linjc16/ctgov huggingface dataset:
Embryonal Tumors of Infancy & Childhood: South Egypt Cancer Institute Experience

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate demographic & disease characteristics of pediatric cancer patients diagnosed with one of embryonal tumors to identify the prevalence, the spectrum of these disease entities & treatment outcomes in these patients.

Detailed Description
-----------------
Background: Embryonal tumors arise from cells that are normally present in the developing embryo and originate in developing tissues and organ systems. These tumors occur almost exclusively in children, and are usually diagnosed in children before age 5 years. The group is heterogeneous and includes relatively common pediatric tumors as well as rare tumors. Three common types of embryonal tumors in children are neuroblastoma, Wilms tumor (WT), and retinoblastoma. Other embryonal tumors, include medulloblastoma and rhabdomyosarcoma. Patients & Methods: From January 2001 to December 2015, retrieval & analysis of the medical records of pediatric patients with embryonal tumors will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Official Title
-----------------
Embryonal Tumors of Infancy & Childhood: South Egypt Cancer Institute Experience

Conditions
-----------------
Neoplasms, Embryonal, Embryonal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose age less than or equal to 18 years. Patients diagnosed with any of embryonal neoplasms. Exclusion Criteria: • Patients whose age more than 18 years.

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
| Overall survival (OS) | Time from the date of initiation of treatment until death from any cause | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 
| Event Free Survival (EFS) | Time from the date of initiation of treatment until disease progression, or death for any reason | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood Cancer, Pediatric Oncology, Embryonal Neoplasms, Embryonic Neoplasms, Embryonic Tumors, Embryonal Tumors
Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure

Study Overview
=================
Brief Summary
-----------------
Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and double-lumen tube.

Official Title
-----------------
Increase of Tracheal Cuff Pressure During Transesophageal Echocardiography Probe Insertion: Double-lumen Tube Versus Single-lumen Tube

Conditions
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Intubation, Intratracheal

Intervention / Treatment
-----------------
* Procedure: balloon pressure adjustment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients scheduled for elective cardiothoracic surgery requiring intraoperative TEE monitoring Exclusion Criteria: patients with tracheal stenosis patients with tracheoesophageal fistula patients with esophageal surgery patients with esophageal varix patients with Barrett esophagus patients with esophageal hernia patients with descending thoracic aorta aneurysm patients with dysphagia patients with vocal fold palsy

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with single-lumen tube<br>Patients who required intraoperative TEE and single-lumen tube; balloon pressure adjustment before TEE probe insertion | Procedure: balloon pressure adjustment<br>* Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion<br>|
| Other: patients with double-lumen tube<br>Patients who required intraoperative TEE and double-lumen tube; balloon pressure adjustment before TEE probe insertion | Procedure: balloon pressure adjustment<br>* Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheal cuff pressure |  | 1 min after TEE probe insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheal cuff pressure |  | every min for 5 min after TEE probe insertion |
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.

Detailed Description
-----------------
Objectives: To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day. To evaluate feasibility and tolerability Exploratory: - To assess pain, symptom burden, functionality, and quality of life

Official Title
-----------------
Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation

Conditions
-----------------
Head and Neck Cancer, Locally Advanced Head and Neck Carcinoma

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven cancer of the head and neck cancer Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0) Planned primary or adjuvant radiation or chemoradiation therapy Willing and able to provide informed consent ECOG PS 0-2 Age ≥ 21 years English speaking Exclusion Criteria: Currently on gabapentin or ketamine Prior non-tolerance of gabapentin or ketamine Unable to administer ketamine intranasally due to anatomical restrictions History of seizure disorder History of schizophrenia History of increased intracranial pressure Glomerular filtration rate <30 mL/min/1.73 m2

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Gabapentin plus Ketamine<br>Gabapentin and Ketamine will be taken 3 times per day. | Drug: Gabapentin<br>* Taken by mouth 3 times per day<br>* Other names: Neurontin;Drug: Ketamine<br>* Administered intranasally 3 times per day<br>* Other names: Ketalar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0) | Up to a maximum planned dose of 40 mg three times a day | Approximately 28 days (Phase I) | 
| Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0) | Number of Participants With Grade 3 or 4 Adverse Events | Up to 30 post-treatment (Phase II) |
Pattern of Dyslipidemia Among Patients With Acute Coronary Syndrome at Sohag University Hospital

Study Overview
=================
Brief Summary
-----------------
In this study, I am aime to analyze lipid profile in patients with ACS who presents at sohag university hospital, and its clinical and complications pattern.

Detailed Description
-----------------
Coronary artery disease (CAD) is the most important cause of death in men and women The great majority of ACS patients have at least one major risk factor. Acute Coronary Syndrome (ACS) is a major reason for Coronary Care Unit ( CCU )sohag university hospital admission The risk of CAD was about 4 and 3 times higher in male and female smokers than nonsmokers respectively (Baba S et. al ; 2006) Dyslipidemia has been identified as one of most important modifiable risk factor for CAD . Treating dyslipidemia has clear benefits in the primary and secondary prevention of coronary heart disease (CHD) in both sexes . This study focused on dyslipidemia as a risk factor of acute coronary syndrome (ACS).

Official Title
-----------------
Pattern of Dyslipidemia Among Patients With Acute Coronary Syndrome at Sohag University Hospital

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: lipid profile
* Other: ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:: clinical diagnosed Acute coronary syndromes - Exclusion Criteria: chronic coronary syndrome

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 |
| --- | --- |
| Normal & abnormal lipid parameters value<br>parameters value among normal and abnormal lipid profile | Other: lipid profile<br>* lipid profile<br>Other: ECG<br>* ECG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dyslipiemia in acute coronary syndrome | pattern of dyslipidemia among patients with acute coronary syndrome at sohag university hospital | one year |
Gestational Diabetes in Central Asia: Prevalence and Management

Study Overview
=================
Brief Summary
-----------------
Evaluate prevalence and management of gestational diabetes in Tajikistan in two different settings (one rural and one urban).

Official Title
-----------------
Gestational Diabetes in Central Asia: Prevalence and Management

Conditions
-----------------
Gestational Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy Exclusion Criteria: known diabetes mellitus

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women in Tajikistan<br> | Other: Observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of gestational diabetes |  | 1 year |
Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure

Study Overview
=================
Brief Summary
-----------------
The goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. Patients are treated with either continuous dialysis or hemofiltration. Outcome measures are death, restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Detailed Description
-----------------
The goal of the present study is the comparison of different renal replacement strategies in critically ill patients with acute renal failure on the intensive care unit. In a prospectively randomized clinical study patients are treated with either continuous dialysis (SLED) or continuous hemofiltration (CVVHD). 200 patients should be included in the study (n=100 each). The primary outcome is death at ICU, secondary outcome measures are restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Official Title
-----------------
Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit

Conditions
-----------------
Dialysis, Acute Renal Failure

Intervention / Treatment
-----------------
* Procedure: Renal replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years or older Written informed consent No pre-existing dialysis dependency Exclusion Criteria: Minors / children No consent Severe electrolyte disturbances which necessitates special dialysis therapy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SLED<br> | Procedure: Renal replacement therapy<br>* ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED<br>* Other names: continous veno-venous hemodiafiltration (CVVHD);|
| Active Comparator: CVVHD<br> | Procedure: Renal replacement therapy<br>* ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED<br>* Other names: continous veno-venous hemodiafiltration (CVVHD);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| costs |  | in hospital | 
| Restitution of renal function |  | 90 days | 
| days on ICU |  | in hospital | 
| hemodynamic stability |  | in hospital | 
| dialysis efficiency |  | in hospital |
Development of Magnetic Resonance (MR) Simulation for Treatment Planning

Study Overview
=================
Brief Summary
-----------------
Retrospectively have access to MR images of patients to develop software that: segment images convert MR values to electron density and then entered into a dose calculation system The project involves software development of data that is already available. No intervention is made at this point.

Official Title
-----------------
Development of MR Simulation for Treatment Planning

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject 18 years of age and older

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 |
| --- | --- | --- |
Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

Study Overview
=================
Brief Summary
-----------------
This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations

Detailed Description
-----------------
This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision. The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool. The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.

Official Title
-----------------
Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of pancreatic ductal adenocarcinoma Signed initial informed consent Participant agrees to genetic counseling Exclusion Criteria: Prospective participant unable to sign informed consent based on referring physician recommendation. Patient has neuroendocrine pancreatic tumor

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 |
| --- | --- | --- |
| We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Patient Experience With Genetic Testing |  | up to 5 years | 
| Summarize patient satisfaction with Genetic counseling |  | up to 5 years | 
| Number of patients who disclose genetic testing results to relatives |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cancer
Compassionate Use of Stiripentol in Dravet Syndrome

Study Overview
=================
Brief Summary
-----------------
Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

Detailed Description
-----------------
This is a treatment protocol for compassionate use, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

Official Title
-----------------
Compassionate Use of Stiripentol in Dravet Syndrome

Conditions
-----------------
Dravet Syndrome

Intervention / Treatment
-----------------
* Drug: Stiripentol


Participation Criteria
=================
Eligibility Criteria
-----------------
Children with genetic confirmation of Dravet syndrome (a documented sodium channel, voltage-gated, type I, alpha subunit (SCN1A) mutation) or clinical confirmation of Dravet syndrome by two pediatric neurologist will be considered to have Dravet syndrome. In order to enter the treatment protocol there will be documented treatment failure of at least two therapeutic anticonvulsants excluding Na channel blockers. Anticonvulsants that are Na channel blockers such as carbamazepine and lamotrigine as known to provoke seizures in this patient population.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Stiripentol|Stiripentol 5-50mg/kg/d divided twice or three times a day by mouth|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sleep Intervention for Pediatric Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop and evaluate a sleep intervention program for improving sleep and health in youth with epilepsy and their parents.

Detailed Description
-----------------
Sleep problems are more prevalent and serious in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Inadequate sleep has long been recognized as a trigger for seizure and poor sleep habits have been associated with unfavorable outcomes in children with epilepsy. Attention to sleep in children with epilepsy as a result is critically important for seizure control and health-related quality of life.

Official Title
-----------------
Evaluation of a Clinic-based Sleep Intervention for Pediatric Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Behavioral: Sleep intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged between 1.5 and 6 years with a confirmed diagnosis of epilepsy based on clinical and electro-encephalogram examinations. Exclusion Criteria: Children born before 37 weeks gestation, children with evidence of structural brain damage, or with cerebral palsy or those who are bedridden.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 6 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep intervention<br>Standard pediatric neurology care plus education and augmented support around adequate sleep habits, appropriate daylight exposure, and beneficial and safe physical activity tailored to each epileptic child's capabilities. | Behavioral: Sleep intervention<br>* Standard pediatric neurology care plus education and augmented support around adequate sleep habits, appropriate daylight exposure, and beneficial and safe physical activity tailored to each epileptic child's capabilities.<br>|
| No Intervention: Standard care<br>Standard pediatric neurology care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sleep | Actigraphic assessed sleep variables | 12-month follow-up |