Kornimate/medical-research-clean huggingface dataset:
breast cancer with intraoperative radiotherapy followed by hypofractionated external beam radiotherapy

Conditions: Breast Cancer

Summary: to evaluate cosmetic outcomes after conservative surgery for breast cancer with intrabeam followed by hypofractionated external beam radiotherapy

to evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (intrabeam) followed by hypofractionated external beam radiotherapy

Eligibility criteria:
inclusion criteria: * histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy. * not pregnant at diagnosis. * signed informed consent form. * age ≥45 years old. * patients candidates to intrabeam. * patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery: * tumor size \> 2.5 cm. * extensive intraductal carcinoma (≥25%) * lymphovascular invasion. * involved focal margins (\<2mm) without ampliation surgery. exclusion criteria: * presence of distant metastasis. * primary chemotherapy. * lymph node involvement. * negative hormonal receptors. * diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas * patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis). * uncontrolled infection. * concurrent treatment with other experimental treatments * lack of signed informed consent form.

Keywords: intraoperative radiotherapy hypofractionated radiotherapy
a study comparing insulin intensification therapies in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.


Eligibility criteria:
inclusion criteria: * present with type 2 diabetes mellitus * have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry * have haemoglobin a1c (hba1c) \>7.0% and \<12.0% exclusion criteria: * within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications * are pregnant or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. * are women who are breastfeeding. * have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night). * do not regularly consume three meals per day. * have a body mass index \>35 kilogram per square meter (kg/m\^2). * have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study. * have cardiac disease with a functional status that is class iii or iv * have a history of renal or liver disease * have used less than or equal to 20 units per day (u/day) of insulin during the past 90 days for more than 14 days (accumulated).

Keywords: metabolic diseases diabetes mellitus, type 2 glargine diabetes mellitus insulin lispro insulin
phase ii study of extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * joined the study voluntarily and signed informed consent form; * age 18-75；ecog 0-2 * esophageal squamous cell carcinoma , radical surgery ≤3 months,r0 resection. the operative incision healed well. * t3-4n0m0, t1-4n1-3m0 (according to ajcc2009) * no radiotherapy, chemotherapy or other treatments pre(post)surgery * ps ecog 0-2 * life expectancy of more than 3 months * hemoglobin(hb)≥9 g/dl • wbc≥3x109/l, neutrophils (anc )≥1.5x109/l • platelet count (pt) ≥100x 109/l • hepatic function: alat and asat \< 2.5 x uln, tbil\<1.5 x uln • renal function: creatinine \< 1.5 x uln * no immuno-deficiency * use of an effective contraceptive for adults to prevent pregnancy. exclusion criteria: * complete esophageal obstruction after surgery, esophageal perforation, haematemesis * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years * participation in other interventional clinical trials within 30 days * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * drug addiction, alcoholism or aids * uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * unsuitable to be enrolled in the trial in the opinion of the investigators

Keywords: esophageal squamous cell carcinoma postoperative radiotherapy
a pilot study of efficacy of lactobacillus cd2 lozenges in preventing high-dose chemotherapy induced oral mucositis in patients undergoing hematopoietic stem cell transplantation

Conditions: Oral Mucositis

Summary: patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (between 95-100%). this mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at times feel difficult to continue treatment. no definite treatment exists for prevention or treatment of oral mucositis in this group of patients. though one study has suggested that use of iv palifermin (a keratinocyte growth factor) will reduce duration and severity. palifermin is very expensive and not available in country. recently the investigators have shown effectiveness of a probiotic lactobacillus cd 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (published online in european journal of cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010). no significant toxicity has been reported with its use. now, the investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. the drug will be supplied by cd pharma india private limited. the investigators further give undertaking that study will be carried as per good clinical practices (gcp) and declaration of helsinki.


Eligibility criteria:
inclusion criteria: 1. age between 10 and 70 years. 2. karnofsky performance score ≥ 70%. 3. confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is an approved modality of therapy. 4. patients eligible to receive high-dose chemotherapy as part of conditioning regime. 5. concomitant co morbid condition if present, controlled by medicines. 6. serum creatinine 1.8mg/dl. 7. total bilirubin 2mg/dl. 8. liver enzymes within three times of normal limit. 9. expected survival \> 6 months. exclusion criteria: 1. pregnant women and lactating mothers. 2. patients with history of aids 3. patients who have taken any other investigational product in last 4 weeks. 4. patients having untreated symptomatic dental infection. 5. patients with who grade 3 or 4 oral mucositis. 6. other serious concurrent illness. 7. inconclusive histological diagnosis. 8. patients on anticancer antibiotics. 9. patients with signs and symptoms of systemic infections. 10. patient's/guardian's refusal to sign informed consent.

Keywords: lactobacillus cd2 lozenges high-dose chemotherapy induced hematopoietic stem cell transplantation
clinical performance of the globe® mapping and ablation system for the treatment of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is an observational, multicentre, prospective, post-market product registry for participants with af for whom ablation by the commercially available globe mapping and ablation system was indicated before enrolment into the registry. the aim of the registry is to confirm the clinical performance and safety of the globe mapping and ablation system in a real-life setting.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. participants with a documented history of atrial fibrillation indicated for ablation using the globe mapping and ablation system before enrolment into registry 3. signed informed consent exclusion criteria: 1. contraindication for catheter ablation with the globe system 2. participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion. 3. physical or mental condition because of which, in the opinion of the physician, the participant is not able to give informed consent or comply with physician instructions.

Keywords: atrial fibrillation radiofrequency rf ablation globe mapping and ablation system
epidural stimulation in multiple sclerosis

Conditions: Multiple Sclerosis; Demyelinating Disorder; Autoimmune Diseases

Summary: a study to quantify changes in motor performance of epidural stimulation in progressive multiple sclerosis (ms) patients over the course of 12 rehabilitation sessions.

the purpose of this trial is to study spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and to measure any changes in motor performance during 12 sessions over the course of one month.

Eligibility criteria:
inclusion criteria: * myelopathy secondary to progressive ms * no clinical or radiologic ms relapses for \> 5 years * edss score of 6.5 (constant bilateral assistance required to walk about 20 meters without resting) as assessed by a neurologist with a specialty in ms * able to ambulate 10 feet independently with or without gait aid use * at least 22 years of age * no changes to spasticity medications or dalfampridine over the last 3 months exclusion criteria: * currently a prison inmate, or awaiting trial, related to criminal activity * pregnancy at the time of enrollment * history of chronic and/or treatment resistant urinary tract infection * spasticity (grade of 4) measured bilaterally in two muscle groups using modified ashworth scale (mas). muscle groups tested will include bilateral knee flexors, extensors; ankle plantarflexors, dorsiflexors * unhealed decubitus ulcer * unhealed skeletal fracture * receiving diathermy treatment * active participation in an interventional clinical trial * any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study. * history of coagulopathy or other significant cardiac or medical risk factors for surgery * ventilator-dependent respiration * diagnosed with cardiopulmonary dysfunction (e.g., chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia) * untreated clinical diagnosis of depression * history of frequent hypotension characterized by light headedness, or loss of consciousness * history of frequent hypertension characterized by headache, or bradycardia * any active, implanted medical device * treatment of chemodenervation and/or neurolysis during the trial, or within 6 months of initiating the trial
effects of cranial electrotherapy stimulation on anxiety of patients after covid-19

Conditions: POST-Covid 19; Anxiety

Summary: the aim of the study is to investigate the effect of cranial electrotherapy stimulation (ces), for one hour a day over 3 weeks pulmonary rehabilitation (pr) program on symptoms of anxiety in post-covid patients.

many patients recovering from covid-19 develop sequelae related to the disease. in addition to lung issues, symptoms of post-covid/long-covid syndrome include fatigue, brain fog, amyosthenia, insomnia, anxiety and depression. these symptoms play a major role in post-covid patients recovery. ces (cranial electrotherapy stimulation) is a non-invasive therapy using low intensity alternating current applied through electrodes attached to the ear lobe. ces has been used to improve the condition of non covid patients suffering from depression, anxiety, fatigue and cognitive disabilities. this is thought to be due to a change in electric waves of the brain with an increase of alpha-waves and a decrease of beta- and delta-waves, as well as a change of concentration of neurotransmitters, e.g. beta-endorphin or serotonin. therefore, this study aims to investigate the effect of ces in addition to normal pr, compared to pr alone on symptoms (e.g. anxiety) in post-covid patients. hypothesis: three weeks of pr including daily use of ces for one hour will have a positive effect on symptoms of anxiety. trial: 40 patients post-covid reffered to inpatient pr will be recruited and allocated to one of two different groups. group1: anxious participants, group 2: non anxious participants. within groups particpants will be randomized to intervention or control/sham. intervention group will be using a functional device, and the other using a non-functional, sham device. anxiety is evaluated using the beck anxiety inventory on admission and at discharge from pr. questionnaires to evaluate fatigue, depression and insomnia are the fatigue assessment scale, phq-9, psqi). a diary will be kept by each participant with a log of general health and mood over the pr program.

Eligibility criteria:
inclusion criteria: group with anxiety: * high beck anxiety inventory score * ≥18 years * post sars-cov-2 infection * written consent group without anxiety: * low beck anxiety inventory score * ≥18 years * post sars-cov-2 infection * written consent exclusion criteria: * acitve implants (cardiac pacemaker,...) * pregnancy, lactation period

Keywords: long-covid/ post-covid ces fatigue insomnia
rates dmbt1 ( glycoprotein) in sputum of cf patients with pseudomonas aeruginosa

Conditions: Malignant Brain Tumor

Summary: rates of dmbt1 (glycoprotein like) in sputum of cf patients with or without may be different according to their pseudomonas aeruginosa chronic colonization status. the aim of this study is to compare rates of dmbt1 (glycoprotein like) in sputum of cf patients with or without a pseudomonas aeruginosa chronic colonization.

rates of dmbt1 (deleted in malignant brain tumor 1) will be compared between 2 groups of 30 cf patients : group 1 : with pseudomonas aeruginosa chronic colonization and group 2 30 cf patients without pseudomonas aeruginosa chronic colonization.

Eligibility criteria:
inclusion criteria: * cf patient 6 years * availability of sputum * signed informed consent exclusion criteria: * cardiac insufficiency * anti-inflammatory drugs on going * oral corticosteroid therapy * inhaled corticosteroids during the two weeks before inclusion, * patient awaiting lung transplantation * patient with a past history of heart/lung transplantation * patient with a sputum examination positive for : atypical mycobacteria, burkholderia cepacia, stenotrophomonas maltophilia, * patient chronically colonized with multiresistant pseudomonas aeruginosa * orkambi© or kalydeco© therapy * change of the cf treatment during the last 4 weeks +/- 2 days before inclusion : corticosteroid, pancreatic extracts, antisecretory drugs...

Keywords: malignant brain tumor patient sputum
routine clinical practice for use of intravitreal aflibercept treatment in patients with diabetic macular edema

Conditions: Diabetic Retinopathy

Summary: the main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. the total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients). this study was designated to answer french health authority (has haute autorité de santé) requirements.


Eligibility criteria:
inclusion criteria: * man or woman aged 18 years or older * patient diagnosed with a visual impairment due to diabetic macular disease (as defined by has (haute autorité de santé) recommendation). * patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study * patient diagnosed with type 1 or 2 diabetes mellitus * patient who has been given appropriate information about the study and who has given his/her written, informed consent exclusion criteria: * patient with other retinal disease at the time of inclusion * patients currently being treated with intravitreal aflibercept. this study will only include patients new to intravitreal aflibercept * systemic use of any anti / pro vegf therapy (vegf: vascular endothelial growth factor) * patient taking part in an interventional study

Keywords: diabetic macular edema
evaluation of a-1 cool cream efficacy for treatment atopic dermatitis

Conditions: ATOPIC DERMATITIS

Summary: atopic dermatitis (ad) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history. initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. the research product a-1 cool is a skin cream approved by the israeli ministry of health for cooling down of skin irritation. a-1 cool is rich in herbal medicine ingredients and does not contain steroids.a-1 cool can be beneficial in atopic dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.

atopic dermatitis (ad) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. in 90% of the cases the disease first appears before the age of five and in 65% of the cases it is already apparent at infancy but it may occur at any age. diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history. initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. topical ointments which grease the skin have shown and reduction of skin inflammation. these products can include active substances such as steroids and anti-inflammatory compounds. systemic treatments for atopic dermatitis mainly include steroids and cyclosporine. the research product a-1 cool is a skin cream approved by the israeli ministry of health for cooling down of skin irritation. a-1 cool is rich in herbal medicine ingredients and does not contain steroids.a-1 cool can be beneficial in atopic dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.

Eligibility criteria:
inclusion criteria: * patient with atopic dermatitis, * hebrew-speaking men and women, * over 18 years old. exclusion criteria: * hospital where the diagnosis of atopic dermatitis is not sure, * patients under the age of 18, pregnant women, no - helpless, soldiers and prisoners, * patients with atopic dermatitis treated with systemic preparations such as cyclosporine, steroids, antibiotics, methotrexate, biological preparations.

Keywords: atopic dermatitis a-1 cool cream
digital motivation to decrease inactive behaviour in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: physical inactivity is a major risk behaviour with a potential for causing premature death, particularly among people with mobility limitations, such as knee osteoarthritis. digital motivational interventions (such as sms) can motive to a healthy behaviour including increased physical activity. the purpose of this study is to investigate if motivational text messages following an exercise intervention to improve mobility limitations will change the physical activity level in patients with knee osteoarthritis. this study is designed as pilot randomized controlled trial, with equal randomization (1:1). eligible participants will be randomised into one of two groups (intervention or control) after completing their baseline measurements. the intervention group will receive weekly motivational text messages and the control group will not receive any attention from the study.


Eligibility criteria:
inclusion criteria: * age ≤18 * diagnosed with knee osteoarthritis * owner of a smart phone or tablet * have just finished an exercise program for knee osteoarthritis exclusion criteria: * not able to read and understand danish * any condition, which in the opinion of the investigator would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.
the hypertension in the very elderly trial (hyvet)

Conditions: Hypertension

Summary: the purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.

the benefit to risk ratio of treating hypertensives aged 80 or older has not been established. it has been suggested that at this age for each stroke prevented there is one non-stroke death. hyvet is designed to help clarify this. hyvet is a randomised, double-blind, placebo-controlled trial in hypertensive subjects aged 80 or older. active treatment consists of indapamide 1.5mg sr with the addition of perindopril 2mg - 4mg to reach a target blood pressure (bp) of \<150/80 mmhg. entry criteria include a systolic blood pressure of 160-199 mmhg. patients with isolated systolic hypertension (ish) have been recruited since august 2003.

Eligibility criteria:
inclusion criteria: * aged 80 or older * sitting systolic bp 160-199 mmhg and sitting diastolic bp \< 110 mmhg exclusion criteria: * known accelerated hypertension (retinal haemorrhages or exudates or papilloedema). * overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. subjects allowed if treated with digoxin only. * renal failure (serum creatinine of more than 150 µmol/l). * previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.) * condition expected to severely limit survival, e.g. terminal illness. * known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause). * gout. * clinical diagnosis of dementia. * resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable). * unable to stand up or walk * participation in a drug trial within the past month preceding selection. * alcohol or drug abuse. * less than 2 months placebo run-in. * contraindications to use of trial drugs

Keywords: aged hypertension stroke