linjc16/ctgov huggingface dataset:
Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.

Official Title
-----------------
Arterial Hypotension and Regional Cerebral Oxygen Saturation During Major Abdominal Surgery. A Randomized Controlled Trial

Conditions
-----------------
Hypotension During Surgery, Hemodynamic Instability

Intervention / Treatment
-----------------
* Device: HPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for abominal surgery Exclusion Criteria: Emergency surgery end-stage renal disease pregnancy obesity atrial fibrillation previous cerebral ischaemia central nervous system disorders severe cardiac valvular disease

Ages Eligible for Study
-----------------
Minimum 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prevention<br>investigator will prevent intraoperative arterial hypotension based on HPI index | Device: HPI<br>* based on HPI values, clinicians will administer drugs or fluids in order to avoid arterial hypotension<br>|
| No Intervention: treatment<br>investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral tissue oximetry | the difference among the two groups of the percentage value of the median value of Cerebral Oxygen Saturation measured by the near-nfrared spectroscopic technology (Foresight sensor) | immediately after surgery |
Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG

Study Overview
=================
Brief Summary
-----------------
A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)

Official Title
-----------------
Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastric Bypass and Sleeve Gastrectomy

Conditions
-----------------
Bariatric Surgery Candidate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older at the time of procedure Undergone either laparoscopic or robotic-assisted Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) Meets qualification for primary bariatric procedure per American Society for Metabolic and Bariatric Surgery guidelines Exclusion Criteria: Subject who underwent bariatric procedure as an emergency procedure Subject who underwent bariatric procedure as an revisional bariatric procedure Subject who underwent bariatric procedure as an secondary procedure

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 |
| --- | --- | --- |
| Perioperative complications | Peri-operative complications include adverse events during the Intra-operative and post-operative periods. | 30 days after surgery |
Change of Depth in a RAE Tube: Tube Fixation at the Midline or Angle and in a Neutral or Neck Extended Position

Study Overview
=================
Brief Summary
-----------------
The investigators compared the depth of the RAE tube [Preformed oral tracheal tubes were first described by Ring, Adair and Elwyn (therefore called RAE tubes)] when fixed at the midline and at the angle of the mouth, and after fixing the tube at the angle.

Conditions
-----------------
Depth of Tracheal Tube

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled for elective surgery under general anesthesia Exclusion Criteria: Patients with anatomical defects of the face, neck, or upper airway

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Endotracheal tube<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depth of tube | from the tube tip to the carina | up to 1 hour |
A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355

Study Overview
=================
Brief Summary
-----------------
The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using dry powder inhalers

Official Title
-----------------
A Single Dose, Open, Randomized, 5-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of PF-00258210 Administered Alone Or PF-00258210 Administered Together With PF-00610355 Either As A Free Or A Fixed Dose Combination

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment D
* Drug: Treatment E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) A positive urine drug screen Pregnant or nursing females

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: Treatment A<br>* PF-00258210 220 µg using inhaler A<br>|
| Experimental: Treatment B<br> | Drug: Treatment B<br>* PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A<br>|
| Experimental: Treatment C<br> | Drug: Treatment C<br>* PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A<br>|
| Experimental: Treatment D<br> | Drug: Treatment D<br>* PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A<br>|
| Experimental: Treatment E<br> | Drug: Treatment E<br>* PF-00258210 220 µg using inhaler B<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma pharmacokinetics AUClast and Cmax |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma pharmacokinetics, AUCinf and Tmax |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy
Racial Variation in ACE--Genetic and Physiologic Bases

Study Overview
=================
Brief Summary
-----------------
To determine whether differences in the activity of the renin-angiotensin and bradykinin systems are involved in the pathogenesis of blood pressure variation in African Americans.

Detailed Description
-----------------
BACKGROUND: Each year, more than 40,000 new patients require treatment for end stage renal disease, a condition which is 4-fold higher among African Americans than Caucasians. Trials of angiotensin converting enzyme inhibitors (ACEIs) in Caucasians support a role of the renin-angiotensin system in the pathogenesis of glomerulosclerosis. Yet, despite the high prevalence of nephropathy among African Americans, Blacks have been under-represented in studies in ACEIs. Data from our laboratory suggest that the renal effects of ACEI may differ in African Americans. African Americans are resistant to the anti-hypertensive effects of ACEI and, thus, may be resistant to the renoprotective effects as well. The ACE deletion allele, a variant associated with increased ACE activity and progression of renal diseases, is increased in frequency in African Americans, while the frequency of the Ang AT1 receptor C allele, a variant associated with antihypertensive responsiveness to ACEI is decreased. Moreover, African Americans exhibit decreased sensitivity to Ang I and increased sensitivity to bradykinin. Taken together, these data suggest the hypothesis that ACE activity is increased in African Americans, leading to decreased bradykinin levels ( and receptor sensitization) and increased tissue Ang II (and receptor desensitization). DESIGN NARRATIVE: The study tests the hypothesis that ACE activity is increased in African Americans, leading to decreased bradykinin levels (and receptor sensitization) and increased tissue Ang II (and receptor desensitization). The effects of race, hypertension and ACE insertion/deletion genotype on ACE activity will be determined, as measured by the pressor and renal vasoconstrictor responses to Ang I and Ang II and the vasodilator response to bradykinin. Specific bradykinin and angiotensin receptor antagonists will be used to determine the relative contribution of increased bradykinin and decreased angiotensin II to the renal hemodynamic effects of ACEIs in African Americans and Caucasians.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, 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 |
| --- | --- | --- |
The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib

Study Overview
=================
Brief Summary
-----------------
An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.

Official Title
-----------------
A Phase I, Randomized, Open Label, 3-Way Cross-Over Study to Determine the Effect of a High-Fat Breakfast, a Low-Fat Breakfast and Fasting State on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers

Conditions
-----------------
Dietary Fats, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Regorafenib (Stivarga, BAY73-4506)
* Drug: Regorafenib (Stivarga, BAY73-4506)
* Drug: Regorafenib (Stivarga, BAY73-4506)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subject Age: 18 to 45 years (inclusive) at the first Screening examination BMI: between 18 and 32 kg / m² Exclusion Criteria: Regular use of medicines at the time of Screening, including prescription medications, herbal supplements and high dose vitamins Sitting systolic BP > 140 mmHg or Diastolic BP > 90 or < 60 mmHg History of hypersensitivity or allergy History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* A single dose of regorafenib will be administered immediately following a high fat breakfast<br>|
| Experimental: Arm 2<br> | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* A single dose of regorafenib will be administered immediately following a low fat breakfast<br>|
| Experimental: Arm 3<br> | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* A single dose of regorafenib will be administered following an overnight fast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary PK parameters: AUC, Cmax of BAY 73-4506 |  | Samples up to 336 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sec. PK Parameters: tmax and t1/2 of BAY73-4506 |  | Samples up to 336 hours post dose | 
| AUC, Cmax, tmax and t1/2 of Metabolites |  | Samples up to 336 hours post dose |
Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
• To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece

Detailed Description
-----------------
To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival To record adverse events per line of therapy To recording of the causes of treatment discontinuation per line of therapy

Official Title
-----------------
Non-Interventional, Multi-center Registry of Recording of Treatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with histological confirmed ER/PR positive, HER2-negative MBC Age >18 years old Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC Adequate hematologic, renal and hepatic function Signed informed consent (ICF) Exclusion Criteria: Active malignancy other than MBC Active infection

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 |
| --- | --- | --- |
| Evaluation of the outcome per treatment line | To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival | 5 years |
Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct

Study Overview
=================
Brief Summary
-----------------
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.

Conditions
-----------------
Post-ERCP Pancreatitis

Intervention / Treatment
-----------------
* Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD
* Device: Cannulotome CT-25mm Cook Medical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high-risk patients for post-ERCP pancreatitis Exclusion Criteria: age < 18 years allargy to the contrast medium previous biliary or gastric surgery neoplastic patients previous biliary or pancreatic sphincterotomy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: loop-tip arm<br>The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.) | Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD<br> <br> |
| Active Comparator: Control arm<br>The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique) | Device: Cannulotome CT-25mm Cook Medical<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post ERCP pancreatitis rate | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
loop-tip, ERCP, cannulation of CBD
Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Study Overview
=================
Brief Summary
-----------------
The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

Detailed Description
-----------------
Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.

Official Title
-----------------
Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification Exclusion Criteria: The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy High myopia with an axial length > 27.0 mm or refractive error > -8.0 diopters The patients followed for less than 6 months postoperatively
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Macular hole patients<br>The patients who underwent vitreous surgery for idiopathic macular hole. | Procedure: Vitrectomy<br>* Macular hole surgery<br>* Other names: Optical coherence tomography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foveal microstructure determined by optical coherence tomography | The integrity of the microstructures of the foveal photoreceptors; the inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined by spectral domain optical coherence tomography. | Preoperative and postoperative 1, 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visual acuity | Preoperative and postoperative best-corrected visual acuity | Preoperative and postoperative 1, 3, 6, 9, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular hole