Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetic (pk) and pharmacodynamic (pd) dose-ranging phase ii study of ticagrelor in paediatric patients with sickle cell disease

Conditions: Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease

Summary: the purpose of this phase ii dose-ranging study is to investigate pharmacokinetic (pk) and pharmacodynamic (pd) properties of various doses of ticagrelor followed by 4 weeks of twice-daily treatment in paediatric patients with sickle cell disease

this is a multicenter, open-label, dose-ranging study of ticagrelor followed by a double blind, placebo-controlled extension phase in paediatric patients with sickle cell disease (scd). part a: patients will be randomised 1:1 to receive one of two dosing schedules consisting of two single weight-adjusted doses of ticagrelor. pharmacokinetic (pk) parameters and pharmacodynamic (pd) measurements will be determined following each dose. platelet aggregation will be measured using the verifynow™ p2y12 assay. following these 2 single doses, all patients will receive open-label one-week treatment with ticagrelor twice daily to determine tolerability prior to randomisation into part b. part b: in this part patients will be randomised (2:1 ratio) to ticagrelor twice daily or placebo for a 4-week treatment phase. during the study, patients will be followed for the occurrence of vaso-occlusive crisis (voc) and for other disease manifestations such as daily pain, analgesic use and complications of scd.

Eligibility criteria:
inclusion criteria * children aged ≥2 to \<18 years of age * diagnosed with homozygous sickle cell (hbss) or sickle beta-zero-thalassaemia (hbs/β0) exclusion criteria * at risk for haemorrhagic or bradycardic events * significant hepatic impairment * renal failure requiring dialysis * concomitant oral or intravenous therapy with strong cyp3a4 (cytochrome) inhibitors, cyp3a4 substrates with narrow therapeutic indices, or strong cyp3a4 inducers. * surgical procedure planned to occur during the study. * patients who are currently pregnant or breastfeeding or planning to become pregnant during the study. * patients who have known hypersensitivity or contraindication to ticagrelor.

Keywords: sickle cell anemia paediatric
a wrist-worn nerve stimulator for remediating persistent post-concussive symptoms in adolescents

Conditions: Concussion, Brain

Summary: the goal of this study is to test a wearable nerve stimulator in adolescents with persistent post-concussive symptoms. the main questions it aims to answer is whether the device will reduce clinical symptom burden, reduce cognitive deficits, and aid in the recovery of clinical symptoms. participants will wear the device daily for six weeks and complete a series of assessments.

the primary aim of this study is to evaluate the effectiveness of the apollo neuro device on remediating clinical symptoms, cognitive deficits and physical symptoms of those patients struggling with persisting post-concussive symptoms. the apollo neuro device offers a convenient novel, non-invasive, non-habit-forming solution to improve performance and recovery under stress by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time. the investigators will carry out a prospective study including any individual over the age of ten years presenting with persisting post-concussive symptoms. an apollo neuro device will be offered as part of a treatment plan to patients with chronic neurological symptoms and will be used as an adjunct along with typical treatment. patients will follow-up for a comprehensive evaluation, per discretion of specialty physicians and weekly symptom surveys will also be emailed to patients to track status. the results of this study will further the understanding of autonomic dysfunction symptomology and recovery and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction in these patients.

Eligibility criteria:
inclusion criteria: * concussion diagnosis * able to follow simple instruction * able to sit upright in a chair for at least 30 minutes without rest exclusion criteria: * previous diagnosis of moderate or severe traumatic brain injury * neuropsychiatric conditions of schizophrenia or bipolar disorder * neurophysiological conditions of epilepsy, cerebral palsy, or severe sensory disorders
regional haemodynamic changes in radial artery assessment with continuous pulsed-wave doppler ultrasound

Conditions: Lung Cancer

Summary: the objective of the trial was to evaluate velocity-associated parameters of pulsed-wave doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management.

the objective of the trial was to evaluate velocity-associated parameters of pulsed-wave doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management. the patients in this trial were visited during the entire operation and just before leaving the post-anaesthesia care unit. velocity-associated data related to pulsed-wave doppler ultrasound and the consumption of phenylephrine were collected.

Eligibility criteria:
inclusion criteria: 1. ethnic chinese; 2. age, 18 to 65 years old; 3. american society of anaesthesiologists (asa) physical status i or ii; 4. required vats for lung surgery and one lung ventilation . exclusion criteria: body mass index exceeding 30 kg/m2; patients with a history of hypertension, diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study. patients with arrhythmias or implanted cardiac pacemakers were excluded. patients with diseases of the central or peripheral nervous system were excluded. patients taking medications affecting the autonomic nervous system, such as b-blockers and calcium channel blockers
voriconazole versus oral steroids in allergic bronchopulmonary aspergillosis

Conditions: Allergic Bronchopulmonary Aspergillosis

Summary: this is a research project to evaluate the efficacy and safety of two different treatment protocols in allergic bronchopulmonary aspergillosis.

allergic bronchopulmonary aspergillosis (abpa) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus aspergillus fumigatus. the management of abpa includes two important aspects - institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. oral corticosteroids are currently the treatment of choice for abpa associated with bronchial asthma.they not only suppress the immune hyperfunction but are also anti-inflammatory. however, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature.itraconazole, an oral triazole with relatively low toxicity, is active against aspergillus spp. in vitro and in vivo. the activity of itraconazole against aspergillus spp. is more than that of ketoconazole. the administration of itraconazole can eliminate aspergillus in the airways and can theoretically reduce the allergic responses in abpa. the new triazoles, such as voriconazole, have recently been found effective in the treatment of fungal infections. the investigators hypothesize that voriconazole might also be useful in the treatment of abpa. the aim of this prospective randomized controlled trial (rct) is to evaluate the efficacy and safety of voriconazole therapy in patients with abpa.

Eligibility criteria:
inclusion criteria: presence of all the following three criteria: * immediate cutaneous hyperreactivity on aspergillus skin test * elevated total ige levels \> 1000 iu/ml * a fumigatus specific ige levels \> 0.35 kua/l and, two of the following criteria: * presence of serum precipitating antibodies against a fumigatus * fixed or transient radiographic pulmonary opacities * total eosinophil count \> 1000/µl * central bronchiectasis on hrct exclusion criteria: * failure to give informed consent * intake of glucocorticoids for more than three weeks in the preceding six months * enrollment in another trial of abpa * any exposure to azoles in the last six months
intensive lipid-lowering in patients with stemi and nstemi (germany on target)

Conditions: ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; LDL-cholesterol

Summary: intensive lipid-lowering therapy guided by a cloud-based software system (climedo gmbh) improves (european society of cardiolofgy/european atherosclerosis society) esc/eas-guideline recommended ldl-cholesterol target attainment and adherence in patients with st-elevation myocardial (stemi) and non-st-elevation myocardial infarctions (nstemi).

patients admitted to the jena university hospital (uks) and 9 other university hospitals in germany with an st-elevation or non-st-elevation myocardial infarction (stemi) will be randomized to standard care or a software-based tool (climedo gmbh) to monitor low-density cholesterol (ldl-c) levels and close follow-ups to achieve esc/eas-guideline recommended ldl-c goals. in this multi-center, prospective, randomized, interventional trial we propose that using a cloud-based software system (climedo gmbh) is superior to standard care in terms of ldl-c target attainment at 6 months and adherence over a time period of 12 months. in the software group ldl-c levels will be monitored on admission, after 1,6, 12, 16, 20 weeks and after 6, 12 and 24 months. in the standard care group patients' ldl-c levels will be determined on admission after 6, 12 and 24 months. the primary endpoint is ldl-c target attainment at 6 months in both groups.

Eligibility criteria:
inclusion criteria: * patients with st- and non-st-elevation myocardial infarctions exclusion criteria: * patient without informed concent * patients in cardiogenic shock * patients with contraindication to lipid-lowering therapy * patients on lipid-lowering medications on admission

Keywords: stemi, nstemi; ldl-c; target attainment
a dose-range study of gsbr-1290 in participants living with obesity or overweight with at least one weight-related comorbidity

Conditions: Obesity; Overweight; Chronic Weight Management

Summary: phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (pk), and efficacy of various gsbr-1290 dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 36-week period.


Eligibility criteria:
inclusion criteria: * signed informed consent * bmi ≥30 kg/m2 or bmi ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity exclusion criteria: * previous documented diagnosis of diabetes mellitus * self-reported change in body weight \>5% within 3 months before screening * have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening) * use of medications intended to promote weight loss, within 6 months prior to screening

Keywords: access ii obesity overweight gsbr-1290 chronic weight management obese small molecule glp-1 receptor agonist structure therapeutics
location and timing of inhaler use, exacerbations and physical activity in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this was an observational pilot study to examine the usefulness of an electronic sensor that monitors short-acting beta-agonist inhaled medication use. the goals of this study were to: 1) test the feasibility of using the inhaler sensor to measure worsening symptoms and exacerbations, 2) characterize physical activity in patients with copd, and 3) examine whether environmental factors can be linked to mild exacerbations measured by the inhaler sensor.

objectives: this study tested the usefulness of a gps-enabled inhaler to study the associations between air pollution, chronic obstructive pulmonary disease (copd) exacerbations, and physical activity. specific aims are 1) test the feasibility of using the inhaler sensor to measure worsening symptoms and exacerbations, 2) characterize physical activity in patients with copd, and 3) examine whether environmental factors can be linked to mild exacerbations measured by the inhaler sensor. research design: a 12-week observational, longitudinal pilot study of patients with copd. methodology: participants recruited at va puget sound performed spirometry and completed baseline questionnaires. an inhaler sensor was placed on their albuterol inhaler to record the time and location of inhaler actuation throughout the three month follow-up. each month participants answered questions regarding their breathing symptoms and physical activity. physical activity was measured by self-report using a weeklong physical activity checklist. a pedometer was worn at three 7 day periods. public use air pollution and meteorological data will be linked to the inhaler data. we will compute descriptive statistics for all measures, including sociodemographics, exacerbation rates, inhaler use, air pollution exposures and physical activity levels. in addition, a time series analysis will be used to test if the frequency of inhaler use is associated with higher levels of daily air pollution.

Eligibility criteria:
inclusion criteria: * fev1/fvc\<0.70 * fev1 \>30% and \<fev1\<65% predicted * participants must be able to walk without assistance * no plans to leave the study area during the 12-week study period * non-smoker and not live with someone who smokes * no history of asthma * use a short-acting bronchodilator
efficacy and safety of diclofenac sodium gel (dsg) in knee osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: this study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee exclusion criteria: * other rheumatic disease, such as rheumatoid arthritis * active gastrointestinal ulcer during the last year * known allergy to analgesic drugs * other protocol defined inclusion/exclusion criteria may apply.

Keywords: knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical nsaid, diclofenac sodium
comparing ciprofol and propofol for sedation in hypotensive icu patients: a single center prospective cohort study

Conditions: Ciprofol; Propofol; Sedation; Low Blood Pressure; Norepinephrine

Summary: this study was a single-center, prospective, 2-year observational cohort study. the study subjects were icu patients requiring vasopressor drugs and requiring sedation. according to the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge according to the condition of the subjects), they were divided into groups: ciprofol group and propofol group. a total of 456 subjects were planned to be enrolled, including 304 subjects in the cyclopofol group and 152 subjects in the propofol group. the data of this study were obtained by extracting the routine clinical diagnosis and treatment records of the enrolled subjects.


Eligibility criteria:
inclusion criteria: * age ≥ 18; * it needs to be treated with vasopressors to maintain mean arterial pressure ≥65 mmhg; * sedative medication required for comfort, safety, and to facilitate life support measures; * obtain the informed consent of the human subjects or their legal representatives. exclusion criteria: * pregnant patient; * patients with proven acute severe intracranial or spinal neurological disease due to vascular, intracranial dilatation, or injury; * history of allergy to cyclopofol, propofol, eggs, or soy products; * history of long-term use of benzodiazepines or opioids; * sedative drugs other than propofol or cyclopofol were used at enrollment, or propofol and cyclopofol were used alternately within 24 hours; * the researchers judged that they are not suitable to participate in this study.
intervention for sleep and pain in youth: a randomized controlled trial

Conditions: Insomnia; Migraine Disorders; Headache Disorders

Summary: insomnia is a common comorbidity among adolescents with migraine. this randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (cbt) for insomnia, as well as the combined effect of cbt insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. the long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

this aims of this study are to: 1) test efficacy of cognitive-behavioral therapy (cbt) insomnia intervention for youth with migraine and comorbid insomnia, and 2) investigate how changes in sleep may modify response to cbt pain intervention. participants will include 250 youth and their parents. youth will be ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. in phase 1, participants will be randomly assigned to receive access to internet-delivered cbt insomnia intervention or internet-delivered sleep education control over 6 weeks. in phase 2, all participants will receive access to internet-delivered cbt pain intervention over 6 weeks. assessments will occur at baseline, immediately after phase 1 intervention, immediately after phase 2 intervention, and 6 month follow-up.

Eligibility criteria:
inclusion criteria: * 11-17 years old * headache present for at least three months and insomnia symptoms for the past month * access to the internet on any web-enabled device exclusion criteria: * non-english speaking * diagnosed sleep disorder (e.g. sleep apnea, narcolepsy) * unable to read at 5th grade level or complete surveys independently * a serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)

Keywords: pediatric children adolescent sleep pain headache cognitive-behavioral therapy
stellate ganglion block on gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: the goal of this clinical trial is to explore clinical effect of stellate ganglion block on gastroesophageal reflux disease. the main question it aims to answer is: • can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given stellate ganglion block once a day additionally. the study lasts 20 days for each participant. researchers will compare the gastroesophageal reflux disease questionnaire, pressure pain threshold, self-evaluation questionnaire for gastroesophageal reflux disease, to see if the stellate ganglion block can help improve the symptom.

gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus. the goal of this clinical trial is to explore clinical effect of stellate ganglion block on gastroesophageal reflux disease. the main question it aims to answer is: • can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given stellate ganglion block once a day additionally. the study lasts 20 days for each participant. researchers will compare the gastroesophageal reflux disease questionnaire, pressure pain threshold, self-evaluation questionnaire for gastroesophageal reflux disease, to see if the stellate ganglion block can help improve the symptom.

Eligibility criteria:
inclusion criteria: * gastroesophageal reflux disease diagnosis after determination of acid reflux by gastroenterologist, with upper endoscopy and/or impedance-phmetry, which confirmed esophagitis and/or hiatal hernia. * aged between 18 and 80 years old. * subjects who tolerate cervical movements in sitting position. * stable vital signs. * normal consciousness exclusion criteria: * contraindications for stellate ganglion block. * peptic ulcer. * previous or present gastric cancer. * previous gastric surgery. * recent fractures or cervical trauma.
improving health outcomes with kefir

Conditions: Systemic Inflammatory Response; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Summary: the purpose of the study is to ascertain whether traditional kefir not only enhances vascular health but also contributes to improved immune outcomes in both male and female participants at higher risk or living with type 2 diabetes (t2d) after 12 weeks of treatment.

participants who sign the written consent form will undergo a screening process to determine eligibility for study entry. at the baseline visit, recruited participants will be randomized in a double-blind manner (participant and study coordinator) to consume either 350 ml of traditional fermented kefir or 350 ml of a placebo (milk) daily. during the 12 weeks of intervention, health outcomes will be measured and collected for further analysis.

Eligibility criteria:
inclusion criteria: 1. females and males (24-70 years old) living in edmonton (or edmonton area/driving distance); 2. overweight or obesity (bmi \>25 caucasian, \>23 asian); 3. at higher risk of t2d (fasting blood glucose ≥ 5.6 - 6.9 mmol/l or/and hba1c ≥ 5.5 - 6.4%); or 4. with diagnosis of t2d (fasting blood glucose ≥ 7.0 mmol/l or/and hba1c ≥ 6.5%). exclusion criteria: 1. a usual high intake (maximum intake 3 servings/week) of fermented foods excluding cheese (i.e., kefir, kombucha, kimchi, etc.) for the past 3 months; 2. gastrointestinal (gi) disorders of any kind; 3. being pregnant or breastfeeding; 4. monogenic dyslipidemias and endocrine disorders except for diabetes; 5. use of medications within the last 3 months (i.e., antibiotics or antifungals, corticosteroids, methotrexate, or immunosuppressive cytotoxic agents); 6. any health conditions deemed to interfere with primary outcomes at the investigator's discretion (e.g., kidney disease, liver disease, cancer, gi surgery, heavy alcohol consumption, etc.); 7. having a pacemaker or any electrical medical device that prevents the individual from undergoing the bioelectrical impedance analysis bioimmunoassay (bia) test."

Keywords: kefir systemic inflammation vascular markers gut microbiota fermented foods
the effect of core stability training in temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: this study is to investigate the effect of core stability training on pain, function, quality of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in individuals with temporomandibular disorder. materials and methods: the study included 40 people over the age of 18, who were diagnosed with temporomandibular disorder from the dentist.


Eligibility criteria:
inclusion criteria: * male and female patients aged 18-55, diagnosed with temporomandibular disease by a dentist exclusion criteria: * having received another treatment for tmr other than the use of night plate in the last 6 months * having a disease that can cause facial pain such as sinusitis, migraine, tension headache, trigeminal neuralgia * skeletal system fractures

Keywords: core stability pain quality of life function temporomandibular disorder