal Muscle

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with obstructive sleep apnea with surgical indication Exclusion Criteria: patients with obstructive sleep apnea without surgical indication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| surgery<br>patients with obstructive sleep apnea | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle | refer patients with oas to the side faringolastia with total preservation stylopharyngeal muscle and evaluate recovery time of swallowing during 30 days. | assess progress daily until the end of swallowing dysphagia during 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle | refer patients with oas to the side faringolastia with total preservation styleopharingeal muscle and evaluate the total recovery time of swallowing, making a daily assessment. | assess progress daily until the end of swallowing dysphagia during 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep apnea, obstructive, Deglutition Disorders
Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome (CVS)

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to characterize the quality of life of youth with Cyclic Vomiting Syndrome (CVS) as well as the strategies they use to cope with stress, their strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at risk youth. The impact of CVS on the child's parent and family will also be assessed. A second aim is to evaluate the associations among coping strategies, personal strengths and vulnerabilities and the frequency and intensity of CVS attacks to determine if particular coping styles and personal characteristics are associated illness severity, psychiatric co-morbidity and quality of life

Official Title
-----------------
Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome

Conditions
-----------------
Vomiting Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CVS Exclusion Criteria: Children and parents who are not English speaking Youth with significant developmental delay, mental retardation, psychotic symptoms, or other significant mental impairments and those with other major medical disorders such as IDDM, congenital heart disease, cystic fibrosis, etc.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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
-----------------
Youth, consensus, criteria, CVS
Medikidz Explain JIA Comic Book- Hebrew

Study Overview
=================
Brief Summary
-----------------
We believe, that the results of this study will show that children learn from the comic book about their disease, and are now more aware and less frightened about it, and increase their compliance.

Detailed Description
-----------------
We believe, that the results of this study will show that children learn from the comic book about their disease, and are now more aware and less frightened about it, and increase their compliance. If so, it may promote the use of comic books or other fun educational tool in teaching children various other diseases.

Official Title
-----------------
Evaluating the Efficacy of a Comic Book as an Educating Tool for Children With Juvenile Idiopathic Arthritis

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Behavioral: reading comics booklet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with JIA aged 10-18 after parents signed ICF Exclusion Criteria: Parents that do not wanf their children to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JIA patients<br>All participants will be evaluated before and after reading the comics booklet | Behavioral: reading comics booklet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30% or more improvement in a knowledge questionnaire (before and after reading the comics booklet) |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10% or higher score in CHQ questionnaire (after reading the comics booklet) |  | 2 Years | 
| better compliance ( >1 score improvement in 1-5 scale score, as evaluated by the physician after reading the comics booklet). |  | 2 years |