linjc16/ctgov huggingface dataset:
First Line Chemotherapy for Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

Detailed Description
-----------------
This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.

Official Title
-----------------
Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: albumin-bounded paclitaxel
* Drug: S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction Adult patients >=18 years of age Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2; At least have one measurable disease(according to RECIST) Adequate bone marrow,renal and liver function Exclusion Criteria: Previous chemotherapy for advanced/metastatic disease Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome

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: albumin-bounded paclitaxel plus S-1<br>arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression | Drug: albumin-bounded paclitaxel<br>* 200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles<br>* Other names: Paclitaxel Albumin-stabilized Nanoparticle Formulation;Drug: S-1<br>* 40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression<br>* Other names: TS-1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 1 year | 
| overall survival |  | 1 year | 
| number of adverse event |  | 1 year |
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.

Official Title
-----------------
Special Drug Use Investigation of Zevalin

Conditions
-----------------
Non-Hodgkin's Lymphoma (NHL)

Intervention / Treatment
-----------------
* Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received In-111 Zevalin to verify that expected biodistribution is present. Exclusion Criteria: Patients who are contraindicated based on the product label.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)<br>* Patients who have received In-111 Zevalin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No] |  | At 48-72 hours after In-111 Zevalin injection | 
| Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No] |  | At 48-72 hours after In-111 Zevalin injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zevalin, CD20+, Non-Hodgkin's lymphoma, Mantle cell lymphoma
Feasibility of Use of BariCare App in Pre-transplant Population

Study Overview
=================
Brief Summary
-----------------
This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.

Official Title
-----------------
Feasibility and Efficacy of Engagement Modules for Renal and Liver Transplant Candidates

Conditions
-----------------
Obesity, Pre-Renal Transplant Candidate, Pre-liver Transplant Candidate

Intervention / Treatment
-----------------
* Behavioral: Use of smartphone app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who are candidates for liver or renal transplant. Individuals who own a smartphone. Individuals who are obese. Exclusion Criteria: Patients with prior history of bariatric surgery. Patients with active psychiatric disorder. Patients with active tobacco use. Patients with active substance use (alcohol, illicit drugs, etc.)

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 |
| --- | --- |
| Other: Smartphone Arm<br>This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in making lifestyle modifications | Behavioral: Use of smartphone app<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smart Phone App Feasibility | The primary objective will be to assess ease and feasibility of use by subjects. They will provide information through questionnaires developed to assess these factors. | 3 months |
HairDx Analytical Validation Study

Study Overview
=================
Brief Summary
-----------------
The HairDx Test reports genetic variants associated with the development of FPHL.

Detailed Description
-----------------
The HairDx Test reports genetic variants associated with the development of FPHL. The variants are detected from a saliva sample collected at home. The HairDx Test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. The information provided by the HairDx Test report is not intended to start, stop or change any course of treatment. The purpose of this study is to collect DNA samples from subjects. The DNA samples will be used for the analytical validation of the HairDx Test. The results of this study will not be shared with the subjects.

Official Title
-----------------
HairDx Analytical Validation Study

Conditions
-----------------
Hair Loss, Hair Loss/Baldness, Female Pattern Baldness, Androgenetic Alopecia

Intervention / Treatment
-----------------
* Device: HairDx Sample Collection Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females over the age of 18 Overall good health Able to give informed consent Willing to collect saliva sample Exclusion Criteria: Xerostomia (dry mouth) Inability to provide informed consent in English Inability to follow instructions for saliva sample collection Non US resident

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects<br>Female subjects providing DNA saliva sample | Device: HairDx Sample Collection Kit<br>* Saliva collection using FDA OTC cleared sample collection device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the accuracy of the HairDx Test | Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing | Baseline | 
| Determination of the precision and reproducibility of HairDx Test | Determination of the precision and reproducibility of HairDx Test in accordance with the laboratory instructions for use documentation | Baseline |
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: DEB
* Device: PTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years critical limb ischemia (Rutherford class 4-6) angiographic stenosis>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled Exclusion Criteria: need for major amputation known before intervention allergy to Paclitaxel contraindication for combined antiplatelet treatment life expectancy <1 year hypersensitivity or contraindication to one of the study drugs lack of consent

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-eluting balloon<br>angioplasty with Litos drug-eluting balloon | Device: DEB<br>* angioplasty with Litos drug eluting balloon<br>|
| Active Comparator: conventional PTA<br>angioplasty with conventional balloon | Device: PTA<br>* angioplasty with conventional balloon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss (LLL) in the target lesion documented by angiography | Late Lumen Loss (LLL) in the target lesion documented by angiography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of events of angiographic occlusive restenosis | number of events of angiographic occlusive restenosis | 6 months | 
| Number of events of target lesion revascularization (TLR) | number of events of target lesion revascularization | 12 months |
Documentation of In-flight Medical Emergencies With Medical Incident Report Forms.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform a descriptive, content-based analysis on the different forms of documentation for in-flight medical emergencies that are currently provided in the emergency medical kits on board commercial airlines.

Conditions
-----------------
In-flight Medical Emergency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical incident report form Exclusion Criteria: no medical incident report form

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.

Official Title
-----------------
A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Interferon beta-1a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study Exclusion Criteria: Any other treatment for the maintenance of remission of Crohn's disease

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon beta-1a|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures: |  |  | 
| The proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 52 |  |  | 
| Time to relapse |  |  | 
| Change from baseline to end of treatment in Quality of Life (IBDQ) score, CDAI score, biological markers of inflammation (CRP and ESR), number of fistulas (including new fistulas and closure of existing ones), and antibodies to interferon beta-1a. |  |  |
Electronic Notification of Teratogenic Risks

Study Overview
=================
Brief Summary
-----------------
This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control). Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.

Official Title
-----------------
Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks

Conditions
-----------------
Teratogens, Abnormalities, Drug-Induced, Contraception

Intervention / Treatment
-----------------
* Other: Clinical decision support
* Other: stream-lined clinical alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-45 seen at a participating primary care clinic Exclusion Criteria: Non-English speakers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multi-faceted decision support<br>Multi-faceted decision support | Other: Clinical decision support<br>* multi-faceted decision support<br>|
| Active Comparator: control<br>stream-lined clinical alert | Other: stream-lined clinical alert<br>* electronic notification that a medication is potentially teratogenic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women prescribed potentially teratogenic medications with documented use of contraception |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Teratogens, Abnormalities, Drug-Induced, Contraception
Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection

Study Overview
=================
Brief Summary
-----------------
The patients were randomized into 3 groups: those patients undergoing a ionic silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after finishing an elective colorectal surgery.

Official Title
-----------------
Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection

Conditions
-----------------
Incisional Surgical Site Infections

Intervention / Treatment
-----------------
* Procedure: ionic silver-containing dressing
* Procedure: Mupirocin ointment application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims. Open surgical approach Exclusion Criteria: Anastomotic leak Mortality Lost to follow-up
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ionic silver-containing dressing<br>After placing the staples, a ionic silver-containing dressing was placed covering the wound. | Procedure: ionic silver-containing dressing<br>* After placing the staples, a ionic silver-containing dressing was placed covering the wound<br>|
| Experimental: Mupirocin ointment application<br>After placing the staples, a Mupirocin ointment application was placed covering the wound. | Procedure: Mupirocin ointment application<br>* After placing the staples, Mupirocin ointment application over the wound was performed<br>|
| No Intervention: Conventional dressing<br>After placing the staples, a conventional dressing, without application of any special gauze or ointment, was placed covering the wound | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional Surgical site infection |  | 30 postoperative days |