Kornimate/medical-research-clean huggingface dataset:
hydroxychloroquine as prophylaxis for covid-19 in healthcare workers (hcqprep)

Conditions: COVID-19; Corona Virus Infection; Wuhan Coronavirus; Prophylaxis; Healthcare Worker; Sars-CoV2; Hydroxychloroquine

Summary: this a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic covid-19 infection. healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. this study will enroll up to 1,700 participates in lafayette, louisiana. the primary outcome will number of symptomatic covid-19 infections. secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.

the study is a double blind placebo controlled at two hospitals in lafayette, louisiana aiming to enroll 1700 participants with a 1:1 randomization. the hcq dose in 400mg twice on day 1, then 200mg twice weekly. the primary outcome variable is development of symptomatic covid-19 infection. the secondary objectives are number of days absent from work due to symptomatic covid-19 infection and rate of severe disease due to covid-19 (hypoxia in setting of \>50% lung involvement on chest imaging, respiratory failure, shock or end-organ damage). the study will enroll participants for four weeks with and plan to treat with hydroxychloroquine versus placebo for a total of 12 weeks.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. healthcare or hospital worker who has direct patient contact 3. willing to participate in the research. 4. able to understand and sign the informed consent form exclusion criteria: 1. age \< 18 years 2. history of ventricular arrhythmia or use of class ia, ic and iii anti-arrhythmics 3. known prolonged qtc interval 4. history of retinal disease 5. kidney failure with gfr \<10% 6. chronic hepatic disease w/ child-pugh class b or c 7. hypersensitivity to chloroquine or hydroxychloroquine 8. currently taking chloroquine or hydroxychloroquine 9. unwilling to participate 10. unable to understand and/or sign the informed consent form.

Keywords: covid-19 covid-19 prophylaxis healthcare workers sars-cov-2 hydroxychloroquine
dose ranging study to assess the efficacy and safety of voclosporin ophthalmic solution in subjects with dry eye syndrome

Conditions: Dry Eye Syndrome; Keratoconjunctivitis Sicca

Summary: a multi-center, phase 2/3, randomized, double-masked, parallel-group, vehicle-controlled, clinical trial to assess the safety and efficacy of voclosporin ophthalmic solution (0.05%, 0.10%, 0.20%) compared to vehicle in subjects with dry eye syndrome.

this is a phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of vos when administered in both eyes (ou) twice a day (bid) over 12 weeks in subjects with mild to moderate des. subjects will undergo a 14- to 17-day run-in period in which vos vehicle will be self-administered ou, bid. subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. it is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * have a documented history of dry eye prior to visit 1. * willing and able to follow protocol procedures and instructions. exclusion criteria: * have undergone cataract or lasik surgery within 1 year prior to visit 1. * recent or current evidence of infection or inflammation in either eye. * current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye. * have used any investigational drug or device within 30 days prior to visit 1. * have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (otc) agents on the date of visit 1. * have worn contact lenses 24 hours prior to visit 1. * have used xiidra® (lifitegrast) within 14 days prior to visit 1. * have used calcineurin inhibitors (cnis) such as restasis® (cyclosporin ophthalmic emulsion) or cequatm within 30 days prior to visit 1.

Keywords: dry eye calcineurin inhibitors dry eye disease
ropivacaine hypobaric spinal anaesthesia in traumatic hip surgery

Conditions: Femoral Neck Fracture

Summary: this is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.


Eligibility criteria:
inclusion criteria: * older than 70 * dorsal decubitus surgery * asa score 1, 2, 3 * mms score \> or equal to 25 exclusion criteria: * local anesthetic allergy * spinal anaesthetic exclusion * mms score lower than 25

Keywords: unilateral spinal anaesthesia hypobaric anaesthesia ropivacaine traumatic hip surgery
performance evaluation of clinical ultrasound in management of acute pulmonary edema in elderly patient

Conditions: Pulmonary Edema; Respiratory Distress Syndrome

Summary: the main objective is to assess the validation of the diagnosis early acute pulmonary edema in elderly patients with acute respiratory distress, admitted in a host of vital emergency services by lung ultrasound associated with the measurement of the inferior vena cava.


Eligibility criteria:
inclusion criteria: * patient with compatible episode with acute edema (tachypnea with respiratory rate\> 25/min and/or oxygen saturation on room air \<90%, auscultation, dyspnea, sudden onset of symptoms) exclusion criteria: * vital signs of distress requiring intubation tracheal immediately * myocardial infarction lower seat with extension to the right ventricle, in the acute phase

Keywords: lung ultrasound pulmonary edema respiratory distress syndrome
correlation of biochemical indexes and retinal hemodynamic in patients with different degrees of diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: all octa data and biochemical indexes of diabetic patients were acquired. a prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

diabetic patients at the department of ophthalmology of the seventh affiliated hospital of sun yat-sen university were selected as research participants. all octa data and biochemical indexes were acquired. a prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes exclusion criteria: * various other types of retinal and choroidal disease; * history of any intraocular surgery or treatment (including intravitreal injection, retinal photocoagulation etc. * with severe refractive medium opacity that could affect fundus examination.
influence of liraglutide, a glp-1 receptor agonist, on brown adipose tissue (bat) activity in humans

Conditions: Obesity; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.


Eligibility criteria:
inclusion criteria: * body mass index over 30 kg/m2. exclusion criteria: * hypersensitivity to liraglutide or any of its vehicle components; * history of diabetes or pre-diabetes - either by fasting glycemia, ogtt or hba1c; * previous treatment within the last 3 months with glucagon like peptide-1 agonists, idpp4 or any medication that is associated with bat activation, including propranolol and benzodiazepines; * liver diseases, except non-alcoholic steatohepatitis (nash); * infection by hiv, hepatitis b or hepatitis c; * addiction to cannabis, heroin, morphine, cocaine, benzodiazepines or amphetamine; * obesity induced by other disorders such as cushing syndrome, hypothyroidism, lipodystrophy * current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tricyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium); * current participation (or within the last 3 months) in an organized weight reduction program * currently or previous using within 3 months before screening of pramlintide, sibutramine, orlistat, topiramate, or metformin (either by prescription or as part of a clinical trial) * participation in a clinical trial within the last 3 months prior to screening * simultaneous participation in any other clinical trial of an investigational drug * previous surgical treatment of obesity; * cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial * liver enzyme (alt and ast) above 2.5 x of reference range * pancreatic enzymes (amylase, lipase) above 3 x the reference range * chronic kidney disease stages 3, 4, or 5 * relevant inflammatory or acute or chronic infectious disease; hyperthyroidism; neurological, psychiatric, gastrointestinal, respiratory, renal, hepatic or cardiac relevant disease, that could interfere with trial results per the judgment of investigator * any condition that at the discretion of investigator could interfere with treatment adhesion on patient safety * blood donation or transfusion within the last 3 months * pregnancy or intention of pregnancy * history of multiple endocrine neoplasia syndrome type 2 (men 2) * history of pancreatitis * less than 80% of liraglutide adherence * calcitonin above the reference range at the screening visit.

Keywords: brown adipose tissue hypothalamic activation non-shivering thermogenesis basal metabolic rate liraglutide victoza body composition body weight adipose tissue biopsy
gut peptides and bone remodeling in individuals with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: both glp-2 and gip reduce bone resorption (measured as ctx) in healthy persons. in this study, we will investigate whether glp-2 and gip is reducing ctx in individuals with spinal cord injury.


Eligibility criteria:
inclusion criteria (individuals with spinal cord injury): * spinal cord injury resulting in the need of a wheelchair * bmi: 16-32 kg/m2 inclusion criteria (healthy controls): * intact spinal cord * matched on gender, age and bmi to the group with spinal cord injury exclusion criteria: * treatment with antidiabetics * treatment with anti-resorptive agents * gastrointestinal disease * smoking * long term steroid treatment * weight change more than 3 kg within the last 3 months. * overweight or intestinal surgery

Keywords: spinal cord injury gip glp-2 ctx p1np bone resorption bone formation bone turnover bone remodeling
effect of propranolol on the autonomic nervous system and muscle pain

Conditions: Temporomandibular Joint Disorders; Myofascial Temporomandibular Disorders

Summary: the project's primary purpose is to test the hypothesis that oral administration of a low single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with masticatory muscle pain.


Eligibility criteria:
inclusion criteria: * meet research diagnostic criteria for temporomandibular disorders (rdc/tmd) for myofascial tmd diagnosis corresponding to group 1a or 1b * characteristic pain intensity (cpi) more than or equal to 20 (axe ii, rdc/tmd questionnaire) * women of childbearing potential must use adequate contraception * signed consent statement exclusion criteria: * other acute pain cause such as acute toothache or a pain condition the investigator estimates to be contraindicated for participation in the experiment * recognized existing malignancy or within last 5 years * known hiv * abuse of drugs including alcohol * recognized raynaud's syndrome * former sympathectomy * known cardiovascular disease including abnormal ekg and blood pressure (ecg-12 is recorded before the first trial session and assessed by the physician) * recognized lung insufficience, including bronchial asthma * known severe hepatic or renal dysfunction * known diabetes mellitus * known severe depression * pregnancy (tests performed in both sessions 1 and 2 before the start of a session) * fertility treatment * lactation * post-menopausal * previous adverse reaction when taking beta-blocker, including hypersensitivity to propranolol or to any of the excipients * patients who can not read and understand the written information * patients who can not follow the protocol * patients who do not agree to comply with the requirements for participation in both studies regarding food intake, physical activity, etc.

Keywords: temporomandibular disorders orofacial pain
pet/ct scan as a tool to rationalize the treatment of patients with advanced colorectal cancer undergoing first-line medical treatment

Conditions: Colorectal Cancer Stage IV

Summary: the purpose of this study is to test whether an early metabolic response, measured by pet/ct scan after the first cycle of chemotherapy, is able to predict which patients with advanced crc have a better prognosis.


Eligibility criteria:
inclusion criteria: * diagnosis histologically confirmed colorectal carcinoma * stage iv disease * patients eligible for standard first-line treatment medical therapy (chemotherapy, and when indicated in association with egfr inhibitor and/or antiangiogenic) for advanced disease, at diagnosis or after primary surgery. * at least one target or non-target lesion according to recist revised version 1.1. * age \> or = 18 years . * ecog ps 0-2. * life expectancy \> 3 months. * signed informed consent. exclusion criteria: * uncontrolled diabetes (glucose \> 200 mg/dl * any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal psa). * pregnant or lactating females. * previous medical therapy for metastatic disease (prior surgery, radiation therapy are permitted, as well as adjuvant medical therapy completed at least 6 months prior to study entry). * any poorly controlled illness (including active infections, significant hepatic, renal, metabolic or cardiac disease, myocardial infarction within previous 12 months) that may, according to physician's judgement, interfere with the patient's ability to undergo chemotherapy and/or the examinations within the study protocol * inability to provide informed consent.

Keywords: metabolic response chemotherapy pet
hsd3b1 gene polymorphisms with outcomes in sars-cov-2 infected patients

Conditions: Covid19

Summary: the study includes 2 sub-projects. sub-project 1: the aim is to evaluate the expression of receptors and activating proteases mediating sars-cov-2 entry and spreading in the local population of ticino. sub-project 2: the aim is to investigate the association between the hsd3b1 gene variations and outcome of covid-19 in the local population of ticino.

sub-project 1: this is an observational retrospective study that aims to evaluate the expression of receptors and activating proteases mediating sars-cov-2 entry and spreading in the local population of ticino. the level of expression of these factors will be compared between infected and non-infected subjects. the sub-project will examine rna samples from nasopharyngeal swabs taken from subjects tested for covid-19. sub-project 2: this is a haplotype- and diplotype-based case-control retrospective study that aims to investigate the association between the hsd3b1 gene variations and outcome of covid-19 in the local population of ticino. the gene status of hsd3b1 will be defined and compared between two groups of patients: the patients who experienced a severe sars-cov-2 infection (severe pulmonary insufficiency, icu admission, eventually death) and the group with a mild-moderate covid-19 disease without pulmonary insufficiency and oxygen need.

Eligibility criteria:
sub-project 1 inclusion criteria: * availability of rna extracted from nasopharyngeal swabs taken from subjects tested for covid-19; * subject is aged 18 years or over; * written informed consent (for sars-cov-2 positive patients only; see §5 for further details). exclusion criteria: - documented refusal. sub-project 2 inclusion criteria: * female and male hospitalized sars-cov-2 patients; * patient is aged 18 years or over; * availability of archival tissue samples collected at any time before sars-cov-2 infection for any clinical reason; * clinico-pathological characteristics of the covid-19 and clinical outcomes recorded in the eoc and clinica luganese moncucco database; * written informed consent (see §5 for further details). exclusion criteria: - documented refusal.
comparison trial of enema vs. peg 3350 for constipation

Conditions: Constipation

Summary: the purpose of this study is to determine if milk and molasses enema or peg 3350 works better for treatment of fecal impaction in children who are constipated.

constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. a general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. disimpaction may be achieved using various oral therapies (e.g. including polyethylene glycol 3350 or peg); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. the optimal treatment has not been established. there are no published randomized studies that compare effectiveness of oral versus rectal treatments. comparison: one milk and molasses enema given to the patient in the emergency department compared to three oral doses of peg 3350 for relief of symptoms due to fecal impaction and constipation.

Eligibility criteria:
inclusion criteria: * constipated children who have one of the following three conditions: * fecal impaction (lower quadrant mass or dilated rectum with hard stool), * functional fecal retention (large diameter stools as determined by caregiver \<twice/week and retentive behaviors, or * excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician exclusion criteria: * ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician) * patients whose evaluation in the ed includes more than plain radiographs or urinalysis * patients who receive analgesia for the abdominal pain in the ed (except acetaminophen or ibuprofen) * non-english speaking patients and families * patients with milk allergy * patients with molasses allergy * patients who are pregnant * patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery * patients who are admitted to an in-patient unit

Keywords: constipation treatment fecal impaction pediatric
volar locked plating for distal radius fractures: should the pronator quadratus be spared?

Conditions: Distal Radius Fracture

Summary: volar locked plates for the distal radius fractures (drfs) are applied through the henry approach and it's modification, this approach entails a routine step to disinsert the pronator quadratus from it's radial and distal attachment. this muscle insertion is mostly fleshy with minimal tendinous tissue and surgeons find it difficult to reattach at the end of the surgery, the hardware come in direct contact with the flexor tendons.

distal radius fractures (drfs) account for about 17.5% of all adult fractures and represent the most common fracture of the upper extremity. for severely displaced or unstable fractures, open reduction and internal fixation (orif) is often indicated. volar locking plate fixation through the flexor carpi radialis (fcr) approach is widely used and considered a standard technique for distal radius fixation. classically, the pronator quadratus (pq) muscle is released from the radial side of the distal radius to expose the fracture and is later repaired after plate fixation. however, this repair is often not feasible or reliable. some authors have suggested that failure to restore the pq may leave the plate exposed to the flexor tendons, increasing the risk of tendon irritation or rupture. to address these concerns, minimally invasive pq-sparing approaches have been developed. imatani et al. first described a technique for volar plating without detaching the pq, and dos remedios et al. reported a similar approach. theoretically, preserving the pq creates a cushion between the plate and the flexor tendons and maintains the muscle's function. several studies have reported better early functional outcomes and less pain post-operatively with pq-sparing than the traditional approach. in this prospective case series at a level i trauma center with a dedicated hand surgery service, the pq-sparing volar plating technique for distal radius fractures is evaluated. the study's main objectives were to determine whether the pq can be preserved without compromising fracture reduction, to describe how a volar locking plate can be applied without releasing the pq, to identify potential benefits of pq preservation, and to assess any drawbacks of this approach.

Eligibility criteria:
inclusion criteria: * isolated closed distal radius fractures exclusion criteria: * fractures \>3 weeks old, * age \>60 years (reflecting our practice of treating most low-demand elderly patients nonoperatively unless the fracture was highly unstable), * pathologic fractures (e.g. metastatic lesions).

Keywords: distal radius fracture
stargardt disease in childhood

Conditions: Stargardt Disease

Summary: retrospective chart review study to elucidate the phenotype and genotype of children with abca4-associated stargardt disease.


Eligibility criteria:
inclusion criteria: * genetically confirmed abca4-associated inherited retinal dystrophy exclusion criteria: * 18 years old and older

Keywords: stargardt disease abca4 inherited retinal dystrophy