Kornimate/medical-research-clean huggingface dataset:
a study of arq 197 in combination with erlotinib

Conditions: Non-small-cell Lung Cancer

Summary: this is a phase i study to determine the safety, tolerability and recommended phase ii dose of arq 197 given in combination with erlotinib as primary endpoints in patients with advanced/recurrent non-small-cell lung cancer. the pharmacokinetic profile and antitumor activity of arq 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.


Eligibility criteria:
inclusion criteria: * voluntary written informed consent for study participation must be obtained * a histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer * history of ≥1 prior chemotherapy regimen (treatment with egfr tyrosine kinase inhibitors will be counted as one regimen) * ecog ps of 0 or 1 * life expectancy of ≥3 months exclusion criteria: * anti-cancer chemotherapy, anti-cancer therapy with egfr-tki, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to arq 197 dose * surgery for cancer within 28 days prior to arq 197 dose * active double cancer * known symptomatic brain metastases * an intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia) * pregnant or lactating * subjects who wish to have a child and who would not agree to use contraceptive measures

Keywords: advanced/recurrent non-small-cell lung cancer
remifentanil for general anesthesia in preeclamptics

Conditions: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications

Summary: the purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.

general anesthesia for cesarean section involves rapid sequence induction with a muscle relaxant and barbiturate followed by endotracheal intubation. although the use of opioids may blunt haemodynamic responses to endotracheal intubation, they are avoided in pregnant patients due to possible respiratory depressants effects on neonates.preeclamptic patients response with exaggerated sympathoadrenal reflex to anesthesia induction and intubation. the resulting hypertension and tachycardia may result in cerebrovascular accident, pulmonary edema, arrhythmias, increased myocardial oxygen consumption and fetal hypoxia by uterine vasoconstriction. several drugs have been used to blunt the hemodynamic disturbances to intubation, but none of them have been implicated for routine use for general anesthesia in preeclamptic patients. recently remifentanil has started to be used in general anesthesia of high risk obstetric patients. remifentanil is a μ-opioid receptor agonist that is metabolized by nonspecific blood and tissue esterase hydrolysis. it has a low distribution volume with a context sensitive half life of 3 minutes. its elimination half life is 12 minutes even after repeated boli. previously remifentanil use in pregnant patients with cardiac pathology has been reported with minimal neonatal side effects. a randomized controlled study in normal parturient has shown that remifentanil is transferred through placenta and may cause mild neonatal depression that is easily managed. umbilical artery and vein remifentanil concentrations has shown that remifentanil is quickly redistributed or metabolized in fetus. thus, remifentanil may be an appropriate drug for induction and maintenance of general anesthesia in severe preeclamptic patients.

Eligibility criteria:
inclusion criteria: * severe preeclamptic parturients with single fetus pregnancy with contraindication to regional anesthesia exclusion criteria: * known allergy to study drugs * known fetal anomaly and /or gestation week and /or estimated to be nonviable (fetal weight \<400 gr, gestational week\<24 weeks) * known cardiac disease diagnosed prior to pregnancy * known drug abuse in the parturient * multifetal gestation * anticipated difficult airway management (mask ventilation and/or endotracheal intubation).

Keywords: pre-eclampsia remifentanil anesthesia, general analgesics, opioid anesthetics, intravenous cesarean section newborn maternal haemodynamic
vital signs monitoring of emergency responders in different states

Conditions: Heart Rate Monitoring

Summary: the goal of this observational study is to learn about emergency responder in different states. the main questions it aims to answer are: * ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (emg), electroencephalogram (eeg), partial pressure of end-expiratory co2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. * eight vital signs and behavioral parameters in different environments (altitude, confined space, energized work, job site) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (emg), electroencephalogram (eeg), and partial pressure of end-expiratory co2 concentration. participants will normal operating conditions, the researcher collects vital sign information.

1. general information: name, age, height, weight, place of origin, smoking history, and whether or not they snore. 2. 10 vital signs and behavioral parameters in different states (quiet, after duty, after physical training), including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (emg), electroencephalogram (eeg), partial pressure of end-expiratory co2 concentration, partial pressure of transcutaneous oxygen, partial pressure of transcutaneous carbon dioxide. 3. 8 vital signs and behavioral parameters in different environments (overhead, confined space, energized work, work site), including: respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (emg), electroencephalogram (eeg), and partial pressure of end-expiratory co2 concentration.

Eligibility criteria:
inclusion criteria: * no history of coronary heart disease, hypertension, asthma, upper respiratory tract infection, decompression sickness, or anemia. voluntarily participated in this study and signed an informed consent form exclusion criteria: * patients with severe heart disease and arrhythmia; patients with vital organ failure; patients with significant generalized edema; patients with dermatologic disease and generalized skin breakdown; and patients with vascular disorders of the limbs.

Keywords: vital signs respiration transcutaneous oxygenation end-expiratory carbon dioxide
monitoring resuscitation in severe sepsis and septic shock

Conditions: Hemodynamics

Summary: our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.

to evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. in addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, icu and hospital length of stay, organ failure and renal function.

Eligibility criteria:
inclusion criteria: * age \> 18 years * clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-). * ≥ 2 sirs criteria: * temperature \ 38.0°c * heart rate \> 90 bpm * respiratory rate \> 20 rpm or paco2 \< 32 mmhg or need of mechanical ventilation. * leukocytes \> 12.0 x109/l or \< 4.0 x109/l * hemodynamic insufficiency defined as (at least one of the following): * sustained systemic hypotension (systolic arterial pressure ≤ 90 mmhg or map \ 30 mm hg in a hypertensive patient. * need of vasopressors. * tachycardia (hr \> 110 bpm) or bradycardia (hr \< 55 bpm) * acute onset of oliguria, defined as a decreased urine output \< 0.5 ml/kg/hr for ≥ 2 hours * serum lactate \> 2 mmol/l * peripheral cyanosis, mottled skin, prolonged capillary refill * mechanical ventilation without any kind of inspiratory effort and vt 7-10 ml/kg, pplateau \< 30 mmh2o. those patients with ards under mechanical ventilation will need to tolerate a tidal volume of at least 7 ml/kg during 30 seconds while the plateau pressure remains \< 30 mmh2o. * prior hemodynamic monitoring by arterial catheter. * central venous catheter. exclusion criteria: * acute myocardial infarction \< 7 days. * pregnancy * prior request of limited code status or expected life length lower than 3 months. * shock \> 12h * cardiac arrhythmia * aortic valvular disease * inability to properly measure arterial pressure wave forms
a clinical investigation of the oxford® partial knee system

Conditions: Osteoarthritis

Summary: the purpose of this prospective data collection is to document the performance and clinical outcomes of the oxford® partial knee system.


Eligibility criteria:
inclusion criteria: * for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. the implant is intended to be implanted with bone cement. exclusion criteria: * infection * use in the lateral compartment of the knee * rheumatoid arthritis or other forms of inflammatory joint disease * revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture * insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device * disease or damage to the lateral compartment of the knee * uncooperative patient or patient with neurologic disorders who is incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, neuromuscular disease * incomplete or deficient soft tissue surrounding the knee * charcot's disease * a fixed varus deformity (not passively correctable) of greater than 15 degrees * a flexion deformity greater than 15 degrees

Keywords: partial knee arthroplasty partial knee replacement arthritis of medial compartment of the knee oxford knee
h1n1v vaccination of pregnant women: a longitudinal cohort study characterizing influenza a h1n1v vaccination in pregnant women

Conditions: H1N1v Influenza

Summary: pregnant women are at particular risk during the imminent h1n1v influenza pandemic. the new h1n1v virus requires urgent political and medical decisions on vaccination strategies in order to minimize severe disease and death from this pandemic. however, there is a lack of evidence to build such decisions upon. a vaccine will be provided in the fourth quarter of 2009, but there is little knowledge on the immunogenicity. particularly its clinical effectiveness and duration of immunity in pregnant women and their newborn infants is unknown. therefore, it will be important to study the optimal vaccination regimens with respect to dosing and use of adjuvant to decide future health policies on vaccination of pregnant women. we have a unique possibility to study these aspects of h1n1v infection in pregnant women in our ongoing unselected, prospective, birth-cohort study recruiting 800 pregnant mothers between q1- 2009 and q4-2010. pregnant women from east-denmark are being enrolled during the 2nd trimester and their infant will undergo a close clinical follow-up. the h1n1v pandemic is expected to reach denmark q4-2009. the timing of this enrollment and the imminent pandemic allows for an "experiment of nature" whereby the first half of the mothers completes pregnancy before the h1n1v pandemic. the other half of this cohort will be pregnant while h1n1v is prevalent in the community and will require h1n1v vaccination. the aim of this randomized, controlled, trial is to compare and evaluate the dose-related immune protection conferred by vaccine and adjuvant (novartis vaccine focetria) in pregnant women and non-pregnant women. in addition the protocol will assess the passive immunity conferred to the newborn from these vaccine regimes. the study will provide evidence-based guidance for health policies on vaccination for the population of pregnant women during future h1n1v pandemics.


Eligibility criteria:
inclusion criteria: * healthy pregnant and non pregnant women living in eastern denmark * fluent in danish exclusion criteria: * heart disease, endocrine disease, tuberculosis and sarcoidosis. * history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins.

Keywords: h1n1v vaccine pregnant women assess whether the adjuvanted vaccine offers a meaningful benefit in pregnant women in terms of immune response over the non-adjuvanted vaccine. assess the persistence of immune response over a 15 month time period after one single vaccination of the pregnant mother. assess whether the immune response to h1n1 in pregnant women is different from that of non-pregnant women of similar age. gain insight on safety of the novartis egg-based mf59 adjuvanted h1n1 vaccine focetria in pregnant women and their babies. assess the maternally transferred specific antibodies against h1n1v in the newborn passive immunity transferred to the infant.
can the use of uricap female device lead to better care for women > 75+years?

Conditions: Urinary Incontinence; Urinary Tract Infections; Incontinence-associated Dermatitis; Cognition Disorders in Old Age; Behavioral and Psychiatric Symptoms of Dementia

Summary: the purpose of the study is to evaluate if uricap female, an uridome for women, can be used instead of traditional incontinence aids to treat urinary incontinence (ui) among women 75 years and older.

the aim is to improve the care for female patients in long-term nursing homes who suffer from ui and to prevent recurrent urinary tract infections (utis). the project organization consist of researchers within primary care, geriatrics and nursing sciences. the investigators will recruit study participants with ui from long-term nursing homes in örebro county that will be randomized in an open randomised controlled trial to an intervention or a control group. the intervention will last for 3 months. the study participants will receive a structured medical assessment before and after the intervention, including assessment of the patient's cognitive functions, genital skin status, neuropsychiatric symptoms and quality of life (qol). the uridome is changed daily while the control group will receive usual incontinence treatment. the investigators will study the number of utis during the intervention period, analyze inflammatory cytokines in urine using olink proteomics and elisa to study inflammation. health economic analysis will be performed. the investigators believe that treatment with uricap female will be more effective in preventing recurrent utis, improve genital skin status, cognitive status and neuropsychiatric symptoms and qol for the women. this will directly lead to individualised care and less strain on primary care resources.

Eligibility criteria:
inclusion criteria: * ui that requires incontinence aids * suitable anatomy (outer labia cover and protect the uricap female cup). exclusion criteria: * active uti * urinary retention (cannot empty the bladder on her own) * macroscopic hematuria * prolapse or similar gynecological disorders * allergy to silicone or latex (the material of uricap female) * short expected survival time

Keywords: long-term nursing homes bpsd urinary incontinence urinary tract infections cognitive decline/dementia
investigation of the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision

Conditions: Children with Low Vision

Summary: the aim of this research is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision the hypotheses of our study: h1: balance coordination and strengthening training has an effect on gait, mobility and posture in children with low vision. h2: balance coordination and strengthening training has no effect on gait, mobility and posture in children with low vision.

the aim of this study is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision. a total of 22 low-vision individuals were included in the study. individuals were randomly divided into two groups as control (n=10) and study (n=12). the treatment group received 70 min balance (20 min), coordination (20 min) and strengthening (20 min) training 3 days a week for 8 weeks. no additional treatment was applied to the control group. evaluations were performed before treatment and at the end of 8 weeks. in the evaluations; bruininks-oseretsky motor proficiency test 2 short form (bot2- kf), new york posture analysis, manual november muscle strength assessment, g-walk gait analysis, independent mobility questionnaire (bma) were used.

Eligibility criteria:
inclusion criteria: * to be in the age december of 7-14, * except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, * having been diagnosed with low vision, * to be able to establish cooperation, * volunteering to participate in the study exclusion criteria: * not being diagnosed with low vision, * except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) having an additional disease, * not volunteering to participate in the study

Keywords: low vision visually impaired balance strength training walking
the efficacy of estratest® tablets in relieving menopausal symptoms in estrogenized, hysterectomized postmenopausal women

Conditions: Menopause

Summary: to determine whether treatment with estratest® tablets is superior to treatment with esterified estrogens tablets


Eligibility criteria:
inclusion criteria: hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the investigator's clinical judgement

Keywords: menopause; postmenopause; estrogen; hormone therapy
did mri appearance of supraspinatus muscle atrophy changes after repair of all kind of rotator cuff tear?

Conditions: Rotator Cuff Tear

Summary: there are two purpose of this study, first is to find whether arthroscopic rotator cuff repair is changing the appearance of supraspinatus muscle atrophy in each and every patient. second, is to find how much approximate change one can expect depending on age and tendon retraction

retrospective review of 209 patients having both preoperative and immediate postoperative mri done. both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient. patient were divided in two major group according to age that is \ 60 years and 3 subgroups of mild, moderate and severe depending on preoperative supraspinatus tendon retraction on coronal view of mri. postoperative occupation ratio was compared with preoperative occupation ratio within the subgroups and change in occupation ratio was used for comparison between the subgroup. change in occupation ratio was also used for comparison between 2 major groups

Eligibility criteria:
inclusion criteria: 1. patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair in our hospital. 2. patients with preoperative mri and postoperative mri within 1 week of surgery in our hospital. 3. patients with minimum grade 1 supraspinatus atrophy in preoperative mri. exclusion criteria: 1. patients with preoperative mri from outside hospital. 2. patients with isolated subscapularis tear. 3. patients with previous operation on the same shoulder joint. 4. patients with mri images that were not usable due to poor quality or absence of appropriate y-view.

Keywords: occupation ratio pseudoatrophy
effects of different exercise training regimens on visceral fat dynamic and resting energy expenditure in obese patients

Conditions: Abdominal Obesity

Summary: in this project, the investigators will test the hypothesis that predominant (two to three times a week 60 min) strength training is more effective in reducing visceral fat mass than endurance training in obese patients.

strength training (st) was shown to be more effective than endurance training (et) in improving glycemic control in the treatment of type 2 diabetes. however, it is unknown, whether different training strategies have different effects on the preferential visceral adipose tissue reduction and changes in resting energy expenditure in a population with abdominal obesity. we will therefore compare st and et (two to three times a week, 60 minutes per training session) in addition to a restricted energy intake of 1500kcal per day for women and 1800kcal per day for men in a prospective study of 200 individuals with abdominal obesity defined by a waist circumference \> 102 cm for males and \> 88 cm for females and a bmi \> 35 kg/m² with regard to: 1. abdominal visceral adipose tissue area dynamic (mri studies) 2. abdominal subcutaneous adipose tissue area dynamic (mri studies) 3. total body fat mass changes (bioelectrical impedance analysis) 4. changes in resting energy expenditure (indirect calorimetry) 5. changes in parameters of glucose metabolism, insulin sensitivity and lipid profile 6. changes in circulating adipokines and markers of inflammation in addition, we will search for novel serum parameters, which predict the individual training response by a serum metabolomics/ proteomics approach.

Eligibility criteria:
inclusion criteria: * bmi \>= 35 kg/m2 * waist circumference \>102cm (men), \>88cm (women) * age 18 - 60 years * written informed consent exclusion criteria: * type 1 or type 2 diabetes * fasting plasma glucose \>= 6.0 mmol/l * 2h-ogtt (oral glucose tolerance test) glucose \>= 11.1 mmol/l * any chronic inflammatory or malignant disease * medical treatment which influences glucose metabolism * drug or alcohol abuse * psychiatric disorders * untreated thyroid dysfunction * cardiac pacemaker or other contraindication for mri * attendant therapy with oral antidiabetic medication, glp-1 mimetics or analoga, insulin, anti-obesity medication (orlistat, sibutramine), falithrom, antipsychotic drugs, any chemotherapeutics * pregnant or nursing women * expected low compliance * current participation in another investigational trial * last exercise training \<= 6 months ago

Keywords: abdominal obesity training fat insulin glucose diet