linjc16/ctgov huggingface dataset:
Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)

Study Overview
=================
Brief Summary
-----------------
The present study investigates the efficacy of a new Endoultrasound guided fine needle biopsy (EUS-FNB) device (AquireTM Boston Scientific= AQUIRE®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..

Detailed Description
-----------------
The AquireTM FNB device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation. The efficiency of the 22 Gauge needle is evaluated in a prospective single arm study. The material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.

Official Title
-----------------
Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®) in Tumors of the Pancreas, Submucosal Tumors and Lymph Node Disease of the Upper GI Tract

Conditions
-----------------
Lymph Node Disease, Tumors of the Pancreas, Submucosal Tumor of Gastrointestinal Tract (Disorder)

Intervention / Treatment
-----------------
* Device: Endoultrasound guided FNB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Indication for EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract will be included Exclusion Criteria: Cystic pancreatic tumors Contraindication for EUS FNB Lesion of interest cannot be reached endosonographically

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Endoultrasound guided FNB<br>Patients with tumors of the pancreas, submucosal tumors or lymphnode disease of the upper gastrointestinal tract, which have to undergo EUS guided FNB. | Device: Endoultrasound guided FNB<br>* EUS FNB with Aquire TM device<br>* Other names: EUS FNB with Aquire TM device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue yield | The primary outcome of the present study is to analyze the percentage in which a representative histological sample can be obtained by EUS-FNB (quality score 3 as defined by Payne et al.). | 12 month after FNB | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endosonography, fine needle biopsy
TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis. To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens. To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients. To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.

Official Title
-----------------
TBTC Study 22: Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Twice-Weekly Rifampin and Isoniazid in the Continuation Phase of Therapy for Pulmonary Tuberculosis

Conditions
-----------------
Pulmonary Tuberculosis

Intervention / Treatment
-----------------
* Drug: Rifapentine
* Drug: Isoniazid


Participation Criteria
=================
Eligibility Criteria
-----------------
Culture-positive, drug-susceptible pulmonary tuberculosis

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rifapentine|nan|
|Drug: Isoniazid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with signs and/or symptoms of a respiratory infection. The study data will be used to support an application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or high complexity CLIA certification.

Official Title
-----------------
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting

Conditions
-----------------
Upper Respiratory Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Displays signs and/or symptoms of respiratory infections Adult patients must provide informed consent Parental consent for children (<18) Exclusion Criteria: Adult patients unable to provide informed consent Children that are currently in foster care, or are wards of the state
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 |
| --- | --- | --- |
| Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness | In general, performance of the FilmArray RP EZ test in the CLIA-waived setting is expected to meet at least 95% positive and negative percent agreement with the results obtained from FilmArray RP in the moderate/high- complexity setting for each pathogen on the panel. | 1.5 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology of respiratory infections in a CLIA-waived setting | Seasonality and rate of respiratory infection at each of the CLIA-waived sites using the FilmArray RP EZ to collect prospectively enrolled specimens will be evaluated at the end of the study. | Up to 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiplex, polymerase chain reaction, PCR, BioFire, respiratory infection, infectious disease, point of care, CLIA waived, rapid diagnostics
Studying Gene Expression in Tissue Samples From Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at gene expression in tissue samples from patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: Screen acute myeloid leukemia (AML) samples to correlate high relative expression levels of PLAGL2 and putative PLAGL2 target genes (implicated in microarray study) with potential pathogenic relevance with respect to AML development. OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.

Official Title
-----------------
Mechanisms of PLAGL2-Induced Leukaemogenesis

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: gene expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia, including inv(16)(p13;q22) abnormalities No t(15;17)(q22;q12) or t(8;21)(q22;q22) abnormalities PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of high relative expression levels of PLAGL2 and putative PLAGL2 target genes with potential pathogenic relevance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies
Tranexamic Acid and Blood Clots in Knee Surgery

Study Overview
=================
Brief Summary
-----------------
This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in total knee replacement patients who received an intraoperative dose of tranexamic acid.

Detailed Description
-----------------
This study is anticipated to consist of 30 participants over 18 years of age scheduled for total knee arthroplasty at Sandoval Regional Medical Center with administered intraoperative tranexamic acid, who do not meet the exclusion criteria. The patients will be examined on postoperative day 1. Lower-extremity ultrasound will be used to screen for deep vein thrombosis (DVT). Incidence data for DVT will then be compared with the historical incidence rate at our institution for total knee arthroplasty without the use of tranexamic acid, which is approximately 12%. Patients found on screening to have deep vein thrombosis will be referred for appropriate care.

Official Title
-----------------
Does the Intraoperative Administration of Tranexamic Acid (TXA) Increase the Incidence of Deep Venous Thrombosis in Total Knee Arthroplasty?

Conditions
-----------------
Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients scheduled for total knee arthroplasty at Sandoval Regional Medical Center with an intraoperative dose of tranexamic acid Exclusion Criteria: Previous deep vein thrombosis or pulmonary embolism episode Known coronary artery disease or peripheral vascular disease Previously diagnosed hypercoagulable states (e.g. Leiden factor V, antiphospholipid antibody, protein C or S deficiency) Pregnancy Creatinine clearance less than 30 ml/min Non-fluency in English

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 |
| --- | --- |
| Knee replacement patients receiving TXA<br>Patients who receive tranexamic acid during total knee replacement surgery | Drug: Tranexamic Acid<br>* Intravenous or local administration of TXA, in any dosage<br>* Other names: Cyklokapron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep Vein Thrombosis | Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1 | One day |
Fatigue One Year After ICU Discharge

Study Overview
=================
Brief Summary
-----------------
The investigators contacted consecutive adult patients admitted to intensive care unit (ICU) and mechanically ventilated for at least 72 hours to invite them to an interview at hospital. The investigators administered Mini Mental Status Examination, Functional Assessment of Chronic Illness Therapy scale for Fatigue (Facit- F) and Short form 36 questionnaires to the consenting patients.

Detailed Description
-----------------
Fatigue is one of the most commonly symptoms reported by patients. There are many causes of pathological fatigue including mental and physical, both neurological (central and peripheral) and non-neurological diseases. Among the last ones, cancer, infections and drugs are factors associated with fatigue, although the mechanism of how non-neurological diseases cause fatigue is not clear. Evidence exists to suggest that patients who have been critically ill continue to face a multitude of physical, psychological and social difficulties in the long term after discharge. As far as fatigue is concerned, greater than 50% of Intensive Care Unit survivors overall reported lowered energy levels and fatigue in the first year after discharge.

Official Title
-----------------
Fatigue in Intensive Care Survivors One Year After Discharge

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged > 18 years able to co-operate at the time of ICU discharge requiring mechanical ventilation for at least 72 hours residents less than 30 km from the hospital Exclusion Criteria: preexisting cognitive deficits pre-existing psychotic illness admitted for anoxic brain injury residents more than 30 km from the hospital

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 |
| --- | --- |
| Intensive care survivors<br>Observational study | Other: Questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short form 36 questionnaire |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Quality of life, Critically ill patients
Acute Effect of Strength Training on Blood Pressure in Cardiac Patients

Study Overview
=================
Brief Summary
-----------------
Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac patient, how high?

Detailed Description
-----------------
12 heart transplant recipients 12 heart failure patients 12 patients with ischemic heart disease

Official Title
-----------------
Acute Effect of Strength Training on Blood Pressure in Cardiac Patients

Conditions
-----------------
Heart Failure, Ischemic Heart Disease, Heart Transplant Recipients

Intervention / Treatment
-----------------
* Other: strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years no strength training > 3 month speak and understand danish Exclusion Criteria: cancer serum creatinin above 200 mmol/l re-transplantation Ejection fraction > 35

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 |
| --- | --- |
| Heart failure<br>strength training | Other: strength training<br>* strength training, lower limb.<br>* Other names: one hour of strength training.;|
| Heart Transplant recipients<br>strength training | Other: strength training<br>* strength training, lower limb.<br>* Other names: one hour of strength training.;|
| patients with ischemic heart disease<br>strength training | Other: strength training<br>* strength training, lower limb.<br>* Other names: one hour of strength training.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure |  | one test, 1 hour, continuated systolic blood pressure surveliance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic blood pressure |  | one test 1 hour, continuated bloodpressure surveliance | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute rise of systolic and diastolic bloodpressure
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor

Study Overview
=================
Brief Summary
-----------------
In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.

Detailed Description
-----------------
In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.

Official Title
-----------------
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor

Conditions
-----------------
Mandibular Fracture

Intervention / Treatment
-----------------
* Device: Condylar reductor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016. Exclusion Criteria: patients refused to participate in the clinical trial; condylar fracture dislocation was not obvious, conservative treatment can be used; mandibular condylar comminuted fracture; mandibular condyle need to be reconstructed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental group<br>In this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures. | Device: Condylar reductor<br>* A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.<br>|
| No Intervention: The control group<br>In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative reduction time |  | intraoperative |
PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis

Study Overview
=================
Brief Summary
-----------------
A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.

Official Title
-----------------
A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.

Conditions
-----------------
Prevention of Radiation Induced Dermatitis.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy. Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed. ECOG PERFORMANCE STATUS 0-1. Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control. No co-morbidities known to affect radiotherapy reactions. No co-existing acute or chronic skin disease. No evidence of infection or inflammation of breast to be treated. Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study. Exclusion Criteria: Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation. Prior radiotherapy to any site. Collagen vascular disease. Diabetes mellitus requiring medication. Uncontrolled hypertension. Participation in other clinical study. Any contra-indicating to treatment with Melatonin. History of allergy to peanuts or fragrances. History of severe allergic reactions (e.g. asthma).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Emulsion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital Camera |  | Weekly |