linjc16/ctgov huggingface dataset:
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV

Study Overview
=================
Brief Summary
-----------------
To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.

Detailed Description
-----------------
Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.

Official Title
-----------------
Open-Label BV-araU Treatment of Pediatric HIV-Infected Patients With Cutaneous, Visceral, or Ocular Varicella-Zoster Viral Disease Who Have Failed or Are Intolerant of Standard Therapy

Conditions
-----------------
HIV Infections, Chickenpox

Intervention / Treatment
-----------------
* Drug: Sorivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. Cutaneous, visceral, or ocular varicella-zoster viral infection. Refractory or intolerant to acyclovir or foscarnet therapy. Consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Inability to take oral capsules or tolerate liquids. Concurrent Medication: Excluded: 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid. Patients with the following prior condition are excluded: History of immediate hypersensitivity to nucleoside analogues. Prior Medication: Excluded: 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry. Required: Prior acyclovir or foscarnet.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sorivudine|nan|

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
-----------------
Herpes Zoster, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, sorivudine, Chickenpox
Genetics and Fat Taste Sensitivity

Study Overview
=================
Brief Summary
-----------------
A cross-sectional quantitative study will be carried out; recruiting female, Caucasian participants aged 18-65 years. The relevance of candidate gene studies is disputed. Research has shown associations between genotype and total fat intake. However, food preference is often described as a result of exposure to food types during upbringing. Many single nucleotide polymorphisms (SNP) have been associated with fat taste sensitivity, the majority of research shows that with a reduced sensitivity comes a higher total fat consumption. This study aims to assess the relationship between rs1761667 genotype, body mass index, fat intake, fat taste sensitivity and fat taste preference.

Official Title
-----------------
The Relationship Between Genetics, Body Mass Index, Fat Intake, Fat Taste Sensitivity and Food Preference

Conditions
-----------------
Taste Sensitivity, Obesity

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: European Citizen. Caucasian Aged between 18-65 years. Female Exclusion Criteria: Currently following a diet or weight loss plan or have not been for over 6 months of the previous year. Suffering from diabetes (type I or II). Have cancer, or have not had cancer in the past. Smoker. Pregnant. Lactose intolerant .

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Whole Sample<br>Female, Caucasian participants aged 18-65 years. | Other: No Intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | September - November 2018 |
Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will collect tissue from patients undergoing trabeculectomy for primary open-angle glaucoma treatment. This tissue would normally be discarded. These trabecular meshwork (TM) cells can be cultured and used experimentally to better understand the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the trabeculectomy using established techniques.

Official Title
-----------------
Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having glaucoma and undergoing a trabeculotomy Sign ICF (Informed Consent Form) Exclusion Criteria: None

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 |
| --- | --- | --- |
| Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma. | TM cell biopsy samples from patients with glaucoma will be harvested and cultured in a laboratory setting to grow primary human TM cells. These cells will be used to test different medications, looking at the medications ability to reduce cellular pathologies commonly seen in TM tissue of patients with glaucoma. Pathologies include myocilin aggregation, and cell death. This will help researchers to determine the most effective compounds in treating glaucoma. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cultured TM cell toxicity caused by new glaucoma medications | Cultured primary TM cells treated with various new medications synthesized to treat cellular pathologies associated with glaucoma, will also be analyzed to look at toxicity caused by the treatments themselves. THis will help to determine the safety of these new medications prior to being administered to patients. | 6 weeks |
EEG@HOME (Phase 1 of the Project)

Study Overview
=================
Brief Summary
-----------------
The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined. In Phase 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, EEG registrations, daily life, ... . In addition EEG-technologists and neurologists will be interviewed about their experience with EEG registrations and what features their dream EEG-cap would have. The purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour. Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50 EEG-technologists or neurologists will be interviewed. The results of the interviews will be analysed by the design company pilipili nv.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epilepsy patient or EEG-technologist or neurologist Exclusion Criteria: No experience with EEG

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interview<br>Interview of epilepsy patients and their family about their experience with epilepsy, EEG registrations and daily life. Interview of EEG-technologists and neurologists about their experience with EEG registrations and expections when thinking of a ideal EEG-cap. | Other: Interview<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User wishes and expectations (questionnaire) |  | 1 hour |
Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .

Conditions
-----------------
Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
-----------------
* Procedure: Biliary cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Naive papilla, ERCP indication common bile duct cannulation Exclusion Criteria: No consent to the study Ongoing pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pancreatic sphincterotomy<br>Pancreatic sphincterotomy technique used in difficult biliary cannulation | Procedure: Biliary cannulation<br> <br> |
| Active Comparator: Double guide wire<br>Double guide wire technique used in difficult biliary cannulation | Procedure: Biliary cannulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post ERCP pancreatitis defined by ESGE guidelines published 2014 | Acute pancreatitis within 48 hours post ERCP. Post-ERCP pancreatitis (PEP) is defined as the presence of abdominal pain attributable to acute pancreatitis, together with a need for an unplanned hospitalization or an extension of a planned hospitalization by at least 2 days, and a serum /plasma amylase at least 3 times above the upper limit of normal at 24 hours after the procedure. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary cannulation success within 15 minutes after randomization | After randomization, timing to get the wire in biliary duct. First assessed the number of procedures succeeded in 15 minutes. | 15 minutes | 
| Biliary cannulation success, total number | The total number of successful biliary cannulations after randomization | 2 hours |
A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

Study Overview
=================
Brief Summary
-----------------
This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients 18 years of age and older Patients who are eligible and able to participate in the study Exclusion Criteria: Severe hypertension History or evidence of a secondary form of hypertension History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion/exclusion criteria may apply

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

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

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: aliskiren|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 8 weeks |  |  | 
| Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, aliskiren, blood pressure
Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

Study Overview
=================
Brief Summary
-----------------
Use of three intralymphatic injections of peanut allergen one month apart to induce tolerance to peanut in peanut allergic people.

Detailed Description
-----------------
Eligible subject undergo a baseline blinded oral peanut challenge. Then the peanut ILIT as described above. Pretreatment with antihistamines, leukotriene modifier and albuterol before each treatment. Following the three ILIT peanut injections a repeat blinded oral peanut challenge is performed. Blood is drawn at each of the 5 study visits for a variety of tests trying to elucidate the mechanism(s) of the induction of tolerance to peanut.

Official Title
-----------------
Intra-lymphatic Immunotherapy for the Management of Peanut Allergy

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

Intervention / Treatment
-----------------
* Biological: Peanut allergen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of peanut allergy Positive prick skin tests or invitro IgE to peanut Positive blinded oral peanut challenge. - Exclusion Criteria: History of life threatening anaphylaxis to peanut Uncontrolled asthma

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 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
Interventional Model Description: All subjects receive the study intervention: Peanut ILIT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Peanut ILIT | Biological: Peanut allergen<br>* Intralymphatic immunotherapy injections.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peanut tolerance | Increase in amount (mg - grams) of peanut ingested without reaction from baseline to one month post ILIT | 4 months |
Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event

Official Title
-----------------
Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis

Conditions
-----------------
Chronic Renal Failure, Peritoneal Dialysis

Intervention / Treatment
-----------------
* Device: Teleconsulting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient under peritoneal dialysis for more than three month Patient thought to be able to perform peritoneal dialysis alone or with the help of health care professionnals Patients or health care professionnals thought to be able to use telemedicine Exclusion Criteria: No DSL Network No GSM Network Patients who can not express their opposition to the participation to this study because of limited mental abilities

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 |
| --- | --- |
| Tele-consulting<br>One visit out of two takes place with teleconsulting and the other is a face-to-face consultation | Device: Teleconsulting<br> <br> * Other names: Telemedicine;|
| No tele-consulting<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe adverse events | Death, Peritonitis, acute pulmonary edema, symptomatic hyperkalemia or with EKG signs, severe and resistant hypertension, with uremia > 40 mmol/L | Within 2 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalisations |  | Within 2 years after enrollment | 
| Number of consultations |  | Within 2 years after enrollment | 
| Number of sanitary transportation |  | Within 2 years after enrollment | 
| Mean length of hospital stay |  | Within 2 years after enrollment | 
| Global costs |  | 6 months after the first patient enrollment | 
| Patients satisfaction |  | 1 year after enrollment | 
| Satisfaction of the professionnals |  | 6 months after enrollment of the first patient |
LCI-HEM-SPEC-001: Tissue Collection for Genetic Analysis of Acute Myelogenous Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain high quality specimens for molecular studies for the identification and characterization of genetic mutations involved in the pathogenesis of familial myeloid malignancies. Specimens obtained will be de-identified, linked to basic clinical data, and sent to Washington University (Division of Oncology, St. Louis, MO) for molecular analyses. Some specimens sent to Washington University may also be used for quality control analyses.

Detailed Description
-----------------
This is a specimen collection study for patients receiving standard of care treatment for AML. Specimens collected will be 1) bone marrow biopsy and aspiration, 2) peripheral blood, 3) skin punch biopsy, and 4) oral rinse. Collection of these specimens will be at timepoints determined by the patient's standard of care and their physician Investigator.

Official Title
-----------------
LCI-HEM-SPEC-001: Tissue Collection for Familial Acute Myelogenous Leukemia Genetic Analysis

Conditions
-----------------
Leukemia, Myelogenous, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have a diagnosis of acute myelogenous leukemia. Family members of patients with acute myelogenous leukemia may be enrolled. Informed consent must be provided by the patient or his/her legal guardian in accord with the practices of Levine Cancer Institute and Atrium Health. Exclusion Criteria Known infection with Hepatitis B or C, HTLV, or HIV.

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 |
| --- | --- |
| Patient<br>Specimen Collection | |
| Relative<br>Specimen Collection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with the mutation for acute myelogenous leukemia. |  | 60 months |