linjc16/ctgov huggingface dataset:
Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who have progressive disease after first line treatment with checkpoint inhibitors. Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib. CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. Disease status will be determined at the site (ie. Investigator and/or radiologist) using RECIST version 1.1. The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with SD/PR/CR per RECIST 1.1.

Official Title
-----------------
An Observational Study to Evaluate the Safety and Efficacy of Lenvatinib in HCC Subjects Who Have Progressive Disease After First Line Treatment With Checkpoint Inhibitors

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Lenvatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old on the day of consent Capable of understanding and complying with the protocol requirements and signed informed consent Documented histological or cytological diagnosis of HCC HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1 Exclusion Criteria: Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma Prior TKI treatment

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 |
| --- | --- |
| Lenvatinib<br>Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib. | Drug: Lenvatinib<br>* Prescribed by physician.<br>* Other names: E7080;|
| Non-Lenvatinib<br>Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RR) | It is the sum of the proportion of stable disease (SD), complete response (CR) and partial response(PR) per RECIST 1.1. That is, RR = SD + CR + PR | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | An adverse event (AE) refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v4.0 were recorded. | 12 month |
ICG- Livertest Versus New Biomarkers as Prognostic Markers in Critically Ill ICG- Livertest Versus New Biomarkers as Prognostic Markers in Critically Ill

Study Overview
=================
Brief Summary
-----------------
ICG- Leberfunktionstest versus neue Biomarker als prognostischer Marker bei intensivmedizischen Patienten

Official Title
-----------------
ICG- Livertest Versus New Biomarkers as Prognostic Markers in Critically Ill

Conditions
-----------------
Critically Ill Patients

Intervention / Treatment
-----------------
* Procedure: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Gruppe 1: Intensiv-Patienten mit Verbrennungen > 10% der Körperoberfläche Alter > 18 Gruppe 2: Intensivpatienten nach grossen chirurgischen Eingriffen Alter > 18 Gruppe 3: Polytraumatisierte, intensivpflichtige Patienten Alter > 18 Exclusion criteria: • Alter < 18 Schwangerschaft Einschluss in eine andere Studie Moribunde Patienten Patienten, die kein Deutsch verstehen Jodunverträglichkeit

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 |
| --- | --- |
| ICU patients<br>Admitted patients to the ICU | Procedure: Observational<br>* Blood draw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.

Official Title
-----------------
An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Sitaxentan sodium/Placebo
* Drug: Sitaxentan sodium/Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the age of 18 and 55 years, inclusive. Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight >45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error. Exclusion Criteria: Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Japanese Cohort<br>Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects. | Drug: Sitaxentan sodium/Placebo<br>* 100 mg and 200 mg, tablet, single and multiple oral doses for 7 days<br>* Other names: Thelin;|
| Experimental: Western Cohort<br>Single oral dose of sitaxentan sodium in 10 healthy subjects. | Drug: Sitaxentan sodium/Placebo<br>* 100 mg and 200 mg, tablet, single oral dose<br>* Other names: Thelin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (spontaneous and solicited) |  | Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2 | 
| ECGs, Vital signs, Safety laboratory test |  | Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2 | 
| Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F |  | Day 1 of Periods 1 and 2 | 
| Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss |  | Days 1 and 7 of Periods 1 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcome |  | No secondary outcome |
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

Study Overview
=================
Brief Summary
-----------------
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day

Official Title
-----------------
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ITCA 650 (exenatide in DUROS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women age 18 to 80 years with type 2 diabetes On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs HbA1c >10.0% and ≤12.0% Exclusion Criteria: Prior treatment with any GLP-1 receptor agonist History of hypersensitivity to exenatide or liraglutide FPG >300 mg/dL History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2 Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months history of pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: ITCA 650<br> | Drug: ITCA 650 (exenatide in DUROS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between Week 39 and Day 0 |  | 39 weeks |
18349-Human Photoallergy Test

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential of a test material to produce a photoallergic response.

Official Title
-----------------
Human Photoallergy Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Other: Sunscreen Lotion , BAY 987521
* Other: Untreated skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products. subjects who are employees of the CRO and/or Bayer or is a household member of an employee

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>All subjects are patched with the same product | Other: Sunscreen Lotion , BAY 987521<br>* 50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. Formulation A: Y49-103, Formulation B: Y71-150.<br>Other: Untreated skin<br>* One site is patched without treatment as control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions is evaluated by 5 point scale |  | Up to 72 hours |
A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations

Study Overview
=================
Brief Summary
-----------------
To determine the prognostic implication of plasma Epstein-Bar Virus (EBV) DNA concentrations, as measured by quantitative polymerase chain reaction (PCR) in patients with nasopharyngeal carcinoma (NPC). To relate pretreatment plasma EBV DNA concentration to WHO classification of these tumors both in endemic and non-endemic areas. To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for both endemic and non-endemic patient populations.

Official Title
-----------------
A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations

Conditions
-----------------
Mouth Cancer, Lip Cancer, Throat Cancer, Lip Neoplasms, Head and Neck Cancers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a new diagnosis of Nasopharyngeal carcinoma. Being treated with either radiotherapy or chemoradiotherapy for this condition. Exclusion Criteria: Age <18 since NPC is a very rare condition in this age group and may have a different biological behavior Patients who are unable to provide informed consents for themselves.

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 |
| --- | --- | --- |
| Plasma Epstein-Bar Virus (EBV) DNA concentrations | measured by quantitative polymerase chain reaction (PCR) | every 6 months until end of study |
Alternative Support for Rural and Isolated Women in an HMO

Study Overview
=================
Brief Summary
-----------------
Evaluate the effects of a workbook/journal for helping isolated women to cope with breast cancer.

Official Title
-----------------
Alternative Support for Rural and Isolated Women in an HMO

Conditions
-----------------
Stress Disorders, Post-traumatic, Depression, Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: workbook/journal on coping with breast cancer
* Behavioral: standard educational materials on breast cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) is a woman; and 2) has been diagnosed with primary breast cancer Exclusion Criteria: 1) is under 18; or 2) can not speak and read in English

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: workbook/journal on coping with breast cancer|nan|
|Behavioral: standard educational materials on breast cancer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression |  |  | 
| posttraumatic stress disorder |  |  |
The Effects of OC000459 on Nasal Mediators

Study Overview
=================
Brief Summary
-----------------
This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study. The study will be a randomised, double blind, placebo controlled, crossover evaluation of the effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects with a known history of allergic rhinitis and screening positive to allergen will be included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety parameters will be monitored throughout.

Official Title
-----------------
The Effects of OC000459 on Nasal Th2 Cytokine Release, Eosinophil Responses, and Nasal Symptoms After Nasal Allergen Challenge (NAC) With Timothy Grass Pollen in Subjects With Allergic Rhinitis Out of Season

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Procedure: Oxagen OC000459


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. Exclusion Criteria: 1. Medical conditions likely to affect the outcome of the study. 2 History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days. 3. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.

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

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

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: Nasal Allergen Challenge Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo followed by Drug (OC000459)<br>Placebo and Drug are followed by Nasal Allergen Challenge | Procedure: Oxagen OC000459<br> <br> |
| Experimental: Drug (OC000459) followed by Placebo<br>Drug and Placebo are followed by Nasal Allergen Challenge | Procedure: Oxagen OC000459<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13 |  | 1 to 9 hours after nasal allergen challenge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic rhinitis
Combined Hormone Therapy, C-reactive Protein(CRP) Levels and Life Quality in Natural Menopause Women

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the effect of low dose combined estradiol and norethindrone acetate hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural menopause women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5 mg Norethindrone acetate).

Official Title
-----------------
The Effect of Low Dose Combined Hormone Therapy (Estradiol And Norethindrone Acetate) on Serum CRP Levels and Life Quality in Natural Menopause Women

Conditions
-----------------
CRP, Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepting consent to participate in the research and signing the form; Postmenopausal women 45-55 years old not having had menstruation for the past 6 months; Hormone results compatible with menopause (FSH> 20 milli-International unit(mIU) / mL, E2 <20 mIU / mL) and presence of vasomotor and/or menopausal symptoms (moderate to severe); no systemic disease (Diabetes, hypertension, hyperlipidemia, ischemic heart disease), or no infectious disease in the past 2 weeks; not taking any hormone therapy or medication for at least 2 months; no contraindications for hormone therapy in routine menopause evaluation; Willingness to take hormone therapy No smoking. Exclusion Criteria: Any systemic disease (DM, HT, hyperlipidemia, ischemic heart disease) presence Smoking Contraindications for hormone therapy Failure to follow-up Inability to complete three months of hormone therapy Stopping hormone therapy due to vaginal bleeding during hormone therapy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 55 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood was drawn for basal CRP from all patients | The patients who were evaluated for the Blatt-Kupperman index and MENQOL questionnaire were given three months of treatment to the patient, which included 1.03 mg , Estradiol hemihydrate and 0.5 mg Norethindrone acetate | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRP, Estradiol, Menopause-Specific Quality of Life questionnaire, Norethindrone Acetate.