linjc16/ctgov huggingface dataset:
Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies

Study Overview
=================
Brief Summary
-----------------
Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer.

Official Title
-----------------
A Phase 1, Open-label, Dose-escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies Or Non-Hodgkin's Lymphoma

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: SNX-5422


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old histologically confirmed solid tumor malignancy refractory to available therapy or for which no therapy is available adequate organ function Exclusion Criteria: CNS malignancy significant GI disease at risk for prolonged QT interval

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: Single Arm<br> | Drug: SNX-5422<br>* dose escalated, tablets every other day; undetermined duration until disease progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events and other safety assessments |  | continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response measured by X-rays or scans |  | after every 2 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid tumor malignancy; Hsp90
Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.

Official Title
-----------------
Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study

Conditions
-----------------
Emergencies

Intervention / Treatment
-----------------
* Device: Masimo Pronto 7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: emergency unit patients requiring an hemoglobin determination Exclusion Criteria: none

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Device: Masimo Pronto 7<br>* non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of Masimo Pronto 7 | correlation, Bland and Altman analysis | 6 months |
Treating Drug-Resistant Childhood Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.

Detailed Description
-----------------
Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic. Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment. Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.

Official Title
-----------------
Treating Refractory Childhood Schizophrenia

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

Intervention / Treatment
-----------------
* Drug: Olanzapine
* Drug: Clozapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder Willingness to use an acceptable form of birth control, if applicable Exclusion Criteria: Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine IQ less than 70 DSM-IV criteria for substance (other than caffeine or nicotine) related disorder Failure of an adequate trial of olanzapine or clozapine

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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> | Drug: Olanzapine<br>* Participants will receive olanzapine for 12 weeks.<br>|
| Active Comparator: 2<br> | Drug: Clozapine<br>* Participants will receive 12 weeks of clozapine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic, manic, aggressive, and depressive symptoms |  | Measured over 12 weeks |
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.

Detailed Description
-----------------
A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children

Official Title
-----------------
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children : A Prospective, Randomized, Double-blind, Placebo Controlled Trial.

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children between the age of 5 years and 15 years with the diagnosis of recurrent acute sinusitis who are attending the outpatient pediatric department, pediatric allergy clinic, and the ear, nose, throat clinic. Exclusion Criteria: patients who have allergic rhinitis, chronic sinusitis, a history of allergic reactions to azithromycin or macrolides, treatments with immunotherapy or IVIG or gentamycin solution or pneumococcal vaccine during study period.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: azithromycin<br>azithrimycin 3 days/week | Drug: azithromycin<br>* azithromycin 3 days/week<br>* Other names: treatment;|
| Placebo Comparator: placebo<br>placebo 3 days/week | Drug: placebo<br>* placebo tablet or syrup 3 days/week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequence of acute sinusitis during 12 mouths of study period |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sinusitis, azithromycin
Protocol-Specified Modification of Immunosuppression Directed to Protocol Biopsy in Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated.

Detailed Description
-----------------
The present randomized-controlled trial in kidney transplant patients aims to compare the outcomes and complications between who underwent immunosuppessive drug modification under surveillance-protocol biopsy and who underwent immunosuppressive drug modification following tough level only.

Official Title
-----------------
The Outcomes of Protocol-Specified Modification of Immunosuppression Directed to Histological Diagnosis by Surveillance Protocol Biopsy

Conditions
-----------------
Surveillance Protocol Biopsy

Intervention / Treatment
-----------------
* Procedure: Surveillance protocol kidney allograft biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All kidney transplant recipients underwent transplantation at Chulalongkorn University Exclusion Criteria: Pregnancy Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc. Non-cooperated recipients

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-biopsy<br>Population in this arm will be adjusted immunosuppressive drug only from the result of tough level. | |
| Experimental: Protocol biopsy<br>Population in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level. | Procedure: Surveillance protocol kidney allograft biopsy<br>* Surveillance protocol biopsy under ultrasound-guided will perform at post-operative day 7, month 3, month 6, month 12, and month 24<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | 24 h-CrCl | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal pathology | interstitial fibrosis, rejection, calcineurin inhibitor toxicity | 24 months | 
| Complications | hematoma, arteriovenous fistula | immediate, 1 month |
Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the safety and efficacy of the combination of imatinib and vinorelbine in patients with advanced, anthracycline resistant breast cancer

Official Title
-----------------
Open-label Trial of Imatinib in Combination With Vinorelbine for Patients With Advanced Breast Carcinoma: ICON

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

Intervention / Treatment
-----------------
* Drug: Imatinib and Vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic Previous anthracycline containing chemotherapy Presence of a certain protein on the cell surface (c-kit (CD117) and /or PDGF-receptor) Preferably tumor samples should be taken within 6 weeks of study entry. Most recent primary tumor tissue has to be available for analysis Acceptable health status (Eastern Cooperative Oncology Group [ECOG]-performance status 0,1, 2 or 3) Exclusion criteria: (for the second-line therapy) Patient with Grade III/IV cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). Patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (HIV) infection. Patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing. Patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry. Patient received either Vinorelbine or Imatinib in previous treatment regimens Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Imatinib + Vinorelbine<br> | Drug: Imatinib and Vinorelbine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) |  | at least 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Tyrosine inhibitor, Chemotherapy, Imatinib
Study of Epratuzumab in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Official Title
-----------------
A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: Epratuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have completed SL0003 Alleviate A through 48 weeks Exclusion Criteria: Development of toxicity to Epratuzumab Significant protocol deviations from SL0003 Study.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To continue to assess the efficacy and tolerability of epratuzumab; |  |  | 
| To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; |  |  | 
| To continue to assess epratuzumab on Health-related quality of life in lupus patients; |  |  | 
| To continue to assess disease status as reported by the patient and physician. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus,, Antibody,, B-Cell immunotherapy
MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop, evaluate, and optimize MigraineManager, the first web-based comprehensive self-management tool for adolescents with migraine, their parents, and clinicians.

Official Title
-----------------
MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Behavioral: MigraineManager: Individualized Self-Management Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is diagnosed with migraines using current International Classification of Headache Disorders criteria (ICHD-3 beta) for migraine with or without aura Patient has headache frequency of 8+ per month Access to the internet whether public (e.g., library) or private (e.g., home, personal) English fluency for patient, caregiver, and clinician Exclusion Criteria: Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of Optimized Prototype<br>Patients and parents will use MigraineManager to complete assessment measures at baseline and post-treatment (i.e., 2 months after baseline). Answers to these measures will determine what interventions each participant will receive. Data obtained in this phase will be used to make final modifications to MigraineManager for large scale testing. | Behavioral: MigraineManager: Individualized Self-Management Tool<br>* Answers provided during the online assessment will result in certain intervention recommendations. Once assessments are completed, a treatment plan will be automatically generated for patient and parent guidance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency | change in number of days with headache | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine
Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP

Study Overview
=================
Brief Summary
-----------------
Multicenter retrospective and prospective observational study based on the collection of sequential anonymized data from principal Italian ITP centers, to describe the clinical course of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patients developing de novo ITP.

Detailed Description
-----------------
Multicenter retrospective and prospective observational study based on the collection - through pre-piloted electronic CRFs - of sequential anonymized data from principal Italian ITP centers representative of national geographical distribution, to evaluate, during a 2-years study period, both the cumulative incidence COVID-19 occurring in patients with prior or ongoing ITP (COVID-19 in ITP) and the cumulative incidence of de novo ITP manifesting during COVID-19 (ITP in COVID-19). Data will be collected to describe the clinical course of patients in the two groups. The enrolment period will last 24 months or terminate at the last day of 1-month-COVID-19 free in Italy, whichever comes first. Each patient will be followed up to the first visit scheduled as per common center practice, including at least six months after hospital discharge or end of quarantine home confinement.

Official Title
-----------------
IMMUNE THROMBOCYTOPENIA (ITP) AND COVID-19: National Retrospective and Prospective Observational Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP

Conditions
-----------------
Immune Thrombocytopenia, ITP, Covid19, ITP Secondary to Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Confirmed diagnosed of ITP (ITP could be past, ongoing, persistent >3 months, chronic >12 months) in patients that are in regular follow-up (at least once a year) and who have been diagnosed with COVID-19 All patients who develop de novo ITP from 1st January 2020 to the end of study after a diagnosis of COVID-19 or during the first 6 months after COVID-19 recovery Signed informed consent Exclusion Criteria: • All subjects not fitting inclusion criteria

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 of ITP patients in which COVID-19 occurs | Cumulative incidence of COVID-19 in adult patients with already known/ongoing ITP | 24 months | 
| Number of COVID-19 patients developing ITP | Cumulative incidence of adult patients with COVID-19 developing de novo ITP | 24 months |