cyrilzakka/clinical-trials huggingface dataset:
Identifying High- and Low-Risk Heart Failure Patients in the Emergency Department (The Stratify Study)

People with heart failure (HF) symptoms who are seen in the emergency department (ED) are often admitted to the hospital even though it may not be necessary. This study will gather information from HF patients seen in the ED to develop a decision-making tool that will help doctors predict the risk of HF-related death or serious complications. Improving the ability of ED doctors to effectively and safely manage low-risk HF patients should lead to fewer unnecessary hospitalizations.

HF is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. Symptoms of HF can include shortness of breath, nausea, fatigue, swelling of the feet or abdomen, and an irregular or rapid pulse. A critical challenge facing ED doctors is how to best manage people who come into the ED with symptoms of HF. Currently, most people evaluated for HF in the ED are admitted to the hospital; however, not all of these people are in need of such intensive treatment. It is estimated that up to 50% of HF-related hospital admissions could be avoided. Improving the ability of the ED doctor to effectively and safely manage low-risk HF patients is essential to avoid unnecessary hospitalizations. This study will gather information from ED patients at risk for HF to develop an algorithm decision tool that will predict patients' risk for inpatient or outpatient death and serious complications from HF. This decision tool will be distributed worldwide for ED use and will hopefully reduce the costs of HF care by appropriately allocating hospital resources.

This study will enroll adults admitted to the ED with possible signs of HF. While in the ED, participants will undergo a digital heart sound recording procedure, a medical record review, blood collection, and a brief cognitive assessment. Five and 30 days following the ED visit, participants will be contacted by phone or will be visited in the hospital by study staff. Information will be collected on health status and unplanned hospital or ED visits that have occurred following the initial ED visit.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the adult ED with difficulty breathing, peripheral edema, or fatigue
* Meets Framingham criteria for congestive heart failure
* Willing and able to give informed consent; this will be determined based on participants' ability to remain in a conscious state, ability to remain awake, ability to ask questions about the study or answer questions that are asked, and ability to date and sign a consent form.
Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder

The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant women with overweight and class I obesity with suspicion of a mental disorder.

The weight gain during pregnancy has been reported as an important factor of being overweight after delivery and comorbidities. There are a lot of restrictions to treat pregnant women due to fetus development. Homeopathy presents itself as an integrative medicine that could treat with less collateral effects improving general health. The investigators are going to test the effects of homeopathy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with less than 28 weeks,
* BMI from 26 to 35 Kg/ m2,
* SRQ-20 positive.

Exclusion Criteria:

* Diabetes
* Cardiopathies
* Hypertension
* Nephropathies
* Psychiatric treatment
* Drug users
* Pulmonary Chronic Disease
* Suicidal ideas
* No eating (appetites)
* Problems of BMI measurements (disabled people)
* Concomitant homeopathic treatment
* People who are looking for just 1 medical appointment
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol

This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Ages 10 to 17 years inclusive
* Diagnosis of heterozygous familial hypercholesterolemia
* On a stable dose of statin monotherapy or are treatment naive to lipid- lowering agents
* On a low-cholesterol diet

Exclusion Criteria:

* Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients
Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients

Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion


Eligibility Criteria:
Inclusion Criteria:

* Subject who need the pleurodesis among subjects diagnosed with a mlignant pleural effusion
* Full lung expansion must be achieved within 12 to 24 hours after drainage
* Expected survival time of at least 2 months
* Subject who score 50 or more on the Karnofsky Performance Scale

Exclusion Criteria:

* Subjects with previous attempts at pleurodesis with sclerosing agent
* Subjects with trapped lung or bronchial obstruction
* Subjects with adverse drug response to mistletoe agents
* Subjects who have participated in another clinical study other than the present study
* Subjects who is taking immune-suppressive agents
* Subjects with medical and psychiatric contraindications for the study drug
* Subjects who are not allowed to participate in the study by legal requirement
* Subjects who are not allowed to participate in the study by the Investigator's discretion
Renal Denervation in Patients With Refractory Hypertension

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure of 160 mmHg or greater
* On 3 or more antihypertensive medications
* eGFR \>= 45 mL/min

Exclusion Criteria:

* Renal artery abnormalities
* Known secondary hypertension attributable to a cause other than sleep apnea
* MI, angina, CVA within 6 months
* Type 1 diabetes
* Others
Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions

This study is aimed to describe the outcomes related to physical activity, activity of disease, quality of life, work productivity and safety in Latin-American patients with Rheumatoid Arthritis (RA) treated with tofacitinib or biological DMARDs after failure to respond to conventional DMARDs in real-life conditions. This will be a non-interventional, hybrid study (prospective and retrospective data collection) comparing tofacitinib to biologic DMARD treatments in patients with RA after failure of conventional DMARDs. The population will be composed by adult patients over 18 years of age diagnosed with RA and who have been prescribed tofacitinib or any biological DMARDs.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age at the time of recruitment
* Patient diagnosed with moderate to severe RA ≥ 6 months before enrollment
* Patients who have had an inadequate response to the continuous use of methotrexate or combination of conventional DMARDs for at least 12 weeks before the study without dose change within the last 8 weeks before enrollment in the study
* Patients with no biological DMARDs use in patient history.
* Patients prescribed with tofacitinib or biological DMARDs in the last two weeks at doses established in ACR guidelines published in 2015 and following medical criteria.
* Acceptance for patients to participate in the study and signing of the informed consent.

Exclusion Criteria:

* Patients who do not have the ability to answer the questionnaires by themselves or who have any kind of mental disorder that may affect their answers.
* Patients diagnosed with autoimmune rheumatic diseases other than RA and Sjogren's syndrome.
* Patients treated with biological DMARDs in monotherapy.
* Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation.
* Patients with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* Patients with lymphoproliferative disorders (e.g., Epstein Barr Virus (EBV) related lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18-55 years
* Have a body weight between 60.0 - 85.5 kg (inclusive) and a body mass index between 20.0 - 28.0 kg/m2 (inclusive)

Exclusion Criteria:

* Have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient
* Have either active or latent TB or who have a history of TB
* Have clinically significant active infection within 4 weeks before the first IP administration
* Have had a history of serious infection
* Have previously been exposed to etanercept, if known
* Have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first IP administration
* Have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the Investigator
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)

This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.

This study is a cross-over study design.

Eligibility Criteria:
Inclusion Criteria:

Subjects must be:

* Between 6 and 11 years of age in good general health
* Premenarcheal if female

Exclusion Criteria:

Subjects who:

* Have known allergies or sensitivities to either of the drug formulations
* Have a medical condition that may interfere with the subject's ability to discriminate between tastes
* Have used any antihistamines within 24 hours prior to dosing
* Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
* Were involved in another clinical or market research study within the past 30 days
Vestibular Function Outcome After Cartilage Cap Occlusion Surgery

The primary objective of this study is to measure objective, functional outcomes of patients undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.

One option for managing a dehiscent superior semicircular canal is surgical intervention. One of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap occlusion of the dehiscent superior semicircular canal.

Eligibility Criteria:
Inclusion Criteria:

* ambulatory
* independent self-sufficient adults
* good general health
* medically stable

Exclusion Criteria:

* Medically unstable
* pregnant
Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

Hypomethylating agents (HMAs), such as decitabine or azacitidine, are considered a standard treatment for older patients with AML. The primary goals of this study are to test whether patients treated with an HMA (either decitabine or azacitidine) in combination with 33A will have better anti-tumor activity and/or survive longer than patients treated with an HMA in combination with placebo.

Patients who meet eligibility criteria will be randomly assigned to one of two treatment groups: 1) 33A plus HMA (Experimental Arm); or 2) placebo plus HMA (Comparator Arm). In addition to evaluating survival and remission rates, the minimal residual disease (MRD)-negative remission rate, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL))
* Intermediate or adverse cytogenetic risk
* Eligible for therapy with either decitabine or azacitidine
* Acceptable hematologic and organ function

Exclusion Criteria:

* AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17)
* Patients who are candidates for allogeneic stem cell transplant at the time of enrollment
* Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
* Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)
Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections

Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and mortality worldwide. While viral replication can be suppressed by antiviral treatment, excessive inflammatory responses, which are increasingly recognized to contribute to severe influenza complications, remain unopposed. Macrolides have been used widely to treat community-acquired pneumonia, and shown to exert anti-inflammatory effects in other respiratory diseases, providing clinical benefits. In this randomized, open-label, multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and disease resolution will be studied. Such results may lead to the development of new therapeutic approaches against severe influenza infection, and provide better insights into disease pathogenesis.

Objectives: (1) We aim to investigate the anti-inflammatory effects of macrolide treatment in patients with influenza LRTI and the impact on viral clearance. (2) To investigate the impact of macrolide treatment on influenza symptom and disease resolution.

Design: A randomized, open-label, multicenter study.

Settings: Acute medical facilities in 3 general public hospitals in Hong Kong.

Subjects, Sampling and Intervention: Adult (\>/=18 years) patients hospitalized for virologically confirmed influenza LRTI who fulfill the inclusion/exclusion criteria will be randomized to receive (1) azithromycin 500 mg p.o. for 5 days (in addition to antiviral, as part of usual care), or (2) no azithromycin (ie, antiviral alone, part of usual care) after informed consent. Serial blood samples will be collected for cytokine/inflammatory response assays. Serial nasopharyngeal swabs will be collected to assess for viral clearance. Symptoms, clinical progress, radiography and adverse events will be monitored.

Eligibility Criteria:
Inclusion Criteria:

1. established influenza A or B infection by virologic tests
2. age \>/=18 years
3. present within 4 days from illness onset
4. clinical evidence of LRTI and require hospital care
5. require antiviral (oseltamivir) treatment
6. able to provide written, informed consent.

Exclusion Criteria:

1. patients on immunosuppressants
2. pregnant or lactating woman
3. known hepatic failure, end-stage renal failure, cardiac arrhythmia (e.g. prolonged corrected QT interval \>450 msec)
4. known contraindications to azithromycin (e.g. allergic reaction)
5. lack of consent for study.
Effects of Low Lactose Milk Containing GOS on Digestive Response in Healthy Chinese Adults

We are aiming to assess the effects of low lactose milk containing galactooligosaccharides (GOS) on digestive response in healthy Chinese adults in comparison with a matching milk containing lactose.

This is planned to be single-center, double-blind, randomized, 2x2 cross-over study.

24 healthy participants of Chinese ethnicity are planned to be enrolled. Participants will be invited to three visit days at the research site: a screening visit and two test days, 3 to 28 days apart.

During the test days, participants will be requested, after overnight fasting, to consume either the investigational product (IP), a skimmed milk powder with low lactose content and GOS, or the comparator product (CP) a matching skimmed milk powder, both reconstituted in water. Participants will then undergo a series of tests to compare the effects of these two drinks on gastrointestinal fluid retention and motility as well as on gut comfort.

Eligibility Criteria:
Inclusion Criteria:

1. Participants declare that they are of Chinese ethnicity as well as both of their biological parents
2. Women and men aged between 18 and 60 years
3. Body mass index (BMI ≥ 18.5 \& \<30 kg/m2)
4. Healthy: no medical conditions or previous gastrointestinal surgery which might affect study measurements (as declared by the participant)
5. Able to understand and to sign written informed consent prior to study entry
6. Informed consent signed
7. Meets all the criteria for MRI Scan
8. Can read and speak English

Exclusion Criteria:

1. Medically diagnosed milk allergy
2. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
3. Diagnosed with any gastrointestinal disorders
4. History of claustrophobia
5. Pregnant (defined by pregnancy test) or breast feeding
6. History or current psychiatric illness
7. History or current neurological condition (e.g. epilepsy)
8. Consumption of \> 21 alcoholic drinks in a typical week (one serving is 0.4 dl of spirits, 1 dl of wine, or 3 dl of beer as declared by participant)
9. Currently smoking (as declared by participant)
10. Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
11. Antibiotic use within the 4 weeks preceding the intervention
12. Probiotic \& prebiotics use within the 2 weeks preceding the intervention
CT in Calcified Coronary Arteries With Photon Counting Detector

Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available CT system equipped with a photon counting detector technology.

Patients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care.

The diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for cardiac CT AND conventional coronary angiography as part of routine preoperative evaluation.

Exclusion Criteria:

* \<65 years old.
* Heart arrhythmia.
* Heart rate \>90/min with contraindication against beta blockers.
* Not capable of giving informed consent
* eGFR \<30 mL/min/1.73m2
A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy

To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of many chemotherapeutic agents, especially antineoplastic agents. To limit the nerve damages, early detection and management of CIPN is crucial and leaves an urgent demand for new diagnostic tools. Perception threshold tracking has enabled assessments of nerve excitability tests of both small and large sensory nerves and may be used to assess CIPN at early stages. The purpose of this study is to examine whether a new nerve excitability test can detect changes in the membrane properties of the small and large nerve fibers during chemotherapy treatment.

In this study nerve excitability tests will be performed with 2 different electrodes using a novel perception threshold tracking technique to assess the Nerve excitability of small and large fibers. Further quantitative sensory tests (QST) will be performed to estimate the vibration threshold, warm and cool perception thresholds, heat and cold pain thresholds, and perceived intensity to static mechanic stimulations will be assessed. Symptoms of CIPN will be assessed using the Common Terminology Criteria for Adverse events scale and a Quality of Life Questionnaire CIPN twenty-item scale.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years
2. Histopathologically verified breast cancer
3. Performance Status according to WHO/ECOG (PS) 0-2
4. Candidate for adjuvant standard treatment with EC and Paclitaxel
5. Not previously treated with chemotherapeutic agents
6. Neurological examination without pathological findings
7. Willingness to voluntarily sign an informed consent

Exclusion Criteria:

1. Previously neoadjuvant treatment with chemotherapy
2. Receives prophylactic bone marrow stimulants
3. HIV
4. Diabetes mellitus
5. Opioid requirement
6. Symptomatic neurosensory disorders
7. Neurological diseases, such as sclerosis and epilepsy
8. Alcohol abuse
9. "Palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet
10. Cannot understand written or oral information in Danish
11. Inability to cooperate