Kornimate/medical-research-clean huggingface dataset:
examining the impact of transcranial focused ultrasound (tfus) on reward neural circuitry

Conditions: Impulsive Behavior

Summary: the investigators aim to examine the immediate effect of transcranial focused ultrasound (tfus) on brain activity and emotions in healthy adults as a first stage toward understanding the predisposing brain mechanisms of underlying substance use disorders.

in a small pilot study the investigators propose to demonstrate feasibility of using tfus to target the ventral striatum (vs) in humans by examining vs target engagement by tfus in healthy human volunteers using a reward processing task that reliably activates the vs.

Eligibility criteria:
inclusion criteria: * 18-35 years of age * no psychiatric history exclusion criteria: * not between 18-35 years of age * has psychiatric history * history of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report) * mini-mental state examination (mmse) score (cognitive state) \<24 * premorbid north american adult reading test (naart) intelligent quotient (iq) estimate\<85 * visual disturbance: \<20/40 snellen visual acuity * left/mixed handedness (annett criteria) * history of alcohol/substance use disorder (sud) (all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (structured clinical interview for diagnostic and statistic manual of mental disorders , 5th edition (dsm-5) (scid-5)). urine tests on scan days will exclude current illicit substance use (except cannabis). salivary alcohol tests on scan days will exclude intoxicated individuals * magnetic resonance imaging (mri) exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy * unable to understand english * individuals with a positive pregnancy test will be excluded from the study and not undergo a computerized tomography (ct) scan or mri scan * present or history of seizure disorder

Keywords: transcranial focused ultrasound magnetic resonance imaging
treatment and monitoring patterns and clinical outcomes in patients receiving palbociclib combination treatment (with ai or fulvestrant) for hr+/her2- a/mbc in a community oncology setting.

Conditions: Breast Cancer

Summary: this is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with hr+/her2- a/mbc who received palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mbc community oncology setting.


Eligibility criteria:
inclusion criteria: patients who are represented in the vector oncology data warehouse who meet all of the following criteria will be eligible for inclusion in the study. * female. * diagnosis of female breast cancer with evidence of metastatic disease or advanced disease. * diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage iiib, stage iiic, or stage iv or identified as having distant metastasis. * indication in the record of er or pr positive disease, or absence of any indication of er and pr negative disease (ie, patients are eligible without affirmative indication of er/pr+ status as long as er/pr- indication is not present). * receipt of a palbociclib plus aromatase inhibitor (ai) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. data collection will prioritize accrual of patients with 1l use of palbociclib plus ai and with 2l use of palbociclib plus fulvestrant before collecting other use of palbociclib users. * age greater than or equal to 18 years at a/mbc diagnosis. exclusion criteria: -there are no exclusion criteria for this study.
co-design and pilot testing of peer-led community outreach to improve equity, veteran-centeredness and uptake of lung cancer screening

Conditions: Lung Cancer

Summary: co-design will be implemented to develop an innovative, veteran-centered intervention (vet peer connects program) that meets the needs of black veterans. next, a feasibility pilot test of the vet peer connects program will be conducted. the peer will lead up to 4 group lung cancer screening orientations in community partner sites to reach around 40 lung cancer screening eligible black veterans. the peer will provide one-to-one tailored support to up to 15 veterans (coaching, goal-setting, navigation to access veterans affairs lung cancer screening). then, the study team will evaluate program delivery through ethnographic observation and field notes, peer activity logs, and weekly check-ins between the study team and peer. investigators will interview veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the vet peer connects program and solicit suggestions for improvement. preliminary data on the outcomes of the vet peer connects program will be collected by study team through administering surveys to assess change in social cognitive theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from va's corporate data warehouse. this work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the vet peer connects program in va lung cancer screening sites and neighboring branches of the national association for black veterans


Eligibility criteria:
inclusion criteria: * self-identified black veterans * meet united states preventive services task force guidelines for lung cancer ( still smoking cigarettes or quit within past 15 years, greater than or equal to 20 pack-years total) * have not yet undergone lung cancer screening exclusion criteria: * non-black veterans

Keywords: screening
neoadjuvant pegylated liposomal doxorubicin and cyclophosphamide +/- trastuzumab followed by docetaxel in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor \> 5 cm.

patients with locally advanced or inflammatory breast cancer have a very bad prognosis. several studies have shown that patients who receive a pathological complete response have the best prognosis. neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. in her2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. recent studies have also demonstrated that evaluation with pet-ct scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.

Eligibility criteria:
inclusion criteria: * pathologically proven breast cancer * inflammatory, locally advanced breast cancer or a tumor \> 5 cm * ecog performance status \< 2 * lvef \> 50% measured by muga (her2 positive patients) * adequate bone marrow, liver and renal function * written informed consent must be obtained exclusion criteria: * another malignancy within 5 years prior to study entry * concurrent treatment with an investigational agent * other disease or condition that contraindicates participation in the study * pregnant or lactating females

Keywords: breast cancer neoadjuvant liposomal doxorubicin pet scan
a study of hedgehog pathway inhibitor gdc-0449 in patients with locally advanced or metastatic solid tumors that are refractory to standard therapy or for whom no standard therapy exists

Conditions: Solid Cancers

Summary: this is a two stage, phase ib study designed to describe the pharmacokinetics of gdc-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists.


Eligibility criteria:
inclusion criteria * histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit); patients with basal cell carcinoma will be excluded from this study unless they do not qualify for another open gdc-0449 clinical trial * for patients with disease that is evaluable by physical examination only, diagnosis must also include biomarker confirmation * eastern cooperative oncology group (ecog) performance status of 0-1 * documented negative pregnancy test for women of childbearing potential and agreement to use an effective form of contraception for the duration of the study * adequate hematopoietic capacity * adequate hepatic function * adequate renal function * at least 3 weeks since last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities exclusion criteria * known, untreated central nervous system (cns) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months * active infection requiring intravenous (iv) antibiotics * clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis * any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis) * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications * pregnant or lactating * treatment with excluded medications, including strong cyp450 inhibitors and inducers

Keywords: hedgehog bcc basal cell carcinoma
prostate cancer detection using the stockholm3 test and mr/fusion biopsies

Conditions: Prostate Cancer

Summary: the sthlm3-mri trial is a study comparing traditional prostate cancer detection using psa and systematic biopsies with the improved pipeline for prostate cancer detection using the sthlm3 test and targeted biopsies in a screening context. the study includes individualised repeat invitations for re-screening to participants not diagnosed with prostate cancer.

the overarching strategy of the sthlm3-mr/fusion projects are to study an improved diagnostic pipeline including an improved blood-based test for identification of men with increased risk of prostate cancer and use of mri to select men for diagnostic workup with targeted prostate biopsies. the aim is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers. the primary endpoints are the number of performed biopsies, the number of performed mri and the number of detected high-risk prostate cancers. secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. additional aims include to assess the health economic consequences and development of automated image-analysis. the sthlm3-mr project is performed in two separate phases, analyzed separately. sthlm3-mr phase 1 closed inclusion 2017-06-01. all participants underwent target and systematic biopsies together with sthlm3 test analysis. the study is constitutes a current practice cohort and levels of the sthlm3 test were not used for selecting participants. sthlm3-mr phase 2 is a study comparing traditional prostate cancer detection using psa and systematic biopsies with the improved pipeline for prostate cancer detection using the sthlm3 test and targeted biopsies in a screening context. sthlm3-mr phase 2 reported outcomes from the first screening round 2023. repeated screening with individualised screening intervals will be offered to participants without prostate cancer detected.

Eligibility criteria:
inclusion criteria: * permanent postal address in stockholm exclusion criteria: * • severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia * contraindications for magnetic resonance imaging (mri) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
action plan to enhance self-management and early detection of exacerbations in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).

early detection of exacerbations by copd patients initiating prompt interventions has shown to be clinically relevant. until now, research failed to identify the effectiveness of a written individualized action plan (ap) to achieve this. the current multicenter, single-blind rct with a follow-up period of 6 months, evaluates the hypothesis that individualized ap's reduce exacerbation recovery time. patients are included from regular respiratory nurse visits and allocated to either usual care or an additional ap providing individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour coded symptom status (reinforcement at 1 and 4 months). although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. exacerbations in both study arms are defined using the anthonisen symptom diary-card algorithm. the clinical copd questionnaire (ccq) is assessed every 3-days. ccq-recovery time of an exacerbation is our primary outcome. additionally, healthcare utilisation, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) ratio \< 70% * age \> 40 years * complaints of chronic cough * smoking history of more than 20 years or 15 pack-years * diagnosis of copd as major functionally limiting disease and * current use of bronchodilator therapy. exclusion criteria: * primary diagnosis of asthma * primary diagnosis of cardiac disease * presence of disease that could either effect mortality or participation in the study (e.g. confusional states).

Keywords: copd emphysema chronic bronchitis
a dental pain study to test the effectiveness of a new pain reliever medicine

Conditions: Pain

Summary: to assess the safety and effectiveness one dose of a new pain reliever medicine (jnj-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. the primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

this is a single-center, randomized, double-blind, placebo- and active-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetic profile of jnj-10450232, administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after molar extractions. subjects will stay at the research center for \~24 hours after administration of study drug. healthy male subjects, ages 18 to 45 years inclusive, will be screened by medical history, vital signs, an electrocardiogram (ecg), and clinical laboratory tests. eligible subjects will return to the clinic on the day of surgery and complete baseline vital signs and clinical laboratory tests. they will undergo dental extraction of a minimum of three third-molars and, if qualified, will be randomly assigned to one of four study treatments for pain.

Eligibility criteria:
inclusion criteria: * subjects aged 18-45 years * at least moderate dental pain assessed by a categorical scale pain intensity scale and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale (pi-nrs) following surgical removal of three third-molars exclusion criteria: * subjects who are not otherwise healthy * test positive for the urine drug screen * taking prohibited medications will not be allowed to participate in this study

Keywords: dental pain post-surgical dental pain
lung ultrasound score as post operative predictive value of pulmonary complications in living liver transplant recipient

Conditions: Pulmonary Complication; Post Operative Complication

Summary: the aim of this study is to determine if lung ultrasound score has a strong predictive value for post operative pulmonary complications in living liver transplant recipient

back ground :traditional diagnostic tools such as auscultation or chest x-ray have inferior diagnostic accuracy compared to the gold standard (chest computed tomography), lung ultrasound is becoming popular in intensive and perioperative care and there is a growing interest to evaluate its role in the detection of postoperative pulmonary pathologies. methodology type of study: observational prospective study * study setting: after obtaining approval from the research ethical committee of ain shams university, this study will be conducted in specialized ain shams university hospitals. * study population : living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in intensive care unit,will reveal that patients will be divided into two groups according to occurance of lung complications to pulmonary complications positive ( group that developed pulmonary complications ) and pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined .

Eligibility criteria:
inclusion criteria: * living liver transplant recipient patients post operative in intensive care unit in first day * age ( adults 21-60 ) * sex ( both genders will be included ) * asa 4 liver failure patients . exclusion criteria: * presence of preoperative chronic lung diseases
efficacy of two algae formulations on lipid metabolism, inflammation and oxidative stress status in individuals with psoriasis

Conditions: Psoriasis

Summary: our overall goal is to evaluate the safety and efficacy of consumption of two algae formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid levels, as well as other health-related markers, in individuals with clinically diagnosed psoriasis.


Eligibility criteria:
inclusion criteria: * males and females with clinically diagnosed psoriasis * plasma ldl-c 80-190 mg/dl, and tg levels below 400 mg/dl. * body mass index (bmi) range will be 22 to 32 kg/m2. * subjects must demonstrate an ability to understand dietary procedures and be judged as compliant and motivated by the investigators. * subjects will be permitted to take stable doses of medications (including drugs for thyroid disease and hypertension)will be permitted if the dose level is maintained stable throughout the study. * potential subjects must have stable psoriasis and their treatments must remain constant throughout the study. exclusion criteria: * recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo * history of chronic use of alcohol (\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin * subjects on anticoagulant therapy (such as warfarin), taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, hmg coa reductase inhibitors, high dose dietary supplements or fish oil capsules (\>4g/day), guggul, lecithin, evening primrose oil within the last six month period will be excluded. in addition, subjects will not be allowed to consume any of these medications during the study * myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months * recent onset and any history of angina, congestive heart failure, heart disease, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer * moderate or high risk for cad * uncontrolled hypertension defined as untreated systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 100 mmhg * pregnant, breastfeeding, or planning to become pregnant during the course of the trial * bleeding disorder, anemia, or significant recent blood loss/donation * allergy/sensitivity to any of the ingredients in the study product or placebo * chronic user of algal products, fiber laxative (greater than 2 doses/wk), or stimulant laxatives or has a history of eating disorders, exercise greater than 15 miles/wk or 4,000 kcal/wk.

Keywords: algae psoriasis lipid metabolism inflammation oxidative stress
flavanol-rich cocoa and cerebral blood flow

Conditions: Hypertension; Diabetes

Summary: the purpose of the study is to learn whether or not cocoa has a beneficial effect on blood flow to the brain in older subjects with diabetes mellitus or hypertension (high blood pressure). we hypothesize that cocoa, which contains flavanols (a type of polyphenol), may help to promote blood flow to the brain in older people with diabetes or hypertension.


Eligibility criteria:
inclusion criteria: * diabetes and/or hypertension exclusion criteria: * alzheimers disease, dementia, stroke, recent angina or heart attack
spanish academy of dermatology and venereology registry of atopic dermatitis therapy

Conditions: Dermatitis, Atopic

Summary: the spanish registry of systemic therapy in atopic eczema, biobadatop, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in spanish daily practice. the main objectives are: 1. to assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance). 2. to assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines. secondary objectives are: 1. to assess short and long-term safety of topical therapies for atopic eczema. 2. to assess effectiveness of different methods of care, including patient training. 3. to describe atopic dermatitis comorbidities.


Eligibility criteria:
inclusion criteria: 1. paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to a specific systemic immuno-modulatory agent (e.g. cya, aza, mtx or new/biologic treatments) for the first time in their life (might have received others, but not this specific one). 2. diagnosis of atopic eczema in keeping with the uk/irish diagnostic criteria. 3. willingness to comply with all study requirements. exclusion criteria: 1. insufficient understanding of the study by the patient and/or parent/guardian. 2. patients who are currently participating in a randomised clinical trial. 3. intention to move to a different geographical area in a short-term (next 3 months).