linjc16/ctgov huggingface dataset:
Demonstrate Efficacy and Safety of Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to to demonstrate equivalence

Detailed Description
-----------------
Patients will receive study drug every 3 weeks.

Official Title
-----------------
Double-blind, Randomised, Parallel Group, Phase III Study

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

Intervention / Treatment
-----------------
* Drug: CT-P6
* Drug: Herceptin
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are females Have a Her 2 over-expression Have ECOG 0 or 1 Exclusion Criteria: Current clinical or radiographic evidence CNS metastases Current Known infection Pregnant or nursing mother

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-P6 & Paclitaxel<br>CT-P6 + Paclitaxel | Drug: CT-P6<br>* Administered every 3 weeks<br>Drug: Paclitaxel<br>* Administered every 3weeks<br>|
| Active Comparator: Herceptin & Paclitaxel<br>Trastuzumab + Paclitaxel | Drug: Herceptin<br>* Administered every 3 weeks<br>* Other names: Trastuzumab;Drug: Paclitaxel<br>* Administered every 3weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Compare Efficacy |  | months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and safety |  | months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herceptin, metastatic breast cancer, CT-P6
The Incidence and Factors of Brown Adipose Tissue in Chinese

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown active brown adipose tissue (BAT) is present in adults and may play important roles in regulating energy homeostasis. However, the majorities of these studies were done in patients undergoing scanning for cancer surveillance, and may not reflect BAT behavior in healthy individuals. In addition, little is known about the ethnic variation in BAT activity, particularly in Chinese adults. Due to the large amount in our cohort, we are able to look at the difference between subjects for cancer surveillance (CS) and subjects for medical check-up (MC), and to clarify the impact of clinical and lifestyle parameters.

Detailed Description
-----------------
We will study scanning database including data from July 2006 to June 2010 in Shanghai. BAT activity will be measured via 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT). Age, imaging date, sex, and outdoor temperature will be collected for all patients. To evaluate the effects of multiple metabolic parameters on BAT activity, we will collect height, body weight, fasting plasma glucose (FPG), medical history, diagnosis, smoking, alcohol consumption, exercise, liver triglyceride content, and thyroid metabolic activity for all patients with detectable BAT and their negative controls, consisting of two patients who underwent PET/CT scans at the same day but without detectable BAT.

Official Title
-----------------
Retrospective Study on the Incidence and Factors of Brown Adipose Tissue in Adult Chinese

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with detectable brown adipose tissue Negative controls, consisting of two subjects who underwent PET/CT scans at the same day but without detectable BAT Exclusion Criteria: Younger than 18 years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brown Adipose Tissue, Incidence, Factor, Human
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

Study Overview
=================
Brief Summary
-----------------
This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy

Detailed Description
-----------------
Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.

Official Title
-----------------
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

Conditions
-----------------
Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease

Intervention / Treatment
-----------------
* Device: Simplus/Eson


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18+ Existing full face mask user or a nasal mask user Prescribed NIV therapy for at least 3 months Exclusion Criteria: Inability to give informed consent Pregnant or think they may be pregnant Anatomical or physiological conditions making NIVtherapy inappropriate Patients who are in a coma or decreased level of consciousness Existing Simplus and Eson users

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full face/Nasal masks<br>Simplus/Eson | Device: Simplus/Eson<br>* Released product Simplus and Eson masks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Leak data | Obtained from the participant's device | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective measurement of Leak | Questionnaire | 2 weeks | 
| Subjective measurement of Comfort | Questionnaire | 2 weeks | 
| Subjective measurement of Ease of Use | Questionnaire | 2 weeks |
REduction of Physical Inactivity Facing the CAncer

Study Overview
=================
Brief Summary
-----------------
Study 1: The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.

Detailed Description
-----------------
Study 2: Because of a recent research, it is shown that a narrative message from a peer generates an identification, a sense of self-efficacy and intention to practice in sedentary patients with breast cancer. The investigator hypothesize that a promotional message about physical activity, issued by a self-determined peer (intrinsic motivation), compared to a non-self-determined peer (extrinsic motivation), generate higher scores of positive beliefs about physical activity and intention to engage in a physical activity program for sedentary patients. These promotional messages will be delivered through two videos, one featuring the self-determined pair, the other featuring the non-self-determined pair.

Official Title
-----------------
Physical Activity in Patients With Cancer: Epidemiological Study of Patients' Beliefs and Promotional Messages Efficiency

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

Intervention / Treatment
-----------------
* Other: Physical activity motivation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PS 0-3 Patients with breast cancer undergoing chemotherapy treatment neoadjuvant, adjuvant, metastatic, any histological type, any stage breast cancer Sedentary Patients (physical activity score of Dijon less than or equal to 20) Exclusion Criteria: Patients with PS greater than 3 Patients with cognitive disorders not allowing them to understand the questionnaires and study procedures

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Physical activity motivation | Other: Physical activity motivation<br>* Physical activity motivation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CaBES | psychometric measures: Cancer Beliefs and Exercise Scale Questionnaire | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Fatigue Inventory | Fatigue level determination | 1 day | 
| Dijon's Score | Physical activity level determination | 1 day |
One Touch® Verio®IQ European Clinical Outcomes Study

Study Overview
=================
Brief Summary
-----------------
Evaluation of the clinical benefits of One Touch VerioIQ system.

Detailed Description
-----------------
Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Official Title
-----------------
One Touch® Verio®IQ European Clinical Outcomes Study

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: One Touch VerioIQ Blood Glucose Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female at least 18 to 80 years old ADA guidelines for FPG and PPG appropriate A1C greater or equal to 8.0% and less than or equal to 10.5% lab A1C greater than or equal to 8.0% in the last 6-12mths Diagnosed with type 1 or 2 in at least last 1 year on stable dose of OADs for at least 3mths prior to screening willingness to test 7 BGM tests per day willing to remain on same therapy as baseline (MDI) for duration of study Exclusion Criteria: unlikely to be compliant to study procedures has or has currently used One Touch VerioIQ Is on fixed doses of insulin for MDI therapy

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

| Intervention/Treatment |
| --- |
|Device: One Touch VerioIQ Blood Glucose Monitor|BGM with pattern alert technology and with associated pattern guide|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C from baseline to week 24 | A1C (also known as hemoglobin A1C or glycosylated hemoglobin) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C from baseline to week 12 |  | 12 weeks | 
| Change in FPG from baseline to 24 weeks | FPG (Fasting plasma glucose) | 24 weeks | 
| Change in proportion of subjects with A1C less than or equal to 7.0% at week 24 |  | 24 weeks | 
| Change in 30 day mean glucose comparing first month to last month after 24 weeks |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood glucose monitor, Pattern management, Pattern guide, Education
Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Study Overview
=================
Brief Summary
-----------------
We can speculate that the best responders to tocilizumab should have multiple related elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play its beneficial role. The study of these elements and its pathways could help identify the best responders to tocilizumab treatment.

Official Title
-----------------
Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Conditions
-----------------
Arthritis,Rheumatoid

Intervention / Treatment
-----------------
* Drug: Tocilizumab
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of all sexes, aged ≥ 18 years. RA Patients (according to ACR / EULAR criteria 2010) of moderate to severe activity (DAS 28> 3.2 or SDAI> 11), and 6 months or more of evolution, starting treatment with ACTEMRA (tocilizumab) or with an anti-TNF, according to the product data. Patients with body weight ≤ 150 kg. Patients who have received written information about the study and gave their informed consent to participate in the study Exclusion Criteria: Patients with a history of autoimmune disease or inflammatory joint disease other than RA. Patients treated with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is greater) before starting treatment with tocilizumab

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tocilizumab treated<br> | Drug: Tocilizumab<br> <br> |
| Anti-TNF treated<br> | Drug: Adalimumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treg phenotype |  | Baseline to 6 months change | 
| ATP (adenosine triphosphate) |  | Baseline to 6 months change |
Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if a Spanish-language HIV and HIV test information video is as effective in delivering basic information regarding HIV and HIV tests to primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test counselor.

Official Title
-----------------
Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos

Conditions
-----------------
HIV, AIDS

Intervention / Treatment
-----------------
* Behavioral: Video or In-Person Presentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-64 years of age Self-identify as Latino Able to give informed consent Spanish speaking Exclusion Criteria: Intoxicated Being treated for acute psychiatric illness Mental incapacitation Significant visual or hearing impairment Prisoner or under home confinement Participating in HIV vaccine trial Critically ill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In Person Counseling<br>Participants will receive an in person HIV and HIV testing counseling session | Behavioral: Video or In-Person Presentation<br>* Participants will be randomly assigned to an in person counseling session or will watch a HIV and HIV testing video<br>|
| Experimental: Video Presentation<br>Participants will watch an HIV and HIV testing video | Behavioral: Video or In-Person Presentation<br>* Participants will be randomly assigned to an in person counseling session or will watch a HIV and HIV testing video<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of an educational video regarding HIV and HIV testing for Spanish speaking Latinos | Participants in both arms will complete an HIV knowledge questionnaire after recieving an in-person presentation or watching the video to compare the effectiveness of an HIV educational video for Spanish speaking Latinos regarding HIV and HIV tests. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, HIV Prevention, HIV testing, HIV Rapid Test
Effects of a Legal Support Program on Women Experiencing Domestic Violence

Study Overview
=================
Brief Summary
-----------------
Intimate partner violence (IPV) is a major public health concern. Worldwide, 1 in 3 women have experienced domestic abuse/ violence in their lifetime. In most cases, family lawyers, advocates are first contact before the police. If the children are involved, finding the legal options become the priority for women before leaving the abuser. The purpose of this study was to compare the effectiveness of the HELP (Health, Education Legal Support Program) intervention among IPV survivors.

Official Title
-----------------
Effects of a Legal Support Program on Women Experiencing Domestic Violence: Help Intervention Study

Conditions
-----------------
Domestic Violence, Anxiety, Depression, Stress

Intervention / Treatment
-----------------
* Other: HELP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female survivors of Intimate Partner Violence 18 years old or older Gives informed consent Exclusion Criteria: Diagnosed mental health condition Terminally ill Chronic condition On psychiatric medication Sexual assault

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>As part of the intervention, along with legal opinions, advise and support, participants were provided counselling support during their time to help survivors with trauma of legal proceedings. | Other: HELP<br>* Individual counseling were given to each intervention group participant. They were assisted with safety, emotional and mental support and referrals for health and financial assistance. Participants were also given handout to manage anxiety and panic situations during the legal procedures.<br>|
| No Intervention: Usual Care<br>Participants were scheduled for legal consultancy only. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety symptoms were assessed using the Hospital Anxiety Depression Scale | Change from baseline anxiety symptoms at 4 weeks | 
| Depression | Depression symptoms were assessed using the Hospital Anxiety Depression Scale | Change from baseline depression symptoms at 4 weeks | 
| Stress | Perceived Stress Scale was used to assess stress symptoms | Change from baseline stress symptoms at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self esteem | Rosenberg's Self-Esteem Scale was used to measure self esteem | Change from baseline self esteem at 4 weeks |
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency

Conditions
-----------------
Renal Insufficiency, Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: tonapofylline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous diagnosis of heart failure. Must have ADHF, requiring hospitalization, with clinical evidence for volume overload Exclusion Criteria: History of an allergic reaction to any xanthine-containing substance. History of seizure History of stroke Myocardial infarction Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy. Serious systemic infection Major surgical procedures within 30 days Acute coronary syndrome Cardiogenic shock Baseline body weight >150 kg Participation in any other investigational study of drugs or devices within 30 days prior to Screening Nursing mothers, pregnant women, or women planning on becoming pregnant during the study Presence of any clinically significant condition that might interfere with optimal safe participation in this 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>.03 mg/kg | Drug: tonapofylline<br>* IV<br>* Other names: BG9928;|
| Experimental: 2<br>.15 mg/kg | Drug: tonapofylline<br>* IV<br>* Other names: BG9928;|
| Experimental: 3<br>.3 mg/kg | Drug: tonapofylline<br>* IV<br>* Other names: BG9928;|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency. |  | 0-60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal insufficiency, diuretic, congestive heart failure, acute decompensated heart failure