Kornimate/medical-research-clean huggingface dataset:
vats ( video-assisted thoracoscopy) compared to reinsertion of a thoracostomy tube for persistent haemothorax

Conditions: Haemothorax; Empyema

Summary: this is a prospective, randomized study comparing vats( video-assisted thoracoscopy ) to reinsertion of a thoracostomy tube in patients with retained haemothorax. the hypothesis is that early vats as opposed to reinsertion of a thoracostomy tube , will lead to less complications and shorter hospital stay.


Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis of retained haemothorax * thoracostomy tube blockage or failure to drain exclusion criteria: * more than one attempt at thoracostomy tube drainage * unable to consent to trial * coexisting pathology requiring other interventions

Keywords: vats( video-assisted thoracoscopy ) thoracostomy tube empyema thoracotomy
therapeutic strategy in postmenopausal women using osteoporotic diagnostic kits

Conditions: Osteoporosis

Summary: the frequency of osteoporosis in japan is increasing. also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. therefore, it is urgently required to improve osteoporosis. life expectancy in nagano prefecture is the longest in japan, however, healthy life expectancy in nagano is not very long in japan. there are several problems in this issue from the medical site and the patient site. the aim of this study is, from the patient site, to increase the motivation of postmenopausal women for osteoporosis using osteoporotic diagnostic kit.


Eligibility criteria:
inclusion criteria: * women, mainly postmenopausal women exclusion criteria: * men

Keywords: to decrease number osteoporotic patients in kami-ina area nagano prefecture
inflammatory biomarkers as tool in diagnosis and management of patients with ischemic stroke

Conditions: Cerebrovascular Accident

Summary: stroke represents the third commonest cause of death after heart disease and all types of cancer combined, and is the leading cause of long-term permanent disability among adults. recombinant tissue plasminogen activator (tpa) is currently the only safe medical treatment for acute ischemic stroke but only a small fraction of patients are eligible for a thrombolysis treatment. current guidelines on thrombolysis post stroke with tpa exclude its uses beyond 3 hours after stroke onset and when time of onset is unknown thus excluding many patients from potentially beneficial treatment. for an appropriate triage and management of patients, it is essential to improve imaging techniques beyond a simple ct scan. perfusion computed tomography (pct), currently considered as an investigational technique, permits a quantitative determination of the cerebral perfusion within the brain. it helps distinguish salvageable ischemic penumbra from irreversibly infarcted core in acute stroke patients. this technique has therefore the potential to select patients who are most likely to benefit from thrombolysis with tpa, can be used to predict the benefit after thrombolysis and determine the suitability for other therapeutic interventions. in patients with a primary diagnosis of tia, pct would help to identify possible persistent cerebral ischemia but also provide important information for rapid instigation of prophylactic strategies. the diagnosis and management of patients with ischemic stroke and tia is challenging and is primarily based on clinical assessment in conjunction with neuroimaging. development of specific molecular biomarkers as additional tools to support a clinical diagnosis, exclude common stroke mimics such as migraine or epileptic seizures, identify patients at risk of disease, and help guide patient treatment by predicting complications following t-pa treatment would be of great value.


Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent and to be compliant with the schedule of protocol assessments 2. diagnosis of acute clinical stroke 3. ages 18 and above inclusive 4. both genders eligible for the study exclusion criteria: 1. intracerebral hemorrhage according to computed tomography (ct) 2. clinical signs of infection on admission 3. patients with chronic inflammatory disease 4. hematologic disorders (anemia) 5. malignant tumor 6. renal or hepatic failure 7. treatment with anti-inflammatory or corticosteroids drugs within a month before stroke

Keywords: cerebrovascular accident, inflammatory biomarkers
procalcitonin level as a surrogate for catheter-related blood stream bacteremia among hemodialysis patients

Conditions: Hemodialysis Catheter Infection

Summary: hemodialysis patients frequently develop catheter-related blood stream bacteremia (crbsi). procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its role as a surrogacy marker in crbsi.

catheter-related blood stream bacteremia is common among hemodialysis patients. clinically, fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated c-reactive protein level are considered as markers for crbsi before blood culture results became available. procalcitonin is a valid indicator of sepsis. in this study, procalcitonin level will be measured in any patient with suspected crbsi and correlation will be tested for proved crbsi by blood cultures.

Eligibility criteria:
inclusion criteria: * hemodialysis patients with a dialysis catheter * signs suggestive of crbsi: fever/chills or leucocytosis with no other site of infection. * informed consent signed to be enrolled in the study exclusion criteria: * patient with identified cause of fever other than crbsi
dreamkit respiratory effort signal validation

Conditions: Sleep Apnea, Obstructive; Sleep Apnea, Central

Summary: this study has been developed in order to demonstrate the validity of the dreamkit respiratory effort signal.

the rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from dreamkit vs. the gold-standard esophageal manometry. data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the dreamkit device and esophageal manometry. data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.

Eligibility criteria:
inclusion criteria: * aged ≥18 years; * fluent in english; * able to provide informed consent. exclusion criteria: * contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon; * pregnancy or planned pregnancy during the study (self-reported); * history of allergic reactions to medical adhesives; * known allergy to lidocaine; * known seizure disorder; * severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy; * chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms or dyspnea; * at risk for excessive bleeding including use of anticoagulants; * an employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including philips); * an employee, or spouse of an employee, of pulmonary \& critical care associates of baltimore.
effect of covid-19 vaccine on blood pressure

Conditions: Blood Pressure; Covid19

Summary: the study aims to investigate (1) if covid-19 vaccine impacts on blood pressure, (2) the extent of impact on blood pressure (if any), and (3) which groups of subjects are more susceptible to be affected by covid-19 vaccine on blood

coronavirus disease 19 (covid-19), which is caused by severe acute respiratory syndrome coronavirus-2 (sars-cov-2), has elicited global pandemic since january 2020. until the end of june 2021, the virus has caused 182 million confirmed covid-19 cases and 3.95 million deaths worldwide. to stop the spread of virus, there has been rapid development of vaccine against sars-cov-2. currently there has been 9 vaccines authorized for emergency use, and 8 vaccines received full approval for use in various countries. extensive studies have been showing the efficacy of different types of vaccines against covid-19 and its variants. safety of covid-19 vaccines has been a concern. despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular covid-19 vaccines. one of the mostly known example is vaccine-induced thrombotic thrombocytopenia (vitt). case series report4 and observational studies on chadox1 ncov-19 vaccine showed high level of autoantibodies to platelet factor-4 (pf4) which could contribute to microvascular damage, micro-bleeding and platelet activation and therefore causes event of thrombosis. apart from the thrombotic risk of chadox1 ncov-19 vaccine, there has been studies providing the preliminary data on effect of mrna-based covid-19 vaccine on blood pressure. yet there remains lack of evidence and detailed description on effect of covid-19 vaccines and blood pressure along the time. given the vast population of hypertensive patients worldwide, the increasing number of people being vaccinated and the importance of blood pressure level to various human organs, it is essential to investigate the short- and long-term effect of covid-19 vaccine on blood pressure.

Eligibility criteria:
inclusion criteria: * subjects aged 18 years old or above * subjects with home blood pressure monitoring device * subjects with smartphone and with healthcap application downloaded * subjects who understand chinese to make an informed consent exclusion criteria: * subjects unable to take regular home blood pressure measurement
prospective femoral versus femoral and sciatic nerve block for anterior cruciate ligament (acl) reconstruction

Conditions: Anterior Cruciate Ligament Tear

Summary: the investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (acl) reconstruction will lead to a decrease in opiate consumption, pain scores, and post-anesthesia care unit (pacu) length of stay. the investigators are prospectively randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.

although femoral nerve blocks improve analgesia after anterior cruciate ligament (acl) reconstruction, patients often complain of posterior knee pain, which can be treated with a sciatic nerve block. in a prospective randomized study, we compare preoperative femoral nerve block to a combined femoral and sciatic block in patients undergoing ambulatory acl reconstruction. we hypothesize that the combined femoral/sciatic nerve block patients would have improved analgesia, fewer opioid-related side effects, and shorter pacu length of stay and improved patient satisfaction.

Eligibility criteria:
inclusion criteria: * age 18 and over * asa status i-ii * scheduled for ambulatory arthroscopic acl surgery exclusion criteria: * allergy to local anesthetics or opiates used in the study * contraindications for regional anesthesia * coagulopathy, anticoagulation, thrombocytopenia * infection at site of injection * chronic pain and high preoperative opiate requirements * high risk for ponv

Keywords: acl reconstruction femoral block sciatic block
internet-based strategic transdisciplinary approach to risk reduction and treatment

Conditions: Hypertension

Summary: i-start is a randomized controlled trial that will evaluate the efficacy of an internet-based program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with hypertension. i-start will be evaluated using objective outcome indices: systolic and diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (hr) modulation and baroreflex sensitivity. the heart and stroke foundation of canada "blood pressure action plan(tm)" (bpap) will be adminisered over a 4-month period, and evaluated in a 2 (intervention vs. wait list control) x 2 (baseline vs. post-intervention) factorial design, blocking for 3 recruitment sites (toronto, london, the grey bruce region of ontario, canada), and stratified for sex and age group (45-59, 60-74 years).


Eligibility criteria:
inclusion criteria: * stage 1 or stage 2 hypertension * 46 -74 years of age * able to read \& write english or french * living in private residence exclusion criteria: * cardiovascular disease * major psychiatric disorder (e.g. psychosis) * dependence on alcohol or drugs with in past year * diabetes \>= 5 years
a placebo-controlled study to investigate safety and efficacy of bia 2-093

Conditions: Epilepsy

Summary: the purpose of this study is to determine the efficacy of bia 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

this clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase ii study. during the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving bia 2 093 once daily (odg - once-daily group), bia 2 093 twice daily (tdg - twice-daily group) or placebo (plg - placebo group), respectively. daily doses of bia 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). on completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18-65 years * patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit * at least 4 seizures per month within the last 2 months prior to randomisation * stable dose regimen of a maximum of two of the following aeds: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation * electroencephalogram (eeg) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy) * written informed consent. exclusion criteria: * patient with nervus vagus stimulation * patient with primarily generalized seizures * known progressive neurological disturbance * a history of status epilepticus within the past 3 months * seizure of non-epileptic origin * restricted legal competence and incapability to follow trial instructions * major psychiatric disorders * concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers * need of excluded concomitant medication (see section 9.4.6.2) * use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit * known hypersensitivity to oxcarbazepine or carbamazepine, or its metabolites * abuse of alcohol, drugs or medications * history of relevant cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, hematologic or oncology disorders * second- or third-degree atrioventricular block not corrected with a pacemaker * relevant laboratory abnormalities (e.g., na+\ 2.0 times the upper limit of normal, white blood cell (wbc) count \<3000 cells/mm3) * pregnancy, nursing or inadequate contraception in women of childbearing age (oral contraception should be combined with a barrier method) * participation in other clinical trials within the last 2 months * history of non-compliance.

Keywords: epilepsy bia 2-093
hypofractionation and ultra-hypofractionation in adjuvant radiotherapy for breast cancer

Conditions: Breast Cancer

Summary: prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years

in alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. providing the available data, principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients. the rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. in breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. the lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment. this study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy. the patients will be randomized into two arms: * control arm: will include 50 patients who will receive standard 40.05 gray (2.67 gy/fx) over 15 fractions with or without boost over 3 weeks biologically effective dose (bed) for early and late effect equal 50.74.gy10 and 75.69 gy3 respectively. * experimental arm: will include 50 patients who will receive 26 gray (5.2 gy/fx) over 5 fractions over 1.5 weeks with bed for early and late effect equal 39.52 gy10 and 71.07 gy3 respectively

Eligibility criteria:
inclusion criteria: * age ≥50 years old. * informed consent. * either breast conservative surgery or mastectomy. * invasive breast cancer with p t1-3, p n0-2. * non metastatic breast cancer proven by clinical examinations and imaging (x-ray chest and ultrasound or ct scan chest and abdomen). exclusion criteria: * evidence of distant metastases. * prior irradiation. * inflammatory breast cancer. * tumor with t4 (skin nodules or fixed to chest wall or ulceration). * tumor with positive margins.

Keywords: radiotherapy hypofractionation ultrahypofractionation 5 fractions
an efficacy and safety study of mitiperstat (azd4831) (mpo inhibitor) vs placebo in the treatment of moderate to severe copd.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is a research study to evaluate the efficacy and safety of the investigational drug mitiperstat (azd4831) in adult patients with chronic obstructive pulmonary disease.

study d6582c00001 is a phase iia randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of mitiperstat (azd4831) in adult participants with moderate to severe chronic obstructive pulmonary disease. approximately 100 sites globally will participate in this study. approximately 406 participants will be randomised to two treatment groups; mitiperstat (azd4831) vs placebo in a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * provision of informed consent. * participants must be deemed as high risk of exacerbations as defined by: \>= 1 moderate or severe exacerbation in the previous 24 months; or frequent productive cough; or post-bronchodilator (bd) forced expiratory volume in the first second (fev1) \< 50% predicted. * participants must be 40-80 years of age inclusive, at the time of signing informed consent form (icf). * participants who have a confirmed primary diagnosis of moderate to severe copd. * participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years. * participants who have a documented stable regimen of triple therapy or dual therapy for ≥ 3 months prior to enrolment. * body mass index within the range 18 to 40 kg/m2 (inclusive). exclusion criteria: * as judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (at sv1 \[screening\] and sv3 \[pre-dose\]) which in the investigator's opinion makes it undesirable for the participant to participate in the study. * current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years. * clinically important pulmonary disease other than copd. * any other clinically relevant abnormal findings on physical examination, laboratory testing including haematology, coagulation, serum chemistry, or urinalysis; or chest ct scan at screening or randomisation, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study. * history of a clinically significant infection (viral, bacterial, or fungal; defined as requiring systemic antibiotics, antiviral, or antifungal medication for \> 7 days) within 4 weeks prior to sv3 (day 1) (including unexplained diarrhoea) or clinical suspicion of infection at time of dosing.

Keywords: mitiperstat azd4831 myeloperoxidase mpo myeloperoxidase inhibitor copd chronic obstructive pulmonary disease lung function
efficacy and safety of yam80 in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the efficacy and safety are evaluated when yam80 is administered orally to the patients of amyotrophic lateral sclerosis (als).


Eligibility criteria:
inclusion criteria: * patients aged between 25 and 65 years * als patients who can visit the clinic for six months * forced vital capacity (fvc) \> 70% * patients who can walk by themselves * change in alsfrs-r score from -1 to -4 during 12 weeks before the initial administration * patients who are willing to give informed consent exclusion criteria: * tracheotomy and invasive ventilation * pregnant or possibly pregnant female patients * female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration * patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases. * patients who are being treated with investigational drugs * patients who are treated with other als drugs within 2 weeks prior to the first administration

Keywords: als