Kornimate/medical-research-clean huggingface dataset:
positive parenting program in foster care

Conditions: Child Behavior Problem; Child Behavior Disorders; Parenting; Foster Care

Summary: the purpose of the study is to evaluate early implementation outcomes of a positive parenting program, child adult relationship enhancement in primary care (pricare), in the foster care setting and to assess the efficacy of pricare in promoting positive parenting and increasing empathy among foster caregivers.

children in foster care have disproportionately high rates of mental and behavioral health concerns. foster caregivers have reported challenges managing such difficult behaviors. such behaviors are associated with placement instability. child adult relationship enhancement (care), an evidence-based positive parenting intervention, has shown promising findings in the primary care setting and its curriculum has been enhanced (pricare). this positive parenting intervention offers a promising strategy to provide foster caregivers with the skills needed to address these behavioral problems. the objectives of this study are 1) to evaluate the acceptability and feasibility of pricare, a positive parenting intervention, in the foster care setting 2) to assess the efficacy of pricare to promote positive parenting, increase empathy among foster caregivers, and improve parenting efficacy and satisfaction and 3) to identify best practices for implementation and dissemination of pricare in the foster care setting. foster caregivers of foster children 18 months-6 years of age in the philadelphia child welfare system will be enrolled in this study. foster caregivers must be english-speaking and age 18 years or older. foster caregivers will be recruited from the children's hospital of philadelphia (chop) fostering health program, chop primary care sites, chop safe place care clinics, direct referrals from social workers and medical providers, and from referrals from philadelphia foster care agencies and organizations. sixty foster caregivers will be enrolled in the study and will be assigned to the enhanced pricare program. each approximately 9 hour care training group will be attended by approximately 4-12 caregivers without their children. an initial interview will be conducted prior to initiation of the pricare program and will include measures to obtain baseline data regarding demographic information, parenting attitudes and parenting strategies. a second interview will be conducted 4-10 weeks after pricare program completion and will include a semi-structured qualitative interview as well as measures of parenting attitudes and parenting strategies.

Eligibility criteria:
inclusion criteria: 1. foster caregiver is age 18 years or older 2. caregiver is a foster parent of a foster child between 18 months and 6 years of age 3. english-speaking 4. foster caregiver provides informed consent exclusion criteria: 1) foster caregivers who have previously completed care or pricare training.
a study for participants with relapsed cutaneous t-cell lymphoma

Conditions: Cutaneous T-Cell Lymphoma

Summary: the purpose of the study is to determine the efficacy and safety of enzastaurin in participants with cutaneous t-cell lymphoma (ctcl) who failed prior therapies.


Eligibility criteria:
inclusion criteria: * histologically confirmed mycosis fungoides or sezary syndrome. * stage ib to ivb disease at screening. * recurrent or refractory disease after at least 1 prior systemic therapy. * have adequate organ function defined as: * hepatic: total bilirubin ≤1.5 times the upper limit of normal (uln); alanine transaminase/aspartate transaminase (alt/ast) ≤2.5 times the uln. * renal: serum creatinine ≤1.5 times the uln. * adequate bone marrow reserve: platelets ≥75 \* 10\^9/liters (l); absolute neutrophil count (anc) ≥1.0 \* 10\^9/l. * at least 30 days must have passed since other treatment for ctcl. exclusion criteria: * receiving concurrent treatment for ctcl. * unable to swallow tablets. * receiving high potency oral or topical steroids. low potency oral steroid may be permitted in participants who have been on a stable dose for at least 4 weeks prior to screening. oral or topical antihistamine is allowed. * unable to discontinue use of carbamazepine, phenobarbital, or phenytoin. * have a serious concomitant systemic disorder or human immunodeficiency virus (hiv). * have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the new york heart association (nyha) class iii or iv. * have electrocardiogram (ecg) abnormalities. * are pregnant or breastfeeding.
effects of pretreatment with ibuprofen in post-electroconvulsive therapy (ect) headache

Conditions: Mental Disorders

Summary: the purpose of the study is to determine whether ibuprofen reduces post-ect headache or reduces its severity.

the aim of the study is to compare the severity of headache between patients who are receiving ibuprofen prior to ect treatment with patients receiving placebo prior to ect treatment. patients will be randomly assigned to receive either 600 mg ibuprofen 90 min prior to treatment or placebo orally, blinded to patient, physician and treatment team. patients will be asked about their headache with a visual analogue scale (vas) 2 hours prior to and within 2 hours after treatment, 2-month, 6- month and 1 year follow-up \[5\].

Eligibility criteria:
inclusion criteria: * patients receiving ect exclusion criteria: * pregnancy, contraindications to ibuprofen

Keywords: psychiatric disorders ect headache ibuprofen
a phase 3 study to evaluate azr-md-001 in patients with abnormal meibomian gland function and dry eye disease (ded)

Conditions: Dry Eye Disease

Summary: this study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of ded using either azr-md-001 0.5% ophthalmic ointment or its vehicle. study drug (either azr-md-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.

this study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of ded using either azr-md-001 0.5% ophthalmic ointment or its vehicle. study drug (either azr-md-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months. following a screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of ded, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio. study follow-up visits will be conducted on day 14, month 1.5, month 3, month 4.5, month 6, month 9, and month 12. patients will exit the study approximately 13 months after the baseline visit. any ongoing treatment-emergent adverse events (teaes) will be followed for an additional 30 days following the month 12 visit.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older at screening. * evidence of active evaporative ded at screening and baseline. * evidence of meibomian gland obstruction in both eyes at screening and baseline. exclusion criteria: * ocular disease (except for meibomian gland dysfunction (mgd) and ded/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator. * patient has glaucoma, ocular hypertension, or an intraocular pressure (iop) of ≥24 mm hg in either eye at screening. * recent (within the past 3 months of screening) ocular surgery, trauma, herpes, or recurrent inflammation. * unwilling to abstain from the use of systemic or topical treatments for mgd or dry eye for the study duration.
study of albuterol and oxandrolone in patients with facioscapulohumeral dystrophy (fshd)

Conditions: Muscular Dystrophies

Summary: this is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with fshd. it also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.

patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. treatment will continue for 52 weeks unless unacceptable side effects occur. patients will undergo testing of muscle function. all patients will return for follow-up assessments at weeks 4, 12, 26, and 52.

Eligibility criteria:
inclusion criteria: * presence of 4q35 "small fragment" of less than 40 kb by standard dna testing * weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris * weakness of scapular stabilizers or foot dorsiflexors * ambulatory * weakness grade 2 or worse in the arm using upper extremity grading scale exclusion criteria: * prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months * concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers * pregnancy * known hypersensitivity to anabolic steroids * any medical or psychological condition that would interfere with the study * requirement for a wheelchair

Keywords: muscle weakness, muscular dystrophy
study of echinaforce junior tablets in children with acute colds

Conditions: Respiratory Tract Diseases

Summary: this study aims to investigate safety and efficacy of echinaforce junior tablets in two dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.


Eligibility criteria:
inclusion criteria: * age between 4 and 12 years * signed informed consent by parents and optionally be the child * daily access to computer / internet * competence of german language exclusion criteria: * 13 years or older, younger than 4 years. * presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at inclusion * participation in a clinical study in the past 30 days * intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing medicines or bronchovaxom at first treatment period * surgical intervention in the 3 months before inclusion or planned intervention during the observation period * known diabetes mellitus * known and treated allergic rhinitis, atopy or asthma * cystic fibrosis, bronchopulmonic dysplasia, copd * immune system disorders, degenerative diseases (e.g. autoimmune disease like aids or leukosis) * metabolic or resorptive disorders * liver or kidney diseases * serious health problems * predisposition for complicated cold episodes in the judgement of the physician (sinusitis, otitis media, bronchitis, pneumonia) * known allergy to plants of the compositae family (camomile or dandelion) or any of the substances of the investigational product
a study of roactemra/actemra (tocilizumab) in patients with active rheumatoid arthritis who have an inadequate response to dmards (remission)

Conditions: Rheumatoid Arthritis

Summary: this open label, single arm study will assess the safety and efficacy of roactemra/actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (dmards). patients will receive roactemra/actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe active rheumatoid arthritis (das28 \> 3.2 at screening) * inadequate response to dmards * body weight \< 150 kg exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment * rheumatic autoimmune disease other than ra * american college of rheumatology (acr) functional class iv * prior history of or current inflammatory joint disease other than ra * previous treatment with any biologic drug that is used in the treatment of ra * intraarticular or parenteral corticosteroids within 6 weeks prior to baseline * pregnant or lactating women * active current or history of recurrent infection, active tb within the previous 3 years, hiv infection
prevalence of faecal bacteriophage in patients with digestive symptoms

Conditions: Gastroenteritis

Summary: define the prevalence of fecal phage carriage in individuals with digestive symptoms (i) determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture) (ii) determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (pcr detection) (iii) explore factors that could impact fecal phage carriage (patients with digestive symptoms vs. healthy individuals, immunocompromised patients vs. immunocompetent patients)


Eligibility criteria:
inclusion criteria: * age between 18 and 60. * persons having developed gastrointestinal symptoms justifying microbiological stool testing at the time of hospitalization. * person having received full information on the organization of the research and not having objected to the use of this data exclusion criteria: * persons covered by articles l. 1121-5, l. 1121-7 and l1121-8 of the french public health code. * pregnant or breast-feeding women, * minors (not emancipated), * adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice), * persons of full age who are unable to give their consent. * persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care by virtue of articles l. 3212-1 and l. 3213-1.

Keywords: bacteriophages
two tracer positron emission tomography combination for efficacy estimation of prostate specific membrane antigen radioligand therapy in patients with metastatic prostate cancer

Conditions: Prostate Cancer; Prostate Adenocarcinoma; Prostatic Neoplasms; Metastatic Prostate Cancer; Metastatic Prostatic Adenocarcinoma; Metastatic Prostate Carcinoma in the Soft Tissue

Summary: single-arm, open-label, phase ii trial in 200 competent adult male patients with eastern cooperative oncology group performance status (ecog ps) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. patients will undergo sequential fdg positron emission tomography (pet) and 18f-dcfpyl pet to assess fdg/dcfpyl concordance fraction. patients with dcfpyl/fdg concordance of 50% or greater will be treated with 131i-psma-1095 radioligand therapy (rlt). best post-treatment serum prostate specific antigen response will be compared to concordance fraction.


Eligibility criteria:
inclusion criteria: * male * age 18 years or older * documented metastatic adenocarcinoma of the prostate * under active medical oncology care * ecog performance status 0 - 3, inclusive * able to understand and provide written informed consent * able to tolerate the physical requirements of two pet/ct scans including lying for up to 30 minutes * progressive disease on any of: bone scan, ct, mri or serum psa as judged by the investigator * serum prostate specific antigen ≥ 1 ng/ml at baseline or ct/mri soft-tissue measurable disease as per recist v1.1 * failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: adt, naad (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic rtx * life expectancy of at least 3 months as judged by the investigator exclusion criteria: * medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * exceeding the weight limit of the pet/ct bed (approximately 400 lbs.) or who cannot fit through the pet/ct bore (approximately 70 cm diameter) * unmanageable claustrophobia * prior failure of psma rlt * prior hemi-body irradiation * impaired organ function as evidenced by any of the following laboratory values: * absolute neutrophil count \< 1.5 x109/l * platelet count \< 75 x109/l * hemoglobin \< 85 g/l * albumin \< 2.5 g/dl (25 g/l) * total bilirubin \> 2 x uln (unless in instances of gilbert's disease) * ast or alt \> 2.5 x uln (or \> 5.0 x uln in the presence of liver metastases)

Keywords: radioligand therapy psma psma therapy 1095
adapting and piloting acceptance and commitment therapy (act) for severe premenstrual mood symptoms

Conditions: Premenstrual Dysphoric Disorder; Premenstrual Exacerbation of Mood Disorder

Summary: in the weeks prior to menstruation, many individuals experience mood and physical symptoms that negatively impact their quality of life and functioning. approximately 5% of women and menstruating individuals have such severe symptoms that they meet criteria for premenstrual dysphoric disorder (pmdd). further, of those with underlying mood disorders (i.e., depression, bipolar disorder) about 60% have cyclical worsening of symptoms classified as premenstrual exacerbation (pme). both pmdd and pme are associated with significant impairment, yet limited effective options exist to treat these conditions. in this project, the investigators will adapt and evaluate an acceptance and commitment therapy (act) group for pmdd and pme, entitled act-premenstrual (act-pm), delivered virtually to maximize accessibility. the investigators will examine whether act-pm is feasible to deliver and whether it is acceptable to group participants and those facilitating the group. the study will lay the groundwork for future research to determine if the group is effective. if effective, the intervention could be scaled up to improve quality of life and outcomes for individuals suffering from pmdd and pme.


Eligibility criteria:
inclusion criteria: * (1) diagnosed by the psychiatrist who conducted the initial assessment with either premenstrual dysphoric disorder (pmdd), or a bipolar or depressive disorder where there is premenstrual exacerbation (pme), after 2-3 months of mood tracking using a validated evidenced based scale for premenstrual mood symptoms (mcmaster premenstrual and mood symptom scale (mac-pmss) or similar; * (2) have internet access and a video-enabled device; * (3) residing in ontario for the duration of the study, necessary because mds and therapists who could deliver the intervention are all licensed provincially; * (4) regular menstrual cycles (\~21-35 days); and * (5) have a regularly treating physician (e.g. psychiatrist or primary care provider). exclusion criteria: * (1) active alcohol or substance use disorder in the previous 12 months; * (2) active suicidal ideation, mania, psychosis, or violence; * (3) current pregnancy or planning a pregnancy during the duration of the study * (4) inability to complete group and/or study measures in english, necessary as the pilot group is only available in english at this time.
drug-drug interaction study of casdatifan in healthy adult participants (arc-29)

Conditions: Healthy Participants

Summary: the purpose of the study is to assess the effects of multiple doses of itraconazole (a strong cyp3a4 inhibitor) on single dose pk of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong cyp3a4 inducer) on single dose pk of casdatifan in healthy adults.


Eligibility criteria:
inclusion criteria: * healthy, adult, male or female 18-55 years of age, inclusive, at the screening visit. * male participants must be vasectomized * continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting. * bmi ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg, at the screening visit * able to swallow multiple tablets and/or capsules. exclusion criteria: * is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the pi or designee. * history of any illness that, in the opinion of the pi or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. * history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds. * history of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by pi or designee. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ab521 casdatifan hif-2α hypoxia-inducible factor 2 alpha
burst-suppression to stop refractory status epilepticus post-cardiac arrest

Conditions: Hypoxia-Ischemia, Brain; Heart Arrest; Status Epilepticus; Refractory Status Epilepticus; Seizures; Anoxic-Ischemic Encephalopathy; Anoxia-Ischemia, Cerebral

Summary: restore is a randomized clinical trial investigating the safety and feasibility of using eeg treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.

rationale: seizures emerge as a complication of hypoxic-ischemic brain injury in near a third of patients successfully resuscitated from cardiac arrest. seizures post-cardiac arrest can be refractory to treatment with anti-seizure medications and anesthetics may be used for refractory status epilepticus control. anesthetic treatment guided by continuous eeg can target burst suppression or seizure suppression, however it is not known which strategy is superior for achieving pcarse control. objective: determine the safety and feasibility of post-cardiac arrest refractory status epilepticus (pcarse) treatment using eeg goals for intravenous anesthetic titration (burst suppression vs. seizure suppression). clinical trial phase: ii study design: prospective, randomized, open-label, blinded end-point, concurrently-controlled, parallel arms design clinical trial. study period: two years study population: unconscious cardiac arrest survivors with return of spontaneous circulation who develop post-cardiac arrest refractory status epilepticus (pcarse). interventions: anesthetic use targeting burst suppression vs. seizure suppression on eeg for 24 hours. intervention maybe repeated using the dame eeg target once in case of pcarse recurrence. sample size: 30 subjects randomized in a 1:1 ratio to either burst suppression or seizure suppression eeg targets. primary endpoints: safety and feasibility of seizure control using burst suppression or seizure suppression eeg targets for pcarse treatment. secondary endpoints: seizure recurrence incidence, time to seizure recurrence, number and dose of anti-seizure medication and anesthetic needed for pcarse control, death or disability according to the cerebral performance category at discharge (30 days), and death or disability according to the modified rankin scale at discharge (30 days). risks: participants receiving anesthetics for pcarse treatment will be monitored for hypotension, propofol infusion syndrome, and hypertriglyceridemia. patients with pcarse are at high risk for death and prolonged hospital stays.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. non-traumatic, out-of-hospital cardiac arrest 3. comatose on admission - defined as not following commands 4. return of spontaneous circulation (rosc) within less than 45 minutes 5. admission to the intensive care unit 6. diagnosis of post-cardiac arrest refractory status epilepticus confirmed with continuous eeg monitoring within 7 days from rosc exclusion criteria: 1. acute cerebral hemorrhage or infarction 2. pregnancy 3. prisoners