Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and efficacy of ionis-ghr-lrx in participants with acromegaly being treated with long-acting somatostatin receptor ligands

Conditions: Acromegaly

Summary: the purpose of this study was to assess the safety, tolerability, and efficacy of ionis-ghr-lrx in up to 60 participants with acromegaly.

this short-term study assessed changes in serum insulin-like growth factor 1 (igf-1) over a 16-week treatment period in a participant population diagnosed with acromegaly being treated with long-acting somatostatin receptor ligands (srl).

Eligibility criteria:
inclusion criteria: 1. males or females with documented diagnosis of acromegaly, aged 18-75 years old (inclusive) at the time of informed consent 2. participants must be on stable maximum or maximally tolerated dose of srl (lanreotide autogel or octreotide lar, per treating physician judgment) every 28 days for a minimum of 3 months prior to screening and will be required to continue their stable dose of srl throughout the study. prior use of other medications for treating acromegaly is allowed but not within 6 weeks of screening. 3. at screening, serum insulin-like growth factor 1 (igf-1) (performed at central lab) between 1.3 to 5 x upper limit of normal (uln), inclusive, adjusted for age and sex 4. females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control exclusion criteria: 1. participants who received surgery for pituitary adenoma within the last 6 months before the trial, or planning to receive surgery during the trial 2. participants who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial 3. participants with pituitary tumor that, per investigator judgement, is worsening as assessed by pituitary/sellar magnetic resonance imaging (mri) protocol at screen or within 6 months of screening 4. evidence of decompensated cardiac function per medical judgement and/or new york heart association (nyha) class 3 or 4 5. clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment 6. participants may not have chronic systemic use of glucocorticoids, weight loss medications or participate in weight loss programs within 2 months before randomization and during study participation. 7. participants on anti-diabetes medication or estrogen containing medications must be on a stable dose and regimen for \>= 3 months prior to screening and throughout the trial 8. participants taking glucagon-like peptide 1 (glp-1) agonists or insulin can be allowed with prior consultation with the sponsor medical monitor

Keywords: acromegaly, ionis-ghr-lrx
irbesartan in type 2 diabetes

Conditions: Type 2 Diabetes; Microalbuminuria; Hypertension

Summary: the aim of this multicenter, doubleblind, randomized study was to investigate the renoprotective effect of irbesartan treatment in patients with type 2 diabetes and microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily or placebo. time to development of overt nephropathy, defined by persistent proteinuria, was the primary outcome measure.


Eligibility criteria:
inclusion criteria: type 2 diabetes. hypertension. persistent microalbuminuria. serum creatinine concentration of no more than 1.5 mg per deciliter (133 µmol per liter) for men and no more than 1.1 mg per deciliter (97 µmol per liter) for women. - exclusion criteria: nondiabetic kidney disease. cancer. life-threatening disease with death expected to occur within two years. indication for angiotensin-converting- enzyme (ace) inhibitors or angiotensin-ii-receptor antagonists. -
exercise timing and gestational diabetes

Conditions: Pregnancy Related; Diabetes; Diabete Mellitus; Type 2 Diabetes; Pre-diabetes; Exercise

Summary: the aim of this study is to understand if the timing of exercise around food intake can help improve blood sugar management in pregnant individuals with diabetes.

between 3 - 20% of women develop gestational diabetes mellitus (gdm) during pregnancy, a condition in which blood sugar control is poor and can have serious health effects for both mom and baby. women with gdm are at elevated risk of developing dangerously high blood pressure during pregnancy and type 2 diabetes later in life. gdm also puts the baby at an increased risk of excessive birth weight, low blood sugar at birth, and future risk of type 2 diabetes. the 2019 canadian guideline for physical activity throughout pregnancy recommends that women be physically active for at least 150 minutes spread over at least 3 days each week. managing high blood sugars with exercise improves outcomes for mom and baby; however, optimal timing of exercise has not been investigated. the goal of this study is to determine if exercising after meals in shorter bouts is more effective at controlling post-meal blood sugars than exercising in larger amounts between meals. this is a fully remote study; participants will receive all necessary equipment in the mail and all interactions with the researcher will be done via phone, video call and email. the study will recruit 30 pregnant women diagnosed (or not) with diabetes (gestational, pre-, or type 2 diabetes mellitus) after 20 weeks' gestation to participate in this 2-week study. following a 2 day baseline period, they will be randomly assigned to: 1) walk for 10 minutes after each meal (short), or 2) walk for 30 minutes once per day at any time except in the hour after eating (long) for 5 days. following a 2- day washout period, women will then complete the alternative exercise protocol for an additional 5 days. women will wear a continuous glucose monitor to track blood sugars, and an accelerometer to track activity patterns (e.g., compliance to the intervention) for seven consecutive days. the investigators hypothesize that women who walk for 10 minutes after each meal will have a blunted rise in blood sugar following food intake, compared to the women in the 30- minute walking group. findings from this novel study may help better treat gdm, improving lifelong health for moms and babies around the world.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * singleton pregnancies * healthy pregnant individuals or diagnosed with gestational, pre- or type 2 diabetes exclusion criteria: * less than 18 years of age * presents with contraindications to prenatal exercise (e.g., preeclampsia) * multiple pregnancies (i.e. twins, triplets etc.) * currently taking metformin
study to assess frequency of serious infections in clinical practice in japan for adult participants with rheumatoid arthritis receiving oral rinvoq tablets

Conditions: Rheumatoid Arthritis (RA)

Summary: rheumatoid arthritis (ra) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. ra can reduce the ability to perform everyday tasks. the purpose of this study is to observe the incidence of serious infections, regardless of their relationship to rinvoq, in japanese daily practice. rinvoq is an approved drug for the treatment of adults with moderately to severely active ra. this study evaluates medical records from institutions participating in the study to identify any adverse events (untoward medical occurrence), and reasons for discontinuation of rinvoq in participants taking the study drug. a target of 1000 japanese participants' data will be observed for 3 years. participants will receive rinvoq per their physicians' usual prescription. individual data will be collected for three years. no additional study-related tests will be conducted during routine clinic visits. only data which are routinely collected during clinic visits will be utilized for this study.


Eligibility criteria:
inclusion criteria: - all participants treated with rinvoq. exclusion criteria: - participants not taking rinvoq.

Keywords: rheumatoid arthritis (ra) rinvoq upadacitinib abt-494
long thoracic nerve blockade for pain treatment after video-assisted thoracoscopic surgery

Conditions: Nerve Block; Video-Assisted Thoracic Surgery

Summary: video-assisted thoracoscopic surgery (vats) provides an opportunity to penetrate the thoracic cavity by video through an incision into the chest wall and facilitate surgical operation of lung pathologies.various regional methods of anesthesia are currently being used to achieve this goal. the aim of the study was to assess the effectiveness of long thoracic nerve bloc on postoperative vats analgesia.


Eligibility criteria:
inclusion criteria: * patients who were in the american society of anesthesiologists (asa) i-iii class and underwent video-assisted thoracoscopic surgery (vats). exclusion criteria: * previous history of opioid use preoperatively, * allergy to local anesthetics, * the presence of any systemic infection, * uncontrolled arterial hypertension, * uncontrolled diabetes mellitus.
effects of early and late time-restricted eating on overweight adults with metabolic syndrome

Conditions: Metabolic Syndrome; Overweight and Obesity; Time Restricted Eating

Summary: investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome


Eligibility criteria:
inclusion criteria: 1. age from 18 to 65 years 2. body mass index (bmi): 24.0-40.0 kg/m2 3. diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5): 1. waist circumference ≥ 90 cm (men) or ≥ 80 cm (women). 2. elevated triglyceride (tg) (use of medications for elevated tg is an alternate indicator) ≥ 150 mg/dl (1.7 mmol/l). 3. reduced high-density lipoprotein cholesterol (hdl-c) (use of medications for reduced hdl-c is an alternate indicator) \< 40 mg/dl (1.0 mmol/l) in males \< 50 mg/dl (1.3 mmol/l) in females. 4. elevated blood pressure (use of hypoglycemic medications is an alternate indicator). systolic blood pressure (sbp) ≥ 130 and/or diastolic blood pressure (dbp) ≥ 85 mmhg. 5. elevated fasting blood glucose (fbg) (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dl (5.6 mmol/l). exclusion criteria: 1. unstable weight (change \> 10% current body weight) for 3 months prior to the study 2. pregnant or breast-feeding 3. night shift workers 4. history of major diseases or related diseases, such as cancer, inflammatory disease, chronic obstructive pulmonary disease and major adverse cardiovascular event 5. active viral hepatitis, acquired immune deficiency syndrome, syphilis and other sexually transmitted diseases, tuberculosis and other infectious diseases 6. being treated with antibiotics or corticosteroids 7. current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite 8. the researcher deemed it inappropriate to participate in the experimenter.
the effect of aerobic exercise on mild traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.

there is substantial evidence that a large number of individuals who experience tbi will demonstrate life-long deficits in cognitive or social functions. an estimated 80-90,000 americans with tbi suffer life-long impairment of physical, cognitive, and psychosocial skills to the degree that they are unable to return to school or work. research on rehabilitation for mtbi has been minimal and typically has focused on speech, pain management, dizziness, fatigue, irritability, and sensory disorders. the results of the few studies that have examined long-term cognitive effects of mtbi have offered conflicting results. the current research will investigate the efficacy of an aerobic exercise intervention among individuals with mild traumatic brain injury (mtbi). this project will examine changes in fractional anisotropy (fa) values and cognitive functioning among individuals diagnosed with mtbi in a monitored aerobic exercise regimen, versus a low impact stretching and toning control group.

Eligibility criteria:
inclusion criteria: * anyone between 18 and 50 years of age, * from the geographic region served by the malcolm randall-north florida-south georgia vamc, * who have sustained a tbi and demonstrate impairment on neuropsychological assessment (criteria for mtbi will be defined as a loss of consciousness for not more than 30 minutes and post-trauma amnesia of not more than 24 hours). exclusion criteria: * tbi occurring less than 6 months or greater than 5 years prior to enrollment, * any metal implants or shrapnel that may put them at risk for injury during an mri scan, * significant cognitive impairment (mmse\<24), * history of stroke, * b-12 deficiency, * hypothyroidism, * organ failure (renal, hepatic, cardiac, or lung), * substance abuse, * seizures, * or any limitation that would preclude them from safely engaging in the aerobic exercise regimen.

Keywords: traumatic brain injury aerobic exercise diffusion tensor imaging neuropsychology rehabilitation
a phase 3, open-label, crossover study to evaluate self-administration of rozanolixizumab by study participants with generalized myasthenia gravis (gmg)

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this study is to evaluate the ability of study participants with generalized myasthenia gravis (gmg) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.


Eligibility criteria:
inclusion criteria: * study participant must have a documented diagnosis of generalized myasthenia gravis (gmg) * study participant is willing to perform and capable of performing home self-administration * study participant is considered by the investigator for additional rozanolixizumab treatment with the posology proposed in this study. * body weight ≥35 kg * study participants may be male or female exclusion criteria: * study participant has a known hypersensitivity to other anti-fc receptor (fcrn) medications, to any components of the study medication, to any of the excipients (including polysorbate 80), or has a known history of hyperprolinemia, since both polysorbate 80 and l-proline are constituents of the rozanolixizumab formulation * study participant with a known tuberculosis (tb) infection, at high risk of acquiring tb infection, or latent tuberculosis infection (ltbi), or current or history of nontuberculous mycobacterial infection (ntmbi) * study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring iv antibiotic treatment) within 6 weeks before the baseline visit * the study participant previously participated in any rozanolixizumab mg study and met any mandatory withdrawal criteria (unless the reason is directly related to mg0020 participation) or mandatory study drug discontinuation criteria. * study participant has received a live vaccination within 4 weeks before starting treatment, or a bacillus calmette-guérin (bcg) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last dose of rozanolixizumab * study participant with severe (defined as grade 3 on the myasthenia gravis activities of daily living (mg-adl) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis

Keywords: generalized myasthenia gravis gmg rozanolixizumab
effect of meal frequency and timing on insulin dose and clock gene in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: this study is undertaken to explore in patients with uncontrolled t2d treated with insulin, whether a diet with large breakfast and lunch with small dinner (bdiet) will enhance cg expression and will be more effective for weight loss and for achieving glycemic control and reduction of total daily insulin dose (first end point), compared to an isocaloric diet with 6 small meals distributed evenly along the day

obese patients with type 2 diabetes (t2d) and insulin resistance (ir), often require sequential increments of total daily insulin dose (tdid). this causes weight gain, worsens ir, leading to further increase of tdid and persistent hyperglycemia. in these patients, weight loss (wl) and reduction of ir are mandatory in order to achieve glucose control with less tdid. impaired clock gene (cg) expression is linked to obesity and ir in t2d and it was shown in animals and t2d patients treated with oral anti-hyperglycemic drugs, that wl diet with restricted meal timing to specific hours, restored cg expression and was more effective for wl and for reduction of hyperglycemia compared to isocaloric wl diet, (commonly recommended for t2d), consisting of small meals randomly distributed along the day. the investigators hypothesized that in patients with uncontrolled t2d treated with insulin, a diet with large breakfast and lunch with small dinner (bdiet) will enhance cg expression and will be more effective for wl and for achieving glycemic control and reduction of tdid, compared to an isocaloric diet with 6 small meals distributed evenly along the day (6mdiet). this will be a randomized parallel, open label clinical study. thirty overweight and obese insulin-treated t2d patients with hba1c\>7.5% will be assigned to 12 weeks of 2 isocaloric diets: either bdiet or 6mdiet. hba1c and cg mrna expression in white blood cells and overall daily glycemia measured during 14 days, will be assessed before diet, after 14 days and at the end of the diet intervention. the tdid (first end point ) will be adjusted by physician, according to the results of self-monitoring of blood glucose on 3 consecutive days at baseline and before each of the visits.

Eligibility criteria:
inclusion criteria: * t2d patients with stable insulin treatment for at least 3 month preceding the study. * hga1c \>7.5 %. * age \> 30 years. * bmi: 27-34 kg/m2. * treatment with antidiabetic drugs (i.e. metformin, dpp4 inhibitors, glinides) and glp-1 analogs. * anti-hypertensive treatment will be allowed. * lipid-lowering medication. exclusion criteria * type 1 diabetes. * major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy). * presently dieting. * change in weight of \> 4.5 kg within 3 month prior to study onset. * night or rotating shift workers. * those who crossed more than 2 time zones during 2-week period prior to study onset.
are supervised exercises and tens necessary along with prescribed home exercises for chronic low back pain?

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to compare the added effects of tens and supervised motor control exercises (smce) over unsupervised home exercise program (uhep) on disability, pain and other outcomes.

chronic low back pain (clbp) is a common problem causing disability and high economic burden in globally as well as in nepal. there is no consensus on treatment of clbp, however motor control exercises have good evidence on improvement in pain and disability in clbp population, whereas transcutaneous electrical nerve stimulation (tens) is a common treatment of choice with some evidence. but, we do not know if supervising these motor control exercises (smce) and tens have any added benefit over home exercise program (hep) which is commonly prescribed mode of exercises. we plan to conduct a three armed randomized control trial to answer this question to compare effects of smce, tens and hep versus smce and hep versus hep alone on disability and pain at two weeks and six months follow up. three way-mixed model analysis of variance (anova) will be used as the statistical test. appropriate post hoc analysis will be done to compare within group and between group differences.

Eligibility criteria:
inclusion criteria: 1. nonspecific low back pain for more than 3 months with pain primarily localized between t12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities. 2. age between 18 to 65 years 3. male or female 4. all educational backgrounds (educated or uneducated) 5. pain intensity more than 2/10 on nprs and 6. disability of more than 20/100 on nodi exclusion criteria: 1. red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.) 2. signs consistent with nerve root compression, this includes any one of the following: 1. reproduction of low back or leg pain with straight leg raise at less than 45 degrees 2. muscle weakness involving a major muscle group of the lower extremity 3. diminished lower extremity muscle stretch reflex (quadriceps or achilles tendon) 4. diminished or absent sensation to pinprick in any lower extremity dermatome 3. prior surgery to the lumbar spine or buttock 4. current pregnancy 5. past medical history of osteoporosis or spinal compression fracture 6. participants who do not provide informed consent for the study -

Keywords: low back pain home exercises chronic pain supervised exercise core stability exercises spinal stabilization exercises
increasing msm in the continuum of care in kazakhstan

Conditions: HIV; Substance-Related Disorders

Summary: this study addresses the disproportionate representation of men who have sex with men (msm) in the human immunodeficiency virus/acquired immune deficiency syndrome (hiv/aids) pandemic in kazakhstan, a country that has seen some of the largest growth in new hiv infections since the turn of the century. using a stepped wedge trial across 3 cities in kazakhstan, the proposed study will test a strategic and innovative social network-based intervention for msm who use drugs in kazakhstan as a strategy to increase their numbers in the hiv continuum of care.

the intervention is designed to utilize msm as experts and leverage social network processes to increase the number of msm in kazakhstan to be engaged in the hiv continuum of care. the unit of randomization will be a city, with the timing of roll-out of the social network-based intervention in each of the study's cities-almaty, nur-sultan (formerly astana), and shymkent-under experimental control. receipt/delivery of an intervention to enrolled participants will depend on whether the city is in the intervention delivery phase or not. if a participant is in a city during a time period where the intervention is not being delivered then for that time period, the participant is in the control condition. if the participant is in a city during a time period where the intervention is being delivered then the participant (in fact, all participants in that city) will be considered assigned to the intervention group at that time. in theory, all participants will have the opportunity to experience and receive the intervention. some participants will be enrolled after the intervention has been rolled out in the city in which they reside; thus, they will only experience the intervention condition and not the control condition.

Eligibility criteria:
inclusion criteria: * be at least 18 years old; * identify as male; and * report oral or anal intercourse with another man in the past 12 months; and * report binge alcohol consumption and/or illicit use of substances in the past 12 months exclusion criteria: * has a language or cognitive impairment that would prevent comprehension of study procedures, risks, and benefits (described in russian during the informed consent process)

Keywords: men who have sex with men (msm)