Kornimate/medical-research-clean huggingface dataset:
left atrial appendage closure compared to standard antiplatelet therapy in patients with af who underwent pci

Conditions: Myocardial Infarction

Summary: the objective of left atrial appendage closure compared to standard antiplatelet therapy in patients with af who underwent percutaneous coronary intervention (lla-pci) study is to evaluate the safety and efficacy of implantation of left atrial appendage closure compared to standard antiplatelet therapy for prevention of thromboembolic events and stent thrombosis in subjects with af who underwent pci.

this will be prospective randomized (1:1) open label pilot study. patients with unstable angina and non-st-elevation acs and history of af will be included in this study. after pci and des implantation tee will be performed for assessing laa anatomy and size eligible for left atrial appendage closure device implantation. after screening all patients will be randomized in two groups. the first (control) group will receive standard antiplatelet and anticoagulation therapy according to the guidelines (2), the second group of patients will undergo left atrial appendage closure device implantation. after the pci the first group will take triple therapy (warfarin + clopidogrel+aspirin) during 45 days and after combination of warfarin+clopidogrel to 6 months after procedure and then only warfarin. the second group will take triple therapy (warfarin+clopidogrel+aspirin) during 45 days following pci and after control tee, warfarin will be discontinued. then patients from the second group will take dapt combination (clopidogrel+aspirin) to 6 months after procedure and then only aspirin. patients will be followed at 45 day, and every 3 months during 12 months of follow up (figure 1). at each follow-up visits the data regarding clinical events and healthcare utilization will be collected.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * acute coronary syndrome without st elevation and unstable angina 2 weeks before enrolment * successful pci procedure with des * history of atrial fibrillation (paroxysmal, persistent or permanent) with ecg documentation within previous 12 month * cha2ds2-vasc ≥ 2 * has-bled ≥ 3 * laa eligible for left atrial appendage closure device implantation (tee data) exclusion criteria: * age \ 80 years old * inr \>3 * recurrent myocardial infarction * myocardial infarction with st elevation * ef\<50% * severe comorbidities * cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support. * anemia \< 100 g/l * uncontrolled hypertension * thrombocytopenia * oncology * obesity, bmi\>40 * laa thrombosis * women of childbearing potential (unless post-menopausal or surgically sterile)
trial of cooling for patients with excel cryo cooling system in intracerebral hemorrhage (ich)

Conditions: Intracerebral Hemorrhage

Summary: the purpose of this study is to determine if cooling the neck of patients with ich decreases brain temperature. in addition, the investigators will determine if the device improves the delivery of oxygen to the brain. a third goal is to determine if cooling the neck lowers intracranial pressure (which is often times high in patients after ich).

this is a non-randomized device efficacy trial. patients with \>20cc supratentorial ich and an invasive brain temperature monitor (either licox or temperature sensing intracranial pressure device) will be enrolled after consent. the excel cryo cooling system collar will be placed around neck in up to 20 patients for two hours. the goal is to determine the effectiveness of this device in cooling the brain. the collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. during the study and for two hours after, the investigators will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood (blood pressure). the investigators will also collect demographic information about you (i.e. age, gender, medical risk factors) and information regarding your current disease process.

Eligibility criteria:
inclusion criteria: 1. patients with brain injury in the neurological icu. 2. consent from the patient or surrogate decision maker. 3. warfarin induced intracerebral hemorrhages only after correction of inr to \<1.4. exclusion criteria: 1. cerebellar hemorrhages. 2. moribund state where the physician team doesn't believe the patient will survive. 3. patients who are being cared for with the intent of making them comfortable. dnr-cc (by ohio law). 4. known history of a blood dyscrasia such as cll or essential thrombocytosis that could affect inflammation. 5. known significant carotid artery stenosis (known \>50% stenosis by history or incidental hospital imaging). this will not be specifically tested. patients found to have significant stenosis later in the hospital stay will have their data interpreted separately as well as in the total group.
effects of covid-19 hospitalization on physical performance

Conditions: Covid19; Physical Disability

Summary: coronavirus disease (covid-19) has resulted in millions of hospital admissions. the physical consequences caused by covid-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. a therapeutic exercise program may reduce the adverse effects of covid-19 on functional capacity and thereby improve the overall health status of these patients. the objectives of this project are 1) to analyze the effect of a therapeutic exercise program in patients who have been hospitalized in intensive care unit (icu) for covid-19. single-blind randomized clinical trial. 118 patients post-icu for covid-19 will be randomized into an intervention group and a control group. the intervention group will perform a therapeutic exercise program for eight weeks in telematic modality. functional capacity will be analyzed using the grip strength, short physical performance battery, gait speed, lower extremity strength and the frail scale at baseline, eight and twelve weeks. the main statistical analysis will be a comparison of means for independent samples assessing the effect of the intervention. given the high prevalence of patients hospitalized for covid-19, establishing strategies to minimize the adverse effects of the virus on patients is a must for the healthcare setting. assessing physical condition after covid-19 will allow the magnitude of the problem to be established. physiotherapy, through therapeutic exercise, could improve physical fitness in these patients and thus improve the overall health status after covid-19.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * have been diagnosed covid-19 positive at the time of hospital admission. * be able to use an online platform to conduct "meetings" with the healthcare professional or have the necessary personal assistance to do so. * be able to read the informed consent form and understand the objectives and conduct of the study. exclusion criteria: * diagnosed neurological or psychiatric disease. * contraindications to physical exercise. * failure to give informed consent for the study. * unavailability to perform the et program twice a week.
a study to evaluate the efficacy and safety of ad-203

Conditions: Acute Gastritis; Chronic Gastritis

Summary: this is a multicenter, active-controlled , randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of ad-203 to demonstrate the non-inferiority of ad-203 compared with mucosta tab. in patients with acute or chronic gastritis


Eligibility criteria:
inclusion criteria: * age is over 20 years old, under 75 years old, men or women * patients diagnosed with acute or chronic gastritis by gastroscopy exclusion criteria: * patients who is impossible to receive gastroscopy * patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit
immunoadsorption versus high-dose intravenous corticosteroids in relapsing multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: treatment of acute relapsing multiple sclerosis (ms) has remained largely unaltered within past years. however, evidence defining the exact role of apheresis treatment in the therapeutic sequence is still incomplete. incident-ms evaluates the mechanism of action of immunoadsorption compared to escalated methyl prednisolone treatment in steroid-refractory ms relapses and thereby will help to identify predictive markers for optimal treatment choice and will generate further insights into the pathophysiology of ms relapses.


Eligibility criteria:
inclusion criteria: * signed informed consent form * diagnosis of relapsing-remitting multiple sclerosis according to 2017 revised mcdonald-criteria * incomplete remission of relapse symptoms following initiation treatment with 1000mg/d intravenous methyl prednisolone * absence of fever or clinically apparent signs of infection exclusion criteria: * baseline edss score \>6.5 points * previous administration of less than 3x1000mg or more than 5x1000mg ivmps for initiation treatment * known pregnancy or rejection to perform a pregnancy test (female patients only) * immunosuppressive treatment for conditions other than multiple sclerosis * ongoing neoplastic disorder or past neoplastic disorder within previous five years * known or newly diagnosed hiv-, hbv- or hcv-infection * regular intake of ace inhibitor drugs * known bleeding disorders (including laboratory abnormalities such as: (i) platelet count\ 1.5, (iii) activated prothrombin time\>50s) or intake of oral anticoagulant drugs

Keywords: immunoadsorption intravenous methyl prednisolone
cerebral oxygenation and spinal anaesthesia in elderly patients with hip fracture

Conditions: Femoral Fracture; Blood Pressure; Cognitive Impairment

Summary: the aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. elderly patients are very frail. hypotension is very frequent during spinal anaesthesia. bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. these complications of spinal anaesthesia could decline cognitive function. in this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.

patients aged 70 years old with hip fracture presenting for surgical repair under intrathecal anaesthesia performed with bupivacaine or l bupivacaine (dose 7 - 9 mg). preoperative haemoglobin and drugs consumption are registered. all patients receive supplemental oxygen during surgery. cerebral oximetry, blood pressure, heart rate and oxygen arterial saturation are measured. level and duration of sensory and motor block are registered. the study observes if there is any correlation between cerebral oximetry and these hemodynamic parameters. the investigators also observe if there is any correlation between cerebral oximetry and cognitive function evaluated pre and postoperatively by spmsq test. postoperative spmsq test will be performed on the 5th postoperative day and the complications registered.patients will be followed for the duration of acute hospital stay.

Eligibility criteria:
inclusion criteria: * patients aged \>70 years old with hip fracture. * no contraindication for spinal anaesthesia. exclusion criteria: * allergic reaction to local anesthetics. * severe aortic stenosis. * local infection. * spmsq test \>7 errors. * patient refusal

Keywords: anaesthesia, spinal cerebral oximetry blood pressure heart rate cognitive symptom
acupuncture in patients with stable angina pectoris

Conditions: Angina, Stable

Summary: this trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and waiting-list. and to confirm the specificity of acupoints on meridian.

the basis of acupuncture is the theory of meridians and acupoints. meridian and collaterals internally pertain to viscera, and externally spread over the extremities. an acupoint is the place where the visceral qi and meridian qi distributed in. besides acupoints are the stimulus points and reactive points for acupuncture to treat the diseases. selecting the acupoints on the specific meridian is the basic principle of acupuncture. recently, as to the existence of specificity of acupoints on the meridian has been questioned by many researchers. this trial using chronic stable angina pectoris as a carrier, select the acupoints on the hand shao yin heart meridian and hand jue yin pericardium meridian to treat chronic stable angina pectoris. compared with acupoints on the other meridian and non-acupoints ,aiming to evaluate the efficacy, furthermore ,to confirm the existence of the specificity of acupoints on meridian.

Eligibility criteria:
inclusion criteria: 1.meet the diagnostic criteria of acc/aha angina pectoris of coronary heart disease. 2.35 ≤ age ≤ 80 years of age, both male and female. 3.the onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week. 4.patients signed the informed consent. exclusion criteria: 1. age≤35 or age≥80 2. pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months. 3. combined with cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system, severe primary disease clinical failed to effectively control the disease. 4. complicated with mental disorders. 5. allergic constitution or bleeding disorder. 6. patients accompany with acute coronary syndrome (including acute myocardial infarction, unstable angina), severe arrhythmias ( severe atrioventricular block, ventricular tachycardia, heartbeat influence the flow dynamics in supraventricular tachycardia, heartbeat frequent premature beats especially premature ventricular contractions ), atrial fibrillation, primary cardiomyopathy, valvular heart disease. 7. the blood pressure and blood glucose fail to meet the treatment targets. 8. cardiovascular disease who had been treated with acupuncture during the previous three months. 9. currently participating in other clinical trials.

Keywords: acupuncture angina stable angina pectoris
assessing efficacy and safety of lacosamide compared to placebo in reducing signs and symptoms of fibromyalgia syndrome.

Conditions: Fibromyalgia Syndrome

Summary: this trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

this was a proof-of-concept study and not powered for statistical comparisons. the trial consisted of a 4-week titration phase, an 8-week maintenance phase, a 1-week taper phase, and a 2-week safety follow-up phase. if subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the maintenance phase. subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. all subjects who completed the 4-week titration phase entered an 8-week maintenance phase. no dose adjustment was allowed during the maintenance phase. the treatment phase was defined as the combined titration and maintenance phases.

Eligibility criteria:
inclusion criteria: * males or females, 18 to 65 years old * fulfills all 3 points of american college of rheumatology (acr) definition for diagnosis of fibromyalgia * at least moderate pain (pain intensity ≥ 5 on likert pain scale (0-10) during the 7 days prior to baseline) * fibromyalgia impact questionnaire (fiq) total score ≥ 50 * completed an adequate washout period for excluded medications prior to beginning the baseline diary phase exclusion criteria: * symptomatic regional or structural rheumatic disease * diagnosed neuropathic pain syndrome * receiving treatment with neurostimulating devices * significant psychopathology * history of chronic alcohol or drug abuse within 6 months prior to screening * been hospitalized for psychiatric or behavioral reasons within 6 months prior to screening * clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias * taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (snris) or tricyclic antidepressants (tcas) * other medical conditions that could compromise the subject's ability to participate in the study

Keywords: fibromyalgia syndrome lacosamide vimpat harkoseride
study of tadalafil once-a day for 12 weeks in men with signs and symptoms of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: this is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.


Eligibility criteria:
inclusion criteria: * males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to visit 1 and an international prostate symptom score (ipss) greater than or equal to 13 at visit 2. * agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study * have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (luts) therapy or phosphodiesterase type 5 (pde5) inhibitors for specified duration of time prior to visit 2. * have a prostate specific antigen (psa) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of visit 1. exclusion criteria: * history of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study * history of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor. * history of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study. * certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study. * nitrate use
the safety and efficacy of henggliflozin in chinese patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: an observational study on the safety and efficacy of henggliflozin in chinese patients with type 2 diabetes primary research objective • to evaluate the safety of henggliflozin in chinese patients with type 2 diabetes mellitus (t2dm) in real world. exploratory research objectives * 1. improvement in metabolic parameters: to assess changes in metabolic indicators, including glycated hemoglobin (hba1c), fasting plasma glucose (fpg), 2-hour postprandial plasma glucose (ppg), blood pressure, and body weight, in t2dm patients treated with henggliflozin. * 2. incidence of specific adverse events: to investigate the occurrence of key adverse events, with a focus on hypovolemia, amputation or amputation risk, fractures, urinary tract infections, genital infections, renal impairment, diabetic ketoacidosis, hepatic dysfunction, and severe hypoglycemia. * 3. impact on muscle health: to evaluate changes in muscle health indicators, such as skeletal muscle mass index, lean body mass, and grip strength, in t2dm patients receiving henggliflozin therapy.


Eligibility criteria:
inclusion criteria: 1. 18 years old≤ age ≤ 80 years old; 2. diagnosed with type 2 diabetes mellitus according to who diagnostic criteria, currently receiving or eligible for add-on therapy with henggliflozin; 3. voluntarily participate in this study and sign the informed consent form. if the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), a witness is required to witness the informed process and sign the informed consent form. exclusion criteria: 1. participation in or current enrollment in clinical trials investigating other glucose-lowering medications within 1 month prior to the initiation of this study. 2. current or history of recurrent urinary tract infections (utis) and/or genital infections. 3. patients judged by the investigator to be unsuitable to participate in this clinical trial, with considerations such as current blood volume status, estimated glomerular filtration rate (egfr), and other clinical parameters.
non-invasive positive pressure ventilation and adult respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: background and objective: to determine the efficacy of non-invasive positive pressure ventilation (nppv) and its effects upon intubation rate and mortality in ards.

methods: this study was performed in the respiratory intensive care unit (icu) at a university hospital. 20 patients who achieved the diagnostic criteria for ards were included. the patients were prospectively allocated into two groups: a standard therapy group and a nppv group. invasive mechanical ventilation indications had been determined before the study. invasive ventilation was applied to those who in need of intubation, while those given intubation received a standard medical treatment.

Eligibility criteria:
inclusion criteria:the following criteria indicated immediate intubation was needed: 1. apne or respiratory pauses with loss of consciousness or gasping for breath or imminent respiratory arrest. 2. inability to increase the patient's pao2 to more than 40 mmhg and spo2 to more than 80% with a fio2\>0.6. 3. inability to increase the patient's ph levels above 7.35, and development of blurred consciousness and confusion (glasgow coma scale \<9) due to respiratory acidosis despite all the support given. 4. instability of the patient's hemodynamic parameters (such as systolic blood pressure \ 1 hour despite fluid resuscitation). exclusion criteria:contraindications for nppv include: 1. the need for urgent intubation. 2. the need for frequent aspiration due to excessive secretions (more frequent than 15 min.). 3. inability of the patient to adapt himself / herself to the device or unwillingness to undergo nppv.

Keywords: ards, noninvasive ventilation, intubation, mortality, intensive care