Kornimate/medical-research-clean huggingface dataset:
a study on suicidality, psychosis or substance abuse with methylphenidate, atomoxetine, amphetamine/dextroamphetamine or lisdexamfetamine

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to estimate the observed incidence of the health outcomes (suicide attempt or ideation, suicide ideation, suicide attempt, psychosis, and substance abuse) in a cohort of participants diagnosed with attention deficit hyperactivity disorder (adhd) who are first-line new therapy with methylphenidate monotherapy, lisdexamfetamine monotherapy, atomoxetine monotherapy, amphetamine/dextroamphetamine combo therapy, and either methylphenidate/lisdexamfetamine/atomoxetine monotherapy or amphetamine/dextroamphetamine combo therapy during the 'on treatment' period from 7 days after the start of exposure through the end of exposure (treatment discontinuation for at least 60 days) and the 'intent to treat' period from 7 days after start of treatment to end of continuous observation; and to compare the hazards of outcomes (suicide attempt or ideation, suicide ideation, suicide attempt, psychosis, and substance abuse) in the target cohort (participants diagnosed with adhd who are first-line monotherapy new users of methylphenidate) versus each comparator cohort (patients diagnosed with adhd who are first-line newly exposed to lisdexamfetamine monotherapy, atomoxetine monotherapy, amphetamine/dextroamphetamine combo therapy) during the 'on treatment' period from 7 days after the start of exposure through the end of exposure (treatment discontinuation for at least 60 days) and the 'intent to treat' period from 7 days after start of treatment to end of continuous observation.


Eligibility criteria:
inclusion criteria: * new users of methylphenidate monotherapy or lisdexamfetamine monotherapy or atomoxetine monotherapy or amphetamine/dextroamphetamine combo therapy * prior diagnosis of adhd
safety and tolerability of spd485 in children aged 6-12 diagnosed with adhd and previously participated in mts trials

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will evaluate the long-term safety of mts in the symptomatic treatment of children aged 6-12 diagnosed with adhd

attention-deficit/hyperactivity disorder (adhd) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. this study will evaluate the long-term safety of spd485 in the symptomatic treatment of children aged 6-12 diagnosed with adhd

Eligibility criteria:
inclusion criteria: * subject must have participated in and completed spd485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study spd485-302. subjects who are participating in n17-021 may enroll in this study following completion of the end of study/termination visit procedures. * females of childbearing potential must have a negative urine pregnancy test at baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives. exclusion criteria: * subject was terminated from spd485-102, spd495-201, spd485-302 or n17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols * female subject is pregnant or lactating
we-pap: a couples-based intervention for sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (osa).

this study will develop and test a novel couples-based intervention for the treatment of osa and sleep health among older couples. the focus of this study is patient who are starting cpap treatment and their partners. couples will be randomized to a 3-session sleep health intervention delivered via telehealth or to standard educational support for cpap. the intervention is based on a transdiagnostic model of sleep and circadian disorders (transs-c) and rooted in the idea that older adults with osa are often also having other sleep problems, and that osa is best treated in the couples context.

Eligibility criteria:
inclusion criteria: patient and partner inclusion criteria: 1. age \>=50 2. access to cellular (active data plan) or wi-fi, in order to complete the telehealth intervention. patients inclusion criteria: 1. diagnosed with osa (ahi\>10 or ahi\>5 with impairment) and intend to start pap treatment 2. pap naïve or non-use of pap for at least 3 years 3. married or cohabiting with a romantic partner for \>1 year 4. able to read/write english. partner inclusion criteria: 1. able to read/write english 2. promis sleep disturbance score \>55 in either patient or partner, or desire to improve sleep. exclusion criteria: patient only exclusion criteria: 1. concomitant osa treatments (bariatric surgery planned in the next 3 months or bariatric surgery in the past year, ear nose and throat surgery for sleep apnea occurring in the 3 months before or planning for within the study period). exclusion criteria for both patient and partner include the following: 1. high risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome) 2. history of cognitive or neurological disorders (e.g., dementia, parkinson's, multiple sclerosis) 3. presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the audit-c (score \>4 for men, \>3 for women), drug use (nida-modified assist score \>3) 4. unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe copd) 5. use of asv, vpap or supplemental oxygen 6. overnight work \> 1x per month 7. pregnancy/ desire to become pregnant in the study period 8. current participation in behavioral sleep treatment (e.g., cbt-i) or completion of cbt-i in the past 3 years 9. concurrent participation in another clinical trial 10. caregiving for an infant \< 2 years old or adult who requires overnight assistance.

Keywords: osa
efficacy study of korean red ginseng to treat depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine whether korean red ginseng are effective in the treatment of the residual symptoms of depression as an adjuvant treatment.

thirty-five female outpatients aging from 18 to 65 years, who were remitted from major depression with residual symptoms (montgomery asberg depression rating scale, madrs ≤ 12), were given korean red ginseng at doses of 3g / day during 8 weeks.

Eligibility criteria:
inclusion criteria: * outpatients who met diagnostic and statistical manual of mental disorders (dsm-iv) criteria for major depressive disorder. * those who are in remission, which is defined as a madrs score 8 on two consecutive visits at a 4-week interval. * their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of korean red ginseng for residual symptoms. exclusion criteria: * those who have a history of substance abuse or dependence within 1 month. * those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results. * those who have a past history of hypersensitivity or intolerance to korean red ginseng. * those who participated in clinical trials within 1 month before entering the study entry. * those who are pregnant or are breast feeding. * those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study. * the patients unable/unlikely to comprehend/follow the protocol.

Keywords: major depressive disorder residual symptoms korean red ginseng
study on the role of treatment with vitamin e on asthmatic responses in allergic asthmatics

Conditions: Allergic Asthma

Summary: asthma is a common respiratory disease of unknown etiology which currently affects approximately 7.5 % of the adult population ( ). asthma is an inflammatory disorder of the airways. airway inflammation is evident not only in patients with fatal asthma but also in mild asthmatics ( ). oxidant stress, defined as inadequately controlled generation of toxic reactive oxygen species (ros) in the cells or tissues is a common feature of inflammation, and has also been documented in asthma ( , ). however, the current understanding of the relationship between the inflammation and the oxidant stress in asthmatic airways is poor. does oxidant stress contribute to the expression of asthmatic phenotypes independently of inflammation? if so, could asthmatics benefit from supplementation of antioxidants? these questions have been nagging us since our laboratory provided credible evidence of oxidant injury in the airways of allergic asthmatics ( ). the purpose of our study is to more precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of antioxidant therapy using vitamin e in allergic asthma.


Eligibility criteria:
inclusion criteria: * normal health status except for allergic asthma * physician diagnosis of mild allergic asthma * positive allergen skin tests to common aeroallergens exclusion criteria: * use of systemic or high doses of inhaled corticosteroids, \>840 mcg of inhaled beclomethasone of its equivalent (as defined in the consensus report (6)) * past history of severe asthma (as defined in the consensus report (6)) * history of asthma exacerbation within the past month * history of recent upper respiratory infection within the past month * active immunotherapy for allergic diseases * significant disease other than allergic asthma and allergic rhinitis, such as coronary disease, hypertension, renal failure, anemia, immunodeficiency, cancer, diabetes * present or remote tobacco smoking * use of over the counter drugs including acetaminophen and pseudoephedrine, herbs, or vitamins * psychiatric illness that would make adherence to protocol difficult * inability to give informed consent * nursing or pregnant women * woman planning to become pregnant during the study or not using adequate birth control methods (barrier or hormonal methods) * h/o sensitivity to tocopherol-derivatives or medications used during bronchoscopy * inability to comply with the research protocol

Keywords: asthma allergy atopy vitamin e gstp1 oxidative stress
symptom evaluation following repetitive transcranial magnetic stimulation

Conditions: Neurologic Symptoms

Summary: a prospective study to evaluate symptoms following repetitive transcranial magnetic stimulation.

open-label, multicenter, prospective pilot study conducted in an adult population receiving rtms treatment.

Eligibility criteria:
inclusion criteria: 1. adults, 22 to 70 years of age 2. voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments. 3. score \> or = 8 on isi scale 4. if subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial. 5. if female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control. 6. subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc. exclusion criteria: 1. subject meets any one or more of the contraindications for tms therapy per current treatment guidelines as determined by the pi. 2. history of head trauma associated with loss of consciousness or diagnosed as concussion. 3. history of fainting, syncope, hearing problems or ringing in the ears (tinnitus) 4. has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc. 5. has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.) 6. has medication infusion device. 7. subjects with any prior tms or mri complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation. 8. phq-9 total score \> or = 10 or qids total score \> or = 11. 9. drug abuse or dependence of the illicit substance. (abuse or dependence, as defined by dsm-v-tr) 10. current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure) 11. other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like obstructive sleep apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by dsm-v-tr. 12. has a clinically significant abnormality on the screening examination. 13. participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
effects of camelina sativa oil in free-living older adults

Conditions: Inflammation; Malnutrition; Hyperglycemia; Dyslipidemias

Summary: the present study aims at evaluating the anti-inflammatory effects of a novel food in older adult volunteers. briefly, this randomized, double-blind and placebo-controlled study is performed on 91 apparently healthy older adults (age≥65 years) before and after 12 weeks' consumption of a snack enriched with camelina sativa oil. subjects were randomized into two groups (active group vs placebo group).

ninety-one volunteers (26m/65f) are enrolled according to the following inclusion criteria i) free-living older adults ≥ 65 years; ii) apparently healthy subjects; iii) subjects who do not take vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids; iv) subjects without food allergies. all volunteers are informed about the purpose of the study and the potential risk and provide their informed consent. subjects are randomized into two groups: active group (13m/36f) vs placebo group (13m/29f). the main objective of this project is to test the efficacy of the 12-weeks consumption of a novel food (snack enriched with camelina sativa oil) on the inflammatory status in older adults. the primary and secondary endpoints are: i) investigation of changes in serum crp levels and serum levels of pro- and anti-inflammatory cytokines, in the active group (volunteers consumed enriched snack with camelina sativa oil) and placebo group, after 12 weeks of snacking (t1), compared to baseline (t0) (primary endpoint). ii) evaluation of changes in serum lipid panel parameters after the consumption of the novel food in both the active and placebo groups (secondary endpoint). iii) evaluation of changes in glucidic status after the consumption of the novel food in both the active and placebo groups (secondary endpoint). iv) evaluation of changes in the levels of omega 3 polyunsaturated fatty acids in both the active and placebo groups (secondary endpoint). v) evaluation of the nutritional status at t0 and at t1 in both the active and placebo groups (secondary endpoint).

Eligibility criteria:
inclusion criteria: * age over 65 * free-living * no food allergy * apparent good health * acceptance and sign of informed consent exclusion criteria: * age under 65 * living in a nursing home, extended care * hospitalized * presence food allergy * without acceptance and sign of informed consent * taking vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids

Keywords: inflammaging healthy aging older adults omega-3 fatty acid camelina sativa inflammation micronutrients deficiency
magnesium and ketamine in postoperative analgesia

Conditions: Postoperative Analgesia

Summary: 90 female patients scheduled for cancer breast surgeries will be assigned to 2 groups, each of 45. group (k) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. group (km) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. the same anaesthetic regimen will be applied to all patients. total intraoperative fentanyl required to maintain mean blood pressure within 20% of its baseline will be recorded. after surgery, all patients will be connected to pca device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. in the follow-up visits after 3 months, all patients will be assessed for neuropathic pain by dn4 questionnaire.

90 female patients aged between 18 and 65 years, scheduled for cancer breast surgeries will be assigned to 2 groups, each of 45. group (k) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. group (km) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. the same anaesthetic regimen will be applied to all patients. total intraoperative fentanyl required to maintain mean blood pressure within 20% of its baseline will be recorded. after surgery, all patients will be connected to pca device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. in the follow-up visits after 3 months, all patients will be assessed for neuropathic pain by dn4 questionnaire.

Eligibility criteria:
inclusion criteria: * patients with class ii physical status (american society of anaesthesiologists) , * age between 18-65 years, * scheduled for breast cancer surgery (e.g. modified radical mastectomy and conservative mastectomy) exclusion criteria: * patient refusal, * cardiac dysfunction (ejection fraction \<45%), * diabetic patients * patients with uncontrolled hypertension * patients have any degree of heart block * patients have renal impairment (creatinine \> 2 mg/dl), * patients have hepatic dysfunction (transaminases \> 2 times normal), * patients with preexisting neurological or psychiatric disease, * patients who are allergic to one of the study drugs, * patients with communication difficulties, * inability to use the patient controlled analgesia (pca) device, * female patients who are pregnant * patients who use preoperative calcium channel blockers or narcotic drugs.

Keywords: magnisum sulfate ketamine analgesia breast cancer surgeries
the defipace study

Conditions: Post-operative Atrial Fibrillation POAF

Summary: prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery. the defipace registry is designed in two phases 1. to document the standard of care in 50 patients with atrial fibrillation (af) 2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients

phase a approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) * data regarding standard of care post-operative pacing and treatment of poaf, if applicable, will be collected from time of surgery until discharge * no use of an external bi-atrial pacing device * no use of defipace * in-hospital data will be collected for all patients * patients that developed poaf (n=50) will be followed-up with a phone call 30 days after surgery. phase b approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned tma implantation * in-hospital data will be collected for all patients * use of the defipace system for the treatment (low-energy cardioversion) and post-operative prevention (bi-atrial pacing) of poaf will be documented (n=100). these patients will be followed-up with a phone call 30 days after surgery

Eligibility criteria:
inclusion criteria: * patient is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery) * patient is at least 18 years old * patient with isolated bypass surgery is at least 70 years old * patient with valve surgery is at least 60 years old * patient provides written informed consent prior to the procedure * phase b only: patient is scheduled for tma implantation during the elective cardiac surgery and is potentially eligible for defipace use exclusion criteria: * clinical history of either permanent, persistend or paroxysmal atrial fibrillation * permanent pacemaker/defibrillator, other intra-cardiac active implanted electronic devices * minimally-invasive surgery * recent stroke within the last 3 months * a history of or current endocarditis * pregnacy at the time of surgery
stepwise and one step techniques in deep dentin lesion

Conditions: Dental Caries, Dental Pulp Exposure

Summary: this double blind, randomized, controlled clinical trial aimed to observe the success of stepwise (sw) and one step (ones) excavation techniques in the management of deep dentin caries. additionally, evaluation of glass ionomer cement (gic) as temporary restorative was also performed. for this purpose, forty participants were selected among the routine patients coming to university clinic. a permanent tooth having caries lesions penetrating to 75 percentage or more of dentin of patient were included. randomization to sw and ones groups were organized by coin method. the periphery of the cavities including enamel-dentin junction was cleaned until reach to hard dentin. afterwards, selective removal to soft dentin on the pulpal side of the cavities was applied manually excavation and covered with pure calcium hydroxide and zinc oxide eugenol cement. gic was used for temporary filling. this process was implemented both the first stage excavation of sw and ones groups. clinical and radiographic evaluations were performed at 6 months according to clinical signs and symptoms and radiographic sings using periapical index (pai). besides, temporary restorations were evaluated according to the of ryge/modified usphs criteria. following this evaluation, on the sw group, the cavities was re-entered and selective removal was applied up to firm dentin and pulp-capping were applied as mentioned above. in ones group, temporary restoration was reduced as a base. all of the cavities were permanently restored with resin composite. whole procedure was completed at one centre by a specialist, and control sessions was performed two experienced experts. participants and experts were blinded in this study.


Eligibility criteria:
inclusion criteria: * molar teeth with primary caries lesion prolonged of 75 percentage or more of dentin radiographically1 existence of vitality with positive response to * electrical pulp test and * cold test * no history of spontaneous pain on the teeth * no sign of pain on percussion and palpation (sensitivity) exclusion criteria: * individuals with the systemic disease who require hospitalization (oncological treatment, transplantation patients) * patients with uncontrolled hyperglycaemia or using insulin * patients with pregnancy/suspected * observation of radiolucency in the apex of the relevant tooth (pai\> 2) * secondary decayed teeth

Keywords: selective caries removal deep dentin lesion permanent teeth stepwise and one step excavation technique