Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of sugammadex in high-risk ambulatory surgeries

Conditions: Ambulatory Difficulty

Summary: in this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center. the primary objective of this study is to evaluate the "fit to discharge time in the pacu." the secondary objectives are pacu adverse events, use of additional medications in the pacu, 0-30 day ed or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.

there is limited published data in the use of sugammadex for high-risk patient populations, such as those undergoing laparoscopic procedures in standalone outpatient surgery facilities. about 90% of the ambulatory surgical patient population at this institution is non-caucasian with the majority of the higher-risk patients having obesity and one or more additional chronic health conditions. in this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center. the primary objective of this study is to evaluate the "fit to discharge time in the pacu." the secondary objectives are pacu adverse events, use of additional medications in the pacu, 0-30 day ed or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge. in this double-blinded randomized controlled study, the study team is evaluating the efficacy and safety of sugammadex in patients undergoing ambulatory surgical procedures. currently, both neostigmine and sugammadex are standard of care in this institution. other than the emergent need for nmb reversal, practice preference and individual indications dictate the selection of reversal medication.

Eligibility criteria:
inclusion criteria: * asa physical score ii and iii * scheduled for a laparoscopic ambulatory surgery * 21-60 years of age * able to understand and sign informed consent exclusion criteria: * known allergy to neostigmine or sugammadex * active pulmonary diagnosis * american society of anesthesia physical score 4 and above * known or suspected neuromuscular disease * documented renal or liver insufficiency (2 fold increase in the labs) * body mass index \>40 * any surgical case brought into the operating room after 4 pm (to avoid any provider bias related to discharging patients before closure of the ambulatory surgery center for the day)

Keywords: high risk chronic health condition laparoscopic surgery
local anesthesia impact on dental sedation

Conditions: Sedative Overdose

Summary: the goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures. the main questions it aims to answer are: * impact of local anesthesia on sedation depth and hemodynamic parameters * impact of presence of local anesthesia on the requirement of propofol to maintain deep sedation. participants were deeply sedated and one group received local anesthesia at the anesthesia induction, while other group of patients received local anesthesia after the maintenance anesthesia was discontinued. if there is a comparison group:

local anaesthesia (la) is often preferred for stabilization of vital signs, depth of anaesthesia in dental restorations but the optimal timing of la administration during sedation is varies according to personal preferences of dentists. aim of this retrospective study is to investigate the effects of the timing of la on hemodynamic parameters, depth of anaesthesia and total dose of anaesthetic drugs given in paediatric patients sedated for dental procedures. records of healthy children who were sedated for dental restorations will be divided into two groups. patients who received la at the beginning of sedation or who received la at the end of sedation after completion of restorations. it is planned to compare the patient groups in terms of demographic data, hemodynamic data, bis scores, ramsey sedation scale scores, total propofol dose administered.

Eligibility criteria:
inclusion criteria: paediatric dental patients who were previously sedated and fulfilled the following inclusion criteria were included in this investigation. patients with an american society of anesthesiologist (asa) physical status classification of i-ii and aged between 2 and 8 years were included in the study. exclusion criteria: exclusion criteria were asa status iii-v, age older than 8 years, having any history of allergy to anaesthetic drugs and renal disease interfering with drug metabolism.
fiber regimens for constipation symptoms

Conditions: Constipation

Summary: the objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.

patients presenting to the urogynecology clinics at parkland health and hospital system and ut southwestern medical center at dallas from july 2003 to july 2005 were screened for symptoms of constipation. subjects were randomized to a 6-week course of either psyllium (konsyl, konsyl pharmaceuticals, easton, md) or a special bowel recipe. the bowel recipe was a modification of that used by behm and consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice. a validated constipation scoring questionnaire12 was administered to participants at the beginning and at the end of the six-week study period. during the six-week trial patients also kept a bowel diary recording characteristics of each bowel movement.

Eligibility criteria:
inclusion criteria: * fluent and literate in either english or spanish. * responds affirmatively to at least two symptoms according to rome ii criteria for functional constipation, for at least 12 weeks exclusion criteria: * pregnant or less than six weeks postpartum * six weeks post abdominal surgery, * colostomy * history of bowel obstruction, inflammatory bowel disease, diagnosis of slow colonic transit time, spinal cord injury, neurogenic disease, myopathic disorders, or cognitive impairment, history of an allergic reaction to psyllium or any of the ingredients contained in the bowel recipe, such as wheat bran, prunes, or apples.

Keywords: bowel recipe bristol stool form scale konsyl psyllium wheat bran
definitive concurrent chemoradiotherapy with docetaxel plus cisplatin versus 5-fluorouracil plus cisplatin in patients with esophageal squamous cell carcinoma

Conditions: Esophageal Neoplasm; Chemoradiation

Summary: in this phase ii study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (ccrt) with docetaxel plus cisplatin (dp regimen) versus 5-fluorouracil plus cisplatin (pf regimen) in patients with esophageal squamous cell carcinoma (escc).

esophageal cancer is one of the most fatal malignancies worldwide. radical surgery has been the primary treatment for patients with resectable esophageal cancer. for medically unfit patients or medically fit patients who decline surgery, definitive radiotherapy plus concurrent chemotherapy has been established as a standard treatment. since the 1980' s, the most widely used chemotherapeutic regimen in combination with radiotherapy for esophageal cancer was cisplatin (cddp) plus 5-fluorouracil (5-fu) (the pf regimen). however, locoregionally persistent or recurrent diseases were still quite common and survival remained poor. several previous studies conducted by the radiation therapy oncology group (rtog) explored the efficacy of radiation dose escalation, but all results turned out disappointing. and studies incorporating intensified pf regimen or new-generation cytotoxic agents such as paclitaxel and oxaliplatin did not show any advantage over the standard-dosage pf regimen either. in this phase ii study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (ccrt) with docetaxel plus cisplatin (dp regimen) versus 5-fluorouracil plus cisplatin (pf regimen) in patients with esophageal squamous cell carcinoma (escc).

Eligibility criteria:
inclusion criteria: * patients with histologically proven squamous cell carcinoma of the esophagus * stage ii-iva disease, including metastatic celiac or cervical nodes, according to the sixth edition of american joint committee on cancer (ajcc) staging system for esophageal cancer * aged between 18 and 70 years * karnofsky performance status (kps) score ≥ 70 * adequate bone marrow function (leukocyte count ≥ 4000/ul, platelet count ≥ 100,000/ul), adequate liver function (serum alanine aminotransferase (alt) level and serum aspartate aminotransferase (ast) level \< twice the upper limit of normal, and serum bilirubin level of \<1.5 mg/dl), and adequate renal function (creatinine clearance ≥ 50 ml/min) * no other serious medical conditions * life expectancy ≥ 3 months * written informed consent exclusion criteria: * detection of distant metastasis (excluding metastatic celiac or cervical nodes) before treatment before treatment * known allergy to cddp, 5-fu, or docetaxel * pregnancy or breast feeding

Keywords: esophageal squamous cell carcinoma concurrent chemoradiotherapy docetaxel cisplatin 5-fluorouracil
avida the vidaza® (azacitidine) patient registry

Conditions: Myelodysplastic Syndromes

Summary: this registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving vidaza, and will provide unique insights into the management of myelodysplastic syndromes (mds) and other hematological disorders and the impact of these disorders on patients.


Eligibility criteria:
inclusion criteria: * patient who is deemed appropriate for treatment with vidaza® by his or her clinician, but who has not already started receiving vidaza® treatment. * patient who is able to read and speak english. * patient who is willing and able to provide informed consent. * patient who agrees to complete patient assessment questionnaires. exclusion criteria: * patients who are currently being treated with vidaza®. * patients who are concurrently participating in a clinical trial. * patients unwilling or unable to complete the baseline and follow-up questionnaires. * patients who are deemed inappropriate for treatment with vidaza®.

Keywords: mds
verily watch cardio (af and ecg) study

Conditions: Atrial Fibrillation

Summary: this study is designed to evaluate the performance of the verily watch cardio for recording electrocardiogram (ecg) and photoplethysmography (ppg) signals and detecting suspected atrial fibrillation (af) episodes, in a free-living environment, in participants at risk for having an af event.


Eligibility criteria:
inclusion criteria: * at least 22 years old * able to read and speak english * participant understands the study requirements and is able and willing to sign written informed consent * at risk of having an af event, as determined by having a diagnosis of paroxysmal af (paf) and meeting one or more of the following: 1. scheduled or to be scheduled to undergo af ablation 2. af burden of ≥25% in the 3 months prior to consent date as confirmed via an implantable loop recorder (ilr), holter monitor, or adhesive monitoring patch 3. cha2ds2vasc score ≥3 4. left atrial diameter ≥4.4 cm as confirmed by transthoracic echo (tte) within one year of consent * without significant limitation in ability to participate in the study, in the opinion of the investigator exclusion criteria: * have a pacemaker or implantable cardioverter defibrillator (icd) * currently on class ic or class iii antiarrhythmic medication that has been successful in eliminating af (no documented af of more than 30 seconds since the initiation of the medication). should be at least one week off medication. * had successful af ablation (no documented af of more than 30 seconds post procedure) * known severe allergy to nickel or metal jewelry * known allergic reaction to polyester, nylon, spandex, adhesives or hydrogels; or with family history of adhesive skin allergies * are diagnosed with persistent af * have an implantable neuro-stimulator * currently wearing an ecg patch that prevents the use of the fda-cleared wearable ecg patch, at the discretion of the investigator. * have discolored wrists (e.g., tattoos, ink), at the discretion of the investigator.
trial of vitamin d supplementation in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study null hypothesis is that vitamin d supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.


Eligibility criteria:
principal inclusion criteria: * medical record diagnosis of copd, emphysema or bronchitis * post-bronchodilator fev1 / fvc \< 70% or post-bronchodilator fev1 / slow vc \< 70% * post-bronchodilator fev1 \< 80% predicted * age ≥ 40 years on day of first dose of imp * smoking history ≥ 15 pack-years * if a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study * able to give written informed consent to participate exclusion criteria: * current diagnosis of asthma * known clinically significant bronchiectasis * known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin d intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years * taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone * taking dietary supplement or topical preparation containing vitamin d up to 2 months before first dose of imp * treatment with any investigational medical product or device up to 4 months before first dose of imp * breastfeeding, pregnant or planning a pregnancy * baseline corrected serum calcium \> 2.65 mmol/l * baseline serum creatinine \> 125 micromol/l
prospective study of 2 mm margins for the biopsy of dysplastic nevi

Conditions: Dysplastic Nevi

Summary: non-interventional study to evaluate the utility of removing dysplastic nevi with a defined 2 mm margin.

this is a prospective, observational study to evaluate the utility of removing dysplastic nevi (dn) with a defined 2 mm margin. this is a non-interventional study that will observe the pathology results following a standard of care biopsy. principal investigator (pi) hypothesize that the majority of lesions removed with this technique will have margins free of nevus cells on examination of histopathological sections. hence, pathologists will not suggest that an additional excision be performed to remove any residual nevus. pi also hypothesize that if biopsy sites are followed over time, the rate of nevus recurrence will be low, because investigators would have removed the majority, if not all of the lesion at the time of initial biopsy.

Eligibility criteria:
inclusion criteria: * all patents seen in the practices of the study physicians are eligible to participate in the study. * patients must be over 18 years of age. * patients who are able to provide informed consent. * patient must have a lesion in which the differential diagnosis includes a dn and for which the study dermatologist deems it is appropriate to perform a saucerization biopsy. exclusion criteria: * patients who are less than 18 years of age. * patients who are unable to provide informed consent. * lesions for which a saucerization biopsy is impractical in the judgment of the study dermatologist based on certain clinical factors (e.g. patient on anticoagulation therapy, lesion size and/or anatomic location).

Keywords: melanocytic neoplasm biopsy saucerization biopsy skin lesion
efficacy and biomarkers of response of tbs in treatment resistant depression

Conditions: Resistant Depression, Treatment; Bipolar Depression

Summary: theta burst transcranial magnetic stimulation (tbs) in dorsolateral prefrontal cortex (dlpfc) has shown efficacy and safety as an adjuvant strategy for resistant to treatment depression (rtd) in daily sessions during 4-6 weeks (20-30 sessions). current investigation in tbs aims to design intensive treatment protocols so as to achieve earlier responses and higher rates of efficacy. however, the implementation of tbs in the public national health service requires cost-effective protocols that ensure and facilitate patients adherence to treatment, and whose design is based on clinical and neuroimaging biomarkers of response so as to adequately select candidate patients. the aim of this study is to assess the efficacy and safety of novel bilateral and unilateral intensive and spaced protocols of tbs in outpatients with unipolar and bipolar rtd compared with sham stimulation. specific objectives: i) comparison of mood change, response and remission of depressive illness at the end of tbs protocol in the groups and maintenance of its effect at 3 months; ii) characterization of neuroimaging cerebral connectivity networks and cerebral metabolism patterns of patients with rtd related to the effects of bilateral or unilateral tbs; iii) identification of clinical and demographic predictors contributing to response to tbs; iv) analysis of the interaction between clinical, demographic and neuroimaging predictors so as to determine a rtd profile of patient that can benefit from tbs.

participants will receive 22 bilateral sessions of sham/active continuous (right dlpfc) and intermittent (left dlpfc) tbs during 6 weeks. simultaneous cerebral pet-mri will be performed before (week 0) and after the treatment with tbs (week 7) * weeks 1 and 2: 1 session 5 days a week (10 sessions) * weeks 3,4,5, 6: 1 session 3 days a week (12 sessions)

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive episode or depressive phase in bipolar disorder dsm-5 criteria. * moderate severity (\>14 points in hdrs) * 2 antidepressant failures or failure in enhancing strategies in the case of bipolar depression. * no changes in treatment 3 week previous to the onset of treatment with tms. * ability to sign informed consent. exclusion criteria: * any psychiatric comorbidity in axis i or ii. * depressive episode with psychotic features. * dysthymia. * treatment with ect in current depressive episode. * multiresistance (\> 6 trials of therapeutic strategies). * suicide risk assessed previous to each session. * patients who miss 2 tms sessions in a row * neurological comorbidities (epilepsy, parkinson disease, neurocognitive disorders). * contraindications to tms: pregnancy, metallic cervical or head implants.

Keywords: tms itbs depression bipolar depression antidepressants neuroimaging pet-mri
effects of real-time feedback assisted self-correction on the posture of scoliotic patients

Conditions: Idiopathic Scoliosis

Summary: scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls. the treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. the place of rehabilitation is disputed because the methods are multiple, non-standardized and the sessions are infrequent. in a previous study (mouvsco, ntc02134704), researchers have identified systematic postural abnormalities in patients with scoliosis, and developped a virtual-brace (medical device, md) to allow real-time self-correction of the trunk position. the aim of the present study is to evaluate for the first time the efficacy of the virtual-brace on the correction of the posture of scoliotic patients. the hypothesis is that intensified rehabilitation with the virtual-brace will improve pathological postures related to scoliosis.

the present study is the first evaluation of the efficacy of the virtual-brace on scoliotic patients. the efficacy of rehabilitation will be estimate on the correction of the posture of scoliosis patients over 6 months by comparing 2 groups: a control group of patients conventionally treated with a night-time brace (g0 group_conventional) and an experimental group of patients wearing a night-time brace, doing postural rehabilitation exercises with the virtual brace and follow-up visits with a physiotherapist (g1 group_virtual-brace).

Eligibility criteria:
inclusion criteria: * patients with idiopathic scoliosis (left lumbar or right thoracic), * patients with moderate scoliosis: cobb angle assessed on the last radiography between 20 ° and 35 °, * patients requiring the wearing of a rigid night-time brace, * patients having a home computer, * patients affiliated to social security or similarly regime, * patients who gave their consent to participate in the study, * patients whose 2 parents have signed the informed consent exclusion criteria: * patients with an unstabilized medical problem, * patients with known allergy to elastane, * patients with sensitivity to dizziness, * patients with pacemaker, * patients with implanted cardiac defibrillator, * patients with cochlear implant, * patients carrying a non-removable metal element, * protected patient concerned by articles l1121-5 and l1121-6 of the public health code, * patients whose parents are protected by article l1121-8 of the public health code

Keywords: vertebral column rehabilitation virtual-brace posture
noninvasive brain stimulation for stroke

Conditions: Stroke

Summary: noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.

noninvasive brain stimulations (nibs) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ... nibs will be applied in a placebo-controlled, double-blind, randomised fashion. behavioural data will be collected before and after nibs, as well as brain functional imaging data.

Eligibility criteria:
inclusion criteria: * stroke with at least slight deficit exclusion criteria: * epilepsy * contraindication to tdcs and/or to fmri * presence of metal in the head * unability to understand / complete behavioural tasks * chronic intake of alcohol or recreative drugs * major health condition * presence of pacemaker * pregnancy

Keywords: stroke