linjc16/ctgov huggingface dataset:
Pilot Clinical Trial to Evaluate the UNI-DEB for Unresectable Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Pilot Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Official Title
-----------------
A Open, Single-arm, Uncontrolled, Single Center, Pilot Study to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma Non-resectable

Intervention / Treatment
-----------------
* Device: UNI-DEB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 years Diagnosis of HCC Unresectable asymtomatic uninodular or multinodular tumor. Subject who maintain clinically normal hepatopetal flow without main portal vein closure At least one measurable target lesion by CT or MRI which 10 mm or more. ECOG Performance Status of 0 or 1. Child-Pugh class A or B Life expectancy of at least 6 months. Exclusion Criteria: Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia Hepatic resection, liver transplantation or Percutaneous local treatment Previously received HCC related medical procedure Previously treated with anthracyclines Only measurable disease is within an area of the liver previously subjected to radiotherapy. Child Pugh C Active gastrointestinal bleeding within 6 months from screening. Total bilirubin > 3mg/dL WBC < 3,000cells/mm3 ANC < 1,500cells/mm3 Platelet < 50,000mm3 Serum creatinine > 2mg/dL INR > 1.4 ALT and AST > 5 times UNL Diffuse HCC defined as >50% tumor involvement of the whole liver.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UNI-DEB<br> | Device: UNI-DEB<br>* Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 4 weeks after treatment |
High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients

Study Overview
=================
Brief Summary
-----------------
High flow oxygen results in better oxygenation in emergency cases needing rapid sequence induction for anaesthesia. Secondary outcome measure is time for any desaturation.

Detailed Description
-----------------
The investigators intend to do the study using high flow oxygen for all emergency cases needing rapid sequence induction. As part of the study the Investigators will measure the oxygen levels in the blood gas sample of the patient and the heart rate of anesthetist in charge of the airway management. After the airway is secured the time for desaturation will be noted.

Official Title
-----------------
High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients

Conditions
-----------------
High Flow Oxygen in Rapid Sequence Induction, Airway Morbidity

Intervention / Treatment
-----------------
* Device: face mask oxygen
* Device: High flow oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency patients needing rapid sequence induction for surgery ≥ 16 years Able to give consent Exclusion Criteria: Patients age under 16 years Inability to give consent Severe respiratory disease

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

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

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

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 |
| --- | --- |
| Active Comparator: Face mask group<br>Patients will be given oxygen via face mask as per routine practice, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted. | Device: face mask oxygen<br>* oxygen given by face mask as per routine practice<br>|
| Active Comparator: THRIVE group<br>Patients will be given oxygen via high flow oxygen in Optiflo, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted. | Device: High flow oxygen<br>* High flow oxygen given via optiflo machine / device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen levels in blood gas sample | Oxygen levels in blood gas sample after the airway is secured | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to desaturation | after airway is secured time will be noted for oxygen levels to fall to 92% before the ventilation is started. | intraoperative or 10 minutes after intubation | 
| heart rate of anaesthetist performing the intubation |  | During the process of induction of anaesthesia and intubation upto 5 minutes post intubation |
Accuracy of Mobile-Based Vision Charts.

Study Overview
=================
Brief Summary
-----------------
Analyzing the accuracy of mobile-based distant vision charts in clinical practice as an economic alternative for standard vision charts.

Detailed Description
-----------------
Accuracy of mobile-based visual acuity testing in clinical practice is still debatable. The aim of this study was to analyze the accuracy of mobile-based distant vision chart in comparison to standard chart projector.

Official Title
-----------------
Accuracy of Mobile-Based Vision Charts in Clinical Practice.

Conditions
-----------------
Visual Spatial Processing

Intervention / Treatment
-----------------
* Diagnostic Test: Distant best corrected visual acuity assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects visited ophthalmology clinic at Al-Nil Hospital, Banha, EGYPT for visual acuity assessment. Subjects that their best corrected visual acuity was ranged from 0.1 to 1.0 in decimal form measured on snellen's chart. Exclusion Criteria: Subjects that refuse to measure visual acuity twice during the same visit. Subjects that their best corrected visual acuity is less than 0.1 in decimal form by the standard chart projector.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 70 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 |
| --- | --- |
| Standard vision chart.<br>Best corrected visual acuity measured by standard chart projector. | Diagnostic Test: Distant best corrected visual acuity assessment<br>* Measuring distant visual acuity on snellen's chart using two methods and results were converted to equivalent logarithm of minimum angle of resolution to compare accuracy of mobile based chart to the standard vision chart.<br>|
| Mobile based vision chart.<br>Best corrected visual acuity measured by mobile based chart with screen mirroring over 24 inch monitor. | Diagnostic Test: Distant best corrected visual acuity assessment<br>* Measuring distant visual acuity on snellen's chart using two methods and results were converted to equivalent logarithm of minimum angle of resolution to compare accuracy of mobile based chart to the standard vision chart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of mobile based snellen chart in measuring distant visual acuity. | To compare the decimal results of mobile based snellen chart for measuring distant vision with the decimal results of the standard snellen chart projector. | Immediately after visual acuity testing using the standard chart projector. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visual acuity, Mobile-based chart, Snellen's chart
Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients.

Official Title
-----------------
Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors

Conditions
-----------------
Brain Tumor, Pediatric

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 3 to 18 To be diagnosed with malignant brain tumors To eligible for radiation therapy Karnofsky performance status ≥ 70 No prior radiation exposure Informed consent signed for blood sample collection and used for research purpose Exclusion Criteria: Patients had received radiotherapy previously. Patients who had no histological diagnosis Patients who do not wish to participate Patients with infections

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- | --- |
| The changes of peripheral blood immune cells | The flow cytometric analysis of lymphocyte subtypes populations would be performed | 6 weeks (prior and post the radiation therapy ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation status of T cells | Activation status of peripheral IFN-γ-producing effector CD8+ T cells by Elispot. | 6 weeks (prior and post the radiation therapy ) | 
| The changs of inflammatory cytokines and chemokines | Human inflammatory cytokines and chemokines will be analyzed by ELISA during radiation therapy. The cytokines and chemokines are IL-2, IL-10, IFN-γ, TNF-α | 6 weeks (prior and post the radiation therapy ) |
Meditation and Youth Mental Health

Study Overview
=================
Brief Summary
-----------------
Youth is a crucial time of life when physical and mental well-being is critical. Students are vulnerable due to academic and pandemic stresses. Meditation research has been showing effects on improved parameters of mental health (sleep quality, attention, memory, and concentration), emotional wellbeing (reduced stress and anxiety), and physiological parameters (better metabolism, circulation, immunity, etc.), which influence the life and academic performance of students. This study is designed to examine the feasibility of conducting a meditation intervention among students of a small liberal arts university in Pakistan. Future larger and longer randomized controlled clinical trials on high-risk youth may be planned at a later stage to see the impact on academic performance and career progression.

Official Title
-----------------
Effect of Meditation on the Young Mental Health - A Feasibility Pilot Quasi-experimental Study

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

Intervention / Treatment
-----------------
* Behavioral: Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy students Exclusion Criteria: Students suffering from a serious illness Students already meditating regularly

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 27 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation<br>Meditation for 30 min 10 days | Behavioral: Meditation<br>* Students will meditate for 30 min every day for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meditation Practice | Determinants of Meditation Practice Inventory | 10 days | 
| Sleep quality (sleep duration, deep sleep, light sleep, REM) | Sleep quality as measure by the fitness watch | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity and Heart Rate | Physical activity as measure by the the fitness watch | 10 days | 
| Stress and Breathing Score | Stress levels as measure by the the fitness watch | 10 days | 
| Food intake and nutrient profile | Dietary pattern measured through an online app | 10 days |
Progenitor Cell Therapy in Dilative Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.

Detailed Description
-----------------
Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (BMC) may enhance left ventricular functional recovery in patients with acute myocardial infarction. It is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to regionally improve left ventricular contractility by selective infusion of BMC into the left anterior descending coronary artery. Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy

Official Title
-----------------
Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy

Conditions
-----------------
Heart Failure, Congestive, Cardiomyopathy, Dilated, Stem Cell Transplantation

Intervention / Treatment
-----------------
* Procedure: intracoronary infusion of BMC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 8-80 Dilated Cardiomyopathy, Ejection fraction < 40% LVEDD > 60mm Stable clinical condition within last 6 months Written informed consent Exclusion Criteria: Myocardial infarction or coronary intervention in the past Change of medical therapy within the last 6 weeks prior to cell therapy Tumor within last 5 years or incomplete remission Active infection Active bleeding Stroke within last 2 years Surgery or trauma within last 2 months Uncontrolled hypertension HIV infection Chronic inflammatory disease Liver disease (GOT > 2x upper normal limit) Renal dysfunction (creatinin > 2.0mg/dl) Thrombopenia < 100.000 Anemia (hemoglobin < 8.5 g/dl) Mental retardation

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intracoronary infusion of BMC|catheter delivery of stem cells|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV function (Ejection fraction within 3 months) Simpson |  | 4 months |
An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.

Official Title
-----------------
A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)

Conditions
-----------------
Lymphocytic Leukemia, Chronic

Intervention / Treatment
-----------------
* Drug: Chemotherapy
* Drug: rituximab [MabThera/Rituxan]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age B cell-lineage chronic lymphocytic leukaemia (B-CLL) Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC Informed consent to data collection Exclusion Criteria: Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study Any other tumour disease

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 |
| --- | --- |
| First line<br> | Drug: Chemotherapy<br>* as prescribed<br>Drug: rituximab [MabThera/Rituxan]<br>* as prescribed<br>|
| Relapsed/refractory<br> | Drug: Chemotherapy<br>* as prescribed<br>Drug: rituximab [MabThera/Rituxan]<br>* as prescribed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (Response rate, duration of response, progression-free survival) |  | 3 years | 
| Chronic lymphocytic leukaemia (CLL) Comorboid Scale |  | 3 years | 
| Quality-adjusted survival analysis (Q-TWIST methodology) |  | 3 years |
Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study

Study Overview
=================
Brief Summary
-----------------
The aim of the proposed research is to measure the effect of drug-induced sedation on the functional connectivity between brain regions as indicated by EEG signal transmission within the human brain. The results of this study will help to identify the neurophysiological correlates of changes in conscious experience that occur during drug-induced sedation.

Detailed Description
-----------------
In the proposed experiments cortical areas will be stimulated using low frequency, low-amplitude transcranial magnetic stimulation (TMS) in healthy human subjects during wakefulness and during drug-induced responsive sedation and unresponsive sedation. Simultaneously, high-density electroencephalography (Hd-EEG) will be recorded to evaluate the temporal and spatial characteristics of evoked responses and induced rhythms over the cortex.

Official Title
-----------------
Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy right-handed men Aged 18-35 Non-smokers No metallic implants Exclusion Criteria: Younger than 18 or over the age of 35.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defining the neurophysiological conditions that are necessary for conscious experience. |  | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding the neurophysiological correlates of conditions associated with restricted conscious experience such as sedation and anesthesia. |  | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cortico-cortical, connectivity, Transcranial, Magnetic, Stimulation
Stress Response in Emergency Among Physicians in Helicopter and Ambulance Based Emergency Medical Systems

Study Overview
=================
Brief Summary
-----------------
Stress reactions in emergency physicians will be measures using cortol-awakening-reaction, heart-rate-variability and standardised stress questionnaires

Detailed Description
-----------------
In a field study with within-subject design, there will be conducted the hormonal and physiological stress strain of emergency physicians working in rescue helicopters or van on different days of service on different headquarters. The investigation of the parameter of stress will be conducted on two days of rescue service, on two days of clinical service and as a control on two days off. The quantification of the hormonal stress strain will be carried out with the cortisol awakening response, there will be conducted 3 saliva samples with identical interval after getting up within 30 minutes. While the labour time on the rescue service and on the clinical service and the whole day off, the heart rate variability will show the degree of physiological stress. This will be measured with a pulse-belt on the chest, which the participant will carry the whole day. In addition, participants will fill out a set of questionnaire on the first day of measurement.

Official Title
-----------------
Hormonal and Physiological Stress Response of Medical Doctors Working in Rescue Helicopter or Van

Conditions
-----------------
Hormone Disturbance, Stress Reaction, Stress Related Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical Doctor working in rescue helicopter or van Exclusion Criteria: Metabolic disease Autoimmune disease Heart disease Blood disease Mental disease Endocrinologic disease BMI>30 >10 cigarettes/day Taking cortisone medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Cortisol-awakening-response (CAR) | Differences on the CAR on rescue services, clinical services and on days off. | 30 min each day, six days | 
| Heart rate variability | Continuous measurement | six days | 
| Stress questionnaire | Subjective perceived strain with questionnaires with validated scores of stress | first day |