Kornimate/medical-research-clean huggingface dataset:
study conducted among patients with cml

Conditions: Chronic Myeloid Leukemia

Summary: retrospective, non-interventional observational cohort study conducted among patients with cml.

a retrospective, non-interventional cohort study was used to address the study objectives. a cohort of adult patients with cml who were treated with tkis were identified using the ibm® marketscan® commercial and medicare supplemental databases (commercial claims; the marketscan database) to have a better understanding of real-world treatment patterns, hru and healthcare costs among patients with cml treated with later lines of therapy (i.e., third line or later). for phase i, the ibm® marketscan® commercial claims and encounters and medicare supplemental databases were used (commercial claims). the commercial claims covered the period from 01/01/2001 to 06/30/2019. the study consisted of the following periods: * the baseline period was defined as the 6-month period before the first line therapy initiation for cml. * the observation period was defined as the period of at least 12 months from the first cml diagnosis to the end of data availability or end of health plan coverage, whichever occurs first; the observation period varied by patient.

Eligibility criteria:
inclusion criteria: patients were selected for the analysis of later lines of therapy in commercial claims (i.e., were previously treated with tkis, who are relapsed/refractory to/intolerant of tkis) if they met the following criteria: * had at least one diagnosis for cml, with first cml diagnosis observed in claims on or after may 10, 2001, the date of fda approval for imatinib * were at least 18 years of age as of the first cml diagnosis * started a first line therapy for cml with imatinib, dasatinib, nilotinib, or bosutinib (conditional on fda-approval dates) * initiated first line therapy within a maximum of 1 month prior to the first diagnosis for cml or a maximum 3 months following the first diagnosis for cml * had continuous health plan enrollment (pharmacy and medical benefits) from the washout period to at least 12 months following the first cml diagnosis exclusion criteria: * patients had a diagnosis for cml remission or relapse anytime prior to first line therapy * patients had a medical claim associated with a clinical trial during the washout period up to the end of the observation period * patients had an hsct during the washout period up to the first line therapy initiation * patients had chemotherapy treatment (except hydroxyurea) during the washout period up to the first line therapy initiation

Keywords: chronic myeloid leukemia, tyrosine kinase inhibitors, treatment patterns, hru, costs
power training on muscle quality and functional capacity in women aged 65-75.

Conditions: Muscle Weakness; Muscle Loss

Summary: muscle power training has proven to be an effective intervention to prevent sarcopenia and frailty in old people. in the last decade, new concepts related to the functionality of old people have been generated, such as muscle quality and functional capacity. the power training consists of rapid movements of short duration that imply a more specialized neuromuscular response and that improve the functional response reflected in activities of daily life that demand a certain manifestation of muscular power (stand up of a chair, climbing stairs, rebalance, accelerate suddenly, among others). therefore, it is important to investigate the dose-response relationships in power training in older people and establish how possible improvements in muscle quality can be reflected in functional capacity. the aim of this study is to compare the effects of power training at two different loads on muscle quality and functional capacity in women aged 65-75

fifty-six women will be randomly assigned to one of two muscle power training supervised for a physical activity instructor with different velocity loss (vl) thresholds: 10% (vl10) and 30% (vl30). subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1rm). between weeks one and four two series will be performed per session. then the number of series will increase to three per session. the inter-set recovery period will be always of 2-min. before and after the muscle power training the following tests will be performed: 1) measure of body composition with dual-energy x-ray absorptiometry for determining the lean mass of thighs; 2) three functional test (chair stand test, time up go test with cognitive task and gait speed test); 3)progressive loading test in a leg extension machine until finding the mean muscle power corresponding to 50% of 1rm (speed of concentric phase of 6.67 ± 0.04 m/s measured using a camera-based optoelectronic system).

Eligibility criteria:
inclusion criteria: * women 65 to 75 years. * healthy volunteers. * have not perform muscle power training in the last six months. exclusion criteria: * history of asthma. * history of uncontrolled diabetes. * history of uncontrolled hypertension. * history of cardiovascular disease. * history of coronary heart disease. * smoker. * arrhythmias. * personal history of surgical procedures in the last three months. * uncontrolled non-communicable diseases. * psychological, sensitive, cognitive, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program. * under medical treatment with anticoagulants, bronchodilators, and/or steroids.

Keywords: muscle quality functional capacity power training
the effect of cervical dilatation on primary dysmenorrhea

Conditions: Dysmenorrhea Primary

Summary: primary dysmenorrhea (pd) is defined as recurrent, crampy pain occurring with menses in the absence of identifiable pelvic pathology. standard initial management of pd includes nsaids as a first-line treatment and oral contraceptives for the relief of pain and improved daily activity. in patients who have persistent dysmenorrhea despite medical therapy of nsaids and/or oral contraceptives, further investigation including pelvic ultrasound, hysteroscopy or laparoscopy may be needed to rule out other underlying pathologies. historically, it is an old clinical observation that primary dysmenorrhea is often completely or partially relieved by childbearing. similarly, the investigators have observed that the diagnostic/operative hysteroscopy led to relive of pain in most of the cases in our practice. therefore, the investigators hypothesized that the process of cervical dilatation can have a role in reducing pain of patients with dysmenorrhea. in this randomized, controlled study, it was aimed to assess the effect of operational cervical dilatation on the pain in patients with primary dysmenorrhea.

patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation) will be assessed for the presence of primary dysmenorrhea by history taking and anamnesis. patients will be randomized to have cervical dilatation and hysteroscopy or no intervention until the follow-up duration.

Eligibility criteria:
inclusion criteria: * patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation) * patients whose history and anamnesis indicate primary dysmenorrhea. * aged over 18 years old * nulliparous women exclusion criteria: * history of uterine surgery/operation * history and clinical examinations which are indicative of secondary dysmenorrhea (endometriosis, adenomyosis, uterine myomas, endometrial polyps, cervical stenosis, etc.) * positive pregnancy test

Keywords: cervical dilatation dysmenorrhea
effects of steroid replacement therapy on metabolic, cardiovascular and bone outcomes in adrenal insufficiency

Conditions: Adrenal Insufficiency

Summary: the current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period.

adrenal insufficiency (ai) can be caused by a disease involving the adrenal gland resulting in inadequate secretion of adrenal cortex hormones, primary adrenal insufficiency (pai). secondary adrenal insufficiency (sai) results from a decreased level of adrenocorticotrophin hormone (acth) released from the pituitary gland. the mainstay of treatment of pai and sai is glucocorticoid (gc) replacement therapy. conventional steroid replacement therapy includes cortisone acetate and hydrocortisone administered 2-3 times a day with the highest dose in the morning and the lowest dose in the afternoon. these dosing regimens have been designed to mimic the peak of cortisol secretion in the morning and avoid overdosing during the night hours, even though a higher risk of developing comorbidities has been shown, notably in patients treated with higher evening doses. in patients with ai on conventional steroid replacement therapy, mortality remains higher than in the general population, mainly due to non-physiological daily gc overexposure and to inadequate cortisol exposure during stress-related events and illness. studies aiming to evaluate the long-term clinical outcomes of patients with ai on conventional steroid replacement therapy clearly showed increased comorbidities, mainly related to the dose used. by contrast, dual-release hydrocortisone (dr-hc) is characterized by once-daily administration with high release of hydrocortisone immediately after intake and a very low release in the evening and nocturnal hours. the switch from conventional gc therapy to dr-hc has been shown to be associated with improvement in bmi, hepatic, bone and glucometabolic parameters and qol. however, long-term clinical outcomes of patients treated with dr-hc in patients naïve to steroid treatment are not known.

Eligibility criteria:
inclusion criteria: * adrenal insufficiency exclusion criteria: * exclusion criteria were adrenocortical carcinoma and congenital adrenal hyperplasia
inhibition of the renin angiotensin system plus corticosteroids for the treatment of proteinuria in iga nephropathy

Conditions: IGA Nephropathy

Summary: to assess the efficacy of the renin angiotensin system plus steroids to decrease the amount of proteinuria in iga nephropathy

patients whose proteinuria was \> 0.5 g/day were to receive enalapril plus valsartan coupled with oral 0.5 g/day of methylprednisone for 6 months.

Eligibility criteria:
inclusion criteria: * patientes with iga nephropathy with proteinuria over 0.5 g/day exclusion criteria: * malignancy, renal failure

Keywords: iga nephropathy steroids enalapril valsartan proteinuria immunoglobulin a nephropathy (iga nephropathy)
characterizing sapho with 68ga-fapi pet/ct

Conditions: SAPHO Syndrome

Summary: 68ga-fapi has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment and follow-up of sapho than 18f-fdg pet/ct.

synovitis, acne, pustulosis, hyperostosis, and osteitis (sapho) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68ga-fapi that targets fibroblast activation protein (fap) is introduced in tumor imaging. however, fap was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for sapho to be imaged with 68ga-fapi. the aim of this study is to evaluate the performance of 68ga-fapi pet/ct in sapho and to compare it with the performance of 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: * suspected or confirmed untreated sapho patients; * 18f-fdg pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against fapi * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
heart failure decompensation and in-hospital mortality

Conditions: Chronic Heart Failure; Decompensated Heart Failure; Morality

Summary: background and objectives heart failure is a leading cause of morbidity and mortality worldwide and it is a major cause of emergency department access for cardiovascular disease patients. aim of this study is to identify the markers, based on short-term temporal repolarization dispersion, capable to individuate decompensated chronic heart failure (chf) patients at high mortality risk. method: we will obtain the following variables from ecg monitor, via mobile phone, during 5-minute recordings in decompensated chf patients: rr, qt end (qte), qt peak (qtp) and t peak to t end (te) and we calculated mean, standard deviation (sd) and normalized index (n).


Eligibility criteria:
inclusion criteria: * at least one symptom or sign compatible with a decompensation and/or a previous documented history of chf exclusion criteria: * pneumonia * pulmonary embolism

Keywords: temporal dispersion of repolarization phase probnp qtvi qt tpeak-tend
impact of the covid-19 pandemic on drug use and monitoring of cancer patients

Conditions: Cancer

Summary: the covid-19 pandemic has profoundly changed the organisation of care. teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus. within the framework of the oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the hospices civils de lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital. this study focuses on a telephone survey to describe the impact of the covid-19 pandemic health crisis on the drug exposure of cancer patients followed in the oncoral program, their treatment management, their perception of teleconsultation and their it resources for remote monitoring.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 and over * ambulatory patients treated with oral anticancer drugs and benefiting from the oncoral multidisciplinary outpatient / hospital program * having benefited from a remote monitoring between march 16, 2020 and may 11, 2020 (the covid-19 pandemic-related containment period) * patients who do not object to participating in the survey and to the use of the data collected exclusion criteria: * patients who do not speak french * patients living in an institution * patients protected by law * patients included in a drug clinical trial * patients refusing to participate in the survey and / or not responding to the 2 telephone calls requesting their participation and / or not responding to any of these calls * patients choosing to stop the interview and no longer answering to the questions asked

Keywords: remote monitoring oral anticancer drugs drug intake covid-19 pandemic
randomized study of recombinant human growth hormone in patients on chronic hemodialysis or peritoneal dialysis

Conditions: Kidney Failure, Chronic

Summary: objectives: i. assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients.

protocol outline: this is a randomized, double blind, placebo-controlled, cross-over study. prior to randomization each patient's protein and calorie intake is assessed and optimized as possible. patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months. at the end of this 6 month period, patients undergo a 4 week washout period. after the washout period, patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * on hemodialysis or peritoneal dialysis for more than 3 months * optimally dialyzed (urea reduction ratio greater than 65%) * suboptimal nutritional status identified by one of the following criteria: -protein catabolic rate less than 0.85 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months -progressive unintentional weight loss of more than 2.5% of the initial or ideal body weight and/or patient weighs less than 90% of ideal body weight -biochemical parameters of malnutrition defined by two or more of the following measurements over the past 3 months: serum albumin no greater than 3.7 g/dl serum transferrin concentration less than 250 mg/dl serum prealbumin concentration less than 30 mg/dl serum igf-1 concentration less than 0.250 mg/ml --patient characteristics-- * no active autoimmune, inflammatory, or infectious disease at least 6 months since any documented malignancy * no unusual dietary restrictions at least 3 months since peritonitis

Keywords: end stage renal disease rare disease renal and genitourinary disorders
transversalis fascia plane block for laparoscopic inguinal hernia repair

Conditions: Laparoscopic Inguinal Hernia Repair; Acute Post Operative Pain

Summary: transversalis fascia plane block (tfpb) is a trunk block that blocks the t12- l2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. the block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair. this study aimed to investigate the effectiveness of ultrasound (us) guided tfpb on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

inguinal hernia repairs are one of the most common general surgical operations and are generally performed with laparoscopic technique. even laparoscopic inguinal hernia repair results in less acute postoperative pain compared to the open technique, untreated early pain may prolong hospital stay, exacerbate general discomfort, and affect the length of recovery, which may also have social and -economic implications. opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. despite their advantages, opioids may be related to pulmonary complications, postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. the use of interfascial plane blocks for pain management has increased recently, as ultrasonography (usg) has become a part of daily routine. interfascial plane blocks provide effective postoperative analgesia. transversalis fascia plane block (tfpb) is a body block that blocks the t12-l2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall its positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open technique inguinal hernia repair. this study aimed to investigate the effectiveness of ultrasound (us) guided tfpb on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i- ii patients * unilateral inguinal hernia repair surgery * elective operations exclusion criteria: * patients with a history of chronic pain * evidence of infection in the intervention area * allergy to local anesthetics * coagulopathy * body-mass index (bmi) ≥ 30 * body weight ≤ 50 kg * patients who do not agree to participate in the study

Keywords: transversalis fascia plane block acute postoperative pain laparoscopic inguinal hernia repair
relationship-based care model in pediatrics

Conditions: Depression, Anxiety; Nurse-Patient Relations

Summary: aim: to evaluate whether the application of the relationship-based care (rbc) model as a treatment called "take 5 minutes" (t5m) affects the level of anxiety and depression of the parent, the level of the parent perceived quality of nursing care and the work satisfaction of the nursing staff. design: single-blind randomized controlled trial. methods: the trial was performed from february to july 2016. the trial was conducted with one intervention (n=101) and one control group (n=90). nurses applied the rbc model as a treatment, named "take 5 minutes", that consisted of dedicating some short time (from 5 to 10 minutes) to the relationship with the parents, using specifically designed communication strategies. the primary outcome was the evaluation of anxiety and depression of parents, the secondary was the parent perceived quality of nursing care.


Eligibility criteria:
inclusion criteria: * the parents of the children admitted to two pediatric units in a nationally renowned university hospital in the north-east of italy * had knowledge of the italian language spoken and written * were available for participation in the study by signing the informed consent exclusion criteria: * parents of hospitalized patients for a duration of less than 4 days

Keywords: relationship-based care pediatric caregiver anxiety nurse job satisfaction nurse
comparison of lens fit and lens power of a new contact lens to two marketed contact lenses in a population of soft contact lens wearers

Conditions: Myopia

Summary: the purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age and no more than 55 years of age. * must sign written informed consent. * optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters. * have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes. * must have visual acuity best correctable to 20/25+3 or better for each eye. * must appear able and willing to adhere to the instructions set forth in this clinical protocol. * have normal eyes with no evidence of abnormality or disease. for the purposes of this study a normal eye is defined as one having: no evidence of lid abnormality or infection; no conjunctival abnormality or infection; no clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); no other active ocular disease. * the subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study. exclusion criteria: * any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * any previous eye surgery involving the anterior segment. * pre-existing ocular disease that would preclude contact lens fitting. * abnormal lacrimal secretions. * keratoconus or other corneal irregularity. * pregnancy, lactating or planning a pregnancy at the time of enrollment. * participation in any concurrent clinical trial. * subject's habitual contact lens type is toric or multifocal. * require any concurrent ocular medication.