Kornimate/medical-research-clean huggingface dataset:
expanded access program to provide bamlanivimab (ly3819253) for the treatment of covid-19

Conditions: COVID-19

Summary: the treating physician/investigator contacts lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.


Eligibility criteria:
inclusion criteria: * reside in a country where there are ongoing lilly-sponsored clinical trials (currently this is only the united states) * present within 10 days of symptom onset * have severe acute respiratory syndrome coronavirus 2 (sars-cov-2) confirmed by reverse transcription polymerase chain reaction (rt-pcr) within the last three days * participants greater than or equal to (≥) 65 years of age or * participants ≥ 12 years of age who weigh at least 40 kilograms and have at least one of the following: * cancer * chronic kidney disease * chronic obstructive pulmonary disease (copd) or other chronic lung disease * immunocompromised state (weakened immune system or on immunomodulatory medications) * obesity (body mass index \[bmi\] of 35 or higher) * serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies * sickle cell disease * diabetes mellitus (types 1 or 2) exclusion criteria: * require hospitalization greater than (\>) 24 hours or hospice care. residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered * bamlanivimab should not be used in patients hospitalized with severe covid-19 respiratory disease
a study to investigate how respiratory syncytial virus (rsv) infection develops and changes over time in pediatric participants

Conditions: RSV Infections

Summary: the primary purpose of this study is to observe how viral load and titer change over time in participants with rsv and how data from hospitalized participants compares with data from non-hospitalized participants.


Eligibility criteria:
key inclusion criteria: * participant who is presenting within 5 days of onset of clinical signs at the time of informed consent. * participant is diagnosed with rsv within 5 days of sign onset. * participant's caregiver must be able to complete daily observer reported outcomes (obsros) and collect nasal swabs key exclusion criteria: * participant is hospitalized for reasons other than rsv infection. * participant is considered by the pi to be immunocompromised, due to an underlying medical condition or medical therapy. * participant has or has had a confirmed respiratory infection with another clinically relevant viral/bacterial pathogen within 14 days of study enrollment. * participant underwent major surgery within 28 days prior to enrollment in the study or has planned major surgery within 15 days of expected study completion. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: respiratory syncytial virus infections lower respiratory tract disease (lrtd)
randomized clinical trial of rehabilitation for subacromial impingement syndrome

Conditions: Shoulder Impingement Syndrome

Summary: the purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. we hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.

subacromial impingement syndrome (sais) is a frequent cause of shoulder pain. clinical trials investigating the effectiveness of manual therapy have demonstrated improvements in outcomes when manual therapy has been added to a program of therapeutic exercise. however, the these clinical trials (3) have significant limitations and generalizability. two of the three 3 trials had a small number of subjects (14 \& 22 subjects) and all 3 trials had only short term follow up (\<12 weeks) and used non-validated self report outcome measures. these limitations reduce the confidence with which clinicians can apply these results to the patients they treat with sais. clear evidence is needed to justify the cost and clinician time required to perform manual therapy in the delivery of patient care. therefore, the purpose of this randomized clinical trial is to examine the short-term and long-term effectiveness of manual therapy in addition to therapeutic exercise as compared to therapeutic exercise only in patients diagnosed with sais.

Eligibility criteria:
inclusion criteria: * symptoms associated with athletic activity (35% of patients) * diagnosis of shoulder impingement syndrome as evidence by all 3 criteria: 1. reproduction of symptoms with impingement test: either hawkins- kennedy or neer test 2. pain during active shoulder elevation at or above 60 degrees 3. weakness of rotator cuff or pain during the empty can test or during resisted shoulder external rotation * shoulder disability: 25/100 (0 = no disability) * able to understand written and spoken exclusion criteria: * severe pain; pain is \> 7/10 on nprs (0 = no pain) * shoulder surgery on affected shoulder * traumatic shoulder dislocation within the past 3 months * previous rehabilitation for this episode of shoulder pain * reproduction of shoulder pain with active or passive cervical motion * systemic inflammatory joint disease * global loss of passive shoulder rom, indicative of adhesive capsulitis * full-thickness rotator cuff tear, as evidenced by any one of the following: 1. markedly reduced shoulder external rotation strength 2. drop arm test 3. external rotation lag sign 4. lift off test 5. positive findings on mri or ultrasonography

Keywords: shoulder pain shoulder impingement syndrome manual therapy rehabilitation
oral vancomycin versus probiotics versus placebo for prevention of clostridium difficile infection in colonized patients

Conditions: Clostridium Difficile Colonization; Clostridium Difficile Diarrhea

Summary: the goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with c. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. the ultimate goal is to conduct an appropriately-powered rct to determine the optimal method for reducing c difficile infection in colonized patients.

in this study, patients will be screened for c. difficile colonization

Eligibility criteria:
inclusion criteria: * adult patients of 18 years of age or older identified as asymptomatic carriers of c. difficile (i.e. not meeting case definition of c. difficile infection, see below) * started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection * patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the chronic kidney disease epidemiology equation (ckd-epi)) and a complete blood count available within 24 hours of enrolment exclusion criteria: * on a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are) * patient with c. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from c. difficile infection * any patients with contra-indications to probiotics or vancomycin: * immunosuppressed (primary or acquired immunodeficiency, including aids (defined as aids defining condition or cluster of differentiation 4 (cd4) nadir of \<200/ul), hematologic malignancies, long-term systemic corticosteroid treatment, active treatment with chemotherapeutic agents or biologicals, autoimmune diseases, nephrotic syndrome) * structural heart disease (e.g. atrial septal defect, ventricular septal defect) * gastroesophageal or compromised gut integrity (e.g. short gut syndrome, intestinal injury or dysfunction, inflammatory bowel diseases including current or past history of crohn's disease and ulcerative colitis) * patients on systemic aminoglycosides, ethacrynic acid, polymixin b, or colistin. * prior or current hearing loss * female patients with known pregnancy or who are planning to get pregnant, or who are breastfeeding * patients with end-stage renal diseases defined as an estimated glomerular filtration rate of \<15ml/min, or absence of a current estimated creatinine clearance * history of an allergic reaction to one of the study drugs, or sensitivity to milk * patients started on probiotics or oral vancomycin while in hospital
a mild supplementation of arabinoxylan fiber improves homa index in overweight and obese subjects.

Conditions: Nutritional and Metabolic Diseases

Summary: the study aimed to investigate whether an arabinoxylan-enriched crackers consumption for 4 weeks in overweight and obese patients without diabetes mellitus have specific healthy effects on glycemic control (reduction of homeostatic model assessment -homa index-). furthermore, study evaluated the effects of arabinoxylan on insulin, lipid and ghrelin.

the beneficial effects of soluble dietary fiber to health are well known: many studies show clearly that it delays the onset of cardiovascular disease and some cancers, and improves glycemic control in type 2 diabetes. (1,2). overweight and obesity are known to be associated with increased rate of diabetes, hypertension and cardiovascular diseases, as well as to colon and breast cancer. the introduction of 25-30gr of dietary fiber daily would therefore indicated not only in type 2 diabetic subjects, but also in obese and overweight patients. most of the foods commonly consumed in western countries are low in dietary fiber: to reach the recommended levels people should introduce whole grain cereals, legumes, vegetables and dried fruits, not always accepted. we tested the effects on health of crackers baked with a special integralbianco® flour, enriched with 3,2g of arabinoxylan / 100g (vs refined flour).

Eligibility criteria:
inclusion criteria: * males and females * age ≥ 18 years * body mass index ≥ 27 exclusion criteria: * diabetes mellitus * already established organ damage * debilitating diseases

Keywords: arabinoxylan, homa index, glycemic control, obesity.
efficacy and safety of vds+su in the treatment of oab-dry in children

Conditions: Overactive Bladder; Pediatric Disorder

Summary: the aim of this study is to give children with dry oab: (1) standard behavioral therapy combined with classical anticholinergic drugs (solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin d supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry oab during follow-up. to provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin d supplements in combination with standard behavioral therapy as an effective treatment for dry oab treatment in children.


Eligibility criteria:
inclusion criteria: 1. children older than 5 years who were admitted to the department of urology, children's hospital affiliated to chongqing medical university and diagnosed with dry oab. 2. the results of our laboratory indicated that the serum vitamin d level was lower than 35ng/ml. 3. the child (guardian) has been informed of the nature of the study, understands the provisions in the protocol, is able to guarantee compliance, and signs the informed consent. exclusion criteria: 1. patients with other urinary system malformations or serious diseases (such as hypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteral reflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder and urethral injuries, etc.); 2. complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.); 3. patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease; 4. history of gastrointestinal surgery and urinary system surgery; 5. dry stool, long-term constipation; 6. are taking anticonvulsant and antiepileptic drugs, hormones, antituberculosis drugs; 7. previous history of hypercalcemia, hyperphosphatemia with renal rickets; 8. history of unexplained hematuria and urinary tract infection in the past 1 year; 9. have a history of allergy or allergic reaction to vitamin d preparations; 10. participating in another clinical study at the time of visit or during the follow-up of another clinical study; 11. those who did not want to participate in the study or had poor follow-up compliance
prophylactic pyloric balloon dilatation during ivor lewis oesophagectomy

Conditions: Postprocedural Delayed Gastric Emptying

Summary: this is a feasibility study to assess recruitment for a randomised control trial comparing prophylactic pyloric ballon dilatation versus control group (no intervention) in ivor-lewis oesophagectomy

the ivor lewis gastro-oesophagectomy is a complex operation that is performed to treat cancer of the oesophagus (food pipe) whereby most of the oesophagus and upper stomach are removed and the remaining stomach is brought into the chest and joined to the remaining oesophagus. in order to reduce the burden of complications of the procedure, research has been conducted in search of methods to improve the procedure and outcomes after the operation. delayed gastric emptying (how quickly food empties out of your stomach into your small bowel) is a common problem after this operation (20% of patients). the situation can lead to a feeling of being full up, loss of appetite and nausea. rarely, in severe cases patients may vomit or food going into lung causing a chest infection or develop a leak from the operative joint which can prolong hospital stay by an average of 5 days. treatment currently is uncertain, as is the scale of problem (how common it is) and there is no standard definition for delayed gastric emptying (there is no agreed standard way to describe slow emptying of food from the stomach into the small bowel by experts). there is a theory that the problem might be caused due to the outlet of the stomach (pylorus) narrowing down. prevention of the problem is also uncertain. in order to investigate prevention of the problem, the study will involve randomising patients during the oesophagectomy to either dilatation (stretching) of the pylorus with a balloon, or not, and completion of an abbreviated quality of life questionnaire (8 multiple choice questions). during the oesophagectomy, all patients routinely have endoscopy (camera test of the gullet and stomach) to assess the tumour. it is during this part of the operation that you will be randomised to either the balloon group or no intervention. the questionnaire is to assess your quality of life, in terms of delayed gastric emptying, at different points after the operation. preoperative endoscopic pyloric balloon dilatation with 20 mm has been shown to decrease incidence of dge (only 18.3 % of the intervention group developed dge compared to 37.5% in the non-intervention group (hadzijusufovic et al., 2019). this however was a cohort study, and the main issue was that the intervention group had 115 patients whilst the non-dilatation group had 24 patients (tumour could not be passed with the scope). there aren't currently any published randomised control trials that looked at intra-operative endoscopic pyloric dilatation and how this relates to incidence of dge.

Eligibility criteria:
inclusion criteria: * all patients over the age of 18 undergoing ivor lewis oesophagectomy in derriford. exclusion criteria * patient declined to participate. * impassable stricture at endoscopy. * patient is unable to give consent.
brivaracetam as add-on treatment of unverricht-lundborg disease (uld) in adolescents and adults

Conditions: Unverricht-Lundborg Disease

Summary: the study will compare the efficacy and safety of brivaracetam with placebo in patients with unverricht- lundborg disease (uld).


Eligibility criteria:
inclusion criteria: - subjects with diagnosed unverricht-lundborg disease (uld) ascertained by appropriate genetic testing for a homozygous or compound heterozygous mutation in the cstb gene- subjects with moderate to severe myoclonus documented by an action myoclonussum score of ≥ 30 (evaluation by investigator)-subjects currently being or having been treated with clonazepam up to the maximum recommended daily dose of 20 mg or up to their individual optimal dose as assessed by the investigator- subjects currently being or having been treated with valproate up to the maximum recommended daily dose 60 mg/kg or serum levels of 100 mcg/ml or up to their individual optimal dose as specified by the investigator- male/female subjects from 16 years onwards. subjects under 18 years may only be included where legally permitted and ethically accepted exclusion criteria: - subjects currently on felbamate or having been on felbamate within less than 18 months prior to visit 1- subjects currently treated with phenytoin or having been on phenytoin in the last month prior to visit 1- subjects currently on vigabatrine. subjects having been on vigabatrine if no visual fields examination report available including standard static (humphrey or octopus) or cinetic perimetry (goldman)- subject taking any drug with possible central nervous system (cns) effects- subjects taking any drug that may significantly influence the metabolism of brv (cyp2c or cyp3a potent inducers/inhibitors)- known clinically significant acute or chronic illness or illness which may impair reliable participation in the trial, necessitate the use of medication not allowed by protocol or represent a safety risk in the investigator's opinion- subjects with history of severe adverse hematological reaction to any drug- impaired hepatic function: alat/sgpt, asat/sgot, alkaline phosphatase, ggt value of more than three times the upper limit of the reference range- history of suicide attempt during the last 5 years- subject with suicidal ideations within the last year or at risk of suicide attempt unless cleared by written confirmation from a psychiatrist and approved by the ucb physician- ongoing psychiatric disorder other than mild controlled disorder

Keywords: unverricht-lundborg disease baltic myoclonus progressive myoclonic epilepsies myoclonus brivaracetam
adjuvant low dose total body irradiation in elderly patients with diffuse large b-cell lymphoma

Conditions: Non Hodgkin's Lymphoma

Summary: the purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy


Eligibility criteria:
inclusion criteria: * previously untreated, pathology verified aggressive non-hodgkin lymphoma of the diffuse large b-cell type according to the who classification. age between 60 years and 80 years.positive for an anti-cd20 antibody. good performance status and normal initial normal blood count. exclusion criteria: * patients with previous lymphoma associated with immune suppression of any sort. diagnosis or history of indolent lymphoma or other malignancies. marked impairment of any vital organ such as the heart, lung, liver or kidneys.

Keywords: diffuse large b-cell lymphoma elderly patients low dose total body irradiation rchop14
retrospective study of intestinal microbiota in association with diabetes

Conditions: Dysbiosis Symptoms Linked to Pathology

Summary: the microbiota interacts with several human organs and influences the physiological process in the host. the predominant phyla of species in the gut microbiota are bacteroidetes (b) and firmicutes (f), accounting for 60-80%, and proteobacteria (p) and actinobacteria (a) in minority. when some of the bacterial phyla species are unbalanced, the pathological state of dysbiosis occurs. a laboratory index used for clinical analyzes is the f / b ratio \<0.8, which characterizes an intestinal dysbiotic state. many causes can affect the intestinal microbiota, thus altering it in a dysbiotic state, first of all the diet. in fact, dysbiosis can be characterized both by the severity with which it manifests itself and is also distinguished in putrefactive and fermentative dysbiosis. furthermore, the variation in the "normal" percentages of the phyla is also related to some pathological alterations. the aim of this study will be to monitor the population and heterogeneity of the microbiota in the italian population. knowing the complex implications of dysbiosis and the extensive data on it, this study will want to detail the state of the gut microbiota in the previously indicated population, focusing attention on peculiar profiles that could reflect a pathogenic spectrum or metabolic disturbances. the study aims to investigate the diffusion and state of the microbiota in the italian territory and if it occurs in association with certain pathologies and / or diet.


Eligibility criteria:
inclusion criteria: * aged between 16 and 80 years old, * patients with completed questionnare * dysbiosis symptoms exclusion criteria: * under 16 years old, * over 80 years old, * patients misidentified

Keywords: microbiote dysbiosis