linjc16/ctgov huggingface dataset:
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.

Official Title
-----------------
Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Biological: Dosage de l'h-FABP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with acute pulmonary embolism diagnosed in the emergency departement Exclusion Criteria: patient under guardianship patient without social insurance pregnant women refusal to sign the consent myocardial infarction in the 10 days before pulmonary embolism

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Dosage de l'h-FABP|Dosage de l'h-FABP|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of death by pulmonary embolism |  | 1 month | 
| life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation) |  | 1 month | 
| recurrent episode of pulmonary embolism |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary embolism, Heart-type fatty acid-binding protein, cardiac biomarkers, risk stratification
Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tumor 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. It may also help doctors understand how patients respond to treatment. PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.

Detailed Description
-----------------
OBJECTIVES: Determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-VEGF therapy. OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory endpoints.

Official Title
-----------------
Alternative Splice Forms of VEGF in Colorectal Cancer - Possible Value in Anti-VEGF Therapy

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: protein expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: immunoenzyme technique
* Other: immunohistochemistry staining method
* Other: immunologic technique


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum Receiving bevacizumab on clinical trial E-3200 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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: gene expression analysis|nan|
|Genetic: protein expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: immunoenzyme technique|nan|
|Other: immunohistochemistry staining method|nan|
|Other: immunologic technique|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean scores for VEGFb and pan-VEGF gene expression by IHC |  | 1 month | 
| Gene expression as measured by tissue microarrays |  | 1 month | 
| Splice form expression as measured by reverse transcriptase-PCR |  | 1 month | 
| VEGF165b protein expression as measured by ELISA |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, stage III colon cancer, stage IV colon cancer
Pin Size Influence the Incidence of Knee Pain

Study Overview
=================
Brief Summary
-----------------
It has been the investigators observation that large diameter traction pins cause more postoperative knee pain than smaller traction pins. To the investigators knowledge, no study to date has identified knee pain as a consequence of traction pin placement. Furthermore, no study has identified whether pin size has an effect on the incidence of postoperative knee pain. The goal of the present study is to establish whether use of temporary skeletal traction is associated with subsequent knee pain and to determine whether traction pin size influences the incidence and/or magnitude of knee pain. Objective #1: Determine whether pin size influences the incidence and/or severity of postoperative knee pain in patients who undergo temporary skeletal traction. Hypothesis: Larger traction pins are associated with an increase in both the incidence and severity of postoperative knee pain. Objective#2: Determine whether pin size affects musculoskeletal function in the postoperative period. Hypothesis: There is no difference between small and large traction pins in postoperative musculoskeletal function.

Official Title
-----------------
Does Pin Size Influence the Incidence of Knee Pain in Patients Undergoing Temporary Skeletal Traction?

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults At least 18 years old Injury (Pelvic, acetabular, or femoral fracture) requiring temporary skeletal traction. Exclusion Criteria: Neurovascular compromise. Ipsilateral fractures presenting contraindication to skeletal traction Patients who are non-ambulatory. Patients less than 18 years of age. Patients who do not speak English. Ipsilateral ligamentous knee injury

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 |
| --- | --- | --- |
| 2000 IKDC Subjective Knee Evaluation form, and pin site Visual Analog Pain Scale (VAS) | Questionaires to assess knee pain | Post-operative follow-up visits up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Musculoskeletal Function Questionnaire (SMFA) | Questionaire to assess musculoskeletal function | Post-operative follow-up visits up to 1 year |
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: M518101
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who are able and willing to give signed informed consent Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator. Who have less than 20% of body surface area (BSA) afflicted with plaques Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. Exclusion Criteria: Who have a history of allergy to vitamin D3 derivative preparations. Who have a history of relevant drug hypersensitivity. Who have a history of contact dermatitis induced by a topical medicine. Who are pregnant or lactating. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study. Whose serum calcium levels exceed the upper limit of reference range Who have used any investigational medicinal product and/or participated in any clinical study within 24 weeks Who have been treated with systemic therapy within 8 weeks Who have been treated with biologics within 12 weeks Who have been treated with topical therapy during the wash-out and lead-in period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: M518101|Proper quantity twice a day|
|Drug: placebo|Proper quantity twice a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of plaque psoriasis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator and Patient overall assessment |  |  |
Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. The primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.

Official Title
-----------------
Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 65 years of age male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization > 24 hours able to read and write in English discharged to home environment Exclusion Criteria: a cardiac transplant candidate experienced an acute coronary event within the previous 30 days of index hospitalization experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization end stage renal disease/hemodialysis have a left ventricular assist device > 400 lbs unable to stand for 90 seconds independently

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events of rehospitalization and/or mortality. | Trial a novel 30-day post-discharge monitoring instrument after hospitalization for heart to evaluate patient status based on patient self-monitoring. | 30 days |
Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

Study Overview
=================
Brief Summary
-----------------
To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

Detailed Description
-----------------
To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration in the abdominal, and to compare this profile with Humulin insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).

Official Title
-----------------
Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Jusline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Non-diabetic Age 18-35 year Normal body mass index (BMI 18-25 kg/m2) Exclusion Criteria: Diabetics Overweight/obese Anemic, with liver, cardiac, renal or thyroid dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Jusline Humulin | Drug: Jusline<br> <br> * Other names: Humulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy subjects
The Effect of Obesity on Ventilation Tube Insertion

Study Overview
=================
Brief Summary
-----------------
Obesity is associated with increased risk of surgical complications. Ventilation tube insertion is one of the most frequent surgical procedures performed on children. However, the impact of obesity on surgical results or surgical related complication following ventilation tube insertion remains poorly understood. The aim of this study was to investigate the effect of obesity on the surgical results of ventilation tube insertion for otitis media with effusion (OME) in pediatric patients.

Detailed Description
-----------------
OME was diagnosed by the presence of fluid in the middle ear on otoscopy or tympanometry according to clinical practice guidelines . The diagnostic findings of pneumatic otoscopy and otomicroscopy include the tympanic membrane dullness, impaired mobility, and an air-fluid level or bubble. In addition, the type B or C tympanogram was considered positive for OME. Indication for ventilation tub insertion includes history of OME lasting 3 months or longer, structural damage to tympanic membrane or middle ear and risk for speech, language learning difficulties. Adenoidectomy is also performed when adenoid hypertrophy is founded during preoperative assessment. Body weight and height were measured before ventilation tube insertion at hospital. Body mass index (BMI) was calculated using the formula weight/ height2 (Kg/m2).

Official Title
-----------------
The Effect of Obesity on Ventilation Tube Insertion

Conditions
-----------------
Obesity, Otitis Media

Intervention / Treatment
-----------------
* Procedure: ventilation tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 2-15 years with a diagnosis of OME who underwent ventilation tube insertion Exclusion Criteria: Children with a previous history of ventilation tube insertion Use of ventilation tubes other than Paparella type I Head and neck anomalies Chronic or systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 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 |
| --- | --- |
| obesity<br>otitis media patient with obesity | Procedure: ventilation tube<br>* ventilation tube insertion<br>|
| non obesity<br>otitis media patient with non obesity | Procedure: ventilation tube<br>* ventilation tube insertion<br>|

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
-----------------
otitis media, obesity, ventilation tube
Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow limitation usually progressive and associated with inflammatory response of lung noxious particles. During a physical activity chronic obstructive pulmonary disease patients may develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased activity performance. The investigators hypothesize that some specific activities of daily living induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure dynamic lung hyperinflation and its influence in dyspnea perception in moderate and severe chronic obstructive pulmonary disease patients after activities of daily living. Methods: The investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen saturation, heart rate and respiratory rate in 19 chronic obstructive pulmonary disease (COPD) patients. These measurements were taken at rest and after daily living activities (such as going up and down a set of stairs, going up and down a ramp and sweeping and mopping a room).

Conditions
-----------------
Dynamic Lung Hyperinflation, COPD Patients, Activities of Daily Livin.

Intervention / Treatment
-----------------
* Other: Hyperinflation and ADL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients diagnosed with moderate to very severe airway obstruction according to GOLD classification (9) clinical stability with no clinical exacerbation during the previous 30 days prior to the beginning of the study and to sign an informed consent form Exclusion Criteria: Inability to perform the slow vital capacity maneuver excessive perceived dyspnea during the test arterial oxyhemoglobin saturation (SpO2) lower than 80% during activities and/or need of oxygen supplementation

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| COPD hyperinflation<br> | Other: Hyperinflation and ADL<br>* Assessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, activities of daily living, pulmonary hyperinflation, exercise
Clinical Trial in Males With BPH (Enlarged Prostate)

Study Overview
=================
Brief Summary
-----------------
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. Free study-related medical care provided.

Official Title
-----------------
Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.

Conditions
-----------------
Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy

Intervention / Treatment
-----------------
* Drug: Alfuzosin (SL770499)


Participation Criteria
=================
Eligibility Criteria
-----------------
Has been suffering for at least 6 months with any of the following symptoms: daytime or nighttime urinary frequency urgent feeling to urinate difficulty starting urinary stream interruption of urinary stream feeling of incomplete urination Has not had a previous episode of acute urinary retention Has not been diagnosed with prostate cancer Has not had previous prostate surgery Is not an insulin-dependent diabetic

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfuzosin (SL770499)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of first episode of acute urinary retention (AUR) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Urinary Retention, AUR, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, BPH, Enlarged Prostate