linjc16/ctgov huggingface dataset:
Pilot Study of Coil Arrays in Patients With Advanced Solid Tumor Malignancies

Study Overview
=================
Brief Summary
-----------------
This is a single center pilot study testing the use of novel coil arrays with MR liver imaging. In part A of the study, up to 30 healthy volunteers will be scanned, with iterative adjustment of coil array geometry and design to optimize imaging characterstics. In Part B of the study, 40 patients with advanced solid tumors and at least one liver metastasis measuring > 1.5 cm in diameter on standard anatomic scans will undergo MR liver imaging with the newly designed coil array, with the use of gadolinium contrast. Patients with liver tumors will have the option of undergoing a second MR liver scan during the course of subsequent systemic therapy.

Official Title
-----------------
A Pilot Study of Novel Magnetic Resonance Coil Arrays to Improve the Characterization of Liver Metastases in Patients With Advanced Solid Tumor Malignancies

Conditions
-----------------
Neoplams

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Part B only - Patients with advanced solid tumor): Advanced solid tumor malignancy and the presence of at least one liver metastasis measuring > 1.5 cm in longest diameter in axial dimension on standard anatomic imaging Exclusion Criteria (Part B only): Contra-indication to gadolinium contrast (e.g. chronic renal disease, prior allergic reaction) for patient studies Exclusion Criteria (Part A [Healthy Volunteers] and Part B): Contra-indication to MRI (e.g. pacemaker, severe claustrophobia, suspected presence of MR-Unsafe surgical implants or shrapnel)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI<br>Day 1 | Procedure: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatial Resolution | Adjust the coil array to optimize spatial resolution in healthy volunteers | Day 1 | 
| Scan coverage | Adjust the coil array to optimize scan coverage of the liver in healthy volunteers | Day 1 | 
| Mean contrast-to-noise ratio | Detectable using the coil array | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum size of detectable metastatic lesion | Detected by MRI scan | Day 1 | 
| Degree signal | Detected by gandolinium contrast in MRI scan within liver metastases | Day 1 | 
| Time-to-peak signal | Detected by gandolinium contrast in MRI scan within liver metastases | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Solid Tumor
Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.

Official Title
-----------------
Clinical Performance of the Investigational InRhythm PT/INR System in a Professional Use Setting

Conditions
-----------------
Blood Dyscrasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - All The subjects must be > 18 years of age. The subjects must be willing and competent to sign an informed consent. The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc. Exclusion Criteria - All The subject is unable to donate fingerstick and venous blood samples. The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture. The subject is enrolled in any other study that involves an investigational drug and/or device. Additional Inclusion Criteria - Therapeutic Group The subject must require oral VKA anticoagulant therapy. The patient must have been anticoagulated for at least three months prior to enrollment. Additional Exclusion Criteria - Normal Group - Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of INR measurements |  | 5 weeks |
Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.

Study Overview
=================
Brief Summary
-----------------
to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.

Detailed Description
-----------------
two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end of the operation.

Official Title
-----------------
Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Local Anesthetic Infiltration in Gynecologic Laparoscopy.

Conditions
-----------------
Post Operative Local Anaesthesia

Intervention / Treatment
-----------------
* Drug: Laparoscopic Guided Bupivacaine
* Drug: local Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients Need Gynecologic Laparoscopy Exclusion Criteria: diagnosed with chronic pain syndrome have a postoperative intraperitoneal drain necessitating alteration to laparotomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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 |
| --- | --- |
| Active Comparator: Laparoscopic<br>Laparoscopic Guided Transversus Abdominis Plane Block using Bupivacaine | Drug: Laparoscopic Guided Bupivacaine<br>* Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block<br>* Other names: marcaine;|
| Active Comparator: local<br>Trocar Site Infiltration of Bupivacaine | Drug: local Bupivacaine<br>* Bupivacaine Trocar Site Infiltration<br>* Other names: marcaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores |  | 24 Hours |
SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma

Official Title
-----------------
A Comparison of Symbicort® Single Inhaler Therapy (Symbicort® 200 Turbuhaler® 1 Inhalation b.i.d. Plus as Needed) & Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents & Adults-a 26-Week, Randomised, Open-Label, Parallel Group, Multicentre Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol Turbuhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma < 3 months Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1 Exclusion Criteria: Smoking history > 10 pack-years Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion Any significant disease or disorder that my jeopardize the safety of the patient. Additional inclusion and exclusion criteria will be evaluated by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Budesonide/formoterol Turbuhaler|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of asthma exacerbations |  |  | 
| Mean use of as-needed medication |  |  | 
| Prescribed asthma medication |  |  | 
| Patient reported Outcomes |  |  | 
| Health care resource use |  |  | 
| Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events |  |  | 
| Induced sputum will be sampled from a subset of patients |  |  | 
| All variables assessed over the 6 months treatment period |  |  |
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.

Detailed Description
-----------------
This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups : Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.

Official Title
-----------------
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Conditions
-----------------
Spontaneous Bacterial Peritonitis, Ascites, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Rifaximin
* Drug: Norfloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous episode of SBP Total protein in the ascitic fluid below or equal to 1.5 g/dL Exclusion Criteria: Allergy to quinolones Antibiotic therapy in the 2 weeks preceding inclusion Recent ( within the previous 2 weeks) episode of digestive hemorrhage Hepatocellular carcinoma or other neoplasias able to shorten life expectancy Pregnant and lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rifaximin<br>Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months. | Drug: Rifaximin<br>* rifaximin 1200 mg daily versus norfloxacin 400 mg once daily<br>* Other names: Gastrobiotic, Trencedia;|
| Active Comparator: norfloxacin<br>Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months. | Drug: Norfloxacin<br>* FDA approved:400mg once daily<br>* Other names: Epinor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with recurrence of SBP | The total number of paper of participitants with recurrence of SBP | 6 months |
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of TAI combine toripalimab in advanced HCC.

Official Title
-----------------
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Combination Product: Transarterial Chemoinfusion (TAI) Combine Toripalimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old and younger than 75 years; ECOG PS≤1; proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; cannot accepted hepatectomy; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent; Exclusion Criteria: cannot tolerate TAI or toripalimab; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: treatment group<br>Transarterial Chemoinfusion (TAI) Combine Toripalimab | Combination Product: Transarterial Chemoinfusion (TAI) Combine Toripalimab<br>* Transarterial Chemoinfusion (TAI) Combine Toripalimab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | From date of randomization until the date of progression, assessed up to 36 months | 
| ORR | objective response rate | From date of randomization until the date of death, assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | From date of randomization until the date of death from any cause, assessed up to 36 months | 
| DCR | disease control rate | From date of randomization until the date of death, assessed up to 36 months |
Prevalence of Pulmonary Hypertension in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The prevalence of an increased pulmonary blood pressure amongst patients with chronic obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood pressure on symptoms. The aim of this study is to determine the prevalence of an increased pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung function test results and blood tests can predict an increased pulmonary blood pressure, and explore whether COPD patients with a high pulmonary blood pressure have more symptoms that their co-patients.

Detailed Description
-----------------
The prevalence of pulmonary hypertension in patients with chronic obstructive pulmonary disease (COPD) is unclear. The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of COPD, but the patients are not currently diagnosed or treated for pulmonary hypertension. The aim of this study is to determine the prevalence of pulmonary hypertension in 200 patients with COPD and explore whether it worsens functional capacity and symptoms. Furthermore we will look into whether blood gas values, NT-proBNP, CRP and lung function test result can predict which patients are at risk of having pulmonary hypertension. Methods: All patients will be screened by echocardiography. Those with signs of pulmonary hypertension will be admitted to right heart catheterization for direct measurements of pulmonary haemodynamics. All patients will perform a 6 minutes walk test and spirometry. Blood levels of NT-proBNP and CRP will be measured. Life quality by the St. George Questionnaire and contacts to the health care system is also assessed. Differences in these parameters are analyzed among patients with no, moderate or severe pulmonary hypertension.

Official Title
-----------------
Prevalence and Influence of Pulmonary Hypertension in COPD Patients

Conditions
-----------------
COPD, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD Prior admittance to hospital with exacerbation in COPD Informed consent Exclusion Criteria: Exacerbation in COPD less than 6 weeks before examination
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
-----------------
COPD, pulmonary hypertension, NT-proBNP, 6 minutes walk test
NFL Dynamics as a Predictor Factor in Patients With Out of Hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
To investigate the pharmacodynamics of light chain of NFL in patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.

Detailed Description
-----------------
To investigate the serum levels of the light chain of NFL at different time points after ICU admission (12, 24, 30, 36, 42, 48 hours after ICU admission) patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.

Official Title
-----------------
Dynamics of Light Chain of NFL as a Predictor Factor of Neurological Outcome in Patients With Out of Hospital Cardiac Arrest

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest, Neurological Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU Exclusion Criteria: trauma, drowning, electrocution, less than 18 years of age,

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 |
| --- | --- |
| Patients with favorable neurlogical outcome<br>CPC 1/2 | |
| Patients with non-favorable neurological outcome<br>CPC3-5 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the dynamics of serum NFL levels measurements in patients with favorable neurological outcome compared to patients with non-favorable neurological outcome | NFL levels | 3 years |
Ultrasound-guided Supraclavicular Brachial Plexus Blockade

Study Overview
=================
Brief Summary
-----------------
Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. We are able to use less drug to achieve the same result. For this reason, we are doing a study to look at the level of freezing drug that accumulates in the body. We feel that the drug levels will be significantly different. We also feel that the time-to-peak drug level will be different than with traditional arm freezing procedures.

Official Title
-----------------
Ultrasound-guided Supraclavicular Brachial Plexus Blockade: A Pharmacokinetic Study of Lidocaine and Adrenaline

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

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing brachial plexus anesthesia as part of disease management who have consented to participate in the study Exclusion Criteria: Contraindication to brachial plexus anesthesia Informed consent not obtained

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lidocaine|Lidocaine, 5 mg/kg, via needle placed adjacent to brachial plexus with ultrasound, dosing separated by 1 week, 2 doses in total, one block will contain 5 mcg/kg of adrenaline|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lidocaine drug level |  | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brachial plexus block quality |  | 30 minutes | 
| Physiotherapy quality |  | within 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Brachial Plexus Anesthesia, Plasma Lidocaine Levels, Ultrasound