cyrilzakka/clinical-trials huggingface dataset:
Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia

A total of 100 patients with ST-elevation myocardial infarction (STEMI) presenting slow-flow after primary-percutaneous coronary intervention (PPCI) will be randomized to pharmacologic treatment with hyperemic drugs versus flow-mediated hyperemia.

Slow-flow phenomena is observed around 15% of patients undergoing PPCI and has been associated with poor prognosis. Hyperemic drugs, such as nitroprussiate and adenosine, have not yet demonstrated to reduce the infarct size and prognosis in patients with slow flow. Controlled flow-mediated hyperemia using a dedicated catheter for intracoronary saline infusion has been shown to stimulate microcirculatory vasodilatation in stable patients similarly as hyperemic drugs.

The aims of the study are to compare the absolute microcirculatory resistance of the infarct-related artery presenting with slow flow after PPCI, as assessed by intracoronary thermo-dilution, treated with standard pharmacologic hyperemia versus flow-mediated hyperemia; and to compare the angiographic TIMI frame count after treatment of slow flow phenomena with the two investigated strategies.

Eligibility Criteria:
Inclusion Criteria:

1. ST elevation myocardial infarction Killip I \<12 hours since symptoms onset.
2. ST elevation \> 2 mm anterior leads or \> 1 mm inferior or lateral leads.
3. Sustained slow coronary flow (TIMI flow 0-2) for at least 30 seconds after stent implantation or stent post-dilatation.

Exclusion Criteria:

1. Previous myocardial infarction in the culprit artery
2. Previous stroke
3. Advanced kidney disease (creatinine clearance \<30 ml / min).
4. Active bleeding
5. Allergy to contrast, nitroprussiate or adenosine.
6. Culprit lesion in coronary bypass, left main coronary artery or stent thrombosis
7. Macroscopic thrombus embolization in the infarct-related artery
Using a Infrared Thermometer to the Early Detection of Catheter Related Infections

This is a pilot study which aims to show the temperatures measured on body surface with an infrared thermometer on inpatients who need a central venous catheter (CVC) for medical care. Because the local temperature could be altered, at least during local infectious processes, seems to be reasonable to think that this approach could be helpful to its early diagnosis.

By convenience sampling, it was expected that during 4 months, a minimum of 30 inpatients of the metabolic, clinical or intensive care wards, at the Clinical Hospital of Ribeirão Preto Medical School, São Paulo, Brazil, would have their data collected

Eligibility Criteria:
Inclusion Criteria:

* Need of a central venous catheter for medical care.
* Be an inpatient of the metabolic, clinical or intensive care wards

Exclusion Criteria:

* Be in treatment course of a catheter related infection.
Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic

In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life. Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic.

Protocol No: Onco_Covid-19

Version no:1.0

Objectives: Firstly the patients recently diagnosed with cancer will be selected for enrollment who are on active treatment during lockdown based on the date of their registration in the hospital. This is followed by a telephonic interview with patients or their attendant to carry out a prospective, cross-sectional, observational study in order to address the issues and challenges faced by them during Lockdown.

Collection of data will be done through telephonic communication. Participation in this study will be entirely voluntary. Telephonic verbal consent will be taken from the patients or their attendants before collection of their response on the study questionnaire and then will be asked questions accordingly based on the questionnaire which is available in English and Hindi both. Data and general information regarding participants will only be collected in questionnaire. No personal data of the participants will be taken which will also be conveyed to the participant or attendant during telephonic verbal consent.

Eligibility Criteria:
Inclusion Criteria:

* Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020
* Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020

Exclusion Criteria:

-
Reliability of Pupil Response to Acute Pain

The purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. Changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.

There is strong rationale to support a role for locus coeruleus (LC) responsivity to acute painful stimuli in regulating speed of recovery after surgery and for LC responsivity as a mechanistic link explaining the risks for slow recovery from weak Conditioned Pain Modulation (CPM), catastrophizing cognitive style, and low enzyme activity catecholamine-O-methyltransferase (COMT) genotype. Preliminary data show feasibility to perform the proposed study.

Primary Hypothesis: An observational study of pupil responses to noxious stimuli shows strong intra-individual reliability over 8 weeks.

Key secondary hypotheses: Compared to individuals homozygous for val at the val158met site of the catecholamine-O-methyltransferase (COMT) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker CPM.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18-70)
* Pain from hip or knee arthritis of moderate intensity
* American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* Inability to complete study questionnaires
* Pregnancy
* Litigation or workers compensation related to hip or knee pain
* Taking \> 50 mg morphine equivalents/day
* History of Raynaud's disease of the feet
* Psychotic disorder or a recent psychiatric hospitalization
* History of eye surgery or topical eye medications that would would directly affect pupil diameter
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers

A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Accepts healthy volunteers

Exclusion Criteria:

* Who has allergy to investigational product
Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health

Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption, with or without a reduced nucleotide content, on markers of metabolic health, such as uric acid concentrations, blood glucose control and blood lipid profiles.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30

Exclusion Criteria:

* On medication (except contraception)
* Smokers
* Diagnosed with any metabolic or cardiovascular conditions
* BMI \< 18 or \> 30
* Dietary restrictions (vegetarians/vegans, etc.)
Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.

Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
* Age 18-75 years
* HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
* Previous therapies had to include, regimens containing an anthracycline and a taxane
* Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
* Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
* Performance status (WHO) 0-2
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit; AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the upper normal limit); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* No radiation of measurable disease (except brain metastases)
* No progressive brain metastases according to clinical or radiological criteria
* No brain metastases without prior radiation therapy
* Written informed consent

Exclusion Criteria:

* Patient unable to take oral medication
* Active infection
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Other invasive malignancy except nonmelanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy

Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with DMD or BMD based on genetic testing. Control subjects are unknown to have any other muscular dystrophy by history and may have had no genetic testing.
* Able to provide informed consent or assent for participation in the study.
* Demographic characteristics for biofluid collection: Males age 5 years and older with DMD or BMD; males and females ages 18 years and older without muscular dystrophy.

Exclusion Criteria:

* Medical history of any of the following: State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and/or C positive.
* Use of anti-platelet drugs within 7 days prior to blood draw; use of anticoagulants within 60 days prior to blood draw.
* Inability or unwillingness of the subject to give written informed consent.
Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk

Patients with coronary or other atherosclerotic cardiovascular disease and those at high risk of developing cardiovascular disease have been defined as the highest clinical priorities for prevention

Cardiovascular disease prevention programs are designed to reduce patients' morbidity and mortality.the European society of cardiology with other partner societies has engaged in a comprehensive programme of cardiovascular disease prevention in clinical practice aimed to improve practice of preventive cardiology by encouraging the development of national guidance on cardiovascular disease prevention

Eligibility Criteria:
Inclusion Criteria:

* Patients having signed an informed Consent Patients aged from 18 to 80 years old at the time of identification At least six and at most 24 months elapsed between the index event (the recruiting diagnostic or treatment criteria below) and the date of interview Patients meeting the recruiting diagnostic or treatment criteria: High CVD risk patients: patients free of CVD, who have been prescribed one or more of the following treatments: blood pressure and/or lipid-lowering and/or glucose lowering (diet and/or oral hypoglycaemic agents)

Exclusion Criteria:

* Patients living outside defined geographical area (Assiut Governorate)
Pharmacokinetics of XueBiJing in Patients With Sepsis

Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

XueBiJing injection, a five-herb combination approved by Chinese FDA in 2004, has been widely used as an add-on therapy in routine sepsis care in Chinese clinics. A comprehensive pharmacokinetic research on this herbal injection has been conducted in healthy human subjects, and the major circulating XueBiJing compounds, as well as their systemic exposure levels and forms and pharmacokinetic characteristics, have been identified. However, it is known that sepsis may induce hepatic, renal and cardiac dysfunction, alter drug metabolizing enzymes and transporters activities, increase capillary permeability, and induce various pathophysiological changes. All these will affect the concentrations at the action sites and pharmacokinetic characteristics of XueBiJing compounds, which contribute to the injection's overall therapeutic action, thus influencing the anti-septic efficacy of the injection. The purpose of this prospective, open label study is to identify the circulating XueBiJing compounds in patients with sepsis after intravenously dosing XueBiJing injection and their systemic exposure forms and levels, pharmacokinetic characteristics, and the associated inter-patient differences of these XueBiJing compounds.

Eligibility Criteria:
Inclusion Criteria:

* 18≤ age ≤70 years old
* Community acquired pneumonia patients who met the Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM) with2 ≤SOFA ≤13
* To use XueBiJing injection as an add-on therapy to treat sepsis decided byclinician
* Informed consent obtained

Exclusion Criteria:

* Diagnosis of sepsis for over 48 h
* Pregnant or lactating women
* Patients with a history of anaphylaxis or allergyto XueBiJing or its component herbs
* Patients participated in an investigational clinical trial within 30 days prior to this study
* Patients unable or unsuitable to participate in this study decided by the investigator (i.e., patients whose death are deemed within 48 h or who poorly adhere to the treatment)
Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients

The investigators conducted a prospective observational pilot study to explore the incidence of peri-operative covert strokes (detected by brain MRI) and the potential impact on delirium and cognitive decline in post-operative cardiac surgery patients at the Hamilton General Hospital. This pilot study assessed the feasibility of a larger prospective international cohort study exploring this objective.

Delirium and cognitive decline are common following cardiac surgery and increase the burden on patients and health care resources. Covert (sub-clinical) strokes are associated with these complications. The investigators conducted a prospective cohort pilot study enrolling consecutive cardiac surgery patients to receive a post-operative brain MRI and a series of questionnaires to assess for changes in cognition, physical function and delirium. Regional cerebral oxygen saturation (rSO2) was recorded during surgery with the use of near-infrared spectroscopy (NIRS) sensors placed on the patients' forehead. The primary aim was to determine the feasibility of conducting a larger study to establish an association between covert stroke and long-term cognitive decline in cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 21 years old
2. Provide written informed consent
3. Scheduled to undergo isolated CABG through a median sternotomy approach
4. Have at least one of the following risk factors:

   1. Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI \<0.9, or previous AAA repair)
   2. Cerebrovascular disease (history of stroke, TIA, or carotid stenosis \>70%)
   3. Renal insufficiency (eGFR \<60 mL/min/1.73m2)
   4. Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
   5. Urgent CABG (in-patient awaiting revascularization for ACS or MI)
   6. Recent smoker (within the last year)
   7. Left ventricular ejection fraction \<35%

Exclusion Criteria:

1. Concomitant cardiac procedure with CABG Prior enrolment in this study
2. Emergency CABG surgery (immediate revascularization for hemodynamic instability)
3. Redo CABG
4. Circulatory arrest planned during the cardiac operation
5. Diagnosed dementia of any types
6. Contra-indication for DW MRI e.g. claustrophobia, unable to lie flat for the duration of the study, pacemaker or ICD in-situ, or other metal implants
Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a "Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)

This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG). The registry will collect patient specific baseline data and established risk scores (Logistic Euroscore I \& II, STS-Score, KBA Score) to enable us to make an estimate about the perioperative risks.

Aortic replacement combined with coronary bypass surgery has an impact on the risk profile for the direct postoperative course and also on the long-time survival perspective.

The advantage of rapid deployment aortic valve prostheses, like the Edward Intuity Elite Valve that is used in this registry, is the greater ease of implantation, because only a few sutures are necessary to secure the device compared to a conventional prosthesis, where more then ten sutures are needed. In procedures where the aortic valve replacement (AVR) is combined with a coronary artery bypass graft (CABG), the use of a rapid deployment valve can shorten the duration of cardiac ischemia and the overall intervention duration, which possibly has an influence on clinical results.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* patients with aortic valve stenosis and coronary heart disease with indication for AVR and CABG
* patients in who the Edwards Intuity Elite valve is to be implanted
* patients who are planned to receive at least one coronary bypass
* patients who have signed an informed consent form

Exclusion Criteria:

* Exclusion Criteria:
* emergency surgery
* re-operation (i.e. any previous opening of pericardium)
* additional heart diseases requiring heart surgery (e. g. subvalvular myectomy and ablation, but not atrial auricle closure or resection)
* legal incapacity or other circumstances that impair the patient's ability to understand the nature, meaning or extent of the trial
* patients wanting a mechanical prosthesis
* patients with contraindications for the Edwards Intuity Elite Valve
* acute endocarditis or other systemic infections
Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in the occurrence of the distractibility in these patients. The aim of this study is to evaluate the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients, by using oculomotor and neuropsychological assessments.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PSP
* Age \> 30 years old
* Disease duration \< 5 years
* Mini mental state (MMS) \> 24
* Antisaccades %: 40-80%

Exclusion Criteria:

* Other parkinsonian syndromes
* MMS \< 24
A Strength-Based Intervention to Improve Job Interview Skills in Neurodiverse Young Adults

the investigators are looking to evaluate the effectiveness of a strength-based program in improving job interview skills in neurodiverse young adults. This program is designed to help participants understand and speak to others about their personal qualities and abilities. The investigators are examining the effects of this program in young adults who may have difficulty with job interviews, and who may want to improve these skills. Some of these young adults have received special education services in the past for learning differences, such as attention deficit hyperactivity disorder (ADHD) or dyslexia.

Practicing job interview skills has been identified as an important target for job employment services in N-TAY. However, the majority of studies using interventions in neurodiverse individuals have taken a deficit-based approach (i.e. to fix what is deficient in a person). This approach has triggered increasing criticism and dissatisfaction from the disability community. Further, focusing on deficits will not result in identification, awareness, or expression of strengths, important skills needed for self-advocacy and transition to adulthood. KF-STRIDE takes a strength-based approach, using principles of positive psychology to help N-TAY identify and express their unique character strengths to future employers. Over the course of a recently funded pilot study, the team has evaluated the efficacy of KF-STRIDE in those on the autism spectrum. The investigators have found that individuals on the spectrum who train with KF-STRIDE show improved job interview skills, and preliminary data indicates that they also have improved chances of obtaining employment in the community. However, KF-STRIDE has never been evaluated in youth other than those on the spectrum, including those with ADHD, dyslexia or other learning differences which may benefit from the training. The investigators aim to evaluate the preliminary effectiveness of KF-STRIDE in a randomized controlled trial comparing KF-STRIDE to services as usual (SAU) to improve employment, as well as identify mechanistic targets which may lead to improved employment, and to evaluate the fidelity, acceptability, usability, and feasibility of the proposed intervention, KF-STRIDE, via initial process evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Lives in the United States of America
* Between the ages of 14-26 Speaks English well
* At a 4th grade reading level

Exclusion Criteria:

* Had a stroke, Traumatic Brain Injury, or neurological injury or disease in the past(like brain tumor or epilepsy)
* Has a history of significant psychiatric illness(like schizophrenia or psychosis)
* Has uncontrolled seizures or other unstable medical complications