Kornimate/medical-research-clean huggingface dataset:
tolerability of inhaled hypertonic saline in infants with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is an open-label pilot study of the safety and tolerability of 7% hypertonic saline inhaled twice daily for 14 days in infants with cf, 12 to 30 months of age.

the efficacy and safety of hypertonic saline (hs) in cf patients over 6 years of age has been demonstrated in clinical trials of 2 to 48 weeks' duration. based on these results, a large randomized, placebo-controlled trial of the efficacy and safety of 7% hs administered twice daily for 48 weeks to infants with cf, 4 to 15 months of age at enrollment, is planned (the infant study of inhaled saline (isis) trial). it is anticipated that 150 infants at up to 16 sites will be enrolled in the isis trial. to date, the only evaluations of the safety of hs in infants with cf have been small single-dose studies. there has been no evaluation of the tolerability of chronic hs administration. the goal of this study is to assess the safety and tolerability of exposure to 14 days of 7% hs administered twice daily in infants with cf, prior to enrolling subjects in the planned large, randomized, controlled trial. conduct of this study will provide evidence for the tolerability of chronic hs administration in infants with cf and estimates of the proportion of infants who do not tolerate chronic hs treatment. the results will be used to establish the appropriate measures of tolerability at enrollment in the isis trial, and to refine sample size estimates to account for withdrawal due to intolerance of hs.

Eligibility criteria:
inclusion criteria: * diagnosis of cf as defined by one or more clinical features of cf and a documented sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations * informed consent by parent or legal guardian * 12-30 months of age at enrollment exclusion criteria: * wheezing at the baseline evaluation at the enrollment visit * oxygen saturation \< 95 % at the baseline evaluation at the enrollment visit * acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate, or new rhinorrhea, nasal congestion or rhinorrhea, with onset in the week preceding the enrollment visit * investigational drug use within 30 days prior to the enrollment visit * known intolerance of albuterol * current enrollment in a therapeutic clinical trial * condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures

Keywords: cystic fibrosis, hypertonic saline
search sapphire phase b

Conditions: HIV

Summary: this study will evaluate the effects of optimized dynamic prevention and treatment packages delivered in a precision community health model on hiv incidence, as well as other health outcomes, in a community randomized trial design.

in the "evaluation" phase b, the search sapphire study will evaluate the effects of dynamic prevention and dynamic treatment intervention packages based on data from phase a (nct04810650) and new advances from outside the study delivered in a precision community health model, on hiv incidence and other health outcomes, in a pair-matched community randomized design. the phase b precision community health intervention will consist of a three part intervention: 1) community-enhanced reach activities 2) person-centered care delivery; and, 3) data-enhancement to improve precision of interventions. the study hypothesis for the phase b population level study is: a precision community health model leveraging existing facility-based outreach and community health workers, enabled by dynamic choice prevention/treatment multi-disease approaches and interactive data systems -will reduce hiv infections, deaths and improve health. structured stakeholder consultations are formally incorporated in the study design and leverage regular and ongoing collaborations the study team has with the hiv, non-communicable disease and general health leads in kenya and uganda ministries of health and pepfar implementing partners at the national and the regional level.

Eligibility criteria:
inclusion criteria: 1. age \>= 15 years 2. living in search study communities 3. provided informed consent exclusion criteria: 1. \<15 years of age 2. living outside search study communities 3. unable to provide consent or parental co-consent as per country guidelines

Keywords: prep hiv treatment hiv prevention community health youth and adolescents hypertension
care of patients with parenteral nutrition at home

Conditions: Crohn's Disease; Peritoneal Carcinomatosis With Intestinal Occlusion; Radiation Enteritis; Chronic Diarrhea; Intestinal Lymphomas

Summary: this research aims to give an overview of a number of aspects related to the quality of care for adult patients on home parenteral nutrition. concretely this study follows up different aspects on different moments in the care of the patient pathways: * process indicators concerning indication, parenteral nutrition, training, team access roads and the succession of complications * outcome indicators * the health-related quality of life * discrepancies in medication use * the role of the different health care providers

adult patients on hpn will be contacted by phone at three different time moments after their discharge to ask them about indicators, quality of life and discrepancies in medication use. after the follow-up, medical dossiers will be consulted to know which indicators are followed in practice. the role of the different health care providers will be investigated by face-to-face interviews with different healthcare professionals.

Eligibility criteria:
inclusion criteria: * patients in flanders who speak dutch, are older then 18 years and are able to give an informed consent. exclusion criteria: * patients who are younger then 18 years.
commets- combination mci metabolic syndrome

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Metabolic Syndrome

Summary: the investigators propose a proof of concept rct (randomized clinical trial), testing the efficacy of intranasal insulin (ini) with semaglutide, a combination therapy with strong biological plausibility to benefit impaired cognition through vascular mechanisms, in older adults with mets (metabolic syndrome) and mci (mild cognitive impairment), who are enriched for cerebrovascular disease and at high dementia risk. the study will focus on cognitive and biological outcomes, allowing identification of relevant mechanisms.

the specific aims of the study are: aim 1. to examine the ease and precision of use of the intranasal device and once daily semaglutide pill. aim 2. to examine the adherence to the two types of treatment. aim 3. to examine the safety profile of the combination of intranasal insulin with semaglutide. the safety profile of each has been published broadly, but the safety of their combination has not been examined. aim 4. although the primary goal of the pilot study is proof of concept essential to design a large combination therapy rct, the investigators will compare the combination of intranasal insulin and semaglutide with the other three groups on a) cognition, b) cerebral blood flow (via asl mri), c) glucose uptake (via fdg pet), adrd(alzheimer's disease and related disorders)-related blood biomarkers (aβ42/aβ40 ratio, ptau181 and 231, nfl and gfap), and expression of insulin signaling genes from brain derived exosomes.

Eligibility criteria:
inclusion criteria: * diagnosis of mci (based on a moca \<27 and a clinical dementia rating scale \[cdr\] score of 0.5 representing questionable dementia). * diagnosis of mets -requiring a) abdominal obesity (waist circumference \>102cm for men and \>88cm for women), and b) glucose intolerance (fasting glucose\>110 mg/dl) and at least one of the following-c) dyslipidemia (high triglycerides \[\>150 mg/dl\] and low hdl \[\ 130/\>85 mmhg). * fluent in hebrew * the study requires an active study partner exclusion criteria: * diabetes (of any type) * taking medications that may affect glucose metabolism (including a glp-1ra). * diagnosis of dementia and its subtypes, conditions that may directly affect cognition, * short life expectancy or a medical condition that precludes consistent participation in the study, * contraindications to either insulin or semaglutide. * medications that may affect glucose metabolism such as corticosteroids.

Keywords: alzheimer disease mild cognitive impairment metabolic syndrome dementia semaglutide intranasal insulin
oral tranexamic acid and topical hydroquinone in the treatment of melasma

Conditions: Melasma

Summary: this study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.

hydroquinone (hq) is considered the gold standard depigmenting agent for melasma, nevertheless, many patients are recalcitrant to this treatment. recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent uv-induced pigmentation.

Eligibility criteria:
inclusion criteria: * moderate melasma (subject with mmasi score of 5 to 7.9), * severe melasma (subject with mmasi score ≥ 8), * willing to follow up for 6 months. exclusion criteria: * pregnant women, * nursing women, * women on exogenous hormones * current treatment with blood thinners, * had a history of thrombosis, * had an abnormal kidney function, * use of topical hydroquinone within 3 months of study enrollment, * use of topical steroids, vitamin a analogs, chemical peels within 1 month of study

Keywords: melasma tranexamic acid hydroquinone mmasi mexameter
yoga for adolescents

Conditions: Yoga

Summary: purpose: specific effects of high-density hatha yoga(hy) training in adolescents have not yet been clarified. aim of our study is to investigate the effects of high-density hy education on physical fitness, pulmonary function and quality of life in healthy adolescents. methods: 28 female adolescents will be randomly divided into two groups as yoga training and control groups. training group will receive high-density hy training for 8 weeks, two days a week under the supervision of a physiotherapist and one day a week home program. control group will not receive any exercise. flexibility of individuals will be determined by sit-reach, back scratching, lateral flexion tests; muscular endurance by sit-ups, sit down-stand up on chair tests, balance by time up-go test; cardiorespiratory capacity by incremental shuttle walking test(iswt) and respiratory functions by spirometry, quality of life will be determined by with the quality of life scale for children.


Eligibility criteria:
inclusion criteria: - female adolescents between the ages of 14 and 18 exclusion criteria: - individuals with recent muscular skeletal, neuromuscular and chronic systemic diseases that could prevent exercise

Keywords: yoga physical fitness adolescent quality of life sleep quality
cognitive and psychophysiological effects of delta-9-tetrahydrocannabinol in bipolar disorder

Conditions: Delta-9-Tetrahydroncannabinol; Bipolar Disorder; Healthy Controls

Summary: the overarching goal of this study is to characterize the acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (thc) in individuals with euthymic bipolar disorder (bd), and to begin probing the mechanisms that may underlie its effects in this illness. this study is expected to contribute to a better characterization of specific effects of thc in individuals with bd compared to healthy controls (hc).

to compare the dose related acute effects of inhaled thc, administered through a vaporizer over approximately 20 minutes, between hc and euthymic bd individuals (referred to as ebd) on a range of subjective and objective parameters as described below: primary aims: * verbal memory, measured by a modified computer version of the rey auditory verbal learning test (ravlt) and/or the cogstate battery, administered while eeg data is collected. * executive functioning measured by the cogstate battery and/or trails making test-part b. secondary aims: * attention, measured by the continuous performance test-identical pairs (cpt-ip). * working memory, measured by the wechsler memory scale-3 letter-number sequencing. * mood, measured by the profile of mood states (poms). * psychotic-type experiences, measured by the psychotomimetic states inventory (psi) and/or the clinician administered dissociative symptoms scale (cadss). * anxiety symptoms, measured by the visual analog scale for anxiety (vas-a). * impulsivity, measured by the balloon analogue risk task (bart). exploratory aims: •serum prolactin, serum acth, serum cortisol and serum endocannabinoid levels.

Eligibility criteria:
inclusion criteria for individuals with bipolar disorder (bd) 1. men and women aged 18-55 years (extremes included). 2. able to provide informed consent in english. 3. a diagnosis of bd type i or bd type ii and good physical health. 4. current euthymic state for at least 4 weeks. inclusion criteria for healthy control (hc) individuals: 1. men and women aged approximately 18-55 years (extremes included). 2. able to provide informed consent in english. 3. no psychiatric diagnoses and in good physical health. general exclusion criteria: 1. cannabis naïve 2. unwillingness to remain alcohol-free, cannabis-free for at least 1 week (in infrequent cannabis users) prior to each test day. 3. evidence of a hearing deficit. 4. iq less than 80. 5. positive pregnancy test, lactation, and refusal to practice birth control.
the effects of ginger supplementation on inflammation in exercising individuals

Conditions: Healthy

Summary: the purpose of our graduate student research study is to observe the effects of ginger on hscrp, il-6, and tnf-α levels in exercising individuals based on their level of activity.

participants will fill out a demographic questionnaire and a quality of life survey, (sf-36). take a 3g supplement of ginger in powder form with meals once/day (preferably in the morning) for 8 weeks. by end of week 4 (halfway through the study), subjects will do another blood test for mid-intervention crp, il-6, and tnf-α values. by end of week 8, participants will do a final blood test for crp values and fill out the sf-36 survey for post-intervention levels.

Eligibility criteria:
inclusion criteria: * 30 - 70 years of age * various levels of activity outlined by the general physical activities defined by level of intensity by the american college of sports medicine (acsm) and the centers for disease control and prevention (cdc). * regular exercisers- at least 30 minutes of moderate to vigorous activity at least 3 times per week. * non-regular exercisers- at least 30 minutes of moderate to vigorous activity 1-2 times per week. exclusion criteria: * individuals currently taking... * vit d * aspirin * coumadin * ginger supplements more than 1x/week within the last month * heparin * nsaids * pain meds * individuals with chronic inflammatory conditions such as cancer, cvd, diabetes, gastroesophageal reflux disease (gerd), ginger allergies, metabolic syndrome, and/or autoimmune diseases such as rheumatoid arthritis
a long-term study of kct-0809 in dry eye patients with sjögren's syndrome

Conditions: Dry Eye With Sjögren's Syndrome

Summary: the purpose of this study is to evaluate of the long-term safety and efficacy of kct-0809 in dry eye patients with sjögren's syndrome.


Eligibility criteria:
inclusion criteria: * dry eye patients with sjögren's syndrome * corneal and conjunctival damage exclusion criteria: * severe ophthalmic disorder * punctal plugs or surgery for occlusion of the lacrimal puncta

Keywords: dry eye syndromes corneal diseases conjunctival diseases
activity in tourette syndrome

Conditions: Tourette Syndrome; Persistent Tic Disorder

Summary: tics are brief repetitive movements or vocalizations. gilles de la tourette's syndrome (ts) is a disorder characterized by recurrent motor and vocal tics. tourette syndrome and tic disorders affect up to 8% of children. peak severity of tic disorders occurs between the ages of 8 to 12 years, therefore during childhood and adolescence the most significant impacts are felt. the quality of life of young people with tics is lower than their peers' and tic severity predicts lower quality of life. studies have also shown negative social perception toward children with tics. approximately 50% of patients with tourette syndrome will have other diagnoses including attention deficit hyperactivity disorder (adhd), obsessive compulsive disorder, anxiety and depression. studies have shown improvements in adhd with physical activity. adhd and tic disorders are thought to involve the same areas of the brain; thus it is possible that tics might also improve with physical activity. however, no studies to date have examined this. the investigators predict that by implementing a motivational physical activity program, in conjunction with physical activity counseling, the investigators will be able to increase levels of physical activity in children with tics and tourette syndrome, with a positive impact on tic severity.


Eligibility criteria:
inclusion criteria: * participants are between 8-16 years of age. * participants are required to have a diagnosis of either tourette syndrome or persistent (chronic) motor of vocal tic disorder as per the dsm v. * participants must be ambulatory. * participants and parents must understand english or french. * participants must be able and willing to complete the questionnaires. * participants cannot have any changes to their medication for tics, or any other psychotropic medications for 4 weeks prior to and for the entire duration of the study exclusion criteria: * participants who cannot ambulate independently. * participants who are not permitted to participate in physical education class at school. * participants or families who are not willing to be randomly assigned to a study group.

Keywords: tourette syndrome persistent tic disorder physical activity quality of life
analgesic efficacy of maxigesic in breast cancer surgery

Conditions: Breast Cancer

Summary: the present study aims to find a perioperative analgesic method that provides sufficient analgesia while reducing immune compromise in cancer surgery. this study is to investigate the analgesic effect and safety of maxigesic inj. (a combination of acetaminophen 1000 mg and ibuprofen 300 mg), which is added to opioid-based iv-pca in patients undergoing breast cancer surgery.


Eligibility criteria:
inclusion criteria: * patient aged 20 to 70 years with asa classification 1 to 3 undergoing breast cancer surgery (cancer resection or reconstruction) exclusion criteria: * asa classification 4/ allergy to acetaminophen, nsaids, opioid/ severe liver or renal dysfunction/ pregnancy
walking exercise on memory, subjective cognitive complaint, and brain-derived neurotrophic factor for hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine the effect of 6-month aerobic walking program on memory, subjective cognitive complaints, and brain-derived neurotrophic factor for older hypertensive women. participants will be randomly assigned to the experimental group and the control group. the intervention group will last for 24 weeks. the outcome measurements included memory, subjective cognitive complaints, and brain-derived neurotrophic factor.

the purpose of this study is to explore an aerobic walking program on memory, subjective cognitive complaints, and brain-derived neurotrophic factor. in quantitative study with experimental design, qualified subjects will be randomly assigned to experimental or control group. experimental subjects will perform six-month aerobic walking program and control group receive routine care. the outcome measurements included memory, subjective cognitive complaints, and brain-derived neurotrophic factor. data will be collected at baseline, the end of the six-month intervention. data will be analyzed using generalized estimation equation evaluate the effect of the intervention program.

Eligibility criteria:
inclusion criteria: 1. aged 60-80 years old, 2. a diagnosed of hypertension ≥ 6 months 3. self-reporting the signs of memory or thinking skills problems exclusion criteria: 1. probable cognitive impairment as assessed by montreal cognitive assessment ( \< 24 points), 2. significant conditions limiting walking ability (e.g. musculoskeletal problems, visual impairment, etc.), 3. already participating in 30 minutes or more of moderate-intensity exercise five times a week 4. a history of severe cardiovascular disease, 5. a history of neurologic or psychiatric disorder such as stroke, head injury dementia, parkinson disease, and depression.

Keywords: walking exercise memory hypertension brain-derived neurotrophic factor subjective cognitive complaint women
occupational therapist-led work intervention in facilitating work maintenance or re-entry to the workforce in patients with stage i to iii breast cancer undergoing chemotherapy

Conditions: Breast Cancer Stage I; Breast Cancer Stage III; Breast Cancer Stage II; Breast Cancer Stage IIA; Breast Cancer Stage IIB; Breast Cancer Stage IIIA; Breast Cancer Stage IIIB; Breast Cancer Stage IIIc; Breast Cancer

Summary: this trial studies how well occupational therapy (occupational therapist-led work intervention) works in facilitating work maintenance or re-entry to the workforce for stages i to iii breast cancer patients who will be undergoing curative intent chemotherapy. occupational therapy may help cancer patients maintain employment or successfully return to work soon after treatment.

patients receive in-person occupational therapist-led work consultation.

Eligibility criteria:
inclusion criteria: * stage i-iii breast cancer patients who will be undergoing curative intent chemotherapy * working in a paid capacity (part or full-time) at time of diagnosis with the intent to maintain or return to work following treatment exclusion criteria: * non-english speaking patients. this study requires completing online questionnaires that are written in english and will not be translated * patients with a psychiatric or neurological condition that impairs capacity to make decisions
proton pump inhibitor (ppi) therapy for newly diagnosed esophagitis

Conditions: Erosive Esophagitis; Reflux Esophagitis; GERD

Summary: this study is being done to for two reasons: * to learn about the effects (good and bad) esomeprazole (an fda approved drug for reflux esophagitis) has on your esophagus when taken correctly. * to learn about the quality of life changes (good and bad) you may experience with this medication.

the plan is to have 50 people take part in this study at mayo clinic rochester. this research study is looking at people who have a new condition called erosive reflux esophagitis. esophagitis is defined as mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. acid reflux, over time, can wear away or erode the lining of your esophagus. this condition is called erosive esophagitis. the treating physician may start you on prescription strength acid reducing group of medications called proton pump inhibitors (ppi). ppi medications can provide 24-hour relief from your painful heartburn symptoms and it can help you heal the erosions in the esophagus that acid reflux may cause.

Eligibility criteria:
inclusion criteria: * age 18 or older * have either mild-to-moderate erosive reflux esophagitis * meet criteria for gerd symptoms. exclusion criteria: * patients already on esomeprazole therapy, have previously failed to respond to esomeprazole, or are intolerant to ppi therapy. * patients expected to travel outside of the united states during the initial 8 weeks of ppi therapy. * pregnant women will be excluded as ppi's are not thought safe for the fetus (pregnancy category c). - children younger than 18 years of age will be excluded. * other vulnerable populations, such as those with diminished mental acuity, will be excluded.

Keywords: erosive esophagitis reflux esophagitis gerd