Kornimate/medical-research-clean huggingface dataset:
usability of the software macufix for the categorization of metamorphopsia

Conditions: Vision Disorders

Summary: the usability of a novel test to categorize a distorted visual impression (metamorphopsia) is examined with the questionnaire "sus"

introduction diseases of the retinal centre (macula) can lead to a distorted visual impression (metamorphopsia). the usability of a novel on-screen test to categorize metamorphopsia is to be examined with the questionnaire "sus" to determine how user-friendly the software is perceived. purpose to examine the usability of the software for persons perceiving metamorphopsia employing the questionnaire sus. aim of the work improvement of the software in terms of user-friendliness. methods for this observational pilot study, 30 persons are to be recruited from the patient pool of a private practice. primary endpoint: score of the sus questionnaire. each participating person performs the test once with each eye wearing appropriate near correction. the test shows on a screen 4 square fields with a grid pattern of horizontal and vertical lines. all 4 fields have lines that are partially distorted. the task of the test person is to select the field with more distinctively distorted lines when viewed with one eye.this selection must be made at least 10 times per eye: an algorithm determines the smallest correctly named distortion difference. afterwards each person answers the system usability scale (sus) questionnaire, sus contains five positive and five negative statements on the usability of the system being evaluated. for each statement, the study participant gives his or her approval or rejection in the form of a scale ranging from 1= "strong approval" to 5= "strong rejection" of the statement. the results of the sus questionnaire are used to calculate a numerical value (sus score).

Eligibility criteria:
inclusion criteria: 1. distorted visual impression in at least one eye, detected with amsler grid: 2. best-corrected visual acuity (bcva): at least 20/200; age over 18 years; presence of a declaration of consent to participate in the study exclusion criteria: no distorted visual impression in both eyes; best corrected visual acuity under 0.1; age under 18 years

Keywords: metamorphopsia age-related macular degeneration diabetic macular edema home test
effect of resistant starch (type-4) on metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. people with metabolic syndrome are at increased risk for heart diseases. research shows benefits of regular fiber intake in metabolic syndrome. however, due to altered taste and texture of the high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients. this study is designed to find if blinded-substitution of regular wheat flour in domestic kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4), minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from wheat.


Eligibility criteria:
inclusion criteria: - any individual aged 18-80 years exclusion criteria: * pregnant * lactating * requires special diets or dietary regimens * on long term antibiotic therapy * diagnosed with gastrointestinal diseases (irritable bowel syndrome, crohn's disease or colitis) * immune compromised * have cancer

Keywords: diabetes obesity cardiovascular disease metabolic syndrome
evaluation of a patient-reported symptom index for nmibc

Conditions: Superficial Bladder Cancer

Summary: this project will develop and evaluate a patient-reported symptom index to assess the impact of treatment for non-muscle invasive bladder cancer on patient burden, toxicity, symptoms and side effects. the symptom index will provide a method for assessing treatments from the patient's perspective; help healthcare professionals make better informed treatment decisions, and provide a method to be able to effectively evaluate treatments for non-muscle invasive bladder cancer.

the overarching aim of this research is to develop and evaluate a patient-reported symptom index (si) for individuals with nmibc (the nmibc-si) that is acceptable to patients, reliable, valid and responsive, and fit for purpose in clinical trials and clinical practice. specific clinical aims: * assess and compare key patient-reported outcomes (pros) across the full range of contemporary treatments for nmibc, and over the disease trajectory including acute treatment and 1year survivorship; * compare pros between patients with low, intermediate, and high risk nmibc. in field test 1, 200 participants will complete one questionnaire either in hard copy (pencil and paper) or online, at a time that is convenient for the participant. the questionnaire may take up to 20 minutes to complete. in field test 2, 250 participants will complete quality of life questionnaires at four different time points; 1) before tumour resection, 2) 1 week after resection, 3) 8 weeks after resection, and 4) 1 year after resection. the questionnaires can be completed in the clinic or at home, either in hard copy (pencil and paper) or online, at a time that is convenient for the participant but still within the relevant time point. the questionnaires may take up to 30 minutes to complete.

Eligibility criteria:
field test 1: inclusion criteria: * diagnosed nmibc * adult (\>18yrs) * able to read and understand english * undergoing active treatment (i.e. one week after tumour resection or intravesical therapy) or completed final treatment for nmibc within the last week exclusion criteria: * unconscious or confused * have cognitive impairment * unable to speak, read and/or write in english * diagnosed with muscle invasive disease * unable to provide informed consent field test 2: inclusion criteria: * newly diagnosed nmibc * adult (\>18yrs) * able to read and understand english * after imaging or flexible cystoscopy, and before active treatment * either before endoscopic resection, or more than 4 weeks since endoscopic resection, but before active/ongoing treatment exclusion criteria: * unconscious or confused * have cognitive impairment * unable to speak, read and/or write in english * diagnosed with muscle invasive disease * unable to provide informed consent * currently undergoing active treatment for any bladder cancer, or finished treatment within last 3 years.

Keywords: nmibc non-muscle invasive bladder cancer patient reported outcome symptom burden questionnaire
a study of nivolumab plus chemotherapy in first line treatment of adult participants with advanced or metastatic gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this observational study is to assess the effectiveness and safety of nivolumab in participants with previously untreated advanced or metastatic gastric cancer (gc), gastro-oesophageal junction (gej) adenocarcinoma, or oesophageal adenocarcinoma (eac).


Eligibility criteria:
inclusion criteria: * diagnosis of her2 negative advanced or metastatic her2-negative gc, gej adenocarcinoma or eac whose tumours express pd-l1 with a cps ≥ 5 * whose physician has decided to start a treatment with nivolumab (according to the german marketing authorization) for the treatment of gc, gej adenocarcinoma or eac and prior to study participation exclusion criteria: * previous malignancy within 3 years or concomitant malignancy, except: those with a 5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer. * participants currently included in an interventional clinical trial for their advanced or metastatic gc, gej adenocarcinoma or eac. participants who have completed their participation in an interventional trial or who are not receiving any study drug anymore and who are only in the follow-up phase for os can be enrolled. for blinded studies, the study drug administered needs to be known at the time of enrolment.

Keywords: opdivo® nivolumab advanced or metastatic gastric cancer prospective study gastro-oesophageal junction oesophageal cancer
predicting treatment response to stimulants in adult adhd using functional magnetic resonance imaging

Conditions: ADHD

Summary: the primary aim of this study is to assess the predictability of treatment response to stimulants in adults with adhd using functional magnetic resonance this study will be a six-week, open-label study including adults ranging from age 18-55 with adhd.

certain brain characteristics have been identified in individuals with persistent and remitted adhd. we predict that neural functional connectivity; specifically decreases in connectivity between the posterior cingulated cortex and medial prefrontal cortex, as well as decreases in anticorrelations between the medial prefrontal cortex and dorsolateral prefrontal cortex, will predict greater response to stimulant treatment.

Eligibility criteria:
inclusion criteria: * male or female adults ages 18-55 years * right handed * a diagnosis current of childhood onset adhd, according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) based on clinical assessment * a score of \> 20 on the adult adhd investigator symptom report scale (aisrs) or a cgi-severity score of \> 4 (moderate severity) exclusion criteria: * a history of non-response or intolerance to stimulants at adequate doses as determined by the clinician * pregnant or nursing females * serious, unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease * glaucoma * clinically unstable psychiatric conditions including suicidality, homocidality, bipolar disorder, psychosis, or lifetime history of a clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis * tics or diagnosis of tourette's syndrome * current (within 3 months) dsm-iv criteria for abuse or dependence with any psychoactive substance other than nicotine * current use of psychotropic medications * current use of mao inhibitor or use within the past two weeks * claustrophobia or an standard contraindications to mri scanning (metal in body) * investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent or grandchild

Keywords: adhd oros-mph adults functional magnetic resonance imaging
effect of the reflexology on insomnia severity index in hypertensive patients

Conditions: Hypertension

Summary: in egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life.

the participated subjects were enrolled based on the inclusion and exclusion criteria , in this study, forty hypertensive female patients between 35 and 45 were divided to two equal groups (a and b). twenty female patients in group (a) got medications and peddling training, while twenty female patients in group (b) had the exact treatment as group (a) as well as reflexology. insomina severity index and a short form 36 quality of life questionnaire were used to assess the patients who took part in the study (isi). they were assessed before and after the eight-week treatment program, which consisted of three sessions each week; following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).

Eligibility criteria:
inclusion criteria: 1. forty hypertensive patients aged 35 to 45 years of both sexes (men and women). 2. clinical and medically, all of the participants were in good health. 3. the bmi ranged from 30 to 34.9 kg/m2 for all participants. exclusion criteria: 1. close myocardial infarcts. 2. heart block or complex ventricular arrhythmia 3. cerebrovascular disease is a condition in which the blood vessels in the brain become inflamed. 4. defects in vision or hearing. 5. significant tightness in the lower limbs and/or a fixed deformity of lower limbs. 6. balance or mentality-related neurological diseases (e.g. epilepsy). 7. abnormalities of lower limb that may be congenital or acquired.

Keywords: reflexology, insomina severity index; hypertensive patients.
dexamethasone for palliation - brain metastases

Conditions: Neoplasm Metastasis

Summary: brain metastases occur when cancer cells from the initial tumour site (for example, lung or breast) spread to the brain. this develops in approximately 10% - 30% of adults with cancer. they can produce different complaints related to their effect on brain functioning, decrease in a person's ability to carry on with their usual activities, a reduction in the quality of life and shortened life expectancy. the standard treatment particularly for people with more than one brain metastasis consists of palliative radiation therapy to the brain and steroids. steroids (such as decadron or dexamethasone) are medication used to reduce swelling around the tumour, and thus symptoms improve. steroids could be very helpful but have a number of potential side effects, particularly if used for longer periods of time. there is no standard dose of decadron used in treating brain metastases patients. the most commonly dose used is 4 mg four times/day. this study will assess if lower doses of decadron - 8 mg every morning for symptomatic patients and 4 mg every morning for asymptomatic patients - are effective in maintaining symptom control in patients with brain metastases, without neurological deterioration that necessitates the patient to go back or to a higher dose at any time. this information will help also in understanding how to decrease the side effects associated with higher doses of steroids in people with your condition.


Eligibility criteria:
inclusion criteria: * known diagnosis of cancer (even if primary unknown) * brain metastases (single or multiple) confirmed by imaging (ct, mri) * no contraindication for rt/steroids * patient will be treated with whole brain radiation therapy * informed consent exclusion criteria: * primary cancer is lymphoma or leukemia * complete surgical excision of brain metastases * patient was on steroids for more then 2 weeks prior to entering the study * confusion or other factors that would impair ability to assess symptoms
natural history of pearson syndrome

Conditions: Pearson Syndrome

Summary: the purpose of this 3-year, multi-site, non-randomized, prospective, observational study is to characterize the natural history of pearson syndrome. the syndrome is a rare mitochondrial disorder due to a large-scale mtdna deletion. children typically present in their 1st two years of life (most in infancy) with anemia and/or pancreatitis. most individuals with pearson syndrome die in childhood. those who survive evolve to kearns-sayre syndrome/chronic progressive external ophthalmoplegia (kss/cpeo) although accurate survival estimates are not yet known.

all patients with confirmed pearson syndrome who satisfy the inclusion/exclusion criteria will be offered enrollment into this study. patients followed at participating namdc clinical sites will be enrolled at those sites. patients who are not followed at participating namdc clinical sites and wish to participate may contact one of the member sites directly or their local doctor may direct them to one of the member sites. both male and female patients from all racial and ethnic backgrounds who satisfy the inclusion and exclusion criteria will be encouraged to participate. children and adults will be eligible to be enrolled, but we expect the patient population to be mostly children. each patient with pearson syndrome who enrolls in the namdc clinical registry will be encouraged to participate in this study. each patient enrolling in this study will be required to enroll in the namdc clinical registry either prior to or upon enrolling in this study. demographic, medical history, biochemical, histological, genetic, and other clinical data from the registry will be incorporated into this study. every effort will be made to minimize the inconvenience to patients of participating in this study. the study-related activities at each patient visit will be kept to a maximum of one hour, and will, whenever possible, be scheduled to coincide with the patient's regular follow-up with his or her treating physician. this study is observational and has no associated medical procedures.

Eligibility criteria:
inclusion criteria: 1. all individuals of any age with confirmed pearson syndrome are eligible to participate. pearson syndrome requires the presence of a large-scale mtdna deletion along with sideroblastic anemia with or without pancreatic insufficiency. 2. all patients must agree to participate in the namdc clinical registry exclusion criteria: 1. patient does not fulfill criteria for pearson syndrome 2. not willing to participate in the namdc clinical registry
study to assess the safety, tolerability, pharmacokinetics (pk) and preliminary efficacy of azd2014

Conditions: Advanced Solid Malignancies

Summary: the main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. the study will also assess the blood levels and action of azd2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist * at least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (ct) magnetic resonance imaging (mri) or plain x-ray and is suitable for repeated assessment * world health organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks exclusion criteria: * patients with severe laboratory abnormalities for haematology, liver or renal function. also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug * patients with abnormal fasting glucose, type i or uncontrolled type ii diabetes * patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Keywords: phase i cancer advanced solid malignancies dose escalation azd2014 mtor kinase inhibitor safety pharmacokinetics
a study to assess the effect of azd0780 on the pharmacokinetics of rosuvastatin.

Conditions: Dyslipidemia

Summary: the purpose of the study is to assess the effect of azd0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of azd0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.

eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. each participant will receive 2 treatments in total throughout the study. the following treatments will be given in randomized order in fasting state: treatment a: single dose of rosuvastatin tablet alone treatment b: single dose of rosuvastatin tablet + azd0780 tablet the study will comprise: 1. a screening period of maximum 28 days. 2. two treatment periods up to 3 days 3. a follow-up period of 10 to 12 days after the last administration of the study drug. following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the clinical unit until up to 48 hours after dosing of the study drug (up to day 3). the total duration of the study will be up to 9 weeks.

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures. * healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture. * females must have a negative pregnancy test at screening and must not be lactating * participants with bmi between 18 and 30 kg/m\^2, inclusive, and weighing between 50 kg and 100 kg, inclusive exclusion criteria: * history or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder * any positive result on screening for serum hepatitis b surface antigen, hepatitis c antibody, or hiv. * severe acute respiratory syndrome coronavirus 2 (sars-cov-2) first vaccination within 30 days prior to randomization and second vaccination within 10 days of screening * confirmed coronavirus disease 2019 (covid-19) infection at admission, by polymerase chain reaction (pcr) test * plasma donation within 1 month of screening or any blood donation/loss more than 500 ml during the 3 months prior to screening * history or presence of severe allergy/hypersensitivity * current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening * positive screen for drugs of abuse, alcohol, or cotinine at screening * use of drugs with enzyme-inducing properties such as st john's wort within 3 weeks prior to the first administration of the study drug * any clinically significant abnormalities in clinical chemistry, hematology, coagulation, urinalysis results, ecg or vital signs

Keywords: hypercholesterolemia elevated low-density lipoprotein-cholesterol (ldl-c) levels drug-drug interaction healthy participants
tanezumab in osteoarthritis of the knee

Conditions: Arthritis; Osteoarthritis

Summary: test the efficacy and safety of 3 doses in osteoarthritis of the knee in patients.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee according to acr criteria with a kellgren-lawrence x-ray grade of 2. * unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery. * pain level and function levels as required by the protocol at screening and baseline. * willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study. * must agree to the contraceptive requirements of the protocol if applicable. * must agree to the treatment plan, scheduled visits, and procedures of the protocol. exclusion criteria: * pregnancy or intent to become pregnant during the study * bmi greater than 39 * other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Keywords: monoclonal antibody rn624 pf-04383119 nerve growth factor anti-nerve growth factor oa pain