Kornimate/medical-research-clean huggingface dataset:
gastric neuromuscular function in gerd

Conditions: GERD

Summary: bodysurface gastric mapping (bsgm) will be used to assess gastric neuromuscular function in healthy controls and patients with medical refractory gastroesophageal reflux disease (gerd). participants will undergo bsgm for 4-hours in addition to high resolution manometry (hrm), ph-impedance monitoring, and gastric emptying breath test.

this is a clinical trial of a non-invasive bsgm medical device (gastric alimetry) in patients with medical refractory gord and healthy controls to determine the differences in gastric electrical activity, and correlate with adjacent measurements of gastro-esophageal function. patients referred to the functional gut clinic for standard care investigation of gord with hrm and ph-impedance monitoring will be recruited. healthy volunteers will be recruited via advertisement. all patients and healthy volunteers will undergo bsgm at the research site, which lasts around 4.5 hours. after a 0.5 hour baseline, subjects will undergo hrm and ph-impedance monitoring concomitantly. a test meal of porridge with c13 labelled octanoic acid will be consumed with bsgm and breath samples recorded for 4.0 hours after meal completion. the hrm catheter will be removed after 1.0 hour from finishing the test meal whist the ph-impedance monitoring will continue for the remainder of the site visit and for the remainder of the 24-hour study period whilst the subject is at home to quantify reflux.

Eligibility criteria:
healthy controls inclusion criteria: * aged 18-70 years old * bmi 18-35 * able to understand written and spoken english * able to provide written consent * able to understand risks and benefits exclusion criteria: * antacid use (e.g. ppi, h2ra or gaviscon) within last 12-months * active use of other medications known to impact gastric motility * upper gi symptoms including but not limited to heartburn, regurgitation, epigastric pain, nausea and bloating * significant medical condition * history of skin allergies or hypersensitivity * active abdominal wounds or abrasions, fragile skin * current pregnancy * vulnerable group e.g. prisoners/cognitive impairment/institutionalised individuals * regular cannabis users (unable to abstain for 7-days) * opioid user * unable to use a tablet device gord patients inclusion criteria * referred for 24-hour ph-impedance monitoring * aged 18-70 years old * bmi 18-35 * able to understand written and spoken english * able to provide written consent * able to understand risks and benefits exclusion criteria * systemic or metabolic disorder known to cause gastric dysmotility other than diabetes (e.g. scleroderma, multiple sclerosis, hyperthyroidism). * history of upper gi surgery or hiatal hernia (\>5cm, paraesophageal, or 'large' on endoscopy report) * diabetic and on insulin * proven mechanical bowel obstruction * history of skin allergies or hypersensitivity * active abdominal wounds or abrasions, fragile skin * current pregnancy * vulnerable group - prisoners/cognitive impairment/institutionalised individuals * regular cannabis users (unable to abstain for 7-days) * opioid user * unable to use a tablet device
specificity trial of the recombinant tuberculosis allergen in bcg vaccinated healthy volunteers

Conditions: Tuberculosis

Summary: the aim of this study is to test the recombinant tuberculosis skin test in the previously bcg vaccinated healthy adults with low risk of tb development, to determine the test specificity.

recombinant tuberculosis allergen (rta) is a recombinant fusion protein cfp10-esat6 produced by the prokaryotic cell line. the test is widely used in russian federation and cis countries for the latent tb diagnosis in adults and children over 8 years old. the current clinical study is a prospective, multicenter, open-label study in the cohort of healthy adults, not classified as at risk of tuberculosis, with no clinical symptoms of the disease, with a negative t-spot.tb test results, to evaluate the specificity of the rta test in 72 hours following administration of the product at a dose of 0.2 μg/0.1 ml.

Eligibility criteria:
inclusion criteria: 1. signed informed consent for the participation in the study. 2. age 18 to 30 years 3. a history of bcg vaccination (confirmed by medical documentation and/or the presence of bcg scar) 4. healthy individual according to physical examination and medical records at screening. 5. willingness to cooperate and follow the recommendations of the investigator in accordance with the protocol. exclusion criteria: 1. a history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study. 2. positive t-spot.tb test at the enrollment in the study 3. treatment with drugs affecting immune system within 3 months prior to the enrollment in the study 4. vaccination against any infections \<1.5 months prior to the enrollment in the study 5. vaccination with bcg \<6 months prior to the enrollment in the study. 6. the mantoux test with 2 tu and/or the test with the recombinant tuberculosis allergen was performed less than 6 months prior to the enrollment in the study. 7. congenital or acquired immunodeficiency. 8. active disease of the immune system 9. hiv infection. 10. the current condition of the skin interferes with the conduct and reading of skin tests (trauma, skin diseases). 11. a disease in which blood sampling poses a risk to the volunteer (hemophilia, other bleeding disorders) or obstructed venous access. 12. the volunteer currently participates in another clinical study or has participated in another clinical study within 3 months prior to the enrollment in the study. 13. previous participation in clinical studies of esat-6 and/or cfp-10 antigens. 14. pregnancy, lactation, pregnancy planning. 15. the reluctance of a female person to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptives during the study. 16. history of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study. 17. use of alcoholic beverages within 24 hours prior to the visit. 18. a condition or disease that, in the opinion of the investigator, is inappropriate for participation in the study.

Keywords: tuberculosis tb diagnosis tuberculosis skin test cfp10 esat6
efficacy and tolerability of beclometasone/formoterol single inhaler in patients with moderate to severe persistent asthma

Conditions: Asthma

Summary: efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

the purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: bdp/ff 400/24 mcg) or beclometasone cfc + formoterol dpi (total daily dose: bdp 1000 mcg + ff 24 mcg) or beclometasone cfc (total daily dose: bdp 1000 mcg) during 24 weeks of treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of moderate to severe persistent asthma (according to gina 2002 guidelines) * fev1 \> 40% and \< 80% of predicted normal post-bronchodilator (and at least 0.7 l absolute value) * patients already treated for at least 2 months with an association of inhaled corticosteroids plus laba at doses of: 750 - 1000 µg beclomethasone dipropionate or equivalent (icss) 24 µg formoterol or 100 µg salmeterol (labas) * or patients naïve of laba already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of saba and/or with clinical symptoms \> 3 times in the week prior to inclusion * a documented positive response to the reversibility test. exclusion criteria: * pregnant or lactating females or women of childbearing potential without any efficient contraception. * heavy smokers defined as smoking for \> 10 pack years. * evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids). * seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer. * clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities. * patients with an abnormal qtc interval value in the ecg test, defined as \> 450 msec in males or \> 470 msec in females. * evidence of asthma worsening during the week preceding randomisation (e.g. pef variability \> 30% during 2 consecutive days, saba use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
clinical evaluation of a novel spectacle lens on slowing down juvenile myopia progression

Conditions: Myopia

Summary: this study will be a 2 year, double-masked, randomized, controlled mono-center monocular exploratory clinical investigation to test and compare the efficacy of the test lens in slowing down the increase of axial length and controlling myopia progression.

the clinical trial aims to assess the efficacy and safety of a test lens, designed to emit red-light when exposed to natural daylight that can produce a cumulative red-light exposure equivalent to the sham device (dong et. al, 2023) when children spend about 30 minutes in a day. the primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.

Eligibility criteria:
inclusion criteria: * children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent. * corrected spherical equivalent refraction (ser) between -0.75 d and -5.00 d with astigmatism not more than 2.50 d. * difference in ser (anisometropia) between two eyes should not exceed 1.00 d. * best corrected visual acuity better than or equal to +0.10 log mar (20/25 or better with snellen). * be in good general health, based on his/her and parent's/guardian's knowledge. * agree to wear spectacles for \>12 hours/day and at least 6 days/week. * willingness and ability to participate in investigation for 2 years and attend scheduled visits. exclusion criteria: * any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, down's syndrome etc.) * any binocular vision anomalies * amblyopia * use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month. * current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. * participation in any clinical investigation within 30 days of the baseline visit.

Keywords: refractive error eye disease axial length myopia control
radiotherapy in palliation of advanced pelvic cancer

Conditions: Palliative Care

Summary: the study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.

he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.

Eligibility criteria:
inclusion criteria: * histologically proven advanced pelvic cancer * excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status * age \> 18 years * eastern cooperative oncology group (ecog) \<3 exclusion criteria: - prior radiotherapy to the same region

Keywords: palliative care pelvic cancer radiotherapy pain quality of life
the effects of video-based yoga interventions for patients with post-corona virus disease

Conditions: Post-COVID-19

Summary: aimed to understand if yoga exercises are superior to posture exercises as an alternative exercise therapy for relieving musculoskeletal pain, improving functional status, and improving quality of life during the post- corona virus disease (covid-19) period?

eighty five of 200 post- covid-19 patients, who met the inclusion/exclusion criteria obtained from the records of the state hospital. the participants were divided into video-based (vb) yoga (n=40), home-based (hb) posture exercise (n=28), and control (n=17) groups. the socio-demographic characteristics, pain status, walking and balance, and quality of life were evaluated twice, once before and eight weeks after the exercises.

Eligibility criteria:
inclusion criteria: * recently diagnosed with covid-19 and discharged from the hospital; * being at level 0: neglected functional limitation or level 1: negligible functional limitation on the post-covid-19 functional status scale, * referred for physical therapy for musculoskeletal pain. exclusion criteria: * having any type of surgery in the last six months, * being pregnant, * being level 2 or above on the post-covid-19 functional status scale

Keywords: pain post-covid-19 patients mild symptoms quality of life functional capacity
maximizing language development in children with hearing loss

Conditions: Hearing Loss

Summary: the purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.


Eligibility criteria:
inclusion criteria: * 6 to 18 months of age * bilateral, moderate to profound congenital hearing loss exclusion criteria: * auditory neuropathy * no known additional disabilities (e.g., cerebral palsy, down syndrome) * both parents have a severe to profound hearing loss

Keywords: hearing loss cochlear implant deaf hearing impairment hard of hearing
research on the nature, diagnosis, and treatment of obesity and diabetes

Conditions: Insulin Resistance; Obesity

Summary: the purpose of this study is to determine whether the level of foxa2 expression in fat tissue is a biomarker of insulin resistance. to test this hypothesis, we will perform euglycemic-hyperinsulinemic clamps in normal and obese human subjects to calculate insulin sensitivity, and see if insulin sensitivity correlates with the foxa2 expression in subcutaneous fat.

the investigators at rockefeller university hospital are engaged in research on the nature, diagnosis and treatment of obesity and diabetes. the investigators are trying to find out why insulin, a blood sugar lowering hormone that is released by the pancreas following a meal, does not work effectively in individuals with obesity or type 2 diabetes. the investigators have recently discovered a protein in fat cells of obese mice that helps fat cells to take up and break down sugar from the blood. this protein (called foxa2) also prevents the generation of more fat cells. foxa2 is only present in obese mice, but absent from fat stores of lean animals. insulin can stimulate the production of foxa2 in fat cells. furthermore, the levels of foxa2 protein correlate with the degree of blood insulin levels. in this study, we are would like to determine whether foxa2 is also produced in fat cells of humans, and if its level correlates with the degree of obesity and insulin resistance.

Eligibility criteria:
inclusion criteria: 1. healthy individuals 2. age 21-45 years old 3. bmi: either \ 40 4. all patients must be willing and able to sign an informed consent form - exclusion criteria: 1. chronic illnesses other the than mild forms of illnesses related to obesity, such as hypertension, hyperlipidemia, and others, that do not require medical treatment 2. diabetes mellitus previously diagnosed as per subject report or an abnormal 2 hour ogtt at screening 3. chronic drug treatment for any medical condition 4. active weight reduction of more than 7 pounds in the last 3 months 5. history of bleeding or blood clotting disorders 6. subjects with hemoglobin \<8.5 gm/dl 7. changes in smoking habits for the last 6 months 8. current pregnancy or current breast-feeding in women 9. allergic reaction to local anesthetics 10. history of anaphylaxis or anaphylactic-like reactions 11. tendency to form scars (keloids) easily 12. irregular menses 13. hiv and hepatitis b or c positive subjects -

Keywords: healthy volunteers
neuramis® volume lidocaine treatment in patients with loss of mid-face volume

Conditions: Aging

Summary: the purpose of this study is to compare the safety and efficacy of neuramis® volume lidocaine, which is a biomaterial prosthesis and graft, with juvederm® voluma® with lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. after the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

this is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. the subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (neuramis® volume lidocaine or juvederm® voluma® with lidocaine). after the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Eligibility criteria:
inclusion criteria: 1. subject aged between 35 and 65. 2. mid-facial region symmetrical, severity greater than mfvds moderate-to-severe level exclusion criteria: 1. those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs 2. those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial. 3. those who has thin skin in the mid-facial area 4. those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics \ inclusion criteria: 1. participated in the pivotal study and completed the end of study visit 2. agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study exclusion criteria 1. those who have following procedual history between completion of the pivotal study and entry of extension study - facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting 2. subjects with asymmetric mvd(mid-face volume deficit) or facial scar interfering with accurate assessment
bipolar disorder in pregnancy and the postpartum period: predictors of morbidity

Conditions: Bipolar Disorder; Psychiatric Morbidity; Neonatal Outcome

Summary: the purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. the main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.


Eligibility criteria:
inclusion criteria: 1. medically healthy adult women (ages 18-45) fulfilling dsm-iv criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period; 2. euthymic at the time of conception; 3. able to give informed consent and comply with study procedures; 4. have a treating psychiatrist, physician or mental health clinician. gravid women between the ages of 18 and 45 exclusion criteria: 1. active suicidality or homicidality; 2. active substance use disorder with 6 months prior to enrollment, or 3. positive urine drug screen at enrollment.
brain abnormalities in late-onset major depression

Conditions: Major Depression

Summary: the objective of this project is to examine the state of the brain in people over 50 years old suffering from late-onset depression by means of an extensive clinical assessment programme, including magnetic resonance imaging (mri), neuropsychological testing, neurological examination, eye examination as well as blood and saliva samples. the results are to be compared with results from a control group matched for gender and age.

major depression is a frequent and serious disorder with different prognoses and complications with respect to lack of treatment response, recurrence and suicide. mri of the brain can provide information about changes in the brain tissue with depression, e.g. lesions of nerve connections, small thrombi or changes in the blood flow. these changes appear primarily after the age of 50 and are seen in cases of diabetes and high blood pressure. furthermore, the connection between disruptions in the body's stress response system and depression will be explored, which is very important since studies indicate that stress and depression can affect certain brain parts permanently. this will give us a better understanding of the connection between brain changes, neuropsychology and depression prognosis, which is decisive for accurate diagnostics, effective treatment and targeted prevention of the disease in the long run. the project is part of a larger clinical assessment programme in the neuropsychiatric unit under the centre for basic psychiatric research, aarhus psychiatric hospital, denmark, which gives us unique possibilities of combining research and daily clinical work. the hope is in the future to be able to offer patients in the risk group better assessment and treatment to prevent complications and recurrence.

Eligibility criteria:
inclusion criteria: * first time major depression * age over 50 years * caucasian * admitted at a psychiatric hospital or treated at a local psychiatric clinic in aarhus amt exclusion criteria: * major brain damage (e.g. stroke, epilepsy, trauma) * major alcohol or drug abuse

Keywords: major depression magnetic resonance imaging white matter lesions perfusion diffusion magnetization transfer vascular risk factors
a real-world study of the safety of hypertension medication therapy in japanese patients with naïve hypertension

Conditions: Hypertension

Summary: this was a non-interventional, secondary use of data, retrospective, cohort study. the data extracted in this study was used as secondary use of collected patient information in the database, japan medical data survey (jamdas), owned by m3 inc. (tokyo, japan). jamdas is a database that aggregates medical information and is constructed mainly from electronic medical record information of medical institutions, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities etc.


Eligibility criteria:
inclusion criteria: 1. diagnosed with essential hypertension or hypertensive heart/kidney disease at the index date. 2. sitting systolic blood pressure (ssbp) ≥150 millimeters of mercury (mm hg) at the index date. 3. at least one prescription of angiotensin-converting enzyme inhibitor (acei), angiotensin receptor blocker (arb), angiotensin receptor neprilysin inhibitor (arni), calcium channel blocker (ccb), diuretics, or these spcs for hypertension at the index date. 4. at least one visit and blood pressure (bp) measurement within 12 weeks from the index date. exclusion criteria: 1. prescription of hypertensive medication including alpha blocker, beta blocker, alpha-beta blocker, aldosterone antagonist, and renin inhibitor within 24 weeks prior to the index date. 2. initial prescription of two or more antihypertensive medicines either with or without spcs at the index date. 3. history of hypotension, hyperkalemia, hypokalemia, or hyponatremia, drug-related or otherwise, or renal failure leading to dialysis, stroke, myocardial infarction, heart failure at the index date or within 24 weeks prior to the index date. 4. history of secondary hypertension (renal parenchymal hypertension, renovascular hypertension \[unilateral or bilateral renal artery stenosis\] coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension, etc.) at any timepoint. 5. pregnant women at any timepoint.

Keywords: essential hypertension high blood pressure