Kornimate/medical-research-clean huggingface dataset:
tdcs combined with ct in opioid use disorder

Conditions: Opioid Use Disorder

Summary: the aim of the present study is to investigate the effect of prefrontal transcranial direct current stimulation (tdcs) combined with cognitive training on cognitive functions in individuals with opioid use disorder (oud). the participants will be allocated into active/sham groups (1:1) and will receive a single session of prefrontal tdcs combined with cognitive training. outcomes of the active and sham groups will be compared.


Eligibility criteria:
inclusion criteria: * being aged between 18-65 years * being in the maintenance phase of the oud treatment * naivety to tdcs * at least 5 years of education exclusion criteria: * current diagnosis of major depressive disorder * current diagnosis or history of bipolar disorders, psychotic disorders, neurocognitive disorders, pervasive developmental disorders, mental retardation, severe neurological disorders, * common tdcs contraindications

Keywords: brain stimulation cognitive functions neuropsychological evaluation opioid use disorder transcranial direct current stimulation
a volumetric coiling in aneurysm registry of the penumbra coil 400tm system

Conditions: Intracranial Aneurysms

Summary: this study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the pc 400 system. data for each patient are collected up to 12 ± 3 months post-procedure for the study.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * intracranial aneurysms \>2mm, ruptured or unruptured exclusion criteria: * fusiform aneurysms * dissecting aneurysms * aneurysms associated with brain avms * multiple aneurysms * re-treated aneurysms * patients in whom endovascular embolization therapies other than pc 400 system are used will be excluded from this study. however, adjunctive use of balloon and stent are acceptable.
acceptance and commitment therapy for insomnia

Conditions: Insomnia

Summary: insomnia is a common sleep problem that impacts both physical and mental health. acceptance and commitment therapy for insomnia (act-i) is proposed as a promising new treatment for insomnia. however, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown. the main goal of this clinical trial is to test the efficacy of stand-alone act-i in adults with insomnia, compared to a waitlist control group. the second goal is to explore the potential working mechanisms of act-i, using network intervention analysis. adults with insomnia will be randomized to an act-i or waitlist group. both the act-i treatment and waiting period span 7 weeks. assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the act-i group. the main questions this rct aims to answer are: * is act-i superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)? * how do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following act-i?


Eligibility criteria:
inclusion criteria: * insomnia severity index score ≥ 15 * clinical insomnia disorder diagnosis, as confirmed by the scid-s-5 insomnia interview * age of 18 years or above * proficiency in dutch * ability to come on-site for the treatment sessions exclusion criteria: * previously received act * started psychotherapy within the last 6 months or currently awaiting psychotherapy * changed psychoactive medication in the last 3 months * diagnosis of psychosis or schizophrenia * severe depressive complaints (bdi-ii score ≥ 29) or active suicidal ideation

Keywords: acceptance and commitment therapy act-i stand-alone efficacy mechanisms randomized controlled trial
study to evaluate estradiol vaginal tablets vs promestriene vaginal cream

Conditions: Vulvovaginal Atrophy

Summary: this is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream

this is an observational, prospective, open-label, parallel-group study to evaluate the acceptability, efficacy, and preferences of postmenopausal women older than 45 between 10 micrograms of estradiol vaginal tablets vs promestriene vaginal cream

Eligibility criteria:
inclusion criteria: postmenopausal women aged 45 years or older. women will be considered postmenopausal with more than 12 months since last menstrual period * women who have been prescribed vaginal estradiol tablets or vaginal promestriene cream· women who have read and signed the informed consent form * women with an intact uterus * one or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. symptoms are moderate if the patient needs a treatment and feels discomfort. symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject's daily activities * in case of doubt, blood estradiol concentration will be determined, and the subject will only be enrolled if the levels are equal to 30pg./ml. or less. exclusion criteria: * women who had a known or suspected history of breast carcinoma * estrogen dependent neoplasia. women with a known, past or suscpected estrogen-dependent malignant tumours such as endormetrial or ovarian cancer * positive or suspicious mammogram results * any systemic malignant disease * hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months women who had abnormal vaginal bleeding or uterine bleeding of unknown cause * vaginal infection requiring treatment * previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) untreated endometrial hyperplasia known thrombophilic disorders (e.g. protein c, protein s, or antithrombin deficiency) active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal known hypersensitivity to the active substances or to any of the excipients porphyria * any serious disease or chronic condition that could interfere with study compliance * history of thrombolytic disorders * use of vaginal contraceptives (diu, vaginal ring...) * participation in another clinical trial in the last three months.

Keywords: vulvovaginal atrophy
a study comparing pf-05089771 ts capsule to pf-05089771 ts oral dispersion in the fasted state

Conditions: Pain

Summary: the primary purpose of this study is to estimate the relative bioavailability and food effect of a pf-05089771 capsule.


Eligibility criteria:
inclusion criteria: * healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years exclusion criteria: * evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen. * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * screening supine blood pressure ≥140 mm hg (systolic) or ≥90 mm hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. single 12-lead ecg demonstrating qtc \>450 msec or a qrs interval \>120 mseca at screening. if qtc exceeds 450 msec, or qrs exceeds \>120 mseca the ecg should be repeated two more times and the average of the three qtc or qrs values should be used to determine the subject's eligibility.
comparison of treatment simplification by lpv/r vs current treatment continuation in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a lopinavir/ritonavir monotherapy versus continuation of current treatment in hiv-infected patients

highly active antiretroviral therapy (haart) has made a significant impact on the natural history of hiv-1 infection, but toxicities and complexities of therapy limit long-term efficacy, and make simpler yet effective haart regimens highly desirable. previous attempts to 'de-intensify' protease inhibitor (pi)-based therapy by discontinuing reverse transcriptase inhibitors (rti) after achieving viral suppression met with failure, probably because plasma levels of most individually administered pi are too low to inhibit viral replication consistently. low-dose ritonavir substantially enhances lopinavir plasma levels, and lopinavir/ritonavir (lpv/r) is effective as part of a combination therapy in both naive and pi-experienced patients. furthermore, lopinavir is known to have a high genetic barrier to selection of resistance. lpv/r monotherapy could thus have the right combination of potency, favorable pharmacokinetics, and high genetic barrier needed to suppress viral replication and prevent the selection of lopinavir resistance. preliminary results with "maintenance"lpv/r monotherapy show interesting results but data from randomized studies are needed.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years * confirmed hiv-1 seropositivity * antiretroviral treatment stable since 3 months at least * hiv-1 arn load \< 50 copies/ml since 6 months at least * signed consent form * no history of treatment failure (= viral load \> 1000 copies/ml) including a protease inhibitor * no opportunistic infection in the previous 6 months exclusion criteria: * neutrophils \< 750/mm3 * hemoglobin \< 8 g/dl * platelets \< 60,000/mm3 * creatinin \> 150 micromoles/l * sgot \> 5 nul (normal upper limit) * sgpt \> 5 nul * current il-2 treatment * hbv infection treated or not by lamivudine or tenofovir * pregnancy or feeding * enrollment in another study not compliant with kalesolo study group assignment

Keywords: hiv-1 treatment simplification lopinavir/ritonavir treatment experienced hiv seropositivity
efficacy and safety of growth hormone treatment in juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis; Still Disease, Juvenile-Onset

Summary: growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. especially those who were under additional treatment with glucocorticoids for high disease activity. the hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. in a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. additionally, we are interested in bone density development in those treated with growth hormone.

growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. especially those who were under additional treatment with glucocorticoids for high disease activity. this is the case in patients with a polyarticular and a systemic form of juvenile idiopathic arthritis. the permanent consequence is short stature at final height. up to 30% of these patients will have a final height below the 3rd percentile, even after discontinuation of glucocorticoid treatment. the hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. in a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. from safety aspects we were interested in the effect of growth hormone on the disease activity. additionally, we are interested in bone density development in those treated with growth hormone up to final height.

Eligibility criteria:
inclusion criteria: * polyarticular or systemic juvenile idiopathic arthritis, * growth velocity below the 25th percentile and or short stature , * treatment with glucocorticoids for at least the previous 6 months before inclusion, * prepubertal stage, * bone age below 10 in girls and 12 in boys, * growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml exclusion criteria: * previous treatment with growth hormone, * endocrinopathy, * additional chronic disease beside juvenile idiopathic arthritis, * malignant disase, * chromosomal aberration or othe syndromal disease, * previous treatment with oxandrolone, * small for gestational age, * elevated fasting glucose level
mobile self management and support for adolescents and young adults with cancer

Conditions: Sarcoma

Summary: this study is the user testing phase of a mobile application intervention which will be designed to promote positive coping skills, illness resilience, and social support, and to serve as a complement to patient-physician interactions in adolescents and young adults (aya) with sarcoma. user testing will be conducted with a prototype of the app. participants will be aya ages 13-25 with sarcoma (n=16). study participation involves the ayas downloading and using the app for 30 days. during the 30 days, participants will interact with the app by inputting their current mood, receiving supportive feedback from the app, reading messages, and doing brief activities (such as relaxation activities, etc.). participants will also participate in an online focus group focused around the user experience. before and after the 30 days of user testing, participants will complete a few brief questionnaires about their behavior, how their symptoms affect their life, and how they receive support from others. these questions will take around 20 minutes to complete at each administration.


Eligibility criteria:
inclusion criteria: 1. parent or self-reported (for participants 18+ years old) physician diagnosis of sarcoma 2. daily use of a smartphone (ios, android, or windows) or tablet 3. current facebook account that participant can use to participate in the focus group (or, be willing to create a facebook account for this purpose). 4. able and willing to give informed assent and comply with study requirements 5. for patients aged 13-17 years, have one caregiver willing and able to participate in the study 6. able to read and speak english exclusion criteria: 1. patients that are not able to participate in the study due to their medical condition and/or treatment regimen, as determined by the patients' treating oncologist in conjunction with patients' family members 2. inability to provide informed assent/permission/consent 3. inability to read, speak, and understand english
combined viscocanalostomy, phacoemulsification, oiogen implant in open angle glaucoma

Conditions: Primary Open-angle Glaucoma

Summary: this prospective, interventional, randomized clinical study was done at alpha vision center, zagazig, egypt. patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (phacovisco group) or phaco-viscocanalostomy with ologen® implant (olophacovisco group) . follow-up period was 2 years. nd:yag laser goniopuncture was done in cases where the intraocular pressure (iop) was elevated above 21 mmhg after discontinuation of corticosteroid eye drops at any follow-up visit. our hypothesis is that using ologen® implant as a spacer in the subscleral reservoir in phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation

background: to study the efficacy of the biodegradable collagen implant ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma. methods: this prospective, interventional, randomized clinical study was done at alpha vision center, zagazig, egypt. patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (phacovisco group) or phaco-viscocanalostomy with ologen® implant (olophacovisco group). follow-up period was 2 years. nd:yag laser goniopuncture was done in cases where the intraocular pressure (iop) was elevated above 21 mmhg after discontinuation of corticosteroid eye drops at any follow-up visit.

Eligibility criteria:
inclusion criteria: * the presence of significant cataract interfering with vision (visual acuity ≤ 0.5) in the presence poag. * if cataract was associated with uncontrolled glaucoma, (iop \> 21 mmhg despite maximally tolerated medical therapy) * if the iop was ≤ 21 mmhg with use of at least two antiglaucoma drugs with medication intolerance * poor patient compliance * patients could not attend medical supervision * patients had visual field deterioration. exclusion criteria: * closed-angle glaucoma * other types of open angle glaucoma (oag), e.g. pigmentary glaucoma, inflammatory glaucoma or neovascular glaucoma, * previous ocular trauma or surgery * lens subluxation * any eye diseases affecting the vision, e.g. anterior uveitis * if there was a large perforation of the descemet's membrane with iris prolapse during surgery (cases with microperforation, which is defined as small perforation with no associated iris prolapse, occurring during surgery were not excluded) intraoperative complications that might affect the iop, e.g. vitreous loss.

Keywords: viscocanalostomy ologen glaucoma phacoemulsification
evaluation of nutrition training augmented with digital technology in graduate medical education

Conditions: Chronic Disease

Summary: investigators will conduct a randomized controlled evaluation of standard nutrition education vs. standard education + nutri, and interactive clinical software that automates diet assessment and guides resident physicians through personalized and evidence-based diet counseling. investigators will evaluate differences in resident-reported diet counseling competence and self-efficacy using survey measures. investigators will evaluate skills using a simulated patient appointment and coding scheme described in prior work.


Eligibility criteria:
inclusion criteria: * dell medical school internal medicine residents * dell medical school family medicine residents exclusion criteria: * n/a

Keywords: medical education nutrition counseling technology
lumateperone for the improvement of apathy in patients with psychotic symptoms.

Conditions: Apathy; Schizophrenia; Schizophrenia; Psychosis

Summary: this study is looking to determine if lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by aes-c-apathy (apathy evaluation scale - clinician - apathy) assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the panss (positive and negative syndrome scale) due to treatment with lumateperone.

1. to determine if lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by aes-c-apathy assessment. 2. to examine a possible correlation between improvement in apathy scores and changes in elements of the panss (positive and negative syndrome scale) due to treatment with lumateperone.

Eligibility criteria:
inclusion criteria: * male or female subjects between the ages of 18-65 that have been diagnosed with schizophrenia, schizoaffective disorder or schizophrenia spectrum and other psychotic disorders. * a bprs score \> 35 at the screening visit. * an aes-c score \> 32 at the screening visit. * if the subject is on a therapeutic regimen, that regimen must be stable for at least 30 days prior to screening. a therapeutic regimen may include medication, supplements, and/or probiotics. * in the opinion of the investigator, the subject is able to participate in all scheduled evaluations, and likely to be compliant and complete all required assessments. * female subjects of childbearing potential must not be pregnant or breast-feeding. female subjects of childbearing potential must have a negative urine pregnancy test. subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 30 days after the last dose of study drug. * must speak and understand english, as the consent and all evaluations will be conducted in english. * must be willing to take and pass a urine drug screen with a negative result in order to rule out psychotic symptoms due to drugs of abuse. exclusion criteria: * a bprs score \< 35 at the screening visit. * an aes-c score \< 32 at the screening visit. * have any clinically significant medical condition or an unstable intercurrent illness that would, in the opinion of the investigator, preclude study participation. * are currently taking more than one antipsychotic medication. * are currently taking a long-acting injectable medication for psychotic symptoms. * have a substance use disorder or show a positive drug screen for stimulants. * are pregnant or of female sex with no evidence of measures for pregnancy prevention. * presence of dementia. * intellectual disability or cognitive impairment that would affect the symptom/apathy assessments, in the view of the investigator. * a diagnosis of parkinson's disease.

Keywords: schizophrenia schizoaffective psychosis psychotic