Kornimate/medical-research-clean huggingface dataset:
long-term safety extension study of olz/sam in pediatric subjects

Conditions: Bipolar I Disorder; Schizophrenia

Summary: to evaluate the long-term safety and tolerability of olz/sam in pediatric subjects with schizophrenia or bipolar i disorder


Eligibility criteria:
inclusion criteria: * subject has completed the treatment period in either the alks 3831-a311 or the alks 3831-a312 study within 10 days of enrolling into this extension study, or subject had terminated early from study alks 3831-a312 due to the clinically significant weight gain criterion. * subject will benefit from continued therapy with olz/sam per clinical judgment. * subject is able to be treated on an outpatient basis. * subject must not be a danger to self or others (per investigator judgement) and has family support available to be maintained as an outpatient. * subject's parent(s)/legal guardian(s) is considered reliable by the investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures. * subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study. exclusion criteria: * subject poses a current suicide risk as assessed by the investigator or as confirmed by the baseline columbia-suicide severity rating scale by a response of "yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit. * subject has any finding that in the view of the investigator or medical monitor would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirement. * subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine * subject has a positive test for opioids. * subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.

Keywords: bipolar i disorder schizophrenia samidorphan pediatric olzanzapine safety lybalvi
the efficacy of local anesthetics to reduce shoulder pain post-steroid injections

Conditions: Shoulder Pain

Summary: the specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology.

shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the patient population registered to general practices and is second only to back pain in patients seeking treatment for musculoskeletal issues in the primary care setting. as a common source of distress, shoulder pain contributes significantly to health care costs. rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder pain and dysfunction. initial treatment consists of a conservative approach of activity modification, oral nonsteroidal anti-inflammatory drugs (nsaids) and supervised physical therapy. however, if the patients' symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a corticosteroid may be indicated as a sequential treatment option. the steroid injection itself can be a painful process, so administering a local anesthetic prior to the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately following the procedure. though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia significantly enhances the pain relieving effect of steroids. should local anesthesia not have a significant impact on the patient's pain intensity, then the use of corticosteroids alone could potentially result in reduced costs in care.

Eligibility criteria:
inclusion criteria: * ages 18 to 70 years old * shoulder pain lasting at least 4 weeks * inability to use arm with restriction of movement and loss of full function. * able to understand study and provide voluntary, written informed consent exclusion criteria: * less than 18 or greater than 70 years old * contraindications of previous injections and previous shoulder surgery * unable to understand consent form (in the opinion of the pi) * non-english speaking individuals * medication contradictions to lidocaine, corticosteroids

Keywords: subacromial injection rotator cuff disease steroid injection
post term pregnancy - induction of labor or monitoring of pregnancy

Conditions: Perinatal Morbidity

Summary: post term pregnancy is a risk pregnancy. aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences. our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity. following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery


Eligibility criteria:
inclusion criteria: * routine ultrasound scan and delivery at st.olav's hospital * ability to speak norwegian * singleton pregnancy * gestational age 289 +/- 2 days * cephalic presentation exclusion criteria: - prelabor rupture of membranes

Keywords: asphyxia neonatorum birth injury meconium aspiration syndrome
effect of deep neuromuscular block on surgical conditions in morbidly obese patients

Conditions: Surgical Conditions

Summary: this is a randomized control trial (rct) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.


Eligibility criteria:
inclusion criteria: * asa i-iii * bmi \> 34 kg/m2 * elective bariatric surgery. exclusion criteria: * known or suspected neuromuscular disorders impairing neuromuscular function * allergies to muscle relaxants, anesthetics or narcotics * a(family) history of malignant hyperthermia * women who are or may be pregnant or are currently breast feeding * renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output \< 0.5 ml/kg/h for at least 6 h.
prevention of smoking related diseases

Conditions: Lung Cancer; Lung Cancer Screening; Smoking Cessation

Summary: this is a prospective, observational, monocentric study. this study wants to test if among a smoking cessation intervention, behavioural counselling by video session is related to higher compliance and higher success rate than standard smoking cessation activity (face to face counselling).

this intervention was structured on sitab guidelines (società italiana tabaccologia - italian tobacco society), who suggest to use long-term counseling for at least six months and preferably for 12, in order to strengthen abstinence and cover the period with the highest risk of relapse. clinicians who follow these guidelines must provide a path greater than or equal to 4 meetings and they will have a greater degree of success if the time that will be devoted to meetings is consistent. the group that will carry out the psychological counselling in the presence will have 6 meetings (spread over 6 months) with a psychologist at the anti-smoking center of the san raffaele hospital and a final phone call 12 months after the first meeting to verify the maintenance of abstinence. the meetings at the anti-smoking center are aimed at monitoring the progress of the smoking cessation process, thanks also to tests (fagestrom test, motivational questionnaire, smoker's diary) and prevent any drop outs. the group that will be followed in remote mode will carry out the same number of interviews as the group described above and a 12-months call will also be made to them to check the state of abstinence. the difference between the two groups is in the way interviews were conducted. both face-to-face interviews and those through videocall allow smokers, in addition to learning strategies to limit the consumption of the substance, to share the path towards de-exhaustion with a professional and be supported by it. the subdivision into the two groups will be carried out through voluntary choice of participants.

Eligibility criteria:
inclusion criteria: * strong smokers (pack years \>= 20) * over or equal the age of 50 * able to sign specific informed consent for the study exclusion criteria: * not having plans to quit smoking

Keywords: lung cancer screening smoking cessation counseling
safety, tolerability, and efficacy of encaleret in participants with autosomal dominant hypocalcemia (adh) type 1

Conditions: Autosomal Dominant Hypocalcemia (ADH); Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Summary: the primary purpose of this study is to evaluate the safety, tolerability and effectiveness of encaleret in participants with autosomal dominant hypocalcemia type 1 (adh1).


Eligibility criteria:
key inclusion criteria: * be able to understand and sign a written informed consent or assent form, which must be obtained prior to initiation of study procedures. * postmenopausal women are allowed to participate in this study * body mass index (bmi) ≥ 18.5 to \< 39 kilograms (kg)/square meter (m\^2) * have an activating mutation of the calcium-sensing receptor (casr) gene * participants being treated with thiazide diuretics may be enrolled if they are willing and able to discontinue thiazides * participants being treated with strong cytochrome p3a4 (cyp3a4) inhibitors should ideally, if clinically appropriate, discontinue these medications during the screening period * participants being treated with magnesium or potassium citrate supplements should discontinue such treatment starting on day -1 during period 1 and period 2 and may be asked to discontinue treatment during period 3 key exclusion criteria: * history of treatment with parathyroid hormone (pth) 1-84 or 1-34 within the previous 3 months * history of hypocalcemic seizure within the past 3 months * blood 25-oh vitamin d level \< 25 nanograms (ng)/milliliter (ml) * participants with hemoglobin (hgb) \< 13 grams (g)/deciliter (dl) for men and \< 12 g/dl for women * estimated glomerular filtration rate (egfr) \< 25 ml/minute/1.73 m\^2 using chronic kidney disease epidemiology collaboration (for participants \<18 years old the schwartz equation will be calculated) * 12-lead resting electrocardiogram (ecg) with clinically significant abnormalities * participants with positive hepatitis b surface antigen (hbsag), hepatitis a immunoglobulin m (igm), or human immunodeficiency virus (hiv) viral serology test results at the screening visit * pregnant or nursing (lactating) women * history of drug or alcohol dependency within 12 months preceding the screening visit * history of thyroid or parathyroid surgery * current participation in other investigational drug studies * unwillingness to refrain from blood donation within 12 weeks prior to screening visit from the start of the study enrollment through one year after the last dose of the study drug note: other protocol defined inclusion/exclusion criteria may apply.
enhancing family based treatment of childhood obesity through social networks

Conditions: Child Obesity

Summary: the purpose of this study is to develop a social network engagement (sne) intervention that will be integrated into a standard treatment program for childhood overweight. the investigators will conduct a pilot trial of sne to assess feasibility and to estimate its effectiveness compared with historical controls who received standard treatment. the historical controls will be participants in the focus trial (family overweight: comparing use of strategies; nct00746629).


Eligibility criteria:
inclusion criteria children * age 7-13 years * at or above the 85th percentile for age- and gender-specific bmi parents • at least one overweight parent (bmi\>25.0) parents and children * english-speaking and at least at a second-grade reading level * live \<50 miles from the treatment site. exclusion children * conditions known to promote obesity (e.g., prader-willi), * participation in another weight control program * recently started taking weight-affecting medications (e.g., stimulants). parents and children * disability or illness that would preclude them from engaging in at least moderate-intensity physical activity, * current or prior diagnosed eating disturbance * thought disorder, suicidality, or substance abuse disorder

Keywords: obesity child weight management behavioral social networks social support
dialectical behavioral therapy as a therapeutic tool in patients with binge eating disorder

Conditions: Binge Eating Disorder

Summary: binge eating disorder (bed) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. from the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients. since dialectical behavioral therapy (dbt) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of dbt versus treatment as usual (tau) in bed patients, and whether plasma ghrelin level will be affected after treatment in both arms.

binge eating disorder (bed) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. from the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients. since dialectical behavioral therapy (dbt) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of dbt versus treatment as usual (tau) in bed patients, and whether plasma ghrelin level will be affected after treatment in both arms, with patients being randomly allocated in both groups.

Eligibility criteria:
inclusion criteria: 1. age above 18 years. 2. patients diagnosed as bed according to the diagnostic and statistical manual of mental disorders- fifth version (dsm-5), after providing a written informed consent 3. overweight or obese patients (body mass index ≥ 25), or patients with a history of overweight or obesity exclusion criteria: 1. patients with known psychotic disorders or substance use disorders 2. patients diagnosed with current major depressive or anxiety disorders 3. patients diagnosed with borderline personality disorder 4. patients who are actively suicidal 5. patients with medical conditions that can affect or alter the frequency of eating and metabolism (e.g., thyroid disorders, diabetes mellitus, malignancy) 6. patients presenting with medical complications of bed 7. the presence of purging or compensatory behaviors 8. current pregnancy or breastfeeding

Keywords: binge eating disorder ghrelin dialectical behavioral therapy
the effects of dual task training in individuals with parkinson's disease

Conditions: Parkinson's Disease

Summary: the primary aim of the proposed project is to characterize dual tasking (dt) deficits to improve motor, cognitive, and quality of life outcomes in individuals with parkinson's disease (pd). phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with pd. this gait analysis will utilize the computer assisted rehabilitation environment (caren) system, a virtual reality system with a fully integrated 3-d motion capture system. the purpose of phase 1 is to generalize characteristics of gait and postural control during specific dt conditions. phase 2 (n=20) involves the clinical translation of these findings. this phase will involve creating a clinical intervention based on the objective information gathered the caren system. the intervention will take place 3x/week for a total of 8 weeks. interventional groups will include: 1) dt clinical group (n=10) and 2) single task group (n=10). outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic pd * able to provide informed consent * ability to ambulate ≥ 300ft with or without an assistive device * hoehn and yahr stage 2-4 exclusion criteria: * undergone any surgical procedure for the treatment of pd, such as deep brain stimulation * those who are considered to be high risk exercisers per american college of sports medicine exercise screening questionnaire * musculoskeletal injury or neurological injury other than pd that would restrict physical activity * inability to follow 2 step commands * significant cognitive impairment as designated by ≥ 3 errors on the short portable mental status questionnaire

Keywords: dual tasking
effect of docosahexaenoic acid on the inflammatory response and clinical outcomes from surgical patients

Conditions: Severe Sepsis; Organ Dysfunction Syndrome

Summary: the purpose of this study is to evaluate if enteral docosahexaenoic acid (dha) administration attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent cardiovascular surgery

severe sepsis and organ failure are leading causes of death in surgical patients. several studies indicate that a causal relationship exists between the surgical or traumatic injury and the predisposition to develop septic/infectious complications and multiple organ failure; this is attributable to uncontrolled inflammatory response. since neonates have an immature immune system, they are in a higher risk to develop uncontrolled inflammatory response and adverse clinical outcomes. n-3 long chain polyunsaturated fatty acids (l-pufas) such as docosapentaenoic and docosahexaenoic acids (epa and dha) have been shown to reduce the inflammatory response by reducing cytokines, infection rates and length of hospitalization in patients with abdominal surgery. therefore, acute and enteral administration of dha may improve clinical outcomes in neonates with cardiovascular surgery

Eligibility criteria:
inclusion criteria: * authorization from both parents for recruiting of the neonate into the study with consent signed form after the purpose and procedures have been explained * gestational age older than 32 weeks * adequate weight for gestational age * gastrointestinal tract that allows tolerate the doses of dha or placebo * no signs of systemic inflammatory response syndrome before the surgery as fever \>38 degrees c or hypothermia \ 19,500 cells/cubic mm or \ 10% immature forms. exclusion criteria: * fasting for more than two days after surgery * discharge to other hospital outside the metropolitan area * parents who decide to decline of the study * patients who necessitate cardiovascular bypass

Keywords: docosahexaenoic acid n-3 long chain polyunsaturated fatty acids omega 3 fatty acids neonates clinical outcomes critically ill patients inflammatory and antiinflammatory cytokines length of intensive care stay
effects of epidural block on the prognosis in patients with pancreatic cancer undergoing distal pancreatectomy

Conditions: Cancer of Pancreas

Summary: the purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. this study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.


Eligibility criteria:
inclusion criteria: 1. undergoing elective distal pancreatectomy for pancreatic cancer . 2. asa statusⅰ-ⅲ. 3. 18 years to 80 years （adults）. 4. able to understand, communicate and sign an informed consent form. exclusion criteria: 1. laparoscopic surgery. 2. preoperative chemotherapy or radiotherapy. 3. pregnancy. 4. allergic to any drugs used during the study. 5. long-term receiving β-blockers. 6. complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery. 7. abnormal coagulation functions (platelet count prior to surgery \ 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery). 8. complicated with severe heart disease (nyha classification \>3), severe renal insufficiency (serum creatinine \>1.8mg/dl or receiving renal replacement therapy), severe hepatic disease (child-pugh classification=c), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/l ), or acute infectious diseases (wbc\>10000/μl) before surgery. 9. bmi \> 35. 10. all contraindications to epidural block. 11. chronic opiate medication/drug abuse. 12. complicated with severe mental illness, cognitive disorder or unable to collaborate during the study. 13. refuse to sign an informed consent form.

Keywords: epidural block pancreatic cancer
the mylunghealth study protocol: engaging patients to enable interoperable lung cancer decision support at scale

Conditions: Lung Cancer; Lung Neoplasms/Diagnosis

Summary: early lung cancer screening (lcs) through low-dose computed tomography (ldct) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. the objective of this trial is to investigate a patient-centered intervention, mylunghealth, delivered through the patient portal. the intervention is designed to improve lcs rates through increased identification of eligible patients and informed decision making.

mylunghealth is a multi-site pragmatic trial, involving university of utah health and new york university langone health primary care clinics. the mylunghealth intervention was developed using a user-centered design process, informed by patient and provider focus groups and interviews. the intervention's effectiveness will be evaluated through a patient-randomized trial, comparing the combined use of mylunghealth and decisionprecision+ (a provider-focused clinical decision support and shared decision-making intervention) against decisionprecision+ alone.

Eligibility criteria:
inclusion criteria for both study 1 and study 2: * aged 50-79 * a history of smoking (e.g., current or former tobacco use) * seen in a study primary care clinic in the 12 months preceding the start of the trial exclusion criteria for both study 1 and study 2: * \>0 but \< 10 pack-year smoking history or quit more than 15 years ago * no use of the patient portal at least once in the year preceding the start of the study * a lung cancer diagnosis at the start of the study * ldct completed in the past 3 years * another chest ct completed in the past year * structured ehr data indicating lcs sdm was provided in the past 3 years * exposed to the intervention during the pilot phase inclusion criteria for study 1: * a 10-19 pack-year smoking history, an unknown pack-year history, unknown quit date for patients who quit smoking, or a 0 pack-year smoking history inclusion criteria for study 2: * at least a 20 pack-year smoking history and are a current smoker or have quit within the last 15 years