Kornimate/medical-research-clean huggingface dataset:
a trial comparing high-flow nasal cannula versus noninvasive ventilation on reintubation and post-extubation respiratory failure in high-risk patients with systolic heart failure

Conditions: Systolic Heart Failure; Respiratory Failure

Summary: this prospective, open-label randomized controlled pilot trial will enroll participants at the yale new haven hospital. patients with systolic heart failure, defined as an ejection fraction ≤40%, who require invasive mechanical ventilation (imv) and are admitted to either the cardiac intensive care unit (cicu) or medical icu (micu) will be included. subjects meeting eligibility criteria will be randomized 1:1 to one of the two treatment groups: * intervention: extubation to high-flow nasal cannula (hfnc) * control: extubation to non-invasive ventilation (niv)

the primary objective is to compare the rates of reintubation and post-extubation respiratory failure for high-risk patients with systolic heart failure extubated to hfnc or niv. reintubation will be at the discretion of the attending physician. in doing so, this pilot study will provide the framework for an appropriately powered randomized controlled trial.

Eligibility criteria:
inclusion criteria: * the patient is a male or non-pregnant female greater than or equal to 18 years of age * the patient is ventilated for greater than 24 hours * the patient has a systolic left ventricular dysfunction defined as an ejection fraction less than or equal to 40% * the patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate institutional review board (irb) or ethics committee (ec). exclusion criteria: * patients actively being treated for a copd exacerbation or known hypercapnia (paco2\>45) on last arterial blood gas (abg) * patients agitated or uncooperative state * patients with do-not-resuscitate orders * patients presenting with tracheostomies or anatomical abnormalities interfering with mask fit * patients are prisoners * patient self-extubates * patients with pre-existing niv prescription (e.g., obstructive sleep apnea, neuromuscular disorders, advanced copd)
a study about patient satisfaction with laser-sintered removable partial dentures

Conditions: Partially Edentulous Jaws

Summary: removable partial dentures (rpds) are traditionally fabricated by lost-wax casting technique, a time-consuming and very laborious manual technique. recently, fabricating removable partial dentures using computer designing and laser sintering techniques have been introduced. the purpose of this study was to evaluate the patient satisfaction with new computer-generated removable partial dentures and compare it to the traditional removable partial dentures.

patients seeking removable partial dentures in the undergraduate clinic at mcgill university were asked to participate in the study. patients were treated by undergraduate students under the supervision of expert prosthodontists. both the dentists treating the case and the patients were blinded to the type of rpd used. the principal investigator was responsible for preparing the laboratory prescriptions and sending the final impressions to the dental lab in order to assure blinding of the patient and the treating dentists. patients were treated according to standardized clinical procedures. both dentures were fabricated from one master cast to ensure standardization. the cast was scanned digitally to fabricate the laser-sintered dentures, and then was used to fabricate the cast dentures traditionally using lost-wax casting technique. for each patient, two dentures were fabricated from one final impression; one by casting technique and the other by laser-sintering. patients were given randomly one denture first and followed-up for 1, 2 and 4 weeks. then, they were given the second denture and followed-up again. at each follow-up visit, patients filled mcgill denture satisfaction instrument. at the end of the study patients were asked which denture they prefer to keep.

Eligibility criteria:
inclusion criteria: * partially edentulous * have adequate space for regularly sized prosthetic teeth and metal frame(s) * be able to maintain adequate oral hygiene and clean their dentures; do not have major systemic health problems that could interfere with general oral health * have an adequate understanding of written and spoken english or french * be capable of giving written informed consent and fill out questionnaires exclusion criteria: * there is a lack of minimum interocclusal space to accommodate a metal frame and acrylic material * they have acute or chronic symptoms of parafunctional disorders * they have inflammatory mucosal conditions such as lichen planus, progressive periodontitis or others * they have a history of radiation therapy to the orofacial region * there are health conditions that may jeopardize the treatment, such as alcoholism, * they are taking any phenytoin (dilantin), cortisone or insulin * they have a severe/serious illness that requires frequent hospitalization * they have impaired cognitive or motor function * they are unable to return for evaluations/study recalls

Keywords: removable partial dentures partial edentulism
the topical application of vitamin b6 in palmar-plantar erythrodysesthesia

Conditions: Palmar-Plantar Erythrodysesthesia

Summary: the study is designed to test the effectiveness of topical b6 cream in patients that developed palmar-plantar erythrodysesthesia (hand foot syndrome).

this will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. the selection of potential participants will be based on inclusion and exclusion criteria. patients will be randomly allocated either to the treatment group or the placebo group. treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks. the intervention group will receive the application of topical vitamin b6 cream to the hands and/or feet of the patients and the control group will receive the placebo. at both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the quality of life, the need for dose-limiting due to ppe and pain intensity using standardized rating scales. data will be analysed with inferential and descriptive statistics.

Eligibility criteria:
inclusion criteria: * adult cancer patients (\>18) * patients receiving capecitabine and/or pld as monotherapy or in combination with other agents * patients that will experience ppe grade 1 or above * willing to participate * ability to complete the psychometric assessments. * a performance status of two or less on the eastern cooperative oncology group (ecog exclusion criteria: * patients with hypersensitivity to vitamin b. * patients with pre-existing dermatological condition affecting the hands or/and feet that may limit the interpretation of results * patients on oral pyridoxine or nicotine patches * patients with a previous history of ppe * patients whose chemotherapy was discontinued for more than a week
cutting-edge imaging technologies to improve the safety and the sustainability of lung cancer screening and the accuracy of non-invasive lung nodules characterization

Conditions: Lung Cancer

Summary: low-dose computed tomography (ldct) is used in individuals at high risk of developing lung cancer (smokers over 50 years of age), as it allows for the identification of pulmonary nodules, which, in a small percentage of cases, may represent early-stage lung cancer. however, according to lung-rads guidelines, individuals undergoing screening must repeat multiple ldct scans, as the comparison between successive ldct scans enables the assessment of existing nodules' progression and the identification of newly developed pulmonary nodules. this results in cumulative exposure to ionizing radiation, increasing the risk of radiation-induced cancers. this study addresses, through the implementation of new imaging techniques utilizing the latest and most advanced technological innovation (high-field 3t magnetic resonance imaging (mri) with artificial intelligence), the critical challenge of reducing radiation exposure in current ldct-based screening programs, proposing the use of mri as an alternative screening method to ldct.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * indication to first lung cancer screening with ldct according to international guidelines * indication to repeated lung cancer screening with ldct according to international guidelines exclusion criteria: * age \< 18 years * contraindication to mri * presence of metallic implants likely to hamper mri image quality * inability to hold breath for 15-20 seconds * claustrophobia * refusal to participate in the study

Keywords: magnetic resonance imaging low dose computed tomography
study evaluating safety, tolerability and pharmacokinetics of single and multiple dose of sam-531

Conditions: Alzheimer Disease

Summary: the main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of sam-531 in healthy subjects


Eligibility criteria:
inclusion criteria: * body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. body weight for elderly subjects must be greater than or equal to 45 kg. * history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ecg readings. exclusion criteria: * presence or history of any disorder that may prevent the successful completion of the study. * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (gi), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.
biobank clinical genetics maastricht (kg01)

Conditions: Genetic Disease

Summary: collection of coded biomaterial and clinical data with patients consent for future research.

collection of coded biomaterial and clinical data with patients consent for future research, with the purpose to indentify new gene mutation and prossibilities for treatment in the future.

Eligibility criteria:
inclusion criteria: * new patients visiting the out patient clinic of the department of clinical genetics of the maastricht university medical hospital * withdrawal of body material for genetic diagnostics. exclusion criteria: * patient does not understand the dutch language.
pde5 inhibitor use and non-arteritic anterior ischemic optic neuropathy (naion)

Conditions: Anterior Ischemic Optic Neuropathy

Summary: the primary objective of this study is to determine whether the use of pde5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of naion.

collected data will be compared to historic data of the same participant in case-crossover design.

Eligibility criteria:
inclusion criteria: * naion onset within 45 days before entry to the study * naion onset definable by the subject within a 2 calendar day window * men who have taken at least 1 dose of pde5 inhibitor(s) at any time in the 1 year prior to enrollment in the study * age 40 years or older exclusion criteria: * history of multiple sclerosis or optic neuritis * evidence of temporal arteritis * history of vasculitis or collagen vascular disease * previous history of naion

Keywords: non-arteritic anterior ischemic optic neuropathy naion pde5 inhibitors vardenafil levitra sildenafil viagra tadalafil cialis acute vision loss vision loss blurred vision optic neuropathy erectile dysfunction.
acute kidney injury in neonates

Conditions: Acute Kidney Injury

Summary: our first aim is to describe how common a sudden decrease in renal function happens in infants in a neonatal intensive care unit. we also want to see how a sudden loss of renal function affects survival. finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.

advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. very little data is available on the impact that acute kidney injury (aki) has on survival in term neonates, but adult and pediatric studies that show that even mild aki independently impacts survival after correcting for severity of illness. the role that aki impacts survival in neonates is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development. our ability to improve outcomes in children and adults with aki has been hampered by the inability to recognize aki early in the disease process. thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of aki. serum and urinary levels of neutrophil gelatinase-associated lipocalin (ngal), urinary interleukin 18 (il-18) others are markedly elevated several hours after aki as opposed to serum creatinine which takes days to rise after the inciting event. early non-invasive biomarkers of aki have not been tested in neonates. inclusion criteria - families of infants (birthweight \>1500g) be asked to participate in the study. exclusion criteria - infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

Eligibility criteria:
inclusion criteria: * families of infants (birthweight \>1500g) be asked to participate in the study. exclusion criteria: * infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

Keywords: kidney neonates
prognostic evaluation prediction model survival spinal epidural metastases

Conditions: Predictive Cancer Model

Summary: patients with symptomatic spinal metatstasis will be prosepectively included in a database after theu signes informed consent. minimally six months after inclusion the survival status is analyzed. these are correlated with factors that are used in an earlier develloped prediction model

the prediction model is web-based and used five parameters: karnofsky performance score (kps) (in case of sudden (\<24 hours) deterioration the score was used just before the deterioration), the curative intention to treat the primary, the spinal level of the symptomatic tumor, histopathology of the metastasis, and sex. these parameters will be recorded in addition to baseline characteristics. the date of presentation will be recorded. four months after inclusion of the last patient survival status of all patients will scored. if applicable the date of death will be noted. patients are eligible if they suffer from a symptomatic epidural spinal metastatic lesion warranting therapy, either radiation therapy or a combination of surgery and radiation therapy. the nature of the lesion should be verified by pathological examination. in case of an active primary that has recently been diagnosed (less than one year previous to presentation of spinal lesion), the metastatic lesion is considered to be related to this primary. however, if the patient has more than one primary in the history, pathological verification of the tissue is obligatory. after the patients provided informed consent of using their data for scientific use including the publication of the results, they will be included. the data will be collected, and electronically and anonymized stored. patients will be included during three successive years. it is estimated that approximately 450 patients can be included. two centers will participate, radboud university medical center and haaglanden medical center. statistical analysis the cox model will be validated as described earlier 4, first graphically the predictive ability will be plotted, whereas next it will be quantitatively expressed as harrel's c-index and the royston -sauerbrei d-statistic, rd2. the calibration slope is also calculated. a sample of one third of all patients will be used for validation purpose. if needed the model is adapted. then the validation is performed using the data of all patients.

Eligibility criteria:
inclusion criteria: * patients with spinal spinal metastasis * symptomatic * adult * informed consent exclusion criteria: * not understanding informed consent
hiv oral testing infographic experiment

Conditions: HIV/AIDS

Summary: premised on the national aids strategy's focus on identifying new hiv infections through increased hiv testing, the purpose of this formative pilot study is to develop and test an integrated hiv self-testing strategy that utilizes a simplicity-model approach to hiv self-testing in emerging adult sexual minority men of color.

in the united states, approximately 1.1 million persons are living with hiv. despite novel pharmacological breakthroughs, comprehensive models of health care, and targeted hiv testing initiatives, over 160,000 persons are still unaware of their hiv serostatus. emerging adult, sexual minority, men of color are disproportionately affected. premised on the national aids strategy's focus on identifying new hiv infections through increased hiv testing, the purpose of this formative pilot study is to develop and test an integrated hiv self-testing strategy that utilizes a simplicity-model approach to hiv self-testing in emerging adult sexual minority men of color. the overall study will focus on: (a) understanding facilitators and barriers to hiv self-testing among emerging adult msm, (b) designing a hiv self-testing infographic that utilizes a simplicity model, (c) finalizing the hiv self-testing infographic with input from a leadership group of hiv community members, (d) conducting a pilot clinical trial with 300 emerging adult (ages 18-34), sexual minority, men of color to test if a collaboratively-designed hiv self-testing infographic can facilitate accurate and effective understanding of how to self-test for hiv when compared to paper-based, hiv self-testing information. by conducting this study, we will gain beneficial insights necessary for presenting hiv self-testing instructions in a meaningful, relevant, and comprehensible way. the results of this pilot study have the potential to inform strategies regarding how self-testing instructions can be worded or visually presented in order to break both literacy and language barriers that affect testing utilization and results accuracy.

Eligibility criteria:
inclusion criteria: * understand and read english * assigned male sex at birth * self-identify as gay, same-gender-loving, or msm * self-report being hiv-negative or unknown hiv serostatus exclusion criteria: • persons with a known hiv diagnosis

Keywords: hiv prevention sexual and gender minorities consumer health informatics
effects of fasting-mimicking diet on central and peripheral components of fatigue, muscular resistance

Conditions: Fatigue; Muscle, Heart; Fasting; Diet, Healthy; Fatigue, Mental

Summary: the aim of the study is to test a fasting mimicking diet (fmd) for its efficacy on improving muscular resistance and endurance. the investigators will perform a randomized clinical trial to test the efficacy of the fmd on improving muscular strength, muscular resistance and endurance in physically active young adults (18-40 years of age). the study will include two arms: placebo (placebo diet) and fmd (3 cycles of 5-day fasting-mimicking diet within two months). study endpoints will include muscular strength evaluation of lower limbs, cardio-pulmonary responses, neuromuscular function and muscle architecture. subjects will be evaluated 4 times within 3 months: at baseline (t1), after the 1st cycle of diet (t2), 7 to 15 days after the 3rd cycle of diet maintaining baseline intensity (t3) and with re-assessment of peak power output (t4).


Eligibility criteria:
inclusion criteria: * male sex; * age range: 18-40 years old; * body mass index (bmi) range between 18.5 and 30; * mets minutes per week - calculated by international physical activity questionnaire (ipaq) - between 600 and 3000. exclusion criteria: * female sex; * history of muscle, joints and nerves injuries to the upper and/or lower limbs in the previous 12 months; * body mass index (bmi) below 18.5 and above 30; * mets minutes per week - calculated by international physical activity questionnaire (ipaq) - below 600 or above 3000.

Keywords: fatigue fasting-mimicking diet healthy young adults exercise
health related quality of life (hrqol) in classical homocystinuria (cbs deficiency)

Conditions: Homocystinuria

Summary: patients, parents of young / handicapped patients, and experts will be interviewed to collect contents relevant for hrqol in cbs deficiency. based on these data, a questionnaire will be developed and tested for comprehensibility in patients and parents of young / handicapped patients. a final questionnaire version will be tested for psychometric criteria including validity and reliability.


Eligibility criteria:
inclusion criteria * patients with cbs deficiency from age 8 years * parents of patient(s) \< 18 years with cognitive impairment * parents of patients between age 4 and 7 * experts on cbs deficiency * able to give informed consent as documented by signature exclusion criteria - sufficient command of the german or the english language
sociodemographic factors and criminal behaviour preceding neurodegenerative disease - retrospective register study

Conditions: Neurodegenerative Diseases; Alzheimer Disease; Frontotemporal Dementia; Lewy Body Disease; Vascular Dementia; Parkinson Disease; Progressive Supranuclear Palsy; Corticobasal Degeneration; Multiple System Atrophy; Amyotrophic Lateral Sclerosis; Huntington Disease

Summary: in this retrospective register study, clinically classified individuals with neurodegenerative disease from the years 2010-2021 will be verified from the clinical records from kuh and oulu university hospital (ouh). based on the finnish social security number, these individuals will be linked to the the national registers of statistics finland and finnish social and health data permit authority findata including incomes, sociodemographic factors, education, occupation, criminal records as well as to the national registers including the bought pharmaceuticals, comorbidities and causes of death. for each study case, 10 randomly selected control cases, matched with age, sex and geographical area, will be used. the aim of the study is to examine: * 1) the prevalence of criminal and other disruptive behaviour in groups of different neurodegenerative diseases prior to and after the diagnosis * 2) changes in employment, residency,income, and marital status prior to and after the neurodegenerative disease diagnosis * 3) hospital diagnoses and reimbursable drugs prior to and after the diagnosis * 4) causes of death in patients with neurodegenerative disease to study excess mortality of the patients


Eligibility criteria:
inclusion criteria: * the diagnosis of neurodegenerative disease (icd-10) in kuh or ouh between the years 2010-2021 * age, sex and residency matched controls (every research patient has 10 controls matched by age, gender, and place of residency) exclusion criteria: * patients will be divided into different diagnostic groups based on the accepted diagnostic criteria in use. if some of the formed groups contain less than 5 subjects, the disease group in question is excluded from the analyses in order to ensure the privacy protection of the subjects