Kornimate/medical-research-clean huggingface dataset:
the arrc iii trial of advanced recovery room care (arrc).

Conditions: Post-Surgical Complication; Economic Problems

Summary: a postoperative high-acuity model of care (arrc) has been shown, in a prospective cohort study of approximately 850 patients, to produce a marked improvement in patient and hospital outcomes, and hospital costs, in medium risk patients (ludbrook g et al., jama surgery 2023). the goal of this observational study is to examine the outcomes after non-cardiac surgery of a larger group of medium risk patients receiving different forms of care -arrc and usual ward care. the main questions it aims to answer are: what are the outcomes for patients and hospital after the different forms of care, who receives benefit from high acuity care, what underlies the improved outcomes seen with high acuity care.

demand for essential surgery is growing, yet we face an increasingly complex casemix and budget challenges. new paradigms to deliver high value care are essential. advanced recovery room care (arrc) is a model of care which, at rah, has been shown to provide substantial improvements in patient outcomes, hospital utilisation, and costs of care. specifically, it showed when compared to usual ward care: improved days at home after surgery (primary outcome), decreased in-hospital complications, and decreased mortality at 1, 3 and 12 months. this model was cost-effective compared to usual ward care: icer of approximately -$250 per dah it is essential to collect high quality data on this model relevant to consumers and hospitals, in order to: * provide a robust mechanism to ensure outcomes are maintained, and ideally improved, within our institution * provide a mechanism to potentially allow benchmarking in the future, across institutions * better identify which surgical subgroups receive benefit from arrc * provide a resource to generate and test hypotheses as to how these benefits are achieved. to that end, the arrc ii study database is to be refined to function in essence as an ongoing registry. this will be initially piloted at rah, the subject of this study.

Eligibility criteria:
inclusion criteria: * scheduled for elective or unplanned surgery * scheduled to stay in hospital at least one night after surgery * 30-day mortality of 0.5% to 8% by the us national safety and quality improvement program risk score (nsqip) exclusion criteria: * undergoing cardiac surgery * scheduled for postoperative intensive care unit management

Keywords: postoperative complications safety health economics quality of recovery after surgery surgery anaesthesia
artificial intelligence (ai) empowered smile simulations: do they accurately predict actual post treatment outcomes

Conditions: Malocclusion

Summary: the aim of the present study is to assess the predictability of invisalign® smileview™ for digital ai smile simulation in comparison to actual smile treatment outcomes, using various smile assessment parameters.


Eligibility criteria:
inclusion criteria: * healthy systemic condition with no chronic diseases * no previous orthodontic treatment * adequate oral hygiene * a healthy periodontium. exclusion criteria: * chronic diseases * previous orthodontic treatment * poor oral hygiene * periodontal diseases
dual-loop target controlled infusion in laparoscopic cholecystectomy (dltci)

Conditions: Cholecystolithiasis

Summary: laparoscopic cholecystectomy applied to artificial pneumoperitoneum and the extent of surgical stimulation cause the wave of hemodynamics increase vigorously, which make it difficult to judge the depth of anesthesia according to traditional hemodynamics index such as heart rate and blood pressure.in case of this, the investigators design this research to study the closed-loop target controlled infusion to anaesthesia of individualization guided by a narcotrend index monitor in laparoscopic cholecystectomy.

anesthetics alter electrocortical activity in a dose-dependent manner,and it is suggested that electroencephalographic(eeg)activity can provide a reliable basis for a surrogate measurement of hypnosis.an eeg monitor,the narcotrend index(ni),has proven useful to titrate hypnotic drugs.because it is a single composite measure monitored continuously,it has been used in controlled studies to automatically guide propofol administration.conversely,automated delivery systems for opioids have seldom been described using eeg activity there are no specific measures to quantify analgesia directly.nevertheless,in the interaction between opioid-hypnotic synergy and loss of consciousness,when the dose of analgesic administered is sufficient to inhibit autonomic response to noxious stimuli,then the required hypnotic concentration is only that needed to achieve loss of consciousness.moreover,a noxious stimulus such as laryngoscopy or periosteal pressure to the tibia may cause electrocortical activation with an increase in narcotrend index,which indirectly reflects the analgesic state or the level of antinociception.finally,an excitatory eeg arousal reaction resulting from nociceptive stimulation can provide a rational basis for analgesia administration.it can then be hypothesized that narcotrend index could also be the controlled variable for opioid administration.

Eligibility criteria:
inclusion criteria: 1. require general anesthesia 2. expected to last\>30 minutes 3. 18\~90 years 4. asa ⅰ\~ⅳ level exclusion criteria: 1. psychiatric illness 2. supraspinal neurological disorders 3. cranial neurosurgical procedures 4. patients equipped with a pacemaker

Keywords: dual-loop tci ni laparoscopic cholecystectomy
improving metabolic control in diabetic young children

Conditions: Type 1 Diabetes Mellitus

Summary: : although intervention or prevention with young children with t1dm may help ameliorate problems or forestall later problems in metabolic control, a number of potential barriers to research have constrained the development of such interventions. to assess the feasibility of intervening with young children and their families, we propose to conduct an exploratory pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed with t1dm. the intervention, derived from the pediatric prevention work of seligman and his colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy, and parent-child collaboration in diabetes management, in order to improve quality of life, adherence, and metabolic control. this exploratory study will allow us to evaluate the feasibility of intervening with young children and their caretakers and to estimate intervention effect sizes in preparation for a randomized controlled clinical trial.


Eligibility criteria:
inclusion criteria: * children aged 7 to 11 * recently diagnosed with t1dm * treated at mount sinai or at north general hospital exclusion criteria: * children below age 7 and above age 11 * individual with diminished mental capacity, such that they would not be able to either complete the assessments or comprehend the materials presented in the intervention, will be excluded. * individuals without sufficient command of the english language to permit participation (due to the verbal nature of the intervention and the assessment package, and the linguistic limitations of the study team).

Keywords: type 1 diabetes mellitus (t1dm) metabolic control adherence optimism parent-child collaboration prevention
effectiveness of dry needling in shortened triceps surae muscle

Conditions: Trigger Point Pain, Myofascial; Myofascial Pain Syndrome

Summary: to date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points. a randomized clinical trial is carried out. a sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15). outcome measurements such as dorsal flexion range of motion, plantar pressures, temperature, superficial muscle activity and trigger points pressure pain threshold are measured immediately before and after treatment.


Eligibility criteria:
inclusion criteria: * myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal flexion range of motion. exclusion criteria: * neurologic disorders, pharmacologic treatment (within the previous 3 months), cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases, autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet agents, and fear of needles.
transforaminal epidural steroid injection to treat hemiplegic shoulder pain

Conditions: Hemiplegic Shoulder Pain

Summary: the purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic hemiplegic shoulder pain.

shoulder pain is the most common complication in hemiplegia after stroke (cva). almost three quarters of all patients with hemiplegia will suffer from shoulder pain in the first twelve months after stroke. because of the lack of effective treatment today, the optimal management of hemiplegic shoulder pain is prevention. although widely studied, all clinical trials for shoulder pain in stroke fail to show efficacy. tf was never investigated to treat hemiplegic shoulder pain (hsp). the investigators hypothesize that injecting the epidural space at the c6 level via transforaminal would desensitize both central medullary components of pain as peripheral sensitized structures such as the suprascapular nerve of the affected shoulder. to test this hypothesis, the investigators developed a treatment protocol consisting of two c6 transforaminal epidural steroid injection with dexamethasone (tf with 0.5ml of lidocaine 1% and 1.5ml of dexamethasone 10mg/ml). this procedure was compared to a sham intervention.

Eligibility criteria:
inclusion criteria: * 3 months of shoulder pain following a stroke * hemiplegia or paresis after a cerebral stroke for at least 6 months * shoulder pain greater than 4 in a visual analogue scale * 50 to 65 years old exclusion criteria: * inability to understand or answer the tools in the study * local inflammation or infection * history of malignancy * use of cardiac pacemaker * allergy to lidocaine or dexamethasone * disorders of coagulation

Keywords: hemiplegic shoulder pain transforaminal treatment interventional
treatment with ziprasidone for schizophrenia patients with obsessive compulsive disorder (ocd)

Conditions: Schizophrenia; Obsessive Compulsive Disorder

Summary: comparing schizophrenic patients with comorbid ocd and schizophrenic patients without ocd in response to ziprasidone and in cognitive functioning as compared with ocd patients


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia and ocd for at least 6 months * minimum score of 14 on ybocs * minimum score of 60 on panss * diagnosis of schizophrenia without oc symptoms exclusion criteria: * patients who are already being treated with ziprasidone * diagnosis of schizophreniform disorder * organic brain syndrome, mental retardation and pervasive developmental disorder * patients having any significantly cardiovascular illness or electrolyte imbalance
pas for lower extremity rehabilitation in tetraplegic patients

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Summary: the investigators have recently shown in incomplete sci patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1,2). in this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level sci and investigate its effectiveness for lower extremity rehabilitation.


Eligibility criteria:
inclusion criteria: * cervical incomplete sci exclusion criteria: * epilepsy * metal inclusion in the head area * pacemaker * hearing device * high intracranial pressure
nutrition and physical activity intervention in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with prednisone and/or dexamethasone

Conditions: Leukemia; Lymphoma

Summary: this trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with treated with prednisone and/or dexamethasone. a nutrition and physical activity intervention may help develop healthier eating habits and prevent rapid excess weight gain in pediatric patients with leukemia or lymphoma who are receiving prednisone and/or dexamethasone.

primary objectives: i. to evaluate if a nutrition counseling intervention will prevent an increase in waist circumference from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone. secondary objectives: i. to conduct qualitative research on diet habits, likeability of low-fat and-low sucrose foods. ii. to conduct qualitative research on exercise habits and willingness to engage in moderate walking. iii. to assess receptivity to electronic dietary and physical activity (pa) interventions in pediatric cancer patients and survivors (pcpss) and their parents. iv. to determine if nutrition interventions will prevent an increase in body mass index (bmi) from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone. v. to determine if a nutrition counseling intervention will help maintain or decrease triglyceride and cholesterol levels, prevent abnormal values of hemoglobin a1c and improve absolute lymphocyte counts (alc) from baseline measurements for pediatric leukemia or lymphoma patients, receiving prednisone and/or dexamethasone therapy. vi. to evaluate caloric intake, nutritional parameters and oxidative stress in pediatric leukemia or lymphoma patients receiving prednisone and/or dexamethasone therapy. vii. to evaluate responses to various energy balance interventions. outline: patients are randomized to 1 of 2 arms. arm i: patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. patients may receive nutrition handouts. arm ii: patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 pa sessions over 1 hour for each session.

Eligibility criteria:
inclusion criteria: * leukemia or lymphoma patient at md anderson children's cancer hospital * patients receiving prednisone and/or dexamethasone therapy at md anderson children's cancer hospital at time of enrollment * karnofsky performance status greater than or equal to 70 * must be cleared by treating oncologist to participate in study * must live close enough to attend measurement sessions at one of the clinical centers exclusion criteria: * patients receiving nutrition counseling or weight management counseling elsewhere * pediatric patients who are already receiving steroids that are not part of treatment * history of psychological disorders as indicated in the medical record (eg: eating disorders, depression)
healthy human control blood collection for validation of biomarker assay

Conditions: Healthy

Summary: human blood will be collected to serve as control in validating clinical studies studying the detection and levels of circulating tumor cells and microvesicles in cancer patients. targeted population is cancer-free 18-60 year old men and women. volunteer selection will rely upon a short health questionnaire. about 20 ml blood will be collected from volunteers up to 20 different timepoints. the procedure involves minimal risk of harm (eg discomfort, bruising) to the volunteer.


Eligibility criteria:
inclusion criteria: * age range: 18-60 years old gender: male and female exclusion criteria: * no previously diagnosed malignancy age: it is important to obtain a healthy, cancer-free volunteer population to serve as negative controls for this detection assay.

Keywords: cancer-free 18-60 year old men and women
post-marketing observational study of safety following vaccination with flublok® compared to licensed iiv in adults

Conditions: Human Influenza

Summary: the primary objective of this study is to retrospectively characterize the safety of flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (iivs), using a methodological approach designed to query the database of electronic health records (ehr) maintained by kaiser-permanente, northern california (kpnc), a large medical care organization (mco).

the primary analysis is a nonrandomized, observational retrospective cohort study. data on adults 18 years of age and older who were enrolled in the kpnc database during the risk intervals after vaccination analyzed for this study who were vaccinated with flublok or an iiv (either iiv3 or iiv4) will be identified for analysis. the rates of occurrence of specific maes of interest in pre-specified risk intervals following flublok and iiv will be compared.

Eligibility criteria:
inclusion criteria: data from the ehr of all adult kpnc members 18 years of age and older, who received flublok for active immunization against influenza as part of routine medical care within the kpnc system. the comparator cohort will include data from all adults in the same age group who received any iiv (trivalent or quadrivalent) during the period of flublok administration. exclusion criteria: healthcare providers are expected not to administer flublok or iiv to individuals with known contraindication to either vaccine (see product package inserts). however, there will be no exclusions other than age and kpnc membership criteria at the time of vaccination.
safety and efficacy study of autologous cultured adipose -derived stem cells for the crohn's fistula

Conditions: Crohn's Fistula

Summary: up to date, a sure cure for crohn's fistula has not known and the fistula recurrence rate is high. on 15 october 2008, orphan drug designation was granted by korea fda to anterogen co. ltd., for human adipose-derived stem cell. in this study, patients are given injection of adipoplus in fistula site and followed for 8 weeks to test the safety and efficacy.


Eligibility criteria:
inclusion criteria: * older than 18 years * prior diagnosis of crohn's disease * patients who have crohn's fistula * negative for urine beta-hcg for woman of childbearing age * agreement to participate, with signed informed-consent exclusion criteria: * patients who have allergy to bovine-derived materials or an anesthetic * patients with a diagnosis of auto immune disease except for crohn's disease * diagnosis of hbv, hcv, hiv and other infectious disease * patients who have a symptom of septicemia * patients with a diagnosis of active tuberculosis * patients who are pregnant or breast-feeding * patients who are unwilling to use an "effective" method of contraception during the study * patients with a diagnosis of inflammatory bowel disease except for crohn's disease * patients who is sensitive to fibrin glue * patients who have a clinically relevant history of abuse of alcohol or drugs * insufficient adipose tissue for manufacturing of adipoplus * patients who are considered not suitable for the study by investigator * patients who have history of surgery for malignant cancer in the past 5 years
a clinical comparison of two daily disposable soft contact lenses

Conditions: Myopia

Summary: this double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon a and stenfilcon a) when fitted to existing wearers of comfilcon a monthly lenses.

this double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon a and stenfilcon a) when fitted to existing wearers of comfilcon a monthly lenses. after a month of re-useable lens wear in the comfilcon a lenses, subjects were randomized to wear each daily disposable lens type for one week.

Eligibility criteria:
inclusion criteria: * subjects will only be eligible for the study if: * they are between 18 and 40 years of age (inclusive). * they understand their rights as a research subject and are willing and able to sign a statement of informed consent. * they are willing and able to follow the protocol. * they are an existing soft reusable spherical contact lens wearer in both eyes. * they have a contact lens spherical prescription between -0.50 to -6.00d (inclusive) based on the ocular refraction. * they have a cylindrical correction of -0.875dc or less in each eye based on the ocular refraction * they own a wearable pair of spectacles and wear them on the day of the initial visit. * they have distance high contrast logmar visual acuity of 0.2 or better in each eye with their habitual spectacles. * they agree not to participate in other clinical research for the duration of the study. exclusion criteria: * they have an ocular disorder which would normally contra-indicate contact lens wear. * they have a systemic disorder which would normally contra-indicate contact lens wear. * they are using any topical medication such as eye drops or ointment. * they are aphakic. * they have had corneal refractive surgery. * they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * they are pregnant or breastfeeding. * they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. * they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.