Kornimate/medical-research-clean huggingface dataset:
longitudinal changes of brain functional connectivity in migraine

Conditions: Migraine

Summary: the purpose of this study is to identify a core fmri feature that determines migrainous brain and plastic fmri features that changes with longitudinal courses of migraine.

migraine is associated with functional alterations in specific brain networks. the investigators aimed to identify network abnormalities which remain unchanged throughout the longitudinal course of migraine. the investigators also aimed to identify networks which change in association with changes in migraine frequency and associated psychiatric conditions. the investigators expect these can serve as neuroimaging biomarkers for diagnosis of migraine brain and monitoring of disease severity.

Eligibility criteria:
inclusion criteria: migrainuers : 1. age 18-50 years 2. migraine with or without aura as defined by the third edition of the international classification of headache disorders (ichd-3 beta) 3. if female, before the onset of menopausal controls: 1. age 18-50 years 2. no headache disorder other than infrequent episodic tension-type headache as defined by the ichd-3 beta exclusion criteria: 1. contraindicated to mri 2. pregnancy 3. require sedation treatment because of claustrophobia when performing mri 4. predicted to be unable to write the headache diary due to cognitive decline 5. refuse study procedure
benefits of applying neuroprosthesis for improving reaching and grasping functions in stroke patients

Conditions: Stroke

Summary: functional electrical stimulation (fes) is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. by contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing. final goal of the study is to evaluate if fes training when applied early during rehabilitation will help stroke patients to use their hands more effectively after discharge from a rehabilitation facility, compared to those patients who have not received fes training.

neuroprosthesis are systems that apply functional electrical stimulation to cause muscle contractions. if the muscle contractions are sequenced properly one can generate various functions such as grasping, standing, and walking. recent studies of others and our pilot study indicate that a neuroprosthesis can be successfully applied as a training device to help stroke patients who have hemiplegic arm to relearn how to reach and grasp various objects. the objective of this research program is to confirm these preliminary results with the broader population of stroke patients, and if successful to propose a method to introduce this rehabilitation treatment into toronto rehabilitation institute, stroke unit as a primary intervention for hand function recovery. specifically, our aim is to1)develop an exercise protocol that uses a neuroprosthesis for reaching and grasping developed by our team in combination with the standard physiotherapy treatments to enhance recovery of hemiplegic arm and hand; and 2) assess qualitatively and quantitatively improvements in the reaching and grasping functions achieved with standard rehabilitation treatment.

Eligibility criteria:
inclusion criteria: * patient must be motivated to participate in the fes study, and must sign the letter of consent. * patients must have hemiplegia and the stroke must be confirmed with a ct scan. * patients must understand that the role of this study is to enhance recovery and not to guarantee it. exclusion criteria: * patients who is motivated and does not sign the letter of consent. * patient who has serious cognitive or psychological impairments. * patients who has skin rush, allergy or wounds. * alcohol or drug abuse. * edema in his/her upper extremity. * patients with shoulder hand syndrome * global aphasia * patients who shows early recovery of the function.

Keywords: cerebrovascular accident stroke
buikwe electronic community health information system impact study

Conditions: Malaria; Diarrhea; Pneumonia

Summary: the purpose of the study is to investigate the impact of the echis intervention on key child health outcomes.

following national guidelines, 2 vhts per village will be supported to provide the full echis community health package. in total 856 vhts in buikwe district will have been trained and equipped with the national strategy and operational guidelines on echis as well as the vht full package (iccm+ and vht basic package (reproductive health, immunization, nutrition) guidelines. the vhts will be equipped with mobile devices and iccm supplies to start the management of community-based health among children aged five years within their respective communities. a cross-sectional cluster randomized controlled trial (crct) will be used to establish study outcomes in children under 5 years in the intervention and control areas using mixed methods (qualitative and quantitative) of data collection. a total sample size of 1,140 children under five: 570 children under five, per arm, was scientifically determined for the study. during data collection, several quality control measures will be applied to ensure the data recorded reflect the facts, responses, observations, and events. a standard operating procedure (sop) with roles and responsibilities of the data collectors will be prepared to ensure standardized methods for capturing data. after endline data collection, difference-in-differences (did) analysis will be done to derive an estimate of the intervention effect on odds of the study outcomes. results will be disseminated through agreed peer-review publications and international conferences. malaria consortium uganda will work with relevant stakeholders at the ministry of health and medic mobile to disseminate findings nationally and throughout the study district.

Eligibility criteria:
inclusion criteria: * · children between 3-59 months, * being resident in the study area, * consent to participate in the study obtained, * willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including attending a designated health centre if their child has malaria symptoms during the data collection period. exclusion criteria: * children aged below 3 months and above 59 months * children resident outside the study areas * those who have not consented to participate in the study
safety and efficacy study of donor natural killer cells given after haploidentical hematopoietic cell transplantation

Conditions: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia

Summary: the protocol treatment is to evaluate clinical effects of donor-derived natural killer cells that are given after hla-mismatched hematopoietic cell transplantation.

those patients with acute leukemia, which is not responding to coventional chemotherapy, will be treated. the clinical effects will be evaulated in terms of safety (side effects) and anti-leukemia effect.

Eligibility criteria:
inclusion criteria: patients with acute leukemia, which are refractory to standard treatment. patients should be 17 years of age or older. the performance status of the patients should be 70 or over by karnofsky scale. patients should not have excessive hepatic dysfunction (bilirubin less than 3.0 mg/dl, ast less than 5 times the upper normal limit). patients should not have excessive renal dysfunction (creatinine less than 3.0 mg/dl). patients should not have clinically-evident cardiac or pulmonary dysfunction. patients and donors must sign informed consent. exclusion criteria: patients who are pregnant or lactating are not eligible.

Keywords: acute myelogenous leukemia acute lymphoblastic leukemia donor natural killer cells hla-haploidentical hematopoietic cell transplantation
a randomized controlled trial of an antiretroviral treatment adherence intervention for hiv+ african americans

Conditions: HIV/AIDS

Summary: project rise is a randomized controlled trial (rct) of an innovative, culturally congruent treatment education (te) intervention for african americans with hiv that targets cultural and social issues contributing to health disparities.

project rise is a randomized controlled trial (rct) of an innovative, culturally congruent treatment education (te) intervention for african americans with hiv that targets cultural and social issues contributing to health disparities. te facilitates patient navigation through the medical system and provides treatment education and client-centered counseling to improve adherence and retention in care. te targets structural issues in healthcare and patients' lives by advocating to providers to improve patient-provider relationships, recommending changes in treatment and/or providers, and referring patients to mental health and social services. a total of 350 black participants will be recruited through apla health and randomly assigned to the intervention or usual care control group (175 per group). adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 13-months post-baseline. viral load will be assessed through venipuncture at baseline and 6- and 13-months post-baseline. it is hypothesized that the intervention group will show better adherence and have a greater likelihood of suppressed viral load than the control group over time.

Eligibility criteria:
inclusion criteria: * hiv-positive * 18 years of age or older * self-identified as african american/black * been prescribed antiretroviral therapy (art) in the past 12 months * self-reported adherence problems (i.e. missed at least 1 art dose in the past month) and/or detectable viral load * willing to use medication events monitoring system (mems) for electronic adherence monitoring. exclusion criteria: * hiv-negative * 17 years of age or younger * not self-identified as african american/black, not on antiretroviral therapy (art) or not prescribed art therapy in the last than 12 months * no self-reported adherence problems and/or no detectable viral load * not willing to use medication events monitoring system (mems) for electronic adherence monitoring.

Keywords: adherence antiretroviral treatment black/ africanamerican
restoration of spectral resolution with hearing-aid amplification

Conditions: Hearing Loss

Summary: the objective of this study protocol is to determine the efficacy of using aided measures of spectral resolution to set the dynamic range of hearing with hearing-aid amplification. measures of spectral resolution will be obtained, as will measures of speech recognition.

adults with hearing loss are more vulnerable to interference from background noise than adults with normal hearing. despite the fact that the ability to extract speech information imbedded in background noise requires decoding differences in level across frequency (spectral information), few studies have addressed the extent to which spectral information can be provided to listeners with hearing loss. this fundamental gap in our knowledge prevents society from effectively addressing the systemic effects of hearing loss on communication, income, and ability to socialize with others. this work is a new application of established methods of characterizing spectral resolution to that of the most common device for rehabilitation of hearing loss, hearing-aid amplification. because hearing aids do not require premarket approval, fda oversight is not applicable to this clinical trial. the experiments will examine the degree to which access to spectral information can be restored to adults with hearing loss and the feasibility of utilizing this information to decrease interference from background noise. aim 1 will delineate the impact of hearing-aid amplification on spectral decoding. technology options that must be set by the clinician or hearing-aid manufacturer will be examined, including the frequency-specific gain, compressor speed, and number of compression channels. the proposed experiments will test the hypothesis that restoration of the lost dynamic range of hearing can support the encoding of spectral information. it is also hypothesized that the combination of technology options that best restore access to spectral information will differ across individuals and that these differences across individuals can be partially accounted for by an estimate of outer hair cell function. aim 2 will determine the extent to which restoring access to spectral information supports speech recognition in background noise, under the guiding hypothesis that improving spectral resolution increases speech understanding. if it can be demonstrated that measures of spectral resolution with the provision of amplification are useful at delineating those who stand to benefit from different technology options, the knowledge gained could then be applied to the clinic to allow for clinicians to more successfully choose among different rehabilitation options.

Eligibility criteria:
inclusion criteria: * normal tympanograms (peak admittance of ≥ 0.2 mmhos, -200 to 50); hearing thresholds for normal hearing group less than or equal to 20 decibels in hearing level (db hl) from .25 to 8 khz. pure-tone average (2, 4 \& 6 khz) hearing thresholds for participants with hearing loss of 30 - 65 db hl. exclusion criteria: * cognitive impairment
accuracy of pulse oximeters in profound hypoxia

Conditions: Hypoxia

Summary: the goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. two devices were placed on each subject with one on the finger and the other on the fingertip. spo2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.


Eligibility criteria:
inclusion criteria: * subject is in good general health with no evidence of any medical problems. * subject is fluent in both written and spoken english. * subject provided written informed consent and is willing to comply with the study procedures. * subject is willing to have their skin color assessed. exclusion criteria: * subject is obese with a bmi over 30. * subject has a known history of heart disease, lung disease, kidney or liver disease. * subject has asthma, sleep apnea, or uses a cpap. * subject has diabetes. * subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation. * subject has any other serious system illness. * subject is a current smoker. * subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly. * subject has a history of fainting or vasovagal response. * subject has a sensitivity to local anesthesia. * subject has raynaud's disease. * subject has unacceptable collateral circulation based on an exam by the investigator. * subject is pregnant, lactating, or trying to get pregnant. * subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures. * subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.
intravenous acetaminophen after cardiac surgery - definitive study

Conditions: Post Operative Delirium; Post Operative Pain; Post-Op Complication; Post-cardiac Surgery

Summary: double blind, double dummy trial of the use of iv acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. the underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. other important secondary outcomes are the total use of narcotics, icu and hospital stay, improved cognitive function at 6 months and 1 year post surgery, nsaid use at each centre and associated nsaid complications.

patients \&gt; or equal to 18 years of going for elective cardiac surgery will be randomized to receive iv either iv acetaminophen and an oral placebo acetaminophen or an iv placebo acetaminophen (saline) and oral acetaminophen every 6 hours for 48 hours after cardiac surgery. the study will be performed at 8 large canadian cardiac surgery centres. all other therapy will be as per standard procedures (pragmatic) at the institutions including including use of their standard opioid protocol. the primary end-point is the development of delirium as assessed by confusion assessment method in the intensive care unit (camicu) and the cam on the regular floor unit for up to 7 days after surgery or discharge if it is sooner. other measures are change from pre-operative cognitive function as assessed by the montreal cognitive assessment score (moca) at 6 months and 1 year, numeric pain score, total opioid use, hospital and icu length of stay. use of opioids and pain score at 1 year also will be assessed. patients will be stratified by site and sex. we also will assess use of nsaid, specifically ketorolac, and any nsaid associated events.

Eligibility criteria:
inclusion criteria: greater or equal to 18 * elective cardiac surgery * stable pre-operative * aorto-coronary bypass with or without 1 valve replacement. exclusion criteria: refusal by surgeon requested late extubation by surgeon or anesthesia intra-aortic balloon pump mechanical cardiac support sensitivity to acetaminophen psychiatric history with current active treatment alzheimer\&#39;s disease seizure in previous 6 months recent history of alcohol misuse cognitive impairment -

Keywords: pain post-operative care cardiac surgery narcotic acetaminophen
examining the impact of mindfulness on patients' experience of osteopathic manipulation

Conditions: Pain; Satisfaction, Patient

Summary: this is a single site, two-arm, parallel group pilot randomized controlled trial examining the effect of coupling a brief mindfulness-based intervention with an osteopathic manipulation session for pain patients.


Eligibility criteria:
inclusion criteria: * patients scheduled for omt at the huntsman cancer institute exclusion criteria: * altered mental status due to delirium, psychosis, or medication sedation as determined by treating clinician.
validity of physical activity questionnaires in persons pursuing bariatric surgery

Conditions: Bariatric Surgery Candidate; Obesity

Summary: the purpose of this study is to determine the validity of the human activity profile and godin self-report questionnaires of physical activity in persons seeking metabolic surgery.

this cross-sectional study will collect subject's medical history, anthropometric measurements, physical activity data through an accelerometer worn on the wrist and indirect physical activity measures via the human activity profile and godin self-report questionnaires. we will collect clinical information from the medical record including predictors of physical activity level in obesity such as nutritional lab and co-morbid conditions.

Eligibility criteria:
inclusion criteria: * age \>19 * bmi \> 30 * able to speak and understand english * consent to provide access to medical records for medical history * will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at nebraska medicine * consent to wear an activity tracker device for 7 days after designated visits. exclusion criteria: • age \< 19

Keywords: physical activity accelerometer bariatric surgery obesity
dmcrn-02-001: assessing pediatric endpoints in dm1

Conditions: Congenital Myotonic Dystrophy; CDM

Summary: the overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and develop biomarkers for the condition.

myotonic dystrophy type-1 (dm1) is an autosomal dominant disorder caused by a toxic ctg repeat expansion in the 3'utr of the dmpk gene. dm1 is the most common adult-onset muscular dystrophy, with an overall prevalence of 1:8000. in approximately 10-20% of individuals with dm1, the onset of symptoms occurs at birth, which is known as congenital myotonic dystrophy (cdm). previous studies have enrolled a very limited number of children with cdm. the rationale for this study is to include a larger population of patients with cdm in order to determine developmental milestones, measures of physical and cognitive function and quality of life, and correlate functional outcome measures with potential biomarkers in cdm .

Eligibility criteria:
inclusion criteria: * age neonate to 3 years 11 months at enrollment. * a diagnosis of cdm, which is defined as children having symptoms of myotonic dystrophy in the newborn period (\ 1,500). * guardian is willing and able to sign consent and follow study procedures exclusion criteria: * any other non-dm1 illness that would interfere with the ability or results of the study in the opinion of the site investigator * significant trauma within one month * internal metal or devices (exclusion for dexa component) * history of bleeding disorder or platelet count \<50,000 * history of reaction to local anesthetic

Keywords: clinical research myotonic dystrophy congenital myotonic dystrophy cdm
acute dose-dependent effects of dmt in healthy subjects

Conditions: Healthy

Summary: n,n-dimethyltryptamine (dmt) is a psychoactive substance with similar effects such as lsd or psilocybin. however, dmt is less well characterized than the latter substances. the present study is a modern randomized cross-over trial, investigating different continuous intravenous dmt dose rates over a broad dose range. thus, different doses will be tested and related to subjective and autonomic effects.

n,n-dimethyltryptamine (dmt) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (ayahuasca). dmt is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. dmt is rapidly metabolized by monoamine oxidase (mao) a. therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\<20 min). in ayahuasca, dmt is consumed together with harmala alkaloids that inhibit mao to increase the oral bioavailablitity of dmt and to prolong its action after oral use. alternatively, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged dmt experience and is currently being investigated. however, to date no clinical study has investigated dose-response effects over a broad range of different doses of dmt within the same patient. the aim of the present study is to experimentally test different intravenous dmt doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of dmt in healthy subjects.

Eligibility criteria:
inclusion criteria: 1. age between 25 and 65 years old 2. sufficient understanding of the german language 3. understanding of procedures and risks associated with the study 4. willing to adhere to the protocol and signing of the consent form 5. willing to refrain from the consumption of illicit psychoactive substances during the study 6. abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions 7. willing not to operate heavy machinery within 6 h of dmt administration 8. willing to use double-barrier birth control throughout study participation 9. body mass index between 18-29 kg/m2 exclusion criteria: 1. chronic or acute medical condition 2. current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders). 3. psychotic disorder or bipolar disorder in first-degree relatives 4. hypertension (sbp\>140/90 mmhg) or hypotension (sbp\<85 mmhg) 5. hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months 6. pregnancy or current breastfeeding 7. participation in another clinical trial (currently or within the last 30 days) 8. use of medication that may interfere with the effects of the study medication 9. tobacco smoking (\>10 cigarettes/day) 10. consumption of alcoholic beverages (\>20 drinks/week)