Kornimate/medical-research-clean huggingface dataset:
mental effects of analgesic drugs: paracetamol and ibuprofen

Conditions: Empathy

Summary: the objective of the present study is to study paracetamol effects on social pain and empathy under standardized international conditions (ich-gcp) for planning, conduction and reporting of clinical pharmaceutical studies in humans. the study included mri imaging of brain activity, analysis of genomic biomarkers potentially explaining interindividual variation. it is controversial whether the effects are of immediate nature or develop during a period of about 10 days. therefore, the study is separated into two study phases. single dosing (sd) is applied in study phase 1 and multiple-dosing (md) in study phase 2. the study compares paracetamol with placebo and in the study phase 1 also with ibuprofen as analgetically active control.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to study. 2. willingness to meet the study instructions and to co-operate with the study personal. 3. no clinically relevant pathological findings in any of the investigations at the screening visit; minor deviations of laboratory values from the normal range may be accepted if judged by the investigator to have no clinical relevance. 4. body weight not less than 48 kg and body mass index (bmi) not less than 17 kg/m² and not greater than 32 kg/m². exclusion criteria: 1. pacemaker devices, implantable or external ones. 2. involvement in the planning and conduct of the study (applies to staff directly employed at the study site / department). 3. known pregnancy or lactation period. 4. history of alcohol and / or drug abuse and / or any abusive use of medicaments. 5. any disease affecting liver or kidney or impairment of the liver or kidney-function. 6. history of severe hypersensitivity reactions, anaphylaxis, psychiatric or neurologic disorder.

Keywords: mental effects social pain
study to investigate relative bioavailability of up to five different formulations of azd5069

Conditions: Uncontrolled and Persistent Asthma

Summary: study to investigate relative bioavailability of up to five different formulations of azd5069

an open-label, single centre relative bioavailability study with an adaptive design comparing up to 5 solid oral azd5069 formulations after single dose administration to healthy volunteers

Eligibility criteria:
inclusion criteria: 1. healthy male and/or female volunteers aged 18 to 50 years (inclusive). 2. non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening. 3. body mass index (bmi) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg. 4. healthy volunteers with neutrophil counts within the laboratory range at screening. - exclusion criteria: 1. a definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to azd5069 and/or the excipients, as judged to be clinically relevant by the investigator. 2. healthy volunteers who have previously received azd5069. 3. volunteers with latent tuberculosis as suggested by their history and judged by the investigator; confirmatory testing with eg, quantiferon(r) -tb gold may be done if required. 4. volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the ip -

Keywords: relative bioavailability, healthy volunteers, neutrophils
effect of omega3 supplementation in diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: the main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.

diabetic retinopathy (dr) is a leading cause of vision loss worldwide and is a major public health problem. in western countries, the prevalence of dr is estimated to be 35% in diabetic patients, while diabetic macular edema (dme) affects 5% of them. currently, apart from the balance of diabetes and other cardiovascular risk factors, no specific treatment is given for the minimal and moderate non-proliferative forms. * dha concentration in the retina can be modified according to the patient's diet. * minimal diabetic retinopathy does not currently benefit from specific treatment outside of diabetic control. * omega 3 are already known for their beneficial effects on the retina, brain and cardiovascular system but their effectiveness has not been tested on diabetic retinopathy. * it is therefore a question of evaluating whether an omega 3 supplementation, at a dosage of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy. a study by salavila et al. has shown that the intake of lcω3pufa, via a mediterranean diet, improved the stage of dr in diabetic patients.

Eligibility criteria:
inclusion criteria: * ≥18 years * for women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study. * diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the etdrs (earlytreatment of diabeticretinopathystudy) classification. * av \> 6/10 * one eye included. if both are affected, the eye with the poorer perfusion should be included. * affiliated to a social security scheme exclusion criteria: * \< 18 years old. * pregnant or breastfeeding woman * other retinal pathologies that may interfere with the results (patients previously treated with anti-vegf, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness \> 280 µm, eyes with spherical equivalent greater than 8 diopters, octa images not interpretable with many artifacts.) * hypersensitivity to any of the components of nutrof or meralut * taking the antivitamin k * known deficit in g6pd- * history of renal lithiasis * kidney failure * immunosuppression * chronic ethylism * history of hepatopathy * intracranial tumor, intracranial hypertension * refusal to participate * patient participating in an intervention study.
frozen-thawed embryo transfer in a natural cycle: hcg triggering versus lh home test

Conditions: Infertility

Summary: the primary aim of this study is to find out if ovulation triggered with hcg provides any additional benefit in comparison to spontaneous lh surge measured with the lh surge home test when transferring frozen-thawed embryo in a natural cycle.

the aim of this study is to find out the best method for the ovulation triggering. we study the live birth rates in the both groups.

Eligibility criteria:
inclusion criteria: * - patient with ivf or icsi cycle and therefore having frozen-thawed embryos * regular menstruation cycle * patient's willingness to participate in the study exclusion criteria: * - irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo * no frozen embryos after ivf cycle * allergy to pregnyl® or some of its ingredients in the medication or other contraindications due to pregnyl®
management strategies for electrical status epilepticus during sleep

Conditions: Epilepsy

Summary: electrical status epilepticus during slow wave sleep is a condition in which the epileptic patient starts to develop neurocognitive deterioration, any type of seizures and continuous electrical activity in the eeg during non rapid eye movement sleep. it is an age related condition and will resolve spontaneously at around the age of puberty. however if left untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration. thus early diagnosis and treatment is essential in these children to preserve neurocognitive function.

electrical status epilepticus in sleep (eses), also known as continuous spikes and waves during slow sleep (csws), is an age related, self - limiting disorder characterized by: 1. epilepsy with different seizure types, 2. neuropsychological regression, and 3. typical eeg pattern of continuous epileptiform activity during non-rapid eye movement sleep (nrem). during wakefulness, the eeg shows focal/multifocal spikes that increase in frequency during the acute stage. during sleep, eses appears and is characterized by (1) marked potentiation of epileptiform discharges during non-rem sleep, leading to (2) a (near)-continuous, bilateral, or occasionally lateralized slow spikes and waves, (3) and these spikes and waves occur "during a significant proportion" of the non-rem sleep with a threshold ranging from 25% to 85% the exact incidence of csws is not known. in pediatric neurology clinics, a reported frequency of 0.2% of childhood epilepsies most probably underestimates the incidence of csws. csws is a devastating syndrome, which requires prompt treatment, the efficacy of which is checked with regular intervals, e.g. three or six months. although epilepsy resolves with time in most cases, many children are left with significant cognitive or language impairment. longer duration of eses appears to be the major predictor of poor outcome. so, early recognition and effective therapy are necessary to improve long-term prognosis in this condition. the goal of treatment is not only to control clinical seizures but also to improve neuropsychological functions and prevent potential cognitive deterioration. there was no agreement on best treatment, but potential candidates included high-dose benzodiazepines, valproate, levetiracetam, and corticosteroids.

Eligibility criteria:
inclusion criteria: * all epileptic patients above 2 years of age presenting with neuropsychological deterioration, seizures and eses in nrem sleep. the degree of epileptic activity during sleep will be measured and expressed as a spike wave index (swi), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration. swi must be at least 25% or more. exclusion criteria: * any epileptic patient not presenting with typical eeg findings and neurocognitive regression.

Keywords: electrical status epilepticus during slow wave sleep seizure cognition continuous spikes and waves during sleep
physical and cognitive performance in older adults with fatigue

Conditions: Fatigue

Summary: fatigue is a common symptom in older adults, often linked to various medical conditions, medications, and psychosocial factors, and it can adversely affect both physical and cognitive performance in the aging population, contributing to functional decline and reduced quality of life. assessment of the physical impact of fatigue on physical and cognitive performance in older adults can offer valuable insights for clinical practice and holistic geriatric care. therefore, this study will validate subjective tools used for measuring the impact of fatigue against objective measures.


Eligibility criteria:
inclusion criteria: * participants aged 60 years old and above both males and females exclusion criteria: * o patients with acute medical illness. * patients with life threatening illnesses. * bedridden patients. * patients with diagnosed malignancy. * patients with debilitating chronic disease (end organ failure) (e.g. heart failure , renal failure, and liver cell failure). * patients with neurological diseases (e.g. moderate to severe dementia, stroke, parkinsonism) that interfere with the assessment process. * patients with musculoskeletal conditions that interfere with the assessment process (fracture, disabling osteoarthritis, painful arthritis). * patients with severe uncorrected hearing loss, vision impairment, or aphasia that may impede effective communication during the assessment.

Keywords: fatigue older adult
vitamin d supplementation in wheelchair indoor athletes

Conditions: Vitamin D Deficiency; Spinal Cord Injury; Drug Effects; Dietary Supplements; Physical Education and Training/Methods

Summary: there is a high prevalence of vitamin d deficiency in switzerland. in indoor-athletes as well as wheelchair users, vitamin d deficiency occurs even more often. it is well established that vitamin d deficiency has a negative effect on health. however, vitamin d supplementation in individuals with a vitamin d deficiency has a positive effect on muscle performance. in recently published studies with able-bodied subjects, it has been shown that a normal vitamin d level (\>75nmol/l) can only be achieved with a high-dose supplementation of vitamin d. the aim of this study is to examine the effect of vitamin d supplementation on exercise performance in wheelchair athletes with vitamin d deficiency . all participants with a vitamin d deficiency are assigned to the intervention group and treated with 6000 iu of vitamin d3 daily over a period of 12 weeks. all participants who have a normal vitamin d level will receive placebo treatment (control group). the physical performance is measured three times at baseline, after six weeks and 12 weeks. the measurements include a wingate and a dynamometer test.


Eligibility criteria:
inclusion criteria: * swiss elite wheelchair athlete * 18 to 60 years * male, healthy * at least 2x45min sports a week exclusion criteria: * participation in another study * medication which influences performance * respiratory and cardiovascular disease * daily intake of \>400iu vitamin d * parathyroid gland disease * kidney insufficiency * visit abroad below the 37th parallel latitude during study or shortly before

Keywords: vitamin d exercise performance wheelchair athletes indoor sports wingate isokinetic dynamometer
validity of profile fitness mapping low back questionnaire

Conditions: Low Back Pain; Pain; Assessment, Self; Disability Physical

Summary: as patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. for this reason, it would be useful to make measurements that evaluate all the parameters of the patients. thus, it would be more advantageous to score both pain and symptoms separately, as well as activity limitations. therefore, neck specific surveys are needed to meet this need. for this reason, this study was planned to determine the validity of the questionnaire named "profile fitness mapping low back questionnaire" in patients with low back pain.

the translation of the original version of "profile fitness mapping low back questionnaire" to turkish will be translated by two independent professional translators. afterwards, a person without a medical history and a native english speaker will be translated into english again. once the translation stages are complete, the translators will be brought together to discuss the two versions of the questionnaire. then the final state will be translated into the main language of the questionnaire and the compliance will be checked. first of all, people who have been suffering from low back pain for at least six months will complete the "profile fitness mapping low back questionnaire", "oswestry disability index" and "sf-36 health related quality of life questionnaire". seven days after the questionnaire, the "profile fitness mapping low back questionnaire" will be completed again.

Eligibility criteria:
inclusion criteria: * low back pain for more than six months during activity or rest * having a problem with low back based on clinical examination and story exclusion criteria: * having neurological problems * having vestibular or cerebellar problems

Keywords: validity low back pain functional pain questionnaire
off clamp randomization

Conditions: Renal Cancer; Renal Ischemia

Summary: the purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.


Eligibility criteria:
inclusion criteria: * patients 18 and older. * patients willing and able to sign consent. * patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (rapn). * patient with karnofsky performance status (kps) equal to or greater than 40. exclusion criteria: * patients under 18. * patients with karnofsky performance status (kps) less than 40. * patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis). * patients with bilateral synchronous renal masses. * patients who can not discontinue plavix, coumadin or other anti-platelet or anti-coagulant medications. * patients with renal lesions determined to be too complex to perform a rapn without clamp by the surgeon. (the renal mass may be deemed too difficult based on pre-operatively radiological findings. the surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a rapn was performed.)

Keywords: off-clamp partial nephrectomy renal cancer treatment renal ischemia
effect of angulus on patient-elevation compliance

Conditions: Ventilator Adverse Event; Ventilator Associated Pneumonia; Hospital Acquired Condition; Hospital-acquired Pneumonia; Recumbency; Head-of-bed

Summary: ventilator-associated events (vae) are a scourge of critical care settings and hospital systems at large. there is extensive evidence that ventilator-associated pneumonia (vap) and related vaes increase mortality rates in critically ill patients by up to 50%, while simultaneously increasing cost of care. c best-practice guidelines state that positioning ventilated patients at an angle between 30-45 degrees significantly reduces the potential for vap and other vae to develop. while the intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to accurately measure patient elevation requires that nurses rely on the head-of-bed (hob) protractor - a tool which reflects the angle of the bed, not the patient - to measure compliance. depending upon the position and posture of the patient in the bed, a patient's elevation angle may be significantly different from the hob angle. critical care teams currently rely on built-in hob protractors and digital inclinometers that measure the angle of the bed not the patient. angulus, llc has developed a dual-component angulus sensor to fill this gap in critical care technology. angulus enables critical care practitioners to instantaneously understand a patient's elevation, identify when the patient is outside of the desired 30-45 degree recumbency scope, and efficiently correct the patient's orientation with immediate feedback. angulus supports real-time minute-to-minute data display as well as longitudinal aggregation of data.


Eligibility criteria:
inclusion criteria: * mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy) * age between 18 and 75 years exclusion criteria: * patients with a known allergy to the encasing materials * patients who are advised to be positioned outside of the 30-45 degree scope. * patients with any major chest wall abnormalities, or defects, including but not limited to: * post-cardiac surgical patients * pectus excavatum (or any congenital chest wall deformity) * complicated skin and soft tissue infections on the chest wall * heart-lung machine systems
single dose iv methadone for post-op pain

Conditions: Pain, Postoperative

Summary: single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.

the adult methadone study will be conducted at a single site, duke early phase research unity (depru), to enroll 24 participants. participants will be treated/monitored overnight with methadone hydrochloride iv (fda approved and commercially available), with daily follow-up visits for 1 week total. the study aims to provide information on the disposition and clinical effects of intravenous methadone to update the drug label.

Eligibility criteria:
inclusion criteria: 1. 18 to \< 40 years of age at the time of enrollment 2. provide informed consent exclusion criteria: 1. history of cardiac dysfunction 2. history of or current qtc prolongation, defined as \> 470 ms in males and \> 480 ms in females 3. known hypersensitivity to methadone hydrochloride or any other ingredient in the methadone hydrochloride injection 4. known acute bronchial asthma or hypercarbia (known history of known paco2 above 45 mm hg) 5. receipt of a serotonergic drug or buproprion within 7 days prior to study enrollment 6. receipt of benzodiazepines, muscle relaxants, or other opioids within 7 days prior to study enrollment 7. receipt of a moderate or strong cyp2b6 inhibitor or inducer - either prescription or non-prescription medications, herbals,34 or foods known to be metabolized by or affecting cyp2b6 - within 30 days prior to study enrollment 1. cyp2b6 inhibitors include clopidogrel, prasugrel, thiotepa, ticlopidine, voriconazole, macrolide antibiotics, azole-antifungal agents, fluconazole, alstonia boonei, mangifera indica, and picralima nitida 2. cyp2b6 inducers include artemisinin antimalarials, barbiturates, carbamazepine, cyclophosphamide, efavirenz, lopinavir, methimazole, nelfinavir, phenobarbital, phenytoin, primidone, rifampicin/rifampin, ritonavir, abacavir, amprenavir, nevirapine, telaprevir 8. receipt of zidovudine, desipramine, or other drugs that may increase serum concentration when combined with methadone within 30 days prior to study enrollment 9. known or suspected gastrointestinal obstruction, including paralytic ileus 10. significant respiratory depression (respiratory rate less than 8 breaths/min or oxygen saturation (spo2) \<95%) 11. bmi ≥ 33 and bmi ≤ 17 12. known history of moderate-to-severe liver (child class b or c) or kidney disease (serum creatinine \> 1.5) 13. known history of drug or alcohol addiction (prior or present addiction or treatment for addiction) 14. females who are pregnant or nursing