linjc16/ctgov huggingface dataset:
A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied. Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.

Official Title
-----------------
A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 (PEG-SN38) Administered Every 3 Weeks in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)

Conditions
-----------------
Advanced Solid Tumors, Lymphoma

Intervention / Treatment
-----------------
* Drug: EZN-2208


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy Measurable or evaluable disease Score of 0 to 2 on the ECOG performance scale Exclusion Criteria: Concurrent serious medical illness Known, clinically suspected, or history of central nervous system (CNS) tumor involvement Active diarrhea Known history of coagulation disorder Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EZN-2208|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the MTD of i.v. EZN-2208 administered q3wk and recommended Phase 2 dose of i.v. EZN-2208 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G as well as detect preliminary evidence of tumor response activity of EZN-2208 |  |  |
Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System

Study Overview
=================
Brief Summary
-----------------
The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.

Detailed Description
-----------------
Electronic Health Records based registries can be an important resource for precision medicine delivery by understanding the population burden of chronic diseases such as heart failure. These registries can allow for a deeper understanding of gaps in guideline recommended therapies among patients who are under the purview of large, integrated Therefore, we have created a live registry within the integrated Yale New Haven Health System-the Yale Heart Failure Registry-that includes all patients with a diagnosis of HF and has detailed information about demographics, comorbidities, laboratories, imaging, medications, and clinical outcomes (including hospital readmissions). The registry is updated daily and can be queried for clinically relevant questions aimed at quality improvement.

Official Title
-----------------
Retrospective and Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System Via a Live Registry

Conditions
-----------------
Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Heart Failure NYHA Class IV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seen within the Yale New Haven Health System Diagnosis of heart failure Exclusion Criteria: Age<18

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants hospitalized for heart failure | Heart Failure hospitalizations | 10 years | 
| Doses of therapies that comprise guideline directed medical therapy | Appropriate use of guideline recommended therapies. This will include doses of beta blockers, ACE inhibitors, ARBs, ARNI, SGLT2i, ICD use. | 10 years |
Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis

Study Overview
=================
Brief Summary
-----------------
There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.

Official Title
-----------------
Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: prednisolone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age at least 18 years diagnosis of SLE by ACR criteria diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV) currently on prednisolone (5 to 20 mg/day) in partial or complete remission for at least 3 months Exclusion Criteria: currently pregnant in end-stage renal failure receiving corticosteroids for an indication other than lupus nephritis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Long-term low-dose prednisolone (5 - 7.5 mg/day) | Drug: prednisolone<br>* 5 - 7.5 mg/day<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Matched placebo to prednisolone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (recruitment rate and protocol adherence) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) time to major renal and non-renal relapses of SLE 2) time to minor relapses of SLE 3) health related quality of life 4) adverse events/side-effects 5) accrual of SLE related organ damage 6) renal function |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
systemic lupus erythematosus, lupus nephritis
Effect of Pregabalin on the Postoperative Analgesia in RFA of Focal Lesions in the Liver

Study Overview
=================
Brief Summary
-----------------
The study aimed to investigate the preemptive analgesia efficacy of of preemptive pregabalin for the postoperative pain management after radiofrequency ablation (RFA) of liver cancer.

Detailed Description
-----------------
Our data will investigate if preemptive administration of pregabalin will have a role in reducing postoperative pain after radiofrequency ablation (RFA) of liver cancer.

Official Title
-----------------
Effect of Preoperative Administration of Oral Pregabalin on the Postoperative Analgesia in Patients Scheduled for Radiofrequency Ablationof Focal Lesions in the Liver

Conditions
-----------------
Hepatocellular Cancer

Intervention / Treatment
-----------------
* Drug: Pregabalin 150mg
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCC patients, Child A, B, scheduled for Radiofrequency ablation of HCC. Exclusion Criteria: Encephalopathy, Renal impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin<br>Pregabalin 150 mg before intervention | Drug: Pregabalin 150mg<br>* Pregabalin 150mg before RFA of liver cancer<br>* Other names: pregab;|
| Placebo Comparator: Placebo<br>Placebo before intervention | Other: Placebo<br>* Placebo before RFA of liver cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue pain scale (VAS Pain) post operatively | Amplitude of pain postoperatively | 2 weeks |
Halaven Post-Marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.

Official Title
-----------------
Post-Marketing Surveillance of Halaven Injection in Korean Patients

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study. This study will be conducted as complete surveillance method; participants who meet the inclusion/exclusion criteria and administrate Halaven for the first time after conclusion of agreement will be enrolled after consent. Inclusion Criteria: Participants who meet all of the following criteria will be eligible for inclusion in the study: Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane. Participants who have verbal or written consent for use of personal and medical information. Investigators will refer to indications regarding inclusion criteria. Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients Breast feeding Pregnancy Investigators will refer to indications and contraindications regarding exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Halaven<br>Participants who are prescribed with Halaven per approved prescribing information of Halaven. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response to Halaven treatment |  | Up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Halaven, Eribulin Mesylate, locally advanced or metastatic breast cancer
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children

Study Overview
=================
Brief Summary
-----------------
Fever is one of the most common problems in pediatrics. Differentiating between bacterial infections, that require antibiotic therapy, and viral infections that resolve on their own is an important challenge for physicians. C-reactive protein (CRP) is a protein that increases in response to inflammation and its level is generally higher in bacterial infections compared to viral infections. it can be measured by a simple blood test, however its utility as a sole marker for bacterial infection is limited. The hypothesis of the study is that measuring CRP velocity, e.g the value of CRP divided by the hours since the fever started will improve the utility of CRP for the diagnosis of bacterial infections in children.

Official Title
-----------------
CRP Velocity as a Marker for Bacterial Infections in Children

Conditions
-----------------
Bacterial Infections, Viral Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children less than 5 years of age, children with no comorbidities and fever > 38 for at least 24 hours, and children with no previous antibiotic therapy. Exclusion Criteria: HIV, immunosuppressive conditions, antibiotic therapy.

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| bacterial infection<br>children with fever due to bacterial infection | |
| viral infection<br>children with fever due to viral infection | |

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
-----------------
CRP velocity
CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the online cohort of EGID patients enrolled in the RDCRN CEGIR CR. In order to achieve this objective, the investigators will determine the agreement between self-reported EGID information by the enrollees and their physician's report and medical records. All participants enrolled in the RDCRN CEGIR CR with EGIDs will be invited via email to participate in this study.

Detailed Description
-----------------
All individuals with EGID and enrolled in the RDCRN CEGIR CR will be invited to participate in this survey. As of 04/28, 1567 EGID patients have enrolled in CEGIR CR [EoE=1,217, EG=56, EGE=65, EC=52; multiple diseases=177] The survey will be conducted through a pre-designed questionnaire. The questionnaire will be sent to participants via an introductory email wherein subjects will be informed about the purpose of this study. The questionnaire will gather self-reported clinical information (such as diagnosis, endoscopic procedures, histological findings in mucosal biopsies, and therapeutic plan). Consent will be obtained from participants to contact their physicians and allow their physicians to share relevant clinical information from their medical records. Physicians identified by participants will be emailed a website link which will take them to a questionnaire. This questionnaire is designed to gather relevant information as documented in the patient's clinical records. Physicians will be able to submit the information online. It is anticipated that responding to this questionnaire would take less than 10 minutes of their time.

Official Title
-----------------
CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry

Conditions
-----------------
Eosinophilic Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in the RDCRN CEGIR Contact Registry, and with Internet access. Diagnosis of EGID (EoE, EG, EGE, EE and/or EC) Age: all ages. Parents/guardian of children < 18 years of age will respond to the questionnaire on behalf of their child. Exclusion Criteria: Inability to provide informed consent and complete survey Unaffected family members of EGID patients European Union participants who did not complete General Data Protection Regulation requirements.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of EGID diagnosis | Assess the validity of self-reported EGID diagnosis by comparing to physician reports. | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eosinophilic Gastrointestinal Disorders
Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

Study Overview
=================
Brief Summary
-----------------
Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.

Detailed Description
-----------------
The objectives of this study are collect subject data on a near-infrared spectroscopy-based glucose meter evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.

Official Title
-----------------
An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

Conditions
-----------------
Insulin Dependent Diabetes, Non Insulin Dependent Diabetes, Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged ≥ 18 and ≤ 50 years of age at time of enrollment Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes. Exclusion Criteria: Severe heart disease as evidenced by peripheral edema (self reported) Currently taking Lasix (self reported) Liver disease as evidenced by jaundice (self reported) Receiving dialysis or having known renal compromise (self reported) Skin damage at optical sampling site Scars, tattoos, rashes or other disruption/discoloration on the right index finger Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported) Current chemotherapy, or chemotherapy within the past 12 months (self reported)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuing validation of near infrared spectroscopy-based glucose meter algorithm |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Gestational Diabetes, Female
Comparison of Two Embryo Culture Media for IVF and ICSI

Study Overview
=================
Brief Summary
-----------------
In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used.

Official Title
-----------------
Comparison of Two Embryo Culture Media for IVF (in Vitro Fertilization) and ICSI ( Intracytoplasmic Sperm Injection ): Randomized Prospective Study

Conditions
-----------------
Culture, ICSI, IVF

Intervention / Treatment
-----------------
* Biological: global medium
* Biological: SSM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any IVF and IVF with ICSI procedure performed in the unit can be included in the study Exclusion Criteria: refusal of patients to be randomized. In this case, the biologist chose the medium to be used and the IVF procedure will not be included in the statistical analysis

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: global medium<br> | Biological: global medium<br> <br> |
| Experimental: SSM<br> | Biological: SSM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pregnancies and deliveries |  | Up to 9 months |