Kornimate/medical-research-clean huggingface dataset:
imaging core aim 2, and udall project 2 aim 2

Conditions: Parkinson Disease

Summary: more than one million people in the united states have parkinson's disease (pd) and the prevalence is expected to double by 2040. over 60% of these individuals will develop debilitating postural instability and gait disturbances (pigd), including freezing of gait (fog). with disease progression, axial motor symptoms typically become resistant to dopamine replacement therapies (e.g. levodopa) and a primary source of disability and morbidity. while subthalamic (stn) and globus pallidus internus (gpi) deep brain stimulation (dbs) using standard locations and stimulation parameters can be highly effective for the treatment of the cardinalmotorsymptomsof pd, both treatments often fail to control levodopa-resistant motor features of pd such as pigd. dbs can also impair cognitive function which further exacerbates pigd, particularly when the task requires attentional resources. thus, despite considerable improvements in appendicular bradykinesia, rigidity and tremor with conventional dbs, the disease can continue to be dominated by pigd, leading to increased falls, decreased mobility, and increased rate of hospitalization and morbidity. this is why one of the top ninds priorities for clinical research in pd is the development of novel therapeutic approaches, such as dbs targeting, to treat levodopa-resistant motor symptoms. this study will provide crucial information to elucidate the functional properties of the networks involved in deep brain stimulation (dbs) treatment. by refining our understanding of the neural networks involved in stimulation of dbs targets, we will improve our ability to program patients to enhance their clinical outcomes and minimize side effects.


Eligibility criteria:
inclusion criteria: * age 21 and up * implanted with mr-compatible dbs device (medtronic percept/percept rc dbs system) for treatment of parkinson's disease * english speaking exclusion criteria: * unable to consent for themselves * implanted with a dbs device that is not mr compatible * pregnant * extreme claustrophobia * any contraindications for mri
a comparison of cognitive training approaches in psychotic disorders

Conditions: Psychotic Disorders

Summary: cognitive remediation (cr) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. cognitive training refers to the training component of cr in which people practice computerized exercises that train specific cognitive abilities. there is no agreed upon approach within the field as to the type of training that is most effective with some studies, training higher level cognitive abilities, some training perceptual abilities, and others training general cognitive skills. this study will directly compare two competing methods of cognitive training on measures of neurophysiology, neurocognition, functional competence, and real-world functional performance.


Eligibility criteria:
inclusion criteria: * psychotic disorder * no previous cognitive remediation in past 6 months exclusion criteria: * brain injury * substance abuse * neurocognitive disorder * developmental disability
the student wellness and emotional growth resiliency (swag-r) program

Conditions: Anxiety; Depression; Stress; Wellbeing; Quality of Life

Summary: the purpose of this research study is to provide a free 6-week, online psychological coaching program to nsu undergraduate students to help with anxiety, depression, and stress, while improving quality of life and healthy coping skills.

* all study participants will first complete a study pre-screen over the phone with a study team member. this screening will take 10-15 minutes. * if participants are eligible to participate in the study, participants will be verbally guided through the informed consent form to determine if participants have any questions. this phone call will take approximately 10 minutes. * participants will then be electronically sent the informed consent form for participant review and to complete and sign, if participants would like to participate in the study. * once investigators receive the signed informed consent document, participants will be assigned a unique study identification number and first assessment measures will be sent to complete (time point 1). this assessment will be completed electronically at participant convenience. * participants will then be randomly assigned to either start the free 6-week online coaching program or will be randomly assigned to the waitlist for 6 weeks. participants have an equal chance of being offered the coaching program right away or being put on the waitlist. * the coaching program will consist of (6) free, 60 minute online coaching sessions. participants will be assigned the same coach for the 6 weeks. participants can coordinate schedule day/time preferences as the sessions will be done through hipaa zoom. everyone in the study will get the same coaching topics in the same order. * 6 weeks later, participants will complete another assessment (time point 2). this assessment will be completed electronically at participant convenience. * if participants were on the waitlist, these participants can now start the free 6 week online coaching program, if participants would like. participants are not obligated to participate but will be offered the program. * if participants already completed the 6 week online coaching program, participants will not have any other coaching sessions during this time. * 6 weeks later, participants will complete another assessment (time point 3). this assessment will be completed electronically at participant convenience. * 6 weeks later, participants will complete another assessment (time point 4). this assessment will be completed electronically at participant convenience.

Eligibility criteria:
inclusion criteria: * currently matriculating nsu undergraduate students (ages 18+) exclusion criteria: * students who are not current nsu undergrads, participants aged 17 and younger, students who are currently enrolled in psychotherapy or mental health services, or students with acute mental health needs (e.g., psychosis, active alcohol or substance use problems, suicidality)

Keywords: anxiety depression stress wellbeing quality of life
medications for obstructive sleep apnea to improve cognition in children with down syndrome

Conditions: Obstructive Sleep Apnea; Down Syndrome

Summary: this is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with down syndrome and obstructive sleep apnea (osa) documented by polysomnography (psg). participants will receive ato-oxy for 6 months. ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. dosing of the study treatment will occur approximately 30 minutes prior to bedtime. participants who withdraw from the study will not be replaced. study participants will undergo eligibility screening that will include an initial screening to determine whether non- psg enrollment criteria are met, followed by a 1 night in-lab psg and health-related quality of life (hrqol) and cognitive assessment for participants who qualify based on non-psg criteria. for participants who are eligible and enroll in the study, the screening psg night will serve as the baseline measure for apnea hypopnea index (ahi) and other psg endpoints. on the final night of dosing for ato-oxy participants will return for inpatient psg and health-related quality of life assessment and cognitive assessment. the primary efficacy endpoint is the change in obstructive ahi from baseline.


Eligibility criteria:
inclusion criteria: 1. male or female participants between 6 to 17 years of age, inclusive, at the screening visit. 2. known diagnosis of down syndrome (trisomy 21, but not translocation or mosaicism) exclusion criteria: 1. presence of central sleep apnea on polysomnography (central ahi ≥ 5) 2. currently using and adherent to positive airway pressure therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report) 3. monoamine oxidase inhibitor use 4. urinary retention 5. prematurity \< 32 weeks estimated gestational age 6. seizure disorder 7. untreated or inadequately treated hypothyroidism 8. significant traumatic brain injury 9. congenital heart disease and not cleared to participate by the patient's cardiologist 10. history of current, untreated depression 11. history of liver disease 12. 3+ or greater tonsillar hypertrophy 13. positive urine pregnancy test 14. hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation \<90%) 15. presence of central sleep apnea on baseline polysomnography (central ahi ≥ 5) 3. absence of osa defined as total ahi \<5 on baseline polysomnography
social anxiety telehealth therapy study

Conditions: Social Anxiety

Summary: the covid-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health outcomes. these problems may be especially acute for individuals with social anxiety disorder (as many as 12% of americans), however there is a limited evidence-base for telehealth options to directly address social anxiety. this project aims to adapt exposure therapy for social anxiety to a telehealth and physical distancing-compatible intervention, and test whether this effectively decreases loneliness in adults with elevated social anxiety.


Eligibility criteria:
inclusion criteria: * age 18+, * liebowitz social anxiety scale (lsas) total score \> 50 * fluent spoken and written english * access to the internet via a smartphone or computer with a camera * ability to provide informed consent. exclusion criteria: * history of mania or psychosis * moderate or severe substance use disorder within the past year * current psychiatric diagnosis of greater impairment than that arising from social anxiety * high risk for suicide (\>8 on the mini international neuropsychiatric interview suicidality section) * prior exposure therapy (more than 2 sessions) * current psychotropic medication use * current psychotherapy other than couples counseling.
safety and efficacy study of interferon gamma-1b in hepatitis c patients with liver fibrosis or cirrhosis

Conditions: Liver Fibrosis; Cirrhosis

Summary: the purpose of this research study is to test the safety and effectiveness of interferon gamma-1b (ifn-g 1b) injected subcutaneously (under the skin) for the treatment of advanced liver fibrosis and cirrhosis in patients with chronic hepatitis c infections. ifn-g 1b is not currently approved for the treatment of liver fibrosis.

this study will evaluate the safety and tolerability of ifn-g 1b in patients with advanced liver fibrosis and cirrhosis due to hepatitis c. this study will also evaluate whether ifn-g 1b is effective in reducing the amount of fibrosis in the liver.

Eligibility criteria:
* men or women 18 to 75 years * chronic hepatitis c infection based on a history of positive anti-hcv antibody and/or hcv rna * history of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated * stage 4, 5 or 6 liver fibrosis according to the ishak scoring system. * cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of gi variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted) * must meet minimum blood chemistry requirements * cannot have unstable or uncontrolled thyroid disease * cannot have a variety of other diseases (listed in protocol * other conditions for enrollment exist which would be discussed with a clinician upon screening for the study.

Keywords: hepatitis c liver fibrosis liver cirrhosis
a prospective incident study of arrhythmias in hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: the purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.

adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. no direct interventions will be performed. prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.

Eligibility criteria:
inclusion criteria: * currently or previously enrolled in 17-003514 and 16-009474 * adults age \>18 years-old with a diagnosis of hypertrophic cardiomyopathy * both sexes * able to consent exclusion criteria: * vulnerable study population * known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation) * pacemaker/icd implantation * pregnancy

Keywords: atrial fibrillation ventricular tachycardia arrhythmia hypertrophic cardiomyopathy
wellness through mobile health

Conditions: Musculoskeletal Diseases; Chronic Pain; Anxiety Disorders; Depression

Summary: this pilot project will evaluate the potential of an affordable smartphone app to improve users' mental well-being.

the goal of this pilot study is to evaluate whether a smartphone wellness application has the potential to improve anxiety and depression symptoms in people who otherwise would not have access to behavioral health care. in this pilot study, participants will include patients who present to an orthopedic specialist for chronic musculoskeletal pain and who also endorse elevated anxiety and/or depression symptoms. patients who otherwise do not have access to adequate behavioral health resources will be eligible to enroll in the study. through the study, participants will have two months of full access to a commercially available smartphone wellness application which offers resources such as cognitive behavioral therapy via an artificial chatbot, mindfulness and deep breathing training, and text-based access to a human well-being coach. participants' baseline and 2-month follow-up anxiety and depression symptoms will be compared. qualitative feedback regarding the user experience with the smartphone application will also be collected.

Eligibility criteria:
inclusion criteria: * presentation to an orthopedic specialist at the washington university living well center for a musculoskeletal condition * score of 55 or higher on patient-reported outcomes measurement information system (promis) depression and/or anxiety measures * advised to consider behavioral health treatment as a component of comprehensive care for a musculoskeletal condition * cannot or does not wish to pursue in-person behavioral health treatment (e.g., with the center psychologist) exclusion criteria: * no access to an electronic device (such as a smartphone) to download and use the wellness app and to electronically complete follow-up self-reported health measures * in active mental health crisis (e.g., suicidal/homicidal thoughts, psychosis) which would require an escalated level of care * initiating care with a behavioral health specialist

Keywords: musculoskeletal disease chronic pain behavioral health anxiety depression mobile health smartphone application
national systemic lupus erythematosus prospective cohort, saudi arabia

Conditions: SLE (Systemic Lupus)

Summary: sle disease in saudi arabia is yet not well defined especially in a population with high consanguinity and high inbreeding coefficient . up until now, there has been no prospective cohort study for sle patients in saudi arabia. as a result, current published literature is focused on retrospective chart reviews which are subjected to many forms of bias. so the investigator proposed this prospective registry which will follow open cohort study design aiming to provide better understanding of disease presentation, course and outcomes especially if complemented by detailed immunological, molecular, genetic and microbiome data.


Eligibility criteria:
inclusion criteria: 1. adult patients defined as age greater than 18 years old. 2. patients should fulfil one of the following classification criteria for sle (acr, slicc or acr/eular criteria). 3. no restriction on time of diagnosis. exclusion criteria: * patients who don't fulfil classification criteria mentioned above.

Keywords: sle lupus erythematosus outcomes phenotypes observational
crossover study comparing ondansetron orally dissolving film strip (odfs) with zofran orally disintegrating tablets

Conditions: Nausea and Vomiting, Postoperative; Nausea With Vomiting Chemotherapy-Induced

Summary: this was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. each treatment was administered after an overnight (10 hours) fast.

this was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. subjects checked into the study center on day -1 of each study period at least 12 hours prior to dosing on day 1. subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods. treatment a: single dose of ondansetron odfs 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 ml room temperature drinking water treatment b: single dose of zofran odt (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 ml room temperature drinking water

Eligibility criteria:
inclusion criteria: * volunteer should have written informed consent. * volunteer healthy adult within 18-45 years of age (inclusive). * body mass index of 18.5 kg/m\^2 and 25 kg/m\^2, body weight not less than 50 kg. * volunteer must be of normal health. * volunteer should have a normal ecg, chest x-ray and vital signs. * if study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study. criteria: exclusion criteria: * volunteer doesn't understand the informed consent. * volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug. * volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures * volunteer who smokes regularly, alcohol or drug abuse * volunteer who has taken over the counter or prescribed medications * volunteer with clinically significant abnormal values of laboratory parameters. * volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 ml in the past 3 months. * female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).

Keywords: bioequivalence, safety, and tolerability
pre-sleep creatine enhances anaerobic power in recreationally active females

Conditions: Anaerobic Performance; Sports Nutrition; Exercise Recovery; Muscle Fatigue; Creatine Supplementation; Recreational Physical Activity; Female Athletes

Summary: this study is a randomized, double-blind, placebo-controlled trial designed to examine the effects of pre-sleep creatine monohydrate supplementation on anaerobic performance and muscle damage markers in recreationally active females. participants will be randomly assigned to receive either 5 grams of creatine monohydrate or a placebo 30 minutes before sleep for seven consecutive days. anaerobic performance will be assessed using the wingate anaerobic test, evaluating peak and average power output and fatigue index. blood samples will be collected before and after the supplementation period to analyze markers of muscle damage, including creatine kinase and lactate dehydrogenase. this study aims to provide insight into the efficacy of short-term, time-specific creatine supplementation for enhancing performance and recovery.


Eligibility criteria:
inclusion criteria: female, aged 18 to 25 years recreationally active (engaging in structured resistance training 3-4 times per week for the past 6 months) regular menstrual cycles (used for scheduling purposes) able and willing to provide informed consent agreement to maintain normal diet and training routines throughout the study exclusion criteria: history of musculoskeletal injury affecting lower or upper limbs within the past 6 months known allergy or intolerance to creatine or maltodextrin use of performance-enhancing substances or supplements within the last 30 days use of recovery modalities such as massage, cryotherapy, or compression garments during the study period current use of anti-inflammatory medication pregnancy or breastfeeding inability to comply with study protocol or scheduled assessments

Keywords: creatine monohydrate pre-sleep supplementation anaerobic power wingate test muscle damage markers creatine kinase (ck) lactate dehydrogenase (ldh) female exercise performance nutritional ergogenic aid resistance training recovery enhancement
in vitro evaluation of immune responses in cutaneous t-cell lymphoma (ctcl)

Conditions: Cutaneous T-cell Lymphoma; Sezary Syndrome; Mycosis Fungoides

Summary: this is an in vitro evaluation of cutaneous t-cell lymphoma using patients' blood and tissue to evaluate immune responses related to identified tumor populations and dendritic/cd 8 cells.

this is an in vitro evaluation of cutaneous t-cell lymphoma using patients blood and tissue to evaluate immune responses related to identified tumor populations and dendritic/ cd 8 cells with the following objectives: * objective i: evaluate the feasibility of the preparation of dendritic cells (dcs), cd8 and sezary cells (all cd4 positive) in vitro, obtained from the buffy coats or a skin biopsy from an area with tumor involvement of subjects with cutaneous t-cell lymphoma (ctcl) and sezary syndrome (leukemic stage of ctcl) undergoing an approved fda therapy, extracorporeal photopheresis (ecp). * objective ii: evaluate antigen loading of the dcs. * objective iii: test the functional capacities of the dcs derived from ctcl subjects to overcome immune tolerance to the tumor cells ex-vivo, by using modified elispot assay in conjunction with granzyme b elispot assay as a measurement of cytotoxicity.

Eligibility criteria:
inclusion criteria: * males or females \<18 years of age * histologically confirmed stage iv cutaneous t-cell lymphoma, with at least 5% of the peripheral blood lymphocytes showing atypical morphology consistent with sezary cells * ambulatory and be in stable medical condition * biopsy positive mycosis fungoides/ctcl or clonal type of ctcl as determined by pcr for tcr and southern blot for tcr exclusion criteria: * received any chemotherapy or radiotherapy within 4 weeks prior to enrollment * significant psychiatric illness which would prevent adequate informed consent in the opinion of the principal investigator * systemic steroid therapy other than maintenance for adrenal suppression * known coagulopathy for non ss subjects.

Keywords: cutaneous t-cell lymphoma sezary syndrome mycosis fungoides immune responses