Kornimate/medical-research-clean huggingface dataset:
development and validation of a tool for patient-reported assessment of cancer-related financial toxicity in italy

Conditions: Cancer

Summary: the aim of this study is to develop and validate a patient-reported-outcome instrument (proftc-i: patient reported outcome financial toxicity in cancer - italy) able to describe and measure financial problems of italian patients receiving cancer treatment.

the project will be conducted according to the methodology delineated by the international society for pharmacoeconomics and outcome research (ispor) patient reported outcomes content validity good research practices task force in the following phases: concept elicitation and coding, item generation and analysis, instrument refinement and internal validation, and external validation.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) * histologically or cytologically confirmed diagnosis of any type of solid cancer or haematological malignancy * written informed consent provided * medical treatment (chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy or combinations of such therapies) ongoing or terminated within the previous 3 months. * caregivers of patients who meet the above criteria exclusion criteria: * patients with major cognitive dysfunction or psychiatric disorders * patients who have never received anticancer medical or radiation treatment

Keywords: economic difficulty, financial toxicity
use-results surveillance study of sovaldi® plus copegus® in japanese patients with chronic genotype 2 hepatitis c virus infection

Conditions: Hepatitis C Virus Infection

Summary: this post-marketing surveillance (pms) study for sovaldi® tablets (sofosbuvir, sof) administered in combination with copegus® tablets (ribavirin, cope) will evaluate the safety and efficacy of sof administered in combination with ribavirin under real world use in japan. among adult patients with chronic genotype 2 hepatitis c virus (hcv) infection and treated with sof+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (adrs) under real world settings.


Eligibility criteria:
key inclusion criteria: * adult patients with serogroup 2 (genotype 2) chronic hcv infection with or without compensated cirrhosis * patients who are prescribed sof+cope key exclusion criteria: * none note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatitis c virus observational post-marketing sofosbuvir
influence of meditation on stress and rumination following objective structured clinical examination (osce)

Conditions: Stress, Psychological; Stress, Physiological; Rumination; Exam Stress

Summary: stress and rumination are linked with the development of many mental disorders. the ecostress study has shown that poor osce performance has a positive effect on the occurence of state-rumination among 4th year medicine students in the context of mock exams. the goal of imsr study is to assess the effectiveness of a post-osce meditation intervention to decrease psychological stress and rumination.

this randomized, controlled and monocentric study will be conducted during the osce tests contributing towards the final exam grades for 4th year medicine students at the claude bernard lyon 1 university. before the test (osce), all the students will receive information about the study and formalize their consent. the students' osce performance will be evaluated by an independent examiner as part of the students' exams. upon finishing the osce, the students will be divided into two groups: one subjected to post-osce meditation and the other one subjected to a control intervention (neutral content video). before both interventions, all the students will be submitted to short questionnaires regarding their feelings. during the 6-min intervention they will be get equipped with an ear pulse sensor. following both interventions, all the students will be submitted to short questionnaires regarding their stress and rumination levels. the main objective is to assess the effectiveness of meditation intervention to diminish post-osce rumination level. the second objective is to have a deeper understanding of the cause of rumination following the osce..

Eligibility criteria:
inclusion criteria: * adult person * registered as medical student at the university * participating at osce examination * have signed an informed consent form. exclusion criteria: * none

Keywords: stress performance and ruminations coping rumination meditation exam health-student
adx10059 as a monotherapy in patients with gastroesophageal reflux (gerd)

Conditions: Gastroesophageal Reflux

Summary: evaluation of the effect of adx10059 on symptom control in patients with gastroesophageal reflux.


Eligibility criteria:
inclusion criteria: * diagnosis of typical gerd * well controlled on a standard clinical symptoms controlled dose of ppi treatment * body mass index ≤32 kg/m2 exclusion criteria: * exclusively atypical symptoms of gerd * symptoms that have been shown not to be associated with gerd * erosive oesophagitis * hiatus hernia \> 3 cm * current diagnosis of co-existing psychiatric disease * known clinically significant allergy or known hypersensitivity to drugs * pregnant or breast-feeding * has received sodium valproate or topiramate within 30 days of screening * has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study

Keywords: gastroesophageal reflux heartburn regurgitation
low dose statins, ezetimibe and nutraceuticals

Conditions: Coronary Artery Disease

Summary: it remains unknown if the association between moderate to low intensity statin therapy and ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin intolerant patients

the aim of this study will be to evaluate whether the association between statin and exetimibe vs statin + ezetimibe + nutraceuticals can lead to higher percentage of ldl target achievement

Eligibility criteria:
inclusion criteria: patients with angiographically assessed diagnosis of coronary artery disease exclusion criteria: none

Keywords: coronary artery disease ldl cholesterol therapeutic target
bioequivalence of two tacrolimus 0.1% topical ointment formulations in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by taro pharmaceuticals inc. and protopic® (tacrolimus), 0.1% topical ointment (astellas pharma us, inc.) and to show superiority over vehicle in the treatment of moderate to severe atopic dermatitis. the secondary objectives are to compare the adverse event (ae) profiles of the two ointments and to investigate their systemic absorption at steady state.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female, 18 years of age or older. * patient has documented evidence that they have been unresponsive to alternative more traditional therapies such as topical corticosteroids, or in the investigators opinion, such first line therapy would be deemed inadvisable because of potential risks to the patient. * if female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, iud, oral, transdermal, injected or implanted hormonal contraceptives). * have confirmed diagnosis of atopic dermatitis using the diagnostic features as described by hanifin and rajka. * have an igsa score of 3 (moderate) or 4 (severe) * have an affected body surface area (bsa) of at least 20% * have a minimum eczema area and severity index (easi) score of at least 15 exclusion criteria: * mild atopic dermatitis as defined by igsa score of 0 (clear), 1 (almost clear), or 2 (mild) or %bsa affected less than 20% or easi score of less than 15. * clinically infected atopic dermatitis at the baseline visit. tacrolimus is not indicated for the treatment of clinically infected atopic dermatitis * any dermatological condition other than atopic dermatitis that in the investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis * females who are pregnant, lactating or likely to become pregnant during the study. * history of allergy or sensitivity to tacrolimus, pimecrolimus, any macrolides such as clindamycin erythromycin * current diagnosis or history or any disease, which in the investigators opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (hiv) and cancer. * use of any nonsteroidal immunosuppressants * regular use of intranasal or inhaled corticosteroids, greater than the equivalent of 2 mg of prednisone/day, within 14 days of the first dosing day. * use of non-sedating histamines are not allowed for at least 7 days prior to the first dosing day or throughout the study.

Keywords: atopic dermatitis
study of denufosol inhalation solution in patients with mild cystic fibrosis lung disease

Conditions: Cystic Fibrosis

Summary: the purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild cf lung disease.


Eligibility criteria:
inclusion criteria: * have confirmed diagnosis of cystic fibrosis * have fev1 of greater than or equal to 75% of predicted normal for age, gender, and height * be able to reproducibly perform spirometry maneuvers * be clinically stable for at least 4 weeks prior to screening exclusion criteria: * have abnormal renal or liver function * have chest x-ray at screening suggesting clinically significant active pulmonary disease * be colonized with burkholderia cepacia * have had a lung transplant
assessment of tolerability of specialized food products made out of vegetable protein and their influence on lipid profile in patients with non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease NAFLD

Summary: to this single-centre randomized controlled comparative study it is planned to enroll 50 patients with non-alcoholic fatty liver disease. all these subjects will receive standard isocaloric diet for 14 days. subjects of the main group will receive vegetable protein-and-fat cutlet or schnitzel insted of the same amount of standard (animal meat based) cutlet or schnitzel. subjects of the control group will receive standard diet, with cutlets or schnitzels made of animal meat. it is planned to make repeated measurements of serum lipid profile and assess general well-being and tolerability of newly developed product compared to regular meal


Eligibility criteria:
inclusion criteria: * willingness to participate; * confirmed diagnosis of non-alcoholic fatty liver disease based on easl guidelines. exclusion criteria: * pregnancy and breastfeeding; * excessive alcohol intake (\>20 g/day women and \>30 g/day men) * liver cirrhosis based on liver histology, or liver stiffness measurement (lsm \> or =14 kpa by fibroscan), or apri \> or= 1; or bard score \> or = 2. * chronic heart failure (i-iv class by nyha). * past bariatric surgery. * clinically relevant acute cardiovascular event within 6 months prior to screening. * uncontrolled arterial hypertension despite optimal anti-hypertensive therapy. * diabetes mellitus type 1. * serum glycated hemoglobin \[hba1c\] concentrations \>9.0%. * hypersensitivity to the studied product or any of its components. * the intake of any medications that may affect the absorption, distribution, metabolism or excretion of investigational products or may lead to the induction or inhibition of microsomal enzymes (for example, indomethacin) - from the moment of randomization to the end of treatment. * any medical conditions that may significantly affect life expectancy, including known cancers; * any clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric diseases; * mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with study protocol requirements. * positive test for to human immunodeficiency virus antibodies . * aspartate aminotransferase (ast) and/or alt \>10 x upper normal limits. * conjugated bilirubin \> 26 mcmol/l (patients with gilbert's disease are allowed to the study). * international normalized ratio \>1.40. * platelet count \<100 x10\^9/l due related to portal hypertension. * clinically relevant renal dysfunction, including nephrotic syndrome, chronic kidney disease (determined based on the estimated glomerular filtration rate \[egfr\] less than 60 ml/min/1.73 m\^2).

Keywords: non-alcoholic fatty liver disease vegetable protein specialized foods plant-based meat analogs meat substitutes tolerability
point of care testing of inflammatory markers in tears

Conditions: Dry Eye Syndrome

Summary: to evaluate the use of a point of care device to measure markers of inflammation in various eye conditions. in particular, matrix metalloproteinase-9 (mmp-9) will be measured. mmp-9 is an enzyme that plays a role in inflammation. the value obtained with the point of care device will be correlated with values obtained using gel electrophoresis to measure mmp-9 from the same sample. these data will be compared to clinical exam findings and questionnaires to help the investigators better understand the role of this marker of inflammation in eye diseases and possibly improve diagnostic abilities.

as a participant in the study a sample of tears will be collected in a non-invasive manner by sitting comfortably at the slit lamp (a slit lamp is the standard device used to examine the eye and merely requires the participant to sit upright and place their chin on a chin rest and their forehead up against the slit lamp apparatus). the participant will then be asked to look upwards and while gently lowering the lower eyelid, a sterile blunt glass pipette will be used to collect tears from the natural tear lake (the tear lake is a reservoir of tears that sits on the surface of the eye and above the lower eyelid). collected tears will then be taken for analysis of inflammatory markers. in addition, a survey to evaluate the symptoms and the symptoms impact daily life (ocular surface disability index survey of national eye institute visual functioning questionnaire- 25).

Eligibility criteria:
inclusion criteria: * patients that present to clinic for evaluation. patients with and without evidence of eye inflammation will be eligible for this study. exclusion criteria: * patients outside the age limits will not be eligible for the study

Keywords: ocular inflammation matrix metalloproteinase 9
the use of autologous mesenchymal stem cell preparation for treatment of refractory migraine

Conditions: Chronic Migraine, Headache

Summary: the present study is being undertaken as a phase i study to determine the safety and feasibility of using adipose derived mesenchymal stem cell preparations (msc) for treatment of cm. intravenous and locally targeted stem cell treatment have already been reported in the context of treating various chronic pain conditions with early evidence of efficacy and a good safety profile. the treatment of cm is based on the model for treatment with botulinum where superficial facial and cranial injections are utilized. in addition, stem cells can be given intravenously as well.

chronic migraine (cm) is a disabling complex neurological disorder recognized as a complication of migraine in the the international classification of headache disorders. patients with cm experience headache on 15 days per month. cm is associated with significant disability and reduced health-related quality of life. approximately 1.3% to 2.4% of the general population suffers from cm, and one in five cm sufferers cannot work because this condition impacts their ability to lead productive lives. cm is frequently complicated by overuse of acute pain medications. some drugs have regulatory approval for migraine prophylaxis; none are approved specifically for cm prophylaxis although recently, botulinum injection has been fda approved for cm treatment with marginal treatment effects with many patients failing to have complete remission. the present study is being undertaken as a phase i study to determine the safety and feasibility of using adipose derived mesenchymal stem cell preparations (msc) for treatment of cm.

Eligibility criteria:
inclusion criteria: * patients must exhibit symptoms that satisfy criteria of chronic migraine (e.g., experiencing headaches at least 15 days per month to a degree that is associated with significant disability and reduced health-related quality of life). exclusion criteria: * advanced stages of any terminal illness or active cancer that requires chemotherapy. * pregnancy, women who may become pregnant or are breastfeeding. * bleeding disorder, untreated.
treatment for calcium phosphate kidney stone disease

Conditions: Calcium Phosphate Kidney Stones

Summary: the investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of calcium phosphate stone formers.

we will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of cap stone formers. the first study will be conducted in hypocitraturic cap stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo. the second study will be conducted in hypercalciuric cap stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.

Eligibility criteria:
inclusion criteria: aim 1 * hypocitraturic cap stone formers * urine citrate \<320mg/d * elevated ph as 24-hr urine ph above 6.40 * \>21 years aim 2 * hypercalciuric cap stone formers * 24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use * high ph as \>6.40 in the absence of urinary tract infection * \>21 years

Keywords: calcium phosphate urolithiasis kidney stones hypercalciuria
effect of momordica charantia administration on anthropometric indicators in patients with obesity

Conditions: Obesity

Summary: momordica charantia has shown to exert anti-obesity effects through numerous mechanisms of action described in preclinical studies. important reductions in body weight and other anthropometric indicators have been reported in clinical trials. however, these beneficial effects of momordica charantia on obesity have been observed mainly in type 2 diabetes mellitus patients. the purpose of this study is to evaluate the effect of momordica charantia administration on anthropometric indicators in patients with obesity.

a randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with obesity according to the body mass index. patients are assigned to two different arms: one group receives momordica charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 12 weeks or placebo, under the same scheme of treatment. body weight, body mass index, waist circumference, body fat percentage and other clinical and laboratory parameters are evaluated. this protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Eligibility criteria:
inclusion criteria: * diagnosis of obesity type i according to body mass index (imc: 30.0 - 34.9 kg/m2) * body weight without variations above or under 5% in the last three months before entering the study * fasting plasma glucose: \<126 mg/dl * total cholesterol: \<240 mg/dl * triglycerides: \<400 mg/dl * women in childbearing years must have a contraceptive method * letter of consent and release signed by each patient exclusion criteria: * women with confirmed or suspected pregnancy * women under lactation and/or puerperium * known uncontrolled renal, hepatic, cardiovascular or thyroid disease * physical impossibility for taking pills * known hypersensibility to the momordica charantia or placebo

Keywords: momordica charantia bitter melon obesity
electronic social network assessment program (esnap) + caregiver navigator

Conditions: Brain Cancer

Summary: the purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the electronic social network assessment program (esnap) + the caregiver navigator.


Eligibility criteria:
inclusion criteria: * english-speaking/reading/writing * able to complete questionnaires (including by proxy) * family caregivers (fcgs) must self-identify as being a primary fcg of a patient with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease diagnosis. a primary caregiver is a family member, friend, or other unpaid person who provides at least some care for a patient at home. * patients must be diagnosed with new or recurrent primary brain tumor, a secondary (metastatic) brain tumor or leptominingeal disease within the last 9 months, receiving at least some evaluation and/or care at moffitt (i.e. at least one appointment), have a prognosis of at least 9 months exclusion criteria: * patients may not participate without a consenting fcg, but fcgs may participate without a consenting patient * patients and fcgs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per moffitt policy.

Keywords: neuro oncology
plan-a data- bio- and plan- bank collection for scca in denmark

Conditions: Anal Cancer

Summary: the study is a prospective registration of treatment related-, toxicity-, quality of life- and outcome data from patients treated in denmark with radiotherapy for squamous cell carcinoma of the anus (scca), as a cooperation within the danish anal cancer group (dacg). substudy one: a prospective biobank is collected with the purpose to identify predictive and prognostic markers for outcome. substudy two: mri scans are performed to investigate the rate of pelvic insufficience fractures at one year post chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy * written and oral consent exclusion criteria: * contraindication to blood sampling or mri scans (substudy 1 and 2) * other malignant disease within 5 years except from basal cell carcinomas
effect of virtual reality glasses as a distraction method on child's anxiety during dental treatment

Conditions: Dental Anxiety

Summary: the aim of the study is to evaluate and compare the effect of virtual reality glasses (vr) to conventional behavior management techniques as a distraction method on child's dental anxiety during dental treatment

the study to be conducted will be a randomized controlled clinical trial .the sample will consist of forty children presented to the department of pediatric dentistry and dental public health, 20 preschoolers of age ranging from 4-5 years old and 20 schoolers of age ranging from 6-8 years old. the eligible participants will be randomly divided into a study group where virtual reality glasses distraction will be used for child behavior management and a control group where conventional behavior management techniques (tell-show-do, distraction, and positive reinforcement) will be used.

Eligibility criteria:
inclusion criteria: * healthy children (asa category i). * frankl behavior rating score 2 or 3. * requiring pulpotomy in one of their primary molars. exclusion criteria: * children taking medications that interfere with measures of salivary cortisol. * presence of any systemic or mental disease.

Keywords: virtual reality distraction salivary cortisol