Kornimate/medical-research-clean huggingface dataset:
a study of the safety, tolerance and assessment of he3286 on insulin sensitivity and hepatic glucose production

Conditions: Insulin Resistance

Summary: the objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg bid) of he3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of he3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.

hollis-eden pharmaceuticals, inc. is developing a new class of therapeutics for the treatment of type 2 diabetes mellitus (t2dm). the investigational drug, he3286, is a synthetic analog of a naturally occurring hormone with a potentially new mechanism of action that may improve the current therapeutic options available to a t2dm patient. the glucose clamp is the gold standard for measurement of insulin sensitivity. given the observed activity of he3286 in reducing insulin resistance in both impaired glucose intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the physiological site of action (i.e. liver vs. skeletal muscle) of he3286 in order to further understand the mechanism of action and to design future clinical trials.

Eligibility criteria:
inclusion criteria: * male or female subject 18-65 years of age * body mass index (bmi) is at least 29 kg/m2 but no more than 35 kg/m2 for females and no more than 37 kg/m2 for males * subject has fasting blood glucose level of \< 126 mg/dl at screening * subject has a 2 hour postprandial (following 75 grams glucose administration) blood glucose of 140-200 mg/dl at screening * subject has fasting plasma insulin \>=10 μu/ml exclusion criteria: * subject has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, clinically significant endocrine disorders (including history of diabetes); or clinically significant neurological or psychiatric condition; * subject has any clinically significant abnormalities in laboratory results at screening

Keywords: phase i safety tolerance insulin resistance obese
accuracy of rhythm detection by a wearable smart watch for cardiac arrhythmias (the watch-rhythm study)

Conditions: Atrial Fibrillation

Summary: it is an attempt to see the reliability of the wearable smart watch in identifying atrial fibrillation and other arrhythmias compared to the data detected from ilrs.

the sensitivity, specificity, positive and negative predictive values for successful identification of normal sinus rhythm, atrial fibrillation and other rhythm disorders from the smart watch will compared to that of an ilr.

Eligibility criteria:
inclusion criteria: * age over 18 years old * patients who have an implantable loop recorder for heart rhythm monitoring purposes * having ios iphone device that can be integrated into apple watch * willing to sign a consent form and participate in the study exclusion criteria: * hemodynamically unstable patients * over 90 years of age * presence of wrist tattoos * presence of av fistula on the wrist on which the wearable is worn. (if the contralateral wrist is unaffected, those patients can be included) * presence of implantable cardiac pacemaker and/or icd * patients with parkinsons disease or tremors

Keywords: wearable technology smart watch ilr afib detection
effect of pf-00734200 in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: to determine the effect of pf-00734200 on hba1c in type 2 diabetic subjects receiving metformin


Eligibility criteria:
inclusion criteria: men or women between 18-80 years of age with poorly controlled type 2 diabetes exclusion criteria: type 1 or secondary forms of diabetes currently using insulin
effects of palatinose™ on weight management and body composition

Conditions: Overweight and Obesity; Diet Modification; Body Weight

Summary: the study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (palatinose(tm)) over a period of 3 months.


Eligibility criteria:
inclusion criteria: * subject is healthy at the time of pre-examination * subject has a bmi of 25 - 35 kg/m² and motivated to lose weight * subject is aged 18 - 60 years at the time of pre-examination exclusion criteria: * person suffers from an acute or chronic disease * person has known dietary restrictions or allergies to foods * intake of medications which interfere with body composition, appetite, satiety or food intake
the effects of cannabinoid on patients with non-gerd related non cardiac chest pain

Conditions: Chest Pain

Summary: background: noncardiac chest pain (nccp) affects 200,000 new cases annually in usa. it is associated with poor quality of life and high health care expenditure of 8 billion dollars a year. gastroesophageal reflux disease(gerd), esophageal motility disorders, and psychological issues may cause nccp. the mechanism(s) for pain continue to be explored and include central and peripheral hypersensitivity, and mechanophysical abnormalities. treatment of nccp has focused on relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone, or adenosine receptor antagonist, theophylline. typically, only 40-50 % respond and clearly there is a large unmet therapeutic need. cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. the main component of cannabis acts through specific receptors, that are located primarily on central and peripheral neurons (including the enteric nervous system) and myenteric plexus where they modulate neurotransmitter release. activation of these receptors reduces excitatory enteric transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks of nccp. study protocol: the investigators will randomize 40 subjects with non-cardiac, non-reflux chest pain to receive dronabinol (5 mg bid), or placebo for 4 weeks. chest pain symptoms and esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom diary and impedance planimetry. the primary outcome measure will be the frequency of chest pain episodes. secondary outcome measures include improvement in esophageal sensory thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and global improvement of symptoms. hypothesis: cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in nccp patients, when compared to placebo. aim: to perform a randomized double blind study to investigate the effects of dronabinol, a cb1 and cb2 agonist, in the treatment of patients with nccp and examine its mechanism of action.


Eligibility criteria:
inclusion criteria: * male or female * ages 18-75 years * non-gerd related non cardiac chest pain (evaluated previously with an egd, esophageal manometry, and 24 hour ambulatory ph study) * at least one episode of chest pain a week in the past month * previous negative cardiac evaluation (ekg ± non invasive stress test ± coronary angiogram) exclusion criteria: * subjects requiring narcotics or other pain medications * subjects with known esophagitis, barrett's esophagus or peptic stricture on endoscopy * subjects with previous upper gastrointestinal surgery * pregnancy * subjects with diabetes, neuromuscular disorders, or other severe co-morbidities (cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric) * subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm) * medications such as baclofen, h2 blockers, ppi, sucralfate and prokinetics. * known history of substance abuse * nursing mothers
effects of training based on the pilates method on the blood pressure of hypertensive women

Conditions: Hypertension

Summary: the main objective of this study is to evaluate and compare the effect of the pilates method associated with aerobic exercise and the traditional pilates method on the blood pressure of hypertensive medicated women. in addition, we aim to analyze and compare the chronic effects of training on cardiac autonomic modulation, on cardiorespiratory fitness, functionality and quality of life.

subjects will be allocated randomly in three groups: (1) traditional pilates group, which will perform only exercises based on the traditional pilates method, (2) modified pilates group, which will perform exercises based on the pilates method alternated with active rest periods on treadmill ergometer, (3) control group: will not perform any physical exercise during the trial period. the sessions will be performed two times a week, during 16 weeks. subjects will be evaluated before and after 16 weeks of intervention.

Eligibility criteria:
inclusion criteria: * hypertensive women * age 30 to 59 * sedentary or who do not practice any form of physical exercise regularly for at least 6 months * make use of antihypertensive medication * who have medical clearance for physical exercise exclusion criteria: * complaint of pain that influences or makes the performance of the tests / exercises proposed impossible * congenital or acquired anomalies of upper limbs and lower limbs * presence of musculoskeletal disease or injury that interfere the performance of exercises * changes in pharmacological treatment during the experimental period * release for physical activity suspended during intervention * absence in more than 25% of the exercise sessions

Keywords: pilates method blood pressure autonomic heart rate modulation
pain palliation in forearm fractures in the emergency department

Conditions: Forearm Fracture; Radius Fractures; Ulnar Fracture

Summary: the aim is to evaluate the success of reduction procedures and pain palliation in patients with forearm fractures undergoing reduction under procedural sedation-analgesia (psa) and ultrasound (us)-guided infraclavicular nerve block (icb) in the emergency department.

forearm fractures are among the most frequent reasons for adults to visit the emergency department. these fractures cause significant pain both due to the fracture itself and during the reduction process. pain management in emergency departments (ed) is crucial. therefore, multimodal approaches are available to reduce or eliminate pain during the reduction process. the aim of this study is to evaluate the success and pain palliation of the reduction process with procedural sedation-analgesia (psa) and with reduction under ultrasound (us)-guided infraclavicular nerve block (icb) in patients with forearm fractures. the secondary aim is to compare patient comfort, physician comfort, side effects, length of stay in the emergency department, and the need for painkillers after discharge between these two procedures, and to identify the most suitable method. this study aims to contribute to practical applications in order to provide optimal pain control in patients with forearm fractures in emergency departments. patients' pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the numeric rating scale (nrs), ranging from 0 (no pain) to 10 (worst imaginable pain).the success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control x-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.

Eligibility criteria:
inclusion criteria: * aged 18 years and older, * diagnosed with forearm fracture using standard radiography, * hemodynamically stable individuals, * without vascular or nerve injury, * without infection in the skin or tissues where the needle will pass, * able to provide written and verbal consent and are capable of giving consent exclusion criteria: * those with allergies to drugs used for sedoanalgesia and peripheral nerve blockade, * those who are hemodynamically unstable, * patients with asa (american society of anesthesiologists) classification 3-4 will not be included in the group for whom psa will be applied, * patients with coagulopathy, liver, or kidney failure, * patients with opioid, alcohol, or substance dependency, * those with skin infections or open wounds in the area where local anesthetic will be administered, * pregnant or suspected pregnant individuals, * those who do not provide written and verbal consent.

Keywords: procedural sedation-analgesia infraclavicular nerve block
prevention of spontaneous dental abscesses in children with x-linked hypophosphatemia : a rct

Conditions: X-linked Hypophosphatemia (XLH)

Summary: this study is a prospective, randomized, single-blind, split-mouth, national multicenter trial, comparing the efficacy of a self-etch adhesive system combined (sam) with a flowable composite to that of a fluoride varnish for the prevention of spontaneous dental abscesses in children with xlh. for each patient, according to randomization, one side of the oral cavity is treated with the experimental treatment (application of the adhesive system to healthy anterior and posterior temporary teeth, and application of the flowable composite to healthy posterior temporary teeth), and the other side with the active comparator (fluoride varnish). the application process for both treatments is similar and will be renewed every 6 months (visits at 6, 12, 18 and 24 months) systematically for the sam and the varnish, and in case of partial or total loss of the composite.

x-linked hypophosphatemia (xlh) is a vitamin d-resistant familial rickets resulting from a mutation of the phex gene. one of the major clinical disorders is dental pulp necrosis, which results in "spontaneous" dental abscesses not related to carious lesions or trauma. these abscesses, which occur in about 67% of children with xlh, can lead to serious complications: loss of teeth, disorders of masticatory, phonetic and aesthetic functions, disorders of occlusion and alveolar-dental development, cervicofacial cellulitis, consequences on the psychological development of the child. this study is the first randomized controlled trial for the prevention of these abscesses. primary objective is to evaluate whether a non-invasive adhesive technique, combining the application of a self-etch adhesive system (sam) to all faces (smooth, proximal and occlusal) of all temporary teeth (anterior and posterior) and a flowable composite applied in the grooves of the posterior temporary teeth, is effective in preventing the development of spontaneous abscesses in children with xlh, compared to the application of a fluoride varnish.

Eligibility criteria:
inclusion criteria: * x-linked hypophosphatemia diagnosed by the doctor specializing in the disease. * patients with at least two healthy contralateral quadrants (right and left) at inclusion defined by the absence of symptomatic or asymptomatic spontaneous abscess, carious lesion and trauma (concussion, subluxation, dislocation, crack, fracture) on all teeth in the quadrant. exclusion criteria: * antibiotic treatment within 15 days prior to inclusion * patients with a mental disability, * patients with cancer, heart disease, sickle cell anemia, pathological bruxism * patients with contraindications to study treatments

Keywords: x-linked hypophosphatemia, child, tooth
study evaluating the addition of fulvestrant to erlotinib in stage iiib/iv non-small cell lung cancer

Conditions: Non Small Cell Lung Carcinoma

Summary: the main purpose of this research study is to see if adding fulvestrant (faslodex) to erlotinib (tarceva) is effective in patients with stage iiib/iv non-small cell lung cancer.

erlotinib is an oral drug which is able to block endothelial growth factor receptor (egfr). egfr stimulates cancer cell growth. fulvestrant (faslodex) block estrogen hormone from gaining access to tumor and stimulating the tumor cells to grow. both of these drugs are already approved by fda but have not been studied in this combination. we will study if the combination of these drugs will delay treatment failure. lung cancer tumors in both males and females can be sensitive to estrogen. only patients whose tumor expresses the estrogen will be eligible for the trial. estrogen sensitivity will be tested on previously removed tumor specimens.

Eligibility criteria:
inclusion criteria: * estrogen or progesterone receptor positive stage iiib/iv non-small cell lung cancer * eligible patients will have stable disease on erlotinib monotherapy at fda- approved doses after a minimum duration of erlotinib therapy of 2 months * 18 years or older * ecog performance status ≤2 * adequate organ function requirements * adequate coagulation function * postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause * all patients must sign a written informed consent. exclusion criteria: * pregnant or breast-feeding women will not be entered on this study * patients who are currently receiving another investigational drugs * patients who are currently receiving other anti-cancer agents. * hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study * patients who have an uncontrolled infection. * patients receiving less than 100mg/day of erlotinib * patients with evidence of progression after 2 months of erlotinib monotherapy. * patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation \[dic\], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy). * patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or mannitol). * patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Keywords: non small cell lung cancer stage iiib stage iv stable on erlotinib exhibit positivity for estrogen or progesterone receptor
to assess the effect of administration of 2 formulation of azd3241 on blood concentration in healthy volunteers

Conditions: Parkinson's Disease

Summary: to evaluate the pharmacokinetics of azd3241 following multiple administration of 2 new, different extended release formulations of tablets of azd3241 (300 mg), in relation to the 100 mg extended release tablet used in a previous study and potential food interaction. the safety and tolerability of azd 3241 will also be investigated as a secondary objective. in addition to these a number of exploratory objectives will be investigated with blood sampling.

a phase i, single-centre, double-blind, randomised, placebo-controlled, parallel group study to assess the pharmacokinetics, safety and tolerability of two different extended release formulations of tablets of azd3241 (300 mg) after administration of multiple doses in healthy male and female volunteers

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture * female volunteers must have a negative pregnancy test at screening and on admission to the cpu, must not be lactating and must be of non childbearing potential, confirmed at screening * male volunteers must be willing to use barrier contraception ie, condoms, from the first day of dose administration until 3 months after the last dose of the ip * volunteers must have a body mass index (bmi) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg exclusion criteria: * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to azd3241 * orthostatic hypotension defined as 25 mmhg decrease in systolic and/or 15 mmhg decrease in diastolic bp as measured at enrolment and/or randomisation * history of intolerance or hypersensitivity to mannitol * prolonged qt interval corrected for heart rate using fridericia's formula (qtcf)\>450 ms or shortened qtcf\<340 ms or a family history of long qt syndrome * abnormal vital signs, after 10 minutes of rest in supine position, defined as any of the following:systolic bp\>140 mmhg., diastolic bp\>90 mmhg., heart rate\ 85 beats per minute.

Keywords: phase 1 parkinson's disease pharmacodynamic biomarkers pharmacokinetics extended release formulation
prone position in non-invasive ventilation and high-flow oxygen therapy

Conditions: Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure

Summary: the aim of this trial is to study the effect of prone position during niv and hfnc on acute hypoxemic respiratory patients.

inclusion criteria: adult patients with: • ards/pneumonia/acute hypoxemic respiratory failure with pao2/fio2 between 150 and 300 (on 5 cmh2o peep level) exclusion criteria * general niv or hfnc contraindications * immediate need for iot * prone position intolerance * patients refusal to participate interventions: * prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to icu) * nurse surveilance: at least every 15 minutes outcomes: * need for iot * effects on the measurements specified above (particularly pao2/fio2)

Eligibility criteria:
inclusion criteria: * adult patients with: * ards/pneumonia/acute hypoxemic respiratory failure with pao2/fio2 between 150 and 300 (on 5 cmh2o peep level) exclusion criteria: * general niv or hfnc contraindications * immediate need for iot * prone position intolerance * patients refusal to participate

Keywords: noninvasive ventilation high-flow nasal oxygen therapy prone position
preventing cardiac complication of covid-19 disease with early acute coronary syndrome therapy: a randomised controlled trial.

Conditions: COVID-19

Summary: the outbreak of a novel coronavirus (sars-cov-2) and associated covid-19 disease in late december 2019 has led to a global pandemic. at the time of writing, there have been 150 000 confirmed cases and 3500 deaths. apart from the morbidity and mortality directly related to covid-19 cases, society has had to also cope with complex political and economic repercussions of this disease. at present, and despite pressing need for therapeutic intervention, management of patients with covid-19 is entirely supportive. despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit. furthermore, the severity of covid-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of covid-19 disease. the exact type of acute of cardiac injury that covid-19 patients suffer remains unclear. there is however mounting evidence that heart attack like events are responsible. tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick covid-19 patients. randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in covid-19 disease. it will also help us determine if there is more we can do to treat these patients.


Eligibility criteria:
inclusion criteria: 1. confirmed covid-19 infection 2. age =/\>40 or diabetes or known coronary disease or hypertension 3. requires hospital admission for further clinical management. exclusion criteria: 1. clear evidence of an acute coronary syndrome or myo-pericarditis that requires specific treatment that precludes randomization. 2. evidence of active bleeding 3. pregnancy. 4. age \<18 years

Keywords: coronavirus, sars-cov-2, covid-19, cardiovascular