linjc16/ctgov huggingface dataset:
Patient Reported Outcomes Registry in Patient With Cancer Cachexia

Study Overview
=================
Brief Summary
-----------------
Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.

Detailed Description
-----------------
The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia. Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively. These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.

Official Title
-----------------
Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia

Conditions
-----------------
Metastatic Pancreatic Cancer, NSCLC, Metastatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV Start of the first line palliative systemic treatment Ability to read and understand German Written informed consent Exclusion Criteria: None

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 |
| --- | --- | --- |
| Rate of patients with loss of > 5 % body weight |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of underweight patients | BMI < 20 kg/qm at start or during observation. | 12 months | 
| General health-related quality of life assessment | At baseline, throughout and at the end of the study with SF 12 questionnaire. | 12 months | 
| Fatigue assessment | At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale). | 12 months | 
| Cachexia assessment | At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Reported Outcome (PRO)
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

Study Overview
=================
Brief Summary
-----------------
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.

Official Title
-----------------
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: GORE® VIABAHN® Endoprosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic peripheral arterial disease in superficial femoral artery lesions
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GORE® VIABAHN® Endoprosthesis<br>Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. | Device: GORE® VIABAHN® Endoprosthesis<br>* On Day 1, Participants will receive the GORE® VIABAHN® Endoprosthesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Assisted Patency | Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a TLR to restore flow after total occlusion. | Day 1 to Month 24 | 
| Freedom from Revascularization | Revascularization for restenosis or occlusion of the treatment lesion | Day 1 to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serious Adverse Events |  | Day 1 to Month 60 | 
| Rate of Stent Fractures |  | Day 1 to Month 60 |
Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Study Overview
=================
Brief Summary
-----------------
Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.

Official Title
-----------------
Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Conditions
-----------------
Infection, Neutropenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Are or will be admitted to Stanford University Hospital for fever and neutropenia Neutropenia - an absolute neutrophil count of <500 per cubic mm Documented fever or report of fever ≥38.3 or ≥38.0 on two episodes separated by at least one hour, resulting in hospitalization for febrile neutropenia Exclusion Criteria: Inability to understand instructions and comply with study-related procedures Any condition that in the opinion of the treating physician will prevent the subject from completing the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis |  | 12 Months |
Canakinumab MAP in COVID-19 Pneumonia With CRS

Study Overview
=================
Brief Summary
-----------------
This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia

Official Title
-----------------
Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia

Conditions
-----------------
Cytokine Release Syndrome in COVID-19-induced Pneumonia

Intervention / Treatment
-----------------
* Drug: canakinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old; Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending); Hospitalized with COVID-19-induced pneumonia; Elevated CRP or ferritin levels; Body weight ≥ 40kg. Exclusion Criteria: Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; On the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day); Use of tocilizumab within 3 weeks prior to dosing with canakinumab; Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19); Patients with significant neutropenia (ANC <1000/mm3); Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: canakinumab|canakinumab|

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
-----------------
canakinumab, Ilaris, ACZ885, COVID-19, coronavirus, pneumonia, CRS, cytokine release syndrome
To Evaluate Success of Cement Treatment of Spinal Compression Fractures

Study Overview
=================
Brief Summary
-----------------
Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

Detailed Description
-----------------
Patients with vertebral compression fracture will be diagnosed and treated with balloon kyphoplasty. Pain and functional status will be assessed at baseline, 1-, 12-, and 24-months post-operatively using VAS pain scale, Oswestry Disability Index, and SF-36.

Official Title
-----------------
Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Procedure: balloon kyphoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
vertebral compression fracture

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

| Intervention/Treatment |
| --- |
|Procedure: balloon kyphoplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 
| disability |  |  |
TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.

Official Title
-----------------
TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Procedure: Emergency portacaval shunt
* Other: Emergency TIPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included. Exclusion Criteria: None
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 |
| --- | --- |
| Active Comparator: A<br>Randomization: By the blind card method to TIPS or emergency portacaval shunt. Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 24 hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months. Rescue Crossover Therapy: When primary therapy has failed. Followup: Lifelong data collection on line, analysis by biostatistician Florin Vaida, PhD. External Advisory, Data Monitoring and Safety Committee by 3 senior academicians. Procedure: Emergency portacaval shunt. | Procedure: Emergency portacaval shunt<br> <br> |
| Active Comparator: B<br>Procedure: Emergency TIPS. | Other: Emergency TIPS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of bleeding and quality of life |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survival and control of hemorrhage
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting conditions.

Official Title
-----------------
A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fasting State

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

Intervention / Treatment
-----------------
* Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
* Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 56 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) | Drug: Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)<br> <br> |
| Active Comparator: 2<br>Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA) | Drug: Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
Assessment of the Effect of Food on ABT-143 Bioavailability

Study Overview
=================
Brief Summary
-----------------
Single-dose, open-label, two-period crossover study of ABT-143

Conditions
-----------------
Pharmacokinetic Variables

Intervention / Treatment
-----------------
* Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )
* Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-55 years of age (inclusive) BMI 19 to 29 inclusive Exclusion Criteria: Asian ancestry Concurrent participation in another study Females pregnant or breastfeeding

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ABT-143 under low-fat meal condition | Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )<br>* one dose under low-fat meal condition<br>* Other names: fenofibric acid/rosuvastatin calcium;|
| Experimental: B<br>ABT-143 under fasting meal condition | Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )<br>* one dose under fasting meal condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food effect, phase I, adverse events
Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

Study Overview
=================
Brief Summary
-----------------
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.

Official Title
-----------------
A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme

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

Intervention / Treatment
-----------------
* Drug: AEE788


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed GBM in first or second recurrence or relapse Adequate hematologic, hepatic and renal function Age ≥ 18 years Karnofsky performance status score ≥ 70% Life expectancy ≥ 12 weeks Exclusion Criteria: Peripheral neuropathy > grade 1 Diarrhea > grade 1 Gastrointestinal dysfunction Compromised cardiac function Concurrent severe and/or uncontrolled medical conditions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AEE788 + non EIACD<br> | Drug: AEE788<br> <br> |
| Experimental: AEE788 + EIACD<br> | Drug: AEE788<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | 2 years | 
| Dose limiting toxicity |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GBM, recurrent/relapse, EGFR, VEGFR
Differential Diagnosis and Clinical Treatment Strategies of Thyroid Nodules.

Study Overview
=================
Brief Summary
-----------------
To investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

Detailed Description
-----------------
In previous studies, we have found highly prevalent TERT promoter mutations in aggressive thyroid cancers. So we plan to perform further research to investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

Official Title
-----------------
Differential Diagnosis and Clinical Treatment Strategies of Thyroid Nodules.

Conditions
-----------------
Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with thyroid nodule Exclusion Criteria: Coagulant function abnormality pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Benign thyroid nodules<br>Benign thyroid nodules | |
| Thyroid Carcinoma<br>Thyroid Carcinoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene sequencing |  | 2 weeks |
Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.

Official Title
-----------------
An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Diagnosis of rheumatoid arthritis > 18 years at index treatment initiation or switch Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug. Read/write English Exclusion Criteria: None

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 |
| --- | --- |
| Patients with rheumatoid arthritis initiating abatacept<br> | |
| Pts with RA initiating other biologic disease-modifying drugs<br> | |
| Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key safety outcomes (targeted infections, malignancies, mortality) |  | Every 6 months throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported infusion reactions |  | Every 6 months throughout the study | 
| Multiple sclerosis, lupus, and psoriasis |  | Every 6 months throughout the study | 
| Adverse events in pregnant women who receive abatacept |  | Every 6 months throughout the study | 
| Adverse events in subjects on abatacept who receive concomitant biologics |  | Every 6 months throughout the study |