Kornimate/medical-research-clean huggingface dataset:
long-term olanzapine treatment in children with autism

Conditions: Autism

Summary: this study will determine the short- and long-term safety and effectiveness of the drug olanzapine (zyprexa®) for reducing symptoms of autism in children.

autism is a serious childhood disorder that can significantly impair functioning and development. educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. haloperidol is the drug most commonly prescribed for symptoms of autism. however, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. the investigation of alternative drug treatments is necessary. this study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children. this study will last 36 weeks and will comprise 2 phases. in phase i, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. participants who do not respond to treatment will complete their participation in the study. participants who respond to their assigned phase i treatment will continue onto phase ii. all phase ii participants will receive olanzapine daily for 6 months. self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.

Eligibility criteria:
inclusion criteria: * diagnosis of autism * parent or guardian willing to provide informed consent exclusion criteria: * uncontrolled seizure disorder * medical illness other than autism affecting the whole body * obesity * history of psychosis * impairment of voluntary movement * history of olanzapine treatment

Keywords: drug treatment child olanzapine
evaluating the feasibility of vr for pediatric renal biopsies

Conditions: Pain, Procedural; Procedural Anxiety; Sedation Complication

Summary: the purpose of this study is to assess the use of virtual reality (vr) as an adjunct or alternative to pharmacologic sedation in pediatric patients undergoing renal biopsy.

children aged 5-17 scheduled for renal biopsy will be offered the option to use a virtual reality (vr) headset that displays an interactive game as part of their renal biopsy experience. the standard of care of sedation medications will still be available to patients who are unable to complete the procedure with only the vr headset without pharmacologic sedation. pain and anxiety will be monitored continuously using validated scales by a pediatric hospitalist and sedation nurse. these providers, as well as patients and parents, may ask for additional medications for adequate analgesia and anxiolysis.

Eligibility criteria:
inclusion criteria: - patients age 5-17 receiving a renal biopsy at the university of california, san francisco (ucsf) benioff children's hospital exclusion criteria: * patients who cannot lie supine for their renal biopsy will be excluded from the study * patients with injuries to the head/face that would prohibit wearing a headset * patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma * patients with open skin, lice, scabies, or other infectious skin conditions on the head/face * patients with a history of or current symptoms of vertigo * patients who are blind * patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver * patients on whom the vr headset does not fit appropriately
percutaneous cryoablation of intercostal nerves for the treatment of rib fractures

Conditions: Trauma; Rib Fractures; Chest Wall Disorder; Respiratory Insufficiency; Pain, Chest; Rib Trauma; Rib Fracture Multiple; Respiratory Failure; Respiratory Distress Syndrome

Summary: the goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. the main questions it aims to answer are: does percutaneous cryoablation improve short and long term pain scores? does percutaneous cryoablation improve short and long term respiratory mechanics? does percutaneous cryoablation improve long term quality of life? does percutaneous cryoablation decrease delirium? researchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery. participants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.


Eligibility criteria:
inclusion criteria: * \> 18 years old * \> 2 rib fractures * verbal pain score \> 5 * incentive spirometry \< 60% of predicted exclusion criteria: * isolated fractures of ribs 1-3 and/or 10-12 * posterior rib fracture \< 4 cm from costovertebral joint * sternal, clavicle, scapula fracture * thoracic spinal fracture of any type * open abdominothoracic surgery * unstable spine * extensive subcutaneous emphysema * bmi \> 35 * plan for rib plating * chronic opioid use * prior to study enrollment: intubated, traumatic brain injury, dementia, cognitive impairment, encephalopathy * coagulopathy, shock at time of ablation * inability to participate in activities of daily living prior to injury * home o2 use prior to trauma * inhalation injury * rib fractures due to cardiopulmonary resuscitation * life expectancy \< 6 months * \> 48 hours from injury * pregnant, incarcerated

Keywords: trauma respiratory failure respiratory distress respiratory insufficiency rib fractures chest wall trauma percutaneous cryoablation multimodal pain therapy multimodal pain regimen
cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis from ovarian cancer (cyto-chip 2)

Conditions: Peritoneal Carcinoma; Ovarian Cancer

Summary: epithelial ovarian carcinoma (eoc) is one of the main cause of death from cancer in women in the western world. it is often diagnosed at an advanced stage and the disease remains confined to the peritoneal cavity for much of its natural history. despite a high rate of response to first-line therapy, about 20% of eoc are naturally resistant to platinum and about 2/3 of patients with initial response will recur within 5 years. most tumour recurrences will develop resistance to systemic platinum over time. the prognosis of these patients with persistent or recurrence disease remains poor despite salvage therapy including alternative systemic chemotherapy and further cytoreductive surgery (crs). since twenty years, centers have pursued comprehensive crs combined with hyperthermic intraperitoneal chemotherapy (hipec) for the management of peritoneal surface malignancies (psm). this combined approach is the standard of care for the management of some rare peritoneal disease such as pseudomyxoma peritonei or peritoneal mesothelioma. eoc should be an ideal target for this loco-regional treatment, as most of its evolution remains confined to intraperitoneal cavity and because of its sensitivity to chemotherapy. intraperitoneal chemotherapy has been shown to have significant efficacy in frontline eoc in 3 large randomized studies. recently, french clinical guidelines have been edited to recommend crs+hipec in patients with ovarian, tubal or primitive carcinomatosis figoi iiic, initially not resectable (grade b). hipec adds some advantages to this intraperitoneal chemotherapy: the hyperthermia effect with its direct cytotoxicity demonstrated in vitro, the synergistic effect with some anticancer agents and, the deliverance immediately following crs, avoiding the problem of "cancer cell entrapment" by postoperative or posttherapeutic adhesions that limits distribution of chemotherapy agents to all sites. the use of hipec for eoc was reported into relatively small case-series from single institutions. results from a single centre cannot be extrapolated to other centres because of the heterogeneity of patient's selection and hipec techniques.


Eligibility criteria:
inclusion criteria: * confirmed peritoneal carcinomatosis from ovarian cancer * metachronous/synchronous peritoneal carcinomatosis * grade figo (international federation of gynecology and obstetrics) iii or iv * peritoneal cancer index (pci) available * indication for cytoreductive surgery +/- hipec * complete macroscopic cytoreduction: ccr (cytoreduction score) -0/1 exclusion criteria: * non complete macroscopic cytoreduction: ccr (cytoreduction score) -2 * peritoneal mesothelioma, pseudomyxoma peritonei * extra peritoneal metastases
multicentric registry of patients with acute leukemia infected by covid-19

Conditions: Acute Myeloblastic Leukemia; Acute Lymphoblastic Leukemia; SARS-CoV-2

Summary: the covid-19 epidemic (coronavirus disease 2019) currently raging in france is an emerging infectious disease linked to a virus of the genus coronavirus (sars-cov-2). epidemiologically, acute myeloblastic leukemias (aml) are the most common of acute leukemias. the incidence of acute lymphoblastic leukemia (all) is 900 new cases in france in 2018, of which 57% in humans. the treatments administered to aml and all patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. patients with aml or all therefore represent a population at high risk of developing a serious form in the event of infection with sars-cov-2. to date, no data is available in the literature to assess the impact of the covid-19 epidemic in the population of patients with acute leukemia. the main objective of the study is to determine the clinical and biological prognostic factors during sars-cov-2 infection in patients with acute leukemia.


Eligibility criteria:
inclusion criteria: * diagnosis of acute leukemia according to who criteria 2016 ≤ 5 years * diagnosis of a proven or probable sars-cov-2 infection according to the following criteria: 1. proven infection: positive polymerase chain reaction (pcr) regardless of the radio-clinical picture (other tests made available later and having good diagnostic performance will be accepted) 2. probable infection: negative pcr but association of 1. evocative clinical signs, of recent installation: fever, respiratory signs (cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache, diarrhea / abdominal pain, frank asthenia, loss of taste / smell, conjunctivitis, type of frostbite and 2. evocative radiological signs, on ct: diffuse or diffuse aspect of frosted glass, condensations including pseudo-nodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on chest radiography: interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral and 3. absence of differential diagnosis exclusion criteria: * none
clinical-pathological characterization and outcomes of renal cell carcinoma in latin american

Conditions: Kidney Neoplasms

Summary: observational study, retrospective and prospective, of an analytical nature. data will be collected from medical records and/or through contact with physicians and institutions (secondary data collection). patients included retrospectively or prospectively will be followed during the data collection period for the evaluation of treatments and survival. no intervention is planned in this protocol.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age; * proven histology of renal cell carcinoma (any subtype); * pathological diagnosis of renal cell carcinoma in january 2015 or later and new cases diagnosed during the period of recruitment of each center; * have the medical record available and suitable for collecting data on patient characteristics, treatment and outcome. exclusion criteria: * synchronous or other primary tumor within the last 3 years (except thyroid cancer or non melanoma skin).
discontinuation of tnf-alpha inhibitors in patients with spondyloarthritis

Conditions: SPONDYLOARTHRITIS

Summary: spondylarthropathy (spa) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. in most of the patients disease activity alternates, and some patients have symptom free periods. tumor-necrosis-factor-alpha (tnf-alpha) antagonists have significantly improved the treatment options for patients with spondyloarthritis. tnf-alpha antagonist therapy is costly, implies an increased risk of infections, including reactivation of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. it is highly relevant to explore to which extent anti-tnf-alpha therapy can be discontinued in spa patients without immediate relapse of disease activity. two studies have investigated discontinuation of a tnf-alpha antagonist (infliximab and etanercept) in ankylosing spondylitis, reporting flares in the majority of patients within the 1-year follow-up period, with the longest times to relapse in patients with the lowest disease activity. the effect of adalimumab discontinuation has never been studied, and, furthermore, the effect of tnf-alpha-antagonist discontinuation has never been studied in patients with early spondyloarthritis not fulfilling the new york criteria.


Eligibility criteria:
inclusion criteria: 1. at least 12 months of treatment with infliximab, etanercept and adalimumab. 2. diagnosis of spondylarthritis according to the european spondyloarthritis study group (essg) criteria or modified new york criteria 3. no clinical active disease, defined as a basdai score \< 4. 4. among other issues: age \>18 years; written informed consent, adequate birth control; no contraindications for anti-tnf-alpha-therapy exclusion criteria: 1. treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening 2. oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening 3. pregnancy or lactation 4. hiv, hepatitis b or c, tuberculosis, other infections 5. malignancies 6. other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease) 7. contraindications to anti-tnf-alpha-therapy 8. contraindications to mri
study of anlotinib plus irinotecan in patients with esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: to compare the effects and safety of anlotinib plus irinotecan versus irinotecan in patients with esophageal squamous cell carcinoma(escc).

in recent years, anti-angiogenic therapy has made some progress in the treatment of advanced esophageal squamous cell carcinoma.in clinical use, the efficacy of antiangiogenic monotherapy was low, with a median progression-free survival (pfs) of only 3 to 4 months.we conducted a randomized, open clinical trial to evaluate efficacy and safety of anlotinib hydrochloride combined with irinotecan versus irinotecan monotherapy in patients with advanced esophageal squamous cell carcinoma.

Eligibility criteria:
inclusion criteria: * histological documentation of esophageal squamous cell carcinoma; * at least one measurable lesion (by recist1.1); * patients who have failed to a chemoradiation treatment; * 18-75，ecog ps:0-1,life expectancy of more than 12 weeks; * no treated with molecular targeted drugs; * main organs function is normal; * patients should participate in the study voluntarily and sign informed consent; exclusion criteria: * allergic to anlotinib and/or its excipients; * patients with any severe and/or unable to control diseases，including： 1. blood pressure unable to be controlled ideally(systolic pressure \>140 mmhg，diastolic pressure\>90 mmhg); 2. patients with grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including qt≥450ms for male， qt≥470ms for female) and patients with grade 3 or higher congestive heart failure (nyha classification) or lvef\<50%; * patients with a clear gastrointestinal bleeding tendency include the following situations: local active ulcer lesions, and fecal occult blood (+ +) ; the patient had a history of black and hematemesis within 2 months; * patients with a bleeding tendency and inr\>1.5,aptt\>1.5 uln ; * patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.); * patients with active brain metastasis, cancerous meningitis, spinal cord compression patients or found in screening stage; * patients treated with vegfr inhibitor; * patients with drug abuse history and unable to get rid of or patients with mental disorders; * patients participated in other anticancer drug clinical trials within 4 weeks; * patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment;

Keywords: anlotinib
effectiveness of tele-rehabilitation apply to stroke inpatient

Conditions: Stroke

Summary: our study is aimed to explore the differences in effects on the motor function and general condition after telerehabilitation for inpatients with stroke.

background: most patients after stroke suffer from poor motor recovery and difficulty in performing activities of daily living. early intervention has a better prognosis for them. however, patients may miss the regular rehabilitation programs due to covid-19. tele-rehabilitation could be a substitution for regular rehabilitation in epidemic situation, by which patients after stroke could have a functional improvement in upper limb motions, adls, and complex activities. furthermore, there is no evidence yet of the effectiveness of telerehabilitation applied to inpatients after stroke. purposes: this study is aimed to know if telerehabilitation could improve the motor function and general condition in inpatients after stroke and to explore the intervention methods for telerehabilitation. methods: inpatients after stroke would be recruited from a hospital of a medical university in northern taiwan. they will be divided into the telerehabilitation group (n = 12) and the bedside rehabilitation group (n = 12). each patient will go on treatment in 10 sections, and each section is 15 or to 30 minutes. a single-blinded evaluator will do the pre-and post-evaluation during the treatment. the evaluations include the postural assessment scale for stroke patients (pass), functional ambulation category (fac), modified barthel index (mbi), patient health questionnaire-9 (phq9), and borg rating of perceived exertion (rpe). in the end, a satisfaction questionnaire will be given. data analysis: nonparametric tests will be used in the comparison of the pre-and post-evaluation data intergroup. the analysis will be carried out using spss statistic (v20.0) and α \< .05. key words: tele-rehabilitation, stroke, inpatients

Eligibility criteria:
inclusion criteria: * first time stroke survivors with hemiplegia after 5 days; * participant or his/her caregiver have ability to hold and reposition the smartphone, tablet, or notebook, and understand verbal instructions by therapists; * participant could sit at the bedside, or his/her caregiver could company aside during session. exclusion criteria: * patients are older than 85 years old and less than 20 years old; * the specific movement functions considered in this study are affected by any reasons of other neurological, cardiopulmonary, cancers or musculoskeletal system disease.
effects of a 12-week suspension versus free weight training program on body composition and handgrip strength in older men

Conditions: Effect of Different Exercise Programs on Body Composition

Summary: the present investigation lasted a total of 16 weeks, of which 4 were employed for assessment and measurements and 12 weeks were used for the exercise treatment. the participants underwent two different training programs carried out in three weekly 75-min sessions, on alternate days (mondays, wednesdays and fridays, in the morning). each session of both training programs consisted of a warm-up at the beginning and general stretching at the end. the exercises used in the suspension training program were: squat, rear deltoid row, biceps curl, chest press, low row, rotational ward, split squat whit y deltoid fly, triceps pushdown. the exercises used in the free weight training program were: squat with support, unilateral squat, hip adduction and abduction, calves, hip flexor, alternating curl, french triceps press, and high row. eleven participants were included in the control group.


Eligibility criteria:
inclusion criteria: * not having chronic disabling diseases * not being bedridden institutionalized or hospitalized * have their own mobility, without assistance from people, even if they have the aid of devices -without amputations. exclusion criteria: * the use of pacemakers and the presence of chronic and uncontrolled metabolic diseases
adolescent mite allergy safety evaluation

Conditions: Allergic Rhinitis; Allergic Rhinoconjunctivitis

Summary: this is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. the purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies. the trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.

this trial is a 28-day, single-arm open-label phase iii trial to evaluate safety of the house dust mite slit-tablet in adolescents (12-17 years of age) with hdm allergic rhinitis/rhinoconjunctivitis with or without asthma. approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite slit tablet. the trial is conducted in several european countries.

Eligibility criteria:
inclusion criteria: * written informed consent * male or female subjects aged ≥12 to ≤17 years * a clinical history of allergic rhinitis/rhinoconjunctivitis (ar/c) when exposed to hdm * positive skin prick test (spt) to dermatophagoides pteronyssinus and/or dermatophagoides farinae at screening * lung function measured by forced expiratory volume in 1 second (fev1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication * the subject must be willing and able to comply with trial protocol and adhere to imp treatment main exclusion criteria: * a subject who has previously been included in studies with the hdm slit-tablet, or otherwise being treated with the marketed hdm slit-tablet (e.g. acarizax, odactra) * any slit or scit treatment with d. pteronyssinus or d. farinae reaching the maintenance dose within the last 5 years. in addition, any slit or scit treatment with d. pteronyssinus or d. farinae within the previous 12 months prior to visit 1 * ongoing treatment with any allergy immunotherapy product at screening * severe chronic oral inflammation * a diagnosis or history of eosinophilic oesophagitis * any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration * female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial * sexually active female of childbearing potential without medically accepted contraceptive method

Keywords: allergic rhinitis house dust mite adolescent pediatric