Kornimate/medical-research-clean huggingface dataset:
italian real-life observational study on the effectiveness, safety and tolerability of atogepant in migraine patients

Conditions: Migraine; Migraine With Aura; Migraine Without Aura; Chronic Migraine

Summary: the purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

atogepant is a small molecule calcitonin gene- related peptide (cgrp) receptor antagonist, part of the gepants family. it is a second generation gepant, currently approved for the preventive treatment of episodic and chronic migraine. previously randomized, placebo-controlled phase 2/3 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine, associated with a good tolerability profile. the most commonly reported adverse events were upper respiratory tract infections, urinary infections, nausea and constipation. in this prospective multicentric study the investigators aim to evaluate atogepant effectiveness and tolerability as preventive migraine treatment in a real-world setting. subjects who meet the inclusion criteria will be enrolled and will participate in the study. baseline demographic and clinical data will be collected at the baseline. patients will take atogepant 60 mg daily for at least 12 weeks up to two years, according to effectiveness, tolerability and eventual approval of reimbursability criteria. data will be collected at baseline and every three months for two years. subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. questionnaires will be collected every three months. data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence. the online database redcap will be used for data collection.

Eligibility criteria:
inclusion criteria: * diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the international classification of headache disorder (ichd-iii); * at least 3 monthly migraine days; * good compliance to study procedures; * availability of headache diary at least of the preceding months before enrollment. exclusion criteria: * subjects with contraindications for use of gepants; * concomitant diagnosis of medical diseases and/or comorbidities that, in the investigator's opinion might interfere with study assessments; * medical comorbidities that could interfere with study results; * pregnancy and breastfeeding.

Keywords: headache medication overuse headache pain migraine prevention gepant
effectiveness of using 3d printed models to educate otolaryngology (ear, nose, nose and throat (ent)) patients about surgery: a survey

Conditions: Pathological Conditions, Anatomical; Deviated Nasal Septum

Summary: within the ear, nose, and throat (ent) medical space, a relatively small number of patients follow through with elective surgeries to fix ailments like a deviated septum or occluded sinus passage. patient understanding of their diagnosis and treatment plan is integral to compliance, which ultimately yields improved medical outcomes and better quality of life. here the investigators report the usage of advanced inkjet 3d printing methods to develop a multimaterial replica of the patient's nasal sinus anatomy, derived from clinical x-ray computed tomography (ct) data. the final patient education model was developed over several iterations to optimize material properties, anatomical accuracy and overall display. a two arm, single center, randomized, prospective study was then performed in which 50 ent surgical candidates (and an associated control group, n = 50) were given an explanation of their anatomy, disease state, and treatment options using the education model as an aid. each patient was then surveyed for their self-rated understanding of their anatomy, disease, and treatment options.


Eligibility criteria:
inclusion criteria: * male and female subjects that are 18 years or older. * surgeon must have recommended nasal or sinus surgery * not excluded as a surgical candidate exclusion criteria: * patients who or not able to read or understand english
gastrointestinal string test with oral immunotherapy

Conditions: Eosinophilic Disorder; Food Allergy

Summary: this string study will examine markers of esophageal inflammation using a minimally-invasive testing device, the esophageal string test (est). the primary objective is to determine the effect of omalizumab (xolair) and dupilumab (dupixent) on markers of eosinophilic inflammation in the esophagus of subjects treated with omalizumab-facilitated moit(mult-allergen oral immunotherapy) and/or moit with concurrent dupilumab.

this is a companion study to a phase 2 randomized, controlled, double-blind clinical trial using biologics to improve multi-allergen oral immunotherapy (moit) outcomes. the parent study (combine nct03679676) consists of a screening period, 8 weeks of omalizumab or placebo injections, and 24 weeks of oit with dupilumab or placebo injections followed by an off-treatment period. this string companion study will examine markers of esophageal inflammation during the combine study using a minimally-invasive testing device, the esophageal string test (est). if participants of combine consent to this companion study, they will undergo an esophageal string test at the following time points in combine: * during screening, prior to week 0, which will be baseline for the string esophageal test * week 8, after the 8 weeks of treatment with omalizumab/placebo * if dose-related gastrointestinal (gi) side effects occur during the week 10-32 treatment period (oit and dupilumab/placebo) * at week 32, after 24 weeks of treatment with oit and dupilumab or placebo

Eligibility criteria:
inclusion criteria: • participants, aged 5-55 years enrolled in the parent combine trial * able to swallow the est. exclusion criteria: • allergy to, or inability to ingest, gelatin -
effect of a music therapy intervention on mood

Conditions: Critically Ill Patient

Summary: the hypothesis is that the music therapy intervention has a positive impact on the critical patients' mood as it has a reassuring effect that allows a connection with emotions, helps to communicate and affects the welfare of patients. it also reduces pain and the consumption of painkillers and sedatives, as well as vasoactive drugs in critical patients.

the aim of the study is to assess the effect of a personalised music therapy intervention with standard treatment on critical patients' mood compared to those who just receive the standard treatment. moreover, the effect of the different interventions on pain and sedative, analgesic and vasoactive drugs will also be assessed. this is a randomized, parallel and open clinical trial that will compare: a) a music therapy intervention combined with the standard care (experimental group), with b) standard care (control group), on critical patients admitted to the general, cardiac and coronary intensive care unit of the santa creu i sant pau hospital. the expected number of patients expected to be included in this trial is 164. patients will be included and randomized the day the music therapy intervention is to take place, once a week. patients' mood will be assessed with a validated questionnaire in spanish for adults, the poms (profile of mood states) survey that consists of a self-report built on the basis of a multidimensional conception of mood and has a likert 5-points type format (0 to 4)

Eligibility criteria:
inclusion criteria: * patients who are oriented in time, space and person * glasgow coma scale of 15 or 11+intubated * negative the confusion assessment method for the icu (cam-icu) * richmond agitation-sedation scale of 0 * patients who are at least conscious and oriented for 48 hours in the icu. exclusion criteria: * auditory deficit * patients that have participated in the study previously
3m veraflo™ cleanse choice complete™ (vfccc) clinical study

Conditions: WOUNDS INJURIES

Summary: the purpose of this external clinical study is to demonstrate the safety and performance of the veraflo™ cleanse choice complete™ dressing kit which will be used in conjunction with the v.a.c.® ulta™ therapy unit, utilizing v.a.c. veraflo™ therapy instillation functions.


Eligibility criteria:
inclusion criteria * subject is at least 22 years old at time of consent. * subject or legal authorized representative is able to provide informed consent. * subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft. exclusion criteria: * subject is pregnant prior to application of the initial dressing\* \*women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for \> 12 months will not be required to undergo pregnancy testing. * subject has been diagnosed with a malignancy in the wound. * subject has untreated osteomyelitis. * subject has an untreated systemic infection. * subject has active cellulitis in the peri-wound area. * subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane. * subject has, in the opinion of the investigator, a clinically significant condition that would impair the subject's ability to comply with the study procedures. * subject has had radiation directly to the wound area. * subject has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the investigator's interpretation of the subject's medical history. * subject has necrotic tissue with eschar present. note: after debridement of necrotic tissue and complete removal of eschar, veraflo™ therapy may be used. * subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of visit 1. * subject has non-enteric or unexplored fistula. * subject has a wound with any unexplored tunneling present. * subject has inadequate hemostasis at the wound site, as determined by the investigator. * subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.
prospective randomized trial on radiation dose estimates of ct angiography in patients scanned with a sequential scan protocol

Conditions: Coronary Disease

Summary: the objective of this study is to compare radiation dose of a standard spiral scan with the a new sequential scan protocol. we hypothesize that the sequential scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior. secondary endpoints of the study include quantitative image quality parameters, diagnostic accuracy for spiral versus sequential studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography.

all patients scheduled for a coronary ct scan are screened for inclusion and exclusion criteria. patients are included if they have stable sinus rhythm (heart rate \<75 bpm for dual source ct and \<65 bpm for 64-slice ct). informed signed consent is obtained from these patients and the ct scan is prepared. after topogram scan and the native scan for ca-scoring, patients are randomized in two groups with the use of sealed envelopes. after that contrast-enhanced coronary ct angiography is performed with the standard spiral protocol or with the sequential protocol. the ct examination is evaluated by two experienced investigators on a per-vessel basis and all results and study-related data are collected in a dedicated database. for assessment of image quality, a previously established 4-point score system is used and quantitative image quality parameters are measured. a 30 day follow-up after the ct examination aims to evaluate if patients underwent invasive coronary angiography or were scheduled for a myocardial stress / perfusion test (such as stress-echocardiography, myocardial scintigraphy or stress perfusion imaging by mri).

Eligibility criteria:
inclusion criteria: * patients with an indication for a coronary ct angiography (planned evaluation of the coronary arteries) * stable sinus rhythm * heart rate \< 75 bpm with dual-source ct or \< 65 bpm with single-source ct * signed informed consent exclusion criteria: * non-ecg triggered studies * non-coronary cta studies, e.g. bypass graft ctas, pre- or post ep studies, cabg planning studies

Keywords: coronary ct angiography radiation dose estimates
rare benign lesion of peins

Conditions: Skin Diseases; Penile Diseases

Summary: pekmb was first named and described by lortat-jacob \& civatte in 1961 and by bart \& kopf later. this rare condition is mostly reported in elderly males. the keratotic scales is usually micaceous and resembles psoriasis. most patients are above 50 years of age and are circumcised later in life, but also reported in younger age group. this mica like scales contains keratin which gets dissolved in 10% potassium hydroxide solution. disease progression may lead to phimosis. differential diagnosis of this disease entity include moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of queyrat, squamous cell epithelioma and verrucous carcinoma. it is primarily a benign entity, it is capable of invasiveness. bart and kopf considered it to be in intermediate stage between benign hyperplasia and squamous cell carcinoma. however, the histological spectrum can range from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. fibro sarcoma has been reported developing in a same patient. etiology is unclear. despite search for a viral agent, human papilloma virus (hpv) has not been demonstrated and its role in pathogenesis or its transformation to verrucous carcinoma has been proved. the treatment of pekmb should be conservative when there is no histological evidence of malignancy. all such patients should be followed up. treatment choices include potent topical steroids, topical 5% 5-flurouracil cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. when frank malignancy is observed, excision with wide margin is the rule.


Eligibility criteria:
inclusion criteria: * 40 years * failed medical treatment exclusion criteria: * psoriasis * allergy * trauma
miles-02: study of chemotherapy treatment and toxicity in elderly patients with advanced non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer

the study design includes three parallel phase ii studies, all with the same rules for patient selection and outcome assessment. in the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases. arm a: gemcitabine: gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 \& 8 of each cycle, every 21 days, for a maximum of 6 cycles. arm b: cisplatin + vinorelbine: vinorelbine 25 mg/m² on days 1 \& 8, followed by cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles. arm c: cisplatin + gemcitabine: gemcitabine 1000 mg/m2,, on days 1 \& 8, followed by cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of nsclc * stage iv or iiib with pleural effusion or metastatic supraclavicular lymphoadenopathy * age \> o = 70 years. * written informed consent. exclusion criteria: * performance status (ecog) ³2 * previous chemotherapy. * symptomatic brain metastases requiring synchronous radiotherapy * previous radiotherapy (completed less than 4 weeks before enrollment) * previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment. * neutrophils \< 2.000/mm³ or platelets \< 100.000/mm³ or hemoglobin \< 10 g/dl. * serum creatinine \> 1.5 times the unl. * got and/or gpt \>1.25 times the unl or serum total bilirubin \>1.25 times the unl without hepatic metastases. * got and/or gpt \>2.5 times the unl or serum total bilirubin \>1.5 times the unl with hepatic metastases. * other concomitant diseases contraindicating the study treatments. * refusal of written informed consent. * follow-up impossible.

Keywords: elderly chemotherapy quality of life adl toxicity
brief internet-delivered cbt after acs

Conditions: Psychological Trauma; Acute Coronary Syndrome

Summary: the purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered cbt protocol provided early after acute coronary syndrome (acs).

acute coronary syndrome (acs; myocardial infarction (mi) or unstable angina (ua)) is one of the leading causes of mortality and health loss globally. acs is a stressful and potentially life-threatening cardiovascular event, and many patients develop symptoms of post-traumatic stress (ptss) and cardiac anxiety post acs, which have been shown to negatively affect patients' long-term cardiovascular prognosis.the aim of the proposed pilot study is to develop and evaluate a brief internet-delivered exposure-based cbt intervention provided early following acs to reduce acs-related ptss, cardiac anxiety. and increase physical activity and quality of life. patients with recent acs (≥ 4 weeks to 6 months) and with elevated ptss and anxiety will be eligible. after informed consent, patients will be randomized to internet-delivered cbt (n=15) or to a wait-list control group (n=15). the treatment is a 5 week, therapist-guided, internet-delivered intervention which includes imaginal exposure, interoceptive exposure, and exposure in-vivo. assessments will be conducted at baseline, immediate post-treatment, and 2- and 6- months after treatment. the wait-list will be crossed over to cbt after completion of the 2 month follow-up.

Eligibility criteria:
inclusion criteria: * (a) acs ≥ four weeks to six months before assessment (mi type 1 stemi/nstemi and ua) * (b) age 18-80 years * (c) symptoms of ptsd and/or cardiac anxiety that leads to distress and/or interferes with daily life (pcl5; ≥ 10, caq: ≥20) * (d) on standard of care medical treatment for the cardiac condition according to swedish cardiovascular guidelines * (e) ability to read and write in swedish. exclusion criteria: * (f) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) * (g) significant valvular disease * (h) planned coronary artery bypass surgery or percutaneous interventions * (i) any medical restriction to physical exercise * (j) severe uncontrolled medical illness i.e., advanced cancer * (k) grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic) * (l) severe psychiatric disorder, active suicidal ideations or cognitive impairment that precludes provision of informed consent or study activities * (m) alcohol dependency * (n) ongoing psychological treatment.

Keywords: acute coronary syndrome posttraumatic stress disorder cardiac anxiety cognitive behavioral therapy
systemic vitamin d supplementation in dental implants patients

Conditions: Osteoporosis

Summary: vitamin d plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.

evidence has demonstrated that vitamin d deficiency plays an important role in dental implants outcomes. low serum levels of vitamin d is considered as a risk factor, not only for low mineral bone density but also in other metabolic pathways such as those involved in immune response and chronic inflammatory diseases. there are few studies demonstrating the role that vitamin d deficiency in the etiopathogenesis of oral diseases and the consequences in dental implants. dentists have not yet well understood the importance of a good bone metabolism response for a successful bone regeneration and osseointegration of implants. an insufficient bone response can not guarantee the necessary stability of the implants placed in it, has been one of the biggest problems of implantology. thus, the aim of this study is to evaluate the efficacy of systemic vitamin d supplementation in menopausal women cadidates for dental implants.

Eligibility criteria:
inclusion criteria: - menopause patients exclusion criteria: * patients with a past history of neurological disorder; * who had received pharmacotherapy for depression within 8 weeks of screening; * who were taking medication known to interfere with vit d; * who had recent psychiatricor systemic illness; * uncontrolled hypertension (blood pressure \> 160/95mmhg); * unstable cardiovascular disease; * user of psychoactive medications; * alcohol excess consumption abuse.
hepatitis c virus (hcv) treatment completion or withdrawal

Conditions: Hepatitis C

Summary: qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis c.

qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis c. two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal.

Eligibility criteria:
inclusion criteria: ever initiated anitiviral treatment for hepatitis c. exclusion criteria: none