Kornimate/medical-research-clean huggingface dataset:
comparison between the imaging consent form and the existing narrative consent form

Conditions: Lumbar Radiculopathy

Summary: this is a single-center, randomized, double-blind clinical study to compare patient comprehension and anxiety by comparing a traditional paper consent form to a multimedia consent form for patients undergoing transforaminal epidural steroid injection.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients undergoing lumbar transforaminal block for the first time * patients who are able to understand the contents of the video consent form and written consent form. exclusion criteria: * patients who have difficulty understanding or answering consent forms * patients who have previously experienced a transforaminal steroid injection

Keywords: lumbar radiculopathy multimedia informed consent
evaluation of a miniaturized microscope device for the detection of barrett's neoplasia: a pilot study

Conditions: Barrett's Esophagus

Summary: the overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. this is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. this is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in barrett's esophagus.


Eligibility criteria:
inclusion criteria: * barrett's without dysplasia * barrett's with dysplasia * esophageal adenocarcinoma exclusion criteria: * subjects unfit for standard upper endoscopy * subjects currently receiving chemo or radiation treatment * subject currently receiving pdt or ablation

Keywords: barrett's esophagus in vivo imaging image guide microscope
the effects of physical training on physiological and psychological stress-reactions and cognitive function.

Conditions: Healthy Volunteers; Sedentary Lifestyle

Summary: one of the biggest challenges of today is the high stress levels among employees in companies and organizations. physical exercise may be an effective preventive measure for stress-related problems. this relatively simple and inexpensive action is believed to be important for increasing and maintaining work ability and reduce the cost of stress-related ill health in the workplace. the aim is to investigate how regular physical exercise affects the individual's ability to mentally and physiologically cope with stress. acute stress physiological responses are measured before and after a 6 -month intervention, where 100 untrained individuals are randomized to either regular physical exercise or a control group. the hypothesis is that exercise leads to lesser activation of the individual's stress physiological systems and to an efficient physiological protection system. mental ability to handle stress is also studied as well as possible effects on the brain's cognitive functions. from a work perspective, cognitive impairment due to high exposure to stress is a major problem leading to substantial costs in businesses and organizations as a result of reduced performance and production. we believe that physical activity can alter and mitigate individual stress reactions. this study brings new knowledge that can contribute to increased motivation to prioritize physical activity in everyday life. the study could also provide evidence for businesses and organizations of the benefits of engaging in interventions and fitness initiatives to facilitate/enable increased physical activity in daily life for its employees. with an aging population, we are expected to work longer, which poses a challenge as the ability to manage stress and maintain cognitive abilities decline with age. for older employees, regular physical activity could be an important factor directly affecting the prospects for a sustainable working life.


Eligibility criteria:
inclusion criteria: * self-reported good health * sedentary * work or study at least 50% exclusion criteria: * diabetes * cardiovascular disease * blood pressure \> 140/90 * psychiatric disease * anemia * medication with substances that could affect any of the outcome measures

Keywords: exercise physical fitness stress, psychological cognition psychophysiology ergometry exercise test sedentary lifestyle
a study of sublingual immunotherapy in peanut-allergic children

Conditions: Food Hypersensitivity

Summary: the specific aim of this study is to determine if peanut allergen-specific slit will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

in spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. it is estimated that about 30,000 food-induced anaphylactic events are seen in u.s. emergency departments each year and that about 200 fatal cases occur in the u.s. each year. either peanuts or tree nuts cause more than 80% of these reactions. no treatments are available and avoidance is the only approved intervention. the goal of this study is to investigate peanut sublingual immunotherapy (slit) as a treatment for children with peanut allergy. this study is primarily designed to evaluate the efficacy and safety of peanut slit compared to placebo after 12 months. secondarily, the study is designed to evaluate the efficacy of extended maintenance dosing of peanut slit in inducing lasting tolerance after discontinuation of the peanut slit. mechanistic studies will be completed concurrently as exploratory endpoints to understand changes in the allergic immune response related to peanut slit.

Eligibility criteria:
inclusion criteria: * peanut ige \> 7ku/l (\> 2ku/l for children aged 2 years and under) and * history of significant clinical symptoms within 60 minutes after the ingestion of peanuts. exclusion criteria: * history of severe life-threatening anaphylaxis to peanut, or * medical history that would prevent a dbpcfc to peanut, or * subjects with wheat or oat allergy (which are used in the placebo), or * unable to cooperate with challenge procedures, or * unable to be reached by telephone for follow-up

Keywords: peanut allergy sublingual immunotherapy
topical gentamicin nonsense suppression therapy of eb

Conditions: Epidermolysis Bullosa

Summary: the overall purpose of this study is to address whether topical gentamicin therapy is an effective and feasible treatment. specifically, we will investigate the effect of non-intensive treatment (once daily or every other day) on skin protein expression, as well as quantify the effect on wound healing in patients with eb caused by psc (part a). furthermore, we will address in vitro whether gentamicin restores protein expression of genes affected by ssm in fibroblasts derived from skin biopsies obtained from patients with eb caused by ssm (part b). if these in vitro experiments yield positive results, the patients donating the cells will be offered to enter part a of this study. the overall duration of part a in this study is planned to be 18 weeks per patients and consists of a 6 weeks treatment period followed by a 12 week follow up period. each patient will attend 3 study visits: at week 0, week 6 and week 18. all patients will be included within a time period of 12 months. the overall duration of part b will be up to 8 weeks per patients of which 4-7 weeks are spent to prepare fibroblasts obtained from skin biopsies. then 5 days of in vitro intervention and subsequent analysis follows. altogether, the duration of the gentelbull study will be 78 weeks or less.


Eligibility criteria:
inclusion criteria: 1. the patient has eb caused by nonsense mutation 2. the patient has a symmetrical distribution of wounds which allows for wounds on one side of the body to serve as control wounds, while study therapy is applied to the other side. 3. the patient (if an adult) or parent(s)/guardian(s) is capable of giving signed informed consent as described in appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 4. women of childbearing potential must use a highly effective contraception method exclusion criteria: 1. known contact allergy against gentamicin sulfate or other ingredients in the ointment 2. known intolerance to gentamicin sulfate of any sort 3. moderate or severely reduced kidney function (egfr \<45) 4. use other experimental therapy against eb 5. receiving systemic aminoglycosides during the last 3 months 6. the patient uses muscle relaxant drug(s)
crt in narrow qrs heart failure: mechanistic insights from cardiac mri and electroanatomical mapping

Conditions: Heart Failure

Summary: cardiac resynchronisation therapy (crt) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. this treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ecg (heart tracing). also crt has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ecg as a narrow qrs complex). the investigators aim to see if cardiac mri can be used to select patients with normal electrical conduction for crt, therefore expanding the number of people who would stand to benefit from this treatment.


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. * nyha grade iii-iv heart failure * lvef\<35% * qrs duration \<120ms * on optimum medical therapy for heart failure * female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter * able (in the investigators opinion) and willing to comply with all study requirements. * willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study. exclusion criteria: * • female participants who is pregnant, lactating or planning pregnancy during the course of the study. * scheduled elective surgery or other procedures requiring general anaesthesia during the study. * participant who is terminally ill or is inappropriate for placebo medication * 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 study, or may influence the result of the study, or the participant's ability to participate in the study. * contraindication to an mri scan * rate uncontrolled atrial fibrillation precluding a cmr * significant peripheral vascular disease precluding an ep study * a contraindication to anticoagulation * a prosthetic aortic or tricuspid valve * significant aortic valve disease * known lv thrombus * insufficient capacity to consent to the study

Keywords: heart failure pacing resynchronization electrophysiology imaging cardiac resynchronization therapy
perioperative optimization with nutritional supplements for patients undergoing gastrointestinal surgery for cancer

Conditions: Gastrointestinal Cancer

Summary: this is a single-center randomized, placebo-controlled, double-blind feasibility study comparing the intervention of perioperative nutritional supplements (immunomodulation, carbohydrate loading, and protein isolate) with an identical placebo for each solution in patients with gastrointestinal cancer undergoing surgery. eligible and consenting patients will be randomly allocated to receive the intervention or placebo in a 1:1 ratio. this study will assess the feasibility of a large, multi-centre trial by establishing the feasibility of randomization to intervention or placebo. this study will be conducted at the juravinski hospital and will enroll 100 patients over 18 months. the study intervention includes three perioperative nutritional supplements: (1) a protein supplement administered 3 times a day for 30 days before surgery, (2) a sugar-based supplement administered the day prior to and the day of surgery, and (3) a formulated liquid diet containing arginine, rna, proteins and omega-6 fatty acids (referred to as immunonutrition for the purposes of this study) administered for 5 days prior to and 5 days after surgery. the primary outcome for each eligible patient is defined as being randomized to intervention or placebo. the criteria for success of this study is defined as the proportion of eligible patients randomized as ≥ 60%. if the estimated proportion is \<40%, the trial will be considered not feasible. if the proportion is between 40%-59%, the trial will be considered feasible with modifications to improve enrolment. other secondary objectives include compliance with study intervention, estimating differences in postoperative complications, length of hospital stay, and quality of life between groups.


Eligibility criteria:
inclusion criteria: * men and women 18 years of age or older * diagnosed with a resectable type of gastrointestinal cancer (e.g. cancers of the gallbladder, liver, pancreas, stomach, small intestine, colon and rectum) for which an elective operation is planned (resection vs. palliative procedure). * patients with distant metastasis are eligible for the study. * patients who are lactose intolerant are also eligible for the study because the amount of lactose in isolution and precovery is minimal (trace). exclusion criteria: * malabsorption syndrome (e.g. chronic pancreatitis) * cannot tolerate oral intake (e.g. gastric outlet obstruction or delayed gastric emptying) * organ failure (liver, kidney); end stage liver disease with a child pugh score ≥ b or end stage renal disease defined as stages 3 and 4 with a glomerular filtration rate between 30-59 for stage 3 and 15-29 for stage 4. * inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematous, crohn's disease and ulcerative colitis * patients currently on steroids * poorly controlled type 1 or 2 diabetes mellitus * female patients who are pregnant and/or lactating * galactosemia * ongoing infection.
clinical trial of sarilumab in adults with covid-19

Conditions: SARS-CoV 2; SARS

Summary: early administration of sarilumab in hospitalized patients infected with covid-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ards) requiring high flow nasal oxygenation (hfno) or either invasive or non-invasive mechanical ventilation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and \<75 years * admission for confirmed respiratory symptoms to covid-19 based on a positive pcr in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring onaf or mechanical ventilation * interstitial pneumonia confirmed by chest radiography or ct * il-6 levels\> 40 pg / ml. in its absence, d-dimer (dd)\> 1500 or\> 1000 may be included if progressive increases are documented * negative pregnancy test in women of childbearing age * signature of informed consent exclusion criteria: * sofa score\> 6 points * patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation * neutrophil count \<2 x 103 / μl * platelet count \<100 x 103 / μl * alt or ast levels\> 5 times the upper limit of normal * severe renal failure (crcr \<30 ml / min) * active bacterial infectious process * active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis * history of intestinal ulcer or diverticulitis * history of hypersensitivity reactions to sarilumab or its excipients * treatment with tnf antagonists * previous treatment with anti-il6 in the previous 30 days * chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. yes, inhaled and topical corticosteroids are acceptable * concomitant treatment with immunomodulators, among which are vitamin d or statins. macrolides such as azithromycin are acceptable * patients on immunosuppressive treatment for any cause * hiv-infected patients with cd4 \<200 / mm3 * past or current history of autoimmune disease or systemic inflammatory disease * patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins * participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product * pregnancy * any other condition that, in clinical judgment, prevents adherence to the patient's protocol
clinical evaluation of two daily disposable contact lenses

Conditions: Refractive Error

Summary: this study seeks to evaluate the clinical performance of two daily disposable contact lenses.


Eligibility criteria:
inclusion criteria: * be between 21 and 39 years of age. * signed written informed consent and investigator to record this on case report form (crf) in appropriate space. * be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). * require a visual correction in both eyes (monovision allowed but no monofit). * have a contact lens spherical distance requirement between -1.00d and -6.00d in both eyes. * astigmatism of 1.00d or less in both eyes. * be able to wear the lens powers available for this study. * be correctable to a visual acuity of 20/30 or better in each eye. * have normal eyes with no evidence of abnormality or disease. for the purposes of this study a normal eye is defined as one having: * no amblyopia. * no evidence of lid abnormality or infection. * no conjunctival abnormality or infection. * no clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities). * no other active ocular disease. exclusion criteria: * requires concurrent ocular medication. * any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * clinically significant (grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear. * diabetic. * infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., hiv). * extended lens wear in last 3 months. * pmma or rgp lens wear in the previous 8 weeks. * has had refractive surgery. has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study. * abnormal lacrimal secretions. * pre-existing ocular irritation that would preclude contact lens fitting. * keratoconus or other corneal irregularity. * pregnancy, lactating or planning a pregnancy at the time of enrollment. * participation in any concurrent clinical trial or in last 60 days."
analysis of intramedullary nail and prosthetic reconstruction after surgical treatment of bone metastases of proximal femur

Conditions: Bone Metastases

Summary: the investigators will collect data of patients treated surgically for impending or pathological fracture of the proximal femur due to bone metastases between 01/01/2000 and 31/12/2023 with imn or tha or hha or megatha or mega. after pre-screening the databases of the respective sites, the investigators expect to find approximately a total of 600 patients. a review will be made from the medical records, radiological imaging, and histological data of partecipants.


Eligibility criteria:
inclusion criteria: * male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in rizzoli orthopaedic institute and in massachusetts general hospital. * age ≥18 y (at the time of surgery) * patients with impending or pathological fracture due to bone metastases of the proximal femur (head/neck, intertrochanteric, subtrochanteric area). * patients who underwent either imn or tha or hha or mega or megatha. * patients with available clinical and imaging data. exclusion criteria: * patients with pathological or impending fracture of proximal femur due to primary bone tumor.

Keywords: bone metastases proximal femur
impact of neurally adjusted ventilator assist (nava) mode on patient ventilator asynchrony using non-invasive ventilation (nava-niv)

Conditions: Weaning Period

Summary: non-invasive ventilation (niv) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. however, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. the presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. neurally adjusted ventilatory assist (nava)could contribute to decreasing asynchrony. its principle is to record the diaphragmatic electrical activity and to control the ventilator. the investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in niv


Eligibility criteria:
inclusion criteria: patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning. exclusion criteria: * contra-indication to non-invasive ventilation * pregnancy