Kornimate/medical-research-clean huggingface dataset:
trial of paclitaxel, bevacizumab, and enzastaurin versus paclitaxel, bevacizumab and placebo for breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * must have signed an inform consent document * have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease * have not received any prior chemotherapy for locally recurrent or metastatic disease * have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment * age 18 years or older at time of informed consent exclusion criteria: * have any clinical evidence of central nervous system (cns) metastases * have a history of seizure * have had a major surgical procedure within 4 weeks prior to assignment to study treatment * have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment * have symptomatic peripheral vascular disease
effects of brain stimulation during a daytime nap on memory consolidation in older adults

Conditions: Older Adults (50-90 Years)

Summary: the beneficial effect of nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. slow wave sleep (sws), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. this impact of sleep on memory performance can be additionally enhanced by exogeneous induction of transcranial slow oscillating stimulation (tsos) within the frequency range of sws in humans (0,7- 0,8 hz) during sleep, as has been demonstrated in young, healthy subjects. if older adults that commonly experiencing cognitive decline, including long-term retention of declarative memory - benefit from transcranial slow oscillatory stimulation (tsos) during sleep in the same way has not been studied so far. the primary goal of the study is therefore to investigate the impact of oscillating current stimulation (tsos) during a daytime nap on declarative memory consolidation in older adults.


Eligibility criteria:
inclusion criteria: * age: 50-90 years * right handed * inobtrusive neuropsychological examination exclusion criteria: * untreated severe internal or psychiatric diseases * epilepsy * other severe neurological diseases eg., previous major stroke, brain tumour * dementia * contraindications to mri

Keywords: aging cognitive decline brain stimulation tsos tdcs sleep nap daytime sleep memory memory consolidation
mobility & vitality lifestyle program

Conditions: Obesity

Summary: move up is a weight management program for adults 60-75 in community settings led by trained community health workers.

move up is a weight management program designed for adults who desire to lose weight and improve their overall health. topics include: overall health, weight management, healthy eating, behavior change, physical activity

Eligibility criteria:
inclusion criteria: 1. age 60-75 at time of program start 2. self-reporting \< 60 minutes per week of moderate structured physical activity 3. bmi \>= 30 but \< 40 for screen. in person measurement on site will allow for 27-45 as inclusion criteria. 4. able to consent for participation and data collection 5. medical release before start of weight management 6. ability to walk with or without an assistive device 7. can regularly attend sessions 8. has not had bariatric surgery over the past year, or current use of weight loss prescription drug. exclusion criteria: 1. uncontrolled diabetes mellitus (fbs \> 300 \& a1c \> 11%) \[to be assessed by physician on medical release\] 2. uncontrolled hypertension (sbp \> 180/110) %) \[to be assessed by physician on medical release\] 3. recent hospitalization (past 6 months) 4. active treatment for cancer (other than non-melanoma skin cancer) 5. significant visual or hearing impairment 6. dementia/psychiatric disorder 7. inability to communicate in english/lack of translator

Keywords: physical function
changes in renal and splanchnic oxygenation during ibuprofen treatment for patent ductus arterious

Conditions: Ductus Arteriosus, Patent

Summary: patent ductus arterious(pda)is frequently seen and potentially pathologic in preterm infants. near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for pda in preterm infants.

patent ductus arterious (pda) is the most common cardiovascular abnormality in preterm infants.there are clear associations between a pda and decreased renal and splanchnic blood flow. the aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (ftoe) in preterm newborns during ibuprofen of the treatment pda.

Eligibility criteria:
inclusion criteria: * gestational age \<32 weeks and \<1500 g * echocardiographic evidence of hemodynamically significant patent ductus arterious exclusion criteria: * major congenital anomalies * intraventricular hemorrhage of grade 3 within the previous 24 hours * serum creatinine level 1.5 mg%,serum urea nitrogen concentration \>50 mg%, * platelet count 60 000/ml3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites) * hyperbilirubinemia necessitating exchange transfusion
safety and efficacy of esmketamine versus dexmedetomidine

Conditions: Osa Syndrome

Summary: a comparative study on the safety and efficacy of esmketamine versus dexmedetomidine during drug induced sleep endoscopy in children with positional obstructive sleep apnea: a consort-prospective, randomized, controlled clinical trial

methods: eighty asa ⅰ - ⅱ patients aged 3-13 years underwent elective surgery under general anesthesia. no serious cardiovascular disease, no liver and kidney dysfunction, no central nervous system disease and mental disease. patients undergoing tonsillectomy under general anesthesia were selected as the research objects. 80 patients were randomly divided into dexmedetomidine group d (n = 40) and ketamine group k (n = 40). both groups were given midazolam 0.2mg/kg intravenously group k: induction: intravenous injection of 1.0mg/kg esmketamine, nasal endoscopy started 3 minutes later, maintained 1.0mg/kg/h esmketamine; group d: induction: dexmedetomidine 1 μ g / kg at least 10 min after intravenous injection + maintain 1 μ after 5 minutes of intravenous injection of dexmedetomidine 1 ug / kg, sufentanil 0.05 mg / kg was given. propofol 0.5 mg · kg-1 was injected intravenously when the patient had body movement heart rate (hr), mean arterial pressure (map), electrocardiogram (ecg), respiratory rate (rr), pulse oxygen saturation (%, spo2) and bis were recorded before (t1), during (t2), after (t3), 1 min after tracheal intubation (t4), 1 min after extubation (t5) and 30 min after extubation (t6). 3.2 onset and maintenance time: the time from administration to endoscopic examination (min); recovery time (min) 3.3 observation and treatment of adverse reactions during and after dis 3.4 observe the sedation score of the two groups during the dis phase and the awake score 30 minutes after waking up objective to observe the application of dexmedetomidine and esmketamine in drug-induced sleep nasal endoscopy, and to explore the best medication scheme, so as to better guide clinical medication.

Eligibility criteria:
inclusion criteria: * eighty asa ⅰ - ⅱ patients aged 3-13 years underwent elective surgery under general anesthesia. no serious cardiovascular disease, no liver and kidney dysfunction, no central nervous system disease and mental disease. patients undergoing tonsillectomy under general anesthesia were selected as the research objects. exclusion criteria: * asa grade iii and above, abnormal heart, lung, liver and kidney function before operation; there were central nervous system diseases and mental diseases, preoperative allergy to anesthetics (dexmedetomidine, esmketamine), family history of malignant high fever, tracheostomy and other artificial airway.

Keywords: pediatrics ;osa syndrome
a phase iii study to assess the immunogenicity and safety of eutravac (dtap-hb combined vaccine) with dtap and hepatitis b vaccines in healthy infants

Conditions: Healthy Infants

Summary: to evaluate and compare the immunogenicity of eutravac (diphtheria-tetanus-acellular pertussis \[dtap\] hepatitis b \[hb\] combined) vaccine with separate but simultaneous administrations of dtap and hb vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.


Eligibility criteria:
inclusion criteria: * were healthy, male or female infants born at full term pregnancy (≥37 weeks) with a birth weight ≥2.5 kg to mothers with a negative hbsag serology, documented prior to giving birth as per routine, site-specific ante-natal care procedures. * signed parental or legally acceptable representative's informed consent was obtained exclusion criteria: * evidence of an acute febrile illness with axillary temperature ≥37.5℃ on the day of the vaccination. infants with symptoms of minor illness eg, mild gastroenteritis, mild upper respiratory tract infection and who did not have a temperature ≥37.5℃ on the day of the vaccination could be included at the investigator's discretion * history of diphtheria, tetanus, pertussis or hepatitis b disease * history of any vaccine-related hypersensitivity or anaphylactic reaction after previous administration of euvax b

Keywords: healthy infants with over than 37 weeks gestation periods. over than 2.5kg at at birth weight.
smf to improve performance of microscopy for the diagnosis of ptb in a high hiv prevalence setting

Conditions: Tuberculosis

Summary: this study is investigating a better method to see if someone has tuberculosis (tb) as compared to the method that is being used now.

tb is a disease caused by a bacterium called mycobacterium tuberculosis that can affect the lungs or other parts of the body. in most of the world and in mbarara, uganda, the method of diagnosis that is used is afb smear microscopy. this method is widely available, inexpensive and rapid. however, this method's ability to truly detect people having tb is poor. that is, if someone has tb, the test results may say that they are negative, leading to delays in diagnosis, disease progression, and an ongoing transmission of the bacteria. the new test for tb diagnosis we are studying is called the small membrane filtration (smf) method. this test that is being compared to the method currently being used and is very similar to the one that is currently used (standard smear microscopy) but has the advantage of concentrating the sputum (mucus) so that we can more easily see if bacteria are present in the sputum. it is hoped that a better way of knowing if someone has tb will help doctors decide when people need to be treated for tb and when not, which will improve the health of patients and help avoid passing the infection to others. this study will enroll 740 hiv-infected and 310 hiv-uninfected adults with culture confirmed pulmonary tb. these individuals will be identified prospectively at two tb clinics in mbarara, uganda. study hypothesis: the investigators will assume that one sputum sample will be equivalent to two (null hypothesis) with respect to sensitivity unless we have evidence that the use of two has higher sensitivity (alternative hypothesis). the investigators will assume that smf is equivalent to afb smear with respect to sensitivity and specificity unless the investigators find evidence it is superior. the investigators will assume that smf is equivalent to xpert unless the investigators find evidence that xpert is superior.

Eligibility criteria:
inclusion criteria: * adult (≥18 years) * pulmonary tb suspect defined as any person who presents with a productive cough for more than 2 weeks and accompanied by at least one other respiratory symptom (shortness of breath, chest pains, hemoptysis) and/or constitutional symptom (loss of appetite, weight loss, fever, night sweats, and fatigue) (6). * willing to undergo tb evaluation and spontaneously expectorate ≥2 ml of sputum * willing to be tested for hiv, if no results available within past 6 months exclusion criteria: * too ill or unable to provide written consent * treated with tb drugs for more than 3 days * extra-pulmonary or disseminated tb without pulmonary involvement (i.e. no cough)
the influence of growth factors (pdgf), applied as autologous thrombocyte concentrate, on functional recovery

Conditions: Rotator Cuff Rupture; Subacromial Impingement

Summary: the purpose of this study is to test the hypothesis that the application of prp leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery.

subacromial surgery of the shoulder is performed often. it concerns space creating interventions (open and arthroscopic subacromial decompression) and rotator cuff surgery (open and arthroscopic). in this kind of surgery good wound healing and tissue recovery is of great importance to achieve optimal results. wound healing disorders, pain and the formation of adhesions may negatively influence the postoperative course and lead to extended rehabilitation. this has an unfavourable influence on the personal well being of the patient and the possibility to return to labour. especially in cuff surgery the course is strongly influenced by the healing of the attachment of the cuff to the bone. besides the development of minimal invasive techniques, it's necessary to look for possibilities to decrease the morbidity of these procedures. recent studies show that growth factors play a major role in wound healing. this concerns particularly tfg-b (transforming growth factor b) and pdgf (platelet derived growth factor) present in thrombocytes. they act as chemotactic agents for polymorphonuclear leucocytes, macrophages, fibroblasts and lymphocytes. both growth factors stimulate the wound healing and cause improved angiogenesis and fibroplasia. they also play a role in wound retraction and remodelling. in animal-experimental models it is proved that the application of tgf-b and pdgf improves woundhealing and leads to better mechanical properties of the scar tissue. faster and better wound healing and decreased development of adhesions after subacromial surgery can possibly be influenced favourably by using thrombocyte concentrate. in the treatment with autologous thrombocyte concentrate a thrombocyte rich concentrate is obtained by a centrifuging method (gravitational platelet system (gps), biomet, warsaw usa) (platelet rich plasma or prp), that can be applied in the operating field. the concentrate is harvest from the patients own blood, sampled during the procedure. at random the concentrated is applicated and both groups are compared postoperatively.

Eligibility criteria:
inclusion criteria: * age \>18 years old * given informed consent * clinical indication for arthroscopic sub-acromial decompression, i.e.: painful arc, pain at abduction, positive hawkinstest insufficient clinical improvement after (at least) 6 months of conservative treatment or clinical indication for a arthroscopic cuff repair of a mri-proven treatable rotator cuff tear. exclusion criteria: * coagulopathy * thrombocytopenia * use of corticosteroids * diabetics mellitus * omarthritis * ac-arthrosis * cuff arthropathy * neurological deficit at the ipsi-lateral extremity * (wish for) pregnancy * vas \ 9
post-op pain after fistula laser closure or ligation of the intersphincteric tract for anal fistula

Conditions: Fistula in Ano

Summary: this is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.

patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (lift). pain scores at rest and movement, at 6 and 24 hours post operatively were measured using the visual analogue scale (vas). operative time was measured in minutes continence and quality of life was assessed via the wexner incontinence scale and sf-36 questionnaire respectively at 0, 3 and 6 months post-operatively.

Eligibility criteria:
inclusion criteria: * complex transphincteric fistulas: * high transphincteric fistula, involving more than 30% of the external anal sphincter * multiple fistulas * anterior fistulas * 18-75 years old * able to give consent * new or recurrent fistulas * fistulas with or without setons exclusion criteria: * active perianal sepsis requiring drainage * fistulas of non-cryptogladular origin- crohn's, tb, malignancy * expected lifespan less than 6 months * pregnant women * patients with more than 1 definitive surgery done for the fistula before * patients with human immunodeficiency virus infection * patients with pre-existing chronic pain disorders * patients with non-steroidal anti-inflammatory drug (nsaids) / paracetamol allergies
vitamin d supplementation in glomerular disease

Conditions: Glomerular Disease

Summary: this multi-site, pilot study will assess vitamin d supplementation in children and young adults with glomerular disease. .

vitamin d deficiency has been linked to a variety of adverse health outcomes. nephrotic patients have very low vitamin d levels, and the underlying mechanisms are not known. furthermore, approaches to safely and effectively supplement vitamin d in these patients have not been established. the purpose of this research study is to learn if vitamin d supplementation is safe and effective in patients with primary glomerular disease and to also help establish the treatment guidelines. about 35 patients with primary glomerular disease, ages 5-30 years old, will take part in this study. participants will be asked to take vitamin d supplements each day for 12 weeks and will have 3 study visits.

Eligibility criteria:
inclusion criteria: * males or females, age 5-30 years * diagnosis of primary glomerular disease (such as steroid-resistant nephrotic syndrome, minimal change disease, fsgs, membranous nephropathy, membranoprolfierative glomerulonephritis, and immunoglobulin a \[iga\] nephropathy) without systemic inflammatory disorders (i.e. lupus, vasculitis) * serum 25(oh)d level \<30 ng/ml and urine protein:creatinine ratio ≥0.5 at screening visit. exclusion criteria: * pregnancy * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2 at screening visit * serum phosphorus \> 5.5 mg/dl or hypercalcemia * chronic medical conditions or medications unrelated to the renal disease that may impact vitamin d status * known history of kidney stone(s)

Keywords: glomerular disease vitamin d steroid-resistant nephrotic syndrome minimal change disease focal segmental glomerulosclerosis (fsgs) membranous nephropathy membranoprolfierative glomerulonephritis immunoglobulin a (iga) nephropathy fsgs iga nephropathy
subcostal tap block for percutaneous nephrolithotomy

Conditions: Nephrolithiasis

Summary: percutaneous nephrolithotomy (pcnl) is a minimally- invasive procedure for removing kidney stones. the small incision of pcnl is performed medially from the posterior axillary line according to stones location. despite the small skin incision patients suffer from postoperative pain due to visceral pain and intercostal nerve injury. the aim of this study is to evaluate the perioperative analgesic effect of subcostal transversus abdominis plane (tap) block performed prior to pcnl procedure. primary outcome of our study was morphine consumption at 48th hour after the surgery. secondary outcomes were perioperative fentanyl consumption; postoperative verbal analog scale and additional analgesic drug requirement.

patients who were scheduled for elective percutaneous nephrolithotomy were randomized into two groups: group tap and group iv. general anesthesia was induced with propofol 2 mg/kg, fentanyl 1 mcgr/kg and rocuronium 0,6 mg/kg and maintained with sevoflurane 2% in 40%:60% oxygen/air mixture and fentanyl 0,5 mcgr/kg and rocuronium 10 mg, if necessary. unilateral transversus abdominis plane block was performed with total of 30 ml volume of local anesthetic solution (20ml bupivacaine 0,125% and 10ml lidocaine 1%) after intubation but before surgery to the group tap patients. paracetamol 1 gr, iv was given to the group iv 20 minutes before the end of the surgery. also 100mg tramadol,iv was administered 20 minutes before the end of the surgery to the both groups. morphine iv patient controlled analgesia was applied to both groups. perioperative fentanyl consumption; postoperative verbal analog scale, morphine consumption and additional analgesic drug requirement were determined. data of perioperative complications and adverse effects were also collected. chi square with yates correction and mann whitney u tests were used for statistical analysis.

Eligibility criteria:
inclusion criteria: * patients enrolled for percutaneous nephrolithotomy (pcnl) surgery * asa (american society of anesthesiologists) score i-iii exclusion criteria: * patients with chronic pain * patients on opioid or other analgesic drugs * bmi (body mass index) higher than 40 * allergies for drugs used in the study * chronic renal failure receiving dialysis

Keywords: percutaneous nephrolithotomy subcostal transversus abdominis plane block pain paracetamol tramadol morphine nephrolithiasis lidocaine bupivacaine