Kornimate/medical-research-clean huggingface dataset:
hypo-fractionated radiotherapy in breast cancer

Conditions: Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer

Summary: this is a prospective interventional phase i/ii study which will be done at tata medical centre, kolkata. total 30 eligible female patients, ≥18 years of age, with locally advance invasive carcinoma of breast, not amenable to curative surgery of metastatic breast cancer, planned for palliative loco regional radiotherapy will be enrolled in the study amongst which patients with left sided breast cancer (at least 10) will be recruited to study the feasibility of voluntary breath hold technique for heart sparing. once consented, all patients will have regional baseline pet-ct scan of breast and tissue biopsy along with blood sampling done before studying radiotherapy. planning ct scan will then be taken, with standard planning ct scan for right breast cancers with implementation voluntary breath hold technique for the left breast disease. all patients will be treated with hypo-fractionated radiotherapy with schedule of 26gy on 5 fractions over 1 week with 6gy simultaneously integrated boost with incorporation of breath hold technique for left breast disease. all patients will be assessed weekly during course of radiotherapy. the toxicity will be assessed using ctcae version 4 and lent soma toxicity criteria and the impact of the hypo-fractionated breast radiotherapy schedule on quality of life in advanced incurable breast cancer patients using fact b scores phq4 questionnaire will also be assessed during treatment and follow-ups tissue bio0psy will be taken after 2 hours of completion of 1 st and last fraction of radiotherapy and biobanked for future radiobiological tests. response evaluation will be done clinically and by regional pet ct scan using persist criteria in 3 months after completion of radiotherapy. after completion of treatment, patient will initially be followed up every month for 1 st three months thereby 3 monthly for 2 years and 6 monthly for next 3 years.


Eligibility criteria:
inclusion criteria: * age ≥18 years * female * invasive carcinoma of the breast * ecog performance status 0-2 * locally advanced breast cancer which is not amenable to curative surgery as decided by multidisciplinary tumour board. * metastatic breast cancer patients: * who are awaiting palliative locoregional radiotherapy for symptom (pain bleeding, ulceration, impending fungation) control. * who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy * able to give informed consent exclusion criteria: * breast reconstruction using implants * concurrent cyto-toxic chemotherapy * prior radiation to the chest wall / breast

Keywords: palliative radiotherapy hypo-fractionated radiotherapy simultaneous integrated boost
tcm differentiation and treatment protocol of covid-19

Conditions: COVID-19

Summary: evaluation of the efficacy and safety of tcm differential treatment of covid-19 in jiangsu province based on the historical prospective multicenter cohort study.

this is a multi-center cross-sectional syndrome investigation study, taking confirmed cases as the main observation object, a prospective multicenter cohort study was designed, focusing on the common type with the largest number of confirmed cases, to evaluate the intervention effect of this project in relieving the disevaluation of the efficacy and safety of tcm differential treatment of covid-19 inease and preventing disease progressio. according to the actual situation of receiving treatment, if the subjects received the combination of western medicine and traditional chinese medicine, it was the exposure group (integrated traditional chinese and western medicine cohort), and if the subjects only received western medicine treatment, it was the control group (western medicine cohort). the choice of treatment for patients is entirely determined by clinicians according to the patient's condition, and patients are free to choose after fully understanding different schemes).the choice of control group: covid-19 (common type) who received routine treatment + antiviral therapy；the choice of exposure group: covid-19 (common type) who received routine treatment + tcm.the sample size is tentatively set at 340.

Eligibility criteria:
inclusion criteria: * it conforms to the diagnostic criteria of confirmed cases of covid-19 that belongs to the common type; * the age ranges from 18 to 80 years old, regardless gender； * in the prospective study, the patient informed consent and sign the informed consent form (if the subject has no capacity, limited capacity and limited expression of personal will, he or she should obtain the consent of his guardian and sign the informed consent at the same time), the retrospective study is visa-free informed consent. exclusion criteria: * women during pregnancy or lactation; * allergic constitution, such as those who have a history of allergy to two or more drugs or food, or who are known to be allergic to drug ingredients observed in this study. * severe complications such as multiple organ failure and shock occurred. * complicated with severe primary diseases such as heart, brain, liver, kidney and so on. * patients have mental illness. * patients who participated in or is currently participating in other clinical trials within the first month of this study.

Keywords: covid-19 syndrome investigation differentiation treatment multicenter cohort study
a study to collect blood biomarker samples from participants with chronic hepatitis b (chb) who received treatment with pegasys (peginterferon alfa-2a) ± nucleoside/nucleotide analogue

Conditions: Hepatitis B, Chronic

Summary: this phase 4 study is designed for the collection of blood biomarker samples from participants who have completed chb treatment with at least 24 weeks of a pegylated interferon alfa-2a (peg-ifn alfa-2a) containing regimen and at least 24 weeks post-treatment follow-up. participants may be enrolled from historical studies supported or sponsored by roche, ongoing studies supported or sponsored by roche, or from general medical practice. the follow-up of individuals who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. data from whole blood deoxyribonucleic acid (dna) samples collected in the gv28555 study or available from previously collected roche clinical repository (rcr) samples will be used for combined analysis with data from other applicable studies. procedures will include blood sample collection (not applicable for participants who previously have consented and donated rcr dna samples) and medical record capture.


Eligibility criteria:
inclusion criteria: * adults greater than or equal to (≥) 18 years of age * chb * previously enrolled in a roche study and treated for chb for ≥24 weeks with peg-ifn ± nucleoside analogue (lamivudine or entecavir) or peg-ifn ± nucleotide analogue (adefovir) and with ≥24 weeks post-treatment follow-up; or * treated in general practice for chb with peg-ifn according to standard of care and in line with the current summary of product characteristics (smpc)/local labeling who have no contraindication to peg-ifn therapy as per local label and have been treated with peg-ifn for ≥24 weeks and have ≥24 week post-treatment response available at the time of blood sample collection exclusion criteria: * hepatitis a, hepatitis c, or human immunodeficiency virus (hiv) infection
comparing the assessment accuracy between submental ultrasound and speech therapists for nasogastric tube removal

Conditions: Dysphagia Rehabilitation

Summary: the goal of this randomized controlled trial is to compare the assessment accuracy between submental ultrasound and speech-language pathologists on nasogastric tube removal in post-acute dysphagia adult patients. the main question it aims to answer is: whether the assessment accuracy of submental ultrasound is the same or better than the assessment speech therapist. participants will undergo submental ultrasound and speech-language pathologists' assessments, and randomly distribute to submental ultrasound (sus) and speech-language pathologist (slp) group for evaluation. sus group will enter oral feeding diet and tube removal training protocol based on the submental ultrasound criteria for swallowing function (maximum hyoid bone displacement≧ 1.38 cm); while the slp group will enter the above training protocols based on the speech-language pathologist's assessment. researchers will compare the nasogastric tube removal rate, vital signs, basic laboratory data, hyoid bone displacement on submental images, chocking and aspiration rate, the success rate of training protocols, functional oral intake scale (fois), etc. to see if the swallowing function and nasogastric tube removal assessment of submental ultrasound is consistent with speech-language pathologists' assessments.


Eligibility criteria:
inclusion criteria: * adults aged 18 and above * patients using a nasogastric tube * patients with a nasogastric tube placed due to acute conditions, such as increased oxygen demand, temporary loss of consciousness, or other illnesses causing weakness and a risk of aspiration. after treatment, there is no longer any indication for continued nasogastric tube placement. exclusion criteria: * patients with impaired consciousness * patients with long-term nasogastric tube placement * patients requiring a high-concentration oxygen mask or mechanical ventilation with intubation * patients with significant drooling or frequent aspiration of saliva * patients who have undergone oral or head and neck surgery * patients who have received radiation therapy for the head and neck

Keywords: nasogastric tube removal submental ultrasound acute dysphagia speech-language pathologist hyoid bone displacement
multicentre international study for the prevention with ialuril® of radio-induced cystitis (mistic)

Conditions: Prostate Cancer

Summary: the study is randomized and it will be conducted in the field of routine clinical practice. a total of 100 consecutive patients planned to receive radiotherapy for prostate cancer will be enrolled. the patients will enter the study as controls (50 patients that won't receive any experimental imp) or as treated-group (50 patients that will be also treated with the experimental imps, ialuril® and ialuril® soft gels) according to a predefined, centre-specific randomization.

radiotherapy will last for 6 weeks. during planning of treatment, regimen and average dose to the whole bladder will be recorded to assess the impact of ebrt on urinary symptoms. the treated-group will receive also intravesical ialuril® weekly for 6 weeks (in the 24 hours before every radiation therapy weekly schedule), plus oral treatment with ialuril® soft gels capsules (1 capsule twice a day after meals, at a distance of 12 hours, for 12 weeks). the control-group will receive radiotherapy only for 6 weeks. the primary objective is to assess the tolerability and safety of ha-cs intravesical instillations (ialuril®) plus an oral combination of curcumin, quercetin, ha and cs (ialuril® soft gels) in male patients undergoing radiotherapy for prostate cancer the efficacy of the treatment will be evaluated at the end of the study once received all the crfs.

Eligibility criteria:
inclusion criteria: * male patients planned to receive primary radiotherapy for prostate cancer. exclusion criteria: * female patients * patients with a life expectancy of less than 24 months * with radiological confirmed metastasis * with documented urethral strictures * undergoing chemotherapy * who received brachytherapy * who received chemo-radiotherapy for prostate cancer in the past * previously treated with bacillus calmette-guerin (bcg) * with post-void residual (pvr) \> 200ml * with clinical evidence of bladder calculi * with neurogenic bladder or neurologic disease at risk for neurogenic bladder * suffering from any lower urinary infections (utis, tuberculosis) * with unstable cardiovascular disease * with congestive heart failure (chf) * with current nitrate use * with current anticoagulants use (i.e. warfarin, heparin, etc.) * with clinically significant hepatobiliary or renal disease * with history of significant cns injuries within 6 months * with any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
assessment of coronary flow reserve by pet-h215o and ffr. comparison with dynamic acquisition using czt camera

Conditions: Coronary Artery Disease

Summary: the study will assess coronary flow reserve by pet-h215o and ffr in patients suspected of coroanry artery disease. this a comparative study with dynamic acquisition using czt camera and 99mctc-mibi. 20 patients will have those measurements.


Eligibility criteria:
inclusion criteria: * patient between 18 and 80 years * suspected coronary disease and / or coronary syndrome patient st- * patient who has been informed of the study and has given his informed consent * patient affiliated to a social security system. exclusion criteria: * patient having no coronary disease at coronary angiography with ffr on the 3 main epicardial arteries (absence of ≥ 50% stenosis of at least one artery) * delay of care grater than 30 days between the pet and spect imaging and the diagnostic coronary angiography * patient with a recent history of myocardial infarction and stemi, unstable angina * patient with extra-cardiac disease whose prognosis can interfere with the treatment decision * pregnant or lactating women * patient allergic to contrast products during coronary angiography * patient with mdrd clearance les than 60 ml / min * patient under guardianship, or unable to understand the purpose of the study
why wait? initiating contingency management in traumatically injured patients during hospitalization

Conditions: Contingency Management; Methamphetamine Use Disorder

Summary: this clinical trial is to implement contingency management (cm) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients. the goals are: * gather effectiveness data on a cm program for participants in hawaii who use methamphetamine during hospitalization and following discharge due to trauma injury * to assess participant perspectives on engaging with a cm program based at a level 1 trauma center. researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program. * to assess the rate of leaving against medical advice (ama) and treatment completion in acute hospital setting in participants. * to assess the optimal timing of cm initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of cm participation and rates of cm program completion and providing negative urine samples) to nct06532370 where cm was initiated after discharge from the hospital. for total of 12 weeks, participants will: * be visited on mondays, wednesdays and fridays by the research team to complete urine analysis during the hospitalization * visit a follow up clinic up to 3 times per week on mondays, wednesdays and fridays to complete urinalysis following discharge from the hospital * complete treatment effectiveness assessments at 6 and 12 weeks * engage in qualitative interview at the end of the cm program


Eligibility criteria:
inclusion criteria: * admitted trauma patients * age greater than 18 years old * urine drug screen positive for methamphetamines during the current hospitalization * report at least weekly methamphetamine use * first methamphetamine use greater than 6 months prior to injury * report at least 4 diagnostic and statistical manual of mental disorders 5th edition, amphetamine-type substance use disorder symptoms (at least moderate disease) * glasgow coma scale ≥13 upon arrival to the emergency department * ability to understand and participate in study procedures * ability to communicate in english * expected discharge date within 45 days on the day of screening / recruitment exclusion criteria: * active psychosis (reporting auditory or visual hallucinations) * under ongoing cardiorespiratory monitoring * evidence of moderate or severe traumatic brain injury * patients who are known to be pregnant * prisoners * individuals incarcerated at the time of their hospitalization * individuals lacking capacity to provide, or are otherwise unable or unwilling to provide written informed consent

Keywords: contingency management methamphetamine use disorder contingency management during acute hospitalization contingency management in trauma injured patients
optimization and follow-up of the consecutive use of two intragastric balloons in the treatment of obesity

Conditions: Obesity; Metabolic Syndrome

Summary: this is a cohort study with the objective of describing during a 12-month follow-up, weight loss in obese patients submitted to treatment using two consecutively air-filled igb (heliosphere® 600 cc and heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.

intragastric balloon (igb) implantation is a widely used technique to treat overweight subjects and those with mild obesity. the effectiveness of the air filled balloon (heliosphere bag®) in improving weight loss, reduction of bmi, percentage of body weight loss, percentage of excess weight loss and complications six months after placement is notable. several methods are available for igb placement and new techniques are being developed to reduce discomfort during and after the procedure. thus, the use of an igb as an effective method to avoid bariatric surgery is proposed. however, the precise protocol to balance complications and discomfort while maximizing weight loss is still to be established. our secondary objectives will be: * describe the weight loss, changes in the bmi and excess weight loss between the implantation of the first igb until its removal; * describe changes in the components of the metabolic syndrome; * describe changes in blood pressure; * estimate the rate of early explant; * describe the conditions of surgery; * describe operative complications; * to describe safety in the perioperative period, in the immediate postoperative period and in the late postoperative period

Eligibility criteria:
inclusion criteria: * class i obesity (30-34.9 kg/m2), class ii obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2). exclusion criteria: * morbid obesity (bmi\>40kg/m2), operative contraindications.

Keywords: intragastric balloon obesity metabolic syndrome bariatric surgery
communication intervention for toddlers with autism

Conditions: Autism Spectrum Disorder

Summary: the goal of this study is to conduct an efficacy trial to determine whether an early communication intervention which blends two evidence-based interventions, enhanced milieu teaching (emt) and joint attention, symbolic play and regulation intervention (jasper), improves social communication in toddlers with autism spectrum disorder (asd).

this study tests the blended intervention (j-emt) in a parent-plus-therapist-implementation model that has been demonstrated to be effective with other populations. the j-emt communication intervention is tailored to the specific social communication characteristics of children with asd and is delivered during a critical period in early communication development for these children. in this study, the investigators compare this blended intervention (j-emt) to a business as usual (bau) comparison group. children assigned to the j-emt group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement j-emt procedures across daily activities. the investigators will examine social communication and child vocalizations, expressive and receptive language, symbolic play, and symbol-infused joint engagement to determine whether j-emt changes both a primary functional outcome and the underlying specific skills that contribute to effective social communication in children with asd. results from this study will indicate the efficacy of this variation of parent-plus-therapist-implemented emt (i.e., j-emt) specifically tailored to the characteristics of young children with asd.

Eligibility criteria:
inclusion criteria: * between 24 and 36 months of age * a diagnosis of asd as confirmed by the ados-2 (module 1) * signed informed consent * parent willing to be trained exclusion criteria: * other diagnosis or disability * abnormal hearing and/or vision * language other than english is the primary language spoken at home
assessment of stress, depression and anxiety in healthcare caring for patients with covid-19

Conditions: Depression

Summary: medical personnel working in the intensive care unit will be examined by means of tests. their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. we also want to check whether people working in such extremely difficult conditions show no greater interest in death.

every day medical staff working in very difficult conditions of intensive care. the covid-19 virus outbreak has set another difficult task for doctors and nurses who have previously had a lot of contact with the death of their patients. the appearance of the covid-19 virus and, above all, the inability to effectively treat the infection causes an additional psychological stimulus in medical personnel. the aim of the study is to assess the occurrence of psychiatric disorders in medical personnel dealing with patients suffering from covid-19 using various psychological tests.

Eligibility criteria:
inclusion criteria: adult employees of the intensive care unit, agreeing to undergo the tests. exclusion criteria: * patient's refusal to participate in the study * not understanding the test questions

Keywords: healthcare workers covid-19 mental health outcomes
home-based visual training in patients implanted with trifocal diffractive intraocular lenses

Conditions: Visual Disturbances and Blindness; Visual Acuity Reduced Transiently

Summary: this multicentre randomised controlled trial aimed to reduce the visual discomfort that patients implanted with trifocal diffractive intraocular lenses may experience after surgery. to this end, a visual training software (optictrain) was developed in which gabor patches were presented to the patient on a hand-held electronic device. patients who met all inclusion criteria and consented to participate underwent half an hour of visual training per day for a period of 20 consecutive days remotely on a colourimetrically characterised samsung galaxy tab a device on which the optictrain software (n=30) or a placebo software (n=30), respectively, was pre-installed. corrected and uncorrected near, intermediate and distance visual acuity (va) and mesopic near and distance contrast sensitivity (cs) were measured monocularly and binocularly at two visits: during the first postoperative week (v0) and after 20 days of visual training with the assigned software (v1). the statistical analysis of the results obtained in the study has not yet been carried out.


Eligibility criteria:
inclusion criteria: * age between 18 an 90 years * patients implanted with trifocal diffractive intraocular lenses * availability and motivation to perform the visual training assigned exclusion criteria: * age under 18 or over 90 years * presence of irregular cornea, illiteracy or cognitive impairment * history of eye surgery or presence of any active ocular disease * intraoperative complications leading to significant visual sequelae * patients implanted with monofocal, extended depth of focus or refractive multifocal iols