linjc16/ctgov huggingface dataset:
Mortality After Endoscopic Retrograde Cholangiopancreatography

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aimed to overview patients with specific and non-specific complications who admitted to intensive care unit following endoscopic retrograde cholangiopancreatography and had fatal course in the facility

Detailed Description
-----------------
The investigators retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol (midazolam 0.02 mgkg-1; fentanyl, 1 mgkg-1; propofol 1 mgkg-1) between 2011 and 2016 after approval of local ethics committee of Umraniye Training Hospital.

Official Title
-----------------
Patients With Mortality After Endoscopic Retrograde Cholangiopancreatography

Conditions
-----------------
Cholangiopancreatography, Endoscopic Retrograde, Mortality, Deep Sedation

Intervention / Treatment
-----------------
* Procedure: complications during procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent elective or emergent ERCP at semi-prone position with routine monitoring and standard sedation protocol Exclusion Criteria: Patients who discharged to ward after treatment and follow-up in ICU

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: complications during procedure|patients may have anesthesia related complications during procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With endoscopic retrograde cholangiopancreatography Related complications | We retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol | 5 years | 
| Rate of anaesthesia related mortality of the endoscopic retrograde cholangiopancreatographyprocedure under sedation | We identified patients who developed complications during procedure and admitted to intensive care unit (ICU). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality |  | 5 years | 
| Value of Charlson comorbidity index (CCI) score for predicting mortality |  | 5 years |
Isolated Pancreatic Loop With Modified Pancreaticojejunostomy

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD

Detailed Description
-----------------
Postoperative pancreatic fistula (POPF) is widely regarded as the most threatening complication following pancreaticoduodenectomy (PD). Its clinical impact and sequelae have been previously described and shown to contribute to the development of other morbid complications and high rates of mortality. The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD. Methods: We report our early experience using a modified PJ technique with an isolated pancreatic loop after after PD in 201 patients between January 2010 and December 2020.

Official Title
-----------------
Modified Pancreaticojejunostomy Technique With Isolated Pancreatic Loop After Pancreaticoduodenectomy Reduces Postoperative Pancreatic Fistula: a Retrospective Study

Conditions
-----------------
Pancreaticoduodenectomy

Intervention / Treatment
-----------------
* Procedure: duodenopancreatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age up to 30 head of the pancreas tumor Exclusion Criteria: body and tail pancreatic tumors

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients operated for pancreas tumors<br>duodenopancreatectomy for head of the pancreas tumors | Procedure: duodenopancreatectomy<br>* resection of the head of the pancreas, the mower part of the biliary duct, and antrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pancreatic fistula | level of lipase in abdominal drain after suregry | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreaticoduodenectomy, pancreaticojejunostomy, Postoperative pancreatic fistula.
A Program of Physician Supervision to Improve the Quality of Patient Referrals From Nurse Practitioners and Physician Assistants

Study Overview
=================
Brief Summary
-----------------
The investigators have previously demonstrated utilizing a validated tool, that the quality of referrals from nurse practitioners (NP) and physician assistants (PA) is less than referrals from physicians. The investigators hypothesize that with local physician input, the quality of referrals from nurse practitioners and physician assistants will improve. This is a prospective study comparing patient referrals from nurse practitioners and physician assistants with and without prior discussion with a local physician.

Official Title
-----------------
Implementing a Program of Physician Supervision to Improve the Quality of Patient Referrals From Nurse Practitioners and Physician Assistants

Conditions
-----------------
Complex Patients

Intervention / Treatment
-----------------
* Behavioral: Consultations between NPs and PAs and their supervising physicians
* Behavioral: versus NPs and PAs who are not required to discuss patient referrals (control group).


Participation Criteria
=================
Eligibility Criteria
-----------------
All nurse practitioners and physician assistants in the Mayo Clinic Health System

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPs & PAs referral discussions with a supervising physician<br>required consultations between NPs and PAs and their supervising physicians | Behavioral: Consultations between NPs and PAs and their supervising physicians<br>* Required discussion with physician prior to referral by a nurse practitioner or physician assistant<br>|
| Other: NPs and PAs - no consultations with supervising physisians<br>NPs and PAs who are not required to discuss patient referrals | Behavioral: versus NPs and PAs who are not required to discuss patient referrals (control group).<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved referrals from nurse practitioners and physician assistants to physicians as determined using a previously validated tool |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
referrals, nurse practitioners, physician assistants, consultative general internal medicine
Emotional Experience and Burnout in Physician

Study Overview
=================
Brief Summary
-----------------
Recent studies have highlighted a high incidence of burnout among surgeons. The aim of this study is in particular to investigate if this is the consequence of performing surgery (i.e. invasive procedures) or whether it is related to the cultural background of surgeons.

Detailed Description
-----------------
A mixed method approach (qualitative approach and quantitative approach) will be used to investigate surgeons, as well as gastroenterologists and radiologists who perform invasive procedures and gastroenterologists and radiologists who do not perform invasive procedures. The qualitative approach will rely on face-to face interviews with purposively sampled physicians of the 5 groups and will be continued until saturation. The quantitative approach will rely on a questionnaire that will be sent to physicians of the 5 groups.

Official Title
-----------------
National Study of the Psychological Consequences Resulting From the Practice of Invasive Therapeutic Interventions: Mixed Evaluation, Qualitative and Quantitative, of Burn Out Among Digestive Surgeons, Gastroenterologists and Radiologists

Conditions
-----------------
Emotional Experience and Burnout in Physicians

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Digestive surgeon, Gastroenterologist, Radiologist Exclusion Criteria: None

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 |
| --- | --- | --- |
| incidence of burnout | Compare the emotional experience and incidence of burnout between surgeons, gastroenterologists and radiologists | quantitative approach 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physicians understanding of the Maslach Burnout Inventory (MBI) questionnaire will be reported by interview |  | quantitative approach 27 months | 
| physician's emotions will be reported by interview and MBI questionnaire | concordance between the questionnaire and the interview | quantitative approach 27 months | 
| Correlation score depending on the specialty and professional experience | Evaluation of the MBI score over time | quantitative approach 27 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emotional experience and burnout in physicians
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Detailed Description
-----------------
The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

Official Title
-----------------
A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: DR-1021


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal Not pregnant or breastfeeding Sexually active at risk of pregnancy Exclusion Criteria: Any contraindication to the use of oral contraceptives Pregnancy within the last 3 months Smoking > 10 cigarettes per day

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DR-1021<br>* 1 tablet daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pregnancy rates |  | Duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events reported by patients and investigators |  | Duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy prevention, oral contraceptives
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.

Official Title
-----------------
A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fed State

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

Intervention / Treatment
-----------------
* Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)
* Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, 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: 56 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>Cefdinir 300 mg Capsule (Sandoz, Austria) | Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)<br> <br> |
| Active Comparator: 2<br>Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) | Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.

Official Title
-----------------
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis

Conditions
-----------------
Pre-hypertension, Hypertension

Intervention / Treatment
-----------------
* Drug: Potassium, Magnesium, Citrate
* Drug: Potassium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 21 years BMI > 18.5 kg/m2 and < 40 kg/m2 Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial. Exclusion Criteria: Taking blood pressure lowering medication Diabetes mellitus Renal disease Active cardiac disease Active liver disease Chronic diarrhea Chronic NSAID use Active or suspected drug use Uncontrolled psychiatric disease HIV infection Missed more than 20% of clinic visits in the last yr Prescription of diuretics for any reason A patient taking nutritional supplements including multivitamins that is unwilling to discontinue them,\ Consumption of greater than 14 alcoholic beverages per week

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potassium Magnesium Citrate<br> | Drug: Potassium, Magnesium, Citrate<br>* Potassium MAgnesium Citrate - 30 mEq potassium, 15 mEq Magnesium, 45 mEq Citrate in a powder mixture twice a day, mixed with a glass of water.<br>|
| Active Comparator: Potassium Chloride<br> | Drug: Potassium Chloride<br>* Potassium Chloride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-hypertension, Hypertension
Transplantation of Fibroblast for Correction of Nasolabial Folds

Study Overview
=================
Brief Summary
-----------------
The study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging

Detailed Description
-----------------
Autologous cultured fibroblast which is obtain from the patient's normal skin is harvested and expanded in an in vitro. Biopsies samples are obtained from the behind of the patient's ear as a source of fibroblasts, then fibroblast cells isolated and expanded through cell culture, and used for the correction of Nasolabial folds, deep wrinkles of the forehead. Prior to final packaging, cell viability is assessed to be at least 85%

Official Title
-----------------
Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds

Conditions
-----------------
Nasolabial Folds, Skin Aging

Intervention / Treatment
-----------------
* Biological: Fibroblast
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Available and willing to attend all follow-up visits. Age > 18 years. Able and willing to give informed consent Exclusion Criteria: Known allergy or sensitivity to any cellular products The subject has received a soft tissue augmentation to the area to be treated within the last 6 months. Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study. The subject has received autologous fat transfer in the last 6 months. Subject is suffering from facial Kaposi's sarcoma. The subject has active skin diseases or inflammation on or near the area of injection positive HIV, hepatitis B virus (HBV), hepatitis C virus (HCV)

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibroblast<br>Injection of Fibroblast | Biological: Fibroblast<br>* Transplantation of 20 million cell by three injection<br>* Other names: Autologous injection of Fibroblast;|
| Placebo Comparator: Placebo<br>the patient receive placebo injection | Biological: Placebo<br>* Injection of Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correction of Nasolabial | Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination | 6 months after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroblast, Cell transplantation
Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed conditions.

Official Title
-----------------
Single-Dose Fed Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg
* Drug: Benicar HCT ® Tablets 40 mg/25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg | Drug: Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg<br> <br> |
| Active Comparator: 2<br>Benicar HCT ® Tablets 40 mg/25 mg | Drug: Benicar HCT ® Tablets 40 mg/25 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 48 hours |