cyrilzakka/clinical-trials huggingface dataset:
Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk.

We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).

The trial consists of two cohorts:

* Cohort A, patients without an indication for OAC prior to TAVI.
* Cohort B, patients with an indication for OAC prior to TAVI (eg. atrial fibrillation, mechanic mitral valve prosthesis).

Eligibility Criteria:
Inclusion Criteria:

* Cohort A

  1. Patient has provided written informed consent.
* Cohort B

  1. Need for long-term oral anticoagulation;
  2. Patient has provided written informed consent.

Exclusion Criteria:

* Cohort A

  1. Need for long-term oral anticoagulation;
  2. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
  3. Bare-metal stent implantation within 1 month prior to TAVI procedure;
  4. Allergy or intolerance to aspirin or clopidogrel.
* Cohort B

  1. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
  2. Bare-metal stent implantation within 1 month prior to TAVI procedure;
  3. Allergy or intolerance to (N)OAC or clopidogrel.
Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures?

This study aimed to determine the effect of Mother-Scented Simulated Hand (MSSH) on promoting comfort among mechanically ventilated preterm neonates during invasive procedures.

Research Hypotheses

* Preterm neonates who receive MSSHH exhibit higher levels of comfort during invasive procedures than those who receive standard care.
* Preterm neonates who receive MSSHH exhibit lower levels of pain and stress during invasive procedures than those who receive standard care

A quasi-experimental, pre-posttest, two group, study was carried out in NICU of in Smouha, Alexandria. A sample of 62 mechanically ventilated neonates were randomly assigned to two equal groups; the study group wrapped with a warm MSSH during the invasive procedures while the control group received standard care of NICU. Two observers independently rated the neonates' level of comfort, distress, and pain during Endotracheal Suctioning (ETS) and heel prick using COMFORTneo Scale.

On day one of mechanical ventilation, the neonates received the same standard care of the NICU, while they wrapped with a warm Mother-Scented Simulated Hand as follow; simulated hand was scented with mothers' body odor by placing it on the mothers' bare chest or behind the neck for one hour. Then, the MSSH was placed under a radiant warmer for a couple of minutes to reach the mothers' unique warm touch. Inside the incubator, the mechanically ventilated neonates were placed in a side-lying flexed fetal position, where they encircled with the two warm simulated human hand to contain them. Where the palm of one MSSH cupped the neonates' head, and the palm of the other hand cupped the lower part of body and extremities. The neonates were kept in such a position throughout the mentioned invasive procedures. Neonates' physiological response, comfort, distress, and pain levels were assessed the same way as the first day.

Eligibility Criteria:
Inclusion Criteria:

* Preterm
* Newly admitted
* Hemodynamic stability

Exclusion Criteria:

* Receiving sedatives
* Low APGAR score lower than three at five minutes
* Hypothermia
* Hypoglycemia
* Hyperglycemia
* Intraventricular hemorrhage grade III\& IV
* Neonatal seizures
Cardiovascular Complications in Children With COVID 19

Prevalance of cardiovascular complications in children with COVID 19 in Assuit university children hospital

In December 2019, coronavirus disease 2019 (COVID-19) was first described in Wuhan, China, in patients complaining of flulike symptoms.1 The virus was isolated and identified as a new strain of coronavirus, now named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2 ) . Cardiovascular complications of COVID-19 have received less medical attention; nevertheless, the first cases of myocarditis in COVID-19 patients have been reported,3, 4, 5, 6 and myocarditis has been recognized as the cause of death in some covid 19 patients.7 Pathology usually is focal within the myocardium, but there is a risk of arrhythmia as well as progression to fulminant heart failure and cardiogenic shock.

Clinical presentation of SARS-CoV-2 myocarditis varies among cases. Some patients may present with relatively mild symptoms, such as fatigue and dyspnea,4 , 5 whereas others report chest pain or chest tightness on exertion.3 , 6 Many patients do deteriorate, showing symptoms of tachycardia and acute-onset heart failure with cardiogenic shock.3, 4, 5 In these severe cases, patients may also present with signs of right-sided heart failure, including raised jugular venous pressure, peripheral edema, and right upper quadrant pain.10 The most emergent presentation is fulminant myocarditis, defined as ventricular dysfunction and heart failure within 2-3 weeks of contracting the virus.8 The early signs of fulminant myocarditis usually resemble those of sepsis: the patient often presents febrile with low pulse pressure, cold or mottled extremities, and sinus tachycardia.10 Myocarditis is an inflammatory disease of the heart characterized by inflammatory infiltrates and myocardial injury without an ischemic cause.8 The most commonly identifiable cause of myocarditis in the United States and other developed countries is viral.9 , Arrhythmia is recognized as one of the possible clinical manifestations of COVID-19 patients. One observational study of the clinical characteristics of COVID-19 patients in Hubei, China, reported a 7.3% incidence of heart palpitations among its 137 patients 13 Moreover, Wang et al reported that arrhythmia was a cause of intensive care unit transfer in 44.4% of COVID- Coagulation and inflammatory parameters are mildly altered in COVID-19 infection, whereas MIS-C is characterized by laboratory evidence of a proinflammatory and procoagulant state

Eligibility Criteria:
Inclusion Criteria:

* Patient less than 18 years old Presented with COVID 19

Exclusion Criteria:

* Not presented with covid19
Evaluating the Impact of Incentives on Clinical Trial Participation

The objective of this study is to investigate the impact of incentives on clinical trial participation. 1) characterize key stakeholders' views on and assessment of incentives, 2) reach consensus among stakeholders on the factors to be considered when choosing incentives and their relative importance, 3) pilot test using vignettes for incentive decision making. We hypothesize that potential study participants make trade-offs regarding the characteristics of a research study when deciding whether to volunteer. This amendment is to document IRB reliance between UCR and USF.


Eligibility Criteria:
Inclusion Criteria:

* people living with HIV
* biomedical HIV researchers
* IRB members/bioethicists involved in HIV research

Exclusion Criteria:

* people under 18 years of age
* people living outside of the United States
* people who do not speak English
Transfer Impedance in Cystic Fibrosis

This study aims to determine whether respiratory system transfer impedance (Ztr) may fill an important clinical function by providing a reproducible, valid, and sensitive measure of airway obstruction in people with CF.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 2 to 25 Confirmed diagnosis of Cystic Fibrosis

Exclusion Criteria:
WheelSee Feasibility Study

Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention (WheelSee) to determine if: 1.WheelSee improves self-efficacy compared to standard care; 2. study design is appropriate; and 3. The WheelSee intervention protocol is suitable. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.

The purpose of this study is to evaluate the feasibility of administering a novel self-efficacy enhanced wheelchair training intervention (WheelSee) for manual wheelchair users who are at least 19 years of age. Self-efficacy for wheelchair use is an important construct, which may influence wheelchair mobility and participation. Pilot data obtained from this study will inform the design of an experimental trial and refinement of the WheelSee intervention and protocol.

This study will use a randomized controlled, single blind design with a sample of 24 (12 intervention, 12 control). Participants will be randomly allocated to the intervention or control group using a computer generated table of random numbers. Participants allocated to the intervention group will take part in WheelSee in groups of 2-4. The WheelSee intervention consists of 6 (twice weekly, minimum 3 days apart) x 1.5 hour sessions. Participants will be encouraged to bring a family member to each session, who may act as a spotter during the practice of wheelchair skills. If no family member is available, a student volunteer spotter will be available to ensure a 1:1 spotter: wheelchair user ratio. All spotters will be trained in appropriate spotting techniques.

Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older
* Reside in the community
* Daily use of a manual wheelchair (≥ 2 hours/day)
* Able to self-propel (using any combination of hands or feet) a distance of 10 m
* Would like to improve confidence using a manual wheelchair
* Have wheelchair mobility goals
* Able to read, write and speak at a Grade 8 English level
* Score 25 or higher on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

* Have previously or are currently taking part in standardized wheelchair training
* Are acutely ill
Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects

The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, aged 18 to 50 years.

Exclusion Criteria:

* Female subjects
Prevalence of Muscle and Nerve and Joint Pain

The purpose of the study is to provide adequate information about the percentage of the main tissue that causing pain in most common spinal disorders either it is muscular, nerve or joint in each spinal parts, that will provide the physical therapist with large data that can be helpful in differential diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. - patients from 18 to 60years
2. - both gender and any condition diagnosed by orthopedic physician with spinal disorders
3. - pre and post operative patient may be included.

Exclusion Criteria:

1. viscerogenic pain
2. cancer
3. psychogenic pain or psychogenic disorder
4. rheumatoid arthritis
5. fibromyalgia.
Does the Advice to Eat a Mediterranean Diet With Low Carbohydrate Intake, Compared With a Low-fat Diet, Reduce Diabetes and Cardiovascular Disease?

This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.

Aim To compare advice on a Mediterranean diet with an energy content (E%) from carbohydrates between 25-30 E% with a traditional low-fat diet with 45-60 E% from carbohydrates.

Primary outcome Incidence of diabetes in non-diabetic patients or glycaemic control in patients with known diabetes.

Secondary outcome Recurrence of cardiovascular disease, blood lipid levels, quality of life by questionnaires.

Study design and study population This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.

Eligibility Criteria:
Inclusion Criteria: Patients treated for ischemic heart disease who are followed up at the cardiac rehabilitation units

Exclusion Criteria: Inability to affect food choice. Severe concomitant disease such as malignancy, renal failure, heart failure or psychiatric disease.
Efficacy of QAX576 in Asthma

The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Female patients must be surgically sterilized or postmenopausal
* Male patients must use two forms of contraception
* Body mass index must be between 18 and 39 kg/m2
* Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists

Exclusion Criteria:

* Smoking history \>10 pack-years
* Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
* Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study
A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State

The primary purpose of this study is to evaluate the effect of the up-titration regimen of ponesimod on heart rate (HR) and other electrocardiogram (ECG) parameters when administrated to healthy adult participants receiving propranolol at steady state.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure (SBP) 90 to 140 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) 50 to 90 mmHg measured on the right arm in supine position after at least 5 minutes rest in the supine position at screening, on Day 1 of the Treatment Period 1, and on Day -2 of Treatment Period 2
* Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2 ) (inclusive) at screening and body weight not less than 50.0 kg
* 12-lead safety electrocardiogram (ECG) without clinically relevant abnormalities at screening, on Day 1 of the Treatment Period 1, and on Day-2 of Treatment Period 2, including:

  1. QT interval corrected for heart rate using the Fridericia correction (QTcF) of less than or equal to (=\<) 450 millisecond (ms) for male participants and =\< 470 ms for female participants
  2. Heart rate (HR) 55 to 100 Beats per minute (bpm) (inclusive)
  3. QRS interval less than (\<) 120 ms
  4. PR interval =\< 200 ms
  5. ECG morphology consistent with healthy cardiac conduction and function
* Female participant must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta- hCG\]) pregnancy test at screening and a negative urine pregnancy test on Day 1 of Treatment Period 1 and Day 2 of Treatment Period 2
* Negative results from urine drug screen at screening, on Day -1 of Treatment Period 1, and on Day -2 of Treatment Period 2

Exclusion Criteria:

* Any cardiac condition or illness (including ECG abnormalities) with a potential to increase the cardiac risk of the participant based on medical history, physical examination, 12-lead safety ECG, or 24-hour Holter ECG at screening, including:

  1. 24-hour Holter ECG with clinically relevant abnormalities
  2. History or evidence of Atrioventricular (AV) block second degree or higher
  3. Any cardiac condition or illness (including ECG abnormalities based on standard 12-lead safety ECG or d- 24-hour Holter ECG) with a potential to increase the cardiac risk of the participant
* Family history of sick-sinus syndrome
* Hepatitis A antibody immunoglobulin M (IgM) positive, positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus \[anti-HCV\]) tests, or other clinically active liver disease at screening
* Known hypersensitivity to any excipients of the ponesimod drug formulation (lactose, microcrystalline cellulose, povidone, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, opadry II brown), or lactose
* History of significant propranolol side effects or known hypersensitivity to propranolol or to any of its excipients
Bone Mineral Density in Patients With Sarcoidosis

To assess the frequency and risk factors of decreased bone mineral density (BMD) and vertebral fractures in Danish patients with sarcoidosis.

An increased risk of bone fracture has been found in patients with sarcoidosis. Some data showed that the risk of fracture was limited to patients treated with glucocorticoid but data are conflicting and not all studies can prove an increased risk of fracture or bone mineral loss in sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)

Exclusion Criteria:

* Age \< 18
* Inability to read or understand English
* Pregnant or nursing women
* Previous allergic reactions to steroid medications
* Current use of systemic steroids
A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)

This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic AF (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
* If female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
* Weigh at least 45 kg
* Receiving adequate anticoagulant therapy

Exclusion Criteria:

* Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
* Severe aortic stenosis
* Systolic blood pressure \<100 mmHg
* New York Heart Association (NYHA) Class III or IV heart failure
* Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
* Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration
* Acute coronary syndrome (including myocardial infarction) within previous 30 days
* History of thyroid dysfunction
* Severe acute respiratory failure or cardiovascular collapse
* Participating in another drug study or has received an investigational drug within 30 days prior to enrollment
* Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population

Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* 0-18 years
* Solid Tumors
* hematological malignancies
* Requiring parenteral nutrition during at least 5 days
* With a central catheter
* With a normal hepatic function test

Exclusion Criteria:

* Liver function tests disrupted
* Patient with a tumor or liver metastases
* Patient with against-indication to the use of lipid