Kornimate/medical-research-clean huggingface dataset:
study of copper isotope in head and neck cancer

Conditions: Head and Neck Tumors

Summary: the distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (zn), copper (cu) and iron (fe), not only in primitive organisms, but also in mammals. the scientific community shows a growing interest in the study of the isotopic distribution of cu in humans: this distribution can vary according to gender or nutrition. concerning pathology, the isotopic distribution of cu seems interesting in wilson's disease or in cirrhosis. additionally, a promising area of study focuses on the role of cu in cancerous tumors, neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways. head and neck cancers are sensitive to platinum salts. links between platinum and cu are important: platinum penetrates into the cell through a cu receptor, it interacts with the regulation mechanisms of cu and platinum. preliminary studies suggest a variation of the measurable isotopic distribution of zn in patients with breast tumor and of cu in patients presenting breast as well as colorectal tumors. the larner et al. study suggest a promising role of zn in breast cancer, indeed, results highlight a variation of distribution of zn in 10 breast tumors. concerning the study of télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast tumors, results are in favor of an increase of mortality when cu 65 is decreased in the serum and the isotopic modifications happen earlier than usual modifications of biochemical tumor markers such as: carbohydrate antigen (ca) 19.9, carcinoma antigen (ca) 15.3, carcinoembryonic antigen (cea). currently, there is no information about the distribution of the stable isotopes of cu in head and neck tumors. the objective of the study is to determine if the distribution of 65cu / 63cu is modified in tumoral tissues compared to healthy tissues. the isotopic distribution of the cu in 2 tumor types, head and neck tumors and lymphomas, will be also investigated in order to determine if this distribution is specific of a tumor type or not. in case of positivity of this variation, the prognostic interest of these parameters will be evaluated.


Eligibility criteria:
inclusion criteria: clinical diagnosis of head and neck malignant tumors or clinical diagnosis of head and neck lymphoma requiring sampling for diagnosis or clinical diagnosis of a non tumoral ent pathology requiring surgery exclusion criteria: refusal of consent inability to consent pregnant or breastfeeding women

Keywords: copper isotopic distribution cancer
myopic control for high myopes using orthokeratology

Conditions: Myopia

Summary: the purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.

orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. to date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. would myopic control be possible for high myopes undergoing partial correction ortho-k treatment? a randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.

Eligibility criteria:
inclusion criteria: * myopia (refractive sphere): \> 5.75d * astigmatism: \< ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25d; astigmatism of other axes ≤ 0.50d * spherical equivalent (se): \> 5.75d * anisometropia: ≤ 1.50d in both refractive sphere, refractive cylinder and se * best corrected monocular visual acuity: equal to or better than 0.10 in logmar scale in both eyes * willingness for randomization * availability for follow-up for at least 2 years exclusion criteria: * strabismus at distance or near * contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex * systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication) * systemic or ocular conditions which may affect refractive development (e.g. down syndrome, ptosis)

Keywords: children corneal reshaping myopia myopia control orthokeratology
the effect of music in alzheimer's patients

Conditions: Alzheimer Disease

Summary: this study was randomized controlled study conducted to determine the effect of nihavent theme on reducing adjustment difficulties in alzheimer's patients. the study was carried out with 30 patients.15 patients constituted the experimental group and 15 patients formed the control group. before the application, the scale was administered to both groups through face-to-face interviews. the patients in the experimental group were informed about the music session in advance.instrumental songs in nihavent theme were played with the sound system to the experimental group. the sessions were lasted 12 weeks in total and there were two sessions per week, and each session took approximately 50 minutes to complete. while no intervention was performed for the patients in the control group. one week after the last music session, the the scale was re-administered to both groups.

adaptation levels of alzheimer's patients should be determined before planning nursing interventions. institutions should support healthcare personnel in organizing music sessions for patients. it is believed that further studies examining the effect of the nihavent theme in decreasing adaptation difficulty in alzheimer's patients should be conducted with larger sample groups. the effects of verbal and non-verbal music on alzheimer's patients should also be evaluated and compared to gain further insight on this important matter.

Eligibility criteria:
inclusion criteria: * 18-90 age range * were conscious able to communicate and active exclusion criteria: * change in their diagnosis, medications, consciousness, and/or drug dose * during the study period they a regression in emotional state (crying, sadness) * those with complex diseases such as cancer

Keywords: alzheimer's disease music adaptation difficulty nursing care
benefit of placebo and different concentrations of triamcinolone acetonide in nail psoriasis

Conditions: Nail Psoriasis; Nail Diseases

Summary: this purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosed with nail psoriasis in at least 2 fingernails * willing to give written informed consent and able to adhere to procedures and visit schedules * must consent to having the fingernails photographed during the study period exclusion criteria: * subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study. this is including, but not limited to: immunodeficiency, onychomycosis, any other nail condition other than psoriasis, allergy to triamcinolone acetonide, local anesthetic, normal saline, or any other material used for procedures * subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for \>1 month within the 6 months of study (exception: inhaled steroids) * subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study * subject who is unwilling to abstain from any cosmetic nail treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa nail treatments, no nail polish use, no other topical prescription nail medication) * subject who is unwilling to abstain from any medical nail treatments on their nails other than the study intervention (i.e. topical steroids, anti-fungal creams) for the duration of the study intervention and for duration of the washout period (if applicable) * subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff

Keywords: nail psoriasis nail diseases triamcinolone acetonide triamcinolone
assessing effectiveness of a diabetes navigator in increasing progression of advanced diabetes technologies

Conditions: Diabetes Mellitus, Type 1

Summary: the goal of this randomized control trial is to determine if the support of a diabetes navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.

this study will recruit 148 individuals, 74 adults (ages 21-75) and 74 youth (ages 5-20) with type 1 diabetes. participants will be randomized to standard care (usual diabetes care) or the intervention arm in which the participants will receive additional support from a diabetes navigator. participants in the intervention group will receive assistance from a diabetes navigator who will help the participants address challenges in acquiring and optimally using advanced diabetes technology. the investigators will compare the group receiving diabetes navigator support with the standard care group to see if the additional support improves progression (increases uptake and/or optimization) in use of advanced diabetes technology and, consequently, improves glycemic control among patients.

Eligibility criteria:
inclusion criteria: * male or female aged 5 to 75 years. * diagnosis of type 1 diabetes * patient of johns hopkins medicine adult or pediatric diabetes clinics * not using or not optimally using diabetes technology. * planned diabetes technology intensification by diabetes provider. * if already on diabetes technology - must be using the specific device for a minimum of 14 days. exclusion criteria: * optimally using diabetes technology * pregnancy or lactation or planned pregnancy in the next 12 months. * other types of diabetes (type 2 diabetes, maturity onset diabetes in youth, cystic fibrosis-related diabetes, steroid-induced diabetes, post total pancreatectomy, transplant-related diabetes) * active participant of any other research study that may interfere with diabetes management.

Keywords: continuous glucose monitor (cgm) insulin pumps hybrid closed loop (hcl) diabetes navigator diabetes navigator toolkit advanced diabetes technology (adt)
prep readiness interventions for sustained motivation (prism)

Conditions: HIV; Methamphetamine Disorders

Summary: this is a hybrid type i, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (cm), motivational interviewing (mi), and mi+cm for optimizing entry or re-entry into the prep care continuum. a total of 840 participants will be randomized to cm (n = 280), mi (n = 280), or mi+cm (n = 280), all delivered via telehealth. monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a prep prescription (verified using a digital photo or detectable tenofovir diphosphate). secondary outcomes will include: self-reported prep clinical evaluation by a prep provider; self-reported meth and other substance use severity (assist), and self-reported receptive and insertive condomless anal sex (cas).


Eligibility criteria:
inclusion criteria: * 18 years or older * assigned male a birth * assigned male at birth * self-reported methamphetamine use (past 3 months) * not on prep exclusion criteria: * unwilling or unable to provide informed consent

Keywords: hiv prevention methamphetamine motivational interviewing contingency management
oropharyngeal exercises and inspiratory muscle training in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the effects of orofarangeal exercises (oe) and inspiratory muscle training (imt) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. imt and oe exercise modalities for patients and practitioners have advantages and disadvantages. it is recommended to compare exercise modalities in the studies. whether oe or imt exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. the aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with osas in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.


Eligibility criteria:
inclusion criteria: \*to be diagnosed with mild, moderate and severe osas. exclusion criteria: * patients with a history of stroke, * neurological disease, * severe obstructive nasal disease, * and infection in the last month, * bmi being 40 kg /m2 or more.

Keywords: obstructive sleep apnea oropharyngeal exercises inspiratory muscle training sleep quality
validation of plant-based vegan meal for gastric emptying testing in 10 healthy subjects

Conditions: Gastric Emptying; Gastroparesis

Summary: the purpose of this research study is to compare the stomach emptying function using a current standard meal which includes eggs and our new vegan meal alternatives for patients who are not able to eat eggs.

10 healthy participants underwent randomized crossover (with concealed allocation) ge scintigraphy with standard and vegan meals, spaced ≥3 days apart to measure ge% at 2h, 4h, and ge t1/2. group comparisons and variance analysis included rank sum tests and bland-altman plots.

Eligibility criteria:
inclusion criteria: * no history of diabetes * not on medications that affect gastric emptying without diagnosis of active gastrointestinal disease * no history of prior gastrointestinal surgery that would interfere with testing * no recent (within last 10 years) gastritis, gastrointestinal infections, covid-19 (within last 2 years), h pylori, peptic ulcer disease * not pregnant, * not actively breast-feeding * no history of stomach cancers * no history of neurodegenerative disorder * able to sign informed consent and take part in study * bmi \<35 exclusion criteria: * history of diabetes * taking medications that affect gastric emptying (e.g., glp-1 agonists, opioids, calcium channel blockers, pramlintide, tricyclic antidepressants, buspirone) * active gastrointestinal symptoms or disease * prior gastrointestinal surgery that could interfere with conduct or interpretation of the studies (gastric bypass, gastric sleeves, esophagectomy, vagal nerve stimulators, etc) * pregnancy or breast-feeding * history of neurodegenerative disorders (parkinson's disease, multiple sclerosis, dementia, documented autonomic dysfunction, amyotrophic lateral sclerosis, etc) * vulnerable population (dementia, severe intellectual disability etc) * any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol which could interfere with the study assessments * allergy to eggs, allergy to soy, allergy to oats, or other study products
effect of arotinolol hydrochloride on cardiovascular events in hypertensive haemodialysis patients

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to ascertain whether arotinolol hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.


Eligibility criteria:
inclusion criteria: * aged between 18-75 years-old; * chronic kidney disease stage 5 with haemodialysis treatment for 2 months; * patients with blood pressure≥140/90 mmhg after receiving 2 or 3 antihypertensive medications for 2 weeks; * patients who receiving alfa or beta blockers will be washed out for 2 weeks; * written informed consent exclusion criteria: * unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months; * patients who taking class i antiarrhythmic drugs; * resting heart rate less than 60; * patients with systolic pressure less than 90 mmhg; * patients with chronic obstructive pulmonary disease and asthma; * patients with cerebral infarction in the last 2 weeks; * severe disorders of liver function; * allergy to the arotinolol; * patients who planning to have kidney transplantation in the near future; * pregnancy and breast-feeding; * malignant tumor

Keywords: chronic kidney disease hypertension
eletriptan for the treatment of migraine in patients with previous poor response or tolerance to oral sumatriptan

Conditions: Migraine With or Without Aura

Summary: to determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (aes) during previous clinical treatment (not a controlled trial).


Eligibility criteria:
inclusion criteria: * male and female subjects age ≥ 18 years who met the international headache society (ihs) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks. * subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit. * female subjects required to be adequately protected against pregnancy. exclusion criteria: * pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ecg abnormalities, and uncontrolled hypertension. * any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination * subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical. * subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-ht1b/1d agonist in addition to study medication.
miravirsen in combination with telaprevir and ribavirin in null responder to pegylated-interferon alpha plus ribavirin subjects with chronic hepatitis c virus infection

Conditions: Hepatitis C, Chronic

Summary: the purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis c virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic hepatitis c genotype 1 infection * bmi 18 and 38 kg/m2 * null responder to pegylated interferon alpha and ribavirin exclusion criteria: * co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * significant liver disease in addition to hepatitis c * decompensated liver disease medical history or current clinical features * histologic evidence of hepatic cirrhosis * concurrent clinically significant medical diagnosis (other than chc) * concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation) * clinically significant illness within 30 days preceding entry into the study * participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication * history of clinically significant allergic drug reactions
cosmo post approval registry: corox otw steroid lv lead monitoring

Conditions: Congestive Heart Failure

Summary: the objective of this post approval registry is to confirm the long-term safety and effectiveness of the corox over-the-wire (otw) steroid left ventricular (lv) lead as used in conjunction with a biotronk cardiac resynchronization therapy defibrillator (crt-d). the corox otw steroid lv lead is capable of providing permanent pacing therapy to the left ventricle in a crt-d system. the following are the specific objectives to be evaluated during this post-approval registry: * long-term effectiveness of the corox otw steroid in providing biventricular pacing * safety of the corox otw steroid lv pacing lead

this post approval registry enrolled 221 patients from 34 centers. the collection of registry data continued for three years for each enrolled subject. potential patients were screened by the enrolling physician according to the detailed inclusion and exclusion criteria below. the specific required visits for this registry are: enrollment, three-month, six month, one-year, routine follow-ups (every subsequent 6 months), interim follow-ups for corox otw steroid lv lead related visits, and out of service visit. data will be collected at each patient follow-up. the programmed pacing parameters, lv pacing impedance, and lv pacing threshold measurement at 0.5ms pulse width will be obtained. the programming parameters will be set to best suit each patient. if adequate system function, including effective crt, cannot be obtained, the patient should not be selected for the registry.

Eligibility criteria:
inclusion criteria: * successfully implanted biotronik crt-d system, including the corox otw steroid lv lead, from 1-30 days prior to enrollment * able to understand the nature of the registry and give informed consent * available for follow-up visits on a regular basis at the investigational site * age greater than or equal to 18 years exclusion criteria: * enrolled in another cardiovascular or pharmacological clinical investigation * planned cardiac surgical procedures or interventional measures within the next 6 months * expected to receive a heart transplant within 6 months * life expectancy less than 6 months * presence of another life-threatening, underlying illness separate from their cardiac disorder * pregnancy

Keywords: congestive heart failure cardiac resynchronization therapy left ventricular lead
multi-pad fes system for drop foot treatment

Conditions: Foot Drop

Summary: functional electrical stimulation (fes) is multi-pad system that allows fast optimization of stimulation patterns for achieving strong dorsiflexion/plantar flexion and automatic real-time control of ankle joint during fes assisted walking. the main aim of the present study is to compare the effects of functional electrical stimulation gait training after stroke and overground conventional physical therapy. with the assumption that the advanced method of functional electrical stimulation will improve gait parameters and functionality in patients with foot drop before and after fes treatment the objectives of this study are to examine the effects of functional electrical stimulation using fes:a method on indicators of walk and function in patients with foot drop before and after fes treatment.


Eligibility criteria:
inclusion criteria: * hemiplegia caused by stroke * inadequate ankle dorsiflexion * passive ankle range of motion to neutral position * adequate cognitive and communication function to give informed consent * sufficient motor ability and endurance to ambulate at least 6 minutes of walking independently with or without an assistive device * calf muscle spasticity not higher than grade 3 according to the modified ashworth scale exclusion criteria: * lower motor neuron injury with inadequate response to stimulation * skin rupture in the area of the electrodes * history of falls greater than once a week * multiple or infratentorial cerebrovascular lesions * severe cardiovascular disease, severe auditory and visual impairments * inadequate response to stimulation (range of motion elicit by maximal pleasant stimulation lower than active range in first 5 days of the therapy).