Kornimate/medical-research-clean huggingface dataset:
the effect of a low fodmap diet in functional dyspepsia patients with meal related symptoms

Conditions: Functional Dyspepsia; FODMAP Diet

Summary: in this study, the investigators will evaluate the fodmap diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of fd.

the study design starts with a baseline period of 2 weeks, includes 6 weeks of a 'strict' fodmap diet (no blinded), followed by a 9 week 'reintroduction' phase (single blind). based on the patients' symptom results following each of these challenges, patients will then follow the 'moderate' fodmap diet, where the fodmaps that did not trigger any symptoms during the challenge tests can now be consumed. finally patients follow 2 weeks of a diet 'moderate' in fodmap levels (no blinded). blood and stool samples will be collected during the complete trial at several timepoints. in addition, before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test.

Eligibility criteria:
inclusion criteria: * patients with functional dyspepsia (postprandial distress syndrome) * written informed consent * 18-70 years exclusion criteria: 1. patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study 2. patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years 3. patients presenting with predominant symptoms of irritable bowel syndrome (ibs) and of gastro-oesophageal reflux disease (gerd) 4. patients who changed their diet over the last 3 months or have previously tried the low fodmap diet are excluded from the study. 5. females who are pregnant or lactating are excluded from the study.
comparison of strategies to prepare severely calcified coronary lesions 2

Conditions: Calcified Coronary Artery Disease

Summary: the isar-calc 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. the objective of this trial is to investigate final angiographic minimal lumen diameter (mld) following a strategy of super high-pressure balloon (opn nc) versus intravascular lithotripsy (ivl) for drug-eluting stent (des) implantation in severely calcified coronary lesions.

detailed information is provided elsewhere.

Eligibility criteria:
inclusion criteria: * age above 18 years and able to give consent * persistent angina despite medical therapy and/or evidence of inducible ischemia * de-novo lesion in a native coronary artery * target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation * severe calcification of the target lesion as determined by visual estimation at coronary angiography * unsuccessful lesion preparation with standard non-compliant balloon (\< 30% reduction of baseline diameter stenosis at maximal pressure) * written informed consent. exclusion criteria: * target lesion is located in a coronary artery bypass graft * target lesion is an in-stent restenosis * target lesion is a chronic total occlusion * target vessel thrombus * limited long-term prognosis due to other comorbid conditions with life expectancy \<12 months
a study to evaluate the efficacy and safety of imsidolimab (anb019) in the treatment of subjects with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: efficacy and safety of imsidolimab (anb019) in subjects with hidradenitis suppurativa

this is a phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult subjects with hidradenitis suppurativa (hs). this study also will characterize the pharmacokinetic (pk) profile of imsidolimab and explore the immune response to imsidolimab in subjects with hs.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 75 years (inclusive) at the time of signing informed consent. 2. clinically confirmed diagnosis of active hs with a disease duration of ≥ 6 months before day 1. 3. hs lesions present in at least 2 distinct anatomical areas. 4. total an count ≥ 5. 5. draining fistulas ≤ 20. 6. stable hs for at least 6 weeks prior to day 1 visit. exclusion criteria: 1. concomitant dermatological or medical conditions that may interfere with the investigators' ability to evaluate the subject's response to therapy.

Keywords: il-36 receptor interleukin 36 imsidolimab
sham cpap vs. straight cpap for chronic cough

Conditions: Chronic Cough; OSA

Summary: chronic cough is an important clinical problem in primary care and sub-specialty practice. besides the distress experienced by patients with chronic cough, significant healthcare resources are expended to understand the role of gastroesophageal reflux, asthma and post-nasal drip in understanding their contribution to cough. obstructive sleep apnea (osa) is common in patients with chronic cough. more importantly, treatment of osa with continuous positive airway pressure (cpap) has led to improvement in cough for chronic cough patients. mechanisms by which osa therapy with cpap can improve cough includes beneficial effects on reflux and airway inflammation. the aim of this study is to definitively establish that cpap therapy for treatment of osa in chronic cough patients improves cough. while these patients with chronic cough are not routinely screened and treated for osa, this study aims to evaluate these chronic cough patients with screening questionnaires for osa and if necessary with polysomnography and randomize them to either cpap or sham cpap for 6 weeks.


Eligibility criteria:
inclusion criteria: * cough of more than 2 month duration * not active smoker with history of stoppage of smoking for more than 6 months * evaluation and treatment by other providers for suspected gastroesophageal reflux disease (gerd), upper airway cough syndrome (uacs), or cough-variant asthma (cva) for at least 1 month * normal chest radiography or computed tomography (ct) scans (patients with up to 2 lung nodules less than 3 mm will be allowed if there is no history of malignancy elsewhere) * normal spirometry with predicted diffusing capacity of the lung for carbon dioxide (dlco) more than 50% predicted. pulmonary function test criteria: no evidence of airflow limitation (fev1/fvc \> 0.7) or significant chest restriction (fvc \> 70% predicted) with predicted dlco more than 50% predicted exclusion criteria: * pregnancy * recent pneumonia (less than 6 months) * congestive heart failure, acute or chronic renal disease, jaundice or chronic liver disease, pulmonary embolism, stroke or neurodegenerative disease, malignancy * use of supplemental oxygen or positive airway pressure therapy (if patients have been diagnosed with obstructive sleep apnea in the past but were non-compliant with positive airway pressure therapy, they will not be excluded) * use of opiates for cough suppression (opiate use for pain suppression can be included) * alcoholism, drug dependence (including chewing tobacco) or illicit drug use * esophageal cancer or laryngeal surgery * craniofacial abnormalities that preclude cpap placement

Keywords: obstructive sleep apnea cpap
memantine on aggression and agitation of alzheimer's disease (ad)

Conditions: Alzheimer's Disease

Summary: alzheimer's disease (ad), is associated with behavioral disturbances in approximately 50% of ad patients in beijing. agitation, and aggression specifically, is considered the most serious noncognitive symptom experienced in patients with dementia. memantine is a recognized treatment for alzheimer's disease either alone or in combination with cholinesterase inhibitors. its efficacy in vascular dementia is also established. family members continue to play a central role in home care for the demented elderly in china. this proposal is to conduct a study in beijing, china to investigate the efficacy and safety of memantine in the treatment of agitation and aggression in ad patients. in addition, this proposal aims to explore the impact of memantine on caregiver burden of ad patients in chinese culture.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. clinical diagnosis of alzheimer's disease. 3. having at least a minimum aggression score on the cohen-mansfield agitation inventory (cmai): a score of ≥ 4 on at least 1 aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occurring at a frequency of 2 and 1 at a frequency of 3. 4. availability of a responsible family member or carer to ensure treatment compliance and provide information for informant assessments. exclusion criteria: 1. unavailability of a responsible family member or carer 2. severe renal impairment. 3. history of seizures 4. diagnosis of any concomitant life threatening illness.

Keywords: alzheimer's disease, agitation, aggression, dementia
safety of cardiac pacemakers in 3 tesla mri

Conditions: Heart Diseases

Summary: to evaluate short-term and long-term effects by mr imaging at 3t on the technical and functional status of cardiac pacemakers.

recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for mr imaging at 1.5 tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for mr imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). at the same time, mr imaging at 3 tesla is evolving from a research application only to an important imaging modality today. using the improved signal-to-noise-ratio, high field mr-systems with a field strength of 3 tesla offer a variety of diagnostic advantages to 1.5 tesla systems. these advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders. in this study, we evaluate the safety of mr imaging of the brain in patients with cardiac pacemakers at 3t.

Eligibility criteria:
inclusion criteria: * urgent need for an mri examination * stable pacemaker physical parameters * battery voltage \> 2.7 v * battery impedance \< 2000 ohm * battery estimated remaining lifetime \> 6 months * lead impedances 200-2000 ohm * stable pacing parameters * pacing capture threshold \<2.5v at a pulse duration of 0.4ms * sensing \> 5mv * minimum 3 months since pacemaker and lead implantation exclusion criteria: * history of ventricular tachycardia (vt) or ventricular fibrillation * unstable angina * myocardial infarction within the previous 3 months * cardiothoracic surgery within the previous 3 months * presence of an abdominal pacemaker with lead length \> 70 cm * presence of mri incompatible bioimplants or other mri incompatible materials

Keywords: pacemaker magnetic resonance imaging safety
a study evaluating safety and tolerability of ym150 compared to warfarin in subjects with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to investigate the optimal daily dose and dose regimen of ym150 in subjects with non-valvular atrial fibrillation (nvaf), primarily based on safety and tolerability data.


Eligibility criteria:
inclusion criteria: * subject with paroxysmal, permanent or persistent nonvalvular atrial fibrillation (nvaf) * subject has prothrombin time international normalized ratio (inr) of 2.0 or below at the baseline visit exclusion criteria: * subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including tia) * subject has active bleeding or any condition associated with increased risk of bleeding * subject has nvaf secondary to other reversible disorders (e.g. thyrotoxicosis) * subject has an indication for warfarin other than af (including planned cardioversion) * subject has had a diagnosis of acute coronary syndrome (acs), coronary artery bypass graft (cabg) or percutaneous transluminal coronary angioplasty (ptca) within previous 3 months of screening * subject has a diagnosis of left ventricular aneurysm or atrial myxoma * subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics \[such as tissue plasminogen activator (tpa), streptokinase\], antiplatelet agents \[such as cilostazol, clopidogrel, ticlopidine, dipyridamole\], anticoagulants \[such as vitamin k antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors\] and chronic use of nonsteroidal anti-inflammatory drugs \[nsaids\] or acetylsalicylic acid use of \>100 mg/day). (see section 5.1.3 and appendix 1 for details) * subject has active infective endocarditis * subject is planned for invasive procedures with potential for bleeding * subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study * subject has participated in any ym150 clinical trials

Keywords: nonvalvular atrial fibrillation (nvaf) factor xa inhibitor stroke thromboembolism transient ischemic attack anticoagulants prevention ym150 warfarin
safety and tolerability of ²¹²pb-dotam-grpr1 in adult subjects with recurrent or metastatic grpr-expressing tumors

Conditions: Cervical Cancer; Prostate Cancer Metastatic; Breast Cancer; Colon Cancer; NSCLC; Cutaneous Melanoma

Summary: a phase 1 sad/mad dose escalation and expansion study to determine the safety and effectiveness of ²¹²pb-dotam-grpr1 in subjects with various grpr-expressing tumors

in this open-label, dose escalation and dose expansion single ascending dose (sad) and multiple ascending dose (mad) phase 1 study, adult subjects with recurrent or metastatic histologically confirmed grpr-expressing tumors will be enrolled. in the dose escalation portion, a classic 3+3 design will be utilized. dose escalation may proceed until the recommended mad dose is determined. up to four cohorts are expected to be enrolled. once the recommended mad dose is determined, no additional subjects will be enrolled in the sad escalation portion and the mad portion of the study will commence. subjects will be treated with up to four cycles administered every 8 weeks.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years old with the following histologically confirmed metastatic or recurrent grpr-expressing tumors: 1. metastatic castrate resistant prostate cancer (mcrpc); 2. hr+/her2- breast cancer; 3. colorectal cancer; 4. cervical cancer; 5. cutaneous melanoma; 6. non-small-cell lung cancer (nsclc). * biopsies must demonstrate the following on immunohistochemistry (ihc): * 51-80% positively staining cells; and * moderate intensity of staining. * subjects with recurrent disease must have progressed on at least 2 prior systemic therapies. * presence of at least 1 site of measurable disease per recist 1.1 within 1 month prior to cycle 1 day 1. for subjects with prostate cancer, bone lesions may be used to fulfill the eligibility requirements per pcwg3 in lieu of measurable disease per recist 1.1. * eastern cooperative oncology group (ecog) status 0-2. * sufficient bone marrow capacity and organ function as defined by: 1. white blood cell (wbc) ≥2,500/ mm³ 2. absolute neutrophil count (anc) ≥1500/mm³ 3. platelets ≥75,000/mm³ 4. hemoglobin (hgb) ≥9.0 g/dl; exclusion criteria: * previous whole-body radiotherapy or peptide receptor radionuclide therapy (prrt) with either alpha or beta emitters, or subjects with mcrpc who have received radium-223 (²²³ra). * known hypersensitivity to any component of ²¹²pb-dotam-grpr1. * exposure to any other grpr-targeting therapeutic agents. * history of chronic pancreatitis * history of pneumonitis. * impaired cardiac function defined as: 1. new york heart association (nyha) class iii or iv; 2. qtc \> 470 msec for females and qtc \>450 msec for males on screening electrocardiogram (ecg) or congenital long qt syndrome; 3. acute myocardial infarction or unstable angina pectoris \< 3 months prior to study enrollment. * cyclical chemotherapy, radiotherapy, or biologic therapy (e.g. antibodies), continuous or intermittent, small molecule therapeutics, or any investigational agents within a period which is ≤ 5 half-lives or ≤ 4 weeks (whichever is longer) prior to day 1.
ureteral stents versus percutaneous nephrostomy for initial urinary drainage

Conditions: Children; Obstructive Uropathy; Acute Renal Failure; Ureteric Stones

Summary: to compare percutaneous nephrostomy (pcn) versus double j stent (jj) as an initial urinary drainage in children

to compare percutaneous nephrostomy (pcn) versus double j stent (jj) as an initial urinary drainage in children with obstructive calcular anuria and acute renal failure due to ureteric calculi to identify selection criteria for initial urinary drainage method to improve drainage, to decrease complications and to facilitate subsequent definitive clearance of stones as this comparison is lacking in literature

Eligibility criteria:
inclusion criteria: * children ≤12 years old presenting with obstructive anuria and acute renal failure due to bilateral ureteric stones exclusion criteria: * patients with grade 0-1 hydronephrosis * fever, pyonephrosis or sepsis. * any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).

Keywords: anuria children nephrostomy stents urinary calculi
evaluation of stress response in diabetic hypertensive patients

Conditions: Diabetes; Hypertension

Summary: in this research, we aimed to examine salivary cortisol changes in the cognitive stress response of patients with hypertension + diabetes mellitus (ht+dm) and hypertension (ht) and to determine the differences between them. the research was conducted by solving an arithmetic task as a stress test in 62 patients with ht+dm and ht that are being treated in the outpatient clinic of medical pharmacology and clinical pharmacology department at istanbul university, istanbul medical faculty hospital.

in this study, saliva samples were taken for cortisol measurement, and patients were instructed to place the cotton piece in the salivette® tubes directly into their mouths without touching it with anything, hold it for 30-60 seconds, and then insert it back into the tubes in the same way, four times total, once before arithmetic stress and three times after stress, on tuesdays, wednesdays, and thursdays between the hours of 12:00-16:00. salivary cortisol was measured using the electro-chemiluminescence immunoassay.

Eligibility criteria:
inclusion criteria: 1. using antihypertensive treatment for the last 3 months 2. diagnosed with type 2 diabetes mellitus and taking medication for at least 3 months 3. being between the ages of 40-65 4. being male 5. having signed the informed consent form exclusion criteria: 1. female gender 2. patients younger than 40 years old or older than 65 years old 3. uncontrolled blood pressure (sbp\>140 mmhg, dbp\>90 mmhg) 4. using antipsychotic medication 5. using current treatment for less than 3 months 6. having a previous mi 7. having a previous stroke 8. having a lung disease 9. having organ failure 10. having cushing's disease 11. having aldosteronism 12. failure to sign the informed consent form

Keywords: diabetes mellitus hypertension cortisol stress aldosterone
comparative study of analgesic effect of ultrasound guided peng block vs femoral block in hip fracture

Conditions: Hip Fracture

Summary: to study the analgesic effect of ultrasound guided peng block vs femoral nerve block in patients with hip fracture presenting to emergency department

comparative study of analgesic effect of ultrasound guided peng block vs femoral nerve block in patients presenting to emergency department

Eligibility criteria:
inclusion criteria: * adults more than or equal to 18 yrs with hip fracture * patients who consent for procedure exclusion criteria: * history of allergy to local anaesthetics * pregnant or lactating women * infection or burns at injection site * patients with polytrauma * patients with hemodynamic instability * patients with low gcs * patients on anticoagulant or hematological disorders * injuries with neurovascular compromise on affected limb * patients with distorted anatomy
interactive acute smooth muscle effects of salmeterol and fluticasone in the airway

Conditions: Asthma

Summary: the addition of an inhaled long-acting beta-adrenergic agonist to an inhaled glucocorticosteroid improves disease control in persistent asthma. this observation has supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination preparations for the management of asthma. currently, salmeterol/fluticasone and formoterol/budesonide are available for clinical use. the long-term beneficial clinical effects of the two drug classes seem to be synergistic, and several mechanisms of glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been invoked to explain this phenomenon.this study, wish to address the question whether glucocorticoids can acutely potentiate the bronchodilator response to a long-acting beta-adrenergic agonist.we expect that in patients with asthma, the short-term bronchodilator effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no short-term bronchodilator effect. to test this premise, we will assess the respective short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone (50/250 µg), and placebo/placebo on spirometric parameters. airway blood flow will also be measured to ensure that vasoconstriction does not occur.

fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the study. all subjects will be allowed to use short-acting beta-adrenergic agonists as rescue medication. inclusion criteria: 1. males and females, 18 to 65 years of age. 2. fev1 60-85% of predicted on the screening day. exclusion criteria: 1. women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. cardiovascular disease and/or use of cardiovascular medications 2. subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. acute respiratory infection within four weeks prior to the study 5. use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

Eligibility criteria:
inclusion criteria: 1. males and females, 18 to 65 years of age. 2. fev1 60-85% of predicted on the screening day. - exclusion criteria: 1. women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. cardiovascular disease and/or use of cardiovascular medications 3. subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. acute respiratory infection within four weeks prior to the study 5. use, within two weeks prior to the study, of any anti-asthma medication not mentioned above -

Keywords: asthma, corticosteroids, bronchodilator, airway blood flow
study of the incidence and prognosis of intrahospital acute kidney injury

Conditions: Acute Kidney Injury

Summary: the goal of this observational study is to investigate the epidemiology of acute kidney injury in hospitalized patients. the main question it aims to answer is: how frequent is the development of acute kidney injury in patients who are hospitalized? data from participants will be retrospectively collected from medical charts.


Eligibility criteria:
inclusion criteria: * patients hospitalised from 01/01/2019 to 31/12/2023 * availability of a hospital discharge form * at least one serum creatinine (scr) determination available exclusion criteria: * day-hospital admission * discharge after an emergency room admission without hospital admission * stage iv and v ckd

Keywords: acute kidney injury hospitalized