Kornimate/medical-research-clean huggingface dataset:
mhealth titration and management

Conditions: Diabetes Mellitus, Type 2; Diabetic Complication

Summary: the principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, fda-cleared smartphone-based insulin titration application connected to bluetooth enabled glucose meters. isage rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. in this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve hgba1c \<7%) and reduce the frequency and severity of hypoglycemia. exploratory measures will include healthcare resource utilization and patient and provider satisfaction. the basal insulin titration algorithms used in isage have had thousands of user-years' experience in fda-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., lantus, levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., tresiba, toujeo). however, the effectiveness of isage with a connected glucose meter has not been studied in a "real world" clinical environment. broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.


Eligibility criteria:
inclusion criteria: * t2dm (who criteria) treated with basal insulin (glargine, detemir, degludec) * hgba1c 8 or above * gfr \>60 ml/min within the last 12 months * english speaking, informed consent * has an android or ios based compatible smartphone (ios 9.0 or above; android 4.4 or above) * currently performs at least 3 fasting fingerstick glucose measurements/week * have a pcp within the ku health system exclusion criteria: * diagnosis of hypoglycemic unawareness within 6 months of enrollment * diagnosis of hyperglycemic hyperosmolar non-ketotic coma (honk) or diabetic ketoacidosis (dka) within 6 months of enrollment * recent (within the last 6 months)/current use of non-topical steroids * insulin requirements in excess of 1u/kg per day * use of pioglitazone or another thiazolidinedione (tzd) * in the opinion of the provider, hgba1c goals should adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
therapeutic education groups for childhood obesity

Conditions: Childhood Obesity

Summary: the goal of this clinical trial is to test the efficacy of an educational therapeutic intervention in treating obesity in a pediatric population. it aims to verify the differences between the experimental group (group-based program) and the control group (individual program) in respect to the bmi z-score values between baseline measurement (beginning of treatment), final measurement (end of treatment) and 18 months follow-up.

one of the aim of this clinical trial is to verify that the direct management of the emotional and relational aspects of patients and family plays an important role in maintaining the weight changes achieved in the long term. the potential added value of the present study concerns the better understanding of the role of psychological and emotional aspects in the treatment of childhood obesity and in maintaining results in the long term. the clinical trial aims to recruit 300 obese children randomized in two groups: experimental group and control group.

Eligibility criteria:
inclusion criteria: * obesity (\>= 95th percentile); * no organic causes of obesity; * sufficient understanding and production of italian language; * age between 7 and 17 years old; * absence of neuropsychiatric diagnosis; * subscription of the informed consent from both parents (or legal guardian). exclusion criteria * degree of obesity\< 95th percentile; * organic causes of obesity; * insufficient understanding and production of italian language; * age \ 17; * presence of neuropsychiatric diagnosis; * one parent (or legal guardian) refuses to subscribe the informed consent.

Keywords: childhood obesity group intervention psychological aspects
to determine the relationship between baseline reversibility and the efficacy of indacaterol

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: in this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.


Eligibility criteria:
inclusion criteria: * diagnosis of copd (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2009) and: 1. post-bronchodilator fev1 \<80% and ≥30% of the predicted normal value 2. post-bronchodilator fev1/fvc (forced vital capacity) \<70% * smoking history of at least 10 pack-years exclusion criteria: * patients who have had a copd exacerbation in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 4 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria may apply

Keywords: indacaterol copd laba reversibility
magnesium sulfate in neonatal hie"

Conditions: Neonates With HIE

Summary: the study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (hie) at a karachi tertiary care hospital. using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe hie. data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. the study aims to provide insights into improving patient outcomes and clinical practice for neonatal hie management.

objective: • to determine the neuroprotective outcomes of intravenous magnesium sulphate in neonates with hypoxic ischemic encephalopathy (hie) at a tertiary care hospital of karachi. methodology: * study setting: this is a prospective study; and will be conducted at tertiary care hospital of karachi (sindh institute of child health and neonatology, k-5). * study design: rndomized clinical trial * target population: the study population will be all term and near term newborns (≥35 completed weeks) with moderate to severe hie. * inclusion criteria: all late preterm and term newborn with hypoxic ischemic encephalopathy (hie) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial. * exclusion criteria: * newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded. * pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes. * congenital anomalies or genetic disorders affecting neurological function. * allergy or known adverse reactions to magnesium sulfate. * participation in another concurrent clinical trial involving investigational drugs or interventions. * inability to obtain informed consent from parents or guardians. * medical intervention: magnesium sulphate as infusion will be commenced to cases. control will be treated as per unit protocol. sample size: sample size was calculated using who software with the following assumptions: level of significance α=0.05 power of study = 80 anticipated population proportion p1 = 0.657 anticipated population proportion p2 = 0.3757 desired precision = 5 required sample size 51 for each population (cases 51 and control 51) so, the total 102 is the minimum sample

Eligibility criteria:
inclusion criteria: all late preterm and term newborn with hypoxic ischemic encephalopathy (hie) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial. - exclusion criteria: * newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded. * pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes. * congenital anomalies or genetic disorders affecting neurological function. * allergy or known adverse reactions to magnesium sulfate. * participation in another concurrent clinical trial involving investigational drugs or interventions. * inability to obtain informed consent from parents or guardians.
ketamine for ms fatigue

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce multiple sclerosis (ms) related fatigue. the investigator proposes a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose ketamine, to assess its efficacy and safety in patients with ms-related fatigue.

the study treatment is designed in two 28-day cycles: for each cycle, participants will receive study infusion on day 1 and complete follow-up visits during days 7 and 28. participants are randomized 1:1 to receive either ketamine (active treatment) or saline solution (placebo treatment) for their first infusion. they will not be blinded to their study assignment: the study doctor will disclose their assigned treatment group. after their first infusion cycle, participents will crossover to the other treatment group. worded differently, if a participant received ketamine during their first infusion, they will receive placebo treatment during their second infusion. conversely, if a participant received saline treatment during their first infusion, they will receive ketamine during their second infusion.

Eligibility criteria:
inclusion criteria: 1. female and male patients with any form of cdms ages 18-65 inclusive 2. report fatigue which is interfering with qol 3. able and willing to sign informed consent 4. stable on dmt for at least 3 months prior to baseline visit 5. not experiencing an ms relapse within 90 days prior to baseline visit. 6. must agree to practice an acceptable method of contraception 7. experiencing significant fatigue due to ms (mfis of ≥10) exclusion criteria: 1. allergy to ketamine 2. taking medications which may interact with ketamine 3. change in dmt within 3 months prior to baseline visit 4. ms relapse within 90 days of the baseline visit 5. confirmed diagnosis of untreated sleep apnea 6. confirmed diagnosis of periodic limb movement disorder 7. serious infection in the 30 days prior to baseline visit. 8. patients with significant comorbid conditions: 1. untreated hypertension (sbp\>160, dbp\>100 at baseline) 2. liver disease 3. significant renal disease 4. history of cardiac arrhythmia 5. any comorbidities which at the opinion of the investigators post undue risk 9. current alcohol or drug abuse 10. participation in another interventional clinical trial in the past 3 months. 11. pregnant or lactating 12. any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.

Keywords: ms related fatigue
relation between mean pulmonary artery pressure and pulmonary acceleration time and comparison with previous formulae

Conditions: Pulmonary Hypertension

Summary: since the pulmonary artery hypertension is defined based on mpap and the two previous formulae relating mpap and pat were derived in western population, the investigator planned to conduct a prospective study to derive a new formula for measuring mpap from pat in indian population and compare the accuracy of all the three formulae

after obtaining ethics committee approval and informed patient consent, minimum 25 patients \> 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure will be enrolled in this study.the demographics and the preoperative echocardiographic measurement will be noted. in the operating room, once the intravenous access is obtained, central venous catheterisation and pulmonary artery catheterisation will be done as per the institutional protocol. once the transthoracic echocardiogram (tte) is performed patient will be induced with opioids, intravenous or inhalational agents, and muscle relaxant according to the patient clinical and hemodynamic condition. once the patient airway is secured with tracheal tube, transesophageal echocardiogram (tee) will be performed before and after bypass, which is routine in all patients undergoing cardiac surgery in the institution. echocardiographic images will be analysed by two separate echocardiographers to detect inter-individual variability. patient blood pressure and heart rate will be maintained within 20% of their baseline value throughout surgery. based on the patient condition at the end of surgery, extubation will be done in the operating room or in intensive care unit (icu) after a period of elective ventilation.

Eligibility criteria:
inclusion criteria: * 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure exclusion criteria: * patients with known right ventricular outflow tract obstruction, intra-cardiac shunt lesions will be excluded
trial of low-dose naltrexone for children with pervasive developmental disorder (pdd)

Conditions: Pervasive Developmental Disorder

Summary: this study will examine the effects of low-dose naltrexone (ldn) on children with autistic spectrum disorders. the investigators hope to show a positive effect on social functioning and language.

fifty children aged three to six years will be recruited for the study. they will be randomly assigned to receive either ldn or placebo for two months after which the treatment groups will be switched over. assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.

Eligibility criteria:
inclusion criteria: * diagnosis of pdd

Keywords: autism pdd ldn naltrexone
cardiac rehabilitation for tia patients

Conditions: TIA (Transient Ischemic Attack)

Summary: the purpose of this study is to determine, in patients following a tia, whether a 6-month case-managed exercise based multi-factorial cardiac rehabilitation program (cr), similar to those used in patients following a heart attack, can significantly improve exercise capacity, reduce cholesterol, reduce depression, and improve thinking ability.

similar risk factors predispose patients to both cardiovascular and cerebrovascular events. two hundred consecutive patients from stroke prevention clinics (spc) at london health sciences centre and the ottawa hospital (100 patients from each site) who have sustained a transient ischemic attack (tia) or mild non-disabling stroke will participate in a randomized controlled trial in which they will either receive usual care (uc) as delivered by the spc, or enter the existing multi-disciplinary 6-month comprehensive cardiac rehabilitation (cr) intervention at lhsc and ottawa in addition to receiving uc. this study seeks to determine the benefits of providing a cr program to tia/mild non-disabling stroke patients.

Eligibility criteria:
inclusion criteria: * documented tia or mild non-disabling stroke within the previous 3 months. * at least one of the following vascular risk factors: hypertension, ischemic heart disease, diabetes mellitus, dyslipidemia or cigarette smoking exclusion criteria: * inability to speak or understand english or provide informed consent. * severe aphasia that renders communication difficult or impossible. * modified rankin scale score of greater than or equal to 3. * mini-mental status examination score of less than or equal to 20. * evidence of intracranial hemorrhage confirmed by ct scan or mri study. * anticipated or recent (\<30 days) carotid endarterectomy, angioplasty and/or stenting. * resides \>1 hour travel time from london or ottawa. * prior participation in a ccr program. * inability to perform expected exercise training of ccr program. * evidence of cardioembolic source for tia/stroke such as atrial fibrillation, valvular disease, septal defect or left ventricular wall motion abnormality. * participation in another clinical trial that could interfere with the intervention or outcomes of the current study.

Keywords: comprehensive cardiac rehabilitation randomized controlled trial tia (transient ischemic attack) mild non-disabling stroke vascular protection
substance abuse treatment for high risk chronic pain patients on opioid therapy

Conditions: Substance Abuse

Summary: chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. unfortunately, there are few treatment resources for such patients. this study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.

this study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.

Eligibility criteria:
inclusion criteria: * chronic pain for \>6 months * history of taking daily opioids for pain for \>6 months * average \>3 on a pain intensity scale of 0 to 10 over past week * able to speak and understand english * chronic neck or back pain as primary pain complaint * willingness to participate exclusion criteria: * current opioid addiction (m.i.n.i. section k) * current diagnosis of cancer or any other malignant disease * acute osteomyelitis or acute bone disease * nonambulatory * present or past dsm-iv diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder * pregnancy * any clinically unstable systemic illness judged to interfere with treatment * an acute condition requiring surgery * taking opioids intermittently

Keywords: pain opioids
shop for success: experimental grocery store study

Conditions: Overweight; Obesity

Summary: the purpose of this research is to study how the price of foods affects food buying choices at the grocery store. the researchers are interested in this topic because the price of foods can have a big impact on what people choose to buy and prices change over time. the researchers are doing this study to see how changes in food prices affect what foods mothers choose for their families.

it is well known that the price of a given food affects the amount of that food an individual purchases. however, little is known about how specific groups, such as overweight/obese and those with lower incomes, change their food purchasing decisions depending on food price changes. evidence has shown that these groups have lower quality diets and worse health outcomes than their normal weight and higher income counterparts. therefore, it is important to gain a better understanding of how food price changes affect purchasing decisions among these populations in order to develop targeted nutrition interventions to improve their diet quality. to investigate this, the researchers will create a laboratory-based grocery store, in which pictures of foods will be used to substitute actual food. food prices will be indicated on each picture. participants will be given play money and a budget, and ask them to "purchase" foods in the mock grocery store. the price of food will be changed throughout the study to investigate how participants change their purchasing decisions based on these price changes.

Eligibility criteria:
inclusion criteria: * have at least one child up to 18 years of age residing in the household * primary grocery shopper for the household * no health conditions or food practices that substantially limit food choice * not currently pregnant * consent to the study design exclusion criteria: * male * \< 18 years of age * not a mother, or children not living with subject in their household * no children below the age of 18 years of age * not the primary grocery shopper for their household * health conditions or food practices that substantially limit food choice * currently pregnant
early passive verticalization in critically ill patients

Conditions: Critical Illness

Summary: in the critically patient bed rest and inmovilization are some of the responsable of the development of respiratory complications. early physical exercise is a tool to prevent respiratory complications as lost of respiratory muscle strength, decrease in functional residual capacity and hypoxemia improving oxygenation. in some cases critically ill conditions implies use of pharmacological sedation. that condition limit the active physical exercise. however, some technicals aids as tilt table allows execution of passive early movilization. the aim of this study is to assess the effect of early passive verticalization assisted by tilt table on alveolar recruitment and pulmonary ventilation in intensive care unit (icu) patients, evaluated with electrical impedance tomography (eit) icu patients included at day of evaluation will be evaluated consecutively with eit in three stages; 1) in the supine position (at 30° of inclination), 2) verticalized in tilt table (at 60º of inclination) 3) in the supine position (at 30° of inclination)


Eligibility criteria:
inclusion criteria: * patient admitted at the intensive care medical/sirurgical unite of clinic saint luc * days of hospitalization between 1 and 10 * hemodynamically stable * patient or family member sign the informed consent * sedated patients exclusion criteria: * with risk of evisceration * therapy withdrawal * with cardiac devices (pace maker) * persistent cough * patches or open wounds in zone of electrodes * presence of high vasopressor medication (noradrenaline \> 3 mg/h) * peep \> 15 cm h2 * acute myocardial infarction * active bleeding * intracranial pressure \> 20 mm hg or with major inestability

Keywords: early physical exercise early passive exercise alveolar recruitment electrical impedance tomography oxygenation ventilation
automated quantitative ulcer analysis study

Conditions: Keratitis

Summary: this is a multiple site observational study that will review patient features (clinical and morphologic) over a 90 day period during care of participants with microbial keratitis with presence of clinically significant ≥2mm stromal infiltrate compared with participants with other forms of keratitis.

the primary objective of this study is to determine associations between participant features (clinical and morphologic) and best corrected visual acuity at day 90. imaging, focused on slit lamp photography and supplemented by other imaging markers will be collected for review. a medical record review at one year following participants initial visit will record any corneal procedure and visual acuity testing that occurred during this window. participants will complete demographic, clinical, and standardized health surveys.

Eligibility criteria:
inclusion criteria: * cases- microbial keratitis (bacterial or fungal) with presence of clinically significant ≥2mm stromal infiltrate * controls- inflammatory, viral, acanthamoeba, or other keratitis exclusion criteria: * pregnancy * prior incisional corneal surgery * no light perception vision * corneal perforation or impending perforation * inpatient status * institutional status * cognitively impaired * prisoner

Keywords: corneal ulcer
scintigraphic evaluation of ipaa function in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (ipaa). the gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.


Eligibility criteria:
inclusion criteria: * ulcerative colitis patients