cyrilzakka/clinical-trials huggingface dataset:
PLATelet Function Operating Room Monitoring

Prospective cohort study on adult cardiac surgery patients. Platelet function evaluated before and after cardiopulmonary bypass. Bleeding and transfusion recorded. Primary endpoint is finding the association between postoperative platelet function and bleeding.

Preoperative platelet function is a known determinant of postoperative bleeding in cardiac surgery patients (1,2). Conversely, there is a lack of information with respect to postoperative platelet function and postoperative bleeding, and specific cut-off values have not been identified yet.

This study will verify the hypothesis that postoperative platelet function is associated with bleeding, and will test the ability of platelet function tests (PFTs) in predicting severe postoperative bleeding. Additional analyses linking platelet function to other preoperative and intraoperative conditions are planned.

Patients: Enrollment between February 2017 and January 2018. 800 consecutive adult cardiac surgery patients are considered based on our usual surgical activity. Exclusion criteria: unwillingness to participate, known congenital coagulopathy. Moderate/severe bleeding occurs in about 12% of our patient population. Considering a 15% dropout rate, there are about 80 predicted events. Power analysis: to build a predictive model, at least 60 events of moderate/severe bleeding are required. The study will be stopped at reaching (whatever comes first) 800 enrolled pts; 60 events; or 31st January 2018.

Methods: all the patients will receive a preoperative (in the operating room) PFT (ADPtest and TRAPtest) using the aggregometry Multiplate (Roche). The same test will be repeated after protamine administration at the end of CPB.

Definitions of bleeding: 12-hours chest drain blood loss; moderate/severe bleeding adjudicated based on the universal definition of perioperative bleeding (3).

Statistics: ROC analysis with identification of adequate cut-off values and definition of the PPV and NPV

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with CPB

Exclusion Criteria:

* Known congenital coagulopathy
Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours

This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years.
* Histological or cytological documentation of non hematologic, malignant solid tumour.
* Have failed at least one previous therapeutic regimen.
* LIfe expectancy \>= 12 weeks.
* ECOG performance status 0 or 1.
* Written, signed and dated informed consent.
* Able and willing to meet all protocol-required treatments, investigations and visits.
* Have adequate organ function.

Exclusion Criteria:

* Clinically significant non-malignant disease.
* Active CNS metastases.
* Subjects with uncontrolled diabetes.
* History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents
* Concomitant use of aspirin (\> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose), heparin within two weeks prior to randomisation, or other anti-platelet drugs.
* History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media.
* Known seropositivity to the human immunodeficiency vies (HIV)
* Women who are pregnant or breast feeding
* Women of child-bearing potential and male subjects who are partners of women of child bearing potential who are unable or unwilling to use effective means of contraception.
* Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.
The Effect Of Preoperative Parameters On Success After DMEK Surgery

The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.

In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. The effects of these parameters on surgical results will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK)
* aged 18 old older

Exclusion Criteria:

* Patients with corneal pathology other than endothelial insufficiency
* Glaucoma patients,
* Patients who have previously had any keratoplasty procedure
Low Calorie Diet in Morbidly Obese Patients

This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. On admission and after finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.

The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal.

At the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. Weight will be measured every morning for the study period.

During the operation fatty tissue samples will be taken subcutaneous and from the omentum major.

This study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.

Eligibility Criteria:
Inclusion Criteria:

* BMI 40-46 kg/m2
* The patients must not conduct a diet before admission.
* Fasting blood glucose \<-7 nmol/l

Exclusion Criteria:

* Diabetes mellitus
* Treatment with antidiabetics
* Allergy for substances in the planned study-diet
Effectiveness of Visceral Manual Therapy in Bruxist Patients

Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.

Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Methods: Subjects will be randomized into 2 groups: an experimental group (EG) to which a visceral manual technique will be applied and a control group (CG) to which a placebo manual technique will be administered. Both groups will receive 2 interventions one week apart. The measurements will be made before and after the interventions, and a last measurement will be made one month after the last intervention. Therefore, the patient will visit the center 3 times.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with bruxism diagnosed and referred by a dentist
* Age: older than 18 years-old.

Exclusion Criteria:

* Recent craniofacial, mandibular or cervical trauma or fracture.
* Temporomandibular joint surgery.
* Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).
* Abdominal surgery.
* Gastric ulcers.
* Gastritis.
* Previous or current gastric neoplasm.
* Neurological or systemic diseases.
* Pregnant, including the period of breastfeeding.
* Patients receiving chemotherapy or radiotherapy.
* Cognitive, psychosomatic or psychiatric illnesses that may affect the data obtained.
* Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).
* Cerebrovascular and brain diseases.
* Arrhythmia and other cardiac problems.
* Implanted electronic devices.
* Drug or alcohol abuse, analgesic or sedative therapy, and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics, and anticonvulsants).
* Patients who have previous experience with manual treatment of the diaphragm
Montelukast in Acute RSV Bronchiolitis

There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 4 weeks \< 2 years
* Duration of respiratory symptoms \< 4 days
* Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales
* First episode of wheezing or shortness of breath
* Randomization within 12 hours of admission
* No need for steroid treatment in the ward
* Informed consent

Exclusion Criteria:

* A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness).
* Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.
Study of Eltrombopag in Platelet Refractory Thrombocytopenia

This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia (low platelet count). Eltrombopag is approved by the FDA for the treatment of thrombocytopenia (low platelet count) in adults who have had an insufficient response to medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to platelet transfusion and so for this study is considered investigational.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory diagnosis of platelet refractoriness
* Diagnosis of platelet dependence
* Adequate liver and renal laboratory screening tests

Exclusion Criteria:

* Patients with thrombocytopenia that are responsive to platelet therapy
* Patients actively receiving intravenous immunoglobulin, plasmapheresis or cytotoxic medications for thrombocytopenia
Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)

Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.

Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.

1. Observe the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known, and whether there is any new adverse effects.Observe the incidence and the situation of adverse effects. Pay attention to the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction. Observe other safety issues related to drug using method, drug packaging method and drug quality.

   \[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day\]

   Secondary Outcome Measures:
2. Furtherly clarify the efficacy of palonosetron hydrochloride capsules, and the widely used population characteristics, and clinical using features of palonosetron hydrochloride capsules.

\[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day\]

Eligibility Criteria:
Inclusion Criteria:

* Use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .
* Elderly patients do not need to adjust the dosage of the drug.
* Children using the drug and dose adjustment need to be evaluated by the doctor.
* Pregnant and lactating patients using the drug need to be evaluated by the doctor.
* 5-HT3RA allergic patients do not recommend the use of this drug.

Exclusion Criteria:

* All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .
The Effectiveness of Health Promotion Programs on the Pre-frail Individuals

This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

Design: A two-arm parallel cluster randomized controlled trial. Older adults ≥60 years old were recruited from eight community units in northern Taiwan. One-hundred and sixty-seven eligible subjects consented to participate in the study. Community units were randomly assigned to either an intervention arm (n=82) or a control arm (n=87). The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet. Assessments were performed at baseline and 16 weeks for physical activity, physical performance, and pre-frailty rate. Analysis of covariance or chi-square test adjusted for pretest evaluated the differences between the two study arms.

Eligibility Criteria:
Inclusion Criteria:

* older adult with age ≥ 60 years
* community-dwelling
* no hearing and visual acuity difficulties

Exclusion Criteria:

* Unconscious
* Cognitive impairment or dementia
Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD

This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.

Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the study will assess the frequency of ineffectiveness in the target population.

Eligibility Criteria:
Inclusion Criteria: ADHD

Exclusion Criteria for both arms:

1. known adverse reactions to lidocaine
2. epilepsy, IQ \<80, severe head trauma, birth weight \<2270 grams, and severe autism;
3. treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers;
4. generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness);
5. mouth sores;
6. Ehlers Danlos syndrome, and
7. red hair.
Whole Body MRI in Oncology

Multicenter, observational, prospective, study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Whole Body-Magnetic Resonance Imaging (WB-MRI) is a radiation-free and, usually, contrast administration-free imaging method for detecting bone and soft tissue pathology. It's part of the "next generation imaging techniques" combining high quality morphological images with "functional" information on diffusivity of water molecules through diffusion- weighted sequences (DWI).

Nowadays WB-MRI has been introduced in several guidelines in oncological settings, in particular for staging and relapse in patients affected by monoclonal plasma cell disorders, screening in patients with cancer predisposition syndromes (Li fraumeni syndrome, hereditary paraganglioma / pheochromocytoma syndrome, neurofibromatosis) and staging and follow-up of cancer patients affected by predominant bone metastatic pattern, particularly advanced prostate cancer and breast cancer.

The current limit on the diffusion of the technique is that it is not widely available as it requires an optimal set up of both the machine with specific sequences and the acquisition protocol, as well as dedicated, trained staff.

DWI is emerging as a core sequence of WB-MRI protocols for disease assessment because of its sensitiveness to tissue cellularity and cell viability offering excellent lesion-to-background contrast and quantification of the degree of water motion by calculation of the apparent diffusion coefficient (ADC); changes in ADC can reflect variations in cellularity. Fat-Fraction (FF) is another emerging sequence for tissue characterization that quantifies the relative amount of fat. A better investigation of these novel sequences can maximize sensitivity and specificity in order to improve our understanding of diseases assessment.

The aim of this observational study is to evaluate whether WB-MRI allows an improvement in identification of site of tumour disease or earlier progression in comparison to other methodologies that are nowadays the standard of care due to their widespread availability in hospitals and quicker execution, particularly Bone Scintigraphy (BS) Computed Tomography (CT), Positron Emission Tomography/Computed Tomography (PET/CT) .

Eligibility Criteria:
Inclusion Criteria:

* Patients candidate to WB-MRI according to clinical practice belonging to the study groups listed above.
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged ≥ 18 years.
* Life expectancy greater than 3 months.

Exclusion Criteria:

* Patients with MRI-unsafe prostheses and devices.
* Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.
The Flow Diverter for Treating Patients With Intracranial Aneurysms

To evaluate the efficacy and safety of the blood flow guide device manufactured by Jiangsu Changyida Medical Technology Co., Ltd. for endovascular embolization of intracranial aneurysms


Eligibility Criteria:
Inclusion Criteria:

●≥18 years old and ≤75 years old, male or unpregnant female

* Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm was defined as the tumor neck ≥4mm or the tumor body/tumor neck ratio \<2)
* The target aneurysm is planned to be treated with blood flow guidance device only, without the need to complete the treatment by stages
* The width of tumor neck should be less than 30mm
* Imaging measurements of the tumor parent artery showed that the diameter was 1.5mm \~ 6.5mm
* The subject or legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent

Exclusion Criteria:

* The target aneurysm has previously received craniotomy clipping or other endovascular interventional treatment
* Target aneurysms were haemacular aneurysms, pseudoaneurysms, arteriovenous malformations and moyamoya disease related aneurysms
* DSA suggested vascular path tortuosity or severe arteriosclerosis, and it was difficult for the instrument to reach the target vessel
* Contraindications to dual antiplatelet therapy and anticoagulation therapy
* Patients with known clear allergy to nickel-titanium alloys and platinum-tungsten alloys
* People with known severe allergy to contrast media (excluding rash)
* patients with known dementia or mental illness
* Preoperative complicated with serious heart, liver, kidney, respiratory system diseases and bleeding disorders
* Life expectancy is less than one year
* Is participating in, or may participate in, any other drug or medical device clinical trial after inclusion in this clinical trial
* Other conditions determined by the investigator to be unsuitable for participation in this clinical trial
Oral and Systemic Levels of TFF-1 and TTF-3 in Periodontal Diseases

Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of patients with gingivitis, stage 3 periodontitis and healthy individuals.

A total of one hundred participants were enrolled for the study. All individuals were assessed clinically and radiographically. Full-mouth clinical periodontal examinations were performed by the measurements of probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements were recorded at six sites around each tooth with a manual periodontal probe. The participants were categorized into three groups: healthy controls (n=25), patients with gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva and serum samples were collected from each participant one day after the clinical periodontal measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the enzyme-linked immunosorbent assay.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals
* No history of smoking
* Individuals between the ages of 25-50 years
* Having at least 20 natural teeth

Exclusion Criteria:

* Any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological disorders, collagen-metabolic diseases, cancer)
* A history of smoking
* Pregnancy or lactation
* A history of surgical/non-surgical periodontal therapy in the past 1 year
* Drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) in the previous 6 months
Effectiveness of Self-monitoring and Treatment of Blood Pressure Following Stroke or Transient Ischaemic Attack

This blinded end point RCT will recruit high risk TIA and mild stroke patients (through the emergency TIA clinics and the acute stroke services at the Norfolk \& Norwich University Hospital) who require anti-hypertensive therapy to examine the clinical and cost effectiveness of self-monitoring and self management of Blood Pressure compared to self monitoring alone and treatment as usual.

Research Question: In patients with a mild/moderate stroke or TIA who require drug treatment for BP control, does BP self-monitoring with or without patient-led management using a previously agreed treatment regime result in better BP control and patient satisfaction than standard GP based management?

Planned sample size: 165 eligible participants distributed 1:1:1 between three groups. Group 1 (control) - treatment as usual (TAU). Group 2 - Self-monitoring only (Se-MO). Group 3 - Self-monitoring and self-management (Se-Man).

Primary outcome: Number reaching target Ambulatory BP levels at follow-up and change in mean Ambulatory BP levels between baseline and follow-up at 6 months.

Secondary outcomes:

Number of changes in anti-hypertensive treatment during study Side-effects profiles and adverse events BP variability Pulse Wave Velocity (PWV) changes All cause and cause-specific mortality outcome at six month Recurrent TIA or stroke Incident CVD- stroke, TIA and myocardial infarction Costs Health related quality of life assessed Quality Adjusted Life Years (EQ-5D based) Patient satisfaction and experience of the process (qualitative data)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged =/\> 18 years old with TIA or stroke of mild/moderate severity (NIHSS =\<15) who require BP management and are able and willing to undertake self BP measurement and guided alterations in therapy.

Exclusion Criteria:

* Those with terminal illness with life expectancy less than six months including end staged condition e.g. end stage COPD
* Dementia or moderate to severe cognitive impairment
* Those not receiving or expected to start anti-hypertensive therapy