Kornimate/medical-research-clean huggingface dataset:
direct comparison of ga-68-dotatate and ga-68-dotatoc

Conditions: Meningioma

Summary: the goal of this study is to propose the first direct comparison of ga-68-dotatate pet/ct or pet/mr and ga-68-dotatoc pet/ct in patients with meningioma.

the investigator is proposing a direct comparison of ga-68-dotatate and -dotatoc in a pilot cohort of patients with meningioma, and hypothesize non-inferiority of dotatoc. this pilot study will form the basis for a subsequent prospective clinical trial and will allow us to optimize our existing imaging protocols, while developing a more cost-effective protocol. primary objectives: * optimize the ga-68-dotatoc pet/ct protocol. * compare ga-68-dotatate pet and -dotatoc pet/ct in patients with meningioma. secondary objectives • correlate ga-68-dotatate pet and -dotatoc pet/ct with clinical and pathological characteristics

Eligibility criteria:
inclusion criteria: * adult patients with clinically suspected meningioma * patients planned for surgery - undergoing preoperative workup * no contraindications to either radiotracer exclusion criteria: * age less than 18 years * inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.
a cross over pilot study of abobotulinum toxin a (dysport) as a treatment for task-dependent upper limb tremor

Conditions: Tremor, Limb

Summary: task-dependent upper limb tremor is a disorder that frequently impairs patients' function and quality of life. few studies exist that quantify the improvements in motor performance and disability with botulinum toxin (injections). the study team aims to perform an exploratory pilot trial using toxin type a (dysport) in 25 patients with task-dependent upper limb tremor, to refine quantitative measures of performance using blinded video analysis, demonstrate efficacy and tolerability of injections, and provide power calculations for a potential future multi-centered double blinded clinical trial.


Eligibility criteria:
inclusion criteria: * patients with task-dependent essential tremor in upper limb. tremor is present during at least one of the study functional tasks i. pointing task (touch between nose and a pen held 2 ft. in front. ii. pouring task (cup: pouring water out/in). iii. feeding task (weighted fork from plate on table to mouth). iv. string instrument bowing or holding instrument in static position. v. computer mouse (simple vertical or horizontal movements). * patients must be capable of performing informed consent. * patients on stable medications for treatment of task-dependent essential tremor for 1 month prior to study entry and maintain them throughout the study. * patients previously treated with bont of any type must have occurred no sooner than 12 weeks prior to study entry. exclusion criteria: * patients with no presence of tremor during study functional tasks. * presence of tremor during the functional task is below minimum amplitude required to be considered for injection based upon investigator's clinical judgment. * patients with unstable medical conditions or psychiatric conditions. * patients with a medical condition that precludes them from receiving bont injections. * pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study. * lithium, valproic acid, amiodarone, typical and atypical neuroleptics. exposure to other than the listed tremorogenic or potentially tremorogenic drugs is allowed only if, in the opinion of the investigator, this will not interfere with the study drug evaluations.

Keywords: upper limb tremor task-dependent
an investigation of the safety and utility of treximet in the treatment of menstrual migraine

Conditions: Menstrual Migraine

Summary: the study is to primarily investigate whether treximet® (imitrex rt/naproxen sodium 500mg) taken at the first onset of menstrual migraine will both terminate the acute headache and assist in preventing headache recurrence and the need for repeat abortive therapy over the ensuing days of menses.


Eligibility criteria:
inclusion criteria: 1. actively and regularly cycling females age 19 years or greater. 2. normal (for subject) menses within 6 weeks prior to randomization 3. history of migraine of ≤ 1 years duration by international classification of headache disorders (ichd) criteria 4. history of menstrual migraine by ichd criteria exclusion criteria: 1. not actively practicing adequate contraception or intending to continue to do so during the treatment. 2. 15 or more days of headache during each of the prior 3 months 3. prior use of treximet for the treatment of menstrual migraine 4. uncontrolled hypertension 5. hemiplegic or basilar migraine 6. clinical evidence of coronary artery disease or other clinically significant and relevant cardiac disease (e.g. vasospastic angina) 7. history of stroke or transient ischemic attack 8. history of ischemic bowel disease 9. clinically significant hepatic disease 10. history of allergy to any nsaid or triptan 11. history of gastritis, peptic ulcer disease, gi bleeding, gastric surgery

Keywords: menstrual migraine migraine treximet
natural history study of patients with mps iiia

Conditions: Mucopolysaccharidosis IIIA

Summary: evaluate the clinical progression in patients with mps iiia who are untreated with any investigational product and to obtain standardized assessments: neurocognitive, behavioral, sleep-wake habits and effect of mps iiia on the quality of life of patients and their families.

this is a multicenter, multinational, longitudinal, observational study in children aged up to and including 9 years, who have been diagnosed with mps iiia. the study will detail the natural course of mps iiia via standardized clinical, biochemical, neurocognitive, developmental, behavioral and imaging measures. this information is anticipated to inform the design and interpretation of future interventional studies.

Eligibility criteria:
inclusion criteria: * documented mps iiia diagnosis * children up to and including 9 years of age * the patient is sufficiently able, in the opinion of the investigator, to adhere to the study visit schedule and other protocol requirements * the patient's parent(s) or legal guardian(s) has signed written informed consent, according to the local regulations and after all relevant aspects of the -study have been explained and discussed exclusion criteria: * the patient is participating in a clinical trial of any potential disease-modifying investigational medicinal product or taking high dose (\>100 mg/kg/day) synthetic genistein (patients on low dose or naturally derived genistein can be included in this study). * the patient has received a hematopoietic stem cell or bone marrow transplant or gene therapy. * the patient has received enzyme replacement therapy in the last 6 months. * homozygous or compound heterozygous for the s298p mutation or the investigator and/or trial steering committee considers the patient not to have the classical severe form of mps iiia. * individuals with rare and unrelated serious comorbidities e.g. down syndrome, intraventricular hemorrhage in the new-born period, or extreme low birth weight (\<1500 grams). * visual or hearing impairment sufficient, in the clinical judgment of the investigator, to preclude cooperation with neurodevelopmental testing. use of hearing aids is permitted.
evaluate the efficacy and safety of jmkx000623 in participants with diabetic peripheral neuropathic pain

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: a phase 2, multicenter, randomized, double-blind, placebo and active drug-controlled trial to evaluate the efficacy and safety of jmkx000623 in participants with diabetic peripheral neuropathic pain

evaluate the efficacy and safety of jmkx000623 in participants with diabetic peripheral neuropathic pain

Eligibility criteria:
inclusion criteria: 1. able to understand the procedures of this trial and provide written informed consent voluntarily; 2. age ≥ 18 years, male or female; 3. diagnosed with diabetic peripheral neuropathic pain for ≥ 24 weeks; 4. visual analog scale (vas) of 40-90 mm, and adps of 4-9; 5. hba1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks. exclusion criteria: 1. with other peripheral neuropathies or painful diseases except for diabetic peripheral neuropathic pain; 2. possibly allergic to the active ingredients or excipients of jmkx000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions; 3. received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial; 4. known treatment failure on pregabalin or gabapentin;
deep brain stimulation (dbs) matchmaker

Conditions: TOR1A; PANK2; HPRT1; EIF2AK2; SOX2; KMT2B; GABRB2; ADCY5; UBA5; GNAO1; SGCE; TNPO2; GNB1; PLA2G6; Movement Disorders; Dystonia; Chorea

Summary: dbs matchmaker (https://www.dbsmatchmaker.com) is a platform designed to connect clinicians worldwide who are treating rare movement disorders with deep brain stimulation (dbs). it facilitates global collaboration and knowledge sharing to enhance patient care by improving patient selection, counseling, treatment, and outcomes for individuals with movement disorders.

deep brain stimulation (dbs) is an effective treatment for childhood-onset dystonia and other hyperkinetic disorders, with emerging evidence supporting its use in an expanding range of monogenic movement disorders. while some conditions, such as tor1a-related dystonia, are well-established indications for dbs, many rare and ultra-rare movement disorders are also being considered for treatment. however, individual centers often have limited experience with these conditions, leading to mostly anecdotal observations. furthermore, the published literature is often scarce or not up to date. to bridge this gap, dbsmatchmaker (https://www.dbsmatchmaker.com) was developed both as a tool to assist clinicians in determining the appropriateness of dbs for their patients, and in supporting therapy adjustments for patients who already have an implant. by connecting specialists worldwide, dbsmatchmaker seeks to improve patient selection, counseling, treatment, and outcomes for individuals with rare movement disorders, ultimately enhancing care for this underserved patient population. by connecting specialists worldwide, the platform aims to: improve patient selection and counseling; enhance treatment strategies and outcomes for individuals with rare movement disorders; ultimately, dbsmatchmaker seeks to elevate the standard of care for this underserved patient population. key features: global collaboration: enables clinicians to connect with peers treating similar conditions with dbs, fostering a worldwide network of specialists. knowledge sharing: facilitates the exchange of experiences and expertise in dbs treatment, promoting collaborative learning. enhanced patient care: aims to improve treatment outcomes through shared insights and collective knowledge. how it works: clinicians can submit information about their cases to dbs matchmaker. the platform adheres to strict safety and privacy protocols; it does not collect identifiable data, and the database is not searchable by users. submitted data may be shared with potential collaborators to facilitate connections between medical centers treating similar cases. developed by the ebrahimi-fakhari laboratory at boston children's hospital, dbs matchmaker is committed to advancing the care of individuals treated with dbs for rare movement disorders.

Eligibility criteria:
inclusion criteria: * individuals of all ages with genetic movement disorders, who are undergoing or being considered for dbs treatment. exclusion criteria: * individuals who have not undergone dbs treatment.

Keywords: deep brain stimulation dbs movement disorders dystonia genetic
a 12-week study to assess the safety of fluticasone propionate/salmeterol 100/50 hydrofluoroalkane (hfa) versus fluticasone propionate 100 hfa in children with asthma

Conditions: Asthma

Summary: this study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. the subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.


Eligibility criteria:
inclusion criteria: * must have asthma. * must be currently taking an inhaled corticosteroid. * must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests that are at least 60% of normal (am fev1 or pef). * have a historical or current fev1 or pef reversibility of \>=12%. exclusion criteria: * has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation). * has a current ear or respiratory tract infection. * has ever had any other major illnesses (such as cystic fibrosis, heart problems, tuberculosis).

Keywords: asthma fluticasone propionate children fluticasone propionate/salmeterol
combination treatment for augmenting language in children with asd

Conditions: Autism Spectrum Disorder

Summary: the study will consist of two main elements: the enrollment of 72 children aged 6-11 years with asd and low language competency to receive a thrice-weekly one hour language intervention for 12 weeks; and, beginning at the same time, subjects will be equally randomized to receive either aripiprazole (abilify) (flexibly dosed from 2-10 mg per day) or placebo for 12 weeks.

following screening for eligibility and baseline, study visits will be scheduled three times per week, with 2 sessions on-site at ucla and one at home for parent training (allowing flexibility, as needed); study physician visits will occur once weekly for 6 weeks, then biweekly. screening procedures may be completed in one or two visits, and measures obtained in other ucla clinical or research setting may be used if assessments were done within one month of screening. major outcome assessments will occur at baseline (week 0), mid-point (week 6), and final week (week 12) by study personnel blind to visit number and drug group assignment; minor assessments will occur weekly along with study physician assessments occurring weekly for side effect and compliance checks. eeg will occur at or prior to baseline and at visit 36 (wk12). arrangements will be made to transfer participants to standard clinical care following visit 36. six months after visit 36, families will be seen for final follow-up assessments of language usage, social communication, overall functioning, health and ongoing treatment.

Eligibility criteria:
inclusion criteria: * boys and girls ages 5-11 years; * criteria for autistic disorder or pdd-nos as defined by dsm-iv-tr and confirmed by clinical examination and adi-r, ados; * low language usage as defined by \<30 functional words obtained from a natural language sample, parent report, and standardized tests; * present placement in a comprehensive educational/intervention setting. exclusion criteria: * any medical condition that would interfere with intervention outcomes during a 12 week study period (eg., active seizures within 3 months); * genetic disorders such as fragile x, down syndrome, or tuberous sclerosis; * sensory impairments such as deafness or blindness; * existing or anticipated need for concomitant psychotropic medication (specifically stimulants, atomoxetine) during study participation( allowed medication include: antidepressants, anticonvulsants, guanfacine, clonidine, supplements, melatonin, diphenhydramine); * severe aggression or self-injurious behavior; * dq \<18 months as assessed by the leiter-revised or mullen.
study of led phototherapy for musculoligamentous lesions

Conditions: Tendinopathy; Sprains and Strains; Muscle Spasm; Epicondylitis; Fasciitis

Summary: the purpose of this study is to determine whether led phototherapy using combined red and near infrared light (approved: ministry of health of russian federation no. 29/06070997/1080-00, eurocat certificate no. cp033321-iv) is effective in the treatment of musculoligamentous lesions in physiotherapy practice


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute or chronic musculoligamentous lesion * must be able to understand instructions and fill in auto administered questionnaires * informed consent exclusion criteria: * use of oral corticosteroids or corticosteroid injections * systemic diseases * general contraindications for phototherapy
a phase ii study of as1411 in renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: the aim of this study is to evaluate the efficacy of as1411 in patients with metastatic renal cell carcinoma


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology * failed or intolerant to 1 or more previous lines of treatments (which must include a tyrosine kinase inhibitor) exclusion criteria: * collecting duct histology * a history of bleeding disorders or currently taking oral vitamin k antagonise medication * unstable brain metastases * history of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)

Keywords: renal cell carcinoma rcc kidney cancer
comparison of two telemonitoring auto-titrating modalities in osa patients

Conditions: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Disordered Breathing; Respiration; Sleep Disorder; Respiratory Tract Disease; Sleep Disorders, Intrinsic; Sleep Wake Disorders

Summary: this study compares the titration pressures achieved through two auto-titrating modalities, a new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in cpap-naïve obstructive sleep apnea patients. the aim of the study is to verify that this new modality achieves a lower titration pressure.

in patients with obstructive sleep apnea (osa) on cpap treatment, a cpap titration test is usually performed to achieve the optimal pressure to maintain upper airway patency, abolish obstructive respiratory events and reduce the occurrence of adverse events. this pressure is called titration pressure. until now, we used to perform, after an adaptation period, a single-night outpatient test with an automated device preset on auto-adjusting pressure modality (apap). the incremental fixed pressure modality (ez start) was initially developed to ease patients into having a positive sleep therapy experience from the very beginning. this mode gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. in each good therapy session, the device performs in fixed pressure overnight and we get a real residual apnea-hypopnea index (rahi). for this study, we will use the same device (dreamstation auto cpap, philips respironics, murrysville, pa, usa), a web-based system to telemonitor patient therapy (encoreanywhere) and perform for each individual patient the two modalities in a telemonitoring crossover randomized single-blind (patient) way.

Eligibility criteria:
inclusion criteria: * age 18-80 * osa diagnosis * cpap therapy indication exclusion criteria: * previous cpap therapy * severe copd * respiratory insufficiency * obesity-hypoventilation syndrome * cardiac failure * recent cerebrovascular disease * central apnea, cheyne stokes or similar * important nasal insufficiency or malformation * previous pharyngeal surgery * shift work * psychosocial disability * refusal to participate

Keywords: cpap titration obstructive sleep apnea telemonitoring telemedicine
dilator muscle activity in health and sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the role of control of peri-pharyngeal muscle tone in the pathogenesis of obstructive sleep apnea (osa) is obvious: pharyngeal obstruction occurs only during sleep; and pharyngeal collapse occurs in almost all healthy subjects during anesthesia. better understanding of these control mechanisms may help identifying the central components of the pathogenesis of osa.

study plan: subjects will be studied first during wakefulness, while breathing against external resistors, to evaluate how are the peri-pharyngeal muscles recruited and activated to prevent pharyngeal collapse in the presence of negative intra-pharyngeal pressures. thereafter, the same parameters will be evaluated during sleep, to assess muscle recruitment during intra-pharyngeal obstruction. the investigaors will record the electromyogram (emg) of several dilator muscles, as well as the pressures above and below the area of pharyngeal collapse, and airflow.

Eligibility criteria:
inclusion criteria: 1. subjects that underwent regular sleep studies and found to have either moderate/severe osa, or no osa. - exclusion criteria: 1. hemophilia 2. use of anti-coagulants -
follicular flushing

Conditions: Fertilization

Summary: patients with infertility often undergo in vitro fertilization (ivf) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. the oocytes are removed during surgery by aspirating the follicles using a single lumen needle with an ultrasound to guide the procedure. there is some data that flushing the follicles with embryo culture media before aspiration using a double lumen needle increases the number of oocytes retrieved, particularly among poor responding patients for whom each additional oocyte recovered may substantially alter the outcome of that ivf cycle. the objective of the research is to evaluate the effect of follicular flushing in poor responders on ivf cycle outcomes.

patients with infertility often undergo in vitro fertilization (ivf) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. the number of embryos obtained is dependent on the number of oocytes retrieved. the objective of the research is to evaluate the effect of follicular flushing in poor responders on ivf cycle outcomes, including the number of oocytes retrieved, number of mature oocytes, fertilization rate, number of embryos transferred, implantation rate, miscarriage rate, live birth rate, operating room time, and luteal estradiol and progesterone levels. the research entails a prospective, randomized, controlled trial of poor-responder patients who are undergoing ivf treatment at the ronald o. perelman and claudia cohen center for reproductive medicine, defined as patients who have ≤ 4 follicles that are ≥ 12mm on the day of hcg trigger. patients identified as poor responders will be consented and randomized to follicular flushing versus aspiration without flushing. a 2-5ml flush using embryo culture media followed by aspiration of the follicle will be performed in the patients randomized to the flushing group, with subsequent flushes until an oocyte is identified or up to 4 flushes maximum. patients being enrolled in this research study will undergo ivf regardless of participation in this research study. randomization: a series of randomized blocks of 2 will be generated for the study. this will provide assurance that after two patients are enrolled, there will be one patient assigned to each group- follicular flushing versus aspiration without flushing. this process of blocked randomization ensures an equal distribution between the two study arms of patients.

Eligibility criteria:
inclusion criteria: * pts ages 18-45 undergoing ivf * pts with ≤ 4 follicles that are ≥ 12mm on day of hcg exclusion criteria: * pts undergoing natural cycles (i.e. those with intentionally low # of follicles)

Keywords: ivf stimulation. poor responders. ivf patients with poor response to stimulation