Kornimate/medical-research-clean huggingface dataset:
differences in prosocial behaviors and related brain networks in children with autism and typical development

Conditions: Autism Spectrum Disorder; Healthy

Summary: the goal of this observational study is to compare the brain functional network between children with autism and typical development, using magnetic resonance imaging (mri), electroencephalogram/event-related potentials(eeg/erps) and functional near infrared spectrum(fnirs). the main questions it aims to answer are as follows: 1. what are the differences of the functional brain network between autism and td children? 2. what are the differences of the brain activity in response to special social stimulus between autism and td children? participants will receive developmental/intelligence assessments (griffiths mental developmental scales/wechsler preschool and primary scale of intelligence-iv/wechsler intelligence scale for children-iv for children of different ages), social assessments(autism diagnostic observation schedule-2nd edition/social communication questionnaire), eeg/erps and fnirs in resting and task states, and head mri in natural sleeping state(without sedative).

the cross-sectional observational study will be performed to compare the differences of functional brain network and reactions to social stimulus between children with autism and typical development. the investigators will recruit children aged between 2 to 17 years and 11 months old. they need to receive the mentioned assessments and medical examinations for at least once.

Eligibility criteria:
case group: inclusion criteria: 1. children diagnosed with asd according to a clinical judgement based on the criteria of asd in dsm-5 and further confirmed with ados-2; 2. ages 2-17 years; 3. parents/caregivers understand the content of the study and agree to participate in. exclusion criteria: 1. rett syndrome, fragile x syndrome, angelman syndrome, prader-willi syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases; 2. children with brain injuries, specific chronic or congenital diseases. 3. the gestational age is less than 37 weeks, or the birth weight is lower than 2500g. 4. children cannot receive the head mri examination. control group: inclusion criteria: 1. healthy children age between 2 to 17 years. 2. children without the family history of asd or other neurodevelopmental/mental diseases. 3. parents/caregivers understand the content of the study and agree to participate in. exclusion criteria: 1. children with brain injuries, specific chronic or congenital diseases. 2. the gestational age is less than 37 weeks, or the birth weight is lower than 2500g. 3. children cannot receive the head mri examination.

Keywords: autism
oxygenation of paravertebral muscles during exercise in chronic low back pain patients

Conditions: Low Back Pain; Rehabilitation Program; Muscular Weakness

Summary: the study evaluate paraspinal aerobic metabolism of chronic low back pain patients and healthy people during an original and standardized isokinetic protocol. the aim of this study is to determine a potential alteration of muscular aerobic metabolism in low back pain patients, in order to establish the underlying cause of pain and muscular fatigability characterizing low back pain patients. then, the aim is to determine if functional rehabilitation program can improve it. the unit of care have access to metabolic adaptations in measuring the muscular oxygenation and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.


Eligibility criteria:
inclusion criteria: * for low back pain patients: suffering from low back pain for at least 3 month * for control subject: no back pain in the past year exclusion criteria: * chronic cardiovascular, pulmonary, metabolic, neurologic disease

Keywords: isokinetic oxygenation deoxygenation aerobic metabolism
personalized treatment of urogenital cancers depends on the microbiome

Conditions: Microbial Disease

Summary: this is a randomized controlled trial where patients undergoing surgical treatment for urogenital cancers will be randomized in a two arms study: surgical treatment + antibiotics or surgical treatment + placebo.


Eligibility criteria:
inclusion criteria: * biopsy verified diagnosis of urological cancer, localized disease exclusion criteria: * hospitalization within three months of surgery * antibiotics within three months of surgery * infectious disease, including uti's within three months of surgery * history of cancers of the genitourinary tract * diabetes
d-serine treatment for tardive dyskinesia

Conditions: Schizophrenia and Schizoaffective Disorder; Tardive Dyskinesia

Summary: presently no generally effective treatments for tardive dyskinesia (td) are available. d-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic nmda receptor. previous studies have suggested that d-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs. the hypothesis under investigation in the present study is that d-serine adjuvant treatment may improve td in schizophrenia patients diagnosed with this disorder.


Eligibility criteria:
inclusion criteria: 1. age 18-70; 2. diagnosis of schizophrenia/schizoaffective disorder according to dsm-iv criteria; diagnosis will be made on the basis of scid interview and information from medical records, previous treating psychiatrists, and family informants; 3. history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks; 4. fulfillment of schooler-kane td research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment. exclusion criteria: 1. meeting criteria for other dsm-iv axis i diagnoses; 2. presence of a neurological disorder or history of significant head injury; 3. substance abuse or alcoholism during entire lifetime; 4. are judged clinically to be at suicidal or homicidal risk; 5. female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.
study with cin-107 following multiple oral ascending doses in healthy subjects

Conditions: Hypertension

Summary: this is a randomized, double-blind, study to assess the safety, tolerability, pk, and pd of multiple oral doses of cin-107 when administered to healthy adult subjects.


Eligibility criteria:
inclusion criteria: 1. healthy subjects between the ages of 18 and 55 years, inclusive, in good health based on medical and psychiatric history, physical examination, ecg, orthostatic vital signs, and routine laboratory tests (blood chemistry, hematology, coagulation, and urinalysis). 2. body mass index (bmi) between 18 and 30 kg/m2, inclusive. 3. nonsmokers who have not used nicotine-containing products for at least 6 months prior to the screening visit. exclusion criteria: 1. actively participating in an experimental therapy study; received experimental therapy with a small molecule within 30 days of day 1, or 5 half-lives, whichever is longer; or received experimental therapy with a large molecule within 90 days of day 1, or 5 half-lives, whichever is longer. 2. a personal or family history of long qt syndrome, torsades de pointes, or other complex ventricular arrhythmias, or family history of sudden death. 3. history of, or current, clinically significant arrhythmias as judged by the investigator, including ventricular tachycardia, ventricular fibrillation, or atrial fibrillation. 4. prolonged qtcf (\>450 msec) based on the average of triplicate ecgs. 5. seated blood pressure higher than 150/90 mmhg or lower than 90/50 mmhg. 6. resting heart rate higher than 100 bpm or lower than 50 bpm , sinus node dysfunction, or clinically significant heart block. 7. temperature (t) greater than 37.6o c (99.68o f, measured orally), and respiration rate less than 12 and greater than 20 breaths/minute. 8. postural tachycardia (ie \>30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic blood pressure (sbp) of ≥20 mm hg or dbp of ≥ 10 mm hg when a person assumes a standing position). 9. serum potassium \> upper limit of normal of the reference range (uln) and serum sodium \< lower limit of normal of the reference range (lln). 10. aspartate aminotransferase (ast) and alanine aminotransferase (alt) values \> 1.2 uln. 11. positive for human immunodeficiency virus (hiv) antibody, hepatitis c virus (hcv) antibody, or hepatitis b surface antigen (hbsag). 12. a known history of porphyria, myopathy, or an active liver disease. 13. positive drug or alcohol test result or a history of alcoholism or drug abuse within 2 years prior to the first dose of study drug as defined by the diagnostic and statistical manual of mental disorders, 4th edition: dsm-iv. 14. typical consumption of ≥14 alcoholic drinks weekly. 15. surgical procedures within 4 weeks of check-in or planned elective surgery during the study period. 16. currently undergoing treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery). 17. pregnant, breastfeeding, or planning to become pregnant during the study.

Keywords: pharmacokinetics (pk), metabolism, baxdrostat
the effect of bevel direction on the pathway of the nasotracheal tube

Conditions: Epistaxis; Intubation Complication

Summary: in this study, the subjects are divided into two groups (group i: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and group ii: conventional group = the bevel of the tube toward the left side of the subject). after the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.

primary outcome * incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril) secondary outcome * intubation time * incidence of epistaxis * severity of bleeding * resistance during insertion of the tracheal tube

Eligibility criteria:
inclusion criteria: * a patient who will take operation which needs nasotracheal intubation under general anesthesia exclusion criteria: * a patient who didn't agree to participate in this study * a patient who has a deformity of the nose * a patient who has a history of severe epistaxis * a patient who has coagulation problem * a patient who has a history of the fracture or surgery of the skull base

Keywords: epistaxis
extension study of bomedemstat (img-7289/mk-3543) in participants with myeloproliferative neoplasms (img-7289-ctp-202/mk-3543-005)

Conditions: Thrombocythemia, Essential; Primary Myelofibrosis

Summary: this is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat (mk-3543, formerly called img-7289) administered orally once daily in participants with an mpn who participated in a prior bomedemstat study such as, but not limited to, img-7289-ctp-102 and img-7289-ctp-201 (referred to hereafter as 'feeder studies').


Eligibility criteria:
inclusion criteria: * completed at least one treatment period (tp) in a prior bomedemstat myeloproliferative neoplasm (mpn) protocol (such as, but not limited to, img-7289-ctp-102/mk-3543-002 or img-7289-ctp-201/mk-3543-003). * in the estimation of the investigator, the risk-benefit favors continued dosing with bomedemstat. exclusion criteria: * ongoing participation in another investigational study (except observational studies). * a history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted). * current use of a prohibited medication (e.g., romiplostim). * medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol. * females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. * women of childbearing potential (wocbp) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.
screening for systemic amyloidosis via the ligamentum flavum

Conditions: Amyloid; Amyloidosis; Spinal Stenosis; Transthyretin Amyloidosis; Primary Amyloidosis of Light Chain Type

Summary: the investigators will prospectively evaluate for the presence of amyloid deposits in ligamentum flavum (yellow ligament) tissue samples obtained from patients undergoing spinal stenosis surgery. patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.

similar to carpal tunnel syndrome, spinal stenosis is associated with systemic amyloidosis and presents earlier than cardiac amyloidosis symptoms - 21-45% of attr patients and case reports in al patients. the investigators' recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 70% of the amyloid-positive group had a history of spinal stenosis and 40% required surgical intervention. surgical intervention for spinal stenosis could provide an opportunity to screen for amyloidosis through yellow ligament (ligamentum flavum) biopsy. this study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for non-congenital spinal stenosis and spondyloarthropathy. the investigators hypothesize that 10% of such patients will be positive for amyloidosis.

Eligibility criteria:
inclusion criteria: * age ≥50 years * undergoing surgical intervention for non-congenital spinal stenosis and/or spondyloarthropathy * able to consent exclusion criteria: * history of congenital spinal stenosis or congenital spondyloarthropathy

Keywords: biopsy surgery screening
observational surveillance study to detect potential safety signals in patients who have had at least one dose of gardasil™ (v501-031)

Conditions: Human Papillomavirus Infection

Summary: this is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used gardasil™.


Eligibility criteria:
inclusion criteria: 3-dose safety population * female 9-26 years at the time of first dose of gardasil™ * completed the 3-dose regimen of gardasil™ per protocol pregnancy safety population * received at least one dose of gardasil™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution autoimmune safety population * female who has received at least one dose of gardasil™ * has been a member of same managed care organization (mco) for at least 12 months prior to the receipt of gardasil™ any dose safety population * female who has received at least one dose of gardasil™ exclusion criteria: 3-dose safety population * male * receives incomplete regimen of gardasil™ * completes the three dose regimen of gardasil™ in more than 12 months * less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3 * younger than 9 or older than 26 years of age at receipt of first dose pregnancy safety population * males * no record of pregnancy at the managed care organization (mco) autoimmune safety population * member of the same mco for less than 12 months prior to receiving the first dose * male

Keywords: human papillomavirus (hpv)
combination therapy with nc-6004 and pembrolizumab in head and neck cancer subjects who have failed platinum regimen

Conditions: SCCHN

Summary: in phase iia, dose-escalation study to determine the optimum tolerated dose and a recommended phase iib (rpiib) dose in combination with pembrolizumab in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck who have failed platinum or a platinum containing regimen. in phase iib, randomized control study between nc-6004 in combination with pembrolizumab versus pembrolizumab alone in the same subject population as part 1 at the rpiib dose identified in piia.


Eligibility criteria:
inclusion criteria: * be willing and able to provide written informed consent for the trial. * males or females aged ≥18 years at screening. * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * have histologically- or cytologically-confirmed hnscc. * have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) hnscc of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies. * having prior platinum failure. exclusion criteria: * subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, nonsquamous histologies. * have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent. * have no more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in part 1 of the study and from randomization in to part 2. * are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment. * were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.
walking estimated limitation calculated by history - study 2

Conditions: Peripheral Artery Disease

Summary: the purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (welch) in patients referred for vascular investigations.

two questionnaires the welch and the "walking impairment questionnaire" (wiq) are submitted to patients referred for vascular investigations for suspêcted peripheral arterial disease (pad). comparison of score to hemodynamic parameters (first goal) or maximal walking distance (mwd) on treadmill (secondary goal). scoring of the wiq is performed according to references. scoring of the welch has been submitted for copyright protection (involves a series of 4 additions a subtraction and a single multiplication)

Eligibility criteria:
inclusion criteria: * french native language * 18 years old or older * signed consent * covered by the french social care system exclusion criteria: * unable to participate for administrative reasons * psychiatric troubles * pain at rest or critical limb ischemia * unable to walk (ex: wheelchair subjects) note: previous inclusion in the protocole is note an exclusion criterion for a new participation.

Keywords: questionnaire peripheral artery disease execise
5 year registry study to track clinical application of decisiondx-um assay results and associated patient outcomes

Conditions: Uveal Melanoma

Summary: uveal melanoma is a rare cancer with approximately 3,000 cases diagnosed in the us every year. nearly half of these experience spread of their cancer outside the eye. the decisiondx-um gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. this study is being done to collect information about how physicians are using the decisiondx-um results to design individual treatment plans. it will also track outcomes or the uveal melanoma population that received decisiondx-um testing.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of uveal melanoma * patients whose physician deems them appropriate for decisiondx-um testing * patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data exclusion criteria: * patients with any other form of cancer

Keywords: occular melanoma melanoma of eye decisiondx-um
efficacy and safety of ultra_hypofractionated radiotherapy in women with breast cancer receiving regional nodal radiation vs nodal moderate hypofractionated radiotherapy

Conditions: Malignant Breast Neoplasm

Summary: the reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. thus, as a reference institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 gy / 5 fractions in one week, in a controlled manner, through this project.the investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.

this is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.

Eligibility criteria:
inclusion criteria: * information to the patient and signed informed consent; * women aged ≥18 years; * breast conserving surgery; * invasive adenocarcinoma (except classic invasive lobular carcinoma); * tnm (tumor, nodes, metastasis) pathologic stage pt1-3 and pn1-3a m0, with indication of lymphatic drainage according to institutional protocol; * eastern cooperative oncology group (ecog) 0 -1; * minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia); * no previous breast or mediastinal radiotherapy; * no hematogenous metastases; * ability to carry out long-term follow-up; exclusion criteria: * previous local irradiation; * concomitant chemotherapy. concomitance with trastuzumab or hormone blockade will be allowed; * histology of metaplastic carcinoma; * history of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed. * diagnosis of autoimmune and connective tissue diseases; * diagnosis of genetic alterations in cell repair genes (ex: fanconi anemia, ataxia teleangiectasia); * indication of internal breast irradiation.

Keywords: dose splitting acute and late toxicity locoregional drainage irradiation breast neoplasm overall survival disease-free survival locoregional control