cyrilzakka/clinical-trials huggingface dataset:
Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

Our hypothesis is that altered cardiac sympathetic activity is present and may contribute to the myocardial stunning observed in the apical ballooning syndrome.

Aim: Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction using carbon-11 hydroxyephedrine (C-11 HED), a positron emission tomography (PET) tracer, in patients with the apical ballooning syndrome.

General methods: Five patients will undergo PET scans within a few days of or during the initial hospital admission for apical ballooning syndrome and during follow-up at 4 to 6 weeks to evaluate regional perfusion using N-13 ammonia and cardiac sympathetic activity with C-11 HED.

PET scanning protocol On the morning of the study, patients will arrive at the Mayo Clinic PET Imaging Center in a fasting state. The use of medications will be ascertained and recorded. An intravenous cannula will be placed in each arm. The subject will then be positioned in the PET scanner . After optimal positioning of the left ventricle within the field of view, a transmission scan will be performed with either a germanium-68 or CT source for subsequent attenuation correction. The PET scanning sequence is outlined below. Because 11C-HED uptake is dependent on flow characteristics, a flow study will be performed using N-13 ammonia. N-13 ammonia (10 to 20 mCi) will be injected over 20 seconds, and dynamic acquisition will be performed for 20 minutes with the following sequence:16 frames at 3 seconds, 10 frames at 12 seconds, and 2 frames at 240 seconds. Following a 50-minute period of N-13 ammonia decay, 11C-HED (20mCi) will be injected over 30 seconds, and a dynamic acquisition will be performed with the following sequence: 6 frames at 30 seconds, 2 frames at 60 seconds, 2 frames at 150 seconds, 2 frames at 300 seconds, 2 frames at 600 seconds, and 1 frames at 1,200 seconds. To correct for 11C-metabolites in the blood activity, venous samples will be drawn at 0, 1, 5, 10, 20, 40, and 60 minutes (total \~25 ml of blood) after the injection of C-11 HED. Heart rate, systemic blood pressure, and a 12-lead electrocardiogram will be obtained noninvasively with each peak isotope activity.

Eligibility Criteria:
Inclusion Criteria:

* Transient akinesis or dyskinesis of the left ventricular apical and mid-ventricular segments with regional wall-motion abnormalities extending beyond a single epicardial vascular distribution.
* Absence of obstructive coronary disease or angiographic evidence of acute plaque rupture.
* New electrocardiographic abnormalities (either ST-segment elevation or T-wave inversion.
* Absence of recent significant head trauma, intracranial bleeding, pheochromocytoma, myocarditis, hypertrophic cardiomyopathy.

Exclusion Criteria:

* Hemodynamically unstable patients (requiring pressor support) will be excluded.
* Breastfeeding women.
* Pregnant women (urine pregnancy test required within 48 hours prior to each set of PET scans.
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject was randomized into Study 20090062 and completed the week 16 evaluation.

Exclusion Criteria:

* Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was considered possibly related to IP.
* Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.
CorPath GRX STEMI Study

This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).

This is a prospective, post-market, single-arm, multi-center, observational study to evaluate the performance of the CorPath GRX System during robotic-PCI for acute ST elevation myocardial infarction (STEMI).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤ 80 years
* Patients with STEMI\<12 h of symptom onset
* Patient deemed appropriate for robotic-assisted PCI
* The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent

Exclusion Criteria:

Cardiogenic shock

* Cardiac arrest
* Need for manual or mechanical thrombectomy
* Failure/inability/unwillingness to provide informed consent
* The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment
LTA Assessement Using Aggregometer TA-8V (Stago®)

Exploring platelet functions requires aggregation tests platelet. The Haematology Laboratory of Hospices Civils de Lyon currently has two new TA-8V plate aggregation automatons® (Stago).

The supplier of these devices does not offer reference values for these tests. There are also no references in the data literature. Therefore reference values must be established from healthy volunteer subjects.

The use of these automatons is subject to the NF (French Standard) EN (European Standard) ISO (International Organization for Standardization) 15189 standard of the COFRAC ( French Accreditation Comity) that requires checking their proper functioning. This audit must be traced in a method validation folder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged between 18 and 70 years
* Weighting more than 50 kg
* Subjects having signed informed consent
* Subjects registered in the French health-care system database

Exclusion Criteria:

* Personal history of anemia, thrombopenia, hemorrhagic disease
* Caffeine intake 2 hours prior to blood sampling
* Tobacco intake in the half hour prior to blood sampling
* Use of any drug impacting platelet function
* for antiplatelet agents: at least 10 days prior to blood sampling
* for anti-depressants: at least 10 days prior to blood sampling
* for non-steroid anti-inflammatories: at least 3 days prior to blood sampling
* Refusal to undergo the 3 visits and 3 blood samples of the study
* Refusal to sign the informed consent form
* No registration in the French Health-care system database
* Pregnant women and women who are breastfeeding
Can Chronic Post-surgical Pain be Reduced by Preserving Intercostobrachial Nerve During Axillary Lymph Node Dissection? : A Randomized Controlled Trial

Intercostobrachial nerve (ICBN) is a cutaneous nerve that provides sensation to the lateral chest, upper medial arm and axilla. It arises from the second intercostal nerve and leave intercostal space at the level of midaxillary line. It then pierces the serratus anterior muscle and enters axilla. Intercostobrachial nerve is encountered during axillary lymph node dissection (ALND) while mobilizing axillary contents laterally off the chest wall and tends to tether axillary contents to the lateral chest wall. Many surgeons routinely sacrifice it as doing so makes mobilization easier and allow exposure of long thoracic neve. Currently there is no consensus on the usefulness of preserving intercostobrachial nerve.

According to a 2020 systemic review and meta-analysis, prevalence of CPSP/ PPSP following breast cancer surgery ranged from 2% to 78% and pooled prevalence was found to be 35%. Higher prevalence was associated with ALND. Several risk factors have been identified which contribute to the development of PPSP. These include; Preexisting pain, preoperative opioid exposure, genetics, psychological factors such as anxiety, depression or catastrophizing, intensity of acute postoperative pain and nerve injury during surgery.

As a result of nerve injury, damaged and non-damaged nerve fibers start generating action potential spontaneously. These are considered ectopic inputs as they do not arise from peripheral terminals. These inputs lead to the development of central sensitization, which is a state of exaggerated functional response of neurons involved in the pain pathway. This increased sensitization results due to increased membrane excitability, enhanced synaptic efficacy and decreased inhibition.

The aim of the present trial is to investigate the effect of ICBN preservation on chronic/ persistent post surgical pain (CPSP/ PPSP). This will be achieved through a randomized control trial with CPSP/ PPSP as a primary outcome measure. Secondary outcome measures will include Health Related Quality of Life (HRQoL), operating time, lymph node yield, functional status of ipsilateral shoulder, post-operative complications and post-operative use of opioid analgesics.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above.
* Known cases of invasive breast Cancer.
* Undergoing Axillary Lymph Node Dissection (ALND) alone, ALND with mastectomy or ALND with breast conservation surgery (BCS)
* Capacity to give informed consent

Exclusion Criteria:

* Chronic diseases limiting motion of shoulder such as neuropathies, history of trauma and autoimmune diseases.
* Patients undergoing redo axillary lymph node dissection.
* Patients undergoing bilateral axillary lymph node dissection.
* History of chronic pain lasting more than 3 months. Potential causes include: arthritis, backache, fibromyalgia, Irritable bowel disease, irritable bowel syndrome and different types of headache.
* M1 stage of the TNM staging system at the time of initial diagnosis.
Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes Mellitus (DM) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus with high risk of macrovascular complications; high risk is one or more as follows:

   * Hypertension (≧ 140/90 or anti-hypertensive therapy)
   * Hypercholesterolemia (LDL-C \> 130 mg/dL or anti-hyperlipidemic therapy)
   * TG \> 200 mg/dL
   * Non proliferative retinopathy or macular edema
   * Microalbuminuria or macroalbuminuria
   * Smoker
2. Patients on no anti PLT drug history
3. Patients who are agree with this research

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Macrovascular complication history
3. Uncontrolled hypertension, unstable angina history
4. Congestive heart failure
5. Bleeding tendency
6. Chronic liver disease (ALT \> 100 or AST \> 100) or Chronic renal disease creatinine \> 3.0 mg/dl)
7. Anemia (hemoglobin \< 10 mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
8. Pregnant or lactation women
9. Plan to be revascularized in 4 weeks
10. Plan to go to surgery or invasive intervention in 4 weeks
11. Plan to need to admission for acute cardiovascular disease in 4 weeks
12. Contraindication of this medication
13. Other anti-PLT drug therapy
A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age at screening
* Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
* Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive

Exclusion Criteria:

* Subjects currently receiving immunosuppressants, interferon, anti-TNFa
* Subjects with evidence of hematopoietic disorders
* Subjects with evidence of active or latent TB
The Effect on Depressive Symptoms in ECF Residents With COPD

The purpose of this study is to assess the effect of treatment with Advair Diskus on depression using the Cornell depression scale in COPD patients in the nursing home.

We are studying 35 residents in the ECF with a diagnosis of COPD. We are evaluating them for depressive symptoms using the Cornell Depression Scale and the MDS 3.0 section D. We are selecting patients who are not currently on treatment with Advair and starting them on Advair Diskus50/250 1 inhalation bid for a period of 16 weeks and reassessing the Cornell Depression SCale and MDS3.0 section D looking for any changes. We are also going to measure FEV1 and FVC using spirometry before treatment and at the end of 16 weeks. This is a pilot study. The numbers are not necessarily adequate to achieve statistical difference-we are looking for trends.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women nursing home residents up to age 95
* Stated diagnosis of COPD or FEV1/FVC \<0.7 or being treated with an anticholinergic
* Presence of depressive symptoms as measured on MDS 3.0 Section D SUM
* Free from conditions likely to be fatal within six months
* Able to read or understand English
* Able and willing to provide informed consent or has a guardian/LAR who can provide informed consent

Exclusion Criteria:

* Currently pregnant
* Unable to read and understand English
* Free from conditions likely to be fatal within six months
* Enrolled in hospice
* New treatment with antidepressant within the last 90 days.
* Current or recent use (within the last 90 days) of Advair Diskus
* Unwilling or unable to provide informed consent
* Expected to be discharged within 3 months
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.


Eligibility Criteria:
Inclusion Criteria:

* Has documented chronic HCV GT1 infection
* Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy

Exclusion Criteria:

* Has received previous antiviral treatment for HCV infection
* Has cirrhosis or decompensated liver disease
* Is pregnant or breastfeeding
* Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen \[HBsAg\] positive) and/or human immunodeficiency virus (HIV)
* Has clinically significant concomitant disease
Platelet-Inhibitor Drug Trial in Coronary Angioplasty

To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in reducing the incidence of coronary events and the severity and incidence of angina.

BACKGROUND:

By dilating coronary stenoses, PTCA can relieve angina pectoris and improve exercise tolerance and left ventricular function. However, restenosis occurs in 20-30 percent of dilated stenoses within three to six months following PTCA making it necessary to restrict patient activities, resume antianginal medications, repeat PTCA, or perform coronary artery bypass surgery.

Balloon dilatation of the atherosclerotic lesion damages the endothelium, intima, and media of the artery. This may lead to restenosis via platelet deposition, mural thrombus formation, and intimal proliferation by mechanisms that appear similar to those causing aortocoronary vein graft (ACVG) occlusions. It had been demonstrated that dipyridamole plus aspirin therapy suppressed these mechanisms of ACVG occlusion in the animal model, prolonged a shortened platelet survival in patients with coronary artery disease, and reduced ACVG occlusions in patients both early and late after the operation. Thus, a trial of these drugs in patients undergoing PTCA was a logical and necessary step to reduce the major shortcoming of the initially successful PTCA therapy, namely the high rate of restenosis.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Patients were randomized to treatment with dipyridamole plus aspirin or placebo.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility Criteria:
Patients to age 80 with angina pectoris.
Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure

The LINKED-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo) that links with all Bluetooth-enabled validated blood pressure (BP) devices, support from community health workers (CHWs), and BP measurement training at community health centers serving high-risk adults to prevent stage 2 hypertension (BP ≥ 140/90 mm Hg). The LINKED-BP Program study will recruit a total of 600 adults (30 from each practice) with elevated BP (120-129/\<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) across 20 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors (HBPM) and will be managed by the patients' primary care clinicians as usual; and (2) the LINKED-BP Program or "intervention arm," which will include training of patients on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. The intervention period for each study participant is 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age as of the date of data extraction
* Self-identify as non-Hispanic white, non-Hispanic African-American or Hispanic
* Have elevated BP (120-129/\<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) (defined by AHA's 2017 hypertension clinical guidelines)
* Receives primary medical care at one of the participating community health centers and primary care practices

Exclusion Criteria:

* Age \<18 years
* Prescribed antihypertensive medication
* Diagnosis of end-stage renal disease (ESRD)
* Condition which interferes with outcome measurement (e.g., dialysis)
* Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
* Patients with serious cognitive impairment or other conditions preventing their participation in the intervention
* Upper arm circumference \>50 cm (maximum limit of the extra-large BP cuff)
* Those planning to leave the practice or move out of the geographic area in 18 months
* Those who no longer consider the practice site the location where they receive primary care
* Unwillingness to provide informed consent
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 or grade 4 according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg \< IOP \< 35 mmHg in the study eye at baseline visit.

Exclusion Criteria:

* Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
* Neovascular glaucoma in the study eye.
* Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
* Prior glaucoma surgery in the study eye.
HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children

The long-term objective of this study is to prove:

* the equivalence of the number of post-operation hemorrhages, and maybe a decrease of the number of secondary hemorrhages
* the decrease of pain and quicker re-feeding
* an easier haemostasis
* the simplification of the tonsillectomy surgical kit
* the decrease of dissection time


Eligibility Criteria:
Inclusion Criteria:

* children from 3 to 10 years old undergoing tonsillectomy (with or without adenoidectomy)
* children without known hemophilia or any coagulation trouble
* children speaking and understanding French
* children's both parents must speak and understand French
* children's both parents must be affiliate to social security or similarly regime

Exclusion Criteria:

* children with known allergy to silicone
* refusal to consent: from child's age to consent or from both parents
* telephone monitoring refusal
* protected person referred to in Articles L1121-6 of the Code of Public Health
* children's both parents are protected persons referred to in Articles L1121-8 of the Code of Public Health
Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids

This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). This project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.

Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the rise, a better understanding of this association may become critically important to public health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese individuals are at greater risk for possessing this same ALOX5 variant and thus obese asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there exists an ALOX5 genotype-related response effect with fish oil. This will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.

Eligibility Criteria:
Inclusion Criteria:

* age 12-25
* BMI \> 25 (age 18-25) or BMI%\>85th (age 12-17) (BMI Liberalized)
* Physician diagnosis of persistent asthma
* Lung function responsiveness by bronchodilator reversibility or bronchoprovocation testing

Exclusion Criteria:

* pregnancy
* currently taking LTRA for asthma control
* other serious chronic medical condition
* bleeding diathesis