Kornimate/medical-research-clean huggingface dataset:
dreamed advisor pro system in subjects with type 1 diabetes treated with mdi therapy

Conditions: Insulin-dependent Diabetes Mellitus; Diabetes Mellitus, Type 1

Summary: a multi center, open label, prospective study that will include up to 100 subjects with type 1 diabetes treated with multiple daily injections (mdi) of insulin according to a predefined sliding scale plan or carbohydrate ratio (cr) and correction factor (cf) plan, and self-monitoring of blood glucose (smbg) or continuous glucose monitoring (cgm). the study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on dedicated apps), for a total period of 9-10 weeks.


Eligibility criteria:
inclusion criteria: 1. documented t1d for at least 1 year prior to study enrolment 2. subjects aged 18 - 65 years old 3. a1c at inclusion ≤ 10% 4. subjects using basal-bolus mdi therapy: 1. basal insulin: glargine, degludec, or determir 2. bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues 5. subjects using cgm or smbg that are compatible with data transmission to the study dms. 6. bmi \< 28 kg/m2 7. subjects willing to follow study instructions: 1. for smbg users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). document blood glucose level, insulin delivery, meals and daily activities. wear blinded cgm. 2. for cgm users: use cgm according to manufacture instructions, document insulin delivery, meals and daily activities. 8. subjects have connection to the internet at home. 9. subjects have a smartphone compatible with study requirements 10. subjects willing and able to sign a written informed consent form. exclusion criteria: 1. an episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment. 2. concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety 3. relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as: * subject has unstable or rapidly progressive renal disease or is receiving dialysis * subject has active proliferative retinopathy * active gastroparesis 4. participation in any other interventional study 5. female subject who is pregnant or planning to become pregnant within the planned study duration 6. subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day. 7. drug or alcohol abuse.

Keywords: diabetes type 1 multiple daily injections
role of functional translation after immersive virtual reality exposure in persons with stroke

Conditions: Hemiparesis as Late Effect of Cerebrovascular Disease

Summary: this is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (vr) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

patients will be randomized to a control or experimental group. the experimental group will receive immersive vr training followed by the translation of related tasks in a real life environment. the control group will perform the same tasks in a real life environment but will receive immersive vr exposure to a non-related task.

Eligibility criteria:
inclusion criteria: 1. 18-90 years old 2. hospitalized at loma linda east campus rehabilitation hospital 3. first time stroke patient 4. upper limb hemiparesis 5. english-speaking 6. manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb exclusion criteria: 1. active neck pain, headaches, or vertigo limiting ability to tolerate virtual reality head mounted device 2. patients with hemicraniectomy 3. current uncontrolled seizures 4. active infections requiring contact precautions 5. cognitively unable to participate 6. vision loss limiting ability to participate with vr therapy
phase ii study of tas-106 to treat head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to determine whether tas-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.


Eligibility criteria:
inclusion criteria: * age 18 ≤ years old at study entry * histologically confirmed head and neck carcinoma * received prior platinum based regimen and developed disease progression or recurrence * measurable disease according to recist guidelines exclusion criteria: * radiological or clinical evidence of brain involvement or leptomeningeal disease * ≥ grade 2 peripheral neuropathy * history of another malignancy
a study to evaluate of the efficacy of enfuvirtide during the induction phase of therapy

Conditions: HIV Infections

Summary: we hypothesize that using a potent antiretroviral such as enfuvirtide during the induction phase of haart therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant hiv-1 strains.

this is an 48 week phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of enfuvirtide in an induction/maintenance treatment model. patients meeting inclusion criteria will be stratified into two groups according to hiv-1 rna viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms. all patients will receive efavirenz 600mg once a day, lamivudine 300 mg once a day, and tenofovir 300mg once a day. after randomization, one half of the patients will receive no additional treatment, while the other half will receive enfuvirtide 90mg sq bid until the viral load is \<50 x 2 consecutive visits or 12 weeks (whichever comes first).

Eligibility criteria:
inclusion criteria: 1. age: 18 to 70 years of age. 2. sex: male or female. 3. documented hiv-1 seropositive by western blot, elisa, or hiv-1 viral load. 4. naïve to haart. 5. viral load \>100,000c/ml. 6. cd4\<200c/ml. 7. volunteers must be willing and able to provide written informed consent to participate in the study. 8. available for at least 48 weeks of follow-up. exclusion criteria: 1. volunteers with an acute and clinically significant medical event as determined by the investigator to result in a life expectancy less then 12 months despite art. 2. volunteers with current psychiatric illness, alcohol abuse or illicit drug use that in the opinion of the principal investigator may interfere with patient's ability to comply with protocol requirements. 3. renal insufficiency (estimated creatinine clearance of \<60ml/min.) 4. patients with malabsorption or severe chronic diarrhea for more than 30 days. 5. inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day). 6. current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. 7. any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results. 8. pregnancy or breastfeeding 9. in a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence 10. patient who is currently receiving an experimental medication.
open radical prostatectomy and erector spinae plane block

Conditions: Prostate Cancer; Anesthesia, Local; Pain, Postoperative

Summary: in the proposed study, a bilateral erector spinae plane (esp) block \[10 ml 1%lidocaine + 10 ml 0.5 % bupivacaine vs normal saline (ns)\] will be performed preoperatively to patients undergoing open radical prostatectomy. analgesic efficacy will be assessed on the numeric rating scale (nrs) along with intra- and 24 h post-operative narcotic consumption.

it has been reported that the esp block produces effective postoperative analgesia for abdominal surgeries by relieving both somatic and visceral pain. in the present study, the investigators presume that an esp block will decrease narcotic consumption and nrs values both intraoperatively and during the first 24 postoperative hours. patients will be divided into two groups: group lb (lidocaine-bupivacaine): a bilateral esp block will be performed preoperatively (10 ml 1%lidocaine + 10 ml 0.5% bupivacaine). in addition, iv morphine patient-controlled analgesia (pca) will be applied postoperatively for 24 hours. group s: a bilateral esp block will be performed preoperatively (20 ml ns).in addition, iv morphine-pca will be applied postoperatively for 24 hours.

Eligibility criteria:
inclusion criteria: americansociety of anesthesiologists (asa) i-iii patients between the ages of 18 and 65 who are scheduled for elective open radical prostatectomy. exclusion criteria: * patients who do not give informed consent or do not want to participate in the study * ages \ 65 * asa iv patients * obesity (\>100 kg, bmi \>35 kg/m2) * contraindications of regional anesthesia (coagulopathy, thrombocytopenia, or infection at injection site) * serious renal, cardiac, or hepatic disease * hypersensitivity to local anesthetics or a history of allergy * history of opioid or steroid use longer than four weeks * psychiatric disorders * analgesic preoperative treatment within the preceding 48 hours * in order to establish better standard surgery, operations shorter than 60 minutes and longer than 180 minutes will also be excluded

Keywords: pain, postoperative ultrasound guided erector spinae plane block prostatectomy
diet and exercise solutions to postprandial hypotension

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.


Eligibility criteria:
inclusion criteria: * spinal cord injury (sci) between c4 and t12 who require use of wheelchair for daily mobility * ais a or b * \>1-year post-injury exclusion criteria: * currently pregnant of breast-feeding * type 1 or 2 diabetes * previous gut augmentation bariatric surgery * neurological impairment other than sci * history of uncontrolled autonomic dysreflexia * history of bone fractures * use of abdominal binder or anti-hypotensive drugs * fitted with pacemaker or defibrillator * currently receiving electrical stimulation training or in the previous year

Keywords: postprandial hypotension electrical stimulation low-glycemic diet
treatment settings for those with an alcohol problem

Conditions: Alcohol Abuse; Alcohol-dependence

Summary: a prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (aud) benefited more from inpatient (ip) than outpatient (op) care, if they presented with high alcohol involvement and/or low cognitive functioning. this study sought to: (a) validate and extend these findings within the uncontrolled environment of a community-based treatment center, and (b) test whether inpatients had fewer days of involuntary abstinence (e.g., incarcerations) relative to outpatients. based on their need for inpatient treatment, using prior cut-points for alcohol involvement and cognitive functioning, participants were randomly assigned within inpatient need group (no need for ip; needs ip) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient treatment, all followed by 6 months of continuing outpatient care. follow-up were conducted an 90-day intervals across 18 months.


Eligibility criteria:
inclusion criteria: * eligible for treatment through the chemical dependency treatment programs of a large, community-based healthcare network * drank alcoholic beverages within the last 90 days * have a current address (not homeless) * free of legal stipulations that would affect treatment decisions * have a past 3 months alcohol use disorder * primary alcohol, or alcohol and drug problem exclusion criteria: * homeless * drug problem only
inhaled beclomethasone to prevent chronic lung disease

Conditions: Bronchopulmonary Dysplasia; Hyaline Membrane Disease; Lung Diseases

Summary: to test if inhaled glucocorticoids, early in the course of respiratory failure in premature infants, permit normal lung growth and differentiation, thus preventing development of bronchopulmonary dysplasia.

background: bronchopulmonary dysplasia (bpd), a fibrotic/emphysematous lung disorder is a common sequela among extremely premature infants. the severity of bpd, but not incidence, has been reduced by surfactant therapy. bpd remains one of the most significant contributors to excessively prolonged hospital stays and, therefore, potentially avoidable costs. research leading to a reduction in bpd morbidity should prove cost effective in the estimated 10,400 affected infants annually (40 percent of a projected 26,000 survivors of birthweights less than 1,250 grams). inflammation is a significant component of both clinical and experimental model bpd and is the subject of numerous basic science investigations begun since the empiric observation that bpd responds favorably to systemic steroids. the known side effects of systemic steroids have led to their cautious sequential controlled clinical investigation, initially for late treatment (at more than 30 days of age), then early treatment (two weeks), then very early treatment (seven days), and even prophylaxis (day one). the prophylactic clinical trial of inhaled steroids, starting at day three for 21 days, is a logical next step in this sequence of determining the least dangerous, yet effective means to prevent or treat the inflammatory components of bpd. design narrative: multicenter, randomized, double-blind, placebo-controlled. the premature infants were randomized to beclomethasone or placebo on day three of life. beclomethasone was delivered in a decreasing dosage, from 40 to 5 micrograms per kilogram of body weight per day, for four days. the primary outcome measure was bronchopulmonary dysplasia at 28 days of age. secondary outcomes included bronchopulmonary dysplasia at 36 weeks of postmenstrual age, the need for systemic glucocorticoid therapy, the need for bronchodilator therapy, the duration of respiratory support, and death. clinical sites included the boston perinatal center at the new england medical center hospitals, the baystate medical center in springfield, massachusetts, and the pennsylvania hospital in philadelphia. the data coordinating center was at boston university school of medicine. support for the trial ended in april, 1999. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
premature boy and girl infants with birth weight less than 1,251 grams, gestational age less than 33 weeks, and postnatal age three to fourteen days, who continue to require mechanical ventilation with an emphasis on enrollment at three days.
single neurons responses during visual recognition in epileptic patients

Conditions: Epilepsy

Summary: the purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients. secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.

in this interventional study, patients explored with mixed intracerebral electrodes (micro and macro-contacts) will be presented sets of images (objects, unknown faces, famous faces). spikes and multi-unit-activity will be recorded and analyzed and compared between conditions.

Eligibility criteria:
inclusion criteria: * patient with temporal or occipito-temporal drug-resistant partial epilepsy, symptomatic, needing surgical treatment * patient having signed informed consent * patient affiliated to social security * patient having undergone preliminary medical examination exclusion criteria: * persons under legal protection or incapable to consent * persons deprived of liberty by juridical or administrative decision * patient with severe visual disorders of neurological or ophthalmological origin * patients with infection risk according to doctor or surgeon * women without effective contraception * pregnant or breast-feeding women
triple in asthma with uncontrolled patient on medium strength of ics + laba

Conditions: Asthma

Summary: the purpose of this study is to evaluate the superiority of chf 5993 100/6/12.5 µg pmdi (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus chf 1535 100/6 µg pmdi (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.


Eligibility criteria:
inclusion criteria: * history of asthma ≥ 1 year and diagnosed before 40 years old * uncontrolled asthma with double therapy only on medium doses of inhaled corticosteroid (ics) in combination with long-acting beta2 agonist (laba) with acq-7 (asthma control questionnaire) ≥1.5 * pre-bronchodilator fev1 \<80% of the predicted normal value * positive reversibility test * at least 1 documented asthma exacerbation in the previous year exclusion criteria: * pregnant or lactating women * diagnosis of chronic obstructive pulmonary disease (copd) * patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening * current or ex-smokers (\>= 10 packs year) * any change in dose, schedule or formulation of ics + laba combination in the 4 weeks prior screening

Keywords: asthma, anticholinergics, triple combination
sole-therapy treatment of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: restore sr ii is a feasibility study on the minimally invasive use of the atricure bipolar system for pv isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).


Eligibility criteria:
inclusion criteria: 1. male or female patient between 18 and 80 years of age 2. patient with symptomatic af and failure or intolerance of one or more class i or class iii aads and: * who describes 3 or more symptomatic af episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of af in the 4 months prior to enrollment or, * who has documented af within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous af) or, * who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of af in the 4 months prior to enrollment. 3. left atrial size \< 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the lv dysfunction is thought to result (at least in part) from af 4. left ventricular ejection fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment) 5. patient is willing and able to provide written informed consent. 6. patient has a life expectancy of at least 2 years. 7. patient is willing and able to attend the scheduled follow-up visits. 8. weight \< 325 lbs exclusion criteria: 1. prior cardiac catheter ablation for the treatment of arrhythmia within 4 months 2. prior cardiac surgery 3. patients requiring any open heart procedure (e.g. cabg, valve replacement or repair, atrial septal defect repair, etc.) 4. class iv nyha heart failure symptoms, unless these symptoms are considered to be due to uncontrolled af 5. cerebrovascular accident within previous 6 months 6. known carotid artery stenosis greater than 80% 7. evidence of significant active infection 8. patient unable to undergo tee 9. pregnant woman 10. requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia 11. presence of thrombus in the left atrium 12. patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery 13. patient is enrolled in another investigational study

Keywords: atrial fibrillation af afib racing heart pulmonary vein isolation pvi mini maze maze
ial vs ps for anterior shoulder dislocations

Conditions: Shoulder Dislocation

Summary: this study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.

this will be a single center, prospective, open-label, randomized controlled trial on a convenience sample of patients presenting to the ed with anterior shoulder dislocations. this study will enroll all patients between the ages of 18 and 70 who meet all of the inclusion criteria and do not meet any of the exclusion criteria, who present to the ed with an anterior shoulder dislocation as determined by the ed physician. written, informed consent will be obtained from each patient. after enrollment, each patient will be randomized either to iv sedation (with the provider's choice of propofol or etomidate) or intra-articular lidocaine. randomization will be done before the initiation of data collection, and will be done with a random number generator. patients who are randomized to the intra-articular group will receive 20 ml of 1% lidocaine injected into the glenohumeral joint using a lateral approach. treating clinicians will be instructed to wait 10 minutes after injection before attempting reduction. the primary outcome measure will be the difference in emergency department length of stay between the procedural sedation and intra-articular lidocaine groups.

Eligibility criteria:
inclusion criteria: * patients 18-70 years old in the emergency department with an anterior shoulder dislocation. exclusion criteria: * pregnant or breastfeeding * is a prisoner. * known allergy to one of the study drugs. * altered mental status. * shoulder fracture (other than a hill-sachs) associated with the dislocation. * attending provider excludes patient.