Kornimate/medical-research-clean huggingface dataset:
comparison of customized and standard facemasks for early treatment of class iii malocclusion

Conditions: Malocclusion, Angle Class III; Extraoral Traction Appliances

Summary: the aim of the study is to compare a customized facemask for the treatment of class iii malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed. this is a single-center, national, controlled, superiority, randomized, crossover, open-label study. each patient will be treated with both the customized facemask and the standard commercial facemask. each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. after 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. in addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.


Eligibility criteria:
inclusion criteria: * age between 5 and 12 years; * class iii malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated. * signing of informed consent exclusion criteria: * cleft lip and/or palate. * craniofacial syndromes.
a study of als-008176 in infants hospitalized with rsv

Conditions: Respiratory Syncytial Virus Infections

Summary: this study will assess the safety, tolerability, pharmacokinetics (pk) and anti-viral effect of single and multiple doses of als-008176 in infants hospitalized with respiratory syncytial virus (rsv)


Eligibility criteria:
inclusion criteria: * male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or \<28 days of age (neonate cohort only). note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an rsv related illness exclusion criteria: * prematurity * receiving invasive endotracheal mechanical ventilation * poorly functioning gastrointestinal tract * anticipated to be discharged from the hospital in \<24 hours from the time of randomization * prior exposure to palivizumab

Keywords: rsv respiratory syncytial virus
the effect of chlorella supplementation on patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: diabetes is a chronic disease and the prevalence of diabetes mellitus is rapidly increasing as a result of population ageing, urbanization and associated lifestyle changes. recently, the use of natural products in chronic diseases such as diabetes has gained more attention. chlorella is a single-celled green algae that contains essential nutrients including amino acids and fatty acids as well as some vitamins and minerals. there have been some studies on the effects of chlorella supplementation in chronic diseases such as nafld, prediabetes and diabetic mice, but none of them examined the effects of chlorella in patients with type 2 diabetes. thus the present study designed to evaluate the effects of chlorella supplementation on glycemic control, lipid profile and anthropometric measurements in type 2 diabetic patients.

this study is a double-blind, randomized controlled trial. 84 patients with type 2 diabetes are recruited. after informing the patients about this study and filling the consent letters, they are randomly assigned into intervention group (n=42) or placebo group (n=42) receiving 1500 mg chlorella vulgaris or placebo daily for 8 weeks. patients are asked not to change their regular physical activity, diet, medicine and dosage during the study. anthropometric and blood pressure measurements are collected and 24-hour food intake recall, ipaq physical activity, pittsburgh sleep quality assessment (psqi) and beck anxiety and depression questionnaires are filled by each patients at the beginning and end of the study. in addition, blood samples are collected at the beginning and end of the study to determine the changes of fbs, hba1c, insulin concentration and insulin resistance (homa-ir) and lipid profile.

Eligibility criteria:
inclusion criteria: * tendency to participate * clinical diagnosis of t2dm * having t2dm for at least 1 year * range of hba1c between 6.5% and 8.5% * triglyceride range lower than 300 mg/dl exclusion criteria: * insulin dependent patients * smoking and alcohol consumption * patients with cardiovascular disease, liver disease, renal and thyroid diseases * pregnancy, lactation and menopause * intake of multivitamin and mineral supplements
cognitive outcome after gamma knife radiosurgery in patients with brain metastases (car-study a)

Conditions: Neoplasm Metastases

Summary: stereotactic radiosurgery (srs) is increasingly applied in patients with brain metastases (bm) and is expected to have less adverse effects on cognitive functioning than whole brain radiation therapy (wbrt). because cognitive functions are essential for daily functioning, and may affect therapy compliance and quality of life in general, a full understanding of cognitive functioning in patients with bm after srs is essential. car-study a is a prospective study to evaluate cognitive functioning in patients with 1-10 bm accepted for treatment with gamma knife radiosurgery (gkrs).

car-study a is a prospective study to evaluate cognitive functioning after gkrs in patients with 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced mri-scan. neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12, 15, and 21 months after treatment. follow-up assessments will be combined with 3-monthly mri-scans.

Eligibility criteria:
inclusion criteria: * histologically proven malignant cancer * 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced mri-scan * maximum total tumor volume 30 cm3 * lesion ≥ 3 mm from the optic apparatus * age ≥ 18 years * karnofsky performance status (kps) ≥ 70 * anticipated survival \> 3 months exclusion criteria: * no prior histologic confirmation of malignancy * primary brain tumor * a second active primary tumor * small cell lung cancer * lymphoma * leukemia * meningeal disease * progressive, symptomatic systemic disease without further treatment options * prior brain radiation * prior surgical resection of brain metastases * additional history of a significant neurological or psychiatric disorder * participation in a concurrent study in which neuropsychological testing and/or health-related qol assessments are involved * contra indications to mri or gadolinium contrast * underlying medical condition precluding adequate follow-up * lack of basic proficiency in dutch * iq below 85 * severe aphasia * paralysis grade 0-3 according to mrc scale (medical research council)

Keywords: brain metastases cognition radiosurgery stereotactic radiosurgery gamma knife radiosurgery quality of life fatigue anxiety depression
phase 3 study of otx-101 in the treatment of keratoconjunctivitis sicca

Conditions: Keratoconjunctivitis Sicca

Summary: this is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of otx-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.


Eligibility criteria:
inclusion criteria: * history of dry eye syndrome (kcs) for a period of at least 6 months * clinical diagnosis of bilateral kcs * lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the screening and baseline visits. * global symptom score (sande) ≥ 40 mm at both the screening and baseline visits * corrected snellen visual acuity (va) of better than 20/200 in each eye. exclusion criteria: * use of cyclosporine ophthalmic emulsion 0.05% (restasis®) within 3 months prior to the screening visit. * previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (restasis). * diagnosis of sjögren's disease ˃ 5 years prior to the screening visit. * clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis. * use of systemic or topical medications within 7 days prior to the screening visit or during the study period that are known to cause dry eye. * use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period. * current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary). * history of herpes keratitis. * corneal transplant * corneal refractive surgery within 6 months prior to the screening visit or postoperative refractive surgery symptoms of dryness that have not resolved. * cataract surgery within 3 months prior to the screening visit.

Keywords: kcs dry eye cyclosporine
study on medical records of women using an intrauterine device (iud) to analyze the risks that the iud will be expelled or perforates the womb in relation to breastfeeding, the point in time when the iud was inserted after childbirth and in relation to different types of iuds

Conditions: Intrauterine Devices

Summary: study to analyze electronic medical records of women using an intrauterine device (iud). the study was required by the fda for the marketed iud mirena (us post-marketing requirement; short name of study: apex iud). the study analyzed the risks that the iud was expelled or perforated the womb for the following group comparisons: * women who were breastfeeding at the time of iud insertion and within 52 weeks postpartum versus women who were not breastfeeding at the time of iud insertion and within 52 weeks postpartum. * women who had a first observed iud insertion within different time periods after childbirth (i.e., ≤ 6 weeks, \> 6 weeks and ≤ 14 weeks, \> 14 weeks and ≤ 52 weeks) versus women who had their first observed iud insertion more than 52 weeks after childbirth, including women without a recorded delivery within the past 52 weeks. an additional analysis involved 5-level postpartum timing (i.e., 0 to 3 days, 4 days to ≤ 6 weeks, \> 6 weeks to ≤ 14 weeks, \> 14 weeks to ≤ 52 weeks) versus the \> 52 week postpartum group. the study also analyzed the risks that the iud was expelled or perforated the womb for different types of iuds. in addition, the study aimed to assess the following interactions: * the extent to which the type of iud (iuds releasing the hormone lng versus copper iuds) modified the risk that an iud was expelled or perforated the womb in relation to breastfeeding and/ or in relation to the point in time when the iud was inserted after childbirth. * the extent to which the breastfeeding status modified the risk that an iud was expelled or perforated the womb in relation to the point in time when the iud was inserted after childbirth.


Eligibility criteria:
inclusion criteria: * women with evidence in the database of insertion of an iud (e.g. levonorgestrel-releasing, copper) during the study time window for each site * enrolled in the database with electronic medical records available for review for at least 12 months before the iud insertion exclusion criteria: - women with more than 50 years of age at the time of the iud-insertion

Keywords: contraception breast-feeding electronic medical records uterine perforation expulsion of intrauterine device
safety and pharmacokinetics of vaped cannabis in healthy volunteers

Conditions: Healthy Volonteers

Summary: the primary objective of this study was to evaluate the pharmacokinetics (pk) of thc, 11-oh-thc and cbd following a single inhaled dose of ppp001 administered by vaporization. the secondary objective of this study was to determine the safety and tolerability of thc and cbd after a single inhaled dose of ppp001 administered by vaporization in healthy volunteers.


Eligibility criteria:
inclusion criteria: * body mass index within 21.0 to 32.0 kg/m2, inclusively * a light-, non- or ex-smoker of nicotine * a history of recreational cannabis use (at least 10 times in the last 5 years) * consumed cannabis in the last 3 months before day 1 of the study, but not within 1 month before day 1 of the study * presence of intact oral mucosa * able to follow instructions at the training vaporizing session * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must have been without clinical significance, as determined by an investigator * no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs), or ecg, as determined by an investigator
white noise and pacifier use on postoperative pain and crying in newborns

Conditions: Pain

Summary: the study was conducted to determine the effect of white noise and pacifier applications on pain and crying time during painful interventions in newborns who underwent surgery

newborns most often experience painful procedures such as heel blood collection and peripheral venous catheter placement in the neonatal intensive care unit. exposure to pain early in life has even been shown to increase the risk of developing problems (chronic pain, anxiety, and depressive disorders) in adulthood. this result implies that newborn or child pain should be adequately managed. thus, pain in newborns or children should be prevented before it occurs, and if it cannot be prevented, it should be determined in the early period and the pain should be alleviated. managing this pain in newborns should be one of the primary duties of newborn nurses. the first and most important determinant in relieving pain is determining the severity of pain, and non-pharmacological or pharmacological methods should be preferred according to the severity of the pain. many non-pharmacological methods are used to manage pain that may occur in interventional procedures. some of these methods are: giving sugar solution, kangaroo care, positioning (kaşıkçıoğlu, 2014), breast milk and breastfeeding and swaddling, listening to music, lullaby. two other effective methods are non-nutritive suction and white noise. as a result of studies, it was proven that the use of multiple non-pharmacological methods together was much more effective in reducing pain. within the scope of the research, no research was found in the literature regarding which application - white noise or pacifier - could be more effective. by examining this information, the effects of the two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

Eligibility criteria:
inclusion criteria: * birth weight over 1500 grams * having passed the newborn hearing screening test * having a history of previous surgery (excluding brain surgeries) * not using sedative substances (dormicum, fentanyl) * not using opioids * having a full stomach 30 minutes before painful interventions * having permission from their mothers * newborns undergoing blood transfusion only exclusion criteria: * being intubated * having hiberbilirubinemia * birth weight below 1500 grams * having cerebral palsy * having hydrocephalus * having spina bifida * having had brain surgery

Keywords: white noise pacifier newborn surgery
effect of wearable health technology on patients treated for chronic pain at geisinger health system

Conditions: Chronic Pain

Summary: this is a proof of concept study to measure the effect of wearable health technology (wht), including the apple watch, iphone, pain app and provider dashboards on important clinical outcomes in patients treated for chronic pain. wht will be tested in a group of chronic pain patients treated at a specialty pain clinic, the geisinger multidisciplinary pain program (mpp). primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. the wht will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. additional data will be collected on device utilization by patients and health care professionals.

this is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of wht on patient and health system outcomes. wht used in this study are the apple watch and iphone, a pain application (pain app) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the wht. the wht will consist of: * applewatch and iphone * patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph) * prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with mpp training subjects will use the wht 20 hours per day, every day for a period of 12 months. subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12. outcome data for control groups will be collected retrospectively from the electronic health record (ehr). assessments will have occurred as part of their standard of care.

Eligibility criteria:
inclusion criteria: * admission to the mpp * completion of the 3-day mpp training * ability to understand and complete the informed consent form prior to the initiation of any study procedures * adequate motor skills needed to utilize wht * willingness to utilize personal electronic devices and wht, as expressed and documented during the informed consenting process * ability to understand spoken and written english exclusion criteria: * cancer diagnosis, aids, end-stage liver disease or end-stage renal disease * hospitalization \>30 days during the 12 months prior to index date * nursing home or hospice care during the 12 months prior to index date * presence of an ehr diagnosis description "opt-out center research" which indicates the subject has opted out of (i.e., does not wish to be included in) any geisinger retrospective research * has a terminated medicine use agreement on their problem list, indicator for substance abuse/dependence

Keywords: wearable health technology iphone apple watch pain medication
investigation of the effects of two different treatment programs on chronic low back pain

Conditions: Chronic Low-back Pain

Summary: this study was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain.

recent study will be carried out on volunteer patients who applied to the physical therapy clinic of "mugla sitki kocman university" training and research hospital, who were diagnosed with chronic non-specific low back pain and who comply with the study criteria. the sample size has been calculated that 80% power can be obtained at 95% confidence level. it was found that at least 21 cases, a total of 44 cases, were required for each group. volunteers will be divided into 2 groups by randomization. conventional physiotherapy applications will be applied to the control group. in addition to conventional physiotherapy methods, kinesio-taping (kt) will be applied to the study group. patients in both groups will be treated 5 days a week for a total of 10 sessions for 2 weeks. kt will be renewed in each session on weekdays.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 to 60 years with chronic low back pain * those who have complained of low back pain for at least 3 months * individuals whose pain intensity is above 3.5 cm according to vas * pain and numbness that does not spread to the legs exclusion criteria: * situations that prevent the evaluation or communication with the individual * illiterate individuals * individuals who have undergone surgical operations on the spine and / or extremities * conditions where specific pathological conditions are proven such as malignant condition, fracture, systemic rheumatoid disease * orthopedic and neurological problems that prevent evaluation and / or treatment * complaints of pain and numbness spreading to the lower extremities * individuals with a diagnosed psychiatric illness * individuals who have received physiotherapy in the last 6 months * individuals who use another treatment method during the study * individuals with musculoskeletal pain in any other part of the body during work * pregnant

Keywords: chronic low back pain, kinesiotape, physiotherapy, awareness
effect of weight reduction on inflammatory markers and genes expression in obese individuals

Conditions: Obesity; Inflammation

Summary: to investigate whether weight reduction by life style modification for 12 weeks will improve circulating inflammatory markers, adipocytokines as well as gene expression of proinflammatory protein obtained from circulating monocytes from obese individuals.


Eligibility criteria:
inclusion criteria: * nondiabetes obese individuals with bmi greater than 27 kgs/m2 exclusion criteria: * diabetes * abnormal hepatic, renal and cardiac function

Keywords: obesity inflammation