Kornimate/medical-research-clean huggingface dataset:
a new modified-release tablet formulation of prednisone (lodotra®) in patients with nocturnal asthma

Conditions: Asthma

Summary: the purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release prednisone on signs and symptoms.

study with completed results acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * the subject must be able to understand the terms of the written informed consent form, and must provide a dated and signed form before the start of any study procedure * at least 18 years old * patient having a diagnosis of asthma dating back more than 6 months at the time of inclusion * asthma necessitating a continuous treatment by oral corticoids * a minimum of 3 nocturnal awakenings due to asthma during the last screening week * stable dose of oral glucocorticoids for at least 4 weeks prior to inclusion into the study * no change in asthma medication during the last 4 weeks prior to v0 * non-smoker or ex-smoker (having stopped smoking more than one year previously and with a smoking history of less than 10 pack years ) * female patients of childbearing potential must be using a medically accepted contraceptive regimen * able to perform the required study procedures including handling of medication containers and diaries exclusion criteria: * poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to visit v0: * hospital admission for asthma (including treatment in an emergency room), * a lower airway infection, * diagnosis of chronic obstructive pulmonary disease or other relevant lung diseases (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, active tuberculosis, interstitial lung disease) * clinically significant abnormalities of the hematological or biochemical constants * pregnancy or breastfeeding * participation in another clinical study within 30 days preceding visit v0, * re-entry of patients previously enrolled in this trial, * suspected inability or unwillingness to comply with the study procedures * alcohol or drug abuse * need to take a non-authorised concomitant treatment (cf. list of medicaments not authorised during the study) in the course of the study * other disease requiring treatment with corticosteroids * subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * patient with a hospitalisation scheduled during the study period * any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension, etc.)

Keywords: asthma nocturnal asthma glucocorticoid dependent persistent asthma signs and symptoms lung function prednisone
correlation of continuous glucose monitoring and glucose tolerance testing with pregnancy outcomes

Conditions: Diabetes, Gestational

Summary: diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. this involves ingesting a 50-gram glucose load, followed by a blood test one hour later. we wish to compare 7-day continuous glucose monitoring to the one-hour glucola test, and determine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.

all pregnant patients without pre-existing diabetes will be eligible for the study. interest in participation will be determined at their initial prenatal visit. those that are interested will be consented. between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (cgms) will be inserted superficially under the skin. the patient will be instructed on how to wear and care for the device. she will wear the cgms for 7 days, then return to the clinic for removal of the device, and downloading of the data. she will perform the routine glucola test sometime between days 2 to 7 . finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the cgms. results of cgms will not be available to the patient or her physician until after completion of the pregnancy. the patient will be treated routinely, based on the results of the routine glucola test.

Eligibility criteria:
inclusion criteria: * pregnant patients * age 18-50 * gestational age less than 28 weeks exclusion criteria: * minors less than 18 years of age * multiple gestation * known fetal anomalies
the effect of thoracic manipulation on upper body stability in basketball athletes

Conditions: Athletic Injuries

Summary: basketball is the most popular sport in the world and has become even more popular as a result of the attention it has received.

the aim of our study was to see the effects of thoracic manipulation on upper body balance in addition to exercise programs of athletes.

Eligibility criteria:
inclusion criteria: * male individuals aged 14-19 years * being a basketball athlete * regular participation in training exclusion criteria: * known neurological disorder * serious orthopedic conditions that prevent exercise * cognitive impairment
a study of pegylated interferon alfa-2a and lamivudine in patients with hbeag-negative chronic hepatitis b virus (hbv)

Conditions: Hepatitis B, Chronic

Summary: this study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (peg-ifn) alfa-2a in participants with hepatitis b e antigen (hbeag)-negative chronic hepatitis b virus (hbv). it will also compare peg-ifn alfa 2a treatment alone and in combination with lamivudine (lam). the anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adults 18-70 years of age; * hbeag-negative chronic hepatitis b for \>/=6 months; * liver disease consistent with chronic hepatitis b. exclusion criteria: * interferon-based, systemic anti-hbv, antiviral, anti-neoplastic, or immunomodulatory therapy \</=12 months before first dose of study drug; * non-responders to previous interferon therapy; * co-infection with hepatitis a, c or d, or with human immunodeficiency virus (hiv); * hepatocellular cancer; * compensated (child a, score 6) or decompensated liver disease (child b or c).
evaluation of a health dashboard intervention to improve engagement with cpap therapy in pap-naïve patients: project neo

Conditions: Sleep Apnea, Obstructive

Summary: this is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of cpap (continuous positive airway pressure/ pap) usage, self-reported sleepiness, blood pressure (bp) and activity (steps).


Eligibility criteria:
inclusion criteria: * participant is at least 18 years old. * participant is using a resmed airsense 10 device and resmed myair mobile app. * participant has been using cpap therapy for less than 2 weeks. * participant has been enrolled in myair for less than 2 weeks. * participants have self-reported resistant hypertension and they take 3 or more drugs to treat their hypertension. * participant owns a mobile device compatible with the neo app (android jelly bean, v16, 4.1.x or newer, and ios 8 or newer) * participant is somewhat to fairly confident about being able to use bluetooth connected devices and apps * participant consents to download the neo app, withings app, create a withings account, and sync withings data to resmed's project neo. * willing and able to give informed consent * can read and comprehend written and spoken english exclusion criteria: * are participating in another app-based research study * cannot participate for the full duration of the study (at least 45 days) * unable to read or write english * participant is pregnant * participant is on medicare
outcome analysis of poem and endoluminal therapies

Conditions: Achalasia; Gastric Fistula; Weight Gain After Primary Weight Loss Surgery; Marginal Ulcer; Stenoses; Gastric Nec

Summary: evaluation of current and newly developed endoluminal therapies in the management of upper and lower gi conditions.

over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. the initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. these treatments have been validated by prior surgery studies.

Eligibility criteria:
inclusion criteria: * adult male and female patients 18-80 years of age * meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s) * gastrointestinal reflux disease * achalasia * barrett's esophagus * post bariatric surgery conditions * other gastrointestinal and postsurgical disorders. exclusion criteria: * adults unable to consent * individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.

Keywords: achalasia fistula obesity poem gerd endoscopic treatments post bariatric surger weight gain endoluminal bariatric surgery barretts
study of aro-apoc3 in adults with dyslipidemia

Conditions: Dyslipidemias

Summary: this is an open-label extension of the parent studies aroapoc3-2001 and aroapoc3-2002. adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. eligible enrolled participants initially received open-label aro-apoc3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.


Eligibility criteria:
inclusion criteria: * adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study * able and willing to provide written informed consent * completed the 48-week study treatment period in the parent study exclusion criteria: * subject was permanently discontinued from aro-apoc3 in the parent study due to elevated glycated hemoglobin (hba1c), aspartate aminotransferase (ast) or alanine aminotransferase (alt) * any new condition or worsening of existing condition or any other situation that would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements or put the subject at additional safety risk * unwilling to limit alcohol consumption to within moderate limits for the duration of the study
evaluation of bis for quantification of lymphedema

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether measuring the fluid in your arms using bioimpedance spectroscopy is as effective at detecting and monitoring lymphedema as measurements with the perometer. the investigators will also evaluate any symptoms you may experience in your arms during and after treatment for breast cancer with a questionnaire.

during the study whenever you have an arm volume measurement using the perometer, we will also measure the fluid in your arms using bioimpedance spectroscopy. these measurements are made by passing a harmless electrical signal of very low strength through your body to determine the difference in the amount of fluid in each arm. the test is simple and painless, and takes about 3 minutes. in addition, whenever you have an arm measurement, you will be asked to complete a questionnaire. while completing the questionnaire, you can skip any questions you do not wish to answer. the questionnaires will take about 10 minutes to complete. arm measurements with the perometer and bioimpedance spectroscopy and completion of the questionnaire will occur every 4-7 months when you are at mgh for regular medical visits.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed invasive or in-situ carcinoma of the breast * participants must have undergone sentinel node mapping or axillary dissection * life expectancy of greater than 1 year. * willingness to comply with required follow up perometer and bis measurements and completion of left-bc questionnaire exclusion criteria: * patients who have known metastatic disease or other locally advanced disease in the thoracic or cervical regions * any patient who will not be returning routinely for follow-up at mgh or dfhcc * participants with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * history of primary lymphedema * history of prior surgery or radiation to the head, neck, upper limb, or trunk * participants who have evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion * any patient who has bilateral lymph node mapping or dissection * any patient with a current case of cellulitis * patients with a history of a different malignancy are ineligible except for the following circumstances. individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
dutasteride in enlarged prostate economic assessment: a retrospective database pooled analysis of early 5-alpha reductase inhibitor use

Conditions: Prostatic Hyperplasia

Summary: this retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ari) therapy in patients with enlarged prostate (ep) receiving 5ari and alpha-blocker (ab) combination therapy. both the integrated health care information solutions and pharmetrics databases will be utilized for this study (2000-2007).


Eligibility criteria:
inclusion criteria: * male patients aged 50 years or older * a medical claim of ep * a prescription claim for a 5ari and ab (provided both are within 180 days of index date) * continuously eligible for 6 months prior to and at least 12 months after index prescription date. exclusion criteria: * diagnosis of prostate or bladder cancer * any prostate-related surgical procedure within 5 months of index date * prescription claim for finasteride indicative of male pattern baldness * 5ari therapy initiated prior to initiating ab therapy

Keywords: enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs
effect of timolol on refractive outcomes in eyes with myopic regression after lasik: a randomized clinical trial

Conditions: Myopic Regression

Summary: in this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after lasik


Eligibility criteria:
inclusion criteria: * patients with myopic regression equal or more than 0.5 d with minimum age of 20 years, * cylinder ≤ -1.00 d, * corrected distance visual acuity (cdva) of at least 20/40 were included. exclusion criteria: * patients with a history of previous ocular surgery, * keratoconus or any ectatic corneal disorder, * keratoconus suspect by topography, * preoperative corneal opacity, * any corneal dystrophies, * presence of pterygium, * retinal disorders, * collagen vascular disorders, * diabetes mellitus, * glaucoma, * cataract, * pregnancy, * breast feeding * systemic corticosteroid therapy were excluded.
gabapentin for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (cts).

a variety of treatment options exist at present for carpal tunnel syndrome (cts) with no universal agreement. recent reports suggested that untreated cts might improve or remain stationary. in this respect, treatment directing towards symptom suppression alone may have a role in the initial management of cts. gabapentin (1-\[aminomethyl\]-cyclohexaneacetic acid; neurontin, pfizer) is an effective drug for treatment of neuropathic pain and has been reported to be effective in case series for the treatment of cts with relatively benign side effects profile. the purpose of this study was to evaluate the safety and efficacy of gabapentin in the treatment of cts.

Eligibility criteria:
inclusion criteria: * sensory symptoms over median nerve distribution for more than three months. * confirmatory electrophysiologic results defined as prolonged median nerve distal motor latencies (dml) \> 4 ms or median-ulnar palmer sensory latency differences \> 0.5 ms. exclusion criteria: * patients with evidence of severe cts: fibrillation potentials or reinnervation on needle examination of the abductor pollicis brevis muscle or clinical examination showing wastage of the thenar muscles. (these patients were referred for surgical decompression on presentation.) * clinical or electrophysiological evidence of accompanying conditions that could mimic cts or interfere with its evaluation, such as proximal median neuropathy, cervical radiculopathy, or significant polyneuropathy. * known epilepsy. * patients who have received previous steroid injection or oral steroid therapy for cts.

Keywords: carpal tunnel syndrome gabapentin
the effects of continuous positive airway pressure (cpap) on sympathetic activity in different sites of activation

Conditions: Radionuclide Imaging (MIBG Scintigraphy); Exercise Test; Blood Pressure Monitoring, Ambulatory; Sympathetic Nerve Activity; Catecholamines

Summary: recent evidences suggest that obstructive sleep apnea (osa) can contribute to cardiovascular disease even in the absence of hypertension. however, there are few data regarding the impact of osa on the sympathetic system in apparently normotensive patients with osa as well as the impact of treatment with continuous positive airway pressure in different sites of activation (heart, peripheral nerves and circulating catecholamines)


Eligibility criteria:
inclusion criteria: * severe osa males exclusion criteria: * smoking * sustained hypertension * heart failure * diabetes * renal diseases * under use of any medication * under treatment for osa

Keywords: sleep apnea, obstructive sympathetic nerve activity treatment
quantitative studies of urinary bladder sensation

Conditions: Interstitial Cystitis

Summary: the purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of interstitial cystitis (ic) based on sensory testing and to determine if subjects with ic have normal counterirritation-related modulatory systems.

to determine whether more than one subpopulation exists of patients with the diagnosis of interstitial cystitis (ic) based on sensory testing and to determine if subjects with ic have normal counterirritation-related modulatory systems. previous studies by the pi suggest that two populations of subjects are present in the ic population but a larger number of subjects with ic would need to be tested in order to determine if this were indeed true. other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. identification of a subset of ic patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.

Eligibility criteria:
inclusion criteria: * must be able to read and speak english * 19 years or older * ic diagnosis exclusion criteria: * over 65 years old * pregnant * children younger than 19 * significant cardiac disease

Keywords: cystitis urinary bladder
long-term follow-up study of covid-19

Conditions: COVID-19

Summary: the goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia. this trial plans to include 5700 inpatients with positive sars cov-2 nucleic acid test results. this trial does not involve the use of specific drug. participants's health and psychological status will be observed at the preset time points. the blood, feces, urine samples of patients will be collected for relevant tests.

after the patients are enrolled, record the patient's treatment regimens, blood routine results, blood biochemistry results, cytokines results, lung imaging results, and cranial imaging results, understand the patient's current clinical manifestations, evaluate the patient's psychological status and quality of life, and collect samples of the patients' blood, feces, urine, and other related tests. collection of clinical samples: collect blood, urine, throat swabs and other samples from patients with confirmed novel coronavirus pneumonia (nucleic acid test positive), and collect samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after discharge of patients, and record the clinical manifestations of patients.

Eligibility criteria:
inclusion criteria: * patients with confirmed covid-19 exclusion criteria: * combined infection with influenza virus, mycoplasma, and chlamydia.