Kornimate/medical-research-clean huggingface dataset:
analgesic effect of maternal breast milk odor in preterm neonates: a randomised controlled trial

Conditions: Neonates Analgesy

Summary: objective : to assess the analgesic effect of maternal breast milk odor in preterm neonates design : a prospective, randomised, controlled, double blinded, monocentric trial. méthods : the neonates were included from 01/01/2012 to 31/12/2014. inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to olsen curves et al. they also had to be: clinically stable, with 48 hours withdrawal of nasal cpap, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. the two legal representatives must have signed an informed consent. the study excluded the neonates for whom no video was recorded during the venipuncture. in the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. in a second control group, the same gesture was made with an odorless diffusor. the primary outcome was the clinical score assessment pipp (premature infant pain profile). the secondary outcomes were the dan score (acute pain of newborn) and the salivary cortisol level.


Eligibility criteria:
inclusion criteria: * neonates fed with their mother breast milk, * gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, * postnatal age ≤ 10 days * birth weight greater than the 5th percentile according to olsen curves et al. * clinically stable, with 48 hours withdrawal of nasal cpap, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease * the two legal representatives must have signed an informed consent. exclusion criteria: * neonates for whom no video was recorded during the venipuncture
comparison of combination of beclomethasone dipropionate and formoterol fumarate versus single components assessed by knemometry and urinary cortisol measurements in asthmatic children

Conditions: Asthma in Children

Summary: single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids


Eligibility criteria:
inclusion criteria: * prepuberal male and female outpatients, ≥ 5 and \< 12 years old in tanner stadium i according to investigator's assessment; * clinical diagnosis of mild asthma during at least two months prior to screening visit; * forced expiratory volume during the first second (fev1) \> 80% of predicted normal values at screening visit; exclusion criteria: * endocrinological diseases including growth impairment or other chronic diseases; * any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;
isb with ssnb & anb

Conditions: Rotator Cuff Tear

Summary: this study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline). the study will compare subjective pain scores (vas score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, il-6, il-8, il-1β, substance p, serotonin, β-endorphin, and norepinephrine.


Eligibility criteria:
inclusion criteria: * a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (mri) * acceptance of arthroscopic surgery including rotator cuff repair * age same as or more than 20 years * acceptance of preemptive regional block and pca, and blood testing exclusion criteria: * did not undergo arthroscopic rotator cuff repair * stopped pca before 48 hours postoperatively because of associated side effects * a history of previous ipsilateral shoulder operation or fracture * a concomitant neurologic disorder around the shoulder * a failure of blood sampling including hemolysis, etc.
clinical feasibility of minimally supervised therapy after stroke with a hand rehabilitation robot

Conditions: Stroke

Summary: the rehapticknob is a robot for hand rehabilitation after stroke. we aim to investigate the feasibility of minimally supervised therapy with the rehapticknob with stroke patients in a rehabilitation clinic, evaluate the usability of the rehapticknob (user interface and implemented exercises which were adapted for independent usage), and quantify the dose of additional robotic therapy that patients perform in a minimally supervised setting. minimally supervised therapy means that after a training phase, where the therapists teach to the patients how to perform the exercises with the robot, the patients can autonomously train with the robot during free time without being directly supervised. our hypothesis is that minimally supervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function with minimal additional burden for therapists and for the healthcare system.


Eligibility criteria:
inclusion criteria: * male and female stroke patients between 18 and 90 years old; * pre-stroke modified rankin score ≤ 1; * acute/subacute stroke (within (≤) 6 weeks from onset); * nihss ≥ 1 in at least one of the items regarding motor function, sensory functions and ataxia; * the patient read, understood and signed the informed consent. exclusion criteria: * modified ashworth scale \> 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers; * moderate to severe aphasia: goodglass-kaplan scale \< 3; * moderate to severe cognitive deficits: levels of cognitive functioning-revised (lcf-r) \< 8; * functional impairment of the upper limb due to other pathologies; * severe pain in the affected arm: visual analogue scale for pain (vasp) ≥ 5; * other pathologies which may interfere with the study; * pacemakers and other active implants.

Keywords: stroke hand impairment robot-assisted therapy minimally supervised therapy neurorehabilitation
evaluation of the reliability of oesophageal temperature in thoracic surgery

Conditions: Hypothermia; Thoracic Neoplasm; Anesthesia

Summary: controlling hypothermia is essential in anesthesia to limit postoperative complications. temperature monitoring is therefore essential. however, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

controlling hypothermia is essential in anesthesia to limit postoperative complications. temperature monitoring is therefore essential. however, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature. the investigators therefore decided to evaluate the reliability of the oesophageal temperature in open chest lung surgery by comparing it to the continuous tympanic temperature.

Eligibility criteria:
inclusion criteria: * all patients needing pulmonary surgery under thoracotomy exclusion criteria: * patient refusal * esophageal or otological pathology preventing the installation of thermal probes

Keywords: thoracic surgery body temperature
evaluation of "uroshield" device impact upon side effects and complications of urinary catheter usage

Conditions: Infectious

Summary: evaluation of "uroshield" device impact upon side effects and complications of urinary catheter usage. the use of urinary catheters is a common medical practice in the perioperative setting. as such, it exposes the patient to certain comorbidities, including urinary tract infections. the infectious process is known to begin with a development of a biofilm on the catheter's surface. this fact makes it an attractive target for uti prevention technology. ultrasound waves were shown to reduce biofilm buildup in-vitro. we plan to determine the efficacy of this method in vivo.


Eligibility criteria:
inclusion criteria: * patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward. exclusion criteria: 1. patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology. 2. patients with a urinary tract infection in the past year. 3. patients with a urinary tract infection when inserting a catheter. 4. pregnant women. 5. patients under the age of 18. 6. without judgment.

Keywords: introduction of urinary catheter
dual-task effects on hand functions in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the aim of the study is to examine the effect of dual-task performance on hand functions in individuals with type 2 diabetes mellitus. it is planned to reach at least 100 participants during the data collection phase of the study. demographic information, plasma glucose levels, and hba1c levels of the participants included in the study will be recorded. the upper extremity problems of the participants will be recorded. minnesota manual dexterity test will be used to evaluate upper extremity functions.

this study is aimed to evaluate the effect of dual-task performance on hand functions in individuals with type 2 diabetes mellitus. the study will conduct in the internal medicine clinic of kutahya health sciences university evliya celebi training and research hospital. approval for the study was granted by the clinical research ethics committee of kutahya health sciences university and written informed consent forms will be obtained from all the participants. this study is planned to reach at least 50 participants with type 2 diabetes mellitus for the study group and 50 participants without diabetes for the control group. the participants will be questioned about their eligibility for the inclusion criteria. the demographic and descriptive data of the participants will be recorded. minnesota manual dexterity test will be used to evaluate upper extremity functions. the test will be performed with and without the dual-task. counting backward from a random three-digit number 3 by 3 will be used for the dual-task. the effect of dual-task will calculate using the difference between the completion time of both tests for both groups.

Eligibility criteria:
inclusion criteria: * having been diagnosed with type 2 diabetes mellitus for at least 5 years for study group, having no diagnosed type 2 diabetes mellitus or prediabetes for control group, * being able to count down 3 by 3 from a three-digit number, * volunteer to take part in the study. exclusion criteria: * history of traumatic or inflammatory injury in the upper extremity, * history of involving the upper extremity in the last year, * having rheumatological/inflammatory arthritis or deformity, * having a deformity caused by osteoarthritis in the upper extremity, * having a neurological problem affecting the upper extremity, * getting 23 points or less on the mini-mental test.

Keywords: type 2 diabetes dual-task hand functions
adaptated physical activity in cancerology

Conditions: Breast Cancer

Summary: this trial will measure the fatigue in breast cancer patients. two groups of patients will be realised: * arm a: physical activity during treatment * arm b: no physical activity during treatment but after the aim of the study is to decrease fatigue, with adequate physical activity, in primary breast cancer patients who receive a treatment for their pathology.

this is an open monocentric study, randomized in two parallel arms with a waiting list. the duration of the physical activty will vary according to the duration of the treatment: from 2 to 6 months. several questionnaries (fatigue, quality of life, ...) will be given to patients at the inclusion, at the end of the period of treatment and 3 to 6 months after the end of treatment. one hundred patients are necessary in this study (fifty in each arm). we expect to a stability of the fatigue in arm a compared to an increase of the fatigue in arm b.

Eligibility criteria:
inclusion criteria: * women aged 18 to 75 years (included) * patient with a breast tumor, regardless of the stage and size (except metastatic patients) * patient with a local recurrence of breast cancer * patient with a second non-metastatic breast cancer * breast cancer treated, regardless of the surgery, at least by radiotherapy, chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy * a mandatory social security affiliation. * obtaining informed consent in writing, signed and dated. * medical certificate of fitness to practice physical (issued by the medical oncologist) exclusion criteria: * cancer other than breast cancer and / or associated with breast cancer * metastatic cancer * in case of surgery before treatment, delay before beginning treatment inferior to 1 month post-surgery * men * woman pregnant * patient with cognitive or psychiatric disorders * patients suffering from disability * significant alterations in nutritional status (malnutrition with bmi \ 40, bmi) * cardiac contraindication to physical activity * knowledge and understanding of the french language enough not to learn the correct way of self-administered questionnaires or respond to questioning * participation in another clinical study with a similar objective * inability to reach the centers where physical activity takes place

Keywords: breast cancer fatigue physical activity
sorafenib in relapse of fms-like tyrosine kinase 3 (flt3)-internal tandem duplication (itd) aml trial

Conditions: Acute Myeloid Leukemia

Summary: in this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention. the investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with flt3-itd aml relapse after allo-hsct.

the preliminary data of the investigators demonstrate potent activity of sorafenib combined with donor lymphocyte infusions (dli) in relapse of flt3-itd+ acute myeloid leukemia (aml) after allogeneic hematopoietic cell transplantation (allo-hsct). the investigators therefore launched an observational multicenter trial. the outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention (chemotherapy-alone-group, chemotherapy/dli group, sorafenib alone group and sorafenib/dli group). the specific interventions to the subjects of the study are assigned by the individual transplant center. the investigators will determine the outcome of each group by monitoring the survival and the response rates (complete remission, disease burden reduction, no response) of patients with flt3-itd aml relapse after allo-hsct.

Eligibility criteria:
inclusion criteria: * histology/pcr proven relapse of flt3-itd+ aml after allo-hsct * age ≥18 years * treatment with either chemotherapy-alone, chemotherapy/dli, sorafenib alone or sorafenib/dli * written informed consent * ability to understand the nature of the study and the study related procedures and to comply with them exclusion criteria: * age \< 18 years * lack of informed consent * patients that cannot be classified in one of the 4 groups: chemotherapy-alone-group, chemotherapy/dli group, sorafenib alone group and sorafenib/dli group

Keywords: flt3-itd aml allo-hsct
autonomic challenges from mild hypovolemia and mechanical ventilation

Conditions: Autonomic Nervous System Imbalance; Hypovolemia; Positive-Pressure Respiration

Summary: heart rate variability (hrv) analysis has been studied in the critically ill patients although it is affected by several uncontrolled variables in the clinical conditions. the aim of this trial is to measure the effects of mildly reduced central volume and cyclic variation of intrathoracic pressure on the variables frequently used to describe the hrv.

twelve healthy volunteers will be studied. mild hypovolemia will be induced by 12 hours fasting from food and drinks. at 8.30 am the study protocol will start. the studied subjects will lie calm supine in a icu bed able to provide passive head up and head down tilt. they will be connected to a siemens sc9000 monitor showing their ecg waves and to a nexfin (bmeye) monitor for continuous noninvasive blood pressure (nbp) assessment. both waves (ecg and nbp) will be recorded on a laptop pc through analogic/digital input/output converter (powerlab 8/35, adinstruments). the studied subjects will undergo to a sequence of (1) spontaneous breathing at 10 degrees head up, (2) spontaneous breathing at 7 degrees head down, (3) noninvasive ventilation at 10 degrees head up, and (4) noninvasive ventilation at 7 degrees head down. the sequence 1-2-3-4 will be randomized. after this four phases, a fluid challenge of ringer acetate 15ml\*kg will be intravenously administered and the a sequence 1-2-3-4 will be repeated after a new randomization. noninvasive ventilation will be provided with a facial mask with ventilatory setting: psupp 8 cmh2o, peep 5 cmh2o, fio2 0.28. psupp will be decreased by 2 cmh2o steps if the inspiratory tidal volume will be \>10ml\*kg. during both spontaneous breathing and noninvasive ventilation the subjects will breathe following a metronome at 18bpm. hrv analysis will be conducted following the recommendation of the task force of the european society of cardiology and the north american society of pacing and electrophysiology (see reference). furthermore, the healthy volunteers will be studied by trans-thoracic ultrasound assessment with a philips epiq7 sonographer, during each study phase.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * history of cardiac, metabolic, respiratory, renal, neurological or hematologic disease of any kind * chronically assuming drugs of any kind * non sinus cardiac rhythm * ectopic beats \>5% of all cardiac beats * claustrophobia or unable to tolerate noninvasive ventilation via facial mask
reducing clinical inertia in hypertension treatment: a pragmatic trial

Conditions: Hypertension

Summary: the goal of this project is to use health information technology and team-based care in novel ways to support the establishment of a patient-centered medical home model of care aimed at improving the diagnosis and management of hypertension. compared with patients who receive usual care, patients who receive intervention will have a lower average systolic blood pressure 9 months after randomization.


Eligibility criteria:
inclusion criteria: * adult men and women age 18-79 * at least 2 blood pressure readings from separate days on record * average of last 3 blood pressure readings (or last 2 if only 2 available) with (systolic blood pressure ≥140 or diastolic blood pressure ≥90) and (last systolic blood pressure ≥135 or last diastolic blood pressure ≥85), recorded by any university of colorado hospital clinic within the last 18 months * no clinic visit in the past month * at least one primary care physician visit in the past 18 months * first primary care physician visit at least 6 months in the past exclusion criteria: * serious comorbidities, including active cancer diagnosis, hospice care, nursing home residence * diagnosis of diabetes (these patients are enrolled in a separate study that also targets blood pressure control) * end-stage renal disease / hemodialysis * primary care physician appointment pending * patient instructed to monitor blood pressure at home / documentation of white coat hypertension * blood pressure managed by specialist or outside provider

Keywords: hypertension blood pressure primary care patient centered medical home health information technology clinical inertia
does medial raw anchor necessary during tendon repair combined with microfracture

Conditions: Full Rotator Cuff Tear; Microfracture Procedure; Double Raw Repair; Lateral Raw Repair

Summary: this study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. the patients with rotator cuff tear were randomly divided into groups before the operation. the patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. in different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, mri performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. in order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear.


Eligibility criteria:
inclusion criteria: * arthroscopy confirmed small to medium full rotator cuff tear * unilateral rotator cuff injury * voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients * young and middle-aged patients aged 20 to 60 exclusion criteria: * previous shoulder surgery (incision or arthroscopy) * combined with diseases of other parts of the same limb * combined with bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on * bilateral onset * unable or unwilling to receive clinical follow-up
tacrolimus ointment pharmacokinetics in infants with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment. efficacy of tacrolimus ointment, evaluated by examination of treated areas, will also be measured.

this is a multi-centre, double-blind, randomised phase ii pharmacokinetic study in infants (3 - 24 months old) suffering from atopic dermatitis and requiring treatment with mid potency topical steroids. patients will primarily be stratified into three groups according to percentage body surface area to be treated and subsequently randomised into treatment groups of once a day (uid) or twice a day (bid) tacrolimus ointment (0.03%) regimens. there will ultimately be a total of six groups. the study will be conducted on an out-patient basis, with each patient's parent/legal representative administering the ointment at home. however all medications on days 1 and 14 will be applied in the clinic by the investigator or his/her designee, as will the morning application on day 4. the ointment application period will be two weeks with a follow-up period of four days. all patients enrolled into the study, who applied at least one dose of study medication and who benefited from treatment will be given the opportunity to enter a long-term study to follow (fg-506-06-33). the patient will be entered into one of the following three groups: stratification group i application area of 5 - 20% stratification group ii application area of \> 20 - 40% stratification group iii application area of \> 40% within these groups the patients will be randomised to either uid or bid.

Eligibility criteria:
inclusion criteria: * patient is between 3 and 24 months old on day 1. * the patient has atopic dermatitis requiring treatment with mid potent topical steroids. * patient's disease involves a percentage area to be treated greater than or equal to 5% of the total body surface area exclusion criteria: * patient has clinically infected atopic dermatitis. * patient has a history of more than two courses of systemic corticosteroid treatment