Kornimate/medical-research-clean huggingface dataset:
pain relief during photodynamic therapy for actinic keratoses with a new irradiation protocol

Conditions: Therapy, Photodynamic; Keratosis, Actinic; Pain

Summary: this pilot study will try to minimize the pain during exposure to a new red light source (rhodoled®, biofrontera bioscience gmbh, leverkusen, germany) used for pdt without compromising its effect on aks. the study design will have an open and prospective, two-armed, split-face design. participants with ak lesions distributed symmetrically on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands are eligible for inclusion. the purpose is to investigate if a modified irradiation protocol can lower the pain while having the same effect on ak clearance rates as compared to the standard pdt irradiation protocol. before any study-related procedures are performed, the participants will be thoroughly informed about the study and will be given the opportunity to ask questions. the participants will thereafter sign and date the informed consent form. this constitutes as visit 0. on visit 1, a randomization to either the standard or the modified irradiation protocol will be performed on one side of the face/body and the other irradiation protocol will then be applied on the other side of the face/body. the participants should have aks on two comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. one side will be randomized to receive pdt with bf200-ala and irradiation with the rhodoled® lamp and the other side will receive bf200-ala and the aktilite cl-128 lamp (photocure asa, oslo, norway), which is the traditional lamp used at our department as mentioned above. the treatment will be given at visit 1. during the treatment, the participants will be asked continuously, every third minute, to estimate the pain on each treatment side using the visual analogue scale, vas, (where 0 is no pain and 10 is the worst pain imaginable). at the end of the treatment, the participants will also be asked to summarize the treatment as a whole on the vas-scale. after visit 1, the participants will fill in a follow-up diary form with questions regarding adverse effects (aes) during the hours and days after the treatment. the efficacy of the treatment will also be assessed at a follow-up (fu) visit, visit 2. the investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation protocol should be at least as good as the standard irradiation protocol. the randomization is blinded for the investigator at the fu visit to minimize the possibility of favoring one irradiation protocol.


Eligibility criteria:
inclusion criteria: * patients with symmetrically distributed aks on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands. * patients \>18 years of age who have signed a written informed consent. exclusion criteria: * pregnant or breast-feeding. * participating in other clinical study at the same time or within 30 days. * conditions associated with poor protocol compliance, e.g. excessive use of alcohol or drug abuse.
safety and tolerability of azd1656 in type 2 diabetes mellitus (t2dm) patients treated with metformin and sulfonylurea

Conditions: Type II Diabetes Mellitus

Summary: the primary aim of this study is to evaluate the safety and tolerability of azd1656 in t2dm patients treated with metformin and sulfonylurea.


Eligibility criteria:
inclusion criteria: * male or females of non-childbearing potential * patients treated with a combination of metformin and su (glyburide, glimepiride, glibenclamide, glipizide or gliclazide) in stable doses for at least 2 months prior to enrolment visit * patients should have fpg in the range of 6,0 to 14 mmol/l (108 to 250 mg/dl) at enrolment and on the morning of randomisation exclusion criteria: * history of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease * impaired renal function in terms of gfr\<60 ml/min * use of insulin, glitazones, gemfibrozil, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent cyp450 inhibitors, e.g., ketoconazole within 14 days before randomisation

Keywords: type ii diabetes mellitus metformin sulfonylurea
effects of empagliflozin on exercise capacity and left ventricular diastolic function in patients with heart failure with preserved ejection fraction and type-2 diabetes mellitus

Conditions: Heart Failure, Diastolic; Diabetes Mellitus, Type 2

Summary: patients enrolled into the study will be randomly allocated either to empagliflozin group or control group. in the empagliflozin group patients will be receiving standard care + empagliflozin 10 mg o.d., in the control group patients will be receiving standard care without sodium glucose contransporter 2 (sglt2) inhibitors.


Eligibility criteria:
inclusion criteria: 1. males and females aged 45 to 80 years at screening 2. diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks 3. hba1c ≥ 6,5% and ≤ 10% at screening 4. diagnosis of hfpef which includes: * symptoms ± signs (as defined in 2016 european society of cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure) * ejection fraction ≥ 50% (by simpson) * increased lv filling pressures at rest or during exercise determined by echocardiography (lv diastolic dysfunction grade ii/iii and/or positive diastolic stress test) \[according to american society of echocardiography and european association of cardiovascular imaging (ase/eacvi) recommendations for the evaluation of left ventricular diastolic function by echocardiography, 2016\] 5. signed and dated informed consent exclusion criteria: 1. pretreatment with empagliflozin or other sglt-2 inhibitor within the last 2 months 2. type-1 diabetes mellitus 3. nyha classification iv or acute decompensated heart failure at screening 4. impaired renal function, defined as egfr \<30 ml/min/1.73 m² of body-surface-area (ckd-epi) 5. systolic blood pressure \> 180 mmhg or \< 90 mmhg 6. permanent atrial flutter or atrial fibrillation 7. other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis and etc. 8. anemia (hb \< 100 g/l) 9. myocardial infarction, coronary artery bypass graft surgery within the last 3 months 10. stroke or tia within the last 3 months 11. indications of liver disease 12. acute genital infection or urinary tract infection 13. pregnancy 14. additional exclusion criteria may apply

Keywords: hf hfpef dm empagliflozin jardiance
study of auditory perception after progressive exposure to aversive sounds in people with misophonia

Conditions: Misophonia

Summary: the primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects.


Eligibility criteria:
inclusion criteria: for all participants * obtain oral consent from the participant after receiving information about the study, * be 18 years or older on the day of inclusion, * be fluent in french (spoken and written), * have no known hearing loss, verified by pure tone audiometry. * declare that they do not have tinnitus, * declare that they do not have hyperacusis, verified by measuring discomfort thresholds. * be affiliated to the social security or equivalent scheme. for participants with misophonia: - declare discomfort, reduced tolerance to specific sounds (mouth noises, throat clearing, breathing, etc.). exclusion criteria: * bear the after-effects of an ear infection and/or have a history of an ent disease that permanently affects hearing or balance (vestibular schwannoma, ménière's disease, sudden or fluctuating deafness, congenital hypoacusis), * be under guardianship, * deprived of liberty by judicial or administrative decision, or subject to legal protection.
feasibility study of hipec for patients with stage iii or only pleural stage iv ovarian carcinoma in first line therapy

Conditions: Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma

Summary: first line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (hipec) after optimal debulking.

addition of hipec to the standard first line treatment of ovarian carcinoma.

Eligibility criteria:
inclusion criteria: * stage iii or only pleural stage iv ovarian carcinoma first line treatment exclusion criteria: * incomplete surgery poor performance status bad general condition

Keywords: hipec ovarian carcinoma bordet
chronic kidney disease (ckd) guideline adherence - a quality improvement study

Conditions: Chronic Renal Insufficiency

Summary: chronic kidney disease (ckd) is defined as kidney damage for greater than 3 months or a glomerular filtration rate less than 60 ml/min per 1.73m2 for greater than 3 months. patients with ckd are at high risk for development of cardiovascular disease and metabolic complications. guidelines for the care of patients with ckd have been developed by the national kidney foundation. despite the wide availability of these guidelines, adherence is low. the goal of the current study is to evaluate whether a multifactorial intervention, including a ckd registry, will improve ckd guideline adherence. the hypothesis is that providers exposed to a multifactorial clinical intervention including education, academic detailing, and a ckd registry will be more likely to adhere to ckd guidelines than those only exposed to education.


Eligibility criteria:
providers: inclusion criteria: * all primary care providers at the wade park veterans affairs medical center (vamc) will be eligible for the study patients: inclusion criteria: * receive primary care from a provider at the wade park vamc * have: * ckd as defined by an estimated glomerular filtration rate (egfr) less than 60 on two separate occasions 90 to 730 days apart, * diabetes, or * hypertension exclusion criteria: * end-stage renal disease * renal transplant recipients * less than 18 years of age on july 1, 2009 * no primary care visit between jan 1, 2008 and july 1, 2009
defining a vascular phenotype of pancreatic ductal adenocarcinoma with ct perfusion using quantitative radiomics

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma

Summary: with ct-perfusion(ctp) it is possible to visualize the enhancement pattern of the tumor. the perfusion ct, interleaved with a routine contrast enhanced ct (cect) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). also, the histopathology will be collected for resected tumors to perform histopathology analysis. ctp parameters will be correlated to immunohistological findings and clinical outcome. the main goal of the study is to create an ai-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (pdac). the investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.


Eligibility criteria:
inclusion criteria: * clinical suspicion of pancreatic cancer * 18 years and older * written (signed and dated) informed consent exclusion criteria: * contra-indications to undergo ct (due to untreatable contrast allergy or renal function impairment) * previous treatment for pancreatic cancer * concomitant malignancies. subjects with prior malignancies must be disease-free for at least 5 years * insufficient command of the dutch language to be able to understand the patient information

Keywords: pancreas pancreatic cancer ct perfusion histopathology imaging biomarker
clinical characterization of very and extremely preterm infants who received excess erythrocyte transfusions with respect to has 2014 recommendations

Conditions: Very Preterm and Extremely Preterm Birth; Anemia; Erythrocyte Transfusion; Excess Transfusion

Summary: prematurity affects around 60,000 births a year in france. extremely premature babies are particularly fragile and require multiple erythrocyte transfusions to maintain an effective hemoglobin level for metabolism and continued somatic and neurological development. many known risk factors, such as multiple blood sampling for biological diagnosis, lead to a more rapid fall in hemoglobin concentration, reducing the amount of oxygen delivered in the tissues. in addition, red blood cell regeneration is very low in premature infants, while the half-life of red blood cells is shorter than in older children and adults. the result is severe anemia. its main treatment is erythrocyte transfusion. it is associated with biological benefits, but has digestive, ophthalmological, pulmonary, metabolic and neurological side effects. to ensure a good benefit/risk ratio, a commission of the has issued recommendations in 2014 for erythrocyte transfusion in premature infants \< 32 weeks of amenorrhea in france. yet many transfusions continue to be performed outside the has 2014 criteria. a retrospective monocentric study was carried out in order to understand this situation. data from premature infants \< 31 weeks of amenorrhea (wks) born between july 2022 and july 2024 were collected via computerized hospitalization records (dxcare, diane and demserv software). their transfusion status during the first twenty-eight days of life was analyzed. the has decision algorithm was used to identify excess transfusions and develop a patient classification.


Eligibility criteria:
inclusion criteria: * age : ≤ 28 days of life * premature newborn with term of birth \< 31 weeks hospitalized in intensive care or neonatology intensive care at chu amiens-picardie (chu-ap) between july 2022 and july 2024, whether born at chu-ap maternity unit or transferred secondarily exclusion criteria: * newborn with term of birth ≥ 31 weeks and \> 28 days of life

Keywords: very preterm and extremely preterm birth anemia erythrocyte transfusion excess transfusion
home-based transcranial direct current stimulation (tdcs) for depression in multiple sclerosis (ms)

Conditions: Multiple Sclerosis; Depression

Summary: this project is a double-blind, sham-controlled, parallel-arm, randomized controlled trial. we will recruit n=170 people living with ms, who are experiencing an episode of depression in the context of a major depressive episode (mde). using our remotely supervised (rs) tdcs protocol, enrolled participants will complete 30 days of 30-minute tdcs (2.0, dlpfc left anodal) while listening to mindfulness meditation. over the course of the study, participants will complete assessments of depression and ms symptoms. participants will be randomized 1:1 active:sham tdcs.


Eligibility criteria:
inclusion criteria: * age: 18-65 years (inclusive) * diagnosis: confirmed diagnosis of multiple sclerosis (ms), including relapsing-remitting or secondary progressive subtypes * stable medications: stable use of antidepressant and disease-modifying therapies (dmts) for at least 30 days prior to enrollment * stable disease activity: defined as no clinical relapse, no new radiological disease activity, and no recent steroid treatment for at least 30 days prior to enrollment * provider contact: confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms * technical ability: ability to use mobile devices and participate in remote, video-supervised sessions exclusion criteria: * neurological or medical disorders: history of primary neurological disorder other than ms (e.g., stroke, parkinson's disease, traumatic brain injury (tbi), intracranial mass, epilepsy, mild cognitive impairment (mci), dementia), major psychiatric disorders (e.g., bipolar disorder, psychotic disorders), or serious medical conditions (e.g., myocardial infarction, thyroid disease, diabetes with complications, atrial fibrillation) * substance use: nicotine use (e.g., smoking or vaping) within the past 6 months * pregnancy and breastfeeding: currently pregnant, planning pregnancy during the study period, or breastfeeding. if able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (iud), or abstinence. participants will be advised not to become pregnant during the study. * seizure history: history of seizures or seizure disorder within the past 5 years * implanted devices or metal objects: presence of metal in the head/neck area (excluding dental fillings) or implanted medical devices (e.g., neurostimulators, pacemakers, defibrillators) * skin conditions: active skin disorders or skin sensitivity near electrode application sites

Keywords: multiple sclerosis depression neuromodulation home-based transcranial direct current stimulation
esmolol effects on heart and inflammation in septic shock

Conditions: Septic Shock

Summary: beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. experimental works demonstrated that esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. a recent mono centric, double blind, randomized clinical work in septic shock patients has shown that esmolol administration is safe and reduces effectively heart rate. however there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.


Eligibility criteria:
inclusion criteria: * septic shock patients following the definition of the surviving sepsis campaign * femoral and central venous catheters for thermodilution monitoring * fluid optimization * with a cardiac index \> 3 l/min/m2 * heart rate \>100 /min exclusion criteria: * cardiogenic shock * bradycardia * history of severe asthma * indications against esmolol

Keywords: septic shock hemodynamic inflammatory status beta adrenergic modulation esmolol
characteristics, phenotypes, and traits of heart failure with preserved ejection fraction (traits-hfpef)

Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary: heart failure with preserved ejection fraction (hfpef), a certain type of heart failure, occurs when the heart doesn't pump blood around the body properly. it can cause breathlessness, tiredness, and swollen feet or ankles. it is not clear why people develop hfpef and treatment options are very limited. traits-hfpef is a study that aims to understand why people develop hfpef, identify new tests and treatments, and gain information on the life expectancy of people living with this condition. it will do this by routinely collecting information on people attending a specialised outpatient hfpef clinic.

hfpef represents the single largest unmet need in cardiovascular medicine (butler et al, 2014). the proportion of patients with hfpef ranges from 22 to 73% of all heart failure patients across all clinical settings, including primary care, hospital care and hospital admission (ponikowski et al, 2016). treatment options in hfpef are very limited, and several clinical trials have demonstrated neutral results when assessing survival benefit from medical therapy. a common theme for this is the heterogeneity that exists in the hfpef patient population and non-targeted therapy is inadequate for this diverse population. patients need to be characterised according to their clinical phenotypes and underlying biological mechanisms in order to provide targeted patient-specific treatment. (shah et al, 2016) traits-hfpef is an observational cohort study that aims to assess the epidemiology, and the association of clinical variables and outcomes of patients with hfpef. a dedicated specialist hfpef clinic provides the opportunity to recruit and collect data on a large cohort of patients that can provide insights into different hfpef phenotypes and their associations and outcomes. this can help direct future research and delivery of specialist care. all patients attending the hfpef clinic at manchester university nhs foundation trust (mft) will be approached. the expectation is to recruit approximately 1,250 patients over a 5-year period. with the patients consent, a blood sample of approximately 10ml will be taken for biobanking to allow measurement of yet to be identified biomarkers, including plasma and dna. this will be optional for patients. all clinical variables will be documented at the time of the recruitment.

Eligibility criteria:
inclusion criteria: * patients attending the hfpef clinic at mft. exclusion criteria: * age \< 18 years * imprisonment * inability to provide full written or verbal informed consent in english
efficacy of intra-articular injections for the treatment of primary glenohumeral osteoarthritis(ghoa)

Conditions: Arthritis Shoulder

Summary: the purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. the efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral oa is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. this study will help elucidate the therapeutic benefit of corticosteroid and platelet rich plasma (prp) injections in this patient population.


Eligibility criteria:
inclusion criteria: * patient ≥18y.o. of age * primary glenohumeral arthritis (bone on bone or near bone on bone) that has been previously diagnosed on radiographs and clinical evaluation. * baseline pain level of vas \>4 exclusion criteria: * secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis) * ipsilateral shoulder surgery within 1 year * any glenohumeral joint injection within 3 months * allergy to lidocaine * known pregnancy * workers compensation case regarding shoulder
a study of tirzepatide (ly3298176) in participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * have had type 2 diabetes (t2d) for ≥6 months according to the world health organization (who) classification. * have hba1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory. * if on metformin, have been treated with stable doses of metformin for at least 3 months. * have a body mass index (bmi) ≥23 and \<50 kilograms per square meter. exclusion criteria: * have type 1 diabetes (t1d). * have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (glp-1 ras) at any time in the past. * have had any of the following cardiovascular conditions: acute myocardial infarction (mi), new york heart association class iii or class iv heart failure, or cerebrovascular accident (stroke). * have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine aminotransferase (alt) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with nafld are eligible for participation in this trial. * have had chronic or acute pancreatitis any time prior to study entry. * have an estimated glomerular filtration rate (egfr) \<45 milliliters/minute/1.73 square meter, calculated by the chronic kidney disease-epidemiology (ckd-epi) equation. * have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry. * have any condition that is a contraindication for use of the glp-1 ra class (per country-specific labels) at study entry or develop such condition between study entry and randomization.