Kornimate/medical-research-clean huggingface dataset:
a digital intervention to prevent the initiation of opioid misuse in adolescents in school-based health centers

Conditions: Opioid Misuse

Summary: the primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids and heroin.

this study's specific aims are to: conduct a randomized controlled trial with 532 high-risk adolescents in 10 school based health centers (sbhcs), to compare playsmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if playsmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.

Eligibility criteria:
inclusion criteria: * participants must: * 1) preferably be enrolled in their high school's school-based health center; * 2) report not having engaged in any prior opioid misuse; * 3) be at "high-risk" based on their report at baseline of past 30-day use of cigarettes, e-cigarettes, juul, alcohol, marijuana (including synthetics), amphetamine, cocaine, benzodiazepines, ecstasy, bath salts, or any other misuse of non-opioid prescription drugs or use of non-opioid illicit drugs or have a score of ≥1 on the phq-2 or a score of ≥1 on the gad-2 (both screening tools used by sbha); * 4) be willing to sit for 60 minutes/session to play the game; * 5) be able to provide assent/parental/guardian consent (if under age 18). exclusion criteria: * failure to meet any of the inclusion criteria.
comparing single versus repeat nmt on the diversity of the neonatal nasal microbiome

Conditions: Staphylococcus Aureus; Microbial Colonization; Neonatal Infection

Summary: this study aims to determine whether a parent-to-child nasal microbiota transplant (nmt) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.

this parent-to-child nmt study will test the effect of an anterior nares, or nasal, microbiota transplant (nmt) on seeding, engraftment, and diversity of the neonatal microbiome. neonates admitted to the johns hopkins neonatal intensive care unit (nicu) will be screened and parents will be approached for enrollment in the study. after consent and baseline screening of parents and neonates, eligible neonates will undergo an nmt.

Eligibility criteria:
inclusion criteria: neonate: 1. neonate has anticipated nicu length of stay \> 7 days 2. neonate ≥25 weeks gestation 3. at least one parent/adult provider not colonized with s. aureus (as determined by baseline screening) 4. neonate is not colonized with s. aureus on baseline screening parent/adult provider: 1. parent/adult provider is able to provide informed consent exclusion criteria: neonate: 1. neonate has had a prior clinical or surveillance culture grow s. aureus 2. neonate is a ward of the state 3. neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency) 4. neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing) parent/adult provider: 1. parent/adult provider had positive covid-19 test in prior 21 days 2. parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough) 3. parent/adult provider has been in close contact with someone in the last 7 days who had a respiratory viral infection, like the cold or the flu? 4. parent/adult provider tests positive on baseline screening test for s. aureus nasal colonization. 5. parent/adult provider tests positive on baseline screening test for a respiratory pathogen. 6. parent/adult provider is not able to provide written informed consent 7. parent/adult provider is not able to be present at the bedside at the time of intervention. 8. parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism. 9. inability or unwillingness to complete the donor questionnaire or a positive response to any question on the donor questionnaire

Keywords: microbiome
impact of a melatonin supplementation on the quality of life in elderly metastatic cancer patients

Conditions: Cancer

Summary: melatonin may represent an effective complementary treatment to standard anticancer treatments in order to reduce asthenia, depression, sleep disturbances, cognitive impairment and performance status as part of quality of life. moreover, melatonin has been evaluated in several clinical trials in cancer patients with no side effects. it could be particularly of interest in elderly cancer patients as they exhibit a significant deficiency of melatonin production . the investigators propose to perform a prospective and randomized study to study the effect of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer patients (age ≥ 70) treated for a locally advanced or metastatic cancer.


Eligibility criteria:
inclusion criteria: * age \> = 70 years. * performance status \< = 2 (who criteria) * life expectancy \> 3months * a patient with solid tumor locally advanced or metastatic * indication of systemic anticancer treatment : oral or iv chemotherapy, endocrine therapy, target therapy or immunotherapy * mms-orientation ≥ 7 (geriatric mini mental state face-to-face questionnaire) * able to swallow and retain oral treatment * patient who signed the participation consent before entering the trial * patient able to read, write and understand french. * affiliation to the french social security scheme (or beneficiary of such a scheme) under the terms of the law of 9 august 2004. exclusion criteria: * haematological cancers * renal failure or hepatic failure * auto-immune disease * diagnosed neurodegenerative diseases * unability to fill out questionnaires * melatonin treatment ongoing or completed for less than 3 months * treatment with an investigational drug, participation to another therapeutic clinical trial within \<30 days * hypersensitivity to melatonin or any of the excipients * current treatment with fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, estrogen * a history of known or suspected excessive alcohol use. * patient refusing to participate and / or unable to give informed consent * patient unable to complete the questionnaires even with the help of a relative or a nurse * patient does not have the capacity to comply with the study requirements * patient deprived of liberty by a court or administrative.

Keywords: quality of life melatonin elderly patient
safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of abgn-168 in psoriasis

Conditions: Psoriasis

Summary: the general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of abgn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: patients with chronic plaque psoriasis covering at least 3% of body surface area. female subjects must be postmenopausal or surgically sterilized. exclusion criteria: recent use of biologic agents, oral psoriasis medications or phototherapy
the effect of hfa - beclomethasone dipropionate qvar on bronchial hyperreactivity in preschool children

Conditions: Asthma; Bronchial Hyperresponsiveness

Summary: respiratory diseases including asthma are high prevalent among preschool children. specific treatment, nowadays, include steroid inhalers and anti leukotrienes. it is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. beclometasone is being used for treating asthma for 30 years. lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation. the investigators' group has reported successfully the possibility to perform pulmonary challenge tests (adenosine, methacholine and exercise) in tender age. other studies reported relation between asthma control and reduction in airway hyperreactivity. the purpose of this study is to evaluate the efficacy of beclometasone dipropionate - qvar to reduce airways hyperreactivity in preschool children, as demonstrated by adenosine challenge test.

26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment beclometasone dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive weeks. adenosine challenge test will be performed another time at the end of this four weeks period. after 2 weeks with no medication (wash out period) the patients will receive the second intervention (beclometasone dipropionate or placebo) in a cross over manner and will be submitted to the last adenosine challenge test. clinical evaluation, resting spirometry and subjective evaluation through an analogical symptoms scale will be recorded in each visit.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild asthma * children aged between 3 - 6 years old * able to perform spirometry and adenosine challenge test * positive challenge test at the time of inclusion * without prophylactic treatment for asthma * signed informed consent to join the research by the parents or legal tutor exclusion criteria: * other chronic diseases * use of oral steroids in the last two months * emergency room visit in the last two months * pneumonia in the last two months * impossibility to perform lung function tests * disagreement of the parents or legal tutor

Keywords: asthma preschool children bronchial hyperresponsiveness beclometasone dipropionate - hfa qvar adenosine challenge test
an initial feasibility study to integrate mri based brachytherapy and ct/mr fused inrt in treatment of advance cervical cancer

Conditions: Integrated MRI Based RT as Standard of Care; Locally Advanced Cervical Cancer

Summary: main cause of mortality in cervix cancer is local relapse in the pelvis. since distant metastasis is quiet rare, increasing local control in the pelvis can directly translate into improvement in survival. obstacles in front of this approach is the dose limitation to normal organs located in the pelvis adjacent to the tumor. 3-d mri based ebrt and brachytherapy will grant safe delivery of more conformal higher doses of radiation to the tumor and allowing sparing of the normal structures.

a total of 10 patients with a diagnosis of locally advanced cervical carcinoma will be enrolled. after diagnosis and written informed consent, patients will undergo investigations prior to treatment planning, including ct imaging as per standard of care. in addition, patients will have an mri of the pelvis + pet scan + eua and gold seeds insertion to verify pelvic organs movement and eb-imrt with daily cone beam ct. brachytherapy treatment planning will be based on mri imaging with the applicator in situ.

Eligibility criteria:
inclusion criteria: * cancer of the uterine cervix considered suitable for curative treatment with definitive radio-chemo-therapy including mri guided bt. (stage ib2 bulky disease-stage iva) * staging according to figo and tnm guidelines * positive biopsy showing squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix * no pelvic nodes \> 2cm * mri of pelvis at diagnosis * mri of the retroperitoneal space and abdomen at diagnosis * mri with applicator in place at time of bt * age 18-70 years * patient informed consent exclusion criteria: * pelvic nodes \> 2cm * previous pelvic or abdominal radiotherapy * previous total or partial hysterectomy * combination of preoperative radiotherapy with surgery * patients receiving neo-adjuvant chemotherapy * patients receiving bt only * contraindications to mri
clinical performance evaluation of two frequent replacement silicone hydrogel multifocal toric contact lenses

Conditions: Presbyopia; Astigmatism

Summary: the purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

participants will be expected to attend 5 office visits for an individual duration of participation of approximately 64 days.

Eligibility criteria:
key inclusion criteria: * habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * manifest cylinder equal to or greater than 0.75 diopter (d) in each eye at screening; * willing to not use readers while wearing study contact lenses for duration of the study; * other protocol-defined inclusion criteria may apply. key exclusion criteria: * use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * monovision contact lens wearers and wearers of contact lens in one eye only; * other protocol-defined exclusion criteria may apply.

Keywords: myopia hyperopia multifocal toric
probing the dry weight by bioimpedance: the resistance stabilization test

Conditions: Uremia

Summary: clinical methods are fundamental in probing the dw. they must be supported by strict bia protocols. rest appears to be a (the) brilliant solution in solving the old problem of dw in hd patients

probing the dry weight (dw) was largely dependent on clinical subjective estimates until recently. new bedside non-invasive tools have been developed with the aim of providing more objective information on volume status and guiding physicians in the quest for dw. among them, bioimpedance (bia) appears to be very promising. very recently, a bia test aimed at assessing dw in hemodialysis (hd) patients has been developed, the "resistance stabilization test" (rest). it is called bia dw. its rationale is based on the achievement of the flattening of the curve of the ratio r0/rt (r0 is resistance at time 0 and rt is resistance at a given time t during the hd session) of less than + 1% over 20 minutes in the presence of ongoing ultrafiltration. study protocol: the clinical dw is the gold standard by definition. it is determined under strict clinical surveillance by the same attending physician. she/he will be helped by a clinical score of volume state about symptoms and signs of hypo- or hypervolemia. then, this clinical dw will be compared with bia dw, as obtained after performing rest

Eligibility criteria:
inclusion criteria * stable uremic patients * thrice weekly hemodialysis treatment * start of hemodialysis treatment since at least 3 months exclusion criteria * overt edema * liver cirrhosis * cardiac failure * serum albumin \< 3g/dl * pregnancy * metallic implants or a pacemaker * limb amputation

Keywords: bioimpedance dry weight hemodialysis resistance
monitoring the changes of tumor-related biomarkers before and after pulmonary nodule biopsy.

Conditions: Lung Cancer

Summary: in the past few years, circulating tumor cells (ctcs), circulating tumor dna (ctdna), micrornas, autoantibodies, and t-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. however, most of previous data were based on late stage tumor patients. this study plans to utilize the minimally invasive method to detect the changes of numbers of ctcs, ctdna hot spot mutations and methylation signals, micrornas, autoantibodies, and t-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.


Eligibility criteria:
inclusion criteria: * confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by ct scans, and the maximum diameter of nodule is between 8mm and 3cm; * male or female, with age of 18\~80 years; * agree to take the pulmonary nodule biopsy, and sign the informed consent. exclusion criteria: * with severe comorbidities and unable to participate in this study; * diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment; * pregnant or maternal women; * diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites; * unable for regular follow-ups according to the research protocol; * blood sample is not qualified for biomarker testing.

Keywords: pulmonary nodule; lung cancer; biopsy; biomarker.
trial of inserting prevalence information into lumbar spine imaging reports

Conditions: Low Back Pain; Back Pain; Lumbar Pain; Backache

Summary: the overall goal of the lumbar image reporting with epidemiology (lire) is to perform a large, pragmatic, cluster randomized controlled trial to determine the effectiveness of a simple, inexpensive and easy to deploy intervention - insertion of epidemiological benchmarks into lumbar spine imaging reports - at reducing subsequent tests and treatments. the investigator's main hypothesis is that for patients referred from primary care providers, inserting epidemiological evidence in lumbar spine imaging reports will reduce subsequent diagnostic and therapeutic interventions, including cross-sectional imaging (mr/ct), opioid prescriptions, spinal injections and surgery.

the long-term public health significance is that a simple, inexpensive intervention has the potential to substantially reduce unnecessary and expensive care for back pain patients. importantly, this approach could be applied to a wide range of other conditions and other diagnostic tests (e.g. other imaging tests, laboratory tests, genetic testing). if this study is positive, adding epidemiologic benchmarks to diagnostic test reporting could become the dominant paradigm for communicating all diagnostic information. to test this hypothesis, the investigators propose to conduct a pragmatic cluster, randomized controlled trial, randomly assigning primary care clinics at four large health systems to receive either standard lumbar spine imaging reports or reports containing epidemiological benchmarks for common imaging findings. the investigators will use a novel stepped wedge randomization scheme that temporally randomizes sites, allowing within-site before/after comparisons in addition to between-site comparisons, while assuring that all sites will eventually receive the intervention. the primary outcome will be a metric of back-related intervention intensity. the primary analysis will occur at the clinic level and not the patient level. this pragmatic trial will demonstrate both the feasibility of randomly assigning clinics within large health systems as well as the feasibility of passively collecting outcomes data up to two years after enrollment using the robust electronic medical records systems available at each health system.

Eligibility criteria:
inclusion criteria: * imaging of lumbar spine requested by primary care provider exclusion criteria: * age \< 18years

Keywords: pragmatic trial stepped-wedge design cluster-randomized trial
testing the effectiveness of different messaging approaches to increase doctor visits amongst individuals with risk factors for diabetes

Conditions: Type 2 Diabetes; Pre-diabetes

Summary: the purpose of the research is to test the effectiveness of different messaging approaches to nudge members of vitality and discovery health, with risk factors for diabetes (based on data from the vitality health check and vitality age assessment), to visit a doctor and test for diabetes. the messages are based on concepts from behavioural economics that aim to make information on screening more salient by using the concept of social proof (person like you) and an authoritative source (a diabetes specialist and the vitality doctor).

members of vitality who are also members of the discovery health medical plan and who have risk factors for diabetes but who have not previously been diagnosed with diabetes will be eligible for the study. subjects will be identified based on the vitality age assessment and the vitality health check done in the previous year. the risk factors identified by these assessments and which are important for eligibility are age ≥45years, overweight and obesity, family history of diabetes, hypertension or raised high blood pressure, low levels of physical activity, cardiovascular disease, and dyslipidemia. it is estimated that approximately 5000 vitality members will be eligible for the study. only the actuarial team assigned to the study will have access to the data. participants will de-identified and randomly allocated to the control and four intervention arms. messages will be sent via email to them which addresses their specific health risks and measures they can take to address those risk. the messages will be in an encrypted pdf sent by email. in compliance with the popia act, as a first step, participants will be asked to provide consent, by confirming their id number, to share their individual risks information with them. messages sent via email will have the same basic structure. all three of the experimental arm messages will include the following: * the same subject line * a description of their risk factors for diabetes * a description of the benefits of visiting a doctor and getting screened for diabetes

Eligibility criteria:
inclusion criteria: * members of vitality who are also members of the discovery health medical plan and who have risk factors for diabetes but who have not previously been diagnosed with diabetes * risk factors are age ≥45years, overweight and obesity, family history of diabetes, hypertension or raised high blood pressure, low levels of physical activity, cardiovascular disease, and dyslipidemia. exclusion criteria: * \ = 65 years * diagnosed with diabetes