linjc16/ctgov huggingface dataset:
FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.

Official Title
-----------------
A Randomized, Masked, Vehicle-controlled Clinical Trial to Assess the Safety and Efficacy of PVP-I (0.4%)/Dexamethasone (0.1%) Ophthalmic Suspension (Foresight Biotherapeutics, Inc) in the Treatment of Acute Adenoviral Conjunctivitis

Conditions
-----------------
Acute Adenoviral Conjunctivitis

Intervention / Treatment
-----------------
* Drug: FST-100 Ophthalmic Suspension
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge. Clinical suspicion of adenoviral etiology. At least three (3) years of age. Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent. Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis: conjunctival injection/inflammation, and conjunctival discharge/exudates. Exclusion Criteria: Conjunctivitis longer than 7 days after initial ocular symptoms. Corneal ulcer, endophthalmitis, or any other confounding infection of the eye. Patients taking ocular anti-inflammatory medications on a chronic basis. Active herpes ocular infection. Known or suspected pregnancy. Known allergy to PVP-I. Known allergy to dexamethasone. Patients with a history of elevation in intraocular pressure as a result of steroid use (steroid responders).

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FST-100 Ophthalmic Suspension<br>FST-100 (PVP-I 0.4% and dexamethasone 0.1%) | Drug: FST-100 Ophthalmic Suspension<br>* FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.<br>|
| Placebo Comparator: Vehicle<br> | Drug: Placebo<br>* A regimen of 2 drops 4 times a day while awake for 5 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA. |  | 1 year |
Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place.

Detailed Description
-----------------
The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital. After the patient has been successfully intubated at the beginning of the procedure, a trained nurse, using standard technique for placement of a oro/nasogastric tube, will place an appropriately sized NAVA catheter in the patient. The lumen of the NAVA tube can be used as a conventional oro/nasogastric tube and the electrodes will be connected to the Servo-I ventilator. Although the Servo-I is a ventilator, it will be used only as a monitor for this study. The position of the nasogastric tube will then be refined using the catheter positioning screen as needed. During the course of the EPSA various arrhythmias may become evident. When these are noted, screen shots will be saved on the Servo-i monitor. Surface and electrogram recordings will be saved at the same time. The NAVA catheter will be disconnected from the Servo-I monitor during the ablation part of the procedure to prevent inadvertent damage to the monitor.

Official Title
-----------------
Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias

Conditions
-----------------
Cardiac Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac arrhythmia Exclusion Criteria: Pregnancy

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 |
| --- | --- | --- |
| Types of cardiac arrhythmia |  | 1 year |
Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

Study Overview
=================
Brief Summary
-----------------
An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.

Detailed Description
-----------------
Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.

Official Title
-----------------
Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.

Conditions
-----------------
Oxygen Toxicity, Oxidative Stress

Intervention / Treatment
-----------------
* Procedure: Room-air


Participation Criteria
=================
Eligibility Criteria
-----------------
Newborn less than 44 weeks postconceptional age No pulmonary disease, no oxygen requirement, or assisted ventilation No genetic syndrome

Ages Eligible for Study
-----------------
Maximum Age: 4 Weeks

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 |
| --- | --- |
| No Intervention: Control<br>High level of supplemental inspired oxygen | |
| Experimental: Room-air<br>Supplemental oxygen only provided if oxygen saturation below target | Procedure: Room-air<br>* Provision of room-air<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous and blood-gas pO2 | Area under curve (AUC) and absolute values of pO2 | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Oximetry | AUC of O2 saturation | 30 min | 
| Atelectasis | Reduced lung compliance as a measure of atelectasis formation | 30 min | 
| Isoprostane | Level of isoprostanes in blood and urine | 4 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newborn, Anesthesia, Oxygen, Hyperoxia
Effect of Meal on Portal and Esophagus Variceal Pressure

Study Overview
=================
Brief Summary
-----------------
The reason why esophagus varices suddenly rupture and start to bleed is unclear. Food intake increase the hepatic blood flow and the portal pressure, but it is yet unknown if there is also an increase in variceal pressure. The aim of this study is to evaluate the efficacy of a meal on variceal pressure with a non invasive endoscopic measurement device, and compare it with portal pressure.

Official Title
-----------------
Effect of Meal on Portal and Esophagus Variceal Pressure

Conditions
-----------------
Cirrhosis, Esophageal Varices

Intervention / Treatment
-----------------
* Behavioral: meal (food intake)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Large Esophageal varices Exclusion Criteria: Treatment with beta-blocking agents Respiratory diseases that contradict endoscopy Gastric-retention Former gastric resection Resent sclerotherapy or former banding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: meal (food intake)|600 kcal. (16% protein, 49%carbohydrate, 35% fatt)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of meal on variceal pressure |  | 30 minutes after the meal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhosis, Portal Hypertension, Esophageal Varices, Meal
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
A study of infliximab in patients with Fistulizing Crohn's Disease

Detailed Description
-----------------
This is a medical research study for patients with Crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). Fistulas are a common complication of Crohn's disease. Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohn's disease. This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas. Subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab.

Official Title
-----------------
ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: infliximab or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single or multiple draining fistulas Crohn's disease of at least 3 months' duration, Exclusion Criteria: Crohn's disease complications for which surgery might be indicated Positive stool culture

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: infliximab or placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the number of draining fistulas |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete fistula response (no draining fistula). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, infusions
Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
Despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in patients with EC.

Official Title
-----------------
Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer

Conditions
-----------------
Resectable Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: esophagectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years resectable esophageal cancer Exclusion Criteria: < 18 years esophageal cancer with preoperative distant metastases

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 |
| --- | --- |
| detection of circulating tumors cells<br>This prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable. Only patients with histologically proven EC were included. Peripheral blood samples for CTC analysis were collected immediately before surgery. | Procedure: esophagectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence-free survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophagus carcinoma, surgery, circulating tumor cells
Whole Body PET-MRI in Paediatric and Adolescent Lymphoma

Study Overview
=================
Brief Summary
-----------------
Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment. Investigators want to investigate if a combined PET-MRI scan could give the same information. Children who join our study will have an extra scan twice during their treatment

Detailed Description
-----------------
Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment. Investigators want to investigate if a combined PET-MRI scan could give the same information. Children who join our study will have an extra scan twice during their treatment Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.

Official Title
-----------------
Feasibility of Using Whole Body PET-MRI to Stage and Restage Paediatric and Adolescent Hodgkin Lymphoma - a Pilot Study

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Radiation: Whole Body MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected or histologically confirmed Hodgkin lymphoma Male or female participants Age 0-20 years inclusive Entered into the EuroNet PHL-C1 trial, LP1 trial or successor Euronet trials, including Euronet PHL C2 due to open from 2013 onwards or planned to receive chemotherapy regimens of said trials without being formally entered into the trial. Participant/Guardian/Parental written informed consent Exclusion Criteria: Participants with contraindications to MRI (including cardiac pacemakers or non-MRI compatible intracranial vascular clips) Participants who are pregnant or nursing

Ages Eligible for Study
-----------------
Maximum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Whole Body MRI|Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigator will determine the technical feasibility of performing functional co-registered combined PET-MRI in this patient group using diffusion-weighted MR imaging. |  | 3 years |
Virtual Reality in Burn Pain Management

Study Overview
=================
Brief Summary
-----------------
To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.

Detailed Description
-----------------
This is a prospective, randomized cross-over study of the safety and effectiveness of the use of a virtual reality distraction intervention to management procedural pain during burn wound care. Up to 20 subjects will be enrolled until 12 complete the study.

Official Title
-----------------
The Use of Virtual Reality Video Games to Control Procedural Pain During Burn Wound Care

Conditions
-----------------
Burns, Pain

Intervention / Treatment
-----------------
* Procedure: Pain management
* Other: Standard of care/no virtual reality game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or oler with thermal injury Understands English patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced ability to use a computer mouse or hit the space bar on a computer keyboard Exclusion Criteria: unhealed burned wounds on face, neck or head history of severe susceptibility to motion sickness presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Standard of care pain management | Procedure: Pain management<br>* Pain mamagement for burn care procedures.<br>* Other names: Snow World or Standard of care;Other: Standard of care/no virtual reality game<br>* no intervention for standard of care<br>* Other names: Standard of care;|
| Experimental: B<br>SnoWorld Virtual Reality Game | Procedure: Pain management<br>* Pain mamagement for burn care procedures.<br>* Other names: Snow World or Standard of care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound care
Pre-analytical Sample Handling Conditions and Their Effects on the Human Urine Metabolome

Study Overview
=================
Brief Summary
-----------------
This study evaluates how urine handling conditions can affect the concentrations of  1,000 urine metabolites and attempts to quantify the degree of attenuation and/or potential bias in epidemiologic associations that may result from less than optimal sample handling conditions.

Detailed Description
-----------------
Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of metabolites simultaneously in a biological matrix, is a versatile analytical technique capable of accelerating biomarker-based discoveries in nutritional science. Recently, metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic studies (2) to identify dozens of novel potential dietary biomarkers. Several large prospective cohort studies, many of which are collaborating in a metabolomics consortium led by the National Cancer Institute, have recently applied metabolomics to banked samples. This has made nutrition-related biomarkers suddenly available for tens of thousands of participants with follow-up for disease endpoints, enabling truly large-scale nutritional biomarkers and disease studies.

Official Title
-----------------
Pre-analytical Sample Handling Conditions and Their Effects on the Human Urine Metabolome

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 65 years at beginning of study. BMI between 18.5 and 35.0 kg/m2. Exclusion Criteria: Presence of cardiovascular disease, kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes. Unable or unwilling to give informed consent or communicate with study staff. Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight. | Urine metabolomics profiling will be conducted at Metabolon, Inc. after the urine has been handled in a number of different ways (placed into tubes with various additives, refrigerated for different lengths of time, and frozen and thawed various numbers of times) | on day one |