linjc16/ctgov huggingface dataset:
A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.

Official Title
-----------------
A Phase I Dose Escalation Study of MK0457 Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a 24-Hour Continuous Infusion Given Every 21 Days in Patients With Advanced Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: MK-0457


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist. Exclusion Criteria: Patients who have had treatment with any investigational therapy within the past 30 days. Patients who have certain types of blood cancers such as leukemia or lymphoma. Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation. Patient is pregnant or nursing.

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: MK-0457<br>Participants received MK-0457 at assigned dose as a continuous intravenous infusion (CIV) over 24 hours; one group of participants also received MK-0457 100 mg capsules, orally, prior to the CIV. | Drug: MK-0457<br> <br> * Other names: VX-680 (an Aurora Kinase Inhibitor);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |  | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans |  | Predose, and at end of Cycles 2 and 6 (up to approximately 4 months) | 
| Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST) |  | Pre-dose through post-study visit (up to 3 years) |
Evaluation of Information Displays A Paper & Pencil, Computer, Simulator, and ICU Based Study

Study Overview
=================
Brief Summary
-----------------
Our objective is to develop intuitive, meaningful and ergonomically efficient informative displays specific to the user's domain. Specifically we aim to enhance and refine the display prototype of ABG information to include gas-exchange, acid-base balance, lung mechanics, ventilation, oxygenation, and metabolism information.

Detailed Description
-----------------
To create an intuitive and meaningful visualization of Arterial Blood Gas (ABG) variables, it is necessary to address usability, ergonomics, domain specific, and expertise specific issues and concerns. Our objective is to develop intuitive, meaningful and ergonomically efficient informative displays specific to the user's domain. Specifically we aim to enhance and refine the display prototype of ABG information to include gas-exchange, acid-base balance, lung mechanics, ventilation, oxygenation, and metabolism information.

Official Title
-----------------
Evaluation of Information Displays A Paper & Pencil, Computer, Simulator, and ICU Based Study

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

Intervention / Treatment
-----------------
* Behavioral: New ICU Display Visualization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU nurses Exclusion Criteria: All participants were screened and excluded from participation if they had previously participated in any of graphical display design and feedback sessions when developing the ICU display.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simulator Group - With Display<br>ICU nurses who viewed the new ICU display visualization | Behavioral: New ICU Display Visualization<br> <br> |
| Simulator Group - Without Display<br>ICU nurses who did not view the new ICU display visualization, but instead viewed a traditional spreadsheet style presentation of ICU trends of data | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nurses using the new ICU display will detect and communicate to an attending physician (confederate) more abnormal patient physiological states than when using the tabular (control) display. |  | At time of observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Information Display, situational awareness, Create intuitive visualization
Zenith® AAA Endovascular Graft Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.

Official Title
-----------------
Zenith® AAA Endovascular Graft Clinical Study

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Roll-in
* Device: Surgical
* Device: Standard Risk
* Device: High Risk
* Device: Compassionate Use
* Device: Treatment for females
* Device: Standard Risk Continued Access
* Device: High Risk Continued Access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm. Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm. Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year. Exclusion Criteria: Patients less than 18 years of age. Patient with a life expectancy less than 2 years. Patients who are pregnant. Patients unwilling to comply with the follow-up schedule. Patient inability or refusal to give informed 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Roll-in | Device: Roll-in<br>* Proctored entry.<br>|
| Other: 2<br>Surgical | Device: Surgical<br>* Surgery<br>|
| Other: 3<br>Standard Risk | Device: Standard Risk<br>* Standard Endovascular repair<br>|
| Other: 4<br>High Risk | Device: High Risk<br>* High Risk Endovascular repair.<br>|
| Other: 5<br>Compassionate Use | Device: Compassionate Use<br>* Endovascular repair for compassionate use patients.<br>|
| Other: 6<br>Treatment for females. | Device: Treatment for females<br>* Endovascular repair in female patients<br>|
| Other: 7<br>Standard Risk Continued Access | Device: Standard Risk Continued Access<br>* Continued Access Endovascular repair for standard risk patients.<br>|
| Other: 8<br>High Risk Continued Access | Device: High Risk Continued Access<br>* Continued Access Endovascular Repair for High Risk Patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

Official Title
-----------------
Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

Conditions
-----------------
Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory

Intervention / Treatment
-----------------
* Drug: Mogamulizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of MF or SS Stage IB, II-A, II-B, III, or IV; Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic therapy. Exclusion Criteria: Current evidence of large cell transformation; Prior treatment with mogamulizumab; History of allogeneic transplant.

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: Mogamulizumab<br> | Drug: Mogamulizumab<br>* For the first 28-day induction cycle (C1), mogamulizumab 1 mg/kg will be administered as an IV infusion through a 0.22- or 0.2-μm in-line filter over at least 60 minutes on Days 1, 8, 15, and 22. For all subsequent 28-day cycles (C2, 3, 4, etc.), mogamulizumab 2 mg/kg will be administered as an IV infusion over at least 60 minutes on Day 1 of each subsequent therapy cycle.<br>* Other names: 0761, KW0761, Poteligeo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number, percentage and severity of treatment emergent adverse events | Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0). | From date of consent, at every treatment and follow up visit, up to 27 months |
The Diagnostic Accuracy of the Clinical Examination

Study Overview
=================
Brief Summary
-----------------
This study examines the diagnostic accuracy of the clinical examination as compared to MRI findings

Detailed Description
-----------------
When patients get musculoskeletal pain and seek care, the healthcare professional performs a detailed clinical examination to determine a diagnosis and determine a plan of care which often includes imaging. There are only a few studies that have looked at the accuracy of the clinical examination in a primary care setting, most studies having been performed in a specialty practice treating Orthopedic or Sports injuries. In these practices, surgery has become and remains the gold standard. However, in primary care, often imaging like Magnetic Resonance Imaging (MRI) has become the the criterion standard. This double blind study will compare the diagnosis reached by clinical exam to the results found on MRI. In addition, the examining clinician will report their recommended plan of care after the examination.

Official Title
-----------------
The Diagnostic Accuracy of the Clinical Examination in Common Musculoskeletal Pathologies

Conditions
-----------------
Musculoskeletal Pain, Musculoskeletal Injury

Intervention / Treatment
-----------------
* Diagnostic Test: clinical examination
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18-80 years old with musculoskeletal pain/dysfunction Exclusion Criteria: Outside the inclusion age range, pain/dysfunction of other than musculoskeletal origin, those in whom MRI is contraindicated for example, with shrapnel in the body

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 |
| --- | --- |
| Patients with Musculoskeletal Pain<br>Subjects reporting for care with complaints of musculoskeletal pain will be examined and a diagnosis and plan of care will be established. The accuracy of the clinical examination will be compared to pathology detected by MRI | Diagnostic Test: clinical examination<br>* Thorough examination including history, screening, motion testing, strength testing, special testing<br>Other: MRI<br>* Low field MRI .25 Tesla<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| likelihood ratios | combination of sensitivity | 5 years | 
| Area under the curve | measure of accuracy of the clinical exam | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic accuracy, Clinical examination, neck, back, shoulder, hip, knee, foot, ankle, stress fracture
Aminophylline Prophylaxis For Postdural Puncture Headache

Study Overview
=================
Brief Summary
-----------------
postdural puncture headache is a rare but serious complication of spinal anesthesia. many drugs were studied in prevention or treatment of that complication. However, there are limited numbers of trials about intravenous aminophylline for prevention. because of that we retrospectively aimed to investigate the effectiveness of aminophylline for postdural puncture headache in cesarean section.

Detailed Description
-----------------
retrospective trial about the effect of intravenous aminophylline for prevention of PDPH after caserean section with spinal anesthesia

Official Title
-----------------
Phase IV Study of Intravenous Aminophylline During Spinal Anesthesia

Conditions
-----------------
Postdural Puncture Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aolder than 18 years old Exclusion Criteria: conversion to general anesthesia

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intravenous aminophylline<br>intravenous aminophylline use during spinal anesthesia | |
| no intravenous aminophylline<br>no use of intravenous aminophylline during spinal anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postdural puncture headache |  | postoperative 2 weeks |
The Role of the Vagus Nerve in Tumor-to-Brain Communication in Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to measure brain metabolism in patients with lung cancer.FDG uptake in the brain in patients with malignant tumors will be compared to the amount of tracer activity found in patients who have benign pulmonary process. if differences between the brain uptake of FDG in the two groups will be found, further assessment will be performed in order to evaluate if such differences could be attributed and specifically localized to the brain regions innervated by the vagus

Official Title
-----------------
Does the Vagus Nerve Play a Role in Tumor-to-Brain Communication? a Preliminary Study in Patients With Newly Diagnosed Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: PET/CT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with SPN referred for routine whole body FDG-PET imaging patients with NSCLC and patients with no evidence of lung cancer on further follow up Exclusion Criteria: patients with a clinical history of vagotomy, abdominal surgery. brain tumor, brain trauma or CVA. or those with a systemic inflammatory disease

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PET/CT imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the imaging modality on patients management |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the imaging modality on patients management |  |  |
Interstitial Lung Abnormalities in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Immunosuppressive drugs such as tacrolimus, cyclosporine, mycophenolate mofetil, sirolimus and everolimus may have toxic pulmonary effects, particularly interstitial alterations. The aim of the present study is to explore the presence of subclinical interstitial lung abnormalities in stable renal transplant recipients taking the different immunosuppressive drugs used as maintenance therapy for renal transplantation.

Detailed Description
-----------------
Prospective, cross-sectional study examining the high-resolution CT scans obtained in 63 stable renal transplant recipients taking immunosuppressive treatment for at least 24 months. The findings in patients taking the newer immunosuppressive drugs (mycophenolic acid, sirolimus and everolimus) are compared with those of the patients treated in the traditional way (cyclosporine, tacrolimus, azathioprine). All patients undergo high-resolution CT scanning. Eligibility criteria: recipients of kidney or kidney-pancreas transplant, on immunosuppressive therapy for at least 24 months, with stable renal function and absence of any overt lung disease or lung alterations induced by other drugs, systemic diseases or occupational exposure to fibrogenic agents.

Official Title
-----------------
Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan

Conditions
-----------------
Renal Transplantation, Kidney-pancreas Transplantation

Intervention / Treatment
-----------------
* Procedure: High-resolution CT scanning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant patients with stable renal function taking immunosuppressive therapy for at least 24 months and providing written informed consent to participate to the study Exclusion Criteria: Overt lung disorders, lung toxicity due to other drugs or occupational exposure to lung-toxic agents Systemic connective tissue disorders or systemic vasculitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 82 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 |
| --- | --- |
| Renal transplant patients<br> | Procedure: High-resolution CT scanning<br>* High-resolution CT scanning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subclinical lung alterations as assessed by high-resolution CT scanning |  | CT is performed at study entry and, if abnormalities are found, it is repeated at 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial lung disease, Immunosuppressive therapy, Renal transplant
Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Comparing the operation times and staple loads used between the use of multiple tubes and a bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.

Detailed Description
-----------------
In this study we are comparing the cost/savings of using a bougie with a one-step suction callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and staple usage. This study is not affecting the treatment of the patients in any way. The surgeons would be using the devices regardless of the study. We are simply looking at procedure information after the fact.

Official Title
-----------------
Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy

Conditions
-----------------
Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Device: Suction callibrated system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient and surgeon have both agreed that a sleeve gastrectomy is a procedure that they want performed. Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCS<br>Treated via suction callibrated system | Device: Suction callibrated system<br>* One-step suction callibrated SG system<br>* Other names: Visigi 3D;|
| Bougie<br>Treated with multiple tubes & bougie | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staples Used | Number of staple loads needed to close stomach | 4 hours for the end of surgery | 
| Operation time | Total operation time | 4 hours for the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrectomy, laparoscopic, sleeve