linjc16/ctgov huggingface dataset:
Cephalosporin Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
Background : Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity. Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity. Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).

Official Title
-----------------
Drug Hypersensitivity Reactions To Cephalosporins

Conditions
-----------------
Drug Hypersensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with one or more ST and DPT tests to cephalosporins Exclusion criteria: - Patients refusing to take part in the study

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- | --- |
| Identify clinical variables associated with allergy to cephalosporins | Identify clinical variables associated with allergy to cephalosporins | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the risk variables associated with allergy to cephalosporins | Determine the risk variables associated with allergy to cephalosporins | 1 day | 
| To calculate the negative predictive value of cephalosporin DTP | In the subgroup of patients for whom we have data on readministration of a negatively tested cephalosporin following drug allergy work-up, we will calculate the negative predictive value of cephalosporin DPT. | 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Hypersensitivity Reaction, Drug Provocation Test, Cephalosporins, Betalactams, Risk Factor
Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Release for Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
To study the safety and clinical effects of intratumor injecting CpG-ODN and in situ release of tumor antigen by interventional ablation or drug-eluting beads to treat advanced solid tumors.

Detailed Description
-----------------
Percutaneous microwave ablation or intratumor injection of drug-eluting beads to destroy cancer cells to release tumor-specific antigens Intratumor injection of type A/C CpG-ODN with or without infusion of CAR-T cells secreting scFv against OX40 Assessing side effects and therapeutic efficacy after the combined treatments

Official Title
-----------------
Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Released by Interventional Approaches for Advanced Solid Tumors

Conditions
-----------------
Lung Cancer, Hepatocellular Carcinoma, Solid Tumor

Intervention / Treatment
-----------------
* Combination Product: CpG-ODN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid advanced malignant tumors Age between18 and 80 years Life expectancy is greater than three months Exclusion Criteria: Benign tumor Life expectancy is less than three months Serious medical comorbidity Others

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: CpG-ODN|CAR-T cells secreting scFv against OX40|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing safety and treatment efficacy on intratumor injection of CpG-ODN and in situ tumor antigen release for advanced tumors | Assessing incidence of side effects and primary clinical response of the intratumor injection of CpG-ODN and therpeutical in situ tumor antigen release for advanced tumors, including CR, PR, SD, and PD. | up to 36 months |
The Longevity Genes in Founder Populations Project

Study Overview
=================
Brief Summary
-----------------
We believe extreme longevity is due to specific genes which function to delay aging and prevent disease. The purpose of our research is to identify the genes/mutations associated with healthier aging; to understand the biological functions of these genes/mutations; and to develop therapies to replicate these preservative genetic activities in individuals who do not have the genetic profile for longevity.

Official Title
-----------------
Searching for Longevity Genes in the Historically Unique Ashkenazi Jewish Population

Conditions
-----------------
Extreme Longevity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ashkenazi Jewish, age 95+, Offspring of person age 95+, Offspring of parents who died age 70 or younger. Exclusion Criteria: Non-Ashkenazis

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Probands<br>Ashkenazi Jews ages 95 and older | |
| Offspring<br>Ashkenazi Jewish offspring of Ashkenazi Jewish parent(s) who lived to at least the age of 95 | |
| Controls<br>Ashkenazi Jewish people with no family history of longevity | |

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
-----------------
95 years of age and older
D-chiro-Inositol in Overweight Type 1 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral supplementation in addiction to folic acid compared to folic acid alone on glycaemic control as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin therapy. A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50 years (13 males, 13 females), with disease duration > 1 year and BMI >25, attending as outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome

Official Title
-----------------
A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: D-chiro-inositol
* Dietary Supplement: Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1D patients aged 17-50 years disease duration > 1 year BMI >25 Exclusion Criteria: learning disabilities presence of chronic conditions potentially able to influence daily activities (visual or auditory disability, motor impairment for neurological or orthopaedic problems). T1D patients affected from diabetic complications pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: 1 g D-chiro-Inositol + 400 mcg Folic Acid<br>1 g D-chiro-Inositol + 400 mcg folic acid once daily | Dietary Supplement: D-chiro-inositol<br>* Treated group<br>Dietary Supplement: Folic Acid<br>* Control group<br>|
| Active Comparator: 400 mcg folic<br>400 mcg folic acid only once daily | Dietary Supplement: Folic Acid<br>* Control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of DCI oral supplementation on metabolic control | efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI kg/m2 | reduction of BMI | 6 months | 
| Insulin Requirement (I.R.) IU/kg | reduction of I.R. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
D-Chiro-Inositol, type 1 diabetes
Retinal Ganglion Cell Layer in Patients With Intracerebral Processes

Study Overview
=================
Brief Summary
-----------------
Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans, retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in adults is considerable rare. It is, however, well established that retrograde transsynaptic degeneration affects other neural systems in humans even when the injury occurs during adulthood. Some histopathological evidence points to the possibility of transsynaptic degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults, but the clinical significance is unknown.' Purpose: To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to intracerebral processes. To correlate GCL with the localization and type of intracerebral lesion. To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2 parameters is more sensitive to show retinal layer abnormalities. To correlate GCL with visual field defects and electrophysiological parameters.

Conditions
-----------------
Ganglion Cells

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with intracerebral lesions within the central visual tract associated visual field defects investigations (OCT, ERG) possible Exclusion Criteria: lesions within the optic nerve without extension in the optic tract neurological disease optic disc anomalies: glaucoma, nystagmus, high myopia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Ganglion cell thickness |  | measurements will be taken at a minimum of 4 weeks after the inital diagnosis |
CMR for Prognosis Assessment in NSTEMI

Study Overview
=================
Brief Summary
-----------------
The prognostic significance of cardiac magnetic resonance (CMR) derived parameters of myocardial and microvascular injury has not been fully elucidated yet in non-ST-Elevation myocardial infarction (NSTEMI) patients. In the present study the investigators aim to comprehensively investigate the prognostic significance of CMR in a prospective, multicentre registry cohort of NSTEMI patients undergoing early percutaneous coronary intervention (PCI). CMR will be performed within the first week following the index event. The primary endpoint is defined as a composite of death, reinfarction, and new congestive heart failure (major adverse cardiac events) at 12 months.

Official Title
-----------------
Comprehensive Cardiac Magnetic Resonance Imaging For Prognosis Assessment After Non-ST-Elevation Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Cardiac magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible for the study if they have: 1) ischemic symptoms in accordance with a possible NSTEMI diagnosis; 2) elevated cardiac troponin levels above the 99th percentile; and 3) identifiable culprit lesion during early invasive coronary angiography with performed PCI. Exclusion Criteria: 1) STEMI; 2) presence of cardiogenic shock; 3) no identifiable culprit lesion or culprit lesion ineligible for PCI; 4) indication for acute bypass surgery; 5) age less than 18 years or more than 90 years; 6) pregnancy; and 7) typical contraindications to CMR (e.g. severe claustrophobia, implanted pacemakers and internal cardioverter defibrillators, cerebral or intracranial metallic implants, known allergy to gadolinium and creatinine clearance <30 mL/min).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cardiac magnetic resonance imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | Composite of death, reinfarction and new congestive heart failure | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-ST-elevation myocardial infarction, cardiac magnetic resonance, prognosis
Echocardiography During Ajmaline Test

Study Overview
=================
Brief Summary
-----------------
In this study the investigators analyse echocardiographic images before and during Ajmaline test. The purpose is to know if any echocardiographic modifications are present during either negative or positive Ajmaline testing.

Detailed Description
-----------------
The diagnosis of Brugada Syndrome is made when a type 1 pattern is present on the electrocardiogram (ECG), either spontaneously or after administration of a sodium channel blocker. For pathofysiological understanding, the investigators will analyse echocardiography images before and during the administration of Ajmaline. Comparing echocardiographies before and during negative Ajmaline test, will allow the investigators to indentify the effect of Ajmaline administration on cardiac function. The comparison between images of negative and positive Ajmaline tests will expose differences related to the occurence of a type 1 ECG.

Official Title
-----------------
Dynamicity of Echocardiography During Ajmaline Test

Conditions
-----------------
Brugada Syndrome

Intervention / Treatment
-----------------
* Drug: Ajmaline test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >17 years old clinical indication for Ajmaline test Exclusion Criteria: History of right ventricular outflow tract ablation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Negative Ajmaline test<br>No appearance of a type 1 ECG during Ajmaline test | Drug: Ajmaline test<br>* Administration of Ajmaline<br>* Other names: Echocardiography;|
| Positive Ajmaline test<br>Appearance of a type 1 ECG during Ajmaline test | Drug: Ajmaline test<br>* Administration of Ajmaline<br>* Other names: Echocardiography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speckle tracking strain measurement | Cardiac function assessed by speckle tracking peak strain and peak strain dispersion | 1 day at the time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ajmaline test
Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.

Detailed Description
-----------------
This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.

Official Title
-----------------
Retrospective Analysis of Response Markers and Adverse Events in a Nationwide Cohort of Advanced Melanoma Patients Treated With Pembrolizumab

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: Pemprolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.

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 |
| --- | --- |
| Patients treated with pemprolizumab<br>All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma. Patients will be included from all 14 WIN-O (Werkgroep Immunologie Nederland voor Oncologie) centers in the Netherlands. Patients are at least 18 years of age. | Drug: Pemprolizumab<br>* All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.<br>* Other names: MK3475;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early serum response markers | Serum markers: S100B, LDH, white blood count differential neutrophils, monocytes, lymphocytes, eosinophils, basophils. Markers will be correlated to early response as measured by RECIST 1.1 criteria at week 12 and 18 of treatment with pembrolizumab. | up to day 126 | 
| Predicitve patient characteristics | Patient characteristics: age, gender, WHO performance status | baseline | 
| Predictive tumor characteristics | Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status. | baseline | 
| Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall survival will be evaluated for all patients treated with pembrolizumab. | 2 years |
Home Electrocardiogram (ECG) Monitoring After Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
The long-term goal of this research is to apply novel technology for detection of donor organ (allograft) rejection to improve patient outcomes following heart transplantation. The specific goal of this study is to determine whether daily monitoring of the transplant recipient's electrocardiogram (ECG) using a simple home device with transmission to an ECG Core Laboratory would provide an early biomarker for acute rejection. Despite routine immunosuppressant drug therapy, acute rejection is common, especially within the first 6 months following transplant surgery. To detect rejection, frequent endomyocardial biopsies of heart tissue are performed. An endomyocardial biopsy is a costly and invasive procedure performed in a hospital cardiac catheterization laboratory that has associated risks. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization resulting in a longer QT interval on the ECG. The specific aims of the study are to: 1) determine whether an increase in the QT interval during the first 6 months following heart transplant is a sensitive and specific biomarker for acute rejection; and 2) determine the timing of QT interval increases relative to biopsy-diagnosed stages of mild/moderate/severe rejection. The potential benefit of finding a simple ECG biomarker of allograph rejection that could be measured at home is that it might yield earlier detection of rejection, allow more timely therapy and reduce mortality from acute allograft rejection.

Official Title
-----------------
Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation

Conditions
-----------------
Cardiac Transplant Rejection, Qt Interval, Variation in

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age first heart transplant surgery not enrolled in other research studies that conflict with study design Exclusion Criteria: clinically unstable at time of enrollment (i.e. clinical symptoms of allograph impairment)

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 |
| --- | --- | --- |
| number and grade of acute allograft rejection episodes |  | within one year after transplant surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year after transplant surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart transplantation, allograft rejection, QT interval, electrocardiogram (ECG)