Kornimate/medical-research-clean huggingface dataset:
passive immunotherapy in patients with sars cov-2

Conditions: COVID-19

Summary: plasma from convalescent individuals (convalescent plasma, cp) has been used for more than a hundred years for the treatment of infectious diseases. among patients with covid-19, it has been used first, in patients with severe infection. although it is a safe treatment, it has not been possible to demonstrate a reduction in mortality in cases of acute respiratory distress syndrome. the objective of the clinical trial is to evaluate the efficacy and safety of the early use (less than 5 days of symptoms) of cp in patients infected with sars-cov-2 with risk factors for severe disease. the primary efficacy endpoint was the proportion of patients requiring oxygen therapy to maintain saturation \>93% on day 14. secondary objectives included, evaluation of the safety of the treatment, measured as the appearance of some adverse event related to the cp infusion; the evolution of covid-19 symptoms and who progression scale status at day 14 and 28 after inclusion; the need for hospitalization due to progression of covid-19. covid-19 progression was considered as worsening of respiratory symptoms requiring oxygen therapy at some point. finally, death from any cause was evaluated at 28 days, after inclusion in the study.


Eligibility criteria:
inclusion criteria: patients with sars-cov-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with covid-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air. in addition, the patients had to present some risk factor for severe disease: * chronic heart failure (nyha ≥ 2) * arterial hypertension under pharmacological treatment * chronic lung disease: copd (bronchitis, emphysema or chronic obstruction) with dyspnoea at least on moderate exertion, or moderate-severe asthma (that required inhaled corticosteroids to control symptoms or had received systemic corticosteroids during the last year due to decompensation) * chronic renal failure (glomerular filtration rate \<60 ml/min/1.73 m², by ckd- ild) * diabetes mellitus requiring pharmacological treatment or obesity grade ≥ i (bmi ≥30 kg/m2). * patients ≥65 years were included, regardless of other risk factors. exclusion criteria: * duration of symptoms \>5 days * dyspnoea at rest * need for supplemental oxygen to maintain o2 saturation \>93% * solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms * patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment * decompensated liver cirrhosis * participation in another clinical trial * history of hypersensitivity to haematological derivatives * pregnancy or lactation, * ast/alt \>5 times the upper limit of normal or at baseline in patients with chronic liver disease * any condition that in the opinion of the investigator limits participation in the study. * patients who had received monoclonal antibodies against sars-cov-2
impact of manual therapy on laryngeal function following total thyroidectomy

Conditions: Total Thyroidectomy

Summary: in this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone. the main questions it aims to answer are: will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy? will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy? will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy? will neck massage, stretches and pain science education improve quality of life after total thyroidectomy? participants will: participate in 4 visits with the participant's endocrine/laryngology surgeon. one prior and 3 after surgery for endoscopic evaluation and tests. participate in 5 speech-language pathology sessions for intervention exercises and tests. one prior and 4 after surgery. complete a journal of the participant's home exercise practice


Eligibility criteria:
inclusion criteria: * the study population consists of individuals with malignant or benign thyroid disease scheduled to undergo total thyroidectomy * native speakers of english * all patients will be greater than or equal to 18 years of age exclusion criteria: * participants will be excluded if they have completed voice therapy prior * are current smokers * have organic vocal fold pathology or clear mucosal changes to the vocal folds that can affect vibration (e.g., vocal fold scar, polyp, or nodules), * pre-existing unilateral or bilateral vocal fold paralysis * have had prior surgical neck or chest history including central or lateral neck dissection * pre- or post-operative abscess or inflammation * have a history of radiation, chronic cervical pain or cervicalgia, abnormal baseline swallowing * have underlying and, or plan to change supplemental hormones * greater than 10% otherwise unexplained weight loss * had a recent aspiration pneumonia * history of esophageal interventions or surgeries

Keywords: manual pain neuroscience education total thyroidectomy speech pathology
quadramune(tm) for prevention of covid-19

Conditions: Covid19; Coronavirus; SARS-CoV 2

Summary: quadramune(tm) is a nutritional supplement which has previously been demonstrated to possess antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies. the current clinical trial aims to assess in a 500 volunteer trial the efficacy of quadramune(tm) in reducing infection in individuals at high risk of covid-19.

quadramune(tm) is composed of 4 natural ingredients. pterostilbene is an analogue of resveratrol, and has been shown to possess antiinflammatory activity. additionally, this compound suppresses macrophage activation while enhancing nk activity. epigallocatechin gallate (egcg) is one of the active ingredients in green tea and has been shown to act as an activator of t cells, and a suppressor of neutrophil mediated inflammation. sulforaphane is derived from broccoli and studies have shown that it protects lungs from inflammatory pathology. thymoquinone, which is chemically related to hydroxychloroquine, possessing antiviral effects and increases nk activity. quadramune is a combination of these ingredients and is believed to possess superior in vitro and in vivo therapeutic properties as compared to when the ingredients are administered individually. the study aims to assess preventative effects of quadramune(tm) administration for 12 weeks.

Eligibility criteria:
inclusion criteria: * informed consent, provided electronically via the edc, demonstrating the subject understands the procedures required for the study and the purpose of the study male or female patients 18 years of age or older that are considered to be high-risk individuals. * high-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities. * subjects must agree to practice at least two highly effective methods of birth control for the duration of the study this includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. at least one of these must be a barrier method. subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized) exclusion criteria: * refusal to provide informed consent any previous positive test for covid-19 by rt-pcr symptomatic for covid-19 diarrhea prior to the start of treatment type i or ii diabetes atherosclerotic coronary artery disease any contraindication for treatment with hydroxychloroquine including: hypoglycemia g6pd deficiency porphyria anemia neutropenia alcoholism myasthenia gravis skeletal muscle disorder maculopathy changes in the visual field liver disease, with alt/ast \> 2.5 upper limit normal and total bilirubin \>2.5 upper limit normal psoriasis any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.

Keywords: immunology innate immune system
an imaging-based quantitative biomarker assay for nafld in children

Conditions: NAFLD; NASH

Summary: this study will validate recently developed magnetic resonance imaging (mri) and ultrasound (us) based methods for liver fat quantification in children with obesity and healthy range of body mass index (bmi).

the severity of the obesity epidemic in the u.s., particularly in wisconsin, is alarming, with overall overweight or obesity rates of 35% in children. \[fryar 2020,\] obesity is a major risk factor for several comorbidities, one of the most common being non-alcoholic fatty liver disease (nafld, also denoted steatotic liver disease). the inflammatory state known as non-alcoholic steatohepatitis (nash) may lead to fibrosis and, if left untreated, can lead to cirrhosis, liver failure, and cancer. for these reasons, there is enormous interest in effective interventions for weight loss and reversing nafld. a central challenge in the development of new interventions is the need for accurate and precise biomarkers to evaluate hepatic steatosis in children. this pilot study focuses on demonstrating the feasibility of mri and us based liver fat quantification in children and addresses technical challenges that may limit the performance of the proposed techniques in the population of interest through the following aims: * aim 1: determine the bias and precision (repeatability) of emerging free-breathing mri-based liver fat quantification in children with obesity and controls using current breath-held methods as a reference. * aim 2: determine the precision (repeatability and reproducibility) of us-based biomarkers of liver steatosis with a focus on the impact of body wall thickness on the precision of the biomarkers.

Eligibility criteria:
inclusion criteria: 1. age: 10 - 14years old 2. bmi: case subjects: bmi\>95th percentile for age and sex healthy bmi volunteers: 5th ≤ bmi \< 85th percentile for age and sex exclusion criteria: 1. children with contraindications to mri. 2. children who did not fast (verbally confirmed by children or guardian) 3. pregnant
poster on dysphagia-specific food procedures: usability and impact

Conditions: Dysphagia

Summary: the aim of this study is to evaluate the use of a poster containing information on dysphagia-specific food procedures at two levels: utility from the point of view of patients' caregivers, and impact on patients' health. half the patients will have the poster placed in their room, whereas the other half will not.

dysphagia is a swallowing disorder that can be associated with clinically relevant complications, and caregivers can play a fundamental role in this process, namely because they feed the patient. however, studies show a lack of professional-caregiver communication in dysphagia, and caregivers' need for more information. communicating dysphagia-specific food procedures through a visual poster might bridge professional-caregiver communication gaps, with consequences for the patient's health.

Eligibility criteria:
inclusion criteria: * patients with post-acute dysphagia (lesion occurring at least six weeks prior, approximately), * remaining in inpatient care for at least one month after the first moment of data collection, * 18 years of age or older, * receiving regular visits from their family members or caregivers. exclusion criteria: * failing to meet inclusion criteria
minocycline to prevent acute kidney injury after cardiac surgery

Conditions: Kidney Failure, Acute; Acute Kidney Insufficiency

Summary: this study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.


Eligibility criteria:
inclusion criteria: * age over 18 years * planned cabg or valvular surgery with cardiopulmonary bypass * serum creatinine available (within 30 days) * estimated gfr 15-90ml/min using the abbreviated mdrd formula (ckd stages 2-4) exclusion criteria: * emergent or urgent surgery (to be performed within the next 36 hours) * end stage renal disease, or gfr \< 15ml/min (ckd stage 5) * estimated gfr\>90ml/min (ckd stage 1 or no ckd) * ongoing infection by positive blood, urine or sputum cultures or pneumonia on cxr * allergy to minocycline or tetracyclines * inability to take oral medications * use of preoperative vasopressor agents at therapeutic doses * pregnant or lactating females * advanced liver disease by history or exam(cirrhosis, ascitis, jaundice) * rising creatinine meeting the definition of acute kidney injury prior to surgery * neurologic signs or symptoms or history of increased intracranial pressure * current participation in another research study involving an investigational drug or device

Keywords: renal kidney injury acute bypass cardiac minocycline prevention acute kidney failure
computer guided visco supplementation in the management of internal derangement of temporomandibular joint

Conditions: Temporomandibular Disorder

Summary: background: the intra-articular injection is considered the first line of minimally invasive treatment in tmj-id patients who do not respond to conservative treatment. image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point. aim of the study: to evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (tmj-id) compared with conventional injection


Eligibility criteria:
inclusion criteria: * 1. patients diagnosed with internal derangement according to wilkins stage i and ii. * patients who would not respond to conservative treatment as a first line of treatment. exclusion criteria: * patients with wilkins stage iii, iv, v. * history of mandibular fracture. * lactating, pregnant or planning pregnancy women. * known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
investigating safety and pharmacokinetics of 2 different single doses of nnc128-0000-2011 in haemophilia a or b patients

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Summary: this trial is conducted in europe and japan. the aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of nnc128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with haemophilia a or b (with or without inhibitors and irrespective of severity) based on medical records * japan: a legally acceptable representative (lar) is required for patients between 18 and 19 years * body weight less than or equal to 100.0 kg * body mass index (bmi) less than or equal to 30.0 kg/m\^2 exclusion criteria: * known or suspected allergy to trial product(s) or related products (including rfviia) * previous participation in this trial defined as administration of trial product * the receipt of any investigational product within 30 days prior to trial start (screening) * congenital or acquired coagulation disorders other than haemophilia a or b * receipt of immune tolerance induction (iti) within the last 30 days prior to screening * any surgery within 30 days prior to screening * planned surgery within the trial period * platelet count below 50,000 platelets/mcl (based on medical records within the last 1 month or laboratory results at screening) * prothrombin time (pt) above 4 times upper limit of normal (uln) or international normalised ratio (inr) greater than 1.7 * hepatic dysfunction or severe hepatic disease as evaluated by the investigator (trial physician) * renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to medical records or laboratory results at screening) * advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.) * any disease, condition, or medication which, according to the investigator's (trial physician) judgement, could imply a potential hazard to the patient or interfere with the trial participation or trial outcome * mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
continued administration of g-202 for one patient with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: patient with advanced liver cancer (cancer that has spread to other parts of the body) continues to receive the study drug (g-202) even though patient no longer meets the criteria to be a part of the main treatment study. patient's cancer responded well to receiving g-202 in the main study and will receive g-202 at the same dose given in the main study.


Eligibility criteria:
inclusion criteria: * history of hepatocellular carcinoma * participation in prior research study where g-202 was administered * tolerance of g-202 treatment * demonstration of stable disease exclusion criteria: * disease progression * occurrence of unacceptable toxicity

Keywords: g-202 hepatocellular
efficacy and safety of botulinum toxin a for the treatment of refractory overactive bladder.

Conditions: Overactive Bladder

Summary: overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. this condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. this study is designed to evaluate the efficacy and safety of botulinum toxin a injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

this study is designed to evaluate the efficacy and safety of botulinum toxin a injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

Eligibility criteria:
inclusion criteria: * overactive bladder with more than 3 episodes of urgency of urge incontinence per day

Keywords: overactive bladder urgency urge incontinence botulinum toxin a quality of life
national egyptian network pediatric stroke and hemiplegia registry

Conditions: Stroke With Hemiparesis; Perinatal Stroke; Focal Neurologic Deficits

Summary: our aim is to establish multi-center national egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.

aims: an open-ended multi-center, national egyptian study to collect and analyze data for children with cerebrovascular stroke and hemiplegia . participants: eligible infants and children with stroke and hemiplegia. design: this study is a prospective cohort study. primary outcome measure: initial acute stroke clinical and radiological presentation, recurrent stroke, mortality, and neurologic deficits in the acute stage, participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Eligibility criteria:
inclusion criteria: * focal neurological deficit of acute onset lasting greater than 20 minutes. and ct or mri showing infarct in location consistent with neurological signs and symptoms * hemiplegia exclusion criteria: 1. cerebral haemorrhage not associated with ischemic infarct. 2. hypoxic ischemic event with diffuse or bilateral infarction alone.

Keywords: stroke congenital stroke neonatal hemiplegia
diabetes electronic prompt for improved care coordination and treatment in the ed

Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); Hyperglycemia; Insulin Dependent Diabetes

Summary: the goal of this clinical trial is to improve the processes of type 2 diabetes (t2d) care coordination and treatment in the emergency department (ed) by utilizing clinical decision support mechanisms in the electronic health record (ehr). the main question is whether electronic prompts triggered by hyperglycemia and elevated a1c results in providers providing earlier treatments and faster time to subsequent primary care appointment and greater reduction in hemoglobin a1c (ha1c). ed clinicians will receive alerts called our practice advisories (opa's) through the epic ehr. the 1st opa triggers when a random point-of-care (poc) glucose is ≥250 mg/dl, prompting a suggested additional ha1c order. a 2nd opa triggers if the resulting ha1c is ≥10%, prompting consideration of further care coordination in the observation unit. investigators will compare the outcomes post-intervention compared to pre-intervention.

type 2 diabetes (t2d) is a growing public health crisis with rates of diabetes steadily increasing over the last 10 years. the ed is commonly the first point of contact for individuals who present with symptoms of hyperglycemia, often with very severe (hba1c \> 10%) underlying diabetes. however, there is currently no national guideline or clinical policy for the ed management of patients who are not in diabetic ketoacidosis (dka) or in a hyperglycemia hyperosmolar state (hhs). the investigators hypothesize that there are two subgroups who may benefit from greater care coordination initiated from the ed: patients who are newly-diagnosed with severe t2d and patients whom t2d is poorly-controlled despite medication adherence. this study designs electronic prompt practice advisories that nudge ed providers towards more aggressive treatment pathways. it is currently unknown whether alert tools can improve the delivery and coordination of care of patients with severe t2d presenting to the ed.

Eligibility criteria:
inclusion criteria: moderate hyperglycemia, (glucose ≥250 mg/dl) * patients who arrive in the emergency department * not pregnant or peri-partum * not sars-cov-2 pcr positive in past 7 days exclusion criteria: * diabetic ketoacidosis (ph \ 25) * diabetic foot ulcer or skin complications * hyperglycemic hyperosmolar state with neurologic impairment * patients who leave against medical advice (ama), elope from the ed, or are transferred to another facility

Keywords: type 2 diabetes electronic prompt emergency department diabetes practice advisory
comparison of adjuvanted hepatitis b vaccine to double dose of engerix™-b in pre- /haemodialysis patients aged ≥15 years

Conditions: Hepatitis B

Summary: persistence of anti-hbs antibodies at month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. the anamnestic response to a booster dose was evaluated in subjects with anti-hbs antibody titres \< 10 miu/ml at previous timepoint. the study also evaluated the effect of a booster dose of the vaccine (month 42) after primary vaccination.


Eligibility criteria:
inclusion criteria: * subjects were to have completed primary vaccination course. a male or female \> = 15 years of age at the time of the first vaccination. * written informed consent obtained from the subject/ from the parents or guardians of the subject. * if the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * pregnant or lactating female.