Kornimate/medical-research-clean huggingface dataset:
calciuric effect and cyclic parenteral nutrition in preterm infants

Conditions: Preterm Infants; Metabolic Bone Disease

Summary: the aim of our work is to study the effect of total parenteral nutrition (tpn) cycling in preterm infants on hypercalcuria (excessive calcium excretion in urine). tpn cycling refers to administering the tpn over a portion of the day rather than the whole day. our hypothesis is that cyclic tpn includes more hypercalcuria in preterm infants as compared to continuous tpn. objectives: measure urinary calcium(ca) during the periods of continuous and cyclic tpn. compare the amount of ca losses in the urine continuous vs. cyclic tpn

randomized cross over design, in which babies will receive tpn either continuously or on a cyclic basis for 3 days. the patients will then be crossed over to receive the other way of administration over the following 3 days, thus each patient will serve as his or her own control. continuous tpn will be administered over 24 hours for 3 days, while the cyclic tpn will be given for 18 hours then followed by a dextrose only solution at the same concentration and rate as the tpn for 6 hours. trophic feeds up to 20 ml/kg/day will be allowed throughout the study period at the discretion of the attending neonatologist.

Eligibility criteria:
inclusion criteria: * preterm babies with birth weights of 1500 gm or less. * expected to be restricted from oral feeding or on trophic feeds * on tpn for at least 6 days exclusion criteria: * infants who at the time of enrollment are on any diuretics (lasix, hydrochlorothiazide, aldactone, etc.) or caffeine * those who are hemodynamically unstable * or have renal or hepatic insufficiency * infants with major congenital anomalies

Keywords: preterm infant parenteral nutrition cycling tpn cycling hypercalcuria
total robotic versus robotic assisted distal gastrectomy for gastric cancer

Conditions: Gastric Cancer; Robotic Gastrectomy

Summary: to evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (ct1-4a, n0/+, m0).

in the field of gastrectomy, hashizume et al. first reported robotic gastrectomy in 2002. since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (gc) have gradually increased. reports of robotic surgery for gc are increasing, especially in asia. several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. however, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. the investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for gc.

Eligibility criteria:
inclusion criteria: 1. age from over 18 to under 75 years 2. primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. ct1-4a (clinical stage tumor), n-/+, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual 8th edition 4. expected to perform distal gastrectomy with d1+/d2 lymph node dissection to obtain r0 resection surgicall results. 5. performance status of 0 or 1 on eastern cooperative oncology group (ecog) scale 6. american society of anesthesiology (asa) class i to iii 7. written informed consent exclusion criteria: 1. women during pregnancy or breast-feeding 2. severe mental disorder 3. history of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. history of previous gastric surgery (except endoscopic submucosal dissection/endoscopic mucosal resection (esd/emr) for gastric cancer) 5. gastric multiple primary carcinoma 6. enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging 7. history of other malignant disease within the past 5 years 8. history of previous neoadjuvant chemotherapy or radiotherapy 9. history of unstable angina or myocardial infarction within the past 6 months 10. history of cerebrovascular accident within the past 6 months 11. history of continuous systematic administration of corticosteroids within 1 month 12. requirement of simultaneous surgery for other disease 13. emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 14. forced expiratory volume in 1 second (fev1)\<50% of the predicted values

Keywords: gastric cancer robotic assisted distal gastrectomy total robotic distal gastrectomy
influence of square-stepping exercise on brain activation, cognitive function and physical performance in frail elders with mci

Conditions: Frailty; Mild Cognitive Impairment

Summary: this study is to elucidate the possible mechanisms of sse by examining brain activation differences between sse patterns and usual walking, as well as the relationship between brain activity and sse performance, between cognitive function and sse performance, and between physical performance and sse performance in frail elders with mci.

background: both frailty and mci exert negative impact on motor and cognitive function, which increase the risks of fall and adverse health condition. sse has been proved to be an effective intervention for motor and cognitive function in older adults. however, the underlying mechanisms of sse still remain undetermined for its possible effects. this study aims to elucidate the possible mechanisms of sse in frail elders with mci. methods: this is a cross-sectional study. the inclusion criteria are: (1) age between 65 and 90 years old, (2) the presence of at least 1 characteristic of the fried frailty criteria, (3) with mini-mental state examination (mmse) score≧24 and montreal cognitive assessment (moca) score \<26 (mci criteria), and (4) ability to walk independently for 1 min without assistive devices. the exclusion criteria are: (1) central nervous system disorders (such as stroke, parkinson's disease, spinal cord injury), and (2) any unstable physical condition, psychiatric disorder, and other neurological disorder or diagnosed with learning disability which may affect participating this study. brain activity during sse and usual walking, sse performance, physical performance, and cognitive function are measured. the purpose of this study is to elucidate the possible mechanisms of sse by examining brain activation differences between sse patterns and usual walking, as well as the relationship between brain activity and sse performance, between cognitive function and sse performance, and between physical performance and sse performance in frail elders with mci.

Eligibility criteria:
inclusion criteria: * age between 65 and 90 years old * presence of at least 1 characteristic of the fried frailty criteria * mini-mental state examination score equal to or more than 24 * montreal cognitive assessment score less than 26 * ability to walk independently for 1 min without assistive devices exclusion criteria: * central nervous system disorders (such as stroke, parkinson's disease, spinal cord injury) * any unstable physical condition, psychiatric disorder, and other neurological disorder or diagnosed with learning disability which may affect participating this study

Keywords: square-stepping exercise frailty mild cognitive impairment
enoxaparin low molecular weight heparin (lmwh) in advanced non small cell lung cancer: effect on survival and symptom control in patients undergoing first line chemotherapy (syringes)

Conditions: Non-Small Cell Lung Cancer

Summary: rationale: a number of recent phase iii randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. the survival advantages observed in the studies persist for months after the active treatment with lmwhs. therefore these survival advantages are thought to be due to effects of lmwhs on tumor cell biology. first line treatment of advanced nsclc patients with the cisplatin + docetaxel combination has been widely studied, and is amongst the most active treatments currently available. the occurrence of grade 3/4 thrombopenia in several phase iii trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with lmwhs in the treatment of advanced nsclc.

purpose: the aim of this study is to evaluate the potential beneficial antitumoral effect of lmwh enoxaparin in patients with locally advanced or metastatic nsclc determined by the time to progression, the overall survival and the symptom control. lmwh will be added to a first line cisplatin-based chemotherapy.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic nsclc (stage iiib or iv) * patients who are not candidates for radical combined modality treatments or high-dose radiation therapy * at least one measurable lesion according to recist criteria * good performance status * adequate haematological, renal and liver function * written informed consent exclusion criteria: * previous chemotherapy for nsclc * brain metastasis * history of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months * indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease * concomitant therapy with an anti-angiogenesis agent * contra-indication for lmwh * life expectancy of \< 3 months * serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol

Keywords: non-small cell lung cancer chemotherapy low molecular weight heparin
hamster: a novel smartphone communication tool for people with ms

Conditions: M-health; Multiple Sclerosis

Summary: hamster is a smartphone app that tracks validated patient reported outcome measures (proms) in people multiple sclerosis (ms). in this study, 50 patients with ms will receive this app for 6 months and be asked to fill out the pro questionnaires on their smartphone. endpoints include the adherence to this app and satisfaction with this intervention.


Eligibility criteria:
inclusion criteria: * any ms according to macdonald criteria * informed consent exclusion criteria: - language barriers

Keywords: m-health multiple sclerosis patient reported outcomes
prevalence of musculoskeletal symptoms in the cambridge nihr bioresource

Conditions: Musculoskeletal Diseases; Musculoskeletal Injury

Summary: musculoskeletal diseases, such as osteoarthritis, represent a large proportion of the global burden of disease with hip and knee osteoarthritis alone being the 11th greatest cause of disease burden. the purpose of this study is to determine the level of musculoskeletal symptoms in members of the cambridge national institute for health research (nihr) bioresource and see if this is associated with their possession of genetic markers that have been identified as being associated with osteoarthritis. this will allow us to determine the real level of musculoskeletal symptoms in this large cohort of volunteers and provide basic information that could be used to facilitate further musculoskeletal research in the nihr bioresource population.

all active members of the cambridge nihr bioresource will be approached. they will be sent an email outlining the purpose of the study and asking that if they would like to take part to please complete the online questionnaire which will be linked to in the email. for those individuals who agree to participate and complete the questionnaire, the cambridge nihr bioresource will provide the genetic marker information it already holds for specific markers that are known to be associated with osteoarthritis.

Eligibility criteria:
inclusion criteria: * member of the nihr bioresource * willing to consent to participate exclusion criteria: * previous self-report of osteoarthritis on joining bioresource
study to determine the safety, maximum tolerated dose, pharmacokinetics of sorafenib (bay43-9006)

Conditions: Carcinoma

Summary: the primary objective of the study was to define the safety profile and maximum tolerated dose (mtd) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors. the secondary objectives were evaluation of pharmacokinetics (pk) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.


Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumors * evaluable disease * eastern cooperative oncology group (ecog) 0 or 1 * life expectancy minimum 12 weeks exclusion criteria: * congestive heart failure * serious arrhythmias * coronary artery disease (cad) or ischemia * hiv (human immunodeficiency virus) * hepatitis b or c * serious active infection * metastatic brain or meningeal tumors

Keywords: sorafenib advanced solid tumors maximum tolerated dose carboplatin and paclitaxel chemotherapy combination
tai chi in rheumatoid arthritis (taichira)

Conditions: Rheumatoid Arthritis

Summary: the investigator's hypothesis is that tai chi sessions would increase physical activity of patients with rheumatoid arthritis. the main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of rheumatoid arthritis patients, compared to a control group without tai chi.

detail protocol: selection and inclusion of patients will be done by principal investigator of rheumatology department. after verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at month 0). they will participate in sessions in a deferred manner due to two per week for each group: * interventional "a" group: 32 sessions (on average 2/week) performed from month 0 to month 4 in 15 patients. * control "b" group: 16 sessions (on average 2/week) performed from month 2 to month 4 in 15 patients. patients of "b" group will be not performing sessions with "a" group patients. sessions lasting about 45 minutes will be proposed from monday to friday in a room planned from this activity within the chu. exercises will be adapted and personalized according to each one. evaluations will be carried out for group 1 (interventional) before the first session of tai chi at month 0, before the session at month 2 and at the end of the protocol at month 4. the same evaluations will be carried out for group b (control) at month 0, before first session of tai chi at month 2 and at the end of the protocol. assessment of pain and stress will be done before and after each session. final assessment will be done at 4 months after randomization. fitness assessment and tai chi sessions will be conducted by apa student. clinical examination of patient, installation and removal of cardio frequency meter will be performed by nurse. data entry will be done by clinical research associate of the rheumatology department. statistical analysis will be carried out by biostatistician affiliated to the study.

Eligibility criteria:
inclusion criteria: * patient age \> 18 years old with ra (acr/eular criteria) in remission (cdai ≤2.8) or with low disease activity (cdai ≤10). * patient able to walk without help * patient able to complete a questionnaire * patient giving informed consent. * patient covered by social security exclusion criteria: * patient with disorder of higher mental function or psychiatric disorders. * patient who has previously contribute to a tai chi program. * patient with an absolute contraindication to physical activity. * protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.

Keywords: rheumatoid arthritis tai chi chuan physical activity
a study of indinavir plus ritonavir plus two nrtis vs. nelfinavir plus two nrtis in hiv positive patients (0639-112)(completed)

Conditions: HIV Infections

Summary: a study comparing indinavir plus ritonavir plus 2 nrtis vs. nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (nrtis) in the treatment of hiv positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (nnrti) containing treatment.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * hiv positive * no active heart disease exclusion criteria: * pregnant or breast feeding * unwilling to use birth control or abstinence to prevent pregnancy * received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study * plan to receive nnrtis while in the study * received therapy which lowers body's ability to fight infection within the past 30 days or while in the study * alcohol or substance abuse * hepatitis

Keywords: hiv treatment experienced
strategies to prevent pneumonia 2 (stopp2)

Conditions: Infections, Hospital; Ventilator-Associated Pneumonia; Mechanical Ventilation Complication

Summary: ventilator-associated pneumonia (vap) is a serious complication in mechanically ventilated critically ill patients. the intervention tested in this project (swabbing the mouth with chlorhexidine before the endotracheal tube is inserted) could reduce the risk of ventilator-associated pneumonia.

ventilator-associated pneumonia (vap) is an acute care complication with high morbidity and mortality, which is costly in length of stay and resources used. application of chlorhexidine (chx) to the mouths of critically ill adults after intubation reduces risk of vap. during intubation, organisms may be dragged by the tube from the contaminated mouth to the sterile lung, and the endotracheal tube (et) provides a pathway for direct entry of bacteria from the mouth to the lower respiratory tract. however, procedures to decontaminate the mouth before intubation are not routine and little is known about the effects of pre-intubation chx in critically ill patients. thus, this project focuses on evaluating the benefit of adding a pre-intubation chx dose to the known benefit of post-intubation chx to reduce the risk of vap. in order to examine the effect of pre-intubation chx on early et colonization, we will perform microbial cultures of ets of subjects who are extubated in the first 24 hours of study participation. we will also explore selected biomarkers (procalcitonin, cytokines) as indicators of development of vap in a subset of subjects. the project will add to knowledge about the relationships among oral health, et intubation and vap, and addresses an important clinical outcome. pre-intubation oral decontamination could reduce risk of vap and its associated morbidity and mortality.

Eligibility criteria:
inclusion criteria: * need for intubation exclusion criteria: * pneumonia at the time of intubation

Keywords: nosocomial (hospital-acquired) infections ventilator-associated pneumonia mechanical ventilation endotracheal intubation
prone breast irradiation for pendulous breasts

Conditions: Breast Cancer

Summary: we hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the ptv, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart.the purpose of this study is to compare the 3-d dose distribution in ptv(planning target volume) and normal tissues in prone position versus supine position.

local excision followed by adjuvant radiotherapy has become standard treatment for women with early-stage breast cancer. adjuvant radiotherapy may encounter technical difficulties in patients with pendulous breasts when treated in supine position. based upon literature and our own preliminary experiences, we hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the ptv, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart. however, no quantitative data are yet available to test this hypothesis. therefore, the aim of our study is to compare the 3-d dose distribution in ptv and normal tissues in prone position versus supine position. for treatment in prone-position an in-house developed device, the "mammaboard" was used.

Eligibility criteria:
inclusion criteria: * patients should have had breast-conserving surgery for breast cancer or dcis (ductal carcinoma in situ) * no indication for radiotherapy of regional nodes * large, pendulous breasts (bra size d and over) exclusion criteria: * regional radiotherapy is indicated * unable to lie in prone position

Keywords: breast cancer breast conserving surgery radiotherapy pendulous breasts
study about patient comfort and long-term outcome after stapled hemorrhoidopexy

Conditions: Internal Hemorrhoids

Summary: the purpose of this study was to determine the influence on patient comfort after stapled hemorrhoidopexy versus milligan morgan (two surgical procedures)in third degree circular hemorrhoids.

there are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available. in most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. all patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the milligan-morgan technique or the stapling procedure. patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. the main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years.

Eligibility criteria:
inclusion criteria: * third degree circular hemorrhoids * symptomatic * reducible exclusion criteria: * single third-degree hemorrhoids * acute incarcerated hemorrhoids * intercurrent acute anal fissure * acute anal fistula * prior hemorrhoidectomy.

Keywords: hemorrhoids surgery hemorrhoidopexy milligan morgan
oral direct factor xa inhibitor bay59-7939 in patients with acute symptomatic proximal deep vein thrombosis(odixa-dvt)

Conditions: Venous Thrombosis; Deep Vein Thrombosis

Summary: the purpose of this study is to compare the safety and efficacy of bay59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin k-antagonist and to find the optimal dose of bay59-7939 for the anticipated phase iii trials and for the future clinical use.


Eligibility criteria:
inclusion criteria: - patients with acute symptomatic proximal deep vein thrombosis exclusion criteria: * contraindication to comparator drugs * symptomatic pulmonary embolism * conditions with increased bleeding risk * unstable patients with reduced life expectancy * severe renal impairment * impaired liver function * strong cyp 3a4 inhibitors * platelet aggregation inhibitors (exception: asa up to 500mg) therapy with anticoagulants or fibrinolytics * nsaids with half-life \> 17 hours

Keywords: embolism and thrombosis pulmonary embolism embolism thrombosis