linjc16/ctgov huggingface dataset:
Gastroparesis in type2 Diabetic Patient

Study Overview
=================
Brief Summary
-----------------
Gastroparesis is defined by objective delaying of gastric emptying without any evidence of mechanical obstruction. Diabetic gastroparesis is a potential complication that occurs in the setting of poorly controlled diabetes, resulting from dysfunction in the coordination and function of the autonomic nervous system, neurons, and specialized pacemaker cells (interstitial cells of Cajal, ICC) of the stomach and intestine, and the smooth muscle cells of the gastrointestinal tract

Detailed Description
-----------------
Hyperglycemia (random blood glucose greater than 200 mg/dL), commonly seen in uncontrolled diabetes, has been associated with diabetic gastroparesis resulting from neuropathy in the setting of chronic hyperglycemia and does not resolve with improved glycemic control. Acute hyperglycemia, on the other hand, though it can also result in delayed gastric emptying, is often reversible with improved glycemic control. Although there is a stronger association between type 1 diabetes and gastroparesis, the incidence of type 2 diabetes is much greater, and therefore, gastroparesis associated with type 2 diabetes is seen more frequently. Additionally, incretin mimetics are used to treat patients with type 2 diabetes, and these medications pose an additional risk factor for developing gastroparesis.Gastric emptying scintigraphy (GES) is the investigation of choice for evaluating the disorders of gastric emptying because it is a simple, physiological, and sensitive investigation to objectively assess gastric emptying. Standard imaging is performed at 0,1,2,4 hours postprandially. A four-hour study is more sensitive and accurate in diagnosing gastroparesis, and clinicians should avoid shortened 2- and 3-hour studies.

Official Title
-----------------
Prevalence Of Gastroparesis In Type2 Diabetic Patients In Assiut University Hospital And Value Of Nuclear Imaging In Diagnosis

Conditions
-----------------
Diabetic Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 DM Age < 40 years >5 years of DM Exclusion Criteria: Type 1 DM History of GIT surgry Medical disease affect gastric emptying Using of prokinetic

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| prevalence of gastroparesis in type 2 diabetic patients |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis | using of Gastric emptying scintigraphy as a tool for diagnosis of gastroparesis | 3 years |
Thorough QT Study of Nelfinavir

Study Overview
=================
Brief Summary
-----------------
To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation

Official Title
-----------------
Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Nelfinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG evaluation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  |
Collaborative Surgical Proficiency Initiative

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide a quantitative base line comparison to determine a surgeon's proficiency based on that surgeon's hand and tool movements while performing simulation tasks.

Official Title
-----------------
Collaborative Surgical Proficiency Initiative

Conditions
-----------------
Surgical Proficiency

Intervention / Treatment
-----------------
* Behavioral: Simuvision Simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical residents and attendings from Banner Good Samaritan Medical Center Range in age from 23-65 years Willing to provide informed consent Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical resident or attending<br> | Behavioral: Simuvision Simulator<br>* Participants will perform common surgical procedures on the simulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ovarian Reserve in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated with disease treatment. Anti-mullerian hormone (AMH) is a reliable indicator of ovarian reserve in women. The aim of this study was to compare serum AMH levels in women with Crohn's disease and healthy controls. In this study, the investigators aimed to investigate AMH and ovarian capacity in the study group with crohn's disease and in the control group without disease.

Official Title
-----------------
Evaluation of Ovarian Reserve in Crohn's Disease

Conditions
-----------------
Crohn Disease, Ovary Disease, Anti-Mullerian Hormone Deficiency

Intervention / Treatment
-----------------
* Other: AMH levels in young women with crohn's disease will be considered.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: crohn's disease; reproductive age women Exclusion Criteria: Over 40 years old, a previous ovarian resection; renal failure (serum creatinine levels N1.2 mg / dL);suspicion of malignancy; the presence of hereditary or acquired hematological disease; pregnancy; current lactation; the presence of a serious comorbid chronic disease; cirrhosis originating from chronic liver disease; abnormal thyroid function tests; a known serious psychological problem; presence of alcoholism and male sex.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>women in reproductive age with crohn's disease | Other: AMH levels in young women with crohn's disease will be considered.<br>* Ovarian Reserve in Young Women of Reproductive Age with Crohn's Disease;Blood will be taken from both the study and control groups and the AMH level will be evaluated.<br>|
| control group<br>women in reproductive age without crohn's disease, | Other: AMH levels in young women with crohn's disease will be considered.<br>* Ovarian Reserve in Young Women of Reproductive Age with Crohn's Disease;Blood will be taken from both the study and control groups and the AMH level will be evaluated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMH levels | AMH levels of subjects taken into groups will be evaluated in lg/L | 1 MONTH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound findings | On the 3rd day of the menstrual cycle, the patients will be given ultrasound and the ovarian volume will be examined. the ovarian volume will be calculated by taking the size of the ovary in three sections. | 1 MONTH |
Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

Study Overview
=================
Brief Summary
-----------------
The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .

Detailed Description
-----------------
All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission. Data collection: For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected. For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.

Official Title
-----------------
Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients age >18 yrs admitted to 24 participating ICUs Exclusion Criteria: No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).

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 |
| --- | --- |
| ARDS, non-ARDS<br>patients with ARDS and patients without ARDS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute respiratory distress syndrome (ARDS) | incidence of ARDS = the number of patients developing ARDS during ICU / the total number of patients admitted to ICU | from ICU admission to 28-day of ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality of patients with ARDS |  | followed up to 3 months after inclusion or to ICU discharge, whichever occurred first | 
| hospital mortality of patients with ARDS |  | followed up to 3 months after inclusion or to hospital discharge, whichever occurred first |
Effectiveness of a Postal Intervention to Improve the Use of PPI

Study Overview
=================
Brief Summary
-----------------
It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months.

Detailed Description
-----------------
The intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. Control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses). The main outcome variable was the number of active prescriptions of each PPI dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.

Official Title
-----------------
Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors

Conditions
-----------------
Drug Overdose

Intervention / Treatment
-----------------
* Other: Letter by post to patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under the care of our organisation who in May 2017 had an active long-term prescription for PPIs at high doses for at least 6 months. Exclusion Criteria: Patients whose GPs declined 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed | |
| Other: Letter by post to patients<br>Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor | Other: Letter by post to patients<br>* Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active prescriptions of each proton pump inhibitors dose after the intervention | Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the intervention | 6 months |
ALF-ONE : ALFuzosin ONcE Daily

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Official Title
-----------------
Study of the Outcome of Patients With Lower Urinary Symptoms Suggestive of Benign Prostatic Hyperplasia and Treated With Alfuzosin 10 mg Once Daily for 3 Months in China

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Alfuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia Exclusion Criteria: Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months Patients previously not improved by an alpha 1-blocker treatment Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI) Known hypersensitivity to alfuzosin History of postural hypotension or syncope Combination with other alpha 1-blockers Hepatic insufficiency Unstable angina pectoris Severe concomitant condition threatening life
Sexes Eligible for Study
-----------------
Male

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous adverse events |  |  | 
| Blood pressure and heart rate measured in sitting position |  |  | 
| International Prostate Symptom Score (IPSS) and quality of life index |  |  | 
| DAN-PSS sexual function score |  |  | 
| PSA levels measured at baseline |  |  | 
| Maximum flow rate and residual urine |  |  |
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.

Official Title
-----------------
Randomized, Open-Label, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex (Reference) Following a 50 mg Dose in Healthy Subjects Under Fed Conditions.

Conditions
-----------------
Prostate Cancer, Hirsutism

Intervention / Treatment
-----------------
* Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
* Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, 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: 64 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA) | Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)<br> <br> |
| Active Comparator: 2<br>Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA) | Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 11 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment
Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Assessment of changes of renal hemodynamics by multiparametric MRI after closure of AVF access.

Official Title
-----------------
Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients: a Pilot Study

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography and MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age > 18 years Patients wishing to close the fistula and planned for surgical fistula closure eGFR CKD EPI ≥ 45 ml/min/1.73m2 at one year post transplantation Stable eGFR within the past 6 months Controlled blood pressure Exclusion Criteria: Kidney Transplantation < 12 months before fistula closure Proteinuria > 500mg/d Presence of donor specific antibodies Rejection within the past 6 months BK virus replication within the past 3 months Cardiac pacemaker, which is not compatible with MRI Claustrophobia

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Echocardiography and MRI|Echocardiography and renal MRI before and after fistula closure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access | Assessing changes in renal perfusion | evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure | 
| Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access | Assessing changes in renal oxygenation | evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics after fistula closure | Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics after fistula closure | evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure |