linjc16/ctgov huggingface dataset:
NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

Detailed Description
-----------------
Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Official Title
-----------------
An Open-label, Randomized, Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: NVP-1805
* Drug: NVP-1805-R1and NVP-1805-R2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult subjects who signed informed consent BMI of >18.0 kg/㎡ and <30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman) Exclusion Criteria: Subjects participated in another clinical trial within 6 months prior to administration of the study drug Inadequate subject for the clinical trial by the investigator's decision Subjects participated in another clinical trial within 6 months prior to administration of the study drug

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: single-dose, crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1805<br>NVP-1805 (80/10/20.8mg) | Drug: NVP-1805<br>* orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)<br>|
| Active Comparator: NVP-1805-R1 and NVP-1805-R2<br>coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg) | Drug: NVP-1805-R1and NVP-1805-R2<br>* orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of plasma: AUClast | period 1,2,3,4 | 0hours - 72hours | 
| Pharmacokinetics of plasma: Cmax | period 1,2,3,4 | 0hours - 72hours |
Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

Study Overview
=================
Brief Summary
-----------------
Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate the response to treatment. Sometimes the images obtained are not specific and the only way to establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to determine if multimodal MR technique will provide tissue signatures that differentiate between tumor progression and treatment related necrosis in high grade glioma patients.

Official Title
-----------------
DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

Conditions
-----------------
Recurrent High Grade Gliomas

Intervention / Treatment
-----------------
* Device: 3T MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven high grae glioma with central pathology review at DHMC Age 18 equal to or greater than 18 years Karnofsky performance greater or equal to 60% Patients must have received radiation therapy and chemotherapy but should not have received any anti-angiogenesis therapy. Exclusion Criteria: Any patient who requires urgent surgical resection of MRI abnormality would not be eligible Pregnant women are not eligible

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 |
| --- | --- |
| Research MRI<br>High Grade Glioma patients who show progression based on MRI | Device: 3T MRI<br>* The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prospectively acquire multiparameter MR variables at 1.5T and 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and radiation necrosis as established by pathologic examination. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T |  | 24 months |
Satisfaction Survey - Cicaplast Mains

Study Overview
=================
Brief Summary
-----------------
The participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. They are evaluated before and after treatment.

Detailed Description
-----------------
The international, open, observational survey is conducted in 3 different countries. Regarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes Satisfied + Very satisfied vs. Neither satisfied nor dissatisfied + Not so satisfied + Not at all satisfied. The 95% Confidence Interval (CI) of the percent of Satisfied + Very satisfied is also given. On patients who already used cream at the inclusion, the following analyses are performed: Cross-tabulation between both visits, Test of the evolution between both visits using a special procedure for ordinal data with repeated measures, Description of a summary variable in 3 classes (Improved / No change / Worsened). For the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. The difference Evaluation-Inclusion is also given. The evolution of the sign is performed by a Wilcoxon test for matched samples.

Official Title
-----------------
Satisfaction Survey - Cicaplast Mains

Conditions
-----------------
Hand Eczema, Hand Dermatoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: professionals that work on different activities related to hair in a beauty salon professionals presenting with current hand problems such as dryness, redness, irritations, cracks and fissures Exclusion Criteria: - professionals that do not meet the inclusion criteria

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction rate | satisfaction questionnaire with a 5-point scale | from baseline to Day28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of hands problems (dryness, redness, irritations, cracks, fissures) | evaluation on a 10-point scale (0 Not at all to 10 Very strong) | from baseline to Day28 |
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)

Study Overview
=================
Brief Summary
-----------------
This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.

Official Title
-----------------
Safety and the Efficacy of GSK Biologicals' Candidate Adjuvanted Vaccines (287615) Containing HBsAg With Various Adjuvants to Induce Cytotoxic T Lymphocytes (CTL) in Healthy Adult Volunteers

Conditions
-----------------
Hepatitis B Disease

Intervention / Treatment
-----------------
* Biological: 287615 containing HBsAg with adjuvants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between 18 and 40 years of age Written informed consent obtained from subject Female of non-childbearing potential Exclusion Criteria: Any hepatitis B vaccination. Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg Pregnancy or lactating female Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 287615 containing HBsAg with adjuvants|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of the CTL response at Week 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited symptoms (7 days), other AEs (up to 6 mths), SAEs (entire study), intensity of CTL response at Week 46, 48, 78; anti-HBs response up to week 78 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBsAg, Adjuvants
Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

Study Overview
=================
Brief Summary
-----------------
This study use an observational study design from patient medical records to obtain data on patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child patients.

Detailed Description
-----------------
All medical record data of LLA child patient at maintenance phase therapy, who came to Cipto Mangunkusumo Kiara Hospital in period 2014 - 2016. the data that are colected consist of age, gender, disease stratification, nutritional status, the dosage of 6-MP, albumin levels, hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.

Official Title
-----------------
Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy at Cipto Mangunkusumo Hospital and Its Affecting Factors

Conditions
-----------------
Acute Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014, with Inclusion Criteria: LLA Patients, male and female, age 1 - <18 years Received chemotherapy maintenance phase based on Indonesian protocol of ALL - 2013 Exclusion Criteria: Incomplete medical record data.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- | --- |
| The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy. | based on medical record data: Incidence of anemia, Neutropenia, and thrombocytopenia in acute limphoblastic leukemia children during maintenance phase therapy. | october 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of the incidence of hematotoxicity with influencing factors | The relationship of the incidence of hematotoxicity (anemia, Neutropenia, thrombocitopenia) with ALL stratification (High risk or Standard risk, as written in the medical record), nutritional status (normal or malnutrition), and albumin levels (normal or Hypoalbuminemia). The determination of nutritional status is based on body weight (Kg) and Height (Meters). Determination of nutritional status using cutoff Z score based on The growth chart of WHO 2006 for children 0-5 years, and ideal weight percentage according to Waterlow criteria for children above 5 years (recommendation of Indonesian Pediatric Association). | November 2017 |
Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).

Official Title
-----------------
Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: EO9(Apaziquone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder Patients who are confirmed to be urinary cytology negative (class I, class II) within 4 weeks prior to the present TURBT. P.S : 0-2 according to the ECOG. Exclusion Criteria: Patients with a primary and solitary tumor. CIS lesions in the bladder or a history thereof. Grade 3 disease or a history thereof. Patients experiencing recurrence within 3 months following TURBT for prior NMIBC. Patients having stage T1 and high-grade disease. Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof. Patients who received intravesical chemotherapy/immunotherapy treatment within 6 months prior to the present TURBT. Patients who underwent systemic chemotherapy or radiotherapy whose field of exposure included the bladder. Patients with suspected bladder perforation at the time of the present TURBT. A complication of a malignant tumor of the upper urinary tract or urethra, or a history thereof. Malignancy within 5 years other than NMIBC (except thyroid cancer) A serious viral or bacterial infection within the last 4 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EO9(Apaziquone)|immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics assessment of EO9 and it's metabolites in blood and urine |  | before, 30, 55, 90 mins of EO9 instillation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder cancer, EO9, Apaziquone
HD18 for Advanced Stages in Hodgkins Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.

Conditions
-----------------
Hodgkins Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: BEACOPP escalated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin Lymphoma (histologically proven) CS (PS) IIB with one or both of the risk factors: bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter) extranodal involvement CS (PS) III, IV Written informed consent Exclusion Criteria: Leucocytes < 3000/µl Platelets < 100000/µl Hodgkin´s lymphoma as composite lymphoma Activity index (WHO) < grade 2

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>8 cycles BEACOPPesc | Drug: BEACOPP escalated<br>* chemotherapy with BEACOPP escalated<br>|
| Experimental: B<br>8 cycles BEACOPPesc plus rituximab | Drug: Rituximab<br>* addition of Rituximab to BEACOPP escalated<br>Drug: BEACOPP escalated<br>* chemotherapy with BEACOPP escalated<br>|
| Active Comparator: C<br>8 cycles BEACOPPesc | Drug: BEACOPP escalated<br>* chemotherapy with BEACOPP escalated<br>|
| Experimental: D<br>4 cycles BEACOPPesc | Drug: BEACOPP escalated<br>* chemotherapy with BEACOPP escalated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 5 years | 
| acute toxicity |  | 5 years | 
| late toxicity |  | 5 years | 
| CR-rate |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin lymphoma, PET, advances stages, Rituximab
The Effect of Message Framing on Blood Donation-Study 2

Study Overview
=================
Brief Summary
-----------------
Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4 percent of the Han population. Therefore, low inventory is often found in blood collection and supply agencies in many regions in China. In order to assess the effects of the gain-versus-loss framing message on blood donation among Rh negative donors, we designed two kinds of self-administered, standardized and structured questionnaires. In addition of the basic socio-demographic characteristics, one questionnaire includes the questions which survey the attitude of saving patients lives, and the other was to survey the attitude of preventing patients from death. The questionnaires were randomly sent to Rh negative blood donors.

Official Title
-----------------
Saving a Life or Preventing a Death: the Effect of Message Framing on Blood Donation Among Rh Negative Donors

Conditions
-----------------
Rh Negative Blood Donor

Intervention / Treatment
-----------------
* Other: Gain-frame questionnaire
* Other: Loss-frame questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rh negative blood donors who have donated blood between 2016 and 2018. Exclusion Criteria: People who are Rh negative blood type but never have donated blood.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gain-frame questionnaire<br>Questionnaire included a picture of a patient lying in bed entitled Will you save his life? Donors in this group will answer the questions about attitude of saving patients' lives. | Other: Gain-frame questionnaire<br>* Questionnaires focusing on the attitude of saving patients' lives were given to Rh negative blood donors in this group.<br>|
| Experimental: Loss-frame questionnaire<br>Questionnaire included a picture of a patient lying in bed entitled Will you prevent him from death? Donors in this group will answer the questions about the attitude of preventing patients from death. | Other: Loss-frame questionnaire<br>* Questionnaires focusing on the attitude of preventing patients from death were given to Rh negative blood donors in this group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of attitude towards different massage framing | After participants view the picture in their questionnaires, they would answer the questions about attitude of saving patients' lives or preventing patients from death. | 1 day |