Kornimate/medical-research-clean huggingface dataset:
evaluation of a music and interaction intervention on patient distress during whole body magnetic resonance

Conditions: Neoplasm Malignant

Summary: this is a randomized controlled trial for the evaluation of the acceptability of whole-body-magnetic resonance imaging (wb-mri) based on music and comunication intervention compared to a standard care condition. subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition.

this study is a randomized controlled trial. subjects referring to the european institute of oncology (ieo) and will undergo to wb-mri for detection, staging, therapy monitoring or screening, will be asked to participate to the study and signed the informed consent. subjects will be divide into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition. the experimental group before the wb-mri examination, complete distress thermometer and received verbal information about the procedure from one of trsm trained, during the examination subjects he has the opportunity to listen to the music of his choice and trsm interacts with the subject four times to know he feels well. before the examination control group complete distress thermometer. after examination both groups will be asked to complete a different wb-mri acceptability questionnaire and distress thermometer. wb-mri acceptability questionnaire is ad hoc questionnaire create to evaluate the acceptability of the wb-mri based on of the interventions carried out.

Eligibility criteria:
inclusion criteria: * subjects who will undergo to wb-mri for detection, staging, therapy monitoring or screening. * acceptance and signature of informed consent. exclusion criteria: * any contra-indication to mri examination (for example, pacemaker, in the first trimester of pregnancy, metal implants, etc.). * anxiety disorder and psychological or pharmacological treatments for anxiety
taking charge of systemic sclerosis

Conditions: Scleroderma

Summary: this study is a collaborative project with partners (people with scleroderma and stakeholders) designed to refine an internet program for patients with scleroderma and to compare the internet program to an authoritative educational book (taking charge of systemic sclerosis \[toss\]). during a 16-week comparative effectiveness 16-week randomized controlled trial, the investigators will recruit up to 250 patients who will be randomized to either toss or authoritative book for patients, the scleroderma book: a guide for patients and families.


Eligibility criteria:
inclusion criteria: * all participants will be residents of the united states * diagnosed with systemic scleroderma, * 18 years of age * possess basic computer literacy and have access to a computer with internet and email capabilities * have the ability to communicate in english exclusion criteria: * no computer access * inability to communicate in english

Keywords: systemic sclerosis ssc
phase iii tolerance and efficacy study of rsd1235 in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is being conducted to demonstrate the effectiveness of rsd1235 in the conversion of atrial fibrillation to sinus rhythm.

there are approximately 2 million reported prevalent cases of atrial fibrillation (af) and atrial flutter in the united states (heart disease \& stroke statistics - 2003 update, aha). these arrhythmias may be occasional or sustained. while not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure. this phase iii trial is cardiome's first pivotal study with rsd1235. the study seeks to confirm the findings of the phase ii proof-of-concept through demonstration of rsd1235's abilities to convert af to sinus rhythm. the patient population will include recent onset af (af duration of 3 hours to 7 days) and patients with longer af duration. this is a double-blind, placebo-controlled, randomized study in patients with af; stratification will be based on duration of af. treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by hour 1.5 (time 0 = start of first infusion). all patients will be evaluated for safety.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days. * have adequate anticoagulant therapy. exclusion criteria: * have a qrs \> 0.14 seconds unless patient has pacemaker or uncorrected qt \> 0.440 seconds as measured on a 12-lead ecg. * have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety. * have received intravenous class i or class iii antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.

Keywords: atrial fibrillation rsd1235 atrial fibrillation of 3 hours to 7 days duration. atrial fibrillation of 3 hours to 45 days duration.
oncogenic role of engrailed (en)-2 in epithelial ovarian neoplasms

Conditions: Ovarian Neoplasms

Summary: detection of the potential oncogenic role of engrailed-2 in epithelial ovarian neoplasms, in order to detect biological markers that could be targeted and blocked by new medications.

epithelial ovarian carcinomas represent more than 90% of all ovarian carcinomas. treatment of these ovarian carcinomas on basis of their histopathological features didn't improve patients' outcomes with very high incidence of relapses and resistance to therapy. detection of novel biological markers which are involved in tumor progression could have promising results if these biological molecules are targeted and blocked by new medications. engrailed-2 is a protein encoded by a gene located on chromosome 7. engrailed-2 is involved in neural development and neural connections during embryological life. it has been proved that engrailed-2 is expressed in non neural neoplasms, especially in prostatic and urinary bladder carcinomas. now estimatiion of urinary and serum levels of engrailed-2 is used as a non-invasive screening tool in to detect prostatic and urinary bladder carcinomas. we aim to evaluated immunohistochemical expression of engrailed-2 in normal and neoplastic ovarian tissues and to compare such expression between normal and neoplastic tissues in order to improve its oncogenic role in ovarian carcinoma.

Eligibility criteria:
inclusion criteria: * all types of epithelial ovarian neoplasms (benign, borderline and malignant). exclusion criteria: * non-epithelial and/ or secondary ovarian tumors. * cases with poor clinical data. * cases who had history of pre-operative chemotherapy.
additional effect of pain neuroscience education to orofacial and neck exercises in temporomandibular disorders

Conditions: Temporomandibular Disorders

Summary: the objective of this study will be to verify the additional effect of pain neuroscience education program to orofacial manual therapy and orofacial and neck motor control exercises for pain intensity and disability and for the secondary outcomes pain self-efficacy, kinesiophobia, and overall perception of improvement in patients with temporomandibular disorders (tmd). this study will be a randomized clinical trial comprising a sample of 148 participants. subjects will undergo a screening process to verify those presenting a diagnosis of painful tmd confirmed by the research diagnostic criteria (rdc/tmd), between 18 and 55 years of both genders, and then the volunteers will be randomized into two groups (g1: pain neuroscience education + orofacial manual therapy/orofacial exercises/neck motor control exercises vs. g2: orofacial manual therapy/orofacial exercises/neck motor control exercises). these volunteers will be recruited at the dentistry clinic of the university of são paulo's school of dentistry of ribeirão preto - university of são paulo. the intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 hour per session. the primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia and overall perception of improvement. the participants will be assessed immediate after the last session and at one and three-month follow-ups.


Eligibility criteria:
inclusion criteria: * a diagnosis of painful tmd research diagnostic criteria for tmd (rdc/tmd) * a history of orofacial pain at least three months prior to the study (treede et al, 2015) * age ranging between 18 to 55 years, considering the greater prevalence of tmd associated with this age period. exclusion criteria: * patients with illiteracy, severe depression (medical diagnoses), clinical history of tumors in the craniofacial region, patients in the post dental surgery period or submitted to previous physical therapy in the past year or to any health/pain education strategy, pregnant women, infections, whiplash-associated disorders and with chronic degenerative inflammatory or neurologic disorders were excluded from this study. patients will be instructed to not use pain relief medications during the intervention period of this trial and if any medication be used, participants will be encouraged to report.

Keywords: pain neuroscience education chronic pain orofacial manual therapy orofacial exercises neck motor control exercises
clinical characteristics of primary liver cancer

Conditions: Primary Liver Cancer

Summary: primary liver cancer (plc) is the sixth most common malignancy in the world and the third most common cause of malignancy death. in 2020, there were about 905,677 new cases of plc worldwide, and 830,180 deaths. despite the availability of a variety of treatments for plc, the 5-year net survival rate is still only 5% to 30%. how to effectively reduce the disease burden of plc is a major public health problem that needs to be solved worldwide. the clinical characteristics and prognosis of plc caused by different pathogenic factors are different. therefore, it is of great significance to fully identify the risk factors of plc, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of plc.

primary liver cancer (plc) is the sixth most common malignancy in the world and the third most common cause of malignancy death. plc mainly includes hepatocellular carcinoma (75%-85%) and intrahepatic cholangiocarcinoma (10%-15%). in 2020, there were about 905,677 new cases of plc worldwide, and 830,180 deaths. despite the availability of a variety of treatments for plc, the 5-year net survival rate is still only 5% to 30%. how to effectively reduce the disease burden of plc is a major public health problem that needs to be solved worldwide. common risk factors for plc include hepatitis b virus (hbv), hepatitis c virus (hcv) infection, alcohol consumption, metabolic factors, etc. although antiviral drugs can control or even cure chronic hbv and hcv to a certain extent, chronic viral infection is still the leading cause of plc worldwide. in addition, with the prevalence of obesity, diabetes and non-alcoholic fatty liver disease (nafld), the incidence of non-infectious plc is gradually increasing. in recent years, nafld has gradually become the leading cause of liver transplant waiting list for patients with hepatocellular carcinoma in the united states. the clinical characteristics and prognosis of plc caused by different pathogenic factors are different. therefore, it is of great significance to fully identify the risk factors of plc, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of plc. currently, there are few large, single-center cohort studies on the clinical features and long-term prognosis of plc.

Eligibility criteria:
inclusion criteria: 1. 18 years or older; 2. initial diagnosis of primary liver cancer based on enhanced ct or enhanced mri or pathology exclusion criteria: 1. other types of malignant tumors; 2. mental illness, severe cardiopulmonary dysfunction, severe renal insufficiency, serious infection and cerebrovascular accident; 3. received liver transplant or other organ transplant.

Keywords: primary liver cancer clinical features
impact of point-of-care eid for hiv-exposed infants

Conditions: HIV/AIDS; Infant Morbidity; Pediatric HIV Infection; Transmission, Perinatal Infection

Summary: this mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (poc) versus conventional early infant diagnosis (eid) on key outcomes including timely return of results to caregivers and time to initiation on treatment for hiv-infected infants. data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. feasibility and acceptability data will be collected through interviews with mothers/caregivers of hiv-exposed infants, and community focus groups.

this study seeks to evaluate the impact of point of care (poc) early infant hiv diagnosis (eid) on turn-around time from sample collection until notification of parents/caregivers of test result, linkage to care, and time to initiation of treatment, and early retention in hiv care (3-6 months) for those infected. the study will take place in two countries, zimbabwe and kenya, with high hiv prevalence, and where egpaf-supported poc eid platforms are being implemented as part of a unitaid-funded poc eid project. as part of poc program implementation activities, in each country up to 50 egpaf-supported sites will implement poc eid platforms. these sites may be prevention of mother-to-child transmission (pmtct) of hiv clinics, hiv clinics or multidisciplinary health facilities. project sites have been selected as part of the program implementation. in each country, 18 sites will be randomly selected as study sites for the impact evaluation. using a stepped wedge design, the intervention (the poc eid platforms) will be rolled out sequentially to the study facilities over three randomly-assigned time periods. quantitative data will be derived from routine medical and laboratory charts and longitudinal tracking and follow-up of hiv-infected infants. qualitative data on feasibility and acceptability of poc will be derived from in-depth interviews with mothers/caregivers of hiv-exposed infants at the beginning and end of the study and community focus group discussions at the end of the study.

Eligibility criteria:
inclusion criteria: * any infant who receives an eid test, either conventional or poc, for the 4-6 week eid indication at one of the study sites (which were randomly selected from project sites in country) * hei under 12 weeks of age or their parents/caregivers * some methods will only include hei who test positive (medical chart extraction and longitudinal follow up) * purposively selected caregivers of hei for in-depth interviews * focus groups with community members will not require participants to have sought testing for eid exclusion criteria: * participants not at selected study sites * for some methods (medical chart extraction and longitudinal follow-up), hei who test negative * for qualitative component, excluded if unable to consent due to age, competence, or inability to speak any of the study languages

Keywords: hiv/aids point of care early infant diagnosis health systems diagnostic tools lmic
study to investigate efficacy and safety of pf-04965842 in subjects aged 12 years and over with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects

Conditions: Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Summary: b7451014 is a phase 3 study to investigate pf-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. subjects responding well to an initial open-label 12 week treatment of pf-04965842 (200 mg) taken orally once daily (qd) will be identified and randomized in a double-blind manner to receive 200 mg qd pf-04965842, 100 mg qd pf-04965842, or qd placebo. efficacy and safety of 2 doses of pf-04965842 will be evaluated relative to placebo over 40 weeks. subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg pf-04965842 together with a marketed topical medicine. eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

responder criteria for randomization at week 12 are defined as a) achieving an iga of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from iga baseline of 2 or more points, and c) reaching an easi-75 response compared to baseline. flare requiring rescue treatment is defined as a loss of at least 50% of the easi response at week 12 and an iga score of 2 or higher.

Eligibility criteria:
inclusion criteria: * 12 years of age or older with a minimum body weight of 40 kg * diagnosis of atopic dermatitis (ad) for at least 1 year and current status of moderate to severe disease (\>= the following scores: bsa10%, iga 3, easi 16, pruritus nrs 4) * recent history of inadequate response or inability to tolerate topical ad treatments or require systemic treatments for ad control exclusion criteria: * unwilling to discontinue current ad medications prior to the study or require treatment with prohibited medications during the study * prior treatment with jak inhibitors * other active nonad inflammatory skin diseases or conditions affecting skin * medical history including thrombocytopenia, coagulopathy or platelet dysfunction, q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator * pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Keywords: atopic dermatitis atopic eczema eczema jak janus kinase
a pilot safety study of inhaled dry powder mannitol in acute exacerbations of copd

Conditions: COPD; Exacerbation

Summary: copd is a major cause of ill health and death in australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. the gold standard treatment of copd is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. however, associated mucus hypersecretion is responsible for much of the inflammation and infection. the use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. there has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. the purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of copd to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.


Eligibility criteria:
inclusion criteria: * fev1 \> 35% predicted * copd * exacerbation * inpatient exclusion criteria: * pneumonia * co2 retention
the effectiveness of lavender aromatherapy combined with slow breathing exercises in improving occupational burnout and sleep disorders among nursing staff

Conditions: Sleep Wake Disorders

Summary: this study investigates the effects of breathing exercises combined with lavender essential oil inhalation on occupational burnout and sleep disturbances in rotating shift nurses.

this study will adopt a randomized controlled trial (rct) design targeting rotating shift nurses with at least six months of clinical experience at a regional teaching hospital in northern taiwan. eligible participants who consent to join the study will be randomly assigned into five groups using block randomization. the randomization process will be conducted via sealed envelopes to allocate participants into the following groups: experimental group 1, experimental group 2, experimental group 3, breathing-only group, and control group. experimental group 1: participants will receive slow breathing training (6 breaths per minute) once daily before bedtime, combined with the inhalation of 3 drops of natural lavender essential oil on a towel, for 3 minutes, over a 4-week period. experimental group 2: same breathing protocol as above, with 3 drops of linalyl acetate-containing essential oil. experimental group 3: same breathing protocol, with 3 drops of linalool-containing essential oil. breathing-only group: participants will perform slow breathing training (6 breaths per minute) for 3 minutes daily before bedtime, without any essential oil inhalation, for 4 weeks. control group: participants will maintain their usual lifestyle without any intervention. the outcomes will be evaluated using a nurse burnout scale and a sleep quality scale. measurements will be taken at three time points: baseline (pre-test), 4 weeks after the intervention (post-test 1), and 8 weeks after the intervention (follow-up/post-test 2). the study is co-led by yao-hsiang chen, assistant head nurse at tri-service general hospital songshan branch, and professor chia-hui lin, school of nursing, national defense medical center.

Eligibility criteria:
inclusion criteria: aged between 20 and 65 years registered nurses with at least 6 months of clinical experience and currently working rotating shifts scores ≥1 in each of the three dimensions (emotional exhaustion, reduced personal accomplishment, depersonalization) on the nursing burnout scale (nbs) willing to participate in the study and accept random assignment exclusion criteria: nurses with less than 6 months of clinical experience individuals with anosmia or reduced sense of smell diagnosed with psychiatric disorders allergic to lavender essential oil not currently working rotating shifts

Keywords: sleep wake disorders