Kornimate/medical-research-clean huggingface dataset:
a study of dose titration of ly2189265 in overweight participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus Type 2

Summary: to study once weekly injections of ly2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (hba1c) change from baseline after 16 weeks in overweight type 2 diabetes mellitus participants.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus \>3 months by history prior to entering the trial, based on disease diagnostic criteria from the american diabetes association (ada 2007). * men or women 18 years of age or older. women must have a negative pregnancy test and be willing to use birth control during study duration and one month post. * have glycosylated hemoglobin (hba1c) of \>7.0% to ≤10.5% as determined by central laboratory at screening. * have a body mass index (bmi) between 27 and 40 kilograms/meter squared (kg/m\^2), inclusive. * have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. chlorpropamide or diabinese, glimepiride or amaryl, tolbutamide or orinase, tolazamide or tolinase, glipizide or glucotrol, glyburide also known as micronase, diabeta, or glynase), biguanides (e.g. glucophage or metformin), thiazolidinediones (e.g. rosiglitazone or avandia, or pioglitazone or actos), or dipeptidyl peptidase 4 (dpp-iv) inhibitors (e.g. sitagliptin or januvia). a combination pill of any 2 of these drugs is allowed (1 only), (e.g. metformin and glipizide or metaglip), (e.g. metformin and glyburide or glucovance), (e.g. pioglitazone and glimepiride or duetact), or (e.g. sitagliptin and metformin or janumet). exclusion criteria: * have known type 1 diabetes mellitus * have taken glucagon-like peptide-1 (glp-1) or any glp-1 analog drug (byetta) * have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty \[ptca\], open heart surgery, or coronary artery bypass graft \[cabg\]), a transient ischemic attack (tia) or stroke (cerebrovascular accident) in the last 6 months prior to screening. * have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. have renal disease or a serum creatinine (blood test) \>2 milligrams per deciliter (mg/dl). if taking biguanides (e.g. metformin or glucophage), or dpp-iv inhibitors (e.g. sitagliptin or januvia or janumet), creatinine must be ≤1.5 mg/dl. * currently taking prescription or over the counter medications to prevent weight loss.
rituximab effect on decreasing glucocorticoid exposition in polymyalgia rheumatica patients recently diagnosed

Conditions: Polymyalgia Rheumatica

Summary: polymyalgia rheumatica (pmr) is prevalent among elderly. untreated, it leads to major reduction in quality of life. glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. a proof of concept study on rituximab (rtx) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (marsman et al. 2021). though promising, the short study duration and small sample size require further confirmation. therefore a larger randomised controlled trial with longer follow up will be performed on rtx efficacy on glucocorticoid free remission in newly diagnosed pmr patients during glucocorticoid taper.


Eligibility criteria:
inclusion criteria: * polymyalgia rheumatica diagnosis fulfilling the 2012 european league against rheumatism (eular)/american college of rheumatology (acr) classification criteria * diagnoses less than 12 weeks ago * glucocorticoid treatment less than 8 weeks and with dose equivalent of prednisolone ≤ 30 mg/day * informed consent exclusion criteria: * treatment with systemic immunosuppressants (other than glucocorticoids) 3 months prior to inclusion; * (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases; * concomitant conditions that might significantly interfere with pmr pain or movement evaluation as judged by the investigator; * previous hypersensitivity for rtx or contra-indications to rtx.
smoking cessation in patients with copd (smocc) in general practice

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: background: smoking cessation is the key element in the treatment of patients with chronic obstructive pulmonary disease (copd). the role of the general practice in assisting these patients with successful quitting smoking was suboptimal. therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with copd in routine general practice, one with (cnb) and one without (cn) the combination with bupropion-sr, compared to usual care (uc) and explored the role of copd symptoms in successful smoking cessation. method: rct with 667 patients with copd, 68 general practices were randomly allocated. the usual care group (uc) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (cn) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. main outcome measure was (biochemically verified) point prevalence.


Eligibility criteria:
inclusion criteria: a software program using anatomical therapeutical chemical (atc) prescription codes and international classification of primary care (icpc) diagnosis codes selected potential patients with copd. criteria: age \>35 years and a diagnosis recorded as copd or as icpc code r95/96, or a prescription of at least three times of bronchodilators (atc code r03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (atc code r03). general practitioners (gps) had to confirm the diagnosis of the selection. patients were eligible to participate if they met the following criteria: * current smoking * suffering from copd according to the gp's diagnosis * in command of the dutch language. exclusion criteria: * too ill * under control of a chest physician * serious physical or psychological comorbidity

Keywords: smoking cessation
comparison of different drugs on ocular surface disease in glaucoma patients: a prospective randomised study

Conditions: Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)

Summary: participants were randomised to receive benzalkonium chloride-containing latanoprost (xalatan) or preservative-free bimatoprost (lumigan). through this study, the investigators would like to analyze the impact of different antiglaucoma medications on ocular surface disease in glaucoma patients.

the purpose of our study is to assess the effect of antiglaucoma medication on ocular surface disease in glaucoma patients before and after treatment with different antiglaucoma medication. all included patients are newly diagnosed with glaucoma and received no previous antiglaucoma treatment. medical records will be collected prospectively from sep. 15th 2019 to aug. 31st 2022. the symptoms and signs of ocular surface disease in each individual will be assessed with questionnaire and clinical exams, including the basal schirmer's test, non-invasive tear film breakup time, meibography, and in vivo confocal microscopy before and at 1, 3, 6 months after treatment.

Eligibility criteria:
inclusion criteria: * patients are not diagnosed with glaucoma and don't receive any ocular hypotensive eye drops at our clinic. * patients accept the rules for follow-up visits for at least six months. exclusion criteria: * patients are with a history of ocular trauma. * patients are with contact lens use. * patients are diagnosed with secondary glaucoma. * patients have significant diseases affecting the meibomian gland and ocular surface. * patients have poor iop control that required additional ocular hypotensive eye drops.

Keywords: benzalkonium chloride ocular surface disease latanoprost bimatoprost
evaluation of remote dbs programming.

Conditions: Deep Brain Stimulation; Telemedicine; Parkinson Disease

Summary: deep brain stimulation (dbs) represents the treatment of choice for advanced stages of parkinson's disease (pd). currently, adaptive closed-loop stimulation systems that apply disease-specific biomarkers, such as local field potentials (lfps), are being actively examined to facilitate dbs programming. however, the most suitable feedback signal, still remains to be determined. the investigators previously tested the usefulness of the patient's subjective rating on a visual analogue scale (vas) as a potential feedback signal for dbs adjustment and found that vas-based programming lead to similar results as our standard approach. one of the practical advantages of using vas-based programming strategies - in addition to saving time - is the principal applicability of such an approach to a remote programming setting, although a validation of such an approach is required. within the scope of a prospective, randomized multicenter clinical trial (the remote trial), the investigators will examine the effectiveness and safety of vas-based remote dbs programming in pd by using a novel and recently introduced software platform (abbott neurospheretm virtual clinic) that allows for the programming through a smartphone-based video connection with the patient. therefore, n = 50 pd patients undergoing stn-dbs surgery will be randomized and subsequent to surgery will have their ipg settings adjusted either during regular visits at the hospital or alternatively be programmed remotely through a vas-based approach. prior to surgery and after a 90 days follow-up period, we will assess specific clinical (mds-unified parkinson's disease rating scale = updrs, parkinson's disease questionnaire-39 sum index = pdq-39 si, beck depression inventory = bdi, montreal cognitive assessment scale = moca) parameters to determine the effectivity and safety of the two different strategies on the patient outcome and to correlate it with vas ratings and mri data. the results will support the examination of remote-based dbs programming and evaluate the patient's subjective judgment as a valid feedback signal.


Eligibility criteria:
inclusion criteria: * age between 35 and 80 yrs. * ability to communicate with the study physician and to understand the requirements of the study * idiopathic parkinson's syndrome; ips (according to mds-criteria) * implantation of a dbs device for the stimulation of the subthalamic nucleus (stn) to treat pd. exclusion criteria: * any inability to communicate with the study physician and to understand the requirements of the study * exclusion criteria of an idiopathic parkinson's syndrome (ips) * fulfills the criteria of dementia (according to the international classification of diseases (icd) 10)

Keywords: deep brain stimulation telemedicine parkinson's disease (pd) subthalamic nucleus (stn) remote
pilot study of triphala and rubia cordifolia on gut microbiome and skin

Conditions: Sebum Production; Stool Microbiome; Transepidermal Water Loss; Facial Brrightness; Erythema; Wrinkles; Facial Shine

Summary: few studies have assessed the effects of triphala and rubia cordifolia from a skin biophysical perspective. here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.

herbal supplements such as rubia cordifolia and triphala \[a mix of emblica officinalis (amalaki), terminalia bellerica (bibhitaki), and terminalia chebula (haritaki)\] are commonly used for skin based treatments in india. however, the scientific evidence for their specific effects on the skin are scant. rubia cordifolia is a root that is used in skin care for pigmentation and inflammation.1 triphala is thought to have antioxidant properties and reduce inflammation in general. herbs have been shown to modulate the gut microbiome, as previous studies have suggested that triphala may modify the gut microbiome.2 however, few studies have assessed the effects of these herbs from a skin biophysical perspective. here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.

Eligibility criteria:
inclusion criteria for subjects: 1. age 18 to 60 years of age 2. subject must be able to read and comprehend study procedures and consent forms. exclusion criteria for subjects: 1. subject should be generally healthy and have no smoking history in the past one year. 2. subjects must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use. 3. those who are unable to discontinue topical medications for two weeks. 4. those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study. 5. those who are unable to discontinue their triphala and rubia cordifolia regimen for one month prior to starting study. 6. subjects who are postmenopausal 7. those who are pregnant or breastfeeding 8. those that are prisoners or cognitively impaired 9. those who have a known allergy to rubia cordifolia, emblica officinalis, terminalia bellerica, terminalia chebula.
golden study: a study to assess safety and efficacy of multiple doses of ionis-fb-lrx in participants with geographic atrophy secondary to age-related macular degeneration (amd)

Conditions: Macular Degeneration; Geographic Atrophy

Summary: evaluate the effect of ionis-fb-lrx on the rate of change of the area of geographic atrophy (ga) secondary to age-related macular degeneration (amd) measured by fundus autofluorescence (faf).

the study will assess the rate of change of the area of ga secondary to amd by measuring faf in up to 330 participants with ga due to amd being treated with ionis-fb-lrx. the study is a phase 2, double-masked, randomized, stratified, placebo-controlled study conducted at multiple centers. it is an adaptive design in which three dose levels will be evaluated in a subset of participants (stage 1) and, following an interim analysis, the number of participants in two of the dose cohorts will be expanded (stage 2).

Eligibility criteria:
inclusion criteria: * females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. * vaccination against neisseria meningitidis and streptococcus pneumoniae received at least 2 weeks prior to first dose of investigational product * well-demarcated geographic atrophy (ga) due to amd * best-corrected visual acuity (bcva) letter score of 35 letters (approx. 20/200 snellen equivalent) or better on the etdrs chart * must have clear ocular media and adequate pupillary dilation in the study eye to permit high-quality fundus imaging exclusion criteria: * clinically-significant abnormalities in medical history * a lack of full recovery from any infection for at least 14 days prior to the study drug administration * chronic treatment with steroids, including topically or intravitreally administered * history or presence of diabetic retinopathy or diabetic macular edema (dme) * history or presence of a disease other than amd that could affect vision or safety assessments * prior treatment with another investigational drug, biological agent, or device * other protocol-specified inclusion/exclusion criteria may apply
study of a tiotropium inhaler for shortness of breath in advanced non-small cell lung cancer

Conditions: NSCLC; Dyspnea

Summary: the feeling of shortness of breath is very common in lung cancer. it is uncomfortable for patients and upsetting for their family. although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. more relief is needed for these patients. the investigators are studying a drug called tiotropium, which is used in emphysema. it is an inhaler that opens the airways to allow easier breathing. every patient will get the drug but also a placebo, in a random (flip of a coin) order. they will get each for 2 weeks. the investigators will see if they feel better with the drug.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically proven incurable stage iiib or stage iv non-small cell lung cancer. 2. dyspnea as defined by a score of 2 or higher on the 10-point dyspnea numeric scale (appendix 2). 3. new dyspnea or worsening dyspnea within the last 6 months per patient reporting. exclusion criteria: 1. age \< 18. 2. an fev1 / fvc ratio \< 0.7 with an fev1 of \< 80% predicted post-bronchodilator. 3. life expectancy \< 3 months. 4. significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure). 5. myocardial infarction within the previous month. 6. heart rate ≥ 120. 7. active tuberculosis or tuberculosis receiving antibiotic therapy. 8. current or previous use of ipratropium, tiotropium, or oxitropium (see appendix 6). 9. sensitivity to atropine. 10. pre-existing diagnosis of asthma or moderate to severe chronic obstructive pulmonary disease 11. use of beta-adrenergic bronchodilators more than once per week. 12. use of experimental therapy with known cholinergic or adrenergic effects. 13. uncontrolled glaucoma. 14. urinary retention. 15. an active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks. 16. symptomatic pleural or pericardial effusion. 17. evidence of reversible proximal endobronchial obstruction. 18. oxygen saturation \< 90%. 19. a hemoglobin of \< 100 g/litre. testing is to be within 4 weeks of randomization. 20. calculated or urine creatinine clearance ≤ 50 ml/min (see appendix 5 for calculation). testing it to be within 4 weeks of randomization. 21. weight loss \> 10% of usual body weight within 6 months. 22. known pregnancy or lactating. 23. unable to independently fill out quality of life forms or give informed consent. -

Keywords: nsclc dyspnea phase ii crossover tiotropium
proportional assist ventilation vs pressure support ventilation

Conditions: Respiration, Artificial

Summary: in this study, we want to compare two different kinds of artificial ventilation to see if one encourages faster weaning from breathing support and if one provides better sleep quality. these artificial ventilation types are: 1. pressure support ventilation; the standard ventilation that we use for the patients in the respiratory acute care unit. pressure support ventilation ventilators use constant air pressure to assist patients with their breathing. 2. proportional assist ventilation; a newer way of helping people with their breathing. the air pressure provided by proportional assist ventilation ventilators varies with the size of the breath that a person takes.


Eligibility criteria:
inclusion criteria: * tracheotomized or endotracheally intubated and mechanically ventilated patients transferred or scheduled to be transferred to the racu. * age 18 years or older. exclusion criteria: * patients who are weaned from ventilatory support within the first 72 hours of transfer to the racu. even though these patients had been randomized, they will be excluded. they will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion. * high spinal cord injury * immunosuppressed patients receiving chemotherapy or radiation therapy (\< 2 months after chemotherapy or radiation therapy). * neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence. * high risk of mortality within 3 months (severe neurological damage and cancer patients in terminal stages of the disease). * patients unable to trigger the ventilator for any reason. * any patient who is not considered a candidate for weaning from ventilatory support * patients consented for another interventional study. * patients requiring more than 30 days to wean once randomized will be excluded. they will be considered in the intention to treat analysis but the final outcome analysis will be performed after their exclusion.
prevalence of hepatitis b in vallés occidental. observational multicentric study

Conditions: Hepatitis B

Summary: the aim of this study is to evaluate the prevalence of hepatitis b in vallés occidental. also, describe the stage of the disease, and whether if they are under medical treatment or not.

the hepatitis b virus ( hbv ) is a global health problem . it is estimated that in the world there are about 350-400 million carriers of hbv surface antigen ( hbsag ) 1 . the prevalence in spain is estimated at a 2-7 % and is considered a second intermediate prevalence. for over 20 years, has carried out a program of primary prevention through universal vaccination against hepatitis b including it in the childhood vaccination schedule and has already been observed that in some estudi3 the prevalence has declined . for this reason , we want to evaluate what is the currently prevalence in our area of influence. there aren't recent studies to assess what is the current status of these patients ( how many , what risk factors which needs of treatment and with answer ...)

Eligibility criteria:
inclusion criteria: * patients with hbsag + visited in digestive/hepatology outpatient visits and hepatology of the participating hospitals exclusion criteria: * patients \< 18 aged * duplicity on record
study to evaluate the effect of micardis® / micardisplus® on metabolic parameters in patients with essential hypertension and diabetes mellitus

Conditions: Hypertension

Summary: the primary objective is to evaluate the effect of the treatment with micardis® or micardisplus® on blood pressure. secondary objectives are the effect of micardis® / micardisplus® on metabolic parameters (triglycerides, cholesterol, blood glucose and hba1c) in patients with essential hypertension and diabetes mellitus


Eligibility criteria:
inclusion criteria: * age \> 18 years * hypertension * diabetes mellitus exclusion criteria: * age \< 18 years
spd489 in adults with persistent executive function impairments (efi) and partial or full remission of recurrent major depressive disorder

Conditions: Major Depressive Disorder

Summary: to evaluate the efficacy of spd489 for the treatment of executive function impairments (efi) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent major depressive disorder (mdd) as measured by the global executive composite (gec) t-score of the behavioral rating inventory of executive functioning - adult version (brief-a).


Eligibility criteria:
inclusion criteria: * adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression exclusion criteria: * current co-morbid psychiatric disorder

Keywords: major depressive disorder