linjc16/ctgov huggingface dataset:
Clinical Research in ALS Study

Study Overview
=================
Brief Summary
-----------------
CRiALS is an umbrella protocol through which people are recruited to participate in a range of research studies being conducted by the ALS Research Collaboration (ARC).

Detailed Description
-----------------
Research goals include elucidation of the complex relationship between ALS and related neurodegenerative disorders, development of both wet and dry biomarkers of disease, and delineation of the full course of the natural history of disease from the early pre-symptomatic stages through established and even late-stage disease. These goals are accomplished through the recruitment and evaluation of patients with ALS and related diseases, family members (including people at genetic risk for ALS, but who are not yet affected), and healthy controls.

Official Title
-----------------
Clinical Research in Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age. Member of at least one of the following categories: Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial) Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases. Healthy controls Able and willing to comply with relevant procedures. Exclusion Criteria: 1. Subject has a condition or is in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

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 |
| --- | --- |
| Individuals affected with ALS<br>This population be sporadic or familial ALS. | |
| Unaffected individuals from families in which the genetic cause of ALS is known<br>This population includes pre-symptomatic individuals at genetic risk for ALS or a related neurodegenerative disorder (i.e., FTD). | |
| Individuals affected with an ALS-related neurodegenerative disease<br>This would include FTD, MSP, IBMPFD, etc. | |
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Since this is an umbrella/gateway protocol through which individuals are recruited to participate in a range of studies, outcome is assessed in terms of recruitment. | Annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetics, biomarkers, pre-symptomatic, natural history
Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.

Study Overview
=================
Brief Summary
-----------------
This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Biological: Intervention A
* Biological: Intervention B
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic plaque-type psoriasis, moderate to severe Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy Exclusion Criteria: Forms of psoriasis other than chronic plaque-type Ongoing use of treatments not allowed for psoriasis 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing Regimen 1<br>Subcutaneous injection | Biological: Intervention A<br>* Prefilled syringe.<br>|
| Active Comparator: Active Comparator<br>Subcutaneous injection | Biological: Intervention B<br>* Prefilled syringe.<br>|
| Placebo Comparator: Placebo<br>Subcutaneous injection | Biological: Placebo<br>* Prefilled syringe to match experimental drug and active comparator.<br>|
| Experimental: Dosing Regimen 2<br>Subcutaneous injection | Biological: Intervention A<br>* Prefilled syringe.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI (psoriasis area and severity index) and IGA (investigator's global assessment) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI (psoriasis area and severity index) and IGA (investigator's global assessment) |  | Week 52 | 
| Vital signs, laboratory values, electrocardiograms (ECG), adverse events |  | Week 12 and 52 | 
| Patient reported outcome questionnaires |  | Week 12 and 52 |
Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.

Detailed Description
-----------------
Sudden cardiac death (SCD) accounts for half of all deaths from cardiovascular causes, with an annual incidence of 1 to 2 deaths per 1000 population. In the United States this translates to between 300,000 to more than 400,000 deaths annually. Results from numerous large, well designed clinical trials have demonstrated the efficacy of the implantable cardioverter-defibrillator (ICD) for improving survival in patients with ischemic heart disease. However, measures used to risk stratify patients, such as left ventricular ejection fraction do not adequately identify those patients who can most benefit from ICD therapy. As a result, many patients who currently receive an ICD do not use the device. In addition, many more patients who could benefit from ICD therapy are outside of current guidelines and do not have access to this life-saving therapy. This prospective study was intended to determine how well the Harbinger Wedensky Modulation Index (WMI) technique risk stratifies patients into two groups: those needing antiarrhythmic therapy and those who do not need antiarrhythmic therapy.

Official Title
-----------------
The Harbinger ICD Patient (HIP) Study

Conditions
-----------------
Sudden Cardiac Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post myocardial infarction patients receiving ICD therapy Exclusion Criteria: Patients unable to give consent Pacemaker dependant patients Pregnant women

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 |
| --- | --- |
| A<br>Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review) |  | Up to two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wedensky modulation, Risk stratification, Electrophysiology, Noninvasive, Ischemic heart disease, ICD guidelines, Myocardial infarction
Disorders of Sex Development (DSD) 46.XY in Three Siblings

Study Overview
=================
Brief Summary
-----------------
This is a case series of three siblings with DSD 46,XY with relevant discussion

Detailed Description
-----------------
This is a case series of three sisters with DSD 46 X,Y. Three sisters, aged nineteen, seventeen, and fifteen years old came with an identical complaint of late menarche. Physical examinations, lab results and karyotypes were performed.

Official Title
-----------------
Disorders of Sex Development (DSD) 46.XY Due to Type 2 5-Α Reductase Deficiency in Three Siblings: Case Report From a Low-Resource Setting

Conditions
-----------------
Genotype

Intervention / Treatment
-----------------
* Diagnostic Test: Karyotype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 female siblings with identical complaints of no menarche Exclusion Criteria: patients outside this family.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>subjects with type 2 5-alpha reductase deficiency | Diagnostic Test: Karyotype<br>* Patients were subjected to karyotype to determine their genotype<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karyotype | Patient's karyotype | 1 month after testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disorders of Sex Development, Type 2 5-alpha reductase deficiency
Assessment of Quality of Life in Food Allergic Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is To validate in french quality of life questionnaires for food allergic children To evaluate if the quality of life of food allergic french speaking children aged 0-12 years is affected by their condition To validate a didactic game for food allergic children

Official Title
-----------------
Assessment of Quality of Life in Food Allergic Children

Conditions
-----------------
Food Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French speaking children with confirmed IgE mediated food allergy Aged 0-12 years old Exclusion Criteria: Inclusion in another trial Chronic severe diseases

Ages Eligible for Study
-----------------
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
-----------------
Children aged 0-12 years, IgE mediated food allergy
Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China

Study Overview
=================
Brief Summary
-----------------
Data on neonatal GBS disease are very limited in China. Acceptance and implementation of prevention measures such as antibiotics prevention or vaccination against GBS disease would require robust data. This study as the first national, multicenter study to investigate the epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to appraise the necessity of appropriate interventions.

Official Title
-----------------
Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study

Conditions
-----------------
Invasive Group B Streptococcal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid. ≤90 days old at the time of GBS confirmation. Voluntary written informed consent provided. Exclusion Criteria: 1. None

Ages Eligible for Study
-----------------
Maximum Age: 90 Days

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 |
| --- | --- | --- |
| Incidence of group B streptococcal (GBS) disease |  | From birth to 3 months of age | 
| Case Fatality Rate of GBS disease |  | From birth to 3 months of age | 
| GBS serotype distribution |  | From birth to 3 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group B streptococcus, Infants, China
MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.

Official Title
-----------------
A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: MK2461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be at least 18 years of age, with adequate organ function, and an ECOG performance of <2 Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A) Exclusion Criteria: No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation Patients must not have primary central nervous system tumor Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK2461|Patients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 & beyond).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of MK2461 |  | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics. |  | 18 Months |
Safety of Overnight Corneal Reshaping Lenses

Study Overview
=================
Brief Summary
-----------------
This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.

Official Title
-----------------
Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses

Conditions
-----------------
Keratitis, Myopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients completing at least 3 months of wearing corneal reshaping lenses Exclusion Criteria: Less than 3 months of wearing corneal reshaping lenses
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 |
| --- | --- |
| Children<br> | |
| Adults<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial keratitis incidence | Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lens, Infection, Cornea
Chronic Hepatitis B and C Recall Northern Holland

Study Overview
=================
Brief Summary
-----------------
The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology laboratories will be explored for registered cases of cHB and cHC. Subsequently the investigators will compare the registered cases with the list of known cHB and cHC patients in hospital care. Patients lost to follow up will be informed and approached via either the Public Health Service (PHS) or their primary care physician. Identified patients will be invited for re-evaluation at the regional hepatitis centre (The North Western Hospital, formerly Medical Centre Alkmaar) to assess the current status of their chronic disease. Evaluation will be performed in accordance with (inter-)national guidelines, no extra interventions will be performed. After completion of re-evaluation, a final report will be made and send to both patient and primary care physician with recommendations for further follow-up.

Official Title
-----------------
Retrieval of Patients Chronically Infected With Hepatitis B or Hepatitis C in Northern Holland

Conditions
-----------------
Hepatitis B, Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic hepatitis B (two positive HBsAg measurements with an interval of 6 months) Diagnosis of chronic hepatitis C (two positive anti-HCV with an interval of 6 months) Exclusion Criteria: Already known in specialized care for chronic HBV or chronic HCV Cured from chronic HBV or chronic HCV
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic hepatitis B<br>Patients diagnosed with chronic hepatitis B | |
| Chronic hepatitis C<br>Patients diagnosed with chronic hepatitis C | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver-related morbidity | At baseline, development of liver related morbidity due to chronic viral hepatitis will be assessed. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recall study, Lost to follow-up
Heparin vs Placebo for Cardiac Catheterization

Study Overview
=================
Brief Summary
-----------------
Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

Detailed Description
-----------------
Patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU), high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.

Official Title
-----------------
A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Drug: Heparin
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation Exclusion Criteria: abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose heparin<br>heparin (25 IU/Kg -maximal dose 3,000 IU) | Drug: Heparin<br>* two doses of heparin<br>|
| Active Comparator: High dose heparin<br>heparin 50 IU/kg -maximal dose 5,000 IU | Drug: Heparin<br>* two doses of heparin<br>|
| Placebo Comparator: Placebo<br>Normal saline 0.9%. | Drug: Placebos<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematoma | >5 cm | 1 hour | 
| radial artery occlusion | by ultrasound | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| access site bleeding | any bleeding | 1 hour | 
| non access site bleeding | bleeding not related to access site, such as gastrointestinal | 1 day | 
| access site complications | pseudoaneurysm, arteriovenous fistula | 1 day | 
| wrist band duration | How long wrist band was on | 3 hours | 
| time to discharge | when patient was able to leave the post procedure care area | 1 day |