linjc16/ctgov huggingface dataset:
Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19

Study Overview
=================
Brief Summary
-----------------
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Official Title
-----------------
Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]

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

Intervention / Treatment
-----------------
* Drug: Bamlanivimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States) Present within 10 days of symptom onset Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days Participants greater than or equal to (≥) 65 years of age OR Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following: Cancer Chronic kidney disease Chronic obstructive pulmonary disease (COPD) or other chronic lung disease Immunocompromised state (weakened immune system or on immunomodulatory medications) Obesity (body mass index [BMI] of 35 or higher) Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies Sickle cell disease Diabetes mellitus (Types 1 or 2) Exclusion Criteria: Require hospitalization greater than (>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bamlanivimab|Administered intravenously (IV).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
HbA1c in Intracytoplasmic Sperm Injection

Study Overview
=================
Brief Summary
-----------------
ICSI has increased nowadays for treating cases of longstanding infertility . HbA1c has an important value in evaluating glucose level in blood

Detailed Description
-----------------
- The level of HbA1c in blood denotesnthe glycemic control over the past 3 months . Its regulation is very important in human reproductive life

Official Title
-----------------
Role of HbA1c in Intracytoplasmic Sperm Injection

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females with infertility from 20 to 42 years old Exclusion Criteria: females with age below 20 or above 42 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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 |
| --- | --- | --- |
| the number of ladies who will get pregnant | the ladies who will become pregnant after ICSI | within one year |
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.

Detailed Description
-----------------
This cross-over prospective study will require a two day admission to the clinical research center. Subjects will undergo closed loop glucose control and will received a diet with controlled macronutrient content.

Official Title
-----------------
Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: High fat meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetes using insulin pump and CGM Exclusion Criteria: renal or hepatic failure cancer or lymphoma malabsorption or malnourishment hypercortisolism alcoholism or drug abuse anemia (hematocrit < 36 in females and <40 in males) eating disorder dietary restrictions Acetaminophen allergy Chronic acetaminophen use Glucocorticoid therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High fat meal<br> | Other: High fat meal<br>* 40 grams saturated fat<br>* Other names: Macronutrient;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin requirements |  | postprandially until 8 hours |
Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement

Study Overview
=================
Brief Summary
-----------------
Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.

Official Title
-----------------
Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: Somnotouch NIBP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to give informed consent Exclusion Criteria: Atrial fibrillation Medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somnotouch NIBP<br>Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device | Device: Somnotouch NIBP<br>* Somnotouch NIBP in addition to standard blood pressure measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean 24h systolic blood pressure | Difference in mean 24h systolic blood pressure | 24 hours |
Does Indoxyl Sulfate Have a Role in Uremic Pruritus?

Study Overview
=================
Brief Summary
-----------------
Itching is a widespread and disturbing complain from patients with chronic kidney disease (CKD); epidemiologic data have suggested that approximately 40% of patients with end-stage renal disease experience moderate to severe itching. The pathogenesis of renal pruritus is multifactorial. Triggering factors may include uremia-related abnormalities, accumulation of uremic toxins, systemic inflammation and cutaneous xerosis. Indoxyl sulfate (IS) is a protein-bound uremic toxin resulting from the metabolism of dietary tryptophan accumulating in patients with end-stage renal disease.

Detailed Description
-----------------
Patients with end-stage renal disease undergoing hemodialysis complaining of itching not related to other cause than renal failure will take activated charcoal with foods and serum level of indoxyl sulphate will be studied

Official Title
-----------------
Does Indoxyl Sulfate Have a Role in Uremic Pruritus? A Laboratory and Interventional Study.

Conditions
-----------------
Pruritus

Intervention / Treatment
-----------------
* Dietary Supplement: Uremic pateints with itching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with end-stage renal failure with itching undergoing regular hemodialysis Exclusion Criteria: Patients with other causes of itching as psoriasis, atopic dermatitis, scabies, and lichen planus

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
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will take activated charcoal for two months
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uremic Pateints group<br>Patients with end-stage renal failure with itching | Dietary Supplement: Uremic pateints with itching<br>* Activated charcoal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of itching | Change of severity of itching by The Visual Analogue Scale score | Two months |
Minimally Invasive Cardiac Output Monitoring Device

Study Overview
=================
Brief Summary
-----------------
The overall goal of this collaborative study is to advance the novel pulse contour analysis to the point at which it can be incorporated into a real-time device. The specific objective is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in units of liters-per-minute. To achieve this objective, the waveforms for analysis and reference pulmonary artery catheter CO measurements will be recorded from critically ill patients and then analyzed off-line at Retia Medical. Successful completion of this study may ultimately help lead to improved outcomes of critically ill patients.

Official Title
-----------------
Development of a Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients

Conditions
-----------------
Cardiac Event

Intervention / Treatment
-----------------
* Device: Retia Non-Invasive Sensors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients admitted to the University of Michigan ICU following cardiac surgery with both a pulmonary and radial artery catheter. Exclusion Criteria: Adult patients with mechanical cardiac support including intra-aortic balloon pumps, LVAD, or ECMO, and persistent ventricular arrhythmias.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Retia Non-Invasive Sensors<br>Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery. | Device: Retia Non-Invasive Sensors<br>* Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output | The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data. | 8 hours post cardiac surgery |
The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the aortic wall. The natural history of AAA is gradual expansion and if left untreated may result in rupture and death. The mechanism of the development of this disease is unknown however it appears to be multifactorial and possibly related to degradation processes within the arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting degeneration of the vessel wall. Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive patients, and are associated with a lower rate of aortic expansion compared to other antihypertensive drugs.

Official Title
-----------------
the Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients

Conditions
-----------------
Aneurysm, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medically treated hypertensive patients, ages 50-80 Exclusion Criteria: pregnant women patients previously treated for aortic disease unable to sign informed consent, minors

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| ARBs<br>Hypertensive patients treated with ARBs | |
| ACE inhibitors<br>Hypertensive patients treated with ACE inhibitors | |
| non ARB/ACE<br>Hypertensive patients treated with non ARBs or ACE inhibitors meds | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Functional Endoscopic Evaluation of Swallowing

Study Overview
=================
Brief Summary
-----------------
The investigators objective is to describe functional endoscopic evaluation of swallowing findings in children with cerebral palsy.

Detailed Description
-----------------
Cerebral palsy (CP) is a predominantly motor disorder and dysphagia is a frequent complaint. Functional endoscopic evaluation of swallowing (FESS) involves anatomic and functional observation of the larynx and pharynx, evaluation of swallowing and maneuvers to improve it, also testing the laryngeal sensitivity. We evaluated nine patients with CP of both sexes, which age varied from 1 to 10 years old, attended at dysphagia multidisciplinary clinic, at NAMI (Integrated Medical Assistance Nucleons).

Official Title
-----------------
Achados da avaliação videoendoscópica da deglutição em crianças Com Paralisia Cerebral.

Conditions
-----------------
Cerebral Palsy, Dysphagia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical diagnosis of cerebral palsy. Exclusion Criteria: medical diagnoses not associated with cerebral palsy that affect swallowing.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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
-----------------
Cerebral palsy, Dysphagia, Deglutition, Endoscopy
Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications: In-stent restenosis lesions: either bare metal or drug eluting stent restenosis Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries Small vessels: treatment of lesions ≤2.75 mm BMS implantation followed by DCB inflation

Official Title
-----------------
Assessment of Safety and Efficacy of the DEVOIR Sirolimus-Coated Balloon for the Treatment of Native Coronary Artery Lesions in the Real-world Clinical Practice

Conditions
-----------------
CAD

Participation Criteria
=================
Eligibility Criteria
-----------------
Patient's inclusion and exclusion criteria are per device instructions for use's indications and contraindications. Inclusion criteria: Patient is at least 18 years old Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm. Exclusion criteria: Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds. Patients with a known hypersensitivity to excipients with phospholipid or related origins. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment. Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator) Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter Patients who cannot receive recommended antiplatelet or anticoagulation 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Adverse Cardiac Events (MACE) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Target Lesion Revascularization (TLR) |  | 12 months | 
| Rate of Target Vessel Failure (TVF) |  | 12 months | 
| Rate of Target Vessel Revascularization (TVR) |  | 12 months | 
| Angiographic success |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DCB, DEB, Sirolimus, PCI, ISR, SVD, Restenosis, Bifurcation, CAD, Coronary artery
Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.

Detailed Description
-----------------
Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured before and after abdominal insufflation in the supine position. After insufflation the head-up position (30°) was made and cuff pressure was recorded.

Official Title
-----------------
Comparison of the Cuff Pressure of TaperGuard Endotracheal Tube and Cylindrical- Endotracheal Tube During Laparoscopic Surgery

Conditions
-----------------
Cuff Pressure

Intervention / Treatment
-----------------
* Device: Cylindrical endotracheal tube
* Device: TaperGaurd endotracheal tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who were underwent laparoscopic cholecystectomy with American Society of Anesthesiologists physical status 1-3 Exclusion Criteria: history with respiratory disease, difficult intubation, and morbid obesity (body mass index more than 35 kg/m2).
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cylindrical endotracheal tube<br>Cylindrical endotracheal tube was intubated in 32 participants | Device: Cylindrical endotracheal tube<br>* Cylindrical endotracheal tube was intubated<br>|
| Experimental: TaperGuard endotracheal tube<br>TaperGuard endotracheal tube was intubated in 32 participants | Device: TaperGaurd endotracheal tube<br>* TaperGaurd endotracheal tube was intubated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cuff pressure |  | 5 minutes after intubation |