linjc16/ctgov huggingface dataset:
Pilot Testing for Midline Measuring Device

Study Overview
=================
Brief Summary
-----------------
Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. Our group have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument (pictures provided in a separate attachment to this project irb) equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by our group in neurosurgery (led by D Matthew Howard). We have not patented it at this time. There is no company involved in manufacturing (we were able to assemble it with the help of the hospital's machine shop)

Official Title
-----------------
Pilot Testing for Midline Measuring Device

Conditions
-----------------
Ventriculo-Peritoneal Shunt Infection

Intervention / Treatment
-----------------
* Device: midline localizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery Exclusion Criteria: Patients who are not able to consent

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: Intervention<br>Patients undergoing ventriculoperitoneal surgery where the midline localizer was used | Device: midline localizer<br>* a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Midline | Does the device indicate the midline correctly based on the postop CT scan | Immediate postop |
Alternate-Day Buprenorphine Administration. Phase I - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.

Official Title
-----------------
Alternate-Day Buprenorphine Administration. Phase I

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid withdrawal |  |  | 
| Opioid agonist effects |  |  | 
| Dose identification |  |  | 
| Pupil diameter |  |  |
Usefulness of DORNASE in COVID-19 on HFNO

Study Overview
=================
Brief Summary
-----------------
COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.

Official Title
-----------------
Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy

Conditions
-----------------
COVID-19 Pneumonia

Intervention / Treatment
-----------------
* Drug: Dornase Alfa
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive SARS-CoV-2 RNA PCR swab inflamatory phase of infection HFNO Exclusion Criteria: pregnancy previous treatment with DNAse alfa

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomised
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4% saline<br>4% Saline inhalations twice daily | Drug: Saline<br>* inhalations twice daily<br>* Other names: 4% Saline;|
| Experimental: Pulmosyme<br>DNAse alpha inhalations twice daily | Drug: Dornase Alfa<br>* inhalations twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubations | Number of intubations necessary | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 | Increase in PaO2/FiO2 ratio | 7 days | 
| inflamation | Reduction of inflamation | 7 days |
Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to evaluate our RN CBT-I program outcomes and determine utility of this program as a high-value care model targeted specifically to our sleep center patient population. Hypothesis: PIRS will improve from baseline to 2 month follow up

Official Title
-----------------
Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: cognitive behaviorial therapy -Insomnia


Participation Criteria
=================
Eligibility Criteria
-----------------
Able to speak english Referred to Mayo Center for Sleep medicine Cognitive behaviorial therapy program for insomnia no dementia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive behaviorial therapy for insomnia group program<br>Behavioral | Behavioral: cognitive behaviorial therapy -Insomnia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburg insomnia rating scale |  | up to 2 months |
Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease

Study Overview
=================
Brief Summary
-----------------
Ocular surface disease is a common adverse effect of systemic isotretinoin therapy. The investigators consider that punctal plugs and Omega 3 is a good line for treatment of ocular surface disease associated with systemic isotretinoin therapy

Detailed Description
-----------------
Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3 months of the study .

Official Title
-----------------
Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin

Conditions
-----------------
Ocular Surface Disease

Intervention / Treatment
-----------------
* Drug: Omega 3
* Device: punctal plug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systemic isotretinoin therapy Exclusion Criteria: systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: punctal plug<br>SOFT PLUG® Preloaded Silicone Plugs by OASIS® | Device: punctal plug<br>* punctal plug will be inserted in inferior punctum<br>* Other names: OASIS SOFT PLUG;|
| Experimental: Combined<br>SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid) | Drug: Omega 3<br>* daily intake of 250 mg<br>* Other names: docosahexaenoic acid;Device: punctal plug<br>* punctal plug will be inserted in inferior punctum<br>* Other names: OASIS SOFT PLUG;|
| No Intervention: control<br>no medication was given | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Break up Time at baseline and during the study | fluorescein sodium stripes will be used for measurement of Break up Time in seconds | 3 months |
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)

Study Overview
=================
Brief Summary
-----------------
This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.

Official Title
-----------------
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Stable isotope tracer (13-C(4)-BHB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2 Subject has been a nonsmoker or has not used nicotine for the past 6 months Exclusion Criteria: Subject has a history of diabetes mellitus Subject has a history of stroke, chronic seizures, or other neurological disorder Subject has a history of cancer, except certain skin cancers Subject consumes more than 3 alcoholic beverages per day Subject consumes more than 6 servings of caffeinated beverages per day Subject has multiple and/or severe allergies to food or drugs Subject has allergy or sensitivity to eggs or soy Subject regularly uses illicit drugs or has a history of drug or alcohol abuse

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Biomarker evaluation | Drug: Stable isotope tracer (13-C(4)-BHB)<br>* A stable isotope tracer (13-C(4)-BHB), a commercially available lipid emulsion, and heparin will be administered intravenously. Ketone body concentrations will be measured before beginning the infusion, at approx. 135 minutes, and at approx. 255 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects |  | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in obese subjects |  | 5 hours |
Framingham Nutrition Studies

Study Overview
=================
Brief Summary
-----------------
To examine hypotheses concerning the relationships between nutrient intake (in particular, specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma lipoproteins, and heart disease endpoints in the population-based Framingham Offspring Studies.

Detailed Description
-----------------
DESIGN NARRATIVE: Longitudinal analyses were conducted on the associations between diet and cardiovascular and cardiopulmonary disease risk in approximately 3,800 Offspring men and women over eight years of follow-up (from 1984 to present). These analyses considered key nutrients as well as newly defined dietary patterns in Framingham men and women. Cross sectional analyses of diet and plasma lipoprotein relationships in Offspring men and women at two examinations (Exam 3, 1984-88; and Exam 5, 1991-94) were also conducted. All analyses evaluated the total (direct and indirect) and joint effects of dietary nutrients. Where appropriate, analyses controlled for plasma nutrient levels (folacin, vitamins B6 and B12 and homocysteine). The influence of potential confounding variables, effect modifiers, and intervening variables that lie in the causal pathway were examined, as appropriate to the statistical model, including traditional cardiovascular disease risk factors and apoE isoform status. Several existing Framingham data sets were utilized, including comprehensive data sets on nutrient intake, cardiovascular disease risk factors, clinically verified cardiovascular and cardiopulmonary endpoints and other covariates. The Offspring Exam 3 and 5 nutrition data sets included multiple day assessments of dietary intake which improved the ability to detect relationships of interest. The investigators completed the Framingham Food Habit Questionnaire data set for Exam 5; this instrument included important covariates for the analyses (including vitamin supplement use). The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
* Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)


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: 20 Years
Maximum Age: 58 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>Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) | Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)<br> <br> |
| Active Comparator: 2<br>Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) | Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiemetic
Potassium Citrate and Crystal Light Lemonade

Study Overview
=================
Brief Summary
-----------------
To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH

Official Title
-----------------
Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Drug: Potassium citrate
* Drug: Crystal light
* Drug: Potassium citrate + crystal light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between age 18-80 years Willing to follow experimental protocol Willing to complete 24-hour urine collections (three total) Willing to sign the informed consent form Completed Litholink Collection with blood work with results a. hypocitraturia OR aciduria i. Hypocitraturics must meet definition of < 450 mg/day for men < 550 mg/day for women. b. Low urine pH must be less than 5.6 c. potassium, BUN, creatinine, eGFR and hemoglobin A1c within normal limits Exclusion Criteria: Patients with severe hypocitraturia < 200 mg/day (men or women) Patients with hyperkalemia, uncontrolled diabetes, chronic kidney disease, adrenal insufficiency, delayed gastric emptying (or drug induced delayed gastric emptying), peptic ulcer disease, or active UTI Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate) Members of vulnerable patient populations Allergies to ingredients in crystal light Patients lacking decisional capacity

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Potassium citrate<br> | Drug: Potassium citrate<br>* 7 days potassium citrate followed by 24 hour urine collection<br>|
| Active Comparator: Crystal light<br> | Drug: Crystal light<br>* 7 days crystal light followed by 24 hour urine collection<br>|
| Active Comparator: Crystal light + potassium citrate<br> | Drug: Potassium citrate + crystal light<br>* 7 days potassium citrate + crystal light followed by 24 hour urine collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine citrate levels | 24 hour urine collection | Day 7 of week 1 | 
| urine citrate levels | 24 hour urine collection | Day 7 of week 3 | 
| urine citrate levels | 24 hour urine collection | Day 7 of week 5 |