Kornimate/medical-research-clean huggingface dataset:
intensive care program for youth with diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * age 8-16 years * type 1 diabetes diagnosed by standard american diabetes association criteria * type 1 diabetes duration of at least 6 months * residence in northeastern u.s. * established clinic patient * fluency in english or spanish exclusion criteria: * major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation) * unstable living environment (e.g., department of social services or department of youth services involvement)

Keywords: type 1 diabetes hemoglobin a1c family involvement responsibility conflict quality of life children
clinical trial to assess bioequivalence of lazertinib between two formulations in healthy volunteers.

Conditions: Healthy Adult Volunteers

Summary: this clinical trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. the subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.

this clinical trial will be conducted in healthy male volunteers at seoul national university hospital (snuh) clinical trial center. it is expected to take approximately 32 days from the first dosing of investigational product until the final follow-up visit. subjects will be hospitalized twice for 4 nights and 5 days with 7-14 days of wash-out period, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the investigational product.

Eligibility criteria:
inclusion criteria: * male, over 19 years of age * male participants must agree to use an adequate contraception method from the first to the third month after the last dose. * participants must have a body mass index (bmi) between 18.5 and 30.0 kg/m2, inclusive(bmi = weight/height2), and body weight not less than 50 kg. * subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis. * participants must be healthy on the basis of clinical laboratory tests performed at screening. * informed of the investigational nature of this study and voluntarily agree to participate in this study. exclusion criteria: * clinically significant medical or psychiatric illness. * hypotension (sbp ≤ 90 mmhg or dbp ≤ 50 mmhg) or hypertension (sbp ≥ 150 mmhg or dbp ≥ 100 mmhg). * a marked baseline prolongation of qtc. * within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications * participants who are planning covid-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.

Keywords: yh25448 non-small cell lung cancer
effectiveness of cannabis in the treatment of tinnitus patients

Conditions: Tinnitus

Summary: the hypothesis of the study is that the use of cannabis will attenuate the tinnitus level as experienced by the patients.


Eligibility criteria:
inclusion criteria: * tinnitus lasting more than 3 months * tinnitus handicap inventory score over 58 * treated previously for tinnitus (2 modalities) exclusion criteria: * prior use of drugs * current use of cannabis * neurologic or psychiatric disease * heart failure * ischemic heart disease * immune deficiency * acoustic neuroma

Keywords: tinnitus cannabis
pilot testing the check up

Conditions: Cannabis Use Disorder

Summary: we propose to pilot test an adapted version of the teen marijuana check up (tmcu) for persistent cannabis users with first episode psychosis (fep) in coordinated specialty care (csc). the adapted version of the tmcu will include tailoring to risks of persistent cannabis use in fep, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain csc engagement and antipsychotic adherence and to reduce harm associated with cannabis use.

we propose to adapt the teen marijuana check up for persistent cannabis users with fep in csc. dr. walker, the developer of the tmcu, will be a consultant. adaptations will include tailoring content of assessment and feedback to risks of persistent cannabis use in fep, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain csc engagement and antipsychotic adherence and to reduce harm associated with cannabis use. we will also develop guidelines for integrating continued collaborative, harm-reduction focused discussion of cannabis use into csc, consider adding booster or check-in sessions, and specify how family members can be brought into the check-up process. to inform these adaptations, we will collect quantitative data from cannabis-using fep patients (n of 40) and conduct qualitative interviews with cannabis-using patients, family members, and csc clinicians (15 of each) about their perspectives on cannabis use and csc participation (aim 1). we will use these data as part of an iterative process to specify the adapted intervention that will integrate information gathered from team discussion and focus groups with fep patients and family members and vetting of intervention components by key stakeholders (aim 2). finally, we will conduct a pilot of the adapted intervention (n of 40 cannabis-using fep patients compared to matched controls) to examine feasibility, acceptability, fidelity, and preliminary impact on intervention targets and outcomes (aim 3). if results are promising, the intervention can be tested in a large rct across the epinet.

Eligibility criteria:
inclusion criteria: 1. age 13-35 2. dsm-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorder, and unspecified schizophrenia spectrum and other psychotic disorder 3. duration of illness: ≤ 2 years 4. enrolled at a coordinated specialty care program 5. report current use of cannabis 6. ability and willingness to provide informed consent to participate exclusion criteria: 1. individuals who do not meet all inclusion criteria are excluded.
effect of omega 3 fats on sperm quality and sexual function

Conditions: Infertility

Summary: this study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. it will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a pde 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.

infertile men commonly have difficulty timing sexual relations around the time of ovulation. there is a high incidence of abnormal sperm morphology in infertile men. omega 3 fats are known to increase the production of nitric oxide, which is the mediator of the male response, and folic acid is an important cofactor in the production of nitric oxide. omega 3 fats are also important in the structure and function of cell membranes. there is a high incidence of deficient intake of omega 3 fats and folic acid in the u.s. population. both folic acid and omega 3 fats are available as nutritional supplements and the doses used in this study are doses commonly recommended as nutritional supplements. comparison: omega 3 fats plus folic acid will be compared with placebo plus folic acid in men age 35 to 55 attempting pregnancy with normal or mildly impaired semen quality. they will fill out dietary questionaires, questionaires regarding sexual function, and will have measurements of serum nitrates, blood pressure, and semen quality before and during use of these nutritional supplements. in men continuing on both omega 3 fats and folic acid, we will compare the effects of a sub-therapeutic dose of a pde 5 inhibitor versus placebo on their sexual function.

Eligibility criteria:
inclusion criteria: * infertile men * age 35 to 55 * expressing difficulty timing relations to their partner's ovulation exclusion criteria: * hypertension, heart disease or other systemic diseases * fatty fish intake more than twice per week * marked semen abnormalities (less than 10 million sperm per ml, less than 20 % a plus b motility, more than 1 million wbc per hpf) * use of anticoagulants * must be willing to not take pde 5 inhibitors during the study * use of other supplements is prohibited during the study

Keywords: infertility semen quality sexual function blood pressure omega 3 fats folic acid
evaluation of the effectiveness of infrared led photobiomodulation in children with sleep bruxism

Conditions: Bruxism, Sleep

Summary: sleep bruxism is a masticatory muscle activity characterized as rhythmic (phasic) or non-rhythmic (tonic). the literature reports the prevalence rates, diverse etiologies and different types of treatment. in children and adolescents, etiological factors, such as breathing pattern and sleep quality, have recently been addressed in studies investigating sleep bruxism. while studies have also reported psychological factors as a causal factor, this aspect requires further research. there are also divergences in opinion regarding the form of treatment. new therapies for adults, such as botulinum toxin, have been investigated, but such techniques are not applicable for individuals in the growth and development phase. thus, photobiomodulation therapy has piqued the interest of researchers, as this noninvasive method has demonstrated positive results in problems related to muscle tissues. this document describes the protocol for a proposed study to evaluate morphological and psychosocial aspects in children and adolescents with awake bruxism and their responses to photobiomodulation therapy with infrared led.


Eligibility criteria:
inclusion criteria: * mixed dentition phase (permanent incisors and molars erupted) * established permanent dentition. exclusion criteria: * dental caries * using medications, such as anti-inflammatory agents, muscle relaxants, corticoids, anticonvulsants and antidepressants * those with chronic diseases that affect muscles or motor coordination * those who do not cooperate during the evaluation
study to compare the clinical effectiveness and cost utility of an all-in-one procedure with an at-home screening trial

Conditions: Neuromodulation; Chronic Pain Patients

Summary: in 2019, the dutch healthcare institute published a consensus report outlining when spinal cord stimulation (scs) for chronic pain qualifies for reimbursement under dutch health insurance. it mandates that adult patients with significant pain (vas ≥50mm or nrs ≥5) undergo an at-home screening trial, which must show at least 50% pain reduction to proceed with permanent implantation. while screening trials allow patients to experience the therapy beforehand, they are costly, duplicative, and carry risks such as infection. a recent uk study (trial-stim) found no significant difference in outcomes between patients who had screening trials and those who received an all-in-one scs procedure, but the trial strategy incurred greater costs. given these findings, and the fact that all-in-one procedures are already used in certain dutch cases, it is reasonable to evaluate this approach more broadly. therefore, a pragmatic, multi-centre, randomized non-inferiority trial will compare the effectiveness of the all-in-one procedure, no trial group (ntg) to the standard two-step approach, trial group (tg) in dutch patients with chronic neuropathic pain.


Eligibility criteria:
inclusion criteria: 1. diagnosed with chronic, neuropathic pain with an approved aetiology in the netherlands psps (persistent spinal pain syndrome) pdn (painful diabetic neuropathy) crps (complex regional pain syndrome) sfn (small fibre neuropathy) 2. suitable candidate according to the inclusion criteria of the dutch "standpoint on neuromodulation in chronic pain" adult patients ≥18 years chronic pain ≥6 months pain intensity of ≥50mm or ≥5 on vas- or nrs-score respectively 3. routinely selected for cl-scs 4. be willing to complete additional trial related questionnaires 5. be willing and capable of giving informed consent. exclusion criteria: 1. general exclusion criteria according to the dutch "standpoint on neuromodulation in chronic pain": drug abuse pregnancy coagulation disorder / use of anticoagulation therapy which cannot be stopped temporarily active infection life expectation ≤12 months intake questionnaires "proms neuromodulatie" not completed by the patient 2. have an existing drug pump and/or scs system or another active implantable device such as a pacemaker, deep brain stimulator (dbs), or sacral nerve stimulator (sns) 3. current or previous treatment with an implanted pain reduction device 4. participation in another clinical trial that may confound the results of this trial

Keywords: neuromodulation chronic pain scs procedure standard of care
group hypnosis for stress reduction

Conditions: Stress, Psychological

Summary: this prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.

in a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis training including cds/mp3 recordings as homework to reduce perceived psychological stress in healthy subjects is investigated. outcomes are measured quantitatively and qualitatively.

Eligibility criteria:
inclusion criteria: * healthy or health-stable participants between 18 and 70 years with subjective increased intensity of stress in the last four weeks on the visual analogue scale rated between 40 -100 mm (vas 0 - 100 mm) * ability to consent and sign declaration of informed consent exclusion criteria: * current or planned participation in a stress management program within the next 17 weeks * current use of psychotherapeutic treatment * presence of moderate or severe acute or chronic disease * presence of an acute or chronic mental disorder * participation in a study within the last 2 months prior to enrollment * lack of understanding of the german language
establishing the vitamin d requirements during lactation

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin d supplementation as a function of ethnicity and latitude in the prevention of vitamin d deficiency in the breastfeeding mother-infant pair. the findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin d requirements and the potential benefit to both mother and infant

mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitd3. mothers, lactating or nonlactating controls will be randomized to either group a: standard treatment(400 iu d3/d), group b: (2,400 iu d3/d), or group c: (6,400 iu d3/d. infants of mothers randomized to group a will receive 400 iu d3/d (recommended practice) and infants of mothers assigned to groups b or c will receive placebo. on 2/5/2009, the protocol was amended and the group b arm was dropped; infants of active subjects randomized to group b as of 2/5/2009 were put on open label treatment (400 iu d3/d) through study completion. newly enrolled subjects after this date were randomized to group a or group c only. by measuring an array of indicators,calcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored. through this study, the prevalence of vitd deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with vitd3 will be assessed.

Eligibility criteria:
inclusion criteria: * mother plans to breastfeed exclusively for at least six months * mother is in good health * infant is 35 weeks' gestation or greater * breastfeeding infant is in good health ( level i nursery; or level ii nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours). exclusion criteria: * mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months * infant has been admitted to neonatal intensive care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours * infant is less than 35 weeks' gestation * infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern * mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal * mother has history of hypercalciuria

Keywords: breastfeeding vitamin d vitamin d deficiency
the substance use and health risk intervention (suhri) for justice-involved youth

Conditions: Substance Use Disorders

Summary: this investigation will adapt and pilot test an integrated health risk-reduction and motivational enhancement intervention for juvenile justice (jj) youth that will ultimately be (after full testing through a subsequent large-scale rct) a sustainable intervention implemented within a jj supervision/case management context to teach and facilitate positive, pro-social, and expected behaviors. the intervention will use graphical approaches to encourage introspection and problem identification, enhance self-regulation, improve analytical problem-solving skills, and promote healthy behaviors in two inter-related target areas: substance use and risky sex practices. existing evidence-based intervention materials will be incorporated and delivered through a web-based application. sessions will be self-directed (require minimal instruction/interaction assistance), and also include a service referral piece whereby youth are provided with a list of treatment and health agencies at the end of sessions that address specific topics. research activities will be carried out in two pilot studies: (1) intervention adaptation and feasibility and (2) protocol feasibility and preliminary efficacy trial. in pilot 1, intervention content will be adapted from existing evidence-based interventions so that it is developmentally appropriate for the target population and suitable for a web-based format (n = 30; 20 youth, 10 jj staff). pilot 2 will test a scaled-down version of an intervention efficacy trial, testing the web-based intervention using a 1-arm design whereby 60 enrolled youth (who meet eligibility requirements) from one juvenile probation department are enrolled to participate. this clinical trial submission, and the accompanying irb protocol are based on pilot 2 only.

a 1-arm design was used to examine preliminary efficacy of the adapted intervention. youth aged 14 to 18 who are disposed to community supervision (deferred adjudication or probation) and meet eligibility requirements (1+ indicator of substance use, under community supervisions, english-speaking, no indication of suicide risk or thought disorder) were sampled from a large urban texas juvenile probation department. protocol administration was proctored by a tcu research assistant at a private space within a juvenile justice office or mutually agreed upon location of participant's choosing. youth were asked to complete all assessments and participate in the 4 individualized technology-based intervention sessions where youth received information and engaged in decision making scenario-based games about substance use, sex risk practices, and related health-risk.

Eligibility criteria:
inclusion criteria: * on community supervision (e.g., deferred adjudication or probation), 1+ indicator of su, english-speaking, exclusion criteria: * no indication of suicide risk or thought disorder
virtual reality as a tool for rehabilitation on elderly people

Conditions: Aged

Summary: assessment of energy expenditure and the quadriceps muscle fatigue of healthy seniors, after two physical activities, being one of an activity guided by interactive video game (xbox) and another on the treadmill. the participants will perform the activities in two different days, the order will be obtained by randomization.


Eligibility criteria:
inclusion criteria: * participate in this study elderly * of both sexes, * over 60 years, * without cardiac and respiratory diseases * who accept to participate in the research, giving your consent by signing the informed consent exclusion criteria: * those who oppose the signing of the informed consent * submit proposals and activities intolerance who can't understand or accomplish correctly the procedures due to physical and or mental limitations.

Keywords: elderly videogame energy expenditure electromyography rehabilitation
perceptual influences from smoking cannabis: an experimental study

Conditions: Cannabis Use; Stress

Summary: the purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate. we expect that participants will be in this research study for approximately one week. the total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.


Eligibility criteria:
inclusion criteria: * 21-65 years of age * endorsement of at least some use of cannabis for coping purposes (\>1 on cmmq) * regularly use flower cannabis products (i.e., ≥1x/week in the last 6 months) * proficient in english language * at least occasional use of cbd+thc or cbd-dominant products (e.g., ≥1x/month) exclusion criteria: * diagnosis or use of medications for substance use or psychotic disorders * report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs * females cannot be pregnant or trying to become pregnant or nursing mothers * not able to provide informed consent
a study of ro6867461 administered in single- and multiple-ascending doses in patients with wet age-related macular degeneration

Conditions: Macular Degeneration

Summary: this multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ro6867461 in patients with wet age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 50 years of age * patients with age-related macular degeneration (amd) * best corrected visual acuity (bcva) of 20/40 to 20/400 (snellen equivalent, on etdra charts) inclusive * evidence of leakage due to choroidal neovascularization (cnv) exclusion criteria: * choroidal neovascularization (cnv) in either eye due to causes other than age related macular degeneration, such as ocular histoplasmosis, trauma, or pathologic myopia * known hypersensitivity to ranibizumab, fluorescein, indocyanin green (icg) or any of the ingredients of the formulation used, or any of the medications used * any other restriction according to the use of ranibizumab * active intraocular inflammation (grade trace or above) in the study eye * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye