Kornimate/medical-research-clean huggingface dataset:
the effects of levcromakalim in patients with cluster headache

Conditions: Cluster Headache

Summary: cluster headache is a primary headache disorder characterized by attacks of unilateral headache of short duration and severe pain intensity. there is an unmet need to understand the underlying disease mechanisms that will ultimately lead to the development of disease-specific medicines. until now, it has been suggested that the calcitonin gene-related peptide (cgrp) plays a major role in the initiation of a cluster headache attack, possibly involving the atp-sensitive potassium channels. the current study aims to determine whether the opening of atp-sensitive potassium channels triggers cluster headache attacks in patients with cluster headache.


Eligibility criteria:
inclusion criteria: * cluster headache patients meeting ichd-3 criteria for episodic and chronic cluster headache of either sex. patients were defined as having episodic cluster headache in the active phase when they had usual attacks within the last 30 days, episodic cluster headache in the remission phase when they were attack-free for at least 30 days, or chronic cluster headache when they had not had more than 30 consecutively attack-free days over the last 12 months or longer. * weight between 50 and 100 kg. * all preventive medications, except steroid treatments or greater occipital nerve blockade within 30 days, were allowed with stable dosing. * negative urinary hcg at baseline. exclusion criteria: * primary headache types except above. * secondary headache disorders, according to ichd-3. * headache at baseline. * anamnestic information or clinical signs of (at inclusion date) hypertension (systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>100 mmhg) or hypotension (systolic blood pressure \< 90 mmhg and/or diastolic blood pressure \< 50 mmhg) * known severe or treatment-requiring cardiovascular disease including cerebrovascular disease. * anamnestic or clinical evidence of mental disorder or substance abuse. * anamnestic or clinical evidence of any disease considered by the investigating physician to be relevant to participation in the study. * pregnant or lactating women.
silymarin in covid-19 patients admitted to hospital with elevated liver enzymes

Conditions: Covid19; Liver Diseases

Summary: of patients admitted to an internal medicine ward with internistic diagnosis/es together with covid-19, substantial proportion has elevated liver enzymes. silymarin / silibinin (milk thistle extract) has been approved as an add-on therapy in various acute and chronic liver diseases; moreover, there is evidence to suggest that it's dual effect (anti-viral and immune-modulatory) might be of benefit in patients infected with sars-cov-2. as there is no effective/approved pharmacotherapy for covid-19, a pilot study with silymarine in hospitalised patients has been undertaken

according to the bosch-barrera et al. paper of 2021, silibinin in a daily dose of more than 1000 mg could improve clinical course of covid-19 by its dual action: 1.direct inhibition of sars-cov-2 replication as well as 2.modulation of innate immune response - 2a. its initial (hyper)inflammation as well as 2b. later reparative phase, respectively. moreover, the drug is known for its safety and has been approved and widely used in the region for liver diseases. therefore, the investigation was set out to determine the efficacy of silymarin (compound closely related to silibinin which is available in the region) in improving the outcome of a liver disease and of covid-19, respectively.

Eligibility criteria:
inclusion criteria: * consecutive, adult, admitted to an internal medicine ward with internistic diagnosis, together with covid-19, and elevated liver enzymes (any of ast, alt, ggt, alp), provided written informed consent exclusion criteria: * too sick - terminal illness (no potential for recovery); critical condition on admission requiring immediate tracheal intubation; or any extra-pulmonary organ failure; completely vaccinated against covid19.

Keywords: covid-19 in-hospital mortality internal medicine
chronic subdural hematoma and aspirin

Conditions: Chronic Subdural Hematoma

Summary: the aim of this randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for chronic subdural hematoma with and without discontinuation of low-dose aspirin

chronic subdural hematoma (csdh) is one of the most common neurosurgical conditions. its significantly higher prevalence among patients older than 65 (69%) versus younger (31%) explains why 41% of the patients are taking blood thinners. antiplatelet therapy in patients with chronic subdural hematoma (csdh) presents significant neurosurgical challenges. studies investigating the effect of acetylsalicylic acid (asa) in cranial neurosurgery are sparse and mostly based on case reports. given the lack of guidelines regarding perioperative management with antiplatelet therapy, it is difficult to balance the patient's increased cardiovascular risk and prevalence of csdh. the aim of our randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for csdh with and without discontinuation of low-dose asa. we will include patients receiving low-dose asa as secondary prophylaxis for various reasons (e.g. coronary artery disease (cad), cerebrovascular disease, etc.) and will randomize them either to a placebo- or aspirin-arm. the patients will receive placebo or asa for 12 days whereas the normal asa treatment will be resumed 12 days after randomization. our study primarily seeks to evaluate the risk of recurrence after burr-hole trepanation for csdh under low-dose asa treatment compared to placebo treatment. secondary objectives are to assess the rate of thrombotic events, perioperative blood loss, postoperative anemia, intra- and postoperative blood transfusion rate, and clinical outcome (mrs, gos, markwalder score). the study will be performed in cooperation with the department of cardiology of the university hospital of basel.

Eligibility criteria:
inclusion criteria: * patients undergoing burr hole trepanation for csdh who are under low-dose aspirin treatment ( aspirin cardio 100mg once a day) for secondary prophylaxis exclusion criteria: * patients under the age of 18years * a recent (30 days before randomization) major cardiac event (i.e. unstable angina, myocardial infarction, or coronary revascularization) * a recent (30 days before randomization) active bleeding event. * patient with known bleeding disorder (e.g. hemophilia) * no informed consent

Keywords: aspirin bleeding risk intracranial bleeding burr-hole drainage chronic subdural hematoma anticoagulation
the effect of self-care emphasizing on balloon-blowing exercise program on severity of sleep apnea and respiratory muscle strength among school age children with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea of Child

Summary: obstructive sleep apnea (osa) is a common condition in school-age children, often leading to sleep disturbances and associated health issues. non-invasive interventions, such as respiratory muscle training, have shown promise in mitigating the severity of osa. this study explores the effects of a self-care-focused balloon-blowing exercise program on improving respiratory muscle strength and reducing osa severity in children. this research aimed to study the effects of a self-care emphasizing on balloon-blowing exercises program on severity of sleep apnea and respiratory muscle strength in school-aged children diagnosed with mild to moderate obstructive sleep apnea (osa), receiving treatment at the outpatient ent department at siriraj hospital.

thirty children participated, divided into two groups: 15 children received the self-care emphasizing on balloon-blowing exercises program for five weeks based on orem's self-care theory (2001), and 15 children received regular nursing care. the research instruments included a severity assessment scale for apnea and a self-care behavior assessment scale for children with osa. both instruments had content validity indexes of 0.95 and 0.80, and their reliability, cronbach's alpha, were 0.83 and 0.76, respectively. respiratory muscle strength was measured using a respiratory pressure meter. data were analyzed using statistical t-tests.

Eligibility criteria:
inclusion criteria: * school-age children aged 6-12 years diagnosed with obstructive sleep apnea (osa) of mild to moderate severity (ahi 1-9 events/hour). * children receiving a consistent medication dosage with no planned adjustments to increase the dosage. * fully conscious, with no hearing problems, and able to understand the thai language. * children voluntarily agree to participate in the study, and their parents consent to provide care during the research period. * have a smartphone or tablet capable of using the line application, with the ability to operate the application under parental supervision. * agree to allow the researcher to communicate via line and phone calls. exclusion criteria: * children with severe comorbidities or chronic illnesses requiring ongoing treatment. * children undergoing treatment with continuous positive airway pressure (cpap) therapy. * children who have engaged in exercise sessions lasting more than 20 minutes per session, at least 3 times per week, within the 6 months prior to the start of data collection.

Keywords: obstructive sleep apnea self-efficacy balloon-blowing muscle strength
the effect of colchicine on the incidence of knee or hip replacements

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: the goal of this clinical trial is to evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on the incidence of first occurrence of knee or hip replacement. the main question it aims to answer is: does colchicine lower the number of knee or hip replacements in participants with osteoarthritis? researchers will compare colchicine to a placebo (a look-alike substance that contains no drug) to see if colchicine works to treat osteoarthritis. participants will: * take colchicine every day for 3 tot 4.5 years * visit the clinic every year for check-up and tests such as blood samples and x-rays * fill in questionnaires every 3 months


Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee or hip oa * 45 ≤ age ≤ 80 (upper age limit is similar to that in the lodoco2 trial and takes in consideration the lower number of joint replacements in people older than 80 years) * documented radiographic changes typical for advanced knee/hip oa (kellgren \& lawrence score ≥ 2), or at least 2-year history of complaints due to oa in the hip and/or knee exclusion criteria: * on a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause * any absolute contraindication for knee or hip replacement in the future * more than one previous hip or knee replacements * other known medical disease that may affect joints * known generalized pain syndromes such as fibromyalgia * renal impairment as evidenced by serum creatinine \>150µmol/l or estimated glomerular filtration rate (egfr) \<50ml/min/1.73m2 * liver function impairment as evidenced by serum alanine transferase (alat) \> 3 uln (upper limit of normal) * blood dyscrasia * high frailty (clinical frailty scale ≥ 7) or predicted life expectancy \< 5 years * peripheral neuritis, myositis or marked myo-sensitivity to statins * current use of colchicine for another indication * intolerance to colchicine * use of macrolide antibiotics (i.e. clarithromycin, erythromycin, azithromycin), antimycotics (i.e. ketoconazole, itraconazole and voriconazole), protease inhibitors \& anti-retroviral drugs (i.e. ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat), anti-arrhythmic drugs (i.e. verapamil, diltiazem), or immunosuppressant (i.e. cyclosporine) * current enrollment in another trial * incapacitated patients * pregnant or breastfeeding female * fertile female participants not taking sufficient anti-conception * male participants unwilling to use effective contraception during the study to prevent pregnancy

Keywords: colchicine knee replacement hip replacement
surveillance of amr in drc

Conditions: Bacteremia

Summary: this study addresses knowledge gaps regarding antimicrobial resistance (amr) in sub-saharan africa, focusing on evaluating the feasibility of amr surveillance and enhancing local research capacity. conducted at a general referral hospital in semirural kinshasa, drc, the study will investigate bacterial infections, their resistance profiles, and related risk factors, including co-infections such as malaria.

antimicrobial resistance (amr) is a significant global health threat, but its full impact in many african regions is still poorly understood. in collaboration with the kinshasa school of public health, the institut national de la recherche biomédicale (inrb) of drc, and the university of oxford, this study will assess the feasibility of implementing amr surveillance in a general referral hospital in semirural kinshasa, where onsite microbiological testing is currently unavailable. a key objective is to strengthen local research capacity by training staff in patient identification and specimen collection for amr surveillance. the study will include patients over six months of age with suspected bloodstream infections at the time of hospital admission who agree to participate and from whom informed consent has been obtained. the focus is on community-acquired infections, excluding patients with significant prior healthcare or antibiotic exposure. blood samples will be analyzed at inrb to determine the bacterial cause of infections, evaluate antimicrobial resistance levels, and identify associated risk factors, including co-infection with plasmodium falciparum. study results will be shared promptly with the hospital team to aid in patient management. participants will be followed up for 28 days post-admission.

Eligibility criteria:
patients older than six months who present with a clinically suspected bloodstream infection upon admission to the hospital, or who have been hospitalized for less than 48 hours, and provide written consent (or consent from their caregiver/legal guardian) to participate will be included. patients with a significant history of healthcare exposure and those with any contraindications for phlebotomy as determined by the clinician's judgment, will be excluded.

Keywords: antimicrobial resistance (amr) surveillance malaria africa democratic republic of congo
external dead space in ventilated covid-19 patients

Conditions: Coronavirus; ARDS, Human

Summary: the objective is to investigate the efficacy of volumetric capnography to detect changes in dead space, co2 elimination and shape factor parameters before and after disconnection of external dead space in ventilated covid-19 patients.

covid-19 patients under mechanical ventilation are currently managed with a lung protective strategy derived from ardsnet recommendations. in order to minimize the risk of spread of coronavirus, filters and associated respiratory tubing are incorporated to the breathing circuit, thus increasing apparatus dead space with subsequent increase in dead space ventilation. considering the already often compromised ability for these patients to adequately clear carbon dioxide (vco2), adding an external dead space can potentially have a substantial impact on co2 homeostasis. the study will use volumetric capnography (vcap) to investigate the influence of external dead space on vco2 and calculated alveolar dead space. objective: 1) to investigate the efficacy of vcap to detect changes in dead space, vco2 and shape factor parameters before and after disconnection of external dead space. 2) to register the external dead space impact on arterial carbon dioxide tension (paco2). 3) to calculate the alveolar dead space based on vcap data and arterial blood gas analysis results. design and setting: prospective observational study in an intensive care center for covid-19 patients in a university hospital. patients: covid-19 positive patients of all age groups under mechanical ventilation. exclusion criteria is ongoing ecmo treatment measurements and results: vcap and tcap parameters will be registered during mechanical ventilation and correlated to an arterial blood gas sample. part of the apparatus dead space will then be reduced via removal of the heat and moister exchange filter (hme) with added tubing resulting in a reduction in volume of approximately 80 ml (i.e. the known volume of the hme filter and associated tubing). after the apparatus dead space is removed, the vcap will be recorded for approximately 15 minutes and an arterial blood gas will be drawn at the end of the period. the hme and associated tubing will then be reattached to the breathing circuit and vcap and tcap parameters will be recorded for approximately 30 minutes and an arterial blood gas will be drawn. vcap data will be analyzed for dead space, slope of phase iii, vco2 and associated shape factor parameters and compared with tcap parameters. changes in vcap parameters will be tested for statistical significance using one and two-way anova for repeated measures and bland-altman analysis will be used for comparison.

Eligibility criteria:
inclusion criteria: covid-19 positive patients of all age groups under mechanical ventilation - exclusion criteria: * exclusion criteria is ongoing ecmo treatment
a randomized, double-blind, 4-way crossover study to evaluate the efficacy of bilastine in the vienna challenge chamber

Conditions: Seasonal Allergic Rhinitis

Summary: this is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. patients will receive a single dose of bilastine 20 mg, cetirizine 10 mg, fexofenadine 120 mg, and placebo in the vienna challenge chamber.

the objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the vienna challenge chamber . this effect will be compared to that action of cetirizine 10 mg, fexofenadine 120 mg, and placebo. to explore the onset of action, patients will receive study drug two hours after the start of the provocation on day 1.patients will remain in thevcc for an additional four hours. on day 2, patients will return to the vcc post-dose hours 22-26.

Eligibility criteria:
inclusion criteria: * have a history of seasonal allergic rhinitis * have a positive (as defined in the protocol) skin prick or rast test within 12 months prior to the screening visit exclusion criteria: * have a clinically significant illness or disease * have unstable asthma * has participated in a clinical trial 30 days prior to the screening visit

Keywords: rhinitis seasonal allergic pollen allergy environmental exposure chamber challenge chamber
energetic abnormalities in heart failure with preserved ejection fraction

Conditions: Heart Failure, Diastolic

Summary: up to half of all patients with heart failure are found to have normal pumping function of the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with blood. these patients often have high blood pressure, and tend to have stiff arteries and stiff heart muscle. we wish to test the hypothesis that these patients have abnormal energy stores in their heart muscle.


Eligibility criteria:
inclusion criteria: * clinical features consistent with heart failure * lvef ≥ 50%, with no evidence of significant valvular disease, no hypertrophic cardiomyopathy, and no evidence of pericardial constriction * a peak vo2 \< 80% predicted, with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation exclusion criteria: * objective evidence of lung disease on formal lung function testing * reversible myocardial ischaemia on contrast-enhanced myocardial stress * echocardiography, and evidence of exercise-induced mitral regurgitation * obesity (bmi \>35) or a locomotor cause for exercise limitation

Keywords: cardiac energetics dynamic diastolic filling assessment heart failure with preserved ejection fraction arterial and ventricular stiffening
evaluating the effect of acupuncture on pain relief using quantitative sensory testing (qst)

Conditions: Pain

Summary: the purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.


Eligibility criteria:
inclusion criteria: 1. subject will be between ages 18 to 65 years. both male and female subjects will be recruited. 2. subject should have had cervical or lumbar radicular pain for at least two months. this requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation. 3. subject has a pain score of 4 or above (visual analog scale (vas): 0 - 10 from no pain to worst pain). 4. cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome. 5. for controls, healthy subjects without radicular pain for at least three months will be recruited. \*we are no longer accepting healthy volunteers.\* exclusion criteria: 1. subject has detectable sensory deficits at the site of qst. sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, aids neuropathy, severe thyroid disease, and severe liver or kidney disorders. 2. subject has scar tissue, infection, or acute injury at the site of qst. 3. subject is on anticoagulation therapy. 4. subject is pregnant. 5. subject is tested positive on illicit drugs.

Keywords: pain pain management
routine bile collection for microbiological analysis during cholangiography

Conditions: Cholangitis

Summary: background: antibiotic treatment of cholangitis often remains insufficient due to inappropriate antibiotic use or bacterial resistance. objective: to evaluate the role of routine bile collection during endoscopic retrograde cholangiography (erc) or percutaneous transhepatic cholangiography (ptc) for microbiological analysis in the antibiotic management of cholangitis and to identify risk factors of microbial growth. design: prospective, observational, diagnostic study. setting: hannover medical school, hannover, germany. patients and interventions: consecutive patients undergoing erc/ptc for biliary complications after orthotopic liver transplantation , malignancy, primary sclerosing cholangitis, benign strictures and choledocholithiasis. main outcome measurements: microbiological examination of bile samples


Eligibility criteria:
inclusion criteria: * age above 18 years * written informed consent exclusion criteria: * age under 18 years * no written informed consent

Keywords: cholangitis antibiotic bacteriobilia bile ercp