Kornimate/medical-research-clean huggingface dataset:
early interventional treatment for cancer pain

Conditions: Cancer Pain

Summary: the purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer.

this is a single arm pilot study evaluating a new system of referral and pain evaluation for patients with advanced solid tumors and moderate-to-severe pain who are not already on high-dose opioids to an anesthesia-trained interventional pain management specialist . a variety of interventional treatments for pain have been proven effective for cancer patients. often without early referral patients do not get evaluated for interventional procedures for their pain unless the pain is very severe, or they are admitted to the hospital. it is expect this intervention will work by providing effective pain treatments to patients sooner than they might normally be referred and will be evaluated by how many patients are candidates for interventional treatments for their pain, whether patients choose to receive these treatments, and whether patients find the pain specialist referral acceptable and helpful the research study procedures include screening for eligibility, study interventions including evaluations and follow up visits, as well as surveys at the beginning, middle, and end of the study. participants will be followed on the study for 4 months. it is expected that about 30 people will take part in this research study. medtronic and is providing funding for this research study

Eligibility criteria:
inclusion criteria: * diagnosis of a metastatic, or locally advanced unresectable malignancy * anticipated prognosis of more than 6 months according to the primary oncologist * age greater than 21 years * persistent pain with an average pain rating of 4 or greater on an 11-point numeric rating scale (nrs) from 0-10 where 10 is considered the most severe. * pain has persisted for at least 2 weeks * pain is due to cancer or sequelae of cancer treatment exclusion criteria: * primary pain syndrome is sensory peripheral neuropathy * patient is taking more than 200 morphine milligram equivalents (mmes) per day on average, at the time of recruitment. * currently cared for by interventional pain management specialist * receipt of prior pain intervention (e.g. celiac neurolysis) * bleeding diathesis, uncontrollable infection, or other contra-indications to pain interventions * history of opioid misuse disorder * inability to speak english * cognitive impairment or any other disorder that would impede study participation and survey completion * if patients are unable to complete the baseline survey, they will no longer be considered eligible for the study; this will serve as an indication of barriers to participation that would make them unable to comply with study procedures.

Keywords: cancer pain
adhd presma response inhibition therapy

Conditions: Attention Deficit Hyperactivity Disorder

Summary: adhd children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. this ability to control involves an area in the brain called the pre-supplementary motor area (pre-sma). scientists have previously shown that the pre-sma is abnormal in adhd patients. in this study, we will use transcranial magnetic stimulation (tms) to stimulate the pre-sma and determine the effects on measures that are related to inhibitory control.

adhd children (ages 12-17 years) will be recruited. cognitive testing and basic anatomic brain mri will be performed during visit 1. during visit 2, baseline tms-based physiologic measures will be obtained. children will also complete a behavioral task (stop signal task) while electroencephalography (eeg) data is collected. after these baseline measures, two trains of intermittent theta burst stimulation (itbs) will be delivered. (intermittent theta burst stimulation is a form of repetitive tms.) the first train of itbs will be randomized to sham vs. active in a 1:1 ratio. the second train of itbs is active for all participants. after both itbs trains are completed, repeat tms-based measures, stop signal task and eeg data will be collected again. visit 3 will be one week after visit 2. visit 3 is a virtual computer-based visit to assess for any potential side effects.

Eligibility criteria:
inclusion criteria: 1. adhd diagnosis 2. ages 12-17 years 3. stimulant use is allowed but must be discontinued 24 hours prior to and during days of tms visit exclusion criteria: 1. medical conditions contraindicated or associated with altered tms risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition 2. presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants) 3. for biological females who are post-menarche, current pregnancy based on urine pregnancy test. 4. baseline problem of hearing impairment or chronic tinnitus 5. any clinically significant finding on brain mri 6. history of dsm-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder 7. non-stimulant medication(s) for adhd (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics) 8. neuroleptic/antipsychotic medication(s) 9. inability to undergo mri 10. active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician 11. substance abuse or dependence within the past year, based on 1) separate screening process of asking parent/guardian and participant, and 2) positive urine drug screen. exception will be made for positive urine drug screen due to prescribed adhd medication

Keywords: adhd transcranial magnetic stimulation
teplizumab in pediatric stage 2 type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to assess the safety and pharmacokinetics (pk) of teplizumab in participants with stage 2 type 1 diabetes who are \<8 years of age.

this is a single-arm, non-randomized, open-label, multicenter study in the u.s. to assess the safety and pharmacokinetics of teplizumab in pediatric participants with stage 2 type 1 diabetes (t1d) (two t1d-related autoantibodies and dysglycemia) who are 0 to \<8 years of age. anti-drug antibodies/neutralizing antibodies (ada/nab) will also be assessed. approximately 20 participants will be enrolled. the regimen consists of an intravenous infusion of teplizumab once daily for 14 consecutive days. the study duration for each individual may last up to approximately 26 months. the safety, tolerability, pk, ada, and t1d clinical feature data will be summarized using descriptive statistics.

Eligibility criteria:
inclusion criteria: 1. participant is a male or female 0 to \< 8 years of age, inclusive, at day 1 2. participant has stage 2 t1d (two t1d-related autoantibodies and dysglycemia) exclusion criteria: 1. participant has any autoimmune disease other than t1d with the exception of stable thyroid or celiac disease 2. has an active infection and/or fever 3. has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv). 4. has any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant.

Keywords: type 1 diabetes stage 2 pediatric type 1 diabetes t1d at-risk
evaluation of the efficacy of serotoninergic antidepressants in bulimia nervosa, according to brain serotonin profile determined by positron emission tomography with [18f] mppf.

Conditions: Bulimia Nervosa

Summary: bulimia nervosa (bn) is a serious mental illness characterized by massive food crises followed by anxiety and compensatory behaviours (vomiting more often). recent data show an increasing prevalence and a serious prognosis, due to excess mortality by suicide but also somatic complications. two types of treatments are validated : serotoninergic antidepressants (ssri) and psychotherapy. many clinical trials confirm the effectiveness of the ssri. but many studies also emphasize the important proportion of non-responders to ssri, few of them analyze the reasons for this non-answer. to better understand the mode of action of ssri, we should analyse the serotonergic activity in the central nervous system in bulimia. recently, specific brain 5ht1a serotonin receptor ligands (\[18f\] mppf or \[11 c\] way-100635), were used in positron emission tomography (pet) to characterize the serotonergic abnormalities of bulimic patients. the ligand \[18f\] mppf has the feature to be sensitive to the level of endogenous serotonin. a first pilot study using pet with \[18f\] mppf realized between the university hospital of saint etienne and lyon cermep showed a diffuse increase of the binding potential of \[18f\] mppf in bulimic patients, suggesting a decrease in serotonin activity. the brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate gyrus and orbitofrontal gyrus. these areas are involved in major bulimic symptoms (impulse, taste, instinct, anxiety and satiety). however, we noticed an interindividual heterogeneity of cortical binding of \[18f\] mppf. in front of the heterogeneity in terms of efficacity of ssri and brain serotoninergic activity, it seems necessary to continues investigations, to determine if there is a link between brain serotonin profile and responding to ssri in bulimia nervosa.


Eligibility criteria:
inclusion criteria: * patient affiliated or entitled to a social security scheme * bulimic patients according to dsm-iv tr: minimum 2 bulimic crises (compulsive eating followed by compensatory behavior) / week for 3 weeks * patients who signed informed consent to the study * bmi greater than or equal to 18.5 kg / m² exclusion criteria: * against-indication to the ssri or fluoxetine * ssri consumption in the previous three months * other addiction (except tobacco, for reasons of feasibility) * diagnosis of binge eating disorder or ednos (dsm-iv-tr) * patients with heart failure * against-indication for pet and / or mri: pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia * subjects with suspected pregnancy or in the second half of their menstrual cycle in the absence of oral contraceptives; positive β-hcg test before the exam

Keywords: bulimia serotoninergic brain activity fluoxetine serotoninergic antidepressant brain serotonin profile positon emission tomography
h-28 delta st-c and minima retrospective study.

Conditions: Osteoarthritis, Hip

Summary: the study aims to assess the clinical and radiographic outcomes of delta st-c in combination with minima stem at 3 years after primary tha surgery, and to evaluate the overall survivorship of the implant.


Eligibility criteria:
inclusion criteria: * underwent to a tha with delta st-c cup and minima stem in 2017 onwards * both genders * any race * a diagnosis in the target hip of one or more of the following: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis 2. rheumatoid arthritis 3. post-traumatic arthritis 4. fractures of femoral neck 5. congenital or acquired deformity * patient willingness to participate exclusion criteria: * local or systemic infection * septicaemia * persistent acute or chronic osteomyelitis * confirmed nerve or muscle lesion compromising hip joint function * vascular or nerve diseases affecting the concerned limb * poor bone stock (for example due to osteoporosis) compromising the stability of the implant * metabolic disorders which may impair fixation and stability of the implant * any concomitant disease and dependence that might affect the implanted prosthesis * metal hypersensitivity to implant materials * required revision of previous standard femoral stem * age \< 18 years old * any clinically significant pathology based on clinical history that the investigator feels may affect the study evaluation including, but not limited to: 1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery 2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device 3. known metabolic disorders leading to progressive bone deterioration * hip replacement on the contralateral side performed within less than one year
the efficacy and safety of pulsed radiofrequency combined with platelet-rich plasma for infraorbital neuralgia

Conditions: Infraorbital Neuralgia; Platelet-rich Plasma

Summary: this is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of prp injections combined with prf treatment with prf alone in patients with iona who are responded poorly to conventional therapies and are reluctant to receive destructive therapies for seeking a better minimally invasive treatment strategy.

infraorbital neuralgia (iona) is one of a rare but devastating type of facial pain and lack of current consensus on the management. previously, we have proved the efficacy of pulsed radiofrequency (prf) in treatment of iona. however, refractory patients have not received more ideal treatment until now. platelet-rich plasma (prp), as supraphysiological concentration of platelets, can provide prolonged neuropathic pain relief with almost no complications. to date, the efficacy of prp combined with prf in the treatment of iona has not yet been proved. we will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of prp combined with prf in treating refractory iona patients who were reluctant to receive destructive therapies.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years; 2. paroxysmal or persistent stabbing pain in the distribution area of the infraorbital nerve and positive response to diagnostic block (1 ml of 2% lidocaine) prior to treatment; 3. nrs score≥7; 4. scheduled for prf treatment for iona； 5. signed informed consent. exclusion criteria: 1. platelet count \<105\*109/l, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders; 2. severe cardiopulmonary or hepatorenal dysfunction; 3. infection at the puncture site; . 4. neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor; 5. history of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc; 6. history of mental disorders； 7. history of narcotic drug abuse; 8. unable to cooperation.

Keywords: infraorbital neuralgia; platelet- rich plasma
dissemination of a tailored tobacco quitline for rural veteran smokers

Conditions: Nicotine Dependence; Tobacco Use

Summary: the project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural veteran smokers. in addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. the investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. the investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Eligibility criteria:
inclusion criteria: * veteran status * 18 + years of age * smoke cigarettes on at least a daily basis * receive primary care from the iowa city va health care system or an affiliated community-based outpatient clinic (cboc) * live in a non-metropolitan area (based on rural-urban commuting area codes (ruca) codes) * be willing to make an attempt to quit smoking in the next 30 days * be capable of providing informed consent * have access to a telephone (land line or cell phone) * have a stable residence exclusion criteria: * planning to move within the next 12 months * presence of a terminal illness * pregnancy * unstable psychiatric disorder (e.g., acute psychosis) * currently pregnant * incarcerated * institutionalized

Keywords: nicotine dependence smoking cessation telehealth alcohol use depression body weight
scopolamine patch and acupressure point p6 stimulation for reduction of nausea and vomiting during cesarean section

Conditions: Nausea; Vomiting; Satisfaction

Summary: the purpose of this study is to compare the effectiveness of reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point p6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just acupressure point p6 stimulation.

nausea and vomiting are very common and unpleasant events experienced during cesarean section under regional anesthesia and in the postoperative period following cesarean section. these side effects are distressing for both the parturient and her family. in addition, intraoperative vomiting causes significant challenges for the surgeon, such as increased procedure length, increased risk of bleeding, increased risk of gastric content aspiration, and potential surgical trauma. to combat the nausea and vomiting seen in all above anesthetic modalities, but to a greater degree in regional anesthesia, a number of pharmacological interventions are currently used with varying degrees of effectiveness in the perioperative period. these medications come from a wide range of drug classes including serotonin and dopamine receptor antagonists, corticosteroids, antihistamines, sedatives and anticholinergics. in our study, we would like to compare the effectiveness of antiemetic agents or technique which cause less severe adverse reactions to the mother and her fetus. out of the available pharmacological agents for reduction of intra-cesarean section nausea and vomiting, transdermal scopolamine patch is one of the safest medications. we would like to compare the effectiveness of the transdermal scopolamine patch with acupressure point p6 stimulation versus just transdermal scopolamine patch versus just acupressure point p6 stimulation.

Eligibility criteria:
inclusion criteria: 1. female subjects ages 18 to 45 2. subjects with asa class i or ii 3. subjects with elective primary or repeat cesarean delivery 4. subjects who receive spinal and/or epidural anesthesia 5. english and non-english speaking subjects will be included in the study exclusion criteria: 1. female subjects \<18 years of age 2. subjects requiring emergent cesarean delivery 3. gestational age \< 37 weeks 4. history of placenta accreta 5. multiple gestation pregnancy 6. asa status iii or higher 7. current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia 8. history of any chronic medication use (other than prenatal vitamins), including inhaler medications 9. current urinary tract infection, pneumonia, or otitis media 10. coagulopathies or skin infections overlying the spine 11. history of open angle glaucoma, seizures or psychosis

Keywords: cesarean section acupressure point p6 scopolamine patch
early intervention, supervision, quality and outcome in asd

Conditions: Autism Spectrum Disorder

Summary: the objective of this study is to examine the significance of knowledge of autism spectrum disorder (asd), and early intensive behavioral intervention, as well as trust in eibi, adequate assessment of eibi quality, and eibi supervision on eibi intervention outcome in asd.


Eligibility criteria:
inclusion criteria: * diagnosis of asd (icd-10), ongoing eibi program exclusion criteria: -

Keywords: allegiance knowledge supervision early intervention autism
urinary biomarkers in overactive bladder in children

Conditions: Overactive Bladder

Summary: it is a single-center, prospective, interventional, single-arm study. aim is to investigate which variables are significantly correlated with prolonged anticholinergic treatment (\>6 months) in children with overactive bladder (oab). investigated variables will include urinary neurotrophins and inflammatory cytokines, sonographic biomarkers, symptom score scale, demographics, and urodynamic findings. secondary aim is to analyze sensitivity and specificity of urinary biomarkers in diagnosis and management of oab compared to urodynamics and treatment outcome.


Eligibility criteria:
inclusion criteria: * urgency with or without frequency, incontinence, enuresis, or nocturia * an unremarkable clinical examination * a minimum of 3 micturitions per day * informed oral and written consent from the child and both parents/legal guardian exclusion criteria: * acute urinary tract infection * diseases of central or peripheral nerve system * anomalies of lumbosacral region * bladder outlet obstruction * operative procedures or anomalies of urinary or genital tract * hypercalcuria, diabetes mellitus, diabetes insipidus * neurogenic bladder * constipation or fecal incontinence * urolithiasis, depression, eating disorders or cardio-metabolic diseases * prior use of anticholinergic treatment during the last year

Keywords: neurotrophins nerve growth factor brain-derived neurotrophic factor urinary biomarkers urodynamics anticholinergics children
the effect of montelukast treatment in wheezy infants

Conditions: Lung Disease, Obstructive; Signs and Symptoms, Respiratory

Summary: the study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. the secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.

the aim of this study was to investigate the effectiveness of montelukast in wheezy very young children with persistent respiratory symptoms. this study was a prospective, double-blind, placebo-controlled study of 6 to 24 months old children, who had at least one physician-diagnosed wheezing episode and persistent asthmatic symptoms. patients were randomised to placebo or montelukast 4 mg / day for 8 weeks period. the clinical response to treatment was determined, the functional residual capacity (frc) and specific air-way conductance (sgaw) was measured using an infant whole-body pletys-mograph, the maximal flow at functional residual capacity (v´maxfrc) was re-corded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric methacholine challenge test.

Eligibility criteria:
inclusion criteria: * at least one physician-diagnosed wheezing episode and history of recurrent cough, dyspnoea and wheeze and successfully performed methacholine challenge test were included. exclusion criteria: * use of ics within 8 weeks prior to the first visit, a cumulative life-time systemic prednisolone use more than 3 days at a dose of 2 mg/kg, an equipotent dose of another systemic corticosteroid or ics use more than 4 weeks, respiratory infection in the 14 days preceding lung function measurement and obvious tracheobronchomalacia or other structural defect.

Keywords: montelukast, very young children, lung function tests