linjc16/ctgov huggingface dataset:
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.

Official Title
-----------------
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

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

Intervention / Treatment
-----------------
* Drug: BMS-833923 (XL139)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment Men and woman, 20 years of age and above Exclusion Criteria: Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments Inability to swallow oral medication Uncontrolled or significant cardiovascular disease Inadequate bone marrow function Inadequate hepatic function Inadequate renal function Pancreatitis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: BMS-833923 (XL139)<br> | Drug: BMS-833923 (XL139)<br>* Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria<br>* Other names: (XL139);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose Limiting Toxicity (DLT) and observed adverse events |  | Within the first 28 days of treatment | 
| Incidence of Dose Limiting Toxicity (DLT) and observed adverse events |  | Up to 90 days additional treatment period plus 60 days of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects experienced DLT |  | Within the first 28 days | 
| Maximum observed concentration (Cmax) of BMS-833923 (XL139) |  | Day1 and Day 29 | 
| Trough observed concentration (Cmin) of BMS-833923 (XL139) |  | Day1 and Day 29 | 
| Time of maximum observed concentration (Tmax) of BMS-833923 (XL139) |  | Day1 and Day 29 | 
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139) |  | Day1 and Day 29 | 
| Effective half-life (T-half,eff) of BMS-833923 (XL139) |  | Day1 and Day 29 | 
| Accumulation index (AI) of BMS-833923 (XL139) |  | Day1 and Day 29 | 
| Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria |  | Up to120 days of treatment period |
Coblation in Endoscopic Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
Chronic Rhinosinusitis (CRS) refers to a pathological condition where the sinonasal mucosa is inflamed for greater than 12 weeks(1). It is associated with a constellation of symptoms, including facial pain, anosmia, and nasal congestion. It has been estimated that CRS affects close to 5% of the Canadian population(2). When medical therapy fails, patients are often referred to Otolaryngology- Head and Neck Surgeons for consideration of surgical management. Endoscopic sinus surgery (ESS) is one of the mainstays of therapy for CRS that has failed medical management(3). Traditionally, the microdebrider has been the go-to tool for performing these surgeries, but recently the Coblator (ArthroCare, Austin, Texas) has begun to define its' role in surgery. By using bipolar radiofrequency energy to ablate tissue (with temperatures up to 60˚ C)(4), theoretically the Coblator will result in less bleeding than so-called cold surgical techniques (i.e. the microdebrider). In a retrospective study by Eloy et. al, patients with CRS and nasal polyposis had a statistically significant amount of less intraoperative blood loss when the Coblator was used in their surgery, than those patients who underwent surgery with the microdebrider. The investigators plan to further investigate this in a randomized, controlled fashion

Official Title
-----------------
The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial

Conditions
-----------------
Blood Loss

Intervention / Treatment
-----------------
* Device: Coblation polypectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18-70 years old, and having a diagnosis of CRS. Exclusion Criteria: previous Endoscopic Sinus Surgery, coagulopathies, being pregnant, or being prescribed anti-coagulants or anti-platelet agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| No Intervention: control: shaver<br> | |
| Experimental: Coblation polypectomy<br> | Device: Coblation polypectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss |  | intra-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood loss between two groups
Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors

Study Overview
=================
Brief Summary
-----------------
This is a pilot study designed to explore the feasibility of non-invasively diagnosing the presence of cancer in the breast using non-invasive magnetic resonance imaging (MRI) methods and an analysis of vessel shape defined from these magnetic resonance images.

Official Title
-----------------
Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors

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

Intervention / Treatment
-----------------
* Other: Magnetic Resonance Angiography (MRA) of the Breast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult women (age >= 18), with Histologically documented newly diagnosed stage II-IV invasive breast cancer appropriate for neoadjuvant (preoperative) systemic therapy. ECOG performance status of 0, 1, or 2 at the initiation of the study. Exclusion Criteria: pregnant women women with contralateral mastectomies known bilateral tumors subjects prone to claustrophobia contraindicated to have MRI mentally impaired not fluent in english

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: Magnetic Resonance Angiography (MRA) of the Breast<br>* Magnetic Resonance Angiography (MRA) of the breast will be performed before or after pre-treatment magnetic resonance imaging (MRI) and then once again before or after the post-treatment MRI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Blood Vessel Tortuosity in Breast With Known Cancer | Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy | up to two weeks prior to start of chemotheraphy |
Data Collection and Analysis of Patients Who Have Had an Electrophysiological Procedure

Study Overview
=================
Brief Summary
-----------------
The purpose of the database is to complete outcomes research of electrophysiological procedures.

Detailed Description
-----------------
The purpose of the database is to complete outcomes research (risk factors, follow-up, procedural data) Perhaps the most important research for any busy clinical laboratory is to appreciate the tendencies and trends that are occurring in their own laboratory setting. This will have a tremendous impact on educating the OSU staff as well as perhaps other centers on best medical practices.

Official Title
-----------------
Data Collection and Analysis of Patients Who Have Had an Electrophysiological Procedure Performed at the Ross Heart Hospital

Conditions
-----------------
Heart Disease, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older have or had a procedure preformed in the Electrophysiology Laboratories at the Ross Heart Hospital Ability to consent Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Data collection group<br>Patients having procedures done at the electrophysiology Laboratories at the Ross Heart Hospital at The Ohio State University Medical Center. | |

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
-----------------
Electrophysiological, Heart Disease, Cardiology, Atrial Fibrillation, Risk Factors, Follow-up, Outcomes
An Imaging Study to Investigate the Distribution of GW842166X in the Brain.

Study Overview
=================
Brief Summary
-----------------
GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought that for the anti-inflammatory action the drug is required to cross inot the brain from the blood. This study aims to look at if the drug crosses into the brain once given orally using an imaging technique called positron emission tomography.

Official Title
-----------------
An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects

Conditions
-----------------
Pain, Inflammatory

Intervention / Treatment
-----------------
* Drug: GW842166X
* Drug: [carbonyl-^11C]GW842166


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged 50 to 80yrs inclusive at the screening visit. subjects with negative HIV and hepatitis B and C test results within 3 months of study start. Exclusion Criteria: A negative Allens test on arm to be used for arterial cannulation. Any contraindications to MRI scanning. History or presence of hepatic or renal disease. Previous involvement in PET or radiological investigations. Family history of cancer. History of claustrophobia Presence of a cardiac pacemaker or any other electronic device or ferromagnetic metal

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving GW842166<br>Subjects will receive single oral dose of 400 milligram (mg) un-labeled GW842166X. After 2-5 hours subjects will receive [carbonyl-^11C]GW842166. | Drug: GW842166X<br>* GW842166X will available with dose strength of 100 mg capsules. Four 100mg GW842166X capsules will be used for the 400 mg oral dose of GW842166X.<br>Drug: [carbonyl-^11C]GW842166<br>* [carbonyl-^11C]GW842166 will b available as Intravenous solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate at which the drug crosses from plasma to brain (ki)using images from the scan |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of drug |  | after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain,, inflammation,, CB2,, PET, analgesia,
Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior

Study Overview
=================
Brief Summary
-----------------
Objectives: Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical neoplasms Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and have a different impact on the health of the patients

Detailed Description
-----------------
Data between the years of 1/1/2002 and 12/31/2013 will be analyzed. The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center will be screened in order to identify patients that had a histopathological diagnosis of parathyroid carcinoma or atypical parathyroid neoplasm.

Official Title
-----------------
Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior

Conditions
-----------------
Parathyroid Carcinoma, Parathyroid Neoplasm

Intervention / Treatment
-----------------
* Other: Chart Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients from MDACC diagnosed with PHPT that have a histopathological diagnosis of PTH carcinoma or atypical parathyroid neoplasm between the years 1/1/2002 and 12/31/2013 Exclusion Criteria: Pediatric patients Cases with incomplete records Patients where the follow-up will be less than six months

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 |
| --- | --- |
| Parathyroid Carcinoma<br>Charts from participants with histopathological diagnosis of parathyroid carcinoma. | Other: Chart Review<br>* Data between the years of 1/1/2002 and 12/31/2013 analyzed.<br>|
| Atypical Parathyroid Neoplasm<br>Charts from participants with parathyroid tumors with some atypical features found in parathyroid carcinoma, but not enough histologic criteria to make the diagnosis of parathyroid carcinoma. | Other: Chart Review<br>* Data between the years of 1/1/2002 and 12/31/2013 analyzed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information Collected on Clinical Characteristics of Parathyroid (PTH) Cancer and PTH Atypical Neoplasms by Conducting a Retrospective Chart Review |  | 5 years | 
| Information Collected on PTH Carcinoma's Biological Behaviour and Impact on the Health of the Patients by Conducting a Retrospective Chart Review |  | 5 years | 
| Information Collected on Atypical Neoplasm's Biological Behaviour and Impact on the Health of the Patients \by Conducting a Retrospective Chart Review |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parathyroid Carcinoma, Parathyroid Neoplasm, Chart Review
Physical Activity and Physical Fitness Parameters in COVID-19 Lockdown

Study Overview
=================
Brief Summary
-----------------
In this study; it was aimed to compare the physical activity levels of students who continued their university education face-to-face before the COVID-19 lockdown, and the values of physical activity levels related to health, physical activity levels and health-related physical fitness parameters in the post-lockdown period.

Detailed Description
-----------------
Within the scope of the course, the demographic information of the students will be recorded and physical activity status, physical fitness parameters, muscle endurance, cardiovascular endurance, flexibility and body composition will be evaluated.

Official Title
-----------------
Comparison of Physical Activity and Physical Fitness Parameters Pre and Post COVID-19 Lockdown in Young Adults

Conditions
-----------------
Assessment, Self

Intervention / Treatment
-----------------
* Behavioral: Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Before the quarantine period, those who completed the physical activity level and physical fitness tests within the scope of Physical Activity I course Students who do not have any physical or mental problems for the tests and measurements to be applied Exclusion Criteria: No internet access, Students who have an obstacle to taking tests and measurements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Evaluation|Within the scope of the course, the demographic information of the students (such as height, weight, body mass index) is recorded and the physical activity status is recorded with International Physical Activity Questionnaire Short Form (UFAA). Cardiovascular endurance with 6-Minute Walking Test, flexibility and circumference of waist, hip and neck with the Sit and Lie Test and body composition and Body Fat Ratio will be evaluated. After a full year of quarantine, the same students who were previously evaluated and accepted to participate in the current study will be evaluated with online remote video viewing methods (Teams, Zoom, etc.) and, with the same tests and measurements under supervision by the researchers.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | International Physical Activity Questionnaire Short Form | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness | 6 Minute Walk Test | 2 days | 
| Flexibility | Sit-Rise Test | 2 days | 
| Body composition | Body fat ratio | 2 days |
Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

Study Overview
=================
Brief Summary
-----------------
The prevalence of onychomycosis among diabetic patients is still a debated question as well as the best way to diagnose the disease. We conducted a prospective study to assess the prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of this disease and to assess the reliability of the diagnosis of onychomycosis.

Detailed Description
-----------------
From December 2000 to January 2005, we followed 100 successive diabetic patients, type 1 and type 2, suffering from (DN). At baseline we assessed age, gender, medical history and medications, foot insensitivity defined by a vibration perception threshold (VPT) >25 volts and onychomycosis by clinical diagnosis. Multiple samples of the most affected nail, often the big toe, were taken. A potassium hydroxide (KOH) test was done by 2 independent and blinded investigators and a culture in a laboratory (lab) specialized in mycology. Pictures of the nails and particularly of the sampled nail were taken. Apart from the laboratory results, two independent and blinded dermatologists gave their diagnosis looking at the pictures.

Official Title
-----------------
Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

Conditions
-----------------
Prevalence of Onychomycosis, Diabetic Neuropathic Patients, Diagnostic of Onychomycosis, Patients Clinically Suspected of Onychomycosis, Reliability of the Diagnosis of Onychomycosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were: presence of diabetes mellitus, type 1 or type 2, age between 18 and 80 years, neuropathy demonstrated by a VPT (Vibration Perception Threshold) >25 volts tested with a neurothesiometer (Horwell Scientific, London, UK) and a clinical diagnosis of onychomycosis. Exclusion Criteria: Exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.

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?
-----------------
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
-----------------
onychomycosis, diabetic neuropathic patients, reliability of the diagnostic of onychomycosis