Kornimate/medical-research-clean huggingface dataset:
transcranial magnetic stimulation (tms) study for adults with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: this is a randomized interventional study designed to evaluate the effects of repetitive transcranial magnetic stimulation (rtms) on neural and behavioral facets of social cognition in adults with autism spectrum disorder (asd).

the primary objective of this study is to determine whether rtms increases the brain response to faces in a population of adults with asd. this study will assess critical aspects of social cognition using the electroencephalogram (eeg), event-related potentials (erps), and eye-tracking (et) prior to and following a single rtms session (or sham) to provide preliminary insight into the potential of rtms as a tool to modify social brain function in this population. participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and a pre and post tms session with eeg (electroencephalogram) and eye-tracking to measure neural and visual attentional social response. two study visits will be scheduled for each participant lasting approximately 4-5hrs total.

Eligibility criteria:
inclusion criteria: * individuals between the ages of 18 and 40 years old with typical development or with a diagnosis of autism spectrum disorder. * individuals able to participate in an eeg and eye-tracking experiment. exclusion criteria: * participants reporting significant head trauma or serious brain illness. * participants with major psychiatric illness that would preclude completion of study measures. * participants with a history of serious medical illness, stroke, seizures, epileptiform eeg abnormalities, or family history of seizures. * participants taking prescription medications that may affect cognitive processes under study. * participants who have taken alcohol or recreational drugs within the preceding 24 hours. * females of known/suspected pregnancy or who test positive on a pregnancy test. * participants with a history of metalworking or injury by shrapnel or metallic objects are also excluded. * participants with a history of prior tms therapy or use of an investigational drug within 12 weeks of visit. * participants with an iq (intelligence quotient) below 80.

Keywords: transcranial magnetic stimulation
rate control in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart rate control in patients with atrial fibrillation and a rapid ventricular rate.


Eligibility criteria:
inclusion criteria: * permanent atrial fibrillation * baseline ventricular rate (prior to treatment) \> 110 bpm exclusion criteria: * history of accessory tract re-entry tachycardia * ejection fraction \< 35% or history of nyha class iii/iv stage c/d heart failure * acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery in the past 2 months * child-pugh class b or c hepatic dysfunction * uncontrolled hypertension * thyroid disease * intolerance to beta-blockers * history of lung disease resulting in hospitalization in the past year
low-dose radiotherapy plus chemotherapy with gem-based doublets and stereotactic radiotherapy for advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: aim of this study is to evaluate if low-dose radiotherapy (ldr) can intensify local effect of a chemotherapy regimen with gem-based doublets administered sequentially with stereotactic body radiotherapy (sbrt) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (lapc).


Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of the pancreas * patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial ct imaging but were found unresectable at surgery * eastern cooperative oncology group (ecog) performance status ≤ 2. age ≥ 18 * patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting treatment * patients with radiographically assessable disease * adequate bone marrow, hepatic and renal function: -hemoglobin \>10.0 g/dl, absolute neutrophil count \> 1.5 x 10\^9/l, platelet count \> 100 x 10\^9/l. -aspartate transaminase (ast or sgot) and alanine transaminase (alt or sgpt) should be ≤ 3 x upper limit of normal (uln). -total bilirubin \ 40 ml/min (calculated according to cockroft and gault) exclusion criteria: * evidence of metastatic disease in the major viscera or peritoneal seeding or ascites * gastric or duodenal obstruction * previous peripheral neuropathy * previous irradiation to the planned field; previous chemotherapy for pancreatic cancer * malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder

Keywords: locally advanced pancreatic cancer stereotactic body radiotherapy chemopotentiator low dose radiotherapy hyper-radiosensitivity
risk evaluation for support: predicting elder life in the community tool (respect)

Conditions: Death

Summary: to develop a mortality risk prediction model that can be applied to the wide spectrum of risks that are seen in the home care setting.

abstract introduction: older adults living in the community often have multiple, chronic conditions and functional impairments. a challenge for healthcare providers working in the community is the lack of a predictive tool that can be applied to the broad spectrum of mortality risks observed and may be used to inform care planning. objective: to develop a mortality risk prediction model for older adults in the home care setting. the final algorithm will be implemented as a web-based calculator that can be used by older adults needing care, as well as their informal and formal caregivers. design: open cohort study using the resident assessment instrument for home care (rai-hc) data in ontario, canada, from january 1, 2007, to december 31, 2013. participants: the derivation cohort will consist of approximately 437 000 home care recipients from january 1, 2007, to december 31, 2012. a split sample validation cohort will include approximately 122 000 recipients from january 1 to december 31, 2013. main outcome measures: predicted survival from the time of an rai-hc assessment. all deaths (n ≈ 245 000) will be ascertained through linkage to the provincial vital statistics records. statistical analysis: proportional hazards regression will be estimated after assessment of assumptions. predictors will include sociodemographic characteristics, social support, health conditions, functional status, cognition, symptoms of decline, and prior healthcare use. model performance will be evaluated for 6- and 12-month predicted risks, including measures of calibration (e.g., calibration plots) and discrimination (e.g., c-statistics). the final algorithm will be generated by combining development and validation data.

Eligibility criteria:
inclusion criteria: * have received a structured rai-hc assessment * between 50 and 105 years of age exclusion criteria: * not eligible for ontario's universal health insurance program (ohip) * did not receive a structured rai-hc assessment

Keywords: frail older adults mortality home care survival analysis clinical prediction rule
determination of the independent effects of beetroot juice components, dietary nitrate and antioxidants, on exercise tolerance and health benefits in individuals with obesity

Conditions: Metabolic Disease; Obesity; Exercise

Summary: the purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. additionally, we will determine if the ergogenic health benefits of beetroot juice is due to the nitric oxide compound within the product, the antioxidant compound within the product, or a combination of the two compounds.


Eligibility criteria:
inclusion criteria: * bmi ≥ 30 kg/m2 * able to perform exercise testing on a cycle ergometer exclusion criteria: * currently taking medications know to affect cardiovascular or respiratory function * currently supplementing with an antioxidant compound * current smoker * currently taking antibiotics * not willing to abstain from mouthwash use * currently participating in regular physical activity
autologous transplantation of bm-ecs with platelet-rich plasma extract for the treatment of critical limb ischemia

Conditions: Leg Ulcer; Diabetic Foot; Gangrene; Peripheral Vascular Disease; Ischemia

Summary: the intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (bm-ecs) and platelet-rich plasma extract (prpe) for the treatment of critical limb ischemia.


Eligibility criteria:
inclusion criteria: limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans) 1. 18 years to 80 years (adult, senior); 2. have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ; 3. patient meets at least one of the following diagnostic criteria for the index limb: 1. abi\<0.7mmhg 2. tcpo2 \<40 mm hg 3. or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization; 4. have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging; 5. despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery; 6. unlikelihood of major amputation of the leg during the next 12 months; 7. expected life span more than 2 years. exclusion criteria: 1. pregnant or lactating; 2. diabetics with poorly controlled blood glucose levels (defined as hba1c\>7% and/or proliferative retinopathy); 3. patients with decompensated cardiac, renal or liver disease; 4. patients with confirmed malignant tumor; 5. subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation; 6. known or suspected disease of the immune system or osteomyelitis; 7. inability to sign informed consent form and to comply with the schedule of the study; 8. there has reason to suspect that the patient is forced to join the study; 9. any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.
radioactive iodine implants for pan-invasive pituitary macroadenomas

Conditions: Pituitary Macroadenoma

Summary: this study is a single arm phase ii pilot trial. patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. the tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.


Eligibility criteria:
inclusion criteria: * pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma * pan-invasive for the purposes of the protocol will be defined as meeting each of the following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and (2). suprasellar extension. in addition, a pan-invasive tumor must meet any one of the following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b) bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension in any direction unlikely to be completely removed by specifically a transphenoidal surgical approach. * patients who meet the two major criteria above (1 and 2) and are medically inoperable for tumor resection (due to confounding co-existing medical problems) are eligible without meeting any of the three minor criteria (a, b, or c). * patients should be immediately threatened for vision loss or other significant neurological impairment directly related to tumor mass effect. as such, all patients enrolled would likely benefit from tumor response (shrinkage). * patients must have visible tumor on imaging studies (mri or ct) * the patient's zubrod performance status must be 0-3. * patients must be at least 18 years of age. * mandatory imaging studies: must be done 45 or fewer days prior to : mri or ct scan of the brain including the entire skull base and all areas of tumor extension exclusion criteria: * patients who are unable to undergo general anesthesia * patients who are unable to undergo placement of a stereotactic head frame * patients who are unable to provide informed consent * patients who are pregnant or nursing * patients with severe kidney dysfunction * patients who have contraindications to mri, such as implanted pacemaker device * patients with diagnosis of pituitary carcinoma

Keywords: pituitary gland
comparison of safety and efficiency of 20w and 30w holmium laser device in management of 2-3 cm diameter kidney stones with retrograde intrarenal surgery

Conditions: Nephrolithiasis

Summary: to compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with retrograde intrarenal surgery (rirs).


Eligibility criteria:
inclusion criteria: * patients who have 2-3 cm kidney stones * patients who are between 18-90 years old exclusion criteria: * patients who have congenital urogenital abnormalities * patients who have previous surgery history for urinary stones

Keywords: holmium laser kidney stones rirs
single dose escalations study of amphotericin b colloidal dispersion in healthy subjects in china

Conditions: Invasive Fungal Disease

Summary: the purpose of this trial is to evaluate the pharmacokinetics of single intravenous of amphotericin b colloidal dispersion(abcd)in chinese healthy subjects.

primary objective: evaluation the pharmacokinetics, safety and tolerability of single intravenous of abcd in chinese healthy subjects. secondary objective: evaluation the safety and tolerability of single intravenous of abcd in chinese healthy subjects. exploratory objective:evaluation the effect of single intravenous abcd on early renal injury indicators (kim-1 and cystatin c) in chinese healthy subjects.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 19 to 26 kg/m2, inclusive 19 and 26. bmi = weight (kg)/\[height(m)\]2. * subjects are fully informed and voluntarily consent to participate in this study. exclusion criteria: * history of allergy or hypersensitivity. * presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs. * during the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc. * a positive result in hepatitis b surface antigen (hbsag), hepatitis b e antigen (hbeag), anti-hepatitis c virus (hcv) antibodies, a syphilis test, or an human immunodeficiency virus (hiv) test. * lost blood or donated more than 400 ml of blood within 3 months prior to the screening. * participation in a clinical drug study 30 days prior to present study. * use of any other drugs within 2 weeks prior to the screening. * subjects planning to give birth or donate sperm during the study or within 3 months after the study. * the partner of the subject is unwilling to take effective contraceptive measures. * other unfavorable factors diagnosed by investigators.
transfusion of fresh frozen plasma in non-bleeding intensive care unit (icu) patients

Conditions: Blood Coagulation Disorders; Hemorrhage

Summary: with the aim to restrict inappropriate fresh frozen plasma (ffp) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (icu) patients undergoing an invasive procedure. the objective is to assess the effectiveness and costs of omitting prophylactic ffp transfusion compared to current practice of prophylactic transfusion, in non-bleeding icu patients with a coagulopathy.

rationale: fresh frozen plasma (ffp) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. in past years, use of ffp has increased, in particular in patients on the intensive care unit (icu), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. retrospective studies suggest that prophylactic use of ffp does not prevent bleeding, but carries the risk of transfusion-related morbidity. however, up to 50% of ffp is administered to non-bleeding icu patients. objective: with the aim to restrict inappropriate ffp transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of icu patients with a coagulopathy undergoing an invasive procedure. the objective is to assess the effectiveness and costs of prophylactic ffp transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding icu patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube). study design: prospective, multicentre, randomized, open-label, blinded end point evaluation (probe) design.

Eligibility criteria:
inclusion criteria: * 18 years and older * inr \>1.5 and \<3.0 * undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy) exclusion criteria: * clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses) * thrombocytopenia of \< 30 x 109/l. * use of abciximab, tirofiban, ticlopidine or activated protein c * use of heparin \< 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses \< 12 hours prior to procedure * history of congenital or acquired coagulation factor deficiency or bleeding diathesis * no informed consent

Keywords: fresh frozen plasma coagulopathy intensive care adverse effects lung injury
effect of pediatric intensive care unit diaries on pics-p

Conditions: Post Intensive Care Syndrome; Narrative Medicine; Post Traumatic Stress Disorder; Anxiety; Depression

Summary: when children become very sick and need to stay in a pediatric intensive care unit (picu), it can have a big impact on their recovery and their family's well-being. sometimes kids and their families feel worried or sad even after they leave the hospital. this can have an impact on the quality of their life after hospital discharge. to help understand and improve these experiences, the investigators want to study the "picu diaries." these are journals that families and hospital staff can write in during the child's time in the hospital. parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. the content is a narrative account of what happens during the child's hospital stay, for the family to take home at picu discharge. the investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. it might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too. the study will include children who have been in the picu and their families. some families will receive these special diaries to use during their time in the hospital, while others won't. we'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference. the investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved.


Eligibility criteria:
inclusion criteria: * children/adolescents admitted to the picu * mechanical ventilation for \> 48 hours * patient's age \<19 years old exclusion criteria: * parents who are unable to communicate in italian language * parents who have not signed and informed consent * patients with a poor prognosis

Keywords: post intensive care syndrome pediatric children diary icu diary narrative medicine pediatric intensive care unit
sudden cardiac death - screening of risk factors

Conditions: Sudden Cardiac Death; Cardiomyopathies; Channelopathies

Summary: the investigators have created a way of quickly collecting information in a large scale young population regarding the presence of some severity indicators that may allow us to classify them into: seemingly "low risk" and possible "elevated risk" for the presence of heart disease. it would have to be a short questionnaire, in order to receive a great adherence but that could simultaneously provide precise information, with an adequate description of symptoms and warning signs, in a way that a triage in the young adult population could be performed in the general young adult population in order to select individuals with an indication for personalized clinical evaluation and possible need of complementary diagnostic means. based on this premise the investigators have developed a fast-response questionnaire named the sudden cardiac death screening of risk factors (scd-sos). this questionnaire has already been tested in a population of approximately 1500 young adults, and some changes have been introduced in order to refine its performance. to best of the investigators knowledge, there are no large scale european surveys estimating the prevalence of cardiac disease and associated clinical symptoms in a non-selected (non-athlete) population of this age group. purpose: to screen a young adult population from central regional of portugal for heart disease possibly associated to a high risk of sudden cardiac death (scd). to determine the national prevalence of clinical symptoms of heart disease and of heart disease with increased risk for scd in this age group. to detect young adults in risk of scd and with an indication for evaluation by a cardiologist, and possible need of: * medical treatment * electrophysiologic (ep) study and percutaneous ablation * an implantable cardiovertor defibrillator * a pacemaker * other type of specialized cardiac intervention


Eligibility criteria:
inclusion criteria: * 12 to 40 years of age * providing an informed consent exclusion criteria: * failure to meet any of the aforementioned inclusion criteria

Keywords: sudden cardiac death young adults cardiac disease arrhythmia sports