linjc16/ctgov huggingface dataset:
ONO-4538 Phase I Study in Patients With Solid Tumor

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.

Official Title
-----------------
ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor

Conditions
-----------------
Advanced Solid Tumors, Recurrent Solid Tumors

Intervention / Treatment
-----------------
* Drug: ONO-4538


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The treatment phase has been completed in the ONO-4538-13 study Exclusion Criteria: The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study. It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: ONO-4538 1mg/kg<br>ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle | Drug: ONO-4538<br> <br> |
| Experimental: ONO-4538 3mg/kg<br>ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle | Drug: ONO-4538<br> <br> |
| Experimental: ONO-4538 10mg/kg<br>ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle | Drug: ONO-4538<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcome: The number of subjects with overall adverse events |  | Approximately 6 months | 
| Safety outcome: The number of deaths |  | Approximately 6 months | 
| PK outcome: Cmax of ONO-4538 |  | Approximately 10 months | 
| Efficacy outcome: Response rate |  | Approximately 6 months | 
| Efficacy outcome: Progression free survival |  | Approximately 6 months |
Expanded Access for KHK2455

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program for eligible participants. This program is designed to provide access to KHK2455 in combination with Mogamulizumab prior to the approval by the local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving this investigational therapy based on the individual patients medical history and eligibility criteria.

Official Title
-----------------
Expanded Access for KHK2455

Conditions
-----------------
Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Drug: KHK2455


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: KHK2455|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Childhood Origins of Asthma (COAST)

Study Overview
=================
Brief Summary
-----------------
Although asthma is likely to be a heterogeneous disease or syndrome, three factors and/or events repetitively emerge for their ability to significantly influence asthma inception in the first decade of life: immune response aberrations, which appear to be defined best by the concept of cytokine dysregulation; lower respiratory tract infections (in particular RSV); and some form of gene by environment interaction that needs to occur at a critical time period in the development of the immune system or the lung. It remains to be firmly established, however, how any one or all of these factors, either independently or interactively, influence the development of childhood asthma. Thus, our efforts to determine and define the importance of these three factors to asthma pathogenesis are the focus and goal of this current grant application.

Detailed Description
-----------------
No more description necessary.

Official Title
-----------------
Rhinovirus Infection and Asthma in Childhood and Adolescents

Conditions
-----------------
Asthma, Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children who had one or more parent with a history of allergy or asthma Exclusion Criteria: pre term infants low birth weight infants respiratory distress at birth

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 2 Minutes

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 |
| --- | --- | --- |
| Evaluate the children longitudinally for the inception and progression of asthma. | Clinical diagnosis of childhood asthma at age 6 years and older. | Birth through age 19 |
Safety and Efficacy Study in Infant With SBS

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group Trial to Assess the Efficacy and Safety of NTRA-9620 in Infants With Short Bowel Syndrome (SBS) Following Surgical Resection

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: NTRA-9620
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment. Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment. After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for nutrient absorption. Exclusion Criteria Subject has undergone any bowel lengthening procedure. Subject has a malabsorption disorder due to: congenital etiology (such as microvilli inclusion disease, tufting enteropathy) Untreated Hirchsprung's disease Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study. Subjects with hyperinsulinemia. Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 52 Weeks

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 |
| --- | --- |
| Experimental: NTRA-9620-A<br>NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day | Drug: NTRA-9620<br>* Oral daily dose<br>|
| Experimental: NTRA-9620-B<br>NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day | Drug: NTRA-9620<br>* Oral daily dose<br>|
| Placebo Comparator: Placebo<br>Placebo To be dosed orally for 24 weeks, 4 times/day | Drug: Placebo<br>* Oral daily dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in %PN/IV | Percent change in %PN/IV from baseline based on caloric intake | baseline and end of treatment or 24 weeks, whichever occurs first |
Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

Study Overview
=================
Brief Summary
-----------------
Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute, complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and sensory function. Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up cell debris, secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process. While this process occurs in most tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and other immune cells are relatively rare, and their activities curtailed by a biochemical mechanism known as immune privilege. In animal studies, it appears that incubated macrophages circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. The concept derives from the pioneering research of Prof. Michal Schwartz at the Weizmann Institute of Science.

Official Title
-----------------
A Phase II Multicenter, Randomized-Controlled Study to Evaluate the Safety and Efficacy of Autologous Incubated Macrophages for the Treatment of Patients With Complete Spinal Cord Injuries

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Procedure: Autologous Incubated Macrophages (cell therapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic SCI during last 14 days Age 16 to 65 years Complete spinal cord injury (ASIA A) Neurological level : C5 to T11 MRI showing lesion Exclusion Criteria: Women who are pregnant or breastfeeding Coma or other severe injury or disease Penetrating injury Ongoing mechanical ventilation Unsuitable based on MRI or other factor

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous Incubated Macrophages (cell therapy)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of ASIA grade |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory scores |  |  | 
| Motor scores |  |  | 
| Bladder and bowel function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paraplegia, quadraplegia, tetraplegia, paralysis, nerve regeneration, Acute, Complete SCI
History of Hepatitis C in Volunteer Blood Donors

Study Overview
=================
Brief Summary
-----------------
Hepatitis C is a disease of the liver caused by the Hepatitis C Virus (HCV). Patients with hepatitis C may feel well and show no signs or symptoms of being ill. However, researchers would like to study the long-term effects of this disease. Volunteer blood donors diagnosed with chronic hepatitis C viral (HCV) and various levels of liver enzyme activity will be offered a complete medical evaluation and liver biopsy. The tests will enable researchers to provide the patients with an idea of how severe their liver disease is. The virus and patient will be studied in order to understand why patients with hepatitis C develop different levels of liver damage.

Detailed Description
-----------------
A selected sample of volunteer blood donors with chronic hepatitis C viral (HCV) infection and various levels of serum aminotransferase activity will be offered a complete medical evaluation and liver biopsy to determine the severity of their liver disease. Various virological and host factors will be studied in an attempt to determine why patients with HCV infection develop differing degrees of liver disease.

Official Title
-----------------
Natural History of Chronic Hepatitis C Among Volunteer Blood Donors

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with chronic hepatitis C. Age 18 to 70 years, male or female. HCV infection indicated by the presence of anti-HCV (by ELISA and recombinant immunoblot assay [RIBA]). Written informed consent. Women must not be pregnant. Patients must not have significant systemic illnesses other than liver disease, including congestive heart failure, renal failure, uncontrolled diabetes mellitus. Patients must not have antiviral or immunosuppressive therapy within the last 6 months. Patients must not have HIV infection. Patients must not have contraindications to liver biopsy (mainly clotting abnormality (coumadin therapy, platelet count less than 50,000/cubic millimeter, prothrombin time more than 4 seconds beyond control)).
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aminotransferases, Anti-HCV, Blood Donors, HCV RNA, Hepatitis C, Liver Biopsy, Serum Aminotransferases, Transfusion
Long Term Barrett's Endoscopic Mucosal Resection Study

Study Overview
=================
Brief Summary
-----------------
Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).

Official Title
-----------------
Long Term Outcomes of Patients Undergoing Endoscopic Resection of Barrett's Oesophagus (BO) With High Grade Dysplasia (HGD) and Early Adenocarcinoma

Conditions
-----------------
Barretts Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or over Have or have had Barrett's Oesophagus Exclusion Criteria: Do not have Barrett's Oesophagus Have not had Barrett's Oesophagus resected at Westmead Hospital

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Post Barretts Excision<br>Patients who have undergone an EMR for Barretts Oesophagus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reviewing patients symptoms following resection | Patients will be contacted via phone and will be required to answer questions over the phone. Health questionnaires may also be sent at the patients request to complete and post back. | up to 3 years |
Rheumatic Diseases: Evaluation of Health LIteracy, Medication adhereNce and Knowledges

Study Overview
=================
Brief Summary
-----------------
A medication non-adherence is reported in chronic rheumatic diseases, in a context of complex and long-term treatments (injectable/per os targeted therapies, biosimilar...). Understanding and integrating the patient into a shared medical decision are key factors for adherence. From this perspective, the level of literacy (an individual's ability to find, understand and use health information) must be explored in order to adapt the communication of information. These are currently insufficiently adapted to the individual understanding of patients. In practice, literacy assessment is very poorly integrated into routine care, while several tools are validated in French. In rheumatology, foreign studies have shown that literacy is positively related to knowledge level. The results remain contradictory regarding its association with medication adherence. Today, the literacy level of patients with rheumatic diseases and its impact on adherence has not been studied in France, although these evaluations would be useful to adapt interventions individually. The acceptance of patients to complete a literacy assessment questionnaire during their care should also be analysed as a condition of its deployment.

Official Title
-----------------
Assessment of the Literacy Level of Patients With Chronic Rheumatic Diseases and Association With the Level of Knowledge and Medication Adherence: For a Better Integration of Patients' Literacy Levels Into Their Therapeutic Management.

Conditions
-----------------
Rheumatic Diseases, Treatment Adherence

Intervention / Treatment
-----------------
* Other: Interview patient


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient older than 18 years Having at least 6 months of disease-modifying rheumatic treatment (methotrexate and/or targeted treatment (anti-JAK) and/or subcutaneous biotherapies) Understanding French, With good visual acuity. Exclusion Criteria: Patients with cognitive disorders Pregnant, parturient and lactating women Persons deprived of their liberty Major persons who are subject to a legal protection measure (guardianship, curators) Persons not affiliated to a social security system

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

| Intervention/Treatment |
| --- |
|Other: Interview patient|to investigate an association between literacy level and medication adherence in patients with rheumatic diseases.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Literacy and medication levels | Correlation coefficient between literacy level (HLS-EU-16: European Health Literacy scale) and medication adherence level (CQR: Compliance Questionnaire Rheumatology). | At inclusion |
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

Study Overview
=================
Brief Summary
-----------------
Compare the long-term safety of pradefovir to adefovir dipivoxyl

Detailed Description
-----------------
Compare the long-term safety of pradefovir to adefovir dipivoxyl Monitor development of resistance Evaluate virologic and biochemical response

Official Title
-----------------
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: pradefovir mesylate
* Drug: adefovir dipivoxyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed 48 weeks of treatment in study RNA200103-201 Exclusion Criteria: Patients who were determined to be treatment failures in study RNA200103-201 Patients who experienced a serious adverse event judged to be related to study drug in study RNA200103-201 Patients with a serum creatinine greater than 2.0 mg/dl on two consecutive determinations in study RNA200103-201

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pradefovir mesylate|nan|
|Drug: adefovir dipivoxyl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Safety: Clinical examinations of laboratory tests |  |  | 
| - Efficacy: Change in viral load over time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Efficacy: Proportion of patients with undetectable viral load |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, Chronic, Hepatitis B Virus, Pradefovir Mesylate, Adefovir Dipivoxyl
Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main objectives of this study is to calculate mortality probability by two different risk score system and to inquire effects of informing anesthesiologist and surgical team; of score of the patient; on length of hospitalization and intensive care and also on actualized mortality.

Official Title
-----------------
Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients

Conditions
-----------------
Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA anesthesia risk group 2-5 patients between 18-70 years of age and with planned cardiac surgery Exclusion Criteria: Terminal malignant diagnosis, multiple organ failure, confirmed brain dead, mechanical ventilation dependent or planned transplantation patients

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 |
| --- | --- |
| ASA<br> | |
| ASA+Euroscore<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of days the patients treated |  | 30 days | 
| mortality |  | With in the 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Length, hospitalization, cardiac surgery, patients, Mortality