linjc16/ctgov huggingface dataset:
A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection

Study Overview
=================
Brief Summary
-----------------
5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will examine the kinetics of inhibition and recovery of the metabolic pathways for fluoropyrimidines in subjects who receive a single oral dose of ADH300004, and may allow optimization of oral 5 FU dosing to subjects in future studies.

Official Title
-----------------
Phase 1 Study of the Evaluation of Dihydropyrimidine Dehydrogenase (DPD), Uridine Phosphorylase (UP), Orotate Phosphoribosyl Transferase (OPRT), and Thymidine Phosphorylase (TP) Activity in Tissue Resected From Subjects Undergoing Planned Resection of Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection, Following Administration of Oral ADH300004 (Adherex Protocol Number AHX-03-101)

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: ADH300004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent > or = 19 years of age Patients with histologically confirmed: primary or metastatic (known or suspected) colorectal carcinoma requiring planned surgical resection with hepatic biopsy and systemic chemotherapy , or primary or metastatic neoplastic disease within the liver from any origin requiring planned surgical resection and systemic chemotherapy Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing Exclusion Criteria: Lack of known or suspected metastatic disease in the liver Known DPD deficiency Severe infection Inability to take oral medication The need for treatment with any fluoropyrimidine within 8 weeks of any ADH300004 dose Stroke, major surgery, or other major tissue injury within 30 days before study entry

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ADH300004|nan|

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
-----------------
Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents;, Dihydrouracil dehydrogenase (NADP); Colorectal Carcinoma; Liver Cancer
Prognostic Value of Cardiac and Renal Markers in Ischemic Stroke and Transient Ischemic Attack

Study Overview
=================
Brief Summary
-----------------
Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome, recurrence of cardiovascular events or vascular death.Until now, no reliable predictive biological marker could be identified in the acute phase of stroke.We hypothese that, in the acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide, BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular events or vascular death. We want to assess which one of these markers has the best prognosis value , in a prospective study of 300 stroke patients followed during 3 years.

Detailed Description
-----------------
Patients with ischemic stroke or TIA will be included in the 48 hours following the onset of symptoms, in 3 university hospitals.For each patient will be collected 1 blood sample for the BNP measure in pg/ml 1 blood sample for the Cystatin C measure in mg/l 2 urinary samples to measure the albumine/creatinine ratio, at inclusion and 5 days after the inclusion, and to study the variation of albuminuria in micrograms/min. The clinical follow-up will be organized during 3 years. The following events will be notified: poor outcome (defined with the Barthel and Rankin scores), recurrence of cardiovascular or cerebrovascular events, vascular death. After adjustment on the main clinical prognosis factors, we want to determine wich one of these markers has the best prognosis significance and allows to identify in the acute phase the high-risk patients, in order to intensify individual treatment and secondary prevention.

Official Title
-----------------
Prognostic Value of Cardiac and Renal Markers in the Acute Phase of Ischemic Stroke or Transient Ischemic Attack :Albuminuria-Brain Natriuretic Peptide-Cystatine C in Stroke

Conditions
-----------------
Ischemic Stroke, Transient Ischemic Attack

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic stroke or TIA in the first 48 hours following the onset of symptoms Exclusion Criteria: Patient unable to give an informed consent Urinary sample impossible to collect

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BNP, stroke, transient ischemic attack, albuminuria, Cystatin C
Clinical Pre-screening Protocol for Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The pre-screening study is established to pre-screen tumor samples from ovarian cancer patients to identify if they, at a later stage of their disease, will benefit from treatment with any investigational cancer drugs available to Oncology Venture, when these drugs are approved for future clinical studies by local authorities.

Official Title
-----------------
Clinical Pre-screening Protocol for Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Device: Drug Response Predictor® (DRP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histological confirmed epithelia ovarian cancer Relapse after 2 or more chemotherapies for ovarian cancer FFPE tumor tissue available Exclusion Criteria: Other primary malignancy within the last 5 years prior to enrolment

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 |
| --- | --- |
| Ovarian cancer patients<br>with formalin-fixed paraffin-embedded (FFPE) tumor tissue available | Device: Drug Response Predictor® (DRP)<br>* A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug | based on FFPE ovarian cancer tissue | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective analysis of whether or not the DRP method can predict and confirm the obtained sensitivity to the prior drugs used in the treatment of ovarian cancer |  | up to 2 years |
Study of Donated Amnion, Fetal Placental Membrane, as Skin Substitute for Burn Patients

Study Overview
=================
Brief Summary
-----------------
Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious. Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair.

Official Title
-----------------
Fetal Membrane as a New Coverage Material

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Procedure: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women Pregnant, delivery expected within the month Exclusion Criteria: Known history of hepatitis, HIV, or active transmissable diseases

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Amnion tissue and blood collection | Procedure: blood draw<br>* blood collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe method of obtaining and processing amnion |  | 0-21 days post harvest | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, Wound healing, Amnion
Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT

Study Overview
=================
Brief Summary
-----------------
The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT.

Official Title
-----------------
Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT With 0.275-sec Gantry Rotation Speed

Conditions
-----------------
Coronary Artery Disease, Cardiac CT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indicated for coronary CT assessment Exclusion Criteria: aortic disease pulmonary embolism severe arrhythmia severe heart failure allergy for iodinated contrast agent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| significant coronary stenosis |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, Cardiac CT, Appropriate Use Criteria (AUC)
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients

Study Overview
=================
Brief Summary
-----------------
Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms are common post-injury, and few MTBI patients receive treatment or follow-up for these symptoms. Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly common form of communication, potentially allowing for accurate assessment of symptom patterns after MTBI and provision of basic education support . The investigators seek to assess the feasibility of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based symptom reports correlate with phone-based follow-up reports at 14 days and whether additional SMS-based educational feedback alters daily symptom patterns.

Detailed Description
-----------------
The investigators seek to assess the feasibility of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based symptom reports correlate with phone-based follow-up reports at 14 days and whether additional SMS-based educational feedback alters daily symptom patterns at 3-months.

Official Title
-----------------
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients

Conditions
-----------------
Head Injury, Minor

Intervention / Treatment
-----------------
* Behavioral: SMS assessments & feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of minor traumatic brain injury English speaking Owns a cell phone with SMS Exclusion Criteria: Critically ill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS assessments & feedback<br>Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity. | Behavioral: SMS assessments & feedback<br>* Daily symptom assessments tied to tailored feedback<br>|
| No Intervention: Control<br>Standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead Post Concussive Questionnaire |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead Post Concussive Questionnaire |  | 3 months |
Study of the Predictive Marker FLT in Patients Suffering From AML

Study Overview
=================
Brief Summary
-----------------
Positron emission tomography uses various radioactive tracers to measure the metabolic activity in a none-invasive way, and specially to follow the activity of the disease during the treatments. Among those new tracers, fluorothymidine (18F-FLT) arouses a lot of interest. This new tool would allow to image and follow time wise acute myeloid leukemia (AML). The investigators want, with the (18F-FLT), to characterise the aggressivity of the tumors and the prognostic before and after chemotherapy treatment. The aim of this study is to be able to identify earlier the responders, because if they are detected sooner, these patients will benefit from more aggressive treatments.

Official Title
-----------------
Use of FLT-TEP Scan as Predictive Marker and Early Prognostic in Patients Suffering From AML Treated by Chemotherapy

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years or above at the time of inclusion; Patients newly diagnosed with acute myeloid leukemia; No contraindication or intolerance to any of the components of the standard chemotherapy by induction (7+3); Patients able to give written informed consent. Exclusion Criteria: Patients unable to tolerate decubitus position for at least 45 minutes; Any previous neoplasia or other neoplasia simultaneously; Previously treated buy radiotherapy, with bone marrow in the field of radiation; Other chemotherapy treatment than the standard chemotherapy by induction (7+3), before the second FLT-TEP was done.

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 |
| --- | --- | --- |
| To mesure the pronostic value of metabolic activity in the bone marrow with FLT-PET prior to chemotherapy in patients with AML disease. |  | September 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AML / LMA
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).

Detailed Description
-----------------
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)

Conditions
-----------------
Fatty Liver

Intervention / Treatment
-----------------
* Drug: Rimonabant
* Drug: Placebo (for Rimonabant)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of NASH Exclusion Criteria: Excessive alcohol use Presence of diabetes mellitus Other chronic liver disease Previous or current hepatocellular carcinoma Use of medication known to cause steatosis Previous bariatric surgery Pregnancy or breastfeeding Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimonabant<br>Rimonabant 20 mg once daily. | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;|
| Placebo Comparator: Placebo<br>Placebo (for Rimonabant) once daily. | Drug: Placebo (for Rimonabant)<br>* Tablet, oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) |  | Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hepatic fibrosis score |  | Baseline to 24 months | 
| Change from baseline in serum hyaluronate (HA) |  | Baseline to 24 months | 
| Change from baseline in hepatic transaminases (AST/ALT) |  | Baseline to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NASH, chronic liver disease
Noninvasive Hemoglobin Monitoring by Spectrophotometry in Blunt Abdominal Trauma Patients for Conservative Management

Study Overview
=================
Brief Summary
-----------------
We aimed to study the efficacy of Noninvasive Hemoglobin Monitoring by Spectrophotometry in monitoring hemoglobin level in trauma patients for conservative management.

Official Title
-----------------
Noninvasive Hemoglobin Monitoring by Spectrophotometry (SpHb) in Blunt Abdominal Trauma Patients for Conservative Management

Conditions
-----------------
Intensive Care Unit

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I to III, of either sex, 18 -80 years of age, non-sedated non-intubated patients who will be admitted to Ain Shams university hospital - surgical intensive care unit, after blunt abdominal trauma planned for conservation. Exclusion Criteria: Patients with fever, hypothermia, history of a neurological, psychiatric, dementia or, who are taking psychotropic drugs Patients with unstable hemodynamic status, and unconscious patients.

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 |
| --- | --- |
| abdominal trauma patients<br>blunt abdominal trauma patients planned for conservation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of hemoglobin measured by the noninvasive device. | accuracy of hemoglobin measured by the noninvasive hemoglobin test device (Radical-7®; Masimo Corp., Irvine, CA) in comparison with standard CBC that is assayed on Coulter LH 750 Cell Counter (Beckman Coulter Corporation, Florida, USA), using reagents supplied by the company in patients suffering frm blunt abdominal trauma aditted to ICU for observation. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
massimo