linjc16/ctgov huggingface dataset:
A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. To observe the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS rate, 2-year OS rate, and CR rate in newly diagnosed ENKTCL patients; and to clarify the prognostic stratification ability of PINK-cpgE compared with PINK-E

Official Title
-----------------
Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma

Conditions
-----------------
Extranodal Natural Killer/T-cell Lymphoma

Intervention / Treatment
-----------------
* Diagnostic Test: circulate free methylated EBV DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed ENKTCL confirmed by pathological tissue, the diagnostic criteria refer to the 2016 WHO diagnostic criteria Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol Exclusion Criteria: The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: circulate free methylated EBV DNA predicts PFS rate in ENKTCL<br> | Diagnostic Test: circulate free methylated EBV DNA<br>* Accuracy of circulating free methylated EBV DNA in predicting 2-year PFS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients |  | 2 years |
Glioma Developmental and HyperActive Ras Tumor (DHART) Board

Study Overview
=================
Brief Summary
-----------------
This study will collect medical records, scan results, and complete surveys to create a registry about people with a neurofibromatosis type 1-associated brain tumor (NF1-associated glioma). A registry is a collection of health information about individuals, and it is usually focused on a specific diagnosis or condition. This registry study will help the researchers learn more about the diagnosis, treatment, and quality of life of people with NF1-associated glioma. The researchers want to understand what happens as a result of different treatments for NF1-associated glioma and how these treatments and the disease itself affect people's lives over a period of time. Information collected during this study could affect how doctors diagnose, test, and treat NF1-associated glioma, and the study could help future patients with this type of cancer.

Official Title
-----------------
Glioma Developmental and HyperActive Ras Tumor (DHART) Board

Conditions
-----------------
Glioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis that meets NIH criteria for NF1 disease by either 1) documented clinical record establishing NF1 or 2) self-reported with supported documentation upon medical record collection. Willing to have historical and future NF1 related health records sent to registry for review. Radiologic or pathologically confirmed glioma. Individuals ≥18 years of age on the date of informed consent. Exclusion Criteria: Unwillingness to sign informed consent. No proficiency in English or Spanish as determined by the Investigator.

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 |
| --- | --- | --- |
| Registry of patients with Neurofibromatosis Type 1 (NF1) associated glioma | The overarching goal of the registry is to collect baseline and follow-up 1) clinical and 2) imaging data to have a centralized and living repository of information about the adult glioma NF1 patient population. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NF1-associated glioma, Neurofibromatosis, Registry, 22-199
Use of Alternative Therapy in Acne Vulgaris Patients

Study Overview
=================
Brief Summary
-----------------
Acne Vulgaris is a chronic skin disease. However, chronic and repetitive due to the quality of life and psychological status of patients can affect. Today, although the treatment is repetitive, chronic and requires follow-up due to the disease patients can turn to alternative and complementary medicine techniques. In recent years, studies on alternative medicine and complementary therapies have been noted in the medical literature. These studies also include Case Reports related to acne vulgaris. However, in our country, there is no study that tells us whether patients with acne vulgaris apply these treatments or not and what the practitioners think about the success of the treatment. The aim of the study will be to clarify issues such as whether patients with Acne Vulgaris apply alternative medicine and complementary therapies for their disease.

Official Title
-----------------
Use of Alternative Therapy in Acne Vulgaris Patients

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Behavioral: Acne Vulgaris


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne vulgaris Patients between age 12-60 Exclusion Criteria: the ones who don't want to answer the questions

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Acne Vulgaris|Alternative medicine and complementary therapies that acne vulgaris patients apply without informing the doctor, how they learn these techniques, what make them use these techniques for their illness|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acne vulgaris questionnaire | Alternative medicine and complementary therapies that acne vulgaris patients apply without informing the doctor, how they learn these techniques, what make them use these techniques for their illness | september 2020 |
Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing

Study Overview
=================
Brief Summary
-----------------
Next Generation Sequencing (NGS) strategy is a powerful tool to identify genes implicated in very rare diseases for which the previous genetic explorations remain negative to date. The aim of this project is based on groups of patients with original clinical phenotypes including neurosensory impairment without genetic cause identified to date. The investigators will study these families using whole exome sequencing to potentially identify new genes and new underlying biological pathways involved in neurosensory diseases.

Official Title
-----------------
Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing

Conditions
-----------------
Neurosensory Diseases, Retinopathy, Hearing Loss

Intervention / Treatment
-----------------
* Genetic: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Original phenotype with neurosensory diseases Written, informed consent obtained Exclusion Criteria: Refusal to participate at the study Prior inclusion in a similar study (NGS)

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
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

| Intervention/Treatment |
| --- |
|Genetic: blood sampling|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole exome sequencing data |  | 21 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Whole exome sequencing
Physiologic Measure of VIPN

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the development of a physiologic endpoint using a novel technology that would provide an objective, easy to use and more sensitive assessment of VIPN in children and adolescents. The ability to more easily detect and monitor VIPN, even before it is clinically evident, would facilitate optimizing the dosing of vincristine for maximal disease response while minimizing the risk of lifelong functional deficits affecting quality of life. This approach would also enable the development of specific therapies to minimize or eliminate the occurrence of VIPN in children and adolescents. This is a single site study that aims to develop a novel device to evaluate and characterize vincristine-induced neuropathic pain. The investigators will enroll patients with ALL following the Delayed Intensification (DI) phase of treatment. At each study visit, the investigators will evaluate the nPRD as well as the TNS-PV. The nPRD will inform the neuropathy index which will be used to compare to the TNS-PV. We anticipate a correlation between the two.

Official Title
-----------------
Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents

Conditions
-----------------
Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
-----------------
* Other: No Intervention, Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-18 years of age at the start of the study, are receiving vincristine in DI (clinical study population) and are willing and able to provide informed consent or assent to study participation. Exclusion Criteria: have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| VIPN Patients<br> | Other: No Intervention, Observational Study<br>* No Intervention<br>|
| Healthy Volunteers<br> | Other: No Intervention, Observational Study<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of neuropathy index in patients with VIPN | The primary objective of this study is the characterization of the neuropathy index in VIPN patients in order to measure VIPN severity. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of neuropathy index with the TNS-PV | The secondary objective is the correlation between the TNS-PV and the neuropathy index. | 1 Year |
AchE Inhibitor and Insulin

Study Overview
=================
Brief Summary
-----------------
The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and insulin secretion response will be evaluated by measuring insulin and glucose at different time points. The test will be carried out twice, once without and once with the administration of a single dose of Pyridostigmine on two separate days. The investigator hypothesizes that inhibiting AChE will potentiate insulin secretion.

Official Title
-----------------
Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Pyridostigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Exclusion Criteria: BMI >30 Kg/m2 fasting glucose >100 Glycohemoglobin (Hemoglobin A1C) 5.7% or more History of asthma Use of medications that may interfere with glucose metabolism

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: IVGTT without pyridostigmine<br>An intravenous glucose tolerance test (IVGTT) will be performed without any medication for baseline comparison. | |
| Active Comparator: IVGTT with pyridostigmine<br>An IVGTT will be performed 2 hours after taking one single dose of pyridostigmine 60 mg | Drug: Pyridostigmine<br>* single oral dose of 60 mg pyridostigmine tablet<br>* Other names: Mestinon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First phase insulin response to IV glucose infusion | Insulin positive incremental area under the curve and the sum of plasma insulin values at 1 minute and 3 minutes after IV glucose infusion | -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose excursion after IV glucose infusion | Glucose positive incremental area under the curve | -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin secretion
Immune Homeostasis in Sepsis and Septic Shock

Study Overview
=================
Brief Summary
-----------------
Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.

Official Title
-----------------
Immune Homeostasis in Patients With Sepsis and Septic Shock: a Single Center Observational Study

Conditions
-----------------
Sepsis, Immunologic Paralysis, Immunologic Suppression, Immune Deficiency

Intervention / Treatment
-----------------
* Other: transcriptomics
* Other: flow-cytometry
* Other: cytokines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sepsis/septic shock (SEPSIS-3) age ≥18 informed consent inclusion within first 24hrs after development/diagnosis of septic shock Exclusion Criteria: disagreement of the patient or legal representative with the entry into the study patients with primary or secondary immunodeficiency presence of active haematological malignancy or an active non-haematological malignancy

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 |
| --- | --- |
| sepsis/septic shock<br>target population | Other: transcriptomics<br>* transcriptomics<br>Other: flow-cytometry<br>* peripheral blood myeloid cells and lymphocytes flow-cytometry<br>Other: cytokines<br>* peripheral blood cytokine analysis<br>|
| non-septic critically ill<br>demographically-matched control group | Other: transcriptomics<br>* transcriptomics<br>Other: flow-cytometry<br>* peripheral blood myeloid cells and lymphocytes flow-cytometry<br>Other: cytokines<br>* peripheral blood cytokine analysis<br>|
| healthy control<br>control group | Other: transcriptomics<br>* transcriptomics<br>Other: flow-cytometry<br>* peripheral blood myeloid cells and lymphocytes flow-cytometry<br>Other: cytokines<br>* peripheral blood cytokine analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response description - flow cytometry | Detailed description of immune response analyzed by mean of flow cytometry | 2024 - 2026 | 
| Immune response description - transcriptomics | Detailed description of immune response analyzed by mean of transcriptomic analysis | 2024 - 2026 | 
| Immune response description - ELISA | Detailed description of immune response analyzed by mean of ELISA | 2024 - 2026 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic immune status panel | Diagnostic tool for immune status assessment | 2026 - 2028 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, septic shock, immune response, immunoparalysis, transcriptomics, flow-cytometry, immunomodulation
An Extended Access Program (EAP) for Perampanel

Study Overview
=================
Brief Summary
-----------------
The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time that the appropriate formulation of perampanel becomes commercially available in the country in which they reside or until no participants remain in the EAP.

Official Title
-----------------
An Extended Access Program (EAP) for Perampanel

Conditions
-----------------
Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome

Intervention / Treatment
-----------------
* Drug: Perampanel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participants who have completed their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338, or who are being rolled over from EAP E2007-G000-401 and, who in the opinion of the treating physician, continue to demonstrate a positive benefit-to-risk ratio from treatment with perampanel. Participants who provide informed consent where applicable per local requirements. Female participants of childbearing potential must agree for the duration of the program and for a period of at least 1 month following last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (example, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]). Exclusion criteria: Participants who reside in countries where the appropriate formulation of perampanel is commercially available. Female participants who are nursing, pregnant, or planning to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Perampanel|Perampanel will be available in 2-milligrams (mg), 4-mg and 8-mg tablets and as 0.5 milligram per milliliter (mg/mL) oral suspension. Participants will start this EAP with the dose that they were receiving at the end of their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401. Doses of perampanel can be adjusted based on clinical judgment.|

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
-----------------
Perampanel, Fycompa, Primary Generalized Tonic-Clonic Seizures, E2007-G000-332, E2007
Pharmacokinetics and Pharmacdynamics of Sildenafil

Study Overview
=================
Brief Summary
-----------------
The study is being done to investigate what happens to sildenafil in the body and how long it takes to get rid of this drug. Understanding how long the drug stays in the body and how it is changed by the body will help doctors determine the best dose. We also want to learn how well the medicine works based on the size of the dose or amount in the bloodstream.

Detailed Description
-----------------
There is no data regarding sildenafil drug disposition in infants and children with pulmonary hypertension. Sildenafil is used at The Children's Hospital of Philadelphia for the treatment of pulmonary hypertension. Patients receiving sildenafil as standard of care will be approached for consent.

Official Title
-----------------
The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Procedure: Obtain blood specimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receive enteral sildenafil as standard of care > 28 days to >18 years of age Informed consent/assent Exclusion Criteria: Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.

Ages Eligible for Study
-----------------
Minimum Age: 28 Days

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>Patients receiving sildenafil as standard of care | Procedure: Obtain blood specimens<br>* Obtain blood samples at multiple timepoints.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension |  | predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension. |  | Multiple time points throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sildenafil, Pediatrics