Kornimate/medical-research-clean huggingface dataset:
transcranial magnetic stimulation for evaluation and treatment of repetetive behaviors in autism

Conditions: Autism; Asperger Disorder; Other Developmental Pervasive Disorder

Summary: this study is a trial of low frequency repetitive transcranial magnetic stimulation( rtms) for subjects with autism spectrum disorders, specially targeting repetitive behaviors.

this project is a 3-week double blind cross-over trial for adolescents and adults who meet criteria for autism and have clinically prominent repetitive behaviors. the investigator will apply low frequency rtms for 20 minutes 5 times a week for 3 weeks targeting the area of brain which was involved in repetitive behaviors. the investigator will obtain clinical measures of repetitive behaviors as well as social functioning pre and post treatment. as a control and a cross-over condition , we will stimulate other area of brain which has nothing to do with repetitive behaviors but may improve social functioning in autism spectrum disorders. in addition to r tms we will perform a pre and post treatment perfusion functional mri and obtain tms measure of excitability of brain.

Eligibility criteria:
inclusion criteria: 1. english speaking 2. capacity to give consent and sign hipaa authorization 3. patients currently taking psychotropic medications must be at the same stable dose and likely to be able to continue at the same dose throughout the study 4. asd diagnosis according to the dsm-iv tr symptom and criterion checklist for asd 5. significant level of repetitive behaviors to distinguish from movement disorders to be in at least 3 out of 6 sub-scales (stereotyped behavior, self-injurious behavior, compulsive behavior, ritualistic behavior, sameness behavior, restricted behavior) - exclusion criteria: 1. women of child-bearing potential not using birth control, pregnant or breast feeding 2. h/o bipolar disorder (lifetime), any psychotic disorder (lifetime) history of major depressive disorder or of substance abuse or dependence within the past year 3. significant sub-average intellectual function (iq\<70) 4. intracranial implants 5. increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, febrile seizure, increased intracranial pressure or history of significant head trauma with loss of consciousness for \> 5 minutes. 6. current significant laboratory abnormality 7. neurological disorder including but not limited to space occupying brain lesion, any history of seizures, history of cerebrovascular accident, fainting, cerebral aneurysm, dementia, huntington chorea, multiple sclerosis -

Keywords: tms transcranial magnetic stimulation rtms recurrent transcranial magnetic stimulation fmri functional magnetic resonance imaging.
immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64, plus revaccination

Conditions: Influenza

Summary: immunogenicity and safety of a cell-derived influenza vaccine in adults aged \>= 18 and \<= 64 years, plus revaccination


Eligibility criteria:
inclusion criteria 1. willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. men and women aged \>= 18 and \<= 64 years. 3. being in good health as judged by medical history, physical examination and clinical judgment of the investigator. exclusion criteria 1. known to be allergic to constituents of the vaccine. 2. a serious adverse reaction after a previous (influenza) vaccination. presence of any significant condition that may prohibit inclusion as determined by the investigator. 3. having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Keywords: influenza phase ii placebo-controlled
probe-based confocal laser endomicroscopy in critically ill covid-19 patients

Conditions: COVID-19

Summary: the study is devoted to the comparative analysis of the data received in patients with covid-19 lung pathology using the method of probe-based confocal laser endomicroscopy of distal airways and two reference methods: high resolution computed tomography and morphology (in some patients).


Eligibility criteria:
inclusion criteria: * patient informed consent; * the diagnosis of covid-19 or one of the following lung diseases: chronic obstructive pulmonary disease, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis x, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease * high resolution computed tomography scans performed not later than one month before pcle (for non-covid-19); * planned or performed histology (for non-covid-19) * severe respiratory failure, exclusion criteria: * pregnancy or breast feeding, * lung bleeding, * any acute or chronic disease that may be a contraindication to bronchoscopy, * any diseases of hematopoietic system, * taking part in other clinical trials
a trial using velcade plus chemoradiation for central nervous system, head and neck, and cervical cancer patients

Conditions: Brain Cancer; Head and Neck Cancer; Cervix Cancer; Central Nervous System Neoplasms

Summary: the purpose of this study is to determine the safety of velcade when used with chemoradiation in cancer patients.

* to determine the maximum tolerated dose (mtd) and a recommended phase ii dose (rp2d) of velcade® when administered as a twice weekly 3-5 second iv bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation. * to evaluate the safety and toxicity profile of velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation. * to evaluate tumor response

Eligibility criteria:
inclusion criteria: * histologically confirmed malignancy * requiring at least grade 2 weeks of radiation therapy * solid tumors of the central nervous system, head and neck area, and cervix * world health organization (who) performance status equal to or less than 2 exclusion criteria: * equal to or greater than grade 2 peripheral neuropathy * myocardial infarction within 6 months * hypersensitivity to bortezomib, boron, or mannitol

Keywords: malignancies of the central nervous system, head and neck area and cervix
safety and adequacy of trans-jugular liver biopsy in patients with liver disease: safe-tjlb study

Conditions: Liver Cirrhosis

Summary: liver biopsy is considered the gold standard for the evaluation of acute and chronic liver disorders. liver biopsy provides information regarding diagnosis, disease progression, and response to therapy in patients with chronic liver diseases. trans-jugular liver biopsy (tjlb) consists of obtaining liver tissue through a rigid cannula introduced into one of the hepatic veins typically using jugular venous access. this approach reduces the risk of hemorrhage after biopsy because the bleeding resulting from the biopsy needle will drain into the hepatic veins. in the past, the specimens obtained by a transjugular approach were considered suboptimal compared with the samples obtained with percutaneous needles because they were smaller and more fragmented. tjlb was initially indicated for patients who had a contraindication to percutaneous biopsy such as those with a coagulopathy or congenital clotting disorders, ascites, acute liver failure, large amount of adipose tissue, and patients after liver transplantation. the clinical role of tjlb has expanded due to the possibility of performing hemodynamic evaluation of the hepatic and portal venous systems, which provides useful information and may guide therapy in patients with portal hypertension. lacuna in literature: there is no prospective study in india evaluating the safety and efficacy of trans-jugular liver biopsy in patients with liver disease.

hypothesis: trans-jugular liver biopsy is safe, gives adequate sample for pathological examination in patients with liver disease. aim of study: to evaluate safety and adequacy of trans-jugular liver biopsy in patient with liver disease. primary objective: 1. adequacy of trans-jugular liver biopsy 2. safety of trans-jugular liver biopsy secondary objective: 1. indications of liver biopsy 2. procedural time (in and out of catheter) 3. number of passes 4. failure rate 5. day care time 6. vas: pain (abdomen and neck, pre and post procedure) 7. complications- arrythmia, hematoma 8. time of fluro exposure patients and methods study design a prospective, observational cohort study will be conducted in patients with suspected or known liver disease between november 2023 to may 2024 at the institute of liver and biliary sciences (ilbs), new delhi. clinical protocol an informed consent was taken from patients with liver disease undergoing liver biopsy as per clinical indication. the following demographic data was recorded at inclusion: age, gender, co-morbidities, type, and etiology of liver disease. laboratory parameters include complete blood count, liver function tests, kidney function tests, inr. severity of liver disease (meld score, ctp score, aarc score).

Eligibility criteria:
inclusion criteria: 1. 18-65 years age. 2. patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication. exclusion criteria: - none
the effects of probiotic supplementation on the results of gastric bypass surgery

Conditions: Gastric Bypass Surgery

Summary: in this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.


Eligibility criteria:
inclusion criteria: * bmi\> 40 or \>35 plus other morbidities * undergoing the gastric bypass surgery * willing to participate in the study exclusion criteria: * history of any chronic gi or kidney disorders, malignancies, or immune deficiencies * taking any immunomodulatory or immunosuppressor medications * taking antibiotics from 4 weeks before and during the intervention * being on special diet such as vegetarian diet * doing as a professional athlete * pregnancy and lactation
cardiac magnetic resonance for early detection of chemotherapy or radiation therapy induced cardiotoxicity in breast cancer (carebest)

Conditions: Chemotherapy Induced Cardiotoxicity

Summary: chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in patients with cancer. the clinical significance of cardiotoxicity is growing with increasing cancer survivor-ship. left ventricular (lv) functional assessment is the standard of reference to diagnose chemotherapy- or radiation therapy-induced cardiotoxicity. the investigators will investigate the usefulness of t1 mapping parameters for early detection and prediction of chemotherapy-, radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients this study aimed to achieve early detection of chemotherapy- or radiation therapy-induced cardiotoxicity using t1 mapping magnetic resonance imaging (mri) and determine a prognostic imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients treated for breast cancer.

screening and follow-up cardiac magnetic resonance imaging (cmr) protocols for diagnosis of cardiotoxicity will be conducted in patients with breast cancer who have received or are planned to receive treatment for breast cancer. the protocol will include t1 and t2 mapping and cine imaging of the lv myocardium.

Eligibility criteria:
inclusion criteria: * patient with breast cancer exclusion criteria: * contraindication of mri * failure with informed consent * fail to scan screening protocol
stabilimax investigational device exemption (ide) clinical investigation patient followup study

Conditions: Spinal Stenosis

Summary: the intent of this study is to complete the collection of clinical data on subjects enrolled in the stabilimax dynamic spine stabilization ide clinical trial (#g060214) sponsored by the now defunct applied spine technologies inc . the applied spine assets, including the clinical trial data, were acquired by rachiotek, llc in 2010. when applied spine ceased their funding of the trial, a number of enrolled patients had not yet completed the two year follow-up visit defined as the study endpoint in the clinical investigation plan. no additional patient treatment is required to complete the study. rachiotek has interest in pursuing ide approval for a new study and the information collected in this study is essential for supporting the new investigational device exemption application.


Eligibility criteria:
inclusion criteria: * any patient that after having met all of the inclusion/exclusion criteria identified for the stabilimax investigational device exemption study had enrolled in the stabilimax investigational device exemption study and were implanted with the stabilimax nz or the control device. exclusion criteria: * any patient that has had the device removed and the adverse event follow-up report stated that the event was resolved. this applies only if the patient was formally withdrawn from the study at that time.
anti-pd-1 antibody and pegaspargase combined with radiotherapy in early-stage enktl

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Summary: aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage nk/t cell lymphoma.all eligible patients will be treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles followed by standard radiotherapy with or without concurrent sintilimab and pegaspargase administered every 3 weeks. after radiotherapy, patients with complete remission with positive plasma ebv-dna or partial response will continue with sintilimab maintenance up to 2 years.

this is a multicentre, open-label, single-arm, phase ii clinical study to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage nk/t cell lymphoma.all eligible patients will be firstly treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles. if the patient achieves complete remission（cr）, standard radiotherapy will be performed, otherwise, they will receive concurrent chemoradiotherapy（ccrt）(radiation 50 gy and two cycles of sintilimab and pegaspargase every 3 weeks). after radiotherapy or ccrt, patients achieving cr with positive plasma ebv-dna or partial response will continue with sintilimab maintenance up to 2 years.

Eligibility criteria:
inclusion criteria: * newly diagnosed enktl * age:18-80years * ann arbor stage ie,or stage iie * at lease one measurable lesion * receive no chemotherapy or radiotherapy before * eastern cooperativeoncology group performance status of 0 to 2. * adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/l, and platelet count≥ 100×10e9/l),renal function (eg, serum creatinine≤1.5 mg/dl and creatinine clearance ≥50 ml minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal) exclusion criteria: * mismatch the inclusion criteria * non-nasal type disease * systematic central nervous system involvement * previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Keywords: sintilimab pegaspargase definitive intensity-modulated radiotherapy (imrt)
screening for individual susceptibility factors to immersion pulmonary edema

Conditions: Pulmonary Edema

Summary: immersion pulmonary edema (ipe) is a relatively new form of hemodynamic pulmonary edema. the number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. the pathophysiological mechanisms of ipe are not completely known. its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. the main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. the impact of internal factors is not known. at this time, no severe forms of ipe have been identified in the military. however, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. the risk of recurrence (greater than 15%) could result in a severe or even lethal accident.


Eligibility criteria:
inclusion criteria: * military or civilian diver with at least 100 dives * between the ages of 18 and 60 * good physical condition (able to run/swim for 30 minutes at a constant pace). exclusion criteria: * divers with a current temporary medical incapacity to dive * persons with contraindications to physical exercise and/or scuba diving * pregnant or breastfeeding women
effect of mentoring on endotracheal tube exchange using a new device

Conditions: Effects of Training

Summary: the purpose of this pilot study is to compare the time it takes to change a breathing tube with a new device, performed by two different groups of anesthesiologists; one group will study on their own how to change the tube, while the second group will also receive expert training, before either group performs the procedure for the very first time. the investigators predict the group who gets expert training will change the tube faster, and those investigators also need to learn how much faster, before moving to a larger study.

after informed consent is obtained, two groups of randomized anesthesiologists will receive detailed instructional materials including a brochure to introduce the new device, a videotape showing how the device is used, a detailed slide show explaining each of the steps, and a checklist of the steps to perform during the exchange (e) in simulation. the mentored group (m) will also receive expert instruction just before the procedure, while the control group (c) will have the same amount of time to review the steps themselves. next, they will perform the first exchange procedure (e1) while the pair of experts observe and measure the simulated patients' apnea time. the experts will then conduct a debriefing with the m group, while the c group will debrief themselves before both groups perform the exchange a second time (e2). both groups will then receive debriefing by the experts. the apnea times and a performance assessment will be compared between m and c to determine the effects of expert training, and will also be compared within each group from e1 to e2, to determine the effect of experience on apnea time and performance. finally, surveys conducted after e1 and e2, and before debriefing, will determine the participants' satisfaction with the new device. data on apnea times will be used for a statistical power analysis to determine the size of a larger group necessary to show significant differences in outcomes.

Eligibility criteria:
inclusion criteria: * physician airway management experts * training in the skill of fiber-optic endoscopic intubation exclusion criteria: * non-physicians * physicians without airway management expertise * physicians without skill in fiber-optic endoscopic intubation

Keywords: mentoring endotracheal tube exchange training
strut coverage with synergy stents and bioresorbable vascular scaffold in acute myocardial infarction

Conditions: Acute Coronary Syndrome

Summary: to assess strut coverage in patients presenting an acute myocardial infarction and treated either with the synergy stent or the bioresorbable vascular scaffold, through a parallel group design.

single center, simple-blind randomized controlled trial, comparing the synergy stent with the bvs device through a parallel group design.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome with st-elevation, * one culprit lesion eligible for percutaneous coronary intervention (pci) with stent implantation, * reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity, * thrombolysis in myocardial infarction (timi) 3 flow before stent deployment in the target vessel, * patient with at least 1 lesion eligible for planned pci next to the culprit lesion, * patient affiliated to the french national health care system, * patient agreed to participate after full information on the study (signature of an informed consent). exclusion criteria: * acute coronary syndrome with st-elevation, * one culprit lesion eligible for percutaneous coronary intervention (pci) with stent implantation, * reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity, * timi 3 flow before stent deployment in the target vessel, * patient with at least 1 lesion eligible for planned pci next to the culprit lesion, * patient affiliated to the french national health care system, * patient agreed to participate after full information on the study (signature of an informed consent).

Keywords: acute coronary syndrome st (software test) -elevation
enhanced recovery after surgery for spine fusion surgeries in the elderly

Conditions: Spinal Stenosis

Summary: elderly patients in our hospital who received spinal fusion surgery after the year 2025 will receive eras treatment.


Eligibility criteria:
inclusion criteria: * elderly patients who received spinal fusion surgeries exclusion criteria: * patients who received non-fusion surgeries

Keywords: spine fusion surgery
prospective clinical utility study to assess the impact of decipher on treatment decisions after surgery

Conditions: Prostate Cancer

Summary: the influence of decipher test on urologist and patient treatment plan choices immediately post rp and at the time of psa rise or bcr

this prospectively decision impact study will evaluate physicians and patient treatment plan choices before and after reviewing decipher results for eligible patient cases. the clinical utility of decipher will be evaluated for patients meeting the inclusion criteria at two time-points post-rp: 1. in the adjuvant setting: within 12 months after surgery (in the absence of detectable psa rise of bcr) 2. in the salvage setting: post-rp with evidence of psa rise or bcr (defined as psa detectable and rising on 2 or more subsequent determinations) a total of 150 patient cases, in each arm, will be prospectively selected from clinical sites. the study as a whole will enroll 300 patient cases. as a condition of participation in the study, each clinical site must agree to provide a minimum of 10 patient cases.

Eligibility criteria:
inclusion criteria: 1. pathological t3 stage of disease (i.e., epe or svi), or 2. positive surgical margins, or 3. detectable psa, defined as psa detectable and rising on 2 or more subsequent determinations exclusion criteria: 1. for adjuvant setting patients: metastatic disease (m+) prior to surgery 2. for salvage setting patients: metastatic disease at psa rise 3. failure of psa to nadir after surgery 4. received any neo-adjuvant prostate cancer treatment before radical prostatectomy 5. received any adjuvant chemotherapy 6. required patient clinical data is not available for evaluation of eligibility criteria 7. for adjuvant setting patients, any treatment received after surgery 8. for salvage setting patients, lack of documented treatment or management recommendation on file 9. tissue specimen is inadequate for sampling and analysis