Kornimate/medical-research-clean huggingface dataset:
the intermittent pneumoperitoneum scheme of work breaks in complex laparoscopic surgery

Conditions: Stress Physiology; Staff Work Load; Artificial Pneumoperitoneum; Anuria

Summary: many people spanning from air traffic controllers to simple production line workers share regular compulsive breaks to revert fatigue whilst they work. this is uncommon for medical operators - a macho image is still as prevalent in real life as it is in countless tv series. we report on the first clinical trial on regular intraoperative breaks. for one time we turned our scientific curiosity to ourselves. this included the intraoperative collection of body fluids and required transparency which was not easy to obtain. it was rewarded with striking results: regular intraoperative breaks lowered significantly the operators stress hormone levels, improved error-performance testing results and musculoskeletal fatigue scores. subjectively the breaks enhanced the practitioners satisfaction. surprisingly the operator's breaks were not at the cost of the patient: because the did not prolong the overall operation time at all and - in our setting- they significantly increased of cardiac output and urine production.

abstract background: work breaks at close intervals are common in fields with high workload but not yet for medical operators. we evaluated the effects of intraoperative breaks (five minutes every half hour) on the surgeon and on the patient. methods: operations were randomized to either a scheme with intraoperative breaks and release of the pneumoperitoneum (intermittent pneumoperitoneum = ipp) or a conventional conduct (cpp). stress hormones and α-amylase were determined in the surgeon's saliva pre-, intra- and postoperatively. mental performance and error scores, musculoskeletal strain and continuous ecg were secondary endpoints. the children's physiology was monitored. findings: regular intraoperative breaks did not prolong the operation. the surgeon's cortisol levels during the operation were reduced. there were fewer intraoperative events in the ipp vs. the cpp group. the pre- to postoperative increase in the error rates of the bp-concentration test was reduced in the ipp group. the relevant locomotive strain-scores were reduced by ipp. there was no negative impact on the patient. interpretation: our data support the idea that work breaks during complex laparoscopic surgery can reduce psychological stress and preserve performance with at least similar patient outcome compared to the traditional work scheme.

Eligibility criteria:
inclusion criteria: * complex laparoscopic operations in children (duration \> 100 minutes) exclusion criteria: * age under 4 weeks * operations which had to be performed in an open surgery mode

Keywords: surgeon's physiology stress response break scheme
selegiline for the treatment of excessive daytime sleepiness in parkinson's disease

Conditions: Parkinson Disease

Summary: this is a multi-center, open-label, single-arm 8-week investigation of selegiline for treatment of eds in pd patients.

this is a multi-center, open-label, single-arm 8-week investigation of selegiline. subjects who have a diagnosis of pd based on uk brain bank criteria with ess\> 7 will be received selegiline as an adjunctive therapy or monotherapy. this study will assess the impact of selegiline treatment on the severity of sleep disturbances among pd patients.

Eligibility criteria:
inclusion criteria: 1. male or female and greater from 30 to 80. 2. diagnosis of idiopathic pd according to the uk brain bank criteria. 3. epworth sleepiness scale (ess) \>7. 4. stable dose of anti-parkinson drugs for at least 30 days. 5. no use of mao-b inhibitors within the preceding 4 weeks. 6. no cognitive impairment, defined by mini-mental state exam score ≤ 26. exclusion criteria: 1. diagnosis of atypical parkinsonian syndrome, vascular parkinsonism or drug-induced parkinsonism. 2. shift-work, which cannot ensure a stable sleep-wake cycle habits. 3. history of contraindications.
below knee dvt study

Conditions: Deep Vein Thrombosis (DVT); Blood Clots

Summary: hospitalized patients are at risk of developing blood clots in the legs (deep vein thrombosis or dvt), which can lead to death if those clots break off and migrate to the lungs. we know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths. it is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. in this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (lovenox), a blood thinner. we will then see if low dose blood thinner has similar results as high dose blood thinner.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 admitted to a trauma or general surgery service will be eligible * patients diagnosed with an isolated distal dvt * able to obtain informed consent exclusion criteria: * patients with a previous diagnosis of hypercoagulability * patients on chronic anticoagulation * patients with a history of heparin induced thrombocytopenia * patients have preexisting contraindications to anticoagulation * patients in renal failure requiring adjusted enoxaparin dosing * pregnant patients

Keywords: lovenox enoxaparin dvt
heart failure and sleep disordered breathing

Conditions: Heart Failure

Summary: the purpose of this study is to analyze and summarize the characteristics of arrhythmia and heart rate variability of chinese patients with three different types of heart failure combined with sleep disordered breathing based on the clinical data, to provide new diagnosis and treatment ideas for domestic patients, and then to improve the prognosis of patients betterly.


Eligibility criteria:
inclusion criteria: 1. age \>18 years. 2. the diagnosis of heart failure conforms to the criteria of the chinese guidelines for the diagnosis and treatment of heart failure . 3. echocardiography, dynamic electrocardiogram and polysomnography monitoring should be improved during the period of hospitalization. 4. patients with sleep apnea have not received standard treatment. exclusion criteria: 1. patients undergoing cardiac surgery in the past 6 weeks. 2. patients with acute decompensated heart failure or heart failure requiring oxygen therapy. 3. all patients with sleep apnea who receive standard treatment. 4. patients who use pacemakers or implantable cardioverter defibrillators. 5. the patient did not complete the echocardiography, dynamic electrocardiogram, and polysomnography monitoring during hospitalization.

Keywords: sleep disordered breathing arrhythmia heart rate variability
study to find maintenance dose for periodic administration of asp3550

Conditions: Prostatic Neoplasms

Summary: to find effective doses of asp3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

asp3550 is administered periodically to patients with prostate cancer. the primary efficacy variable is the effect of asp3550 on the maintenance of serum testosterone suppression. in addition, the safety and pharmacokinetics of asp3550 will be investigated.

Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer (adenocarcinoma) of all stages * a patient in whom endocrine treatment is indicated. patients with rising serum psa after having prostatectomy or radiotherapy performed with curative intention * serum testosterone level above 2.2 ng/ml * an ecog (eastern co-operative oncology group) p.s. (performance status) score of 0 to 2 * serum psa level above 2 ng/ml exclusion criteria: * previous or present endocrine treatment for prostate cancer. however, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months * treated with a 5α-reductase inhibitor * a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months * concurrent or a history of severe liver disease * abnormal ecg such as long qtc * a patient receiving asp3550 in past times * administered drug in another clinical study or a post-market clinical study in the 28 days prior to the study

Keywords: prostatic neoplasms degarelix asp3550 prostate cancer
assessment of dynamic balance in idiopathic scoliosis compared to normal subjects

Conditions: Idiopathic Scoliosis

Summary: the purpose of this study is to assess dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.

adolescent idiopathic scoliosis (ais) is one of the most common forms of scoliosis. it is a three-dimensional deformity of the spine and trunk with a lateral deviation of ≥ 10°, which can occur during the growing years from 10 years to puberty, with an apparent gender dominance rising with age and severity with a female to male ratio of 1.5:1 to 10:1. dynamic balance is the ability to maintain and regain the center of gravity within the base of support in response to outside perturbations or voluntary movements. it has been reported that ais is associated with trunk imbalance and could negatively influence the sensorimotor control of posture and decrease postural balance capabilities, which increases susceptibility to injuries and impacts the individual's ability to engage in daily living activities. previous research reported that postural stability control in adolescents with idiopathic scoliosis is as good as in healthy individuals, and others found that ais patients have poorer static balance control than age-matched patients without ais. so the current study will be conducted to investigate the dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.

Eligibility criteria:
inclusion criteria: 1. females with age between 10-20 years. 2. idiopathic scoliosis will be diagnosed based on clinical examination and radiological measures. 3. cobb's angle will be between 20° and 40°. 4. their bmi from 18 to 24.9 kg/m2. 5. they must be willing to participate in the study. exclusion criteria: 1. history of previous back surgery. 2. neurological deficit. 3. current lower extremity symptoms. 4. symptoms of vertigo or dizziness. 5. no other disorders in the vertebral column (disc prolapse, spondylosis, fracture).

Keywords: adolescent idiopathic scoliosis dynamic balance cobb angle stability index
nasal inhalation of tobramycin in patients with cystic fibrosis and pseudomonas aeruginosa colonization

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Summary: the purpose of this study is to determine whether the nasal inhalation of gernebcin® is effective to decrease the pseudomonas aeruginosa bacterial count in the nasal lavage fluid.


Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of cystic fibrosis * detection of p. aeruginosa in nasal lavage (culture) with chronic p.a. colonization of the lung (from day -28) * informed consent of the patients or parents * subject is older than 7 years * subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol * women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol exclusion criteria: * subject has a critical condition defined as: fev1 \< 30% and / or sao2 \< 93% without o2-substitution; need of o2-substitution * subject had an ent surgery within 3 months prior to study * subject shows signs of nasal bleeding * subject has an ear drum perforation * subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aerug. * subject is unlikely to comply with the procedures scheduled in the protocol * subject has a known allergic reaction to the medication * subject is pregnant or breastfeeding * subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study. * systemic (oral or intravenous) antibiotic treatment against p.a. 14 days prior to the inclusion and during the study * if serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study. * progressed renal insufficiency * severe damage of the n. acusticus * dizziness (potential damage of. n. vestibularis)

Keywords: subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
sta-9090 for treatment of aml, cml, mds and myeloproliferative disorders

Conditions: AML; CML; MDS; Myeloproliferative Disorders

Summary: the purpose of this study is to characterize the safety and efficacy of sta-9090 (ganetespib) in subjects with hematologic malignancies.


Eligibility criteria:
inclusion criteria * males and females 18 years or older * eligible subjects must have one of the following relapsed or refractory hematologic malignancies: aml, mds, cml, or myeloproliferative disorders as defined in the protocol * must have acceptable organ function during screening as defined in the protocol exclusion criteria * pregnant or breast-feeding women * patients must meet the washout periods for prior chemotherapies and radiation * history of stroke within 6 months of treatment * poor venous access for study drug administration * treatment with chronic immunosuppressants * other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation

Keywords: synta sta-9090 aml cml mds myeloproliferative disorder hematologic malignancy ganetespib
a trial of gemcitabine plus paclitaxel and gemcitabine plus docetaxel in metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the combination of docetaxel and gemcitabine has shown significant activity in patients with metastatic breast cancer. several studies have activity in patients of multiple lines of therapy, including patients that have been treated with prior taxane therapy. overall responses have ranged from 30% to 79%. the major side effects of the combination chemotherapy have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever


Eligibility criteria:
inclusion criteria: * advanced or metastatic breast cancer * disease that can be measured by the physician or radiologic test. * may have had one chemotherapy treatment for advanced or metastatic disease. * patients may have received any prior adjuvant chemotherapy, including taxane containing regimens, provided this treatment was completed at least 6 months prior to enrollment. * patients may have received prior hormone therapy or immunotherapy. exclusion criteria: * patients with only non-measurable disease * cancer that has spread to the brain * a patient who received a taxane with metastatic disease. * pregnancy * patients who received prior gemcitabine
a study to investigate the effects of heated humidification during non-invasive ventilation

Conditions: Chronic Obstructive Pulmonary Disease; Chronic Respiratory Hypercapnic Failure; Neuromuscular Disease; Obesity Hypoventilation Syndrome

Summary: noninvasive ventilation (niv) is a form of ventilation delivered by a mask and is an important mode of treatment in patients with both acute and chronic respiratory (breathing) failure. humidification is widely accepted as an essential part of the ventilation strategy in patients receiving invasive ventilation (i.e. via a tube inserted into the mouth), but its role during niv use is not proven. consequently, there is a variation in practice with regard to humidification during niv. humidification is important in maintaining upper and lower airway mucosal function and patients requiring niv often report symptoms, such as throat dryness, due to a lack of airway humidity. success of niv in the acute setting is dependent on many factors including, patient tolerance of niv during the acute phase. in patients with chronic obstructive airways disease (copd), poor tolerance results in niv failure, which necessitates endotracheal intubation or treatment failure. furthermore, invasive ventilation increases the risk of a hospital acquired pneumonia, which is associated with a worse outcome. in the long term setting of niv use, again patients frequently report symptoms due to drying of the airways and adherence to niv can be highly variable. adherence in these patients is important in improving both quality and length of life. humidification devices may be technically effective, but clinicians have concerns regarding potential negative effects of these devices. there is a requirement to evaluate the use of humidification in both the acute and long term use of niv, particular, in terms of patient ventilator interaction, which will impact on comfort and adherence to niv. this will effect the overall effectiveness of ventilation. the investigators propose a randomised controlled trial to investigate the effects of a humidification system during noninvasive ventilation.


Eligibility criteria:
inclusion criteria: * hypercapnic respiratory failure * age \> 18 * requiring non-invasive ventilation exclusion criteria: * psychiatric illness * pregnancy

Keywords: chronic respiratory hypercapnic failure
comparative effects of dual task and pnf on balance ,cognition and motor function in chronic stroke patients .

Conditions: Stroke

Summary: the aim of this study is to compare the effect of dual tasking and proprioceptive neuromuscular facilitation on balance, cognition and motor function in chronic stroke patients. it will be randomized clinical trial.

stroke is the major cause of disability and mortality worldwide. a stroke is defined as an abrupt neurological outburst caused by impaired perfusion through the blood vessels to the brain. every year the number of patients affected by stroke is rising thereby putting extra pressure on socioeconomic conditions in developing countries. major complications of stroke include hemiplegia leading to upper limb dysfunction along with gait abnormalities. this study will be conducted to determine the effects of proprioceptive neuromuscular facilitation exercises versus dual-task training on balance, cognition, and motor function in chronic stroke patients. the randomized clinical trial will be conducted, participants will be selected through non-probability convenience sampling technique and then randomly allocated into two treatment groups.

Eligibility criteria:
inclusion criteria: item * both male and female * age 50-70 years. * person should be able to walk 10meter distance with or without assistance. * patient should be cognitively able to perform required task. * chronic stroke patients with strength \>2 on manual muscle testing. exclusion criteria: item * any gait impairment . * patients with comorbidities like cardiac pathologies. * patients with dementia . * history of fall in last 6 months. * history of severe freezing episodes. * history of camptocormia (axial deformity. * central or peripheral paresis.

Keywords: chronic stroke pnf dual task hemiplegia
xbox kinect, sleep quality, anxiety and functional capacity in older adults

Conditions: Sleep; Anxiety; Aging; Exercise

Summary: the present study aims to examine the effects of xbox kinect exercise training program on the sleep quality, anxiety and functional capacity in older adults. older adults were randomized into two groups. the xbox group performed exercise with xbox kinect during 60 min, three times/week for 6 weeks. the control group did not exercise. pittsburgh sleep quality index was used to evaluate sleep quality, anxiety symptoms by the state-trait anxiety inventory, and the functional capacity was analyzed using following tests: chair stand test, 8-foot up and go test, and 6-min walk test.


Eligibility criteria:
inclusion criteria: 1. ability to perform exercises with xbox kinect and/or physical/functional tests and to answer the questionnaires; 2. score ≥ 24 on the mini-mental state examination exclusion criteria: (a) using psychiatric drugs or beta-blockers; 1. functional limitations 2. exercise regularly (e) smoking (b) previous experience with xbox kinect games.
factors and outcomes associated with postpartum cabergoline use

Conditions: Lactation Suppressed; Cabergoline Adverse Reaction; Postpartum DVT; Postpartum Depression

Summary: cabergoline is frequently being requested by many postpartum women with a live newborn to suppress lactation. the aim of the study is to investigate which women desire such an intervention, and what side effects they are experiencing.

cabergoline is a dopamine receptor agonist. outside of the united states, it is occasionally used to suppress lactation, most commonly after a pregnancy loss or stillbirth. however, the investigators noted that the patient population in israel has been requesting cabergoline for administration after healthy births, for immediate lactation suppression. use of cabergoline after delivery comes with many concerns. one primary concern is that this medication can increase the risk of venous thrombotic events, particularly during postpartum when thrombosis risk is already elevated. secondly, it may have effects that alter mood, which are similarly concerning during a vulnerable period when postpartum depression and other mental health disorders are common. finally, of course, is the issue that so many women are requesting lactation suppression immediately after birth, and therefore will not accrue the neonatal and maternal benefits of lactation. the investigators want to understand the characteristics, demographics and other factors that lead these women to make this choice, as well as assess their risk of medical and psychological adverse effects from cabergoline used in the postpartum period. during this study, the investigators will not be prescribing cabergoline or in any way affecting its use. the study will be recruiting as subjects women who requested and received cabergoline prescriptions independently, as is common practice throughout the country. the study will involve three questionnaires with these subjects: one in the hospital, after birth; one a week after birth; and one 6 weeks after birth. the questionnaires will involve medical history, a validated lactation questionnaire, as well as demographic data. all data will be held in a private, password-locked database.

Eligibility criteria:
inclusion criteria: * postpartum women * after a live birth * requesting cabergoline for lactation suppression exclusion criteria: * those who request cabergoline for lactation suppression after a stillbirth or pregnancy loss

Keywords: cabergoline, lactation, suppression, postpartum care
a trial to investigate the impact of nocturnal hypoglycaemia on sleep in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the impact of low blood sugar during the night on sleep in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening * currently treated with any anti-diabetic treatment (incl. diet and exercise) except insulin with a stable dose for more than 4 weeks prior to screening * body mass index below 35 kg/m\^2 exclusion criteria: * severe hypoglycaemic event during the past 6 months or hospitalisation for diabetic ketoacidosis during the previous 6 months * any other chronic disorder or severe disease by clinical information (including chronic obstructive pulmonary disease (copd), sleep apnoea and epilepsy) which, in the opinion of the investigator might jeopardise subject's sleep, safety or compliance with the protocol, or subjects with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator, should not participate in the trial * use of antidepressants, antipsychotics, hypnotics, sedatives or other drugs known to influence sleep within 12 weeks prior to screening