cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.

Dyspnea (shortness of breath) is a common symptom affecting as many as 25% of patients seen in ambulatory settings. It can be caused by many different underlying conditions, some of which arise acutely and can be life-threatening, making rapid clinical evaluation and targeted diagnostic studies of central importance. A number of disorders cause dyspnea, including acute decompensated heart failure (ADHF), chronic obstructive pulmonary disease (COPD), asthma, pulmonary embolism, pneumonia, metabolic acidosis, neuromuscular weakness, and others. The overlapping clinical presentations of these conditions and comorbid diseases can make the diagnostic evaluation of dyspnea a significant challenge.

Acute heart failure (AHF) is a major cause of serious morbidity and death in the general population and one of the most common medical causes of hospitalization among people aged over 60. Patients presenting to the ED with ADHF must be evaluated and treated rapidly to ensure the best possible outcomes. The diagnosis should be made as soon as possible and therapy initiated. Delayed diagnosis at presentation may also result in patients being inappropriately transferred to non-specialist wards, resulting in longer stays, increased re-admission and poorer outcomes. The key to improving the time to diagnosis depends on the clinical evaluation alongside a readiness to initiate relevant additional tests.

Previous studies showed that the TPD has the potential to differentiate between the cardiac cause of dyspnea and any other cause.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with acute onset dyspnea (defined as shortness of breath (SOB) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration.
* Patients designated to undergo chest X-ray as part of standard of care assessment.

Exclusion Criteria:

* Obvious trauma contributing to dyspnea
* Inability to provide written informed consent
* Not speaking English or Spanish
* Right-sided lobectomy
* Patients with implanted ventricular assist device
* Patient is unable to undergo the TPD test
* Patient is already enrolled in a clinical study with experimental medications
Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

The objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.

Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.

Eligibility Criteria:
Inclusion Criteria:

Before corrective procedure for CHD, two of bellow ten criteria should be met:

* Decreased respiratory infection \& decreased exercise tolerance
* Pulse SaO2 \< 93% in left-right shunt CHD case (in room air)
* EKG: right ventricular hypertrophy, right atrial dilatation
* Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
* Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
* Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels
* Pp/Ps \> 0.75
* Qp/Qs \<1.5
* PVR \> 9WU/m2
* Rp/Rs \> 0.5

Exclusion Criteria:

* a body weight of \< 2 kg,
* prematurity (birth 36 weeks postconceptual age)
* renal dysfunction (creatinine \>= 1.5 mg/dL 48 hours before surgery)
* PLT \< 50,000\*109/L and obvious bleeding
* LCOS or hypotension on arrival to the intensive care unit

After corrective procedure for CHD:

* deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
* severe arrhythmia led to low cardiac output
Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke. A Feasibility Study

The purpose of the study is to test the technical functionality, safety, and feasibility of a bimanual robotic exoskeletal platform and associated serious games in order to offer information on technological and functional advances that will be included in the device's finalization.

In addition, a secondary goal will be to assess the therapeutic effects of a rehabilitation therapy based on the bimanual configuration, comparing it to a unimanual treatment delivered on the same platform (using the specific configuration).


Eligibility Criteria:
Inclusion Criteria:

* height between 150 and 190 cm;
* weight not exceeding 130 kg;
* ischemic injury;
* first cortical and supra-tentorial event;
* moderate motor deficit of the upper limb (score on the Fugl-Meyer Assessment - Upper Extremity between 29 and 42);
* time since stroke event between 1 and 6 months;
* trunk control test score greater than or equal to 48;
* healthy bone density and skeleton that does not suffer from unhealed fractures.

Exclusion Criteria:

* Relevant medical comorbidities (severe neurological diseases, cardiovascular diseases, diabetes / unstabilized hypertension);
* Cognitive impairment that prevents understanding of the exercises administered;
* Unavailability to provide informed consent;
* Pregnant women;
* Severe spasticity (Ashworth 4);
* Major muscle contractures;
* Excessive asymmetry in the length of the arms;
* Upper limb prostheses;
* Excessive joint limitations that make it difficult or painful to use the device;
* Use of pacemakers or implantation of active devices;
* Patients who already participate in another clinical study or who are already undergoing another similar robotic rehabilitation treatment.
Study of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome (MDS)

The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.

DN-101 is an experimental drug that has not been approved by the Food and Drug Administration (FDA). It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. The natural vitamin D found in dairy products or in typical vitamin pills, must be chemically changed by the liver and kidney into calcitriol before it is biologically active. The body normally uses small amounts of calcitriol to regulate its blood calcium levels. However, for any possible therapeutic effect, MDS patients require much higher levels of calcitriol than the body can produce from dietary vitamin D. DN-101 provides MDS patients with high doses of calcitriol in a pill form.

Laboratory studies have demonstrated evidence supporting the use of calcitriol in MDS. High dose calcitriol slows the growth of leukemic cells (cancerous cells) and increases the growth of normal bone marrow cells. Some patients with MDS may have low levels of calcitriol in their bone marrow.

Clinical study results in patients with MDS have been mixed- some positive and some negative results. Elevated calcium in the blood occurred frequently and prevented the use of higher, more potentially therapeutic doses.

Novacea tested a new formulation of calcitriol, DN-101, in a Phase 1 study. In that study the maximum tolerated dose of DN-101 that did not cause high blood calcium levels when given weekly for several months was determined. That dose is within the range that is potentially therapeutic for MDS patients and will be used in this MDS study.

The purposes of this study are to determine if HDPA DN-101 treatment:

* increases the number of red blood cells, white blood cells, and platelets in the blood
* reduces the number of blood transfusions
* reduces the number of serious infections requiring antibiotics
* reduces the number of serious bleeding events
* improves fatigue

Eligibility Criteria:
* Diagnosis of low or intermediate-1 risk MDS
* Dependent on monthly blood transfusions
* No cancer within the last 5 years (cured skin cancer is allowed)
* No heart attack or stroke within the last 6 months
* No kidney stones within the last 5 years
Prospective Observational Study of Antitumor Activity Correlation Between Hormonal Therapy and Expression miRNA100

Mono-centric, observational, prospective study, designed for pts with diagnosis of hormone-positive breast cancer to evaluate the correlation between the response to hormonal treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of patients

The potential role of miRNAs will be studied as a predictor of hormone sensitivity in hormone-positive breast carcinomas. The miRNA100 obtained on biopsy will be compared with the expression levels of those obtained from the surgically removed tumor, in order to assess the possible modulation of miRNA100 following hormonal treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Age greater than 18 years
* histological diagnosis of invasive carcinoma of the breast
* X-ray evidence (mammography and / or ultrasound) strongly suggestive for the presence of invasive breast cancer (BIRADS 4c or BIRADS 5) of greater than 15mm diameter.
* Carcinoma stage I (if diameter\> 15 mm) or II, unresectable, or
* Carcinoma in stage II or III, operable as a result of presurgical therapy, or
* Carcinoma in IV debut stage, asymptomatic, with primary operable breast cancer, or as a result of presurgical therapy
* Positivity for the estrogen receptor and / or to the progestin defined as the expression of one or both hormone receptors in ≥10% of tumor cells
* Negativity for HER2
* Cell proliferation, defined as the percentage of Ki67 positive tumor cells,\> 5% (corresponding to a value of 1.79 after log-normal transformation)
* Postmenopausal status
* Ability to take an oral therapy, in the absence of malabsorption syndrome known, previous stomach surgery or the small intestine
* Ability to perform the staging examinations and screening provided for in the
* Protocol
* Eastern Cooperative Oncology Group (ECOG) = 0
* The patients will have a normal bone marrow function, liver and kidney

Exclusion Criteria:

* Previous treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.
* Other cancers diagnosed in the last five years, with the exception of basal cell or squamous cell carcinoma of the skin, melanoma in situ or cervical cancer in situ.
* Premenopausal
* Known hypersensitivity to letrozole or to any of its excipients (for example: women with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or mal absorption of glucose / galactose).
* Evidence of a severe and poorly controlled systemic disease affecting the lung, heart, liver, kidney that may compromise adherence to treatment or an extended follow-up.
* Inflammatory bowel disease not controlled (eg Crohn's disease, ulcerative colitis).
* Active infection and / or inadequately controlled.
* Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.
* Breast cancer triple negative, or negative for both HER2 overexpression for the expression of hormone receptors.
Effects of Olive Oil and MLCT on Glycolipid Homeostasis in Patients With Metabolic Syndrome

The type of cooking oil used is a crucial factor influencing dietary quality. The purpose of this study is to investigate the effects of olive oil and MLCT oil intervention on glucose and lipid homeostasis in patients with MetS.

We conducted a 6-month RCT to evaluate the effects of olive oil and MLCT as cooking oils on glucose and lipid homeostasis in patients with MetS; investigate the changes in lipoprotein subfractions and metabolites using NMR spectroscopy, alongside gut microbiota alterations, to elucidate potential mechanisms; and identify baseline variables associated with the anti-obesity effects of olive oil and MLCT.

Eligibility Criteria:
Inclusion Criteria:

Participants eligible for the study were those with a confirmed MetS diagnosis according to the IDF criteria53, aged between 40 and 70, and who reported infrequent consumption of meals outside the home (≤3 times per week)

Exclusion Criteria:

(i) current breastfeeding or pregnancy; (ii) history of cardiovascular disease, including heart disease, coronary artery disease, stroke, cerebral infarction, viral hepatitis (e.g., hepatitis A or B), chronic kidney disease (estimated glomerular filtration rate \[GFR\] \<60 ml/min), or malignancy; (iii) presence of diabetic ketoacidosis or hyperketonemia; (iv) recent alterations in prescribed medication within the previous 6 months; (v) current use of insulin therapy; (vi) consumption of MLCT in the preceding 6 months; (vii) participation in other clinical research studies within the last 6 months; and (viii) premenopausal women
Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis

This is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate the effects of three different doses of N-acetyl L-cysteine (NAC) and placebo on patient safety and on physical and transport properties of expectorated sputum. Patient sumptoms, quality of life and exacerbation will also be followed as well as pulmonary function testing and functional exercise capacity. We hypothesized that a prolongeed course of oral NAC favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* Smokers (past or current,20 pack years) with diagnosis of chronic bronchitis
* expectorate sputum daily
* FEV1 of 40-70%
* understand and fill out questionnaire daily

Exclusion Criteria:

* other investigational within 30 days
* change in smoking habit within 6 months
* pulmonary diagnosis other that chronic bronchitis
* significant renal, cardiac, hepatic or endocrine diseases
* psychiatric disorder or evidence of alcoholism or drug abuse within year
Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)

The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.

This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
* No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
* Previously genotyped as part of a research study that enables recontact of participants
* Receiving primary care at a participating institution.

Exclusion Criteria:

* Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
* Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
* Future use of statins contraindicated
* Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
* Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
* Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)
The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Focal neurological deficit
* Clinical diagnosis of acute hemispheric ischemic stroke
* CT or MRI results compatible with clinical diagnosis of acute hemispheric stroke
* NIH Stroke Scale Score between 6 and 22, both inclusive
* Functionally independent prior to stroke with a pre-stroke Rankin Score of 0 or 1
* Randomization and first treatment with the trial medication within 12h after stroke onset
* Informed consent given by the patient and/or the patient's legally acceptable representative

Exclusion Criteria:

* Evidence on CT/MRI of acute or chronic intracerebral hemorrhage, SAH, AVM, cerebral aneurysm, or neoplasm
* Signs of herniation, increased intracranial pressure or likely etiology other than brain ischemia at baseline CT scan
* Patients with a substantial decrease of consciousness or alertness at the time of randomization, defined as score of 2 or more one of the NIH Stroke Scale questions 1a.
* Neurological signs and symptoms that improve rapidly during screening and are likely to resolve completely within 24h
* Severe coexisting systemic disease that significantly limits life expectancy
* Systolic blood pressure over 220 mmHg or diastolic blood pressure over 120 mmHg on repeated measurement (interval of 30 min) prior to study entry
* Severe congestive heart failure or presentation with acute myocardial infarction at study entry
* Epilepsy or epileptic seizures at onset of stroke
* Pre-existing disorders or conditions that would impair interpretation of neurological assessment (eg. severe dementia, severe psychiatric illnesses, etc).
* Concomitant treatment with other neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational neuroprotective substances)
* Patients which cannot tolerate or have contraindication to aspirin or Cerebrolysin treatment
* Concomitant treatment with substances that have a dilative effect on blood vessels like naftidrofuryl, cinnarizine, flunarizine or nimodipine
* Pregnancy and lactation period; for women with child-bearing potential a negative pregnancy test is required
* Participation in a clinical trial with an investigational drug in the past 4 weeks
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
* Participants must weigh at least 15 kilograms (kg)

Exclusion Criteria:

* Participants must not be pregnant or nursing
* Participants must not have any acute, serious, or unstable medical condition
* Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
Workplace Intervention Among Pregnant Hospital Employees

The aim of this study is to reduce sick leave and improve wellbeing. This is measured as physical and mental health, general work ability, work-life balance, manager support and completed work adjustments among pregnant health care professionals. It is hypothesised that pregnant employees participating in preventive sessions with their manager and a midwife in addition to the hospital standard pregnancy policy management will have less sick leave and report better wellbeing compared to the reference group.

Sick leave during pregnancy is frequent and studies report proportions of employees on sick leave between 36-75%. Reasons for sick leave in early pregnancy are nausea, vomiting and dizziness whereas Braxton Hicks contractions, low back and pelvic girdle pain are more common in late pregnancy. Further, sick leave is strongly associated with working conditions and appropriate work adjustment.

The study design is cluster randomization with participation of all departments at Aarhus University Hospital (AUH), Denmark. Half of the departments are randomized to the intervention and the remaining to the reference group. The intervention group will receive a protocolized intervention with midwifery support as an add-on to usual practice. The reference group will receive protocolized usual practice.

Data are obtained from the hospital payment system and by survey (RedCap).

The sample size is calculated to find a difference of ≥ 7 days with a standard deviation of 25. To achieve a statistical power of 80% with a significance level of p ≤ 0.05 an estimated 202 participants will be required in each of the groups.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant employees working as health care professionals at Aarhus University Hospital

Exclusion Criteria:

* Gest. week \> 20