Kornimate/medical-research-clean huggingface dataset:
assessment of efficacy of lightwalker (nd:yag, er:yag) laser therapy on incidence, severity and duration of oral mucositis in patients undergoing hematopoietic stem cell transplantation (hsct). prospective randomized open-label study

Conditions: Oral Mucositis; Bone Marrow Transplant Complications

Summary: oral mucositis (om) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (hct). it is treated symptomatically with pain relief medications. the use of low-level laser therapy (lllt) to prevent tissue damage has been postulated for almost forty years, however, there are only a few reports concerning old generation lasers in mucositis prophylaxis in hct recipients. here we hypothesized, that a new generation lllt (nd: yag fotona lightwalker®) laser may be an effective prophylaxis in shortening and reducing the severity of this complication.

this clinical trial is a prospective, randomized open-label study. all patients qualified to hematopoietic stem cell transplantation will be informed about possibility of taking part in this study. patients who meet the inclusion criteria will be enrolled and randomized into two groups. patients in the first group will receive standard supportive treatment. patients in the second group, except for the supportive treatment (as in the first group), will additionally receive prophylactic laser therapy of oral mucosa during high-dose chemotherapy conditioning before hsct. patients will undergo laser treatment daily from the first day of conditioning regimen till the second day after stem cell transfusion. the procedure will be carried out by trained staff at the bedside. severity of oral mucositis and pain will be measured in both groups on days 0, 4, 7, 11, 14, 18 and 21 after hsct. severity of oral mucositis will be assessed according to five-point who scale pain intensity will be measured on the basis of ten-point nrs scale. in addition, the need for opioid analgesics and total parenteral nutrition will be evaluated. photographic documentation will be made on days -7, 0, 7, 14, 21. all obtained results will be collected in a database and subjected to statistical analysis. additional analysis will be carried out during the study to evaluate whether the differences in results between studied groups reach statistical significance with less than a predetermined number of patients.

Eligibility criteria:
inclusion criteria: * written, informed consent for participation in the study * oral sanation * myeloablative conditioning exclusion criteria: * lack of patient's consent * pathological lesions in oral cavity on the first day of conditioning regimen * renal failure * active infection

Keywords: oral mucositis low-level laser therapy biomodulation hematopoietic stem cell transplantation
adjunctive right atrial ablation for persistent atrial fibrillation

Conditions: Atrial Fibrillation, Persistent

Summary: persistent atrial fibrillation (peraf) can induce right atrial (ra) enlargement. our previous study demonstrated patients with peraf and ra enlargment may benefit from adjunctive ra ablation. therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive ra ablation.

long-term persistent atrial fibrillation (peraf) may induce right atrial (ra) enlargement and subsequently atrial functional tricuspid regurgitation (af-tr) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. enlarged ra and significant af-tr may aggravate atrial remodeling and contribute to af sustaining. previous studies showed that ra enlargement was closely related to the recurrence of af after catheter ablation. however, unlike the left atrium, the ra mechanism has been poorly studied and generally excluded from the therapeutic target. in an animal model of right heart disease, the ra enlargement associated with re-entrant activity serves as the prominent mechanism of af genesis. using sophisticated mapping techniques, recent study has confirmed that up to one-third of af drivers are located in the right atrium. furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven af have concomitant ra enlargement. therefore, it is plausible to hypothesize that the presence of ra enlargement represents the necessity of adjunctive ra ablation. currently, the value and timing of ra intervention are still under debate. therefore, the purpose of the present study was to testify whether patients with peraf and ra enlargement may benefit from adjunctive ra ablation

Eligibility criteria:
inclusion criteria: * diagnosed as persistent atrial fibrillation according to the latest clinical guidelines; * ineffective or intolerable to ≥1 anti-arrhythmia drug treatment. exclusion criteria: * uncontrolled congestive heart failure; * history of severe valve disease and/or prosthetic valve replacement; * myocardial infarction or stroke within 6 months; * severe congenital heart disease; * ef \<40%; * contrast agent allergy; * the use of anticoagulant drugs is contraindicated; * severe lung disease; * left atrial thrombus confirmed by preoperative esophageal ultrasound; * contraindications for cardiac catheterization; * atrial fibrillation ablation; * have performed any cardiac surgery within 2 months; * poor general health; * life expectancy \< 6 months.

Keywords: catheter ablation atrial fibrillation driver ablation
the volume of blood submitted for culture in neonates - a multicentre quality improvement initiative.

Conditions: Neonatal Sepsis

Summary: the study will examine if introducing the practice of checking the volume of blood culture samples in neonates by bedside weighing will improve the sensitivity of the test and increase confidence in negative results affecting the rate of extended antibiotic treatment in neonates with negative blood cultures.

in the first part of the study (pre-intervention) the actual volumes of blood submitted for culture in neonates from participating neonatal units will be examined for the period of six months. the culture vials will be pre-weighted using precision scale before delivery to the units. after collecting the sample the vials will be weighted again at the time of admission to microbiology laboratory. at the end of the first phase, the results will be revealed to clinical teams and discussed. the sample volume control by using bedside precision scale will be introduced to the participating units along with educational actions to raise the awareness of importance of collecting adequate volume of blood for culture. the minimum volume of blood will be defined as at minimum 1 ml. the paramount role of blood culture in process of ruling out newborn sepsis will be emphasized. in the second phase of the study clinicians in participating centres will have an opportunity of measuring the volume of samples just after collecting. the volumes will also be independently controlled in the microbiology laboratory. the second phase will also last six months. collected volumes will be compared to results from pre-intervention period. clinical outcome measured by frequency of antibiotic treatment in newborn patients with negative blood culture will be compared before and after implemented changes. we hypothesize that introducing routine bedside control of the blood volume submitted for culture will result in increase confidence in negative blood culture results and decrease of antibiotic use in newborn population.

Eligibility criteria:
inclusion criteria: - any infant in a neonatal ward who has a blood culture collected (either early-onset or late-onset sepsis suspected). exclusion criteria: - there is no exclusion criteria.

Keywords: blood culture newborn blood volume quality improvement neonatal sepsis
study of abiraterone acetate plus prednisone in patients with chemo-naive metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate cancer (mcrpc).

this is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. all patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). the study will consist of a screening phase (within 28 days prior randomization on cycle 1, day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to month 60, focusing primarily on survival status). patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.

Eligibility criteria:
inclusion criteria: * has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease * prostate cancer progression documented by psa progression or radiographic progression * asymptomatic or mildly symptomatic from prostate cancer * surgically or medically castrated, with testosterone levels of \<50 ng/dl * previous anti-androgen therapy and progression after withdrawal * ecog performance status score of 0 or 1 * if opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of cycle 1 day 1 * if radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of cycle 1 day 1 * if previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days * life expectancy of at least 6 months exclusion criteria: * active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated * any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily * pathological finding consistent with small cell carcinoma of the prostate * liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months * prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mcrpc) * radiation or radionuclide therapy for treatment of mcrpc * uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment * history of pituitary or adrenal dysfunction

Keywords: prostate cancer metastatic castration resistant prostate cancer abiraterone acetate prednisone zytiga
bronchoscopic sampling techniques in sarcoidosis

Conditions: Mediastinal Lymph Node Enlargement; Sarcoidosis; Tuberculosis; Lymphomas

Summary: the development of endobronchial ultrasound (ebus) and ebus-guided transbronchial needle aspiration (ebus-tbna) has improved the safety and diagnostic accuracy of the mediastinal lymph node (mln) sampling. still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. the aim of the study is to compare the diagnostic accuracy of ebus-tbna and two other, more invasive procedures to obtain histological samples from mln in patients with clinical and radiological features of sarcoidosis. bronchoscopy with bronchoalveolar lavage (bal), ebus-tbna, ebus guided transbronchial forceps biopsy (ebus-tbfb), large bore (19g) histology tbna as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis. diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.


Eligibility criteria:
inclusion criteria: * provided informed consent * mediastinal lymph node enlargement that requires bronchoscopy and transbronchial sampling * clinical presentation that might be consistent with sarcoidosis exclusion criteria: * age below 18 years * known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders * lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node involvement

Keywords: mediastinal lymph node enlargement sarcoidosis bronchoscopy ebus guided transbronchial needle aspiration (ebus-tbna) transbronchial needle aspiration (ebus-tbna) ebus guided transbronchial forceps biopsy ebus-tbfb)
sentence shaping - dhh

Conditions: Hearing Loss, Bilateral

Summary: the proposed research addresses a long-standing and important challenge of improving literacy skills of children who are deaf and hard of hearing, a historically under researched group. the investigators aim to leverage shape coding - an empirically validated intervention approach for constructing sentences in spoken english - for improving how efficiently children who are deaf and hard of hearing learn to correctly construct sentences in written english. to advance the promising yet underutilized research on shape coding, the investigators complete the next logical step of applying the visual supports provided with shape coding to written language for deaf and hard of hearing children. shape coding has been effective for teaching sentence structure in spoken english to children with language disabilities and has recently been applied to sentence structure in american sign language with deaf and hard of hearing children. intervention involving shape coding is predicted to result in increased accuracy of word order in sentences in written english because deaf and hard of hearing children often benefit from visual information. the investigators will accomplish this aim using single case multiple probe across participants design studies with 30 fifth through eighth grade children who are deaf and hard of hearing. the knowledge gained will guide language and literacy intervention for children who are deaf and hard of hearing.


Eligibility criteria:
inclusion criteria: * children in grades five through eight * deaf or hard of hearing * use spoken english and american sign language (asl) * bilateral hearing loss * the ability to read and understand the grammatical structures of interest * already be writing sentences, but demonstrate errors in word order and/or grammar. exclusion criteria: * diagnosis of dyslexia * uncorrected vision impairment (i.e., identified vision loss without use of corrective lenses that interferes with eligibility evaluation tasks) * evidence of severe motor impairment (i.e., insufficient motor skills to complete eligibility evaluation tasks independently).
cognitive behavioral therapy treatment of depression with smartphone support

Conditions: Depression

Summary: the purpose of this study is to investigate whether face-to-face cognitive behavioral therapy (cbt) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. the study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.

mild to moderate depression is a major health problem, which lowers the quality of life for the individual and generates enormous costs for society. several forms of psychotherapy have been found to be effective in the treatment of depression. among these, behavioral activation has a strong empirical base. the efficacy of behavioral activation for treating major depressive disorders has been established in a number of studies over the last four decades. moreover face-to-face treatments could benefit from using smartphones as an adjunct to the regular sessions, which in the case of behavioral activation treatments for depression could facilitate activity scheduling and homework, which are crucial elements of the treatment. it may also be possible to reduce the number of sessions. since it has been shown that full behavioral activation is an effective treatment for mild to moderate depression, this study will be designed as a so-called non-inferiority study in which the treatment group, given fewer meetings face-to-face, but instead support in the form of a smartphone application. instead of a traditional behavioral activation treatment of 10 sessions, the treatment group will be given four face-to-face cbt sessions and a smartphone app as a complement and support to the four sessions. as a control, the investigators will give full behavioral activation with 10 sessions of face-to-face therapy.

Eligibility criteria:
inclusion criteria: * depressive symptoms according to dsm-iv * have access to a smartphone and to the internet * have good knowledge of the swedish language exclusion criteria: * recent (during last 6 weeks) change in psychiatric medication * presently in any other psychological treatment * severe depression * suicidal ideation

Keywords: depression behavioral activation smartphone application face-to-face blended therapy
capturing multiorgan effects of covid-19

Conditions: Coronavirus Infection; Multi-Organ Disorder

Summary: the c-more study is prospective observational holistic longitudinal study which will characterise the prevalence of multi-organ injury among covid-19 survivors post hospital discharge and assess its effects on quality of life, exercise tolerance and mental health.

since the outbreak of coronavirus disease (covid-19), hundreds of thousands of lives have been lost and millions significantly affected. although primarily a respiratory viral illness, emerging data suggests that multiorgan involvement is common in those with moderate-severe infections. whether or not persistent multiorgan damage will be seen in covid-19 survivors is unknown. c-more is an observational study that aims to investigate the long-term effects of covid-19 on the lungs, heart, brain, liver and kidneys using advanced state-of-the art magnetic resonance imaging (mri) technology. the study will assess 616 patients with laboratory-confirmed covid-19 from leading uk centres and undertake multi-organ magnetic resonance imaging at 3, 6, and 12 months following the onset of covid-19 symptoms. in addition, assessments of breathing, exercise capacity, cognition and mental health will be carried out. the study will describe the prevalence of persistent multi-organ injury in covid-19 patients and assess how this relates to comorbid conditions, severity of acute respiratory illness, immunological response, genetic factors, quality of life and mental health.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * diagnosis of covid-19 infection confirmed by detection of viral nucleic acid on reverse-transcription polymerase chain reaction (rt-pcr). * infection should be of moderate to severe intensity (i.e, patients with clinical signs of pneumonia such as respiratory rate \> 30 breaths/min; or severe respiratory distress; or spo2 \ 48 hours. * controls: participants with no serological evidence of previous infection, or active/previous symptoms suggestive of covid-19, and who may or may not have comorbidities. exclusion criteria: * contraindication to mri e.g. pregnancy, pacemaker, ferromagnetic implant, shrapnel injury, severe claustrophobia, inability to lie flat. * any other significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study. * any signs of active covid-19 infection on day of visit. * significantly impaired renal function (egfr\<30 ml/min)

Keywords: coronavirus disease mri multi-organ injury quality of life mental health
creon in hiv patients with steatorrhea

Conditions: Steatorrhea

Summary: the study investigates the effect of pancreatic enzymes on steatorrhea in hiv patients.


Eligibility criteria:
inclusion criteria hiv positive patients with clinically stable disease (karnofsky performance status \> 40); * steatocrit \> 2 %; * females of child-bearing potential must have a negative pregnancy test during prestudy or the subject must be surgically sterile or be at least 1 year postmenopausal as judged by the investigator; * women of child-bearing potential must be using a medically acceptable method of birth control throughout the study exclusion criteria * known allergy to pancreatin or any history of abnormal drug reaction; * known diagnosis of pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or cystic fibrosis or pancreatectomy; * intake of an experimental drug within four weeks prior to entry into the study; * alcohol abuse within the last six months; * suspected non-compliance or non-cooperation; * any other lack of fitness, in the investigator's opinion, to participate in or to complete the study; * patients with a stool fat excretion \<= 7 g/day according to van de kamer during the run-in period

Keywords: hiv steatorrhea