Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of ruxolitinib cream in participants with prurigo nodularis (pn)

Conditions: Prurigo Nodularis

Summary: the purpose of this study is to evaluate the safety and tolerability of ruxolitinib cream in participants with prurigo nodularis (pn).

the study comprises of a 12 week double-blind, vehicle-controlled (dbvc) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period during the double blind period, all pn-affected areas identified at baseline will be treated, and during the open label period, only active pn-affected areas will be treated.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pn ≥ 3 months before screening. * ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% bsa. * iga-cpg-s score of ≥ 2 at screening and baseline. * baseline pn-related wi-nrs score ≥ 7. * willingness to avoid pregnancy or fathering children. exclusion criteria: * chronic pruritus due to a condition other than pn * total estimated bsa treatment area (excluding the scalp) \> 20%. * neuropathic and psychogenic pruritus * active atopic dermatitis lesions within 3 months of screening and baseline. * uncontrolled thyroid function * concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of pn such as immunocompromised status, acute/chronic infections, active malignancy, history of tb, history of dvt/vte, etc protocol defined abnormal laboratory results. * use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching. * psoralen and ultraviolet a or ultraviolet b therapy within 4 weeks before baseline or ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline * pregnant or lactating, or considering pregnancy. * history of alcoholism or drug addiction within 1 year * known allergy or reaction to any of the components of the study drug. * committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities. * employees of the sponsor or investigator or otherwise dependents of them. * the following participants are excluded in france: 1. vulnerable populations according to article l.1121-6 of the french public health code. 2. adults under legal protection or who are unable to express their consent per article l.1121-8 of the french public health code. 3. individuals not affiliated with the social security system.

Keywords: pn incb18424-320 incb18424 prurigo prurigo nodularis skin diseases dermatitis ruxolitinib
singing for chronic pain, a new intervention for the management of chronic pain

Conditions: Chronic Pain

Summary: the aim of the project is to determine the feasibility of delivering a singing for chronic pain (scp) programme to patients with chronic pain attending a pain clinic. the investigator will also be looking to provide a preliminary estimate of the benefit of scp on self-efficacy, self -management skills, mindfulness and well-being as measured by standardized outcome measures.


Eligibility criteria:
inclusion criteria: * 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more. exclusion criteria: * having a mental health and/or physical health diagnosis that might prevent active engagement/participation in group sessions; severe hearing impairment; severe/profound cognitive impairment that may limit active engagement/participation in group sessions.
the effect of ulnar nerve injury localization on sleep quality in patients with ulnar nerve entrapment neuropathy

Conditions: Ulnar Neuropathies

Summary: regardless of the cause of ulnar nerve entrapment neuropathy, we are planning to investigate the relationship between sleep quality disorder that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.


Eligibility criteria:
inclusion criteria: * having ulnar nerve entrapment neuropathy with clinical examination and emg (electroneuromyography) * to be between the ages of 18-65 * be give informed consent exclusion criteria: * malignancy * surgical history in the ipsilateral upper extremity * sleep apnea * narcolepsy
focused suicide prevention strategy for youth presenting to the emergency department with suicide related behaviour

Conditions: Suicide; Suicide Prevention; Suicidal Ideation; Self-Injurious Behavior; Behavioral Symptoms; Suicide, Attempted; Suicide and Self-harm

Summary: suicide is the leading cause of death due to illness among canadian youth, claiming more lives than any medical illness, including cancer. suicide prevention is possible, and early intervention is needed. the investigators will examine the effectiveness of a previously-piloted, ed-based suicide prevention intervention, across canadian sites, using a randomized clinical trial design. the investigators will determine whether the patient- and family-centered intervention is more effective than enhanced usual care in reducing suicide-related behaviors in 330 youth at high-risk of suicide.

this is a multi-site randomized controlled trial of a patient- and family-centered suicide prevention intervention added to usual care (safe + uc) for adolescents aged 12 to 17 years who present to the emergency department (ed) with suicidal ideation or suicide risk behaviours. the investigators will determine whether the safe + uc intervention is more effective than enhanced usual care (telephone navigation + uc) in reducing suicide-related behaviors in 330 youth at high-risk of suicide across canadian sites. safe + uc is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. the family component addresses conflictual relationships that may be present in the family as well as improving family communication. telephone navigation (nav) + uc consists of up to 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ed team and provide additional resources as needed.

Eligibility criteria:
inclusion criteria: * youth presenting in the emergency department with siq-jr score ≥ 31, * has a participating parent or caregiver who is able to communicate easily in english, or is willing to communicate using a hospital-organized translator, * between the ages 12-17 years old, * living in the catchment area of one of the three hospital sites and access to a telephone. exclusion criteria: * score of 3 on ksads screen for current psychosis or elevated mood * moderate to severe intellectual disability, and/or autism based on clinical chart.
e-cigarettes for harm reduction in smokers with opioid use disorder

Conditions: Opioid Use Disorder; Cigarette Smoking

Summary: the purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus telehealth motivational counseling with combination nicotine replacement therapy (nrt) + telehealth counseling on combustible cigarettes smoking reduction among persons with opioid use disorder (oud) in methadone and buprenorphine treatment programs (opioid use disorder treatment programs (oudtp)). oudtp patients are a population with exceptionally high combustible cigarettes smoking burden and yet limited success in achieving meaningful clinical outcomes in tobacco treatment. if effective, electronic cigarettes would provide an additional tool for tobacco harm reduction among this difficult-to-treat vulnerable population.


Eligibility criteria:
inclusion criteria: 1. currently smokes 5 or more cpd 2. age ≥ 21 years 3. has a diagnosis of opioid use disorder 4. in oudtp (buprenorphine or methadone) ≥ 12 weeks via self-report or ehr records 5. stable methadone or buprenorphine dose for two weeks via self-report or ehr records 6. interested in reducing combustible cigarette (cc) smoking but not necessarily trying to quit 7. own a mobile phone or have regular access to a mobile phone. 8. able to provide an additional contact to improve follow-up rates. exclusion criteria: 1. does not speak english or spanish 2. are pregnant or breastfeeding 3. not able to provide consent 4. used tobacco products other than cc in the past 2 weeks (e.g., ec, cigarillo) 5. currently engaged in an attempt to quit cc smoking 6. reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months) 7. reports current major depressive or manic episode, current psychotic disorder, past-year suicide attempt or psychiatric hospitalization, or current suicidal ideation with plan or intent.

Keywords: cigarettes smoking smoking reduction oud oudtp buprenorphine methadone
a phase ii trial of adjuvant chemotherapy with s-1 plus oxaliplatin for locally advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: patients with advanced gastric cancer have showed poor prognosis. only 81% of the patients could underwent curative surgery. in those, about 60% of patients would survive after 5 years from the surgery. as a result, role of chemotherapy has been increased. in acts-gc trial, s-1 adjuvant therapy after d2 gastrectomy increased overall survival rate in advanced gastric cancer patients. however, subgroup analysis showed that s-1 adjuvant therapy was insufficient in patients with stage iii or iv (according to the ajcc 6th criteria) gastric cancer. in addition, classic trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after d2 gastrectomy in advanced gastric cancer patients. notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. we aimed to evaluate efficacy of s-1 plus oxaliplatin as adjuvant chemotherapy after d2 gastrectomy in stage iii (according to the ajcc 7th criteria) gastric cancer patients.


Eligibility criteria:
inclusion criteria: * age, between 19 and 75 * histologically proven advanced gastric cancer * r0 resection after d2 gastrectomy * stage iii (according to the ajcc 7th criteria) * ecog status 0 to 2 exclusion criteria: * malignancy history other than gastric cancer * previous chemotherapy history for gastric cancer * previous radiotherapy history for gastric cancer * pregnancy or breast milk feeding * grade 3 or more of neuropathy * active infection * severe hepatic dysfunction * severe renal dysfunction * severe bone marrow dysfunction * significant neurologic or psychologic disease * inadequate condition for receiving chemotherapy due to significant systemic disease * patients who receives drugs which can be interacted with s-1

Keywords: oxaliplatin, s-1, gastric cancer, adjuvant chemotherapy
cementless triathlon 5yr follow-up

Conditions: Knee Arthroplasty, Total; Knee Osteoarthritis; Radiostereometric Analysis

Summary: all artificial joint implants need to be solidly held (fixed) within the bone. cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. the primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. as this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called "radiostereometric analysis". the study will use weight-bearing computed tomography (ct) to measure bone density and texture features and correlate that with implant stability. the investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. all 33 participants from the original study cohort will be invited to participate in this study.


Eligibility criteria:
inclusion criteria: * were in the originally investigated cohort * had successful imaging at 1-year post-operation * minimum of 5 years post-operation exclusion criteria: * pregnancy * unable to follow-up

Keywords: osteoarthritis cementless fixation gut microbiome weight-bearing computed tomography
motivational interviewing to reduce substance use among depression patients

Conditions: Depression; Substance-Related Disorders

Summary: the study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug use and depression symptoms, improve functional status and promote appropriate health services utilization, in a sample of 300 adults seeking treatment for depression who also report hazardous drinking or drug use with depression.

this study addresses important questions regarding how to identify and treat patients in psychiatry who present for services with alcohol or drug use that may exacerbate depression. the investigators propose a study of brief motivational intervention (bmi) to reduce drug and alcohol use among patients with depression, and to enhance engagement with a kaiser chemical dependency recovery program (cdrp) as needed. patients with depression who use drugs or alcohol even at sub-diagnostic levels are at high risk for escalation of substance problems. bmi is an innovative, evidence-based approach that could decrease drug and alcohol use and improve outcomes. but it has not been tested among depression patients. this study sample will include 300 outpatients in treatment for depression in kaiser permanente northern california hayward/fremont psychiatry. inclusion criteria are based on drug use (any illicit drug use and non-prescribed use of prescription drugs) and hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men), and moderate to severe depression symptoms at intake. three hundred patients will be randomized to receive one in-person bmi session and two telephone bmi sessions within 6 weeks of intake (intervention) or a brochure on risks of drug and alcohol use (control). the investigators anticipate that the intervention will be effective in reducing frequency of drug use and hazardous drinking at 3-, 6-, and 12-month telephone follow-up interviews; improving mood and functional outcomes; increasing depression treatment retention (number of psychiatry visits, based on healthcare effectiveness data and information set (hedis) standards); and facilitating patient initiation of chemical dependency program treatment if needed, and will be cost effective. for the improvement of patient care, it will also yield important information on integrating alcohol and drug intervention in psychiatry and how best to help patients access specialty cdrp services when needed.

Eligibility criteria:
inclusion criteria: * hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men) * drug use (including any illicit drug use and non-prescribed use of prescription drugs in the prior 30 days) * moderate or greater symptoms of depression based on a score of ≥ 5 on the patient health questionnaire (phq-9) exclusion criteria: * current mania or psychosis

Keywords: depression substance-related disorders mental health
positive psychology program in cardiac rehabilitation

Conditions: Acute Coronary Syndrome

Summary: study to try to clarify the role of the dimensions of positive psychology as cardioprotective factors, controlling the classic cvr factors, both biomedical and psychosocial, as well as develop and test the effectiveness of a program protocolized psychological intervention (pi), in a randomized clinical trial.

it is intended to develop a collaborative study between hospital universitario 12 de october and the faculty of psychology of the camilo josé cela university of madrid to try to clarify the role of the dimensions of positive psychology as cardioprotective factors, controlling the classic cvr factors, both biomedical and psychosocial, as well as develop and test the effectiveness of a protocolized psychological intervention, in a randomized clinical trial that will be developed in different phases of the cardiac recovery process in people who have had an acute coronary syndrome (acs). the psychological intervention will include (1) a brief early intervention during hospitalization (based on psychoeducation, relaxation techniques, behavioral activation and focus on positive attitudes), and (2) during the follow-up phases, from two months after the hospital discharge, an intervention that will be made up of different packages depending on the individual profile (management of emotions, lifestyle healthy, post-traumatic growth and resilience, consolidation of intentions), versus a control group that will follow the standard cardiac rehabilitation program.

Eligibility criteria:
inclusion criteria: * patients diagnosed with acute coronary syndrome (acs) referred to the cr program and consent to participate in the trial. exclusion criteria: * presence of diagnosed major psychiatric disorders according to dsm 5 criteria, who will be referred directly to the psychiatry service. * inability to participate in a cardiac rehabilitation program for any reason.
national registry of rfviia (novoseven) in haemorrhagic traumatology

Conditions: Hemorrhage; Bleeding

Summary: the rfviia (novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. a national register has been set up in france identifying the patients which received rfviia. those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization. the aim of this present study is to report the first clinical results in those situations of patients treated with rfviia.

it consists of a study of a prospective cohort in 36 centers, for 3 years, from april 1st 2008. the data of all patients who received rfviia in traumatic situation were collected. the investigators colligated clinical and biological parameters; have been analyzed treatment received during initial care, in intensive care before and after they received rfviia, length of stay in icu, secondary effects, complications and patients outcome. iss and triss score were calculated to predict mortality.

Eligibility criteria:
inclusion criteria: * people affiliated to social security * patients admitted in isu for haemorrhagic trauma * patients received rfviia after the other treatment for bleeding control exclusion criteria: * allergy or hypersensitivity to rviia or one of its component

Keywords: trauma haemorrhagic rviia complication of trauma hemorrhage bleeding rfviia administration for hemorrhage after trauma
synthesis of glutathione from low birth weight newborn babies

Conditions: Low Birth Weight

Summary: the aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.the protocol is constituted of two steps. the objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. in this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.


Eligibility criteria:
inclusion criteria (first step): * full term newborn babies * gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile * eutocic delivery inclusion criteria (second step): * low birth weight newborn babies (gestational age \< 32 weeks of amenorrhea and/or weight of birth \< 1500 g and/or weight of birth \< third percentile for their gestational age) * full term newborn babies (gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile) exclusion criteria (first and second step): * mother diastolic blood pressure \> 90 mmhg during pregnancy, * ph \< 7.2 at umbilical cord and/or difference in ph \< 0,02 between arterial ph and venous ph * dystocic delivery * bacterial or viral maternofoetal infection * foetal malformation * foetal disease * taking n-acetyl-cystein or vitamines and antioxidant minerals by the mother for the last 24 hours

Keywords: glutathione cysteine synthesis rate newborns low birth weight newborn babies
integrated management of pronation deformity in cerebral palsy

Conditions: Cerebral Palsy

Summary: pronation deformity is a very common problem in children with cerebral palsy. this deformity is usually has neural and non-neural aspects. in this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .

spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. there is very limited information about how to treat this deformity in the current literature. in this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with bont-a injections on spasticity, and passive range of motion (prom) of children with cp having pronation deformity.

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy * mas score of pronator muscles at least 2 * gross motor functional classification scale level of i-iv * scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles exclusion criteria: * severe cognitive or behavioural problems * less than 40 degrees of available passive range of motion in pronation * severe dystonia in the affected upper limb * received orthopedic surgery to affected upper limb

Keywords: cerebral palsy botulinum toxin-a pronator deformity
contrasting the brain effects of risperidone and invega with functional magnetic resonance imaging (fmri) and positron emission tomography (pet) scanning

Conditions: Schizophrenia

Summary: the purpose of this study is to better understand brain function and psychiatric and neurological illness when taking invega or risperdal. the objective is to compare the brain effects of invega to risperdal in patients with schizophrenia. this comparison will be evaluated with pet imaging, fmri, and neurological ratings and assessments.


Eligibility criteria:
inclusion criteria: * are currently taking risperdal and have been on the medication for at least three weeks * are diagnosed with schizophrenia * are able to provide written informed consent * can safely have an mri exclusion criteria: * are treatment resistant or intolerant to risperdal * have participated in another drug study in the past 28 days * are pregnant or trying to become pregnant or are breastfeeding * are colorblind * have a history of alcohol, cannabis, or cocaine abuse within two weeks prior to the study * have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant * certain medications are also exclusionary including aripiprazole.