Kornimate/medical-research-clean huggingface dataset:
freestyle libre 2 flash glucose monitoring system control phase study for pediatric patients - bg

Conditions: Diabetes Mellitus

Summary: this is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (smbg) when used to manage diabetes in pediatric patients.

approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. subjects and/or their caregivers will utilize capillary smbg for managing diabetes for 6 months. subjects and/or their caregivers will maintain a diary/log book of adverse events experienced during the duration of the study. assessment of adverse events will occur via self reporting at each monthly visit and/or phone call.

Eligibility criteria:
inclusion criteria: * subject must be 4 - 17 years of age. * subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment. * subject is currently using smbg for managing their diabetes. * subject and/or caregiver must be able to read and understand english. * in the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. * subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate. exclusion criteria: * subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months. * subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. * subject is known to be pregnant or is attempting to become pregnant at the time of enrollment. * subject is on dialysis at the time of enrollment. * subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. * subject currently is participating in another clinical trial. * subject is unsuitable for participation due to any other cause as determined by the investigator.
acne and mood: impact of treatment on depression, anxiety, and sexual function

Conditions: Acne Vulgaris

Summary: this study seeks to examine if there is any relationship between spironolactone use prescribed for acne vulgaris and depression, anxiety, and/or sexual function.


Eligibility criteria:
inclusion criteria: female subjects between 18 and 65 years of age currently taking spironolactone for a diagnosis of acne vulgaris or female subjects between 18 and 65 years of age currently taking oral antibiotics for a diagnosis of acne vulgaris and subjects able to complete an online survey in english exclusion criteria: subjects less than 18 years of age or older than 65 years of age subjects that have ever been diagnosed with any mood disorder by a clinician prior to starting spironolactone (history of mood disorder or current mood disorder) subjects taking hormonal contraception (including but not limited to oral contraceptive pills) for a duration of less than 6 months subjects that have ever been diagnosed with any type of sexual dysfunction prior to starting spironolactone subjects not able to complete an online survey in english subjects taking oral isotretinoin for a diagnosis of acne subjects that are currently pregnant
tracheobronchial secretion removal

Conditions: Respiration, Artificial; Respiratory Insufficiency

Summary: patients undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. timing of the procedure is mainly based on clinical parameters. tba care® is a new commercially available device designed to generate a signal when secretions are present in the respiratory tract of intubated patients, thus indicating the need for endotracheal suctioning only when necessary and prior to clinical deterioration. in a prospective randomized trial in intubated and mechanically ventilated patients of a general icu the researchers investigated the efficacy of tba care® in detecting the presence of retained secretions compared to the standard indicators.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * presence of an endotracheal tube to provide mechanical ventilation * expected duration of mechanical ventilation greater than 48 hours. exclusion criteria: * age \< 18 years, pregnancy * presence of active bronchial bleeding
a drug interaction study investigating the effect of rifabutin on the pharmacokinetics of maraviroc

Conditions: HIV Infection; HIV-1 Infection; Mycobacterium Avium Complex (MAC)

Summary: healthy volunteers are being recruited for this pharmacokinetics study. the objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-o-desacetyl-rifabutin pharmacokinetics compared to the literature.


Eligibility criteria:
inclusion criteria: * able and willing to sign informed consent prior to any study-related activities. * male or female participants between 18 and 65 years of age inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * healthy, i.e. not suffering from an acute or chronic illness and not using medications. * acceptable medical history, physical examination, and 12-lead ecg at screening. * acceptable laboratory values that indicate adequate baseline organ function at screening visit. * willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: grapefruit, grapefruit juice, st. john's wort. * willingness to abstain from alcohol use for 3 days prior to and during the study. * participant must practice a reliable method of birth control while they are participating in the study; for instance an intrauterine device (iud), condom with spermicidal gel or foam, diaphragm with spermicidal gel or foam, vasectomy, tubal ligation, hysterectomy or abstinence or female must be post menopausal for at least one year. exclusion criteria: * have serological evidence of exposure to hiv * female patients of childbearing potential who has a positive urine pregnancy test at screening * participants not willing to use a reliable method of barrier contraception during the study. * is breastfeeding. * inability to adhere to protocol. * use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen. * participants taking oral contraceptive medications. * any condition possibly affecting drug absorption (eg, gastrectomy). * patients may be excluded from the study for other reasons, at the investigator's discretion.

Keywords: healthy volunteers
gemcitabine/abraxane chemotherapy and dose escalated radiotherapy for locally advanced, unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study will analyze the effects, good and/or bad, of the drug abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. all of the medications used in this study are fda-approved for use in patients with pancreatic cancer.

the long term goal is to improve survival of patients with unresectable pancreatic cancer. additional potential benefits include increased probability of local control and decreased distant metastases.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven carcinoma of the pancreas that is locally advanced * ecog performance status 0- 2 * adequate labs * no prior abdominal radiation therapy * no other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years * all disease must be encompassed within a radiotherapy portal * not pregnant or nursing exclusion criteria: * patient has metastatic disease on radiological staging * systemic therapy. * patient has known active infection with hiv, hepatitis c or hepatitis b * patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug. * patient is deemed to be have obvious resectable disease at presentation * received any investigational agent within a month prior to enrollment. * neuroendocrine tumors of the pancreas

Keywords: pancreatic cancer
vildagliptin and the glucagon response to hypoglycemia in type 1 diabetes

Conditions: Diabetes; Hypoglycemia

Summary: the study examines whether dpp-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.

vildagliptin (50 mg bid) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * age \>18 years * hba1c 6.5-8,5% exclusion criteria: * pregnancy * lactation * acute infection * liver disease * treatment with cortisol

Keywords: dpp-4 glp-1 glucagon catecholamines counterregulation type 1 diabetes
changes on pain and range of motion by the use of kinesio taping in patients diagnosed with cervical pain

Conditions: Mobility Limitation; Myofascial Trigger Point Pain

Summary: the aim of this study is to demonstrate that the application of kinesio taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain.

the use of kinesio taping has become very popular for the treatment of many musculoskeletal disorders in recent decades. of the six variants of application that has the kinesio taping, the space correction technique is suggested for pain management. the increased space achieved with this variant decreases the pressure by raising the skin directly over the treatment area, reducing chemical irritation receptors and therefore pain. the aim of this study is to demonstrate that the application of this variant of kinesio taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain. for this, the pressure pain threshold will be measured with a algometer on the trigger point, the perception of pain with a visual analog scale and the range of motion with a cervical goniometer.

Eligibility criteria:
inclusion criteria: * agree to participate in the study (signed informed consent) * presence of active myofascial trigger point in upper trapezius. * presence of neck pain exclusion criteria: * subjects in which not clearly identified myofascial trigger point in the upper trapezius . * subjects who suffer or have suffered pathologies of upper limb deformities or orthopedic injuries that can alter static and biomechanics of shoulder and neck. * subjects who suffer or have suffered rheumatic or neurological disease or chronic shoulder pain and/or neck * subjects diagnosed with fibromyalgia, myelopathy or radiculopathy. * subjects suffering from any psychiatric disorder (such as anxiety or depression). * subjects who have suffered post-traumatic alteration (whiplash type) or cervical surgery. * pregnancy risk of abortion. * have used analgesics in the 48 hours before participating in the study * subjects presenting any contraindications to the application of kinesio taping. * know the kinesio taping technique applied in the study. * be receiving physical therapy for any shoulder or neck pathology.
art therapy to promote wellbeing and self-care in resident physicians.

Conditions: Work-Related Stress

Summary: this study evaluates if an art therapy intervention could lower resident physician's work-related stress and if it could promote their self-care.

the objective of this study is to determine if an art therapy intervention could promote the well-being of resident physicians of an university tertiary hospital, as specialized physicians trainees exposed to the risk of burnout. using a cycle of 6 bimonthly sessions of group art therapy, the intervention stimulates the creative activity of the participants through various art materials and techniques. next, they are invited to share their reflexions about the artworks produced, with the group and in presence of the art therapist. the study mainly evaluates the work-related stress and the self-care grade of the participants, before the intervention, just after it and after a follow-up period.

Eligibility criteria:
inclusion criteria: * belonging to the resident physicians collective of the santa creu i sant pau hospital. exclusion criteria: * being with a diagnostic of major depression * receiving psychotherapy o similar

Keywords: resident physician art therapy self-awareness sel-care
comparison of analgesic efficacy of us guided esp block with port site infiltration following laparoscopic cholecystectomy

Conditions: Postoperative Pain

Summary: to compare the efficacy of ultrasonography (usg)-guided bilateral erector spinae plane block (espb) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.


Eligibility criteria:
inclusion criteria: * patients with the american society of anesthesiologists (asa) physical status i/ii, * age between 18 and 60 years with a body mass index (bmi) of 18-35 kg/m2, * patients scheduled for elective laparoscopic cholecystectomy. exclusion criteria: * allergy to local anaesthetics, * infection at the site of injection, •, coagulopathy, * chronic pain syndromes, * prolonged opioid medication, * patients who received any analgesic 24 h before surgery

Keywords: cholecystectomy esp block port site infiltration
insulin glulisine, insulin lispro and insulin glargine in type 1 or 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: primary: * to compare the efficacy and safety of insulin glulisine to insulin lispro in subjects with type 1 or type 2 diabetes mellitus. * to compare the frequency of hypoglycemia of insulin glulisine to insulin lispro. secondary: * to compare insulin glulisine to insulin lispro in terms of the change in hba1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetic patients * measure hba1c 6.5% to 11.0% at visit 1 * more than 3 months of continuous insulin treatment immediately prior to study entry exclusion criteria: * pregnant women the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effects of exercise intervention in patients with spondylolisthesis related lbp

Conditions: Low Back Pain; Spondylolisthesis

Summary: the first purpose of this study is to define parameters of the trunk neuromuscular functions that are pathologically altered in patients with low back pain due to spondylolytic spondylolisthesis. the second and also the main purpose of the study is to examine the effects of exercise intervention on patients with low back pain due to spondylolytic spondylolisthesis. our overall hypothesis is that specific exercise intervention will improve neuromuscular functions of the trunk in patients with low back pain due to spondylolytic spondylolisthesis.

low back pain is known to affect a considerable portion (\> 75%) of the society, causing enormous financial burden for the healthcare systems. exercise interventions incorporated into low back pain patients rehabilitation protocols are known as successful treatment strategies, but ore often focused on strength training and not on functional stabilization. spondylolytic spondylolisthesis is one of the most known types of spine instabilities. to date, no studies examined the effects of exercise intervention on patients with low back pain due to spondylolytic spondylolisthesis. research will be carried out as a cross-sectional study, where patients with spondylolytic spondylolisthesis will be randomly arranged in one controlled and two experimental groups. for the forth group healthy asymptomatic participants will be recruited. exercise intervention will last 12 weeks with a frequency of three times a week and duration of 60 minutes per training unit. exercise intervention will include congregated set of trunk stabilisation exercises, starting with simple isometric tasks. dynamic and more complex movements will be added progressively to achieve whole body tasks involving fast and sudden movements. neuromuscular functions of the trunk will be measured before and after the intervention.

Eligibility criteria:
inclusion criteria: * low back pain presence for at least three months. * age between 20 and 60 years. * isthmic spondylolisthesis (1st and 2nd level according to meyerding) at l5/s1 and l4/l5. * body mass index below 30. * without neurological pathological conditions. exclusion criteria: * intermittent claudication pain. * history of operational treatment of the lumbar spine. * traumatic, oncological, infectional pathology of the spine * degenerative stenosis of the lumbar spinal canal.

Keywords: exercise electric stimulation
transcutaneous electric nerve stimulation (tens) in children with enuresis

Conditions: Enuresis; Nocturnal Enuresis; Urinary Incontinence

Summary: this is a randomized, double blind, placebo controlled study of the effect of sacral transcutaneous electric nerve stimulation (tens) in fifty-two children with monosymptomatic nocturnal enuresis (mne).

objectives: nighttime urinary incontinence (enuresis) is seen by 5-10% of children from six to fifteen years. enuresis is a socially and psychologically stressful condition that can lead to bullying and low self esteem. today the condition is treated with desmopressin or bells, that awake children at nighttime urination. one third of children suffering from enuresis are refractory to first line of treatment. transcutaneous electric nerve stimulation (tens) has been documented efficacious on symptoms in children with daytime incontinence. little is known regarding the effect of tens on monosymptomatic nocturnal enuresis (mne). the aim of our study is to investigate the effect of tens on children diagnosed with mne. methods: this is a randomized, double blind, placebo controlled study of the effect of tens in fifty-two children with mne. the study period is from september 2015 to september 2016. the children recruited will receive tens one hour during daytime and one hour during sleep for a total treatment period of ten weeks. the surface electrodes will be placed on the skin over s2-s3. tens is safe and not associated with adverse effects. expected results: the investigators hypothesize a reduction in number of wet nights in the enuretic children receiving active tens. if tens proves effective in children with enuresis it will be implemented as part of enuresis treatment in the clinical practice.

Eligibility criteria:
inclusion criteria: * unremarkable clinical examination * 3 or more wet nights per week * no treatment of enuresis 1 week before the treatment starts (for bells two weeks) exclusion criteria: * nighttime urine production on wet nights \> 130 % of "maximum voided volume" (mvv) for age * ongoing constipation and/or faecal incontinence that are not successfully treated * daytime incontinence * prior or ongoing treatment with tens * current or previous clinical history, clinical or laboratory findings or daily treatment with drugs that can be related to diseases or conditions that are expected to change the parameters investigated, especially diseases of the kidney and urinary tract or endocrine disorder * neurological and/or significant anatomical abnormalities of the urinary tract * previous operation in the urinary tract * recurrent urinary tract infections * incomplete bladder emptying (assessed with ultrasound) which means post micturition urine volume in the bladder \> 20 ml or \> 10 % of the total urine production
assessment of efficacy and safety of amicomed®, for the management of essential hypertension

Conditions: Essential Hypertension; Primary Hypertension

Summary: this is a multicenter, randomized, single-blind, parallel-group study to evaluate the efficacy and safety of amicomed® compared with usual care (uc) over a 24-week treatment period in subjects with essential hypertension (mean, home based systolic blood pressure (sbp) ≥ 140 and/or diastolic blood pressure dbp ≥ 90 mm hg on day 1).

amicomed is a digital therapeutics service and program for bp management and reduction. the key features of amicomed include: 1. an automatic, expert system based, finite-machine ai algorithm for assessing the evolution of blood pressure levels, 2. an automatic, expert system based, finite-machine ai algorithm for generating and delivering a detailed lifestyle program (dietary and physical activity) starting from the general lifestyle suggestions of the hypertension and cardiovascular prevention guidelines and producing a truly personalized program. 3. a behavioral strategy embedded into the app to increase adherence and persistence into the program. the amicomed digital therapeutics service and app for hypertension management and intervention has been shown to significantly improve bp levels in case-control studies .these initial results demonstrated a 5mmhg systolic bp reduction across all amicomed subscribers and 7.9 mmhg systolic bp reduction in subject with \>= stage 1 hypertension. comparable reduction of diastolic bp was also achieved. the aim of this study is to investigate the long-term efficacy of the amicomed® digital therapeutics program, compared to usual care, in reducing systolic and diastolic blood pressure in subjects with primary hypertension.

Eligibility criteria:
inclusion criteria: * male or female with age ≥ 18 years * diagnosed with essential hypertension and exhibiting a mean home-based sbp ≥ 140 and/or dbp \> 90mm hg, i.e., grade i hypertension . * disease duration: 12 (+/-) 3 months * unmedicated, or currently treated by a stable regimen for hypertension with sub-optimal response to usual care treatments (delta sbp \< 5 mm hg; and/or delta dbp \< 5 mm hg) * not participating in physical exercise or dietary programs during the last 12 months from visit 1. * willing and able to return for all clinic visits and to complete all study-required procedures * able to use the app, \[self-report compliance over 80%\]. compliance is defined as the capacity to provide at least 6 bp measurements per week during the beginning, middle and end week of the 24 weeks program. exclusion criteria: * pregnancy or planning to become pregnant during the study period * use of medications that may interfere with the study intervention * severe kidney or liver disease * active cancer treatment