linjc16/ctgov huggingface dataset:
Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has in this patient population.

Official Title
-----------------
A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: IDEC-114


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed IRB-approved informed consent Greater than or equal to 18 years of age Proof of follicular lymphoma Progressive disease requiring treatment after at least 1 prior standard therapy Acceptable hematologic status, liver function, and renal function Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment Exclusion Criteria: No response to prior Rituxan® or Rituxan®-containing regimen Presence of CLL or CNS lymphoma Known history of HIV infection or AIDS Prior diagnosis of aggressive NHL or mantle-cell lymphoma Serious nonmalignant disease Pregnant or currently breast feeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: IDEC-114<br>* Dose Group 1 - 125 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study |  | March 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate PK |  | March 2010 | 
| To evaluate efficacy |  | March 2010 | 
| To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation |  | March 2010 |
Study to Identify the Reduction of Exacerbations Resulting in Hospital Admission in Patients With COPD.

Study Overview
=================
Brief Summary
-----------------
identification of the reduction of exacerbations resulting in hospital admission in COPD patients after the use of the Breath Detect telemedicine platform.

Official Title
-----------------
Identification of the Reduction of Exacerbations Resulting in Hospital Admission in COPD Patients After the Use of the Breath Detect Telemedicine Platform.

Conditions
-----------------
COPD Exacerbation

Intervention / Treatment
-----------------
* Diagnostic Test: Breath Detect Platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD diagnosed in GOLD II state or higher Exclusion Criteria: Can´t read and talk in spanish

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| COPD<br>Patients over 65 years old diagnosed with COPD in GOLD II state or higher who uses Breath Detect Platform for monitoring their respiratory health status. | Diagnostic Test: Breath Detect Platform<br>* Use of the Breath Detect platform for respiratory health monitoring.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital admissions due to exacerbations |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemedicine
Nurse Perspectives Regarding Use of the Labor Mirror

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to examine the views of Labor & Delivery nurses regarding use of the labor mirror during the active phase of the second stage of labor.

Detailed Description
-----------------
A survey link will be sent to Labor & delivery nurses via hospital group email. The nurses will be asked to share their experiences regarding the following: if use of the labor mirror helps patients push more effectively, how often patients accept the labor mirror, why they feel patients may decline use of the labor mirror, how often they offer the labor mirror to eligible patients, and a range of how long they have been a labor & delivery nurse at this facility. The survey is voluntary and the results are anonymous.

Official Title
-----------------
Nurse Perspectives Regarding Use of the Labor Mirror

Conditions
-----------------
Second Stage Labor

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Labor & Delivery Nurses at Mount Carmel East Hospital Exclusion Criteria: All others
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey|anonymous survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L&D Nurse views regarding use of the labor mirror | Does use of the labor mirror help patients push more effectively? | survey will be open for one month |
Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of Transfusion, One-year Graft Survival and Mortality. Cohort Study,

Study Overview
=================
Brief Summary
-----------------
RBC requirement ein DBD and DCD liver transplants

Detailed Description
-----------------
Background: Controlled donation after cardiac circulatory death (cDCD) is accepted to expand the donor pool for liver transplantation (LT). However, transfusion requirements and perioperative outcomes should be elucidated. The aims of this multicentre study are to assess the red blood cell (RBC) transfusions, one-year graft and patient survival after LT with cDCD compared to donors after brain dead (DBD). Methods: 591 LT patients conducted in ten centers during 2019 were reviewed. Thromboelastometry was used to manage coagulation and blood product transfusion in all centres. Normothermic regional perfusion was the standard technique for organ recovery.

Official Title
-----------------
Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of

Conditions
-----------------
Liver Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing LT Exclusion Criteria: acute liver failure

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 |
| --- | --- |
| liver donors<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC transfusion |  | intraoperative |
Prospective Studies of the Pathogenesis of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use structural and functional magnetic resonance imaging (MRI) to study children at high risk for schizophrenia. It is hypothesized that children at high risk for schizophrenia will have abnormalities of brain development, especially of the cerebral cortex. The study will also describe normal brain development in children from birth to age 6 years

Detailed Description
-----------------
We are currently following enrolled children at 4 and 6 years of age. We are obtaining structural MRIs and rsfMRIs. In addition, we are assessing cognitive function and behavior with Stanford-Binet, BRIEF and BASC.

Official Title
-----------------
Prospective Studies of the Pathogenesis of Schizophrenia (Center Title) Early Brain Development in High Risk Children (Project Title) Early Brain Development in One and Two Year Olds (Associated Grant Title)

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: control, offspring of mother with schizophrenia or bipolar illness; child with MVM Exclusion Criteria: major neurological or medical illness

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- | --- |
| Control<br>Typically developing | |
| Mild ventriculomegaly (MVM)<br>Fetal isolated mild ventriculomegaly | |
| Schizophrenia High Risk<br>Offspring of mothers with schizophrenia | |
| Bipolar High Risk<br>Offspring of mothers with schizophrenia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| magnetic resonance images (structural and functional) |  | birth, ages 1, 2 , 4 and 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive development |  | 0,1,2,4 and 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, brain development, MRI
Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis

Official Title
-----------------
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Biological: ABT-874
* Biological: etanercept
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Psoriasis for 6 mo. BSA 10%, PASI 12 or above, PGA 3 or above Exclusion Criteria: Previous exposure to either etanercept or ABT-874

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Biological: ABT-874<br>* SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8<br>|
| Active Comparator: B<br> | Biological: etanercept<br>* SQ injection 50 mg BIW<br>|
| Placebo Comparator: C<br> | Drug: placebo<br>* SQ placebo injections for ABT-874 and etanercept<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 |  | 12 Weeks | 
| Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12 |  | 12 Weeks |
The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: IDP-108
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed onychomycosis of the target nail Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected Has a positive KOH examination from the target nail Has a positive dermatophyte culture from the target nail Exclusion Criteria: Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-108<br> | Drug: IDP-108<br>* Topical application once a day for 48 weeks<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Topical application once a day for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who achieve clinical cure |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who achieve clinical efficacy |  | 52 weeks | 
| Percentage of patients who achieve mycologic cure |  | 52 weeks |
Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism

Study Overview
=================
Brief Summary
-----------------
Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.

Official Title
-----------------
Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism.

Conditions
-----------------
Infective Endocarditis

Intervention / Treatment
-----------------
* Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified Duke Exclusion Criteria: Age < 18 years Pregnancy and feeding Health not allowing to give the assent Innate abnormalities of the haemostasis More than a week before the inclu antibiothérapie adapted begun

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient<br> | Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test<br> <br> |
| Other: control<br> | Other: ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embolic events occurring during the antimicrobial treatment a |  | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation. |  | 30months |
Electrochemotherapy for the Inoperable Vulva Carcinoma

Study Overview
=================
Brief Summary
-----------------
Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma

Detailed Description
-----------------
Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .

Official Title
-----------------
Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma

Conditions
-----------------
Advanced Inoperable Vulva Carcinoma

Intervention / Treatment
-----------------
* Procedure: Electrochemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age ≥ 55 years (postmenopausal) histologically proved cutan accessible vulva carcinoma a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm applied electrochemotherapy with electroporation Exclusion Criteria: Non compliant patients Patients with symptomatic or rapidly progredient metastasis outside of the vulva

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECT<br> | Procedure: Electrochemotherapy<br>* Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local tumor control | according to RECIST criteria | Baseline | 
| Symptom control | exulceration, secretion | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality | EORTC QLQ | Baseline, 3, 6 months | 
| Pain | Visual scale | Baseline, 3, 6 months |
Dose-Exposure-Response in Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).

Official Title
-----------------
Dose-Exposure-Response Relationship of Insulin Glulisine (HMR1964) in Subjects With Type 1 Diabetes Mellitus Assessed With the Euglycemic Clamp Technique Using the Biostator (TM)

Conditions
-----------------
Diabetes Mellitus, Type I

Intervention / Treatment
-----------------
* Drug: Insulin glulisine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin glulisine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measures: Glucose infusion rate, insulin concentrations. |  |  | 
| Outcome:In T1DM, glulisine, like RHI, displays dose proportionality in exposure over the dose range 0.075 to 0.3 U/kg, which partly only translates into dose proportionality in glucodynamics. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin glulisine, Euglycaemic clamp, Diabetes mellitus Type 1