Kornimate/medical-research-clean huggingface dataset:
effects of epidurally administered ropivacaine concentration on the hemodynamic parameters

Conditions: Epidural Anesthesia; Ropivacaine Concentration; Hemodynamics

Summary: in this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery.

one hundred and twenty patients scheduled for major abdominal surgery under tea combined general anesthesia were randomized in a double-blinded method to receive one of three different concentration study solutions in 8 ml of volume after the induction of anesthesia: 0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg). in each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. the acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.

Eligibility criteria:
inclusion criteria: all of the followings needed. * asa i or ii patients * 18 to 65 years old * undergoing major upper abdominal surgery * planned combined thoracic epidural analgesia and general anesthesia exclusion criteria: * any contraindication to epidural analgesia * allergy to local anesthetics of the amide type * communication difficulties that would prevent reliable assessment * known significant cardiac or respiratory disease * pregnant * patients who were not in cardiac sinus rhythm

Keywords: epidural, local, ropivacaine epidural administration stroke volume variability
phase i safety trial of streptococcus pneumoniae whole cell vaccine (spwcv) + alum in healthy adults

Conditions: Pneumococcal Vaccines

Summary: the purpose of this study is to determine if a streptococcus pneumoniae whole cell vaccine (spwcv) given with alum is safe and well tolerated by healthy adults.


Eligibility criteria:
inclusion criteria, healthy adults: * if female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests. * in good health with normal laboratory results * willing to comply with study restrictions, study schedule, and can be reliably contacted exclusion criteria: * currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women. * current use or likely requirement for medications with potential for liver injury or effect immune system * history of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease * history of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as hiv, hepatitis b or c
chest wall oscillation for asthma and copd exacerbations trial (coat)

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Undifferentiated Asthma/COPD

Summary: the objective of this study was to evaluate the use of high frequency chest wall oscillation (hfcwo) early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (copd).

acute asthma and chronic obstructive pulmonary disease (copd) are exceedingly common, which together account for nearly 1 million hospitalizations each year in the united states alone. beta agonists, anticholinergics, and corticosteroids delivered in aerosolized forms (via respiratory inhalers or nebulization) are recommended in the treatment of acute asthma and copd. these medications rely on deposition into distal airspaces to suppress airway inflammation or promote bronchodilation. unfortunately, excessive mucous production and impaired airway mucociliary clearance can lead to airway plugging, and thereby reduce the deposition of and response to aerosolized medications. these considerations highlight the need for therapies that clear airways of mucus in the acute management of asthma and copd. high frequency chest wall oscillation (hfcwo) creates high velocity, low amplitude oscillatory airflows when applied through a pneumatic vest worn over the thorax, and is used for airway mucus clearance in patients with cystic fibrosis, bronchiectasis, and neuromuscular disorders. this was a randomized, multi-center, double-masked phase ii clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or copd at four academic medical centers. patients received active or sham treatment for 15 minutes three times a day for four treatments. medical management was standardized across groups. the primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. secondary outcomes included change in borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.

Eligibility criteria:
inclusion criteria: * age 18 years and older * admission to the inpatient medical service * physician-diagnosed asthma or asthma/copd or copd exacerbation. * evidence of airflow obstruction on spirometry exclusion criteria: * more than 24 hours since admission to the inpatient medical service * admission to an intensive care unit * hospital discharge planned within the next 24 hours * other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis) * chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest * chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest * physician declines to provide consent * patient unable (e.g., history of cognitive impairment, unable to understand english) or declines to provide consent * previous participant in this study * corticosteroid therapy (prednisone \>0 mg/d equivalent) for \>1 week prior to admission
randomized controlled trial of stress management training in hiv

Conditions: HIV Infections

Summary: the introduction of highly active antiretroviral therapy (haart) has dramatically changed the consequences of an hiv infection, which is now viewed as a chronic disease. as in other chronic diseases, emotional distress and depressive symptoms are highly prevalent in hiv-infected patients. psychological factors such as these have been associated with lower quality of life, lower adherence to therapy and also with a higher risk for mortality and disease progression. psychosocial interventions, such as group-based cognitive behavioral stress management (cbsm) training, have been shown to reduce distress and psychological symptoms in hiv-infected patients. these psychosocial effects are paralleled by changes in physiological parameters, such as cortisol, dhea-s, testosterones, catecholamines, and naïve t-cell counts. while these results are congruent with recent evidence of the interaction between psychological, neuroendocrine and immunological parameters in hiv-infected patients, it needs to be shown whether the reported effects hold true in the haart era. most importantly, it also needs to be ascertained whether these interventions have an impact on immunological and virological hiv parameters as well as on mortality and morbidity in hiv patients. we propose a randomized controlled one-year prospective evaluation of a group-based cbsm training in 80 hiv-infected patients. participating patients will be recruited at cooperating centers of the swiss hiv cohort study and randomly assigned to cbsm training or waiting control group condition. at baseline, post-training and two follow-up (6 and 12 months) assessments, effects of the cbsm on psychological, physiological and clinical out-come variables in hiv-infected patients under haart will be evaluated. additionally, the effects of cbsm on the neuroendocrine and autonomic stress reactivity in hiv-infected patients will be assessed, thus evaluating a possible direct pathway between emotional distress and physiological hiv-relevant parameters. in conclusion, the planned research project evaluates the effectiveness of a standardized psychosocial intervention as a possible component of a comprehensive disease management in hiv-infected patients under haart.


Eligibility criteria:
inclusion criteria: * adults between 18 and 65 years of age * sufficient german-speaking abilities to participate in group therapy * cartwithin the previous three months, * cd4 lymphocyte count above 100 cells/ml exclusion criteria: * active opportunistic infection at baseline * formal psychotherapy within the previous three months * intravenous drug users * diagnosable current major psychiatric disorder (bipolar affective disorder, psychotic disorders, major depression with melancholia) and diagnosis of antisocial and borderline personality disorders at baseline
efficacy and safety of shr-1020 combined with albumin-bound paclitaxel in the second-line treatment of pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study is being conducted to explore the efficacy and safety of shr-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.

this trial is a prospective, single-center, single-arm clinical research. advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. for advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. shr-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect. the safety and efficacy of this study will be assessed through orr, dcr,pfs, os , and adverse effects as graded by ctcae 5.0.

Eligibility criteria:
inclusion criteria: * patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to recist 1.1 criteria. * disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy * ecog score 0-2 * adequate organ and bone marrow function * the expected survival time is ≥ 12 weeks * had normal swallowing function, without dysfunction of gastrointestinal absorption * willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures exclusion criteria: * the patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel; * the first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy * known to be allergic to the active ingredients or excipients in this study. * had other active malignant tumors within 5 years before entering the study. * subject with cerebral metastasis * have a clear history of serious and uncontrolled other disease or mental disorders; * other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional chinese medicine should be used for anti-tumor therapy * other situations that the researcher considers inappropriate to participate in the research.
study of the impact of administering t the scale of brazelton on the mother's confidence in her newborn born premature at the approach of returning home

Conditions: Infant, Premature

Summary: in france, the last national perinatal survey show that 6.6% of live births are premature. for these infants, transfer in neonatology sector may result in mother-child separation can last several weeks or months. this hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him. a study of mothers of premature shows the interest of the brazelton scale to help them identify the skills their child and adjust their own behavior.


Eligibility criteria:
inclusion criteria: * mother: over the age of 18, affiliated to a health social security. * newborn: born to a term of less than 36 s.a., hospitalized in neonatology, said leaving in three days. exclusion criteria: mother : * legally protected * inability to understanding and monitoring of the protocol's terms (not master the french language, intellectual impairment, psychotic disorder ...) * who have had a premature child born. new born : * opposition of one of the holders of parental authority to the award of the brazelton scale * having withdrawal syndromes or malformation syndromes requiring oxygen therapy, gastrostomy or nasogastric tube * twins and more.
preoperative daptomycin prophylaxis in two-stage exchange arthroplasty: a prospective, randomized, double-blinded trial

Conditions: Periprosthetic Joint Infection

Summary: the gold standard for treating prosthetic joint infection (pji) is two-stage exchange arthroplasty. this includes the first stage of debridement and removal of the artificial joint, and the second stage of reimplantation of the artificial joint. methicillin-resistant staphylococcus aureus (mrsa) infection is one of the factors leading to the failure of artificial joint infection treatment. before the second stage of the joint surgery, the surgeon will prescribe prophylactic antibiotics based on previous bacterial cultures. the usual preoperative antibiotic is a first-generation cephalosporin antibiotic. if it is mrsa, vancomycin will be given. increasingly, literature reports link prosthetic joint infections to mrsa, but no changes have been made to the routine recommendation for mrsa prophylactic antibiotic use. daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones, and its safety and tolerability have been confirmed. therefore, it can effectively combat gram-positive organisms, including mrsa. daptomycin has many characteristics of an ideal prophylactic: short infusion time, low adverse events during administration, and a range limited to gram-positive organisms. we aim to assess whether adding antibiotics that cover mrsa would reduce prosthetic joint infections and increase surgical success rates, in addition to the standard recommended prophylactic antibiotics. thus, this prospective randomized trial is designed to assess, besides using the first-generation cephalosporin antibiotic, the effects of adding an antibiotic with mrsa coverage (daptomycin vs. vancomycin).


Eligibility criteria:
inclusion criteria: 1. patients aged 18 or older with an infection that meets the 2018 international consensus meeting (icm) criteria7 at the time of the first-stage resection arthroplasty with a gram-positive organism, especially mrsa. 2. will undergo a second stage of reimplantation. exclusion criteria: 1. patients with a fungal infection or culture-negative infections 2. known allergies to cefazolin, daptomycin, or vancomycin. 3. currently receiving surgical treatment for acute postoperative or acute hematogenous pji. 4. chronic kidney disease (creatinine clearance rate \[ccr\] \< 30 ml/min/1.73m2)
evaluating length of treatment with pd-1/pd-l1 inhibitor in advanced solid tumors

Conditions: Advanced Solid Tumors; NSCLC; Bladder Cancer; HNSCC; Renal Cancer; Melanoma; Anal Cancer; Colorectal Cancer; Cholangiocarcinoma; Gastric Cancer; Hepatocellular Carcinoma; Merkel Cell Carcinoma; Cervical Cancer

Summary: based on the overwhelming positive response to this survey and the large number of patients being treated with pd-1/pd-l1 therapy in the upmc system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. the investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.

within the upmc system, approximately 2,300 patients received pd-1/pd-l1 therapy for a variety of advanced solid tumors within the past year. it is anticipated that this number will increase as the clinical indications for treatment with these agents also increase. the investigators conducted a survey of 60 medical oncologists within the upmc system regarding their interest in a trial that will attempt to address the question of optimal length of pd-1/pd-l1 treatment. fifty-two (86.7%) physicians indicated that they would participate in a clinical trial that had a primary goal of determining whether it was feasible to stop immunotherapy after 1 year of treatment.

Eligibility criteria:
inclusion criteria: * all patients must have an advanced solid tumor malignancy (specifically nsclc, bladder, hnscc, renal, melanoma, cervical, merkel cell, mmr/msi \[colon, rectal, cholangio, esophageal, ovarian, uterine\], anal, gastric and ge junction, hepatocellular, triple negative breast cancer) that is being treated with a pd-1/pd-l1 inhibitor including pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab according to standard of care treatment. * patients who initially started treatment with another agent in combination with the pd-1/pd-l1 inhibitor, i.e. chemotherapy, ipilumumab, are eligible. * patients must have at least stable disease as evidenced by scans performed within 6 weeks of randomization. * signed informed consent allowing randomization to stopping immunotherapy at 1 year ± 6 weeks versus continued treatment beyond 1 year. * patients can have measurable or non-measurable disease per recist v1.1. * patients cannot be enrolled in a clinical trial. exclusion criteria: * patients with documented progressive disease prior to randomization. * patients with an immune-related toxicity preventing the continuation of treatment beyond 1 year at the treating physician's discretion.
evidence-based neurorehabilitation in children with cp

Conditions: Cerebral Palsy

Summary: this 3-year research project aims to investigate and compare the treatment effectiveness (in terms of motor and psychosocial outcomes) and potential predictors (in terms of demographical, biological and psychosocial domains) of the intensive and distributed child- and family-friendly cit protocols with an equivalent intervention period in children with cp by quasi randomized controlled study design. in addition, the selection and examination of outcome measures were based on the icf-cy model to provide comprehensively documents.

upper limb dysfunction is a common and disabling consequence of children with cerebral palsy (cp). as children with hemiplegia primarily have one better funcitoning side of their body and one more affected side, they often tend not to use the affected extremity resulting in the phenoema of developmental disregard. recent evidence suggests that constraint-induced therapy (cit) is the most effective technique to improve the use of the affected hand and reduce the developmental disregard in children with cp. however, despite the cumulative evidence supporting the effects of pediatric cit, the concerns of feasibility and gaps of current knowledge prompt us to conduct this current proposal. the concerns of the feasibility include this approach is emotionally problematic at early stages and researchers suggested that the orginal cit protocols may be too intrusive for children and their families. the gaps of current knowledge include: no study has directly investigated the effectiveness differences between various cit models; no study examines, monitors and compares the psychosocial outcomes while receiving the cit protocols for children and their parents systematically and comprehensively; and no study investigates the possible clinical characteristics of children that may influence the training effects of the various cit models. investigators will recruit a total of 60 children with cp from the cp association, medical centers, and special educational systems and participants will be assigned to the two intervention groups. the intensive cit is delivered by the group-based design with 6 hours a day for 6 days (36 hours in total) and the distributed cit will be delivered by individualized home-based intervention with 2.25 hours a day, two times a week, for 8 weeks (36 hours in total).

Eligibility criteria:
the inclusion criteria of this study are: 1. aged between 5 and 13 years 2. diagnosed with congenital hemiplegic or children with cp with one more affected side 3. apparently disuse phenomenon of the more affected hand at spontaneous contexts participants will be exclude for: 1. excessive muscle tone (modified ashworth scale ≤ 2 at any joints of the upper limb) before beginning treatment 2. severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation 3. injections of botulinum toxin type a or operations on the ue within 6 months

Keywords: upper limb neurorehabilitation neurological rehabilitation upper extremity
oxytocin administration prior planned caesarean section

Conditions: Respiratory Insufficiency Syndrome of Newborn; Breastfeeding Status

Summary: spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations (e.g. avp (arginine vasopressin) /copeptin) incommensurable with child or adult levels measured in any other situation. in contrast, infants delivered by primary caesarean section without preceding labour have low stress hormone concentrations at birth unless other stressors are present, including chorioamnionitis or intrauterine growth restriction. infants delivered by caesarean section after a trial of labour show copeptin concentrations between these two extremes. objectives:1) to reduce neonatal respiratory morbidity and admission to the neonatal intensive care unit and increase bonding and breastfeeding by triggering uterine contractions prior to planned caesarean delivery. 2) to collect prospectively weight data of infants in the first 6 months of life to validate and expand our online neonatal weight calculator. study design: open label; randomised, placebo controlled trail intervention: oxytocin challenge test (oct): infusion of oxytocin 5 iu/500 ml ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped. primary endpoint: - incidence of neonatal respiratory morbidity secondary endpoints: * umbilical cord blood copeptin levels * postnatal neonatal weight change * breastfeeding status


Eligibility criteria:
inclusion criteria: * singleton pregnancy \>34 weeks * primary caesarean section, that is without preceding contractions or rupture of the membranes, * absence of a contraindication to oxytocin exclusion criteria: * chromosomal aberration * malformation, * iugr, * nonreassuring fetal heart rate pattern, * placenta praevia, * maternal substance abuse, * infections, * hypertension, * preeclampsia, * diabetes type i or ii, * autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.), * renal disease, * history of more than one previous caesarean section.

Keywords: caesarean section oxytocin challenge test