linjc16/ctgov huggingface dataset:
Persantine: Variation in Response Trial

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.

Detailed Description
-----------------
Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the gene for the adenosine transporter will be evaluated.

Official Title
-----------------
Persantine: Variation in Response Trial

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: dipyridamole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 21 years old Patient undergoing cardiac catheterization with planned PTCA or with a significant coronary lesion of either the LAD or Circumflex Exclusion Criteria: Theophylline or oral Persantine use in 24hrs Second or third degree AV block, or sick sinus syndrome without a functioning pacemaker Active asthma or bronchospasm Patients with severe hepatic insufficiency Patients experiencing an acute transmural infarction at the time of the index visit Conditions that are known to affect resistive vessel function or myocardial flow

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects receive dipyridamole<br>Compare to baseline | Drug: dipyridamole<br>* 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously<br>* Other names: Persantine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function. | To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow. |  | 6-12 months |
A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.

Conditions
-----------------
Ulcerative Colitis, Large Intestine, Diarrhea, Abdominal Pain

Intervention / Treatment
-----------------
* Drug: LT-02
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 years or older who have given written Informed Consent Patients with proven ulcerative colitis Active disease course for the last 6 weeks or longer with bloody diarrhea Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine. Exclusion Criteria: Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis, Crohn's disease, Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis, Treatment with other investigational medicinal product within 3 months prior to study entry

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LT-02 Dose 1<br>0.2g IMP per dose | Drug: LT-02<br>* Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks<br>|
| Experimental: LT-02 Dose 2<br>0.4g IMP per dose | Drug: LT-02<br>* Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks<br>|
| Experimental: LT-02 Dose 3<br>0.8g IMP per dose | Drug: LT-02<br>* Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks<br>|
| Placebo Comparator: Sugar pill<br>placebo matching to 0g of IMP, | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis |  | From day 1 of treatment until end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis |  | After study is completed |
Baclofen as a Perioperative Analgesic Adjuvant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Detailed Description
-----------------
Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours following surgery.

Official Title
-----------------
Baclofen as a Perioperative Analgesic Adjuvant

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Baclofen 10mg
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (age >= 19 y.o.) scheduled for kidney stone-related surgery Exclusion Criteria: History of allergy to baclofen Any condition which might limit appropriate report and treatment of postoperative pain (e.g., non-English speaking; severe psychiatric disease)

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid Tolerant - baclofen<br> | Drug: Baclofen 10mg<br>* Baclofen administration pre-operatively<br>|
| Placebo Comparator: Opioid Tolerant - placebo<br> | Other: Placebo<br>* Placebo administration<br>|
| Experimental: Opioid Naive - baclofen<br> | Drug: Baclofen 10mg<br>* Baclofen administration pre-operatively<br>|
| Placebo Comparator: Opioid Naive - placebo<br> | Other: Placebo<br>* Placebo administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Opioid Requirements | Patients Patients' opioid requirements for acceptable pain control will be assessed based on the total oral morphine equivalent needed for post operative pain control. | From 0 hours post-operatively to 24 hours post-operatively |
Vasovist Endoleak Study

Study Overview
=================
Brief Summary
-----------------
After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is needed to monitor the effectiveness of the treatment. One parameter in this follow-up is endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.

Detailed Description
-----------------
After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with computed tomographic (CT) angiography yearly after Endovascular Aneurysm Repair (EVAR). The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks. The advantages of magnetic resonance imaging with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.

Official Title
-----------------
Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: Computed tomography angiography
* Procedure: Magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is more than one year after endovascular abdominal aortic aneurysm repair Patient has a stable or growing aneurysm according to diameters measured on CT angiography images No evidence of endoleak on recent CT angiography Exclusion Criteria: contraindication for MRI examination claustrophobia pacemaker other non-MRI compatible implants contraindication for use of contrast agent known allergy to drugs or contrast media MRI examination with the use of gadolinium within 24 hours of the blood-pool agent injection severe renal impairment = creatine > 2 mg/dl (=176 mmol/l) patient clinically instable Participation in drug research within 30 days before and 1 day after MRI-examination with use of Vasovist.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Computed tomography angiography|Computed tomography angiography|
|Procedure: Magnetic resonance imaging|Magnetic resonance imaging after injection of Vasovist|

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
-----------------
endoleak
A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

Study Overview
=================
Brief Summary
-----------------
To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.

Detailed Description
-----------------
Patients are randomized to one of four treatment arms. ddC is administered at 1 of 2 doses every 8 hours. AZT is administered at 1 of 2 doses (every 4 hours while awake or every 8 hours).

Official Title
-----------------
A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Zidovudine
* Drug: Zalcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. CD4 count 100 - 500 cells/mm3.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zidovudine|nan|
|Drug: Zalcitabine|nan|

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
-----------------
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
The ALIGHIERI Survey: an Italian Overview of Global Impact of tHe COVID-19 pandemIc on General surgERy practIce

Study Overview
=================
Brief Summary
-----------------
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. R

Detailed Description
-----------------
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. .

Official Title
-----------------
The ALIGHIERI Survey: an Italian Overview of Global Impact of tHe COVID-19 pandemIc on General surgERy practIce

Conditions
-----------------
Surgery and covid19

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: alla surgeon in activity Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey|survey among surgeon|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery volume during covid19 lockdown | number of surgical procedure performed all over italy during covid19 first lockdown | 8months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery volume after the first covid19 lockdown | number of surgical procedure performed all over italy during re start period | 3 months |
The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy

Study Overview
=================
Brief Summary
-----------------
Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus

Detailed Description
-----------------
The prevalence of diabetes mellitus is increasing recently, especially in the urban area of developing countries. Subjects with diabetes have higher rate of hospitalization and have higher mortality. Diabetes results in various complications including diabetic retinopathy, nephropathy, neuropathy, and cardiovascular complications. Among these, cardiovascular autonomic neuropathy is one of clinical important complication of diabetes. Diabetic subjects with reduced cardiovascular autonomic function have been shown to strongly associate with an increased risk of silent myocardial ischemia and increased mortality. They also have higher risk of sudden death, intraoperative and perioperative cardiovascular instability. Formation of advanced glycation end product (AGE) and oxidative stress are important causes of diabetic neuropathy. Vascular adhesion protein-1 (VAP-1), an adhesion molecule with an activity of semicarbazide-sensitive amine oxidases (SSAO), which can catalyze endogenous amines to produces corresponding aldehydes, H2O2, and ammonia. We have demonstrated that serum VAP-1 is a source of systemic AGE and oxidative stress, and is associated with nephropathy and atherosclerosis. There are reports demonstrating that subjects with diabetic retinopathy or stroke have higher serum VAP-1. To our best knowledge, there is no report regarding the relationship between serum VAP-1 and neuropathy. In present study, we will measure serum VAP-1 and check cardiovascular autonomic function. We will also explore the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus.

Official Title
-----------------
The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy

Conditions
-----------------
Neuropathy; Peripheral, Autonomic, in Diabetes Mellitus (Manifestation)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus Exclusion Criteria: arrythmia

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 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 |
| --- | --- |
| diabetic mellitus screen<br> | |

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
-----------------
diabetes, cardiovascular autonomic neuropathy, VAP 1
The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7 8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.

Conditions
-----------------
Valvular Heart Disease Patients

Intervention / Treatment
-----------------
* Procedure: remote ischemic postconditioning
* Procedure: valvular surgery with bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are undergoing valvular heart surgery Adult age 19-80 Exclusion Criteria: peripheral vascular disease with circulation deterioration Renal replacement therapy preconditioning medication Myocardiac infarction within 3 weeks active infective endocarditis high dosage steroid therapy mental retardation unlettered person

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: post-ischemic conditioning group<br> | Procedure: remote ischemic postconditioning<br>* Remote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles.<br>|
| Placebo Comparator: valvular surgery with bypass group<br> | Procedure: valvular surgery with bypass<br>* valvular surgery with bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria |  | 5 days |