linjc16/ctgov huggingface dataset:
Study of Value of Cardiac PET Scans With or Without CT Angiography and/or Measurement of Coronary Flow Reserve

Study Overview
=================
Brief Summary
-----------------
How does PET myocardial perfusion imaging involving CT angiography and measurement of coronary flow reserve affect patient care.

Detailed Description
-----------------
The purpose of this research is to determine how PET myocardial perfusion imaging involving CT angiography and measurement of coronary flow reserve affects patient care. This research will also compare the effectiveness of these scans to other similar tests and compare the cost-effectiveness of these scans to other similar tests over time.

Official Title
-----------------
PET Myocardial Perfusion Imaging With CT Angiography and Measurement of Coronary Flow Reserve: A Prospective Study of Effectiveness, Impact on Patient Management, Prognostic Value, and Downstream Costs

Conditions
-----------------
Chest Pain, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to Kettering Medical Center for PET myocardial perfusion imaging with or without CTA and/or coronary flow reserve measurement. Patients over 18 years of age. Exclusion Criteria: Patients who do not consent to participate.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET myocardial perfusion imaging, Cardiac PET, Rubidium, Coronary Artery CT Angiogram, Coronary Flow Reserve, Adenosine stress test
Supraglottic Airway Needed To Achieve Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to compare if insertion of laryngeal mask airway (LMA) vs. use of face mask, will reduce the time needed to achieve adequate ventilation prior to insertion of the breathing tube.

Official Title
-----------------
Supraglottic Airway Needed To Achieve Ventilation (SANTA)

Conditions
-----------------
Airway Complication of Anesthesia, Difficult or Failed Intubation

Intervention / Treatment
-----------------
* Other: Airway and Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥ 35. Patients willing to participate and provide an informed consent. Patients scheduled to undergo an elective surgical procedure including laparoscopic or robotic that requires GETA. Exclusion Criteria: Patients who require administration of succinylcholine for induction/intubation Patients with history of uncontrolled GERD.

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 |
| --- | --- |
| Laryngeal Mask Airway<br> | Other: Airway and Ventilation<br>* Insertion of Laryngeal Mask airway for ventilation or use of Face Mask<br>|
| Face Mask<br> | Other: Airway and Ventilation<br>* Insertion of Laryngeal Mask airway for ventilation or use of Face Mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful ventilation | Compare time needed to achieve ventilation | Up to 15 minutes during the initial period of intubation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective criteria of difficult ventilation and intubation |  | Up to 30 minutes during the initial period of intubation |
In-patient Study in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.

Official Title
-----------------
A Randomized, Open-label, Placebo-controlled, Repeat-dose Study to Assess the Pharmacokinetics and Pharmacodynamics of 5 Micrograms Exenatide Administered Subcutaneously Twice Daily for 7 Days in Healthy Normal Volunteers and in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have type 2 diabetes mellitus that has been diagnosed for at least three months must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea must be willing to wash-out of these medications for 14 days prior to the start of the study must have bloodwork that meets certain criteria (for example, total cholesterol < 240 mg/dL) Exclusion Criteria: must not have any other major illness other than diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

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

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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic measurements during 7 days of dosing. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic measurements during 7 days of dosing. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exenatide, pharmacokinetics, pharmacodynamics
Comparing Methods to Biopsy Pancreas Mass

Study Overview
=================
Brief Summary
-----------------
This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.

Official Title
-----------------
Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses

Conditions
-----------------
Pancreas Mass Diagnosis

Intervention / Treatment
-----------------
* Procedure: FNB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult pancreas mass Exclusion Criteria: coagulopathy mass not approachable by endoscopic ultrasound biopsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fine needle aspiration needle<br>standard Beacon FNA needle | Procedure: FNB<br> <br> |
| Other: fine needle biopsy needle<br>SharkCore fine needle biopsy needle | Procedure: FNB<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of passes |  | 1 week |
Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas

Study Overview
=================
Brief Summary
-----------------
In this work, the investigators count through the integrated multi-omics analysis to identify different tumor subgroups in pancreatic neuroendocrine tumors and carcinomas regardless of their grade and stage. To achieve this, they will resort to the use of next-generation sequencing approaches (RNAseq, then use of MCP Counter for the absolute quantification of the eight populations of immune cells in the tumor microenvironment), alterations in epigenetics with study of the methylome by MeDIP, ChIPseq, telomere (ALT) study, as well as correlation with peripheral blood neutrophil to lymphocyte ratio and immunohistochemistry data such as Ki67, p53, Rb, DAXX, ATRX, PDL1, immune cell labeling. This will be done on frozen or paraffin material. This work will provide a more complete biological picture of pancreatic neuroendocrine tumors and carcinomas.

Official Title
-----------------
Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas

Conditions
-----------------
Cancer of Pancreas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) Subject with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas Subject with tumors or neuroendocrine carcinoma of the pancreas regardless of the stage of the disease Supported at the University Hospitals of Strasbourg between 01/01/2008 and 01/09/2019 Near therapeutic blood count available (less than 6 months) Availability of frozen and/or paraffin tumor material Patients who have already given their consent for their biological resources to be kept at the CRB or in the anatomopathology department of the HUS, and subsequently reused, as well as the anonymous data associated with them, for scientific research purposes. Exclusion criteria: Opposition of the patient to participate in the study Diagnosis other than pancreatic neuroendocrine tumor Biological tissue from a patient who does not meet all the inclusion criteria Impossibility of giving informed information to the subject Patient under judicial protection En savoir plus sur ce texte sourceVous devez indiquer le texte source pour obtenir des informations supplémentaires Envoyer des commentaires Panneaux latéraux

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer of Pancreas, Neuroendocrine Tumors, Carcinoma, Neuroendocrine
Comparison of Two Multifocal Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon B contact lens
* Device: Comfilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 35 years of age. Sign written Informed Consent Spectacle add of +0.50 to +2.50D. Best corrected visual acuity of at least 20.30 in both eyes. Currently wearing soft contact lenses at least 5 days per week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment. Currently enrolled in any clinical trial. Astigmatism > 1.00D. Strabismus/amblyopia. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Other: Lotrafilcon B / Comfilcon A<br>Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. | Device: Lotrafilcon B contact lens<br>* Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use<br>* Other names: AIR OPTIX AQUA MULTIFOCAL;Device: Comfilcon A contact lens<br>* Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use<br>* Other names: BIOFINITY MULTIFOCAL;|
| Other: Comfilcon A /Lotrafilcon B<br>Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. | Device: Lotrafilcon B contact lens<br>* Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use<br>* Other names: AIR OPTIX AQUA MULTIFOCAL;Device: Comfilcon A contact lens<br>* Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use<br>* Other names: BIOFINITY MULTIFOCAL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Vision | Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best. | One week of wear |
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb Company (Cefzil) 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose In Healthy Adults Volunteers Under Fed Conditions

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

Intervention / Treatment
-----------------
* Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)
* Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria) | Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)<br> <br> |
| Active Comparator: 2<br>Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA) | Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study of the Safety and Tolerability of Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Either Schizophrenia or Bipolar Disorder With an Optional Open-Label 26-Week Extension Study

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria Age 18 to 55 Body weight 100-250 lbs Be sufficiently stable to allow discontinuation of antipsychotic medication Exclusion Criteria: Acutely psychotic subjects Subjects that are acutely manic Subjects with a psych diagnosis other than Bipolar Type I Disorder

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decreasing Titration Study, Schizophrenia, Bipolar, Pharmacokinetic
Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of High-dose Zinc Therapy and Albendazole in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children

Conditions
-----------------
Enteropathy

Intervention / Treatment
-----------------
* Drug: Albendazole
* Drug: Placebo
* Dietary Supplement: High-dose Zinc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-3 years of age Lives in study villages Exclusion Criteria: Unable to drink 100 mL of sugar water Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema Apparent need for acute medical treatment for an illness or injury Parent refusal to participate and return for 7-week follow-up

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 3 Years

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

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 |
| --- | --- |
| Experimental: Zinc therapy<br>High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days | Dietary Supplement: High-dose Zinc<br>* Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days<br>|
| Experimental: Albendazole<br>Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following. | Drug: Albendazole<br>* Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age<br>|
| Placebo Comparator: Placebo<br>Placebo will be given for 14 days | Drug: Placebo<br>* Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in urine lactulose:mannitol (L:M) ratio following therapy course. |  | 4 weeks, 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood endoCAb |  | 7 weeks | 
| Change in fecal calprotectin mRNA |  | 4 weeks, 7 weeks |