Kornimate/medical-research-clean huggingface dataset:
a real world study of ensartinib in advanced alk-positive nsclc

Conditions: Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase I1171N; Ensartinib

Summary: the primary objective of this study is to evaluate the efficacy and safety of ensartinib in advanced alk-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to ensartinib.

participants will receive ensartinib at 225 mg orally once a day (qd). treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). at the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. blood specimens of 8 ml were collected each time for ctdna ngs testing, and evaluation of ensartinib population pharmacokinetics with blood sampling after 8 weeks.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed stage iii b or iv nsclc, according to the international association for the study of lung cancer staging manual in thoracic oncology, 8th edition. 2. documented alk-positive disease according to fish , ventana ihc ,rt-pcr or ngs; 3. patients must have demonstrated progression during or after alk-tki treatment; 4. eastern cooperative oncology group performance status (ecog ps) of 0-2, overall survival\>3 months; 5. patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc. 6. initially general blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry were performed as a routine screening in order to identify any abnormalities. 7. male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication. exclusion criteria: -

Keywords: carcinoma, non-small-cell lung anaplastic lymphoma kinase ensartinib real world study
shifts in the oral biofilm of patients with known oral health risk factors

Conditions: Dental Caries; Gingivitis

Summary: this study is observational only and is intended to evaluate changes in the makeup and function of bacteria naturally present in the mouth during treatment with braces to straighten teeth.


Eligibility criteria:
inclusion criteria: * asa i or ii (asa i is a healthy patient, asa ii is patient with minor systemic disease) * patient must be receiving orthodontic treatment at the university of north carolina school of dentistry and not yet be in active treatment exclusion criteria: * patients who have used antibacterial therapy in the past 3 months * patients who report current smoking * asa iii or above (patients with severe systemic diseases)
improving negative stressful perseverations in insomnia to revitalize expecting moms (inspire)

Conditions: Insomnia; Depression

Summary: nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. the purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. the investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.

the investigators will conduct a pilot hybrid type 1 effectiveness-implementation randomized controlled trial (rct) wherein 100 pregnant women with dsm-5 insomnia disorder and comorbid depression (edinburgh postnatal depression scale ≥ 10) are randomized to a mindfulness-based intervention--perinatal understanding of mindful awareness for sleep (pumas)--or cognitive behavioral therapy for insomnia (cbti). patients will be recruited from women's health clinics across henry ford health in metro detroit including underserved women, serving as real-world implementation. per clinic operations since the pandemic, therapies will be via telemedicine to meet patient expectations. study outcomes will be assessed before and after treatment, then across the first postpartum year.

Eligibility criteria:
inclusion criteria: 1. singleton pregnancy, gestational week 14-31. 2. dsm-5 insomnia disorder (acute or chronic). 3. insomnia severity index (isi) score ≥ 11. 4. edinburgh postnatal depression scale (epds) score ≥ 10. 5. ensure adequate sleep opportunity. 6. age ≥ 18, english-speaking. 7. reliable internet access (treatment, assessments) exclusion criteria: 1. high risk pregnancy (age \>40y, pre-eclampsia, any condition deemed serious risk to mother/fetus; hypertension and diabetes allowed). 2. active suicidal intent (ideation is allowed). 3. night or rotating shift work. 4. epworth sleepiness scale\>15 (excessive sleepiness) 5. health condition unsafe for sleep restriction (bipolar, epilepsy, etc.).

Keywords: pregnancy postpartum telemedicine cognitive arousal insomnia depression mindfulness
cognitive-motivational behavior therapy for pathological gamblers

Conditions: Pathological Gambling

Summary: in the proposed two-arm randomized controlled trial, 200 patients meeting dsm-iv criteria for pg will be randomized to 12 sessions of cognitive-motivational behavior therapy (cmbt) or to cognitive behavior therapy (cbt).

cmbt has been developed by our team over the last five years, and has shown very promising results in a small, nimh-funded randomized pilot trial (r21 mh 064568). we will assess patients biweekly during the active treatment phase and follow them for 12 months after the end of treatment to obtain data on long-term treatment outcome. we hypothesize that cmbt will show higher efficacy and retention than cbt in the treatment phase, and that gains will be maintained at a higher rate during follow-up. a second major purpose of the proposed study is to elucidate the presumed mechanisms of change by examining potential mediators (readiness to change, irrational beliefs about gambling, coping skills, therapeutic alliance) and moderators (psychiatric comorbidity with axis i and ii disorders, family history of pg, impulsivity, and baseline motivation to change) of treatment response. a better understanding of how the proposed interventions work will help advance the science and treatment of pg and will be helpful in the future refinement and adaptation of cmbt. identifying patient subgroups for which the intervention is particularly effective is essential for rational treatment selection. thus, the immediate goal of the project is to compare cbmt versus cbt for the treatment of pg. a long-term goal of the proposed research is to establish effective treatment procedures that reduce the considerable individual and social costs of pg.

Eligibility criteria:
inclusion criteria: * pathological gambling * be able to read, understand and sign an informed consent form prior to any procedure and must be willing to comply with all study procedures and timelines exclusion criteria: * to meet dsm-iv criteria for comorbid substance use disorders in the last six months * current comorbid psychiatric conditions which require treatment and are not clearly secondary to pathological gambling * psychotropic medication
safety and efficacy of bibf 1120 at high dose in idiopathic pulmonary fibrosis patients

Conditions: Pulmonary Fibrosis

Summary: idiopathic pulmonary fibrosis (ipf) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. in a large phase 2 trial (1199.30) (nct00514683), investigating the effects of 52 weeks of treatment with bibf 1120 in patients with ipf, a positive effect was seen on lung function of patients treated with high dose of bibf 1120 compared to placebo. hence it is the purpose of this trial to investigate and confirm the efficacy and safety of bibf 1120 at a high dose in treating patients with ipf, compared with placebo. the trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. respiratory function is globally accepted for assessment of treatment effects in ipf patients. the chosen endpoint (forced vital capacity (fvc) decline) is easy to obtain and is part of the usual examinations done in ipf patients.


Eligibility criteria:
inclusion criteria: 1. age \>= 40 years; 2. ipf diagnosed, according to most recent american thoracic society (ats), european respiratory society (ers), japanese respiratory society (jrs), latin american thoracic association (alat) ipf guideline for diagnosis and management, within 5 years; 3. combination of high resolution computerized tomography (hrct) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of ipf 4. dlco (corrected for hb): 30%-79% predicted of normal; 5. fvc\>= 50% predicted of normal exclusion criteria: 1. aspartate aminotransferase (ast), alanine aminotransferase (alt) \> 1.5 x upper limit of normal (uln) 2. bilirubin \> 1.5 x uln; 3. relevant airways obstruction (i.e. pre-bronchodilator fev1/fvc \< 0.7); 4. patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation); 5. myocardial infarction within 6 months; 6. unstable angina within 1 month; 7. bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic cns event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months); 8. thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months; 9. international normalised ratio (inr) \> 2, prolongation of prothrombin time (pt) and partial thromboplastin time (ptt) by \> 50% of institutional uln); 10. n-acetyl cystein, prednisone \> 15mg/day or equivalent received within 2 weeks of visit 1; 11. pirfenidone, azathioprine, cyclophosphamide, cyclosporine a received within 8 weeks of visit 1;
early therapy response monitoring in melanoma patients using pet/mri

Conditions: Malignant Melanoma Stage IV

Summary: therapeutic agents used in malignant melanoma treatment such as braf/mek inhibitors and anti-ctla-4/anti-pd-1 antibodies go along with harmful side effects in a considerable proportion of patients and treatment costs may cause relevant medical expenditures per month. currently, therapy response assessment in melanoma patients is performed using recist criteria which are based on changes in tumour size. pet/ct combines morphological and metabolic information. thus, the so-called percist-criteria were introduced integrating change in size and glucose utilization for response assessment in solid tumors. due to the different mechanism of action these new agents introduce different response patterns increase in tumor size due to inflammation for antibody therapies). in conventional chemotherapies, re-staging is usually performed 3 months after treatment initiation which is the result of empirical investigations. moreover, it has recently been shown, that response to new targeted therapies can be detected much earlier using pet or functional mr techniques. this forms the rationale for the monitoring of melanoma patients using a combined pet/mr technique after only 2 weeks of therapy initiation. especially for patients in stage iv with a medium survival time of 12 months, a 2.5 months earlier re-staging and therapy adjustment would have significant consequences for the individual clinical course.


Eligibility criteria:
inclusion criteria: * patient with diagnosed unresectable malignant melanoma stage iv * age: ≥18 years * planned systemic therapy with either new therapies (braf/mek inhibitors, anti-ctla-4/anti-pd-1 antibodies) or conventional chemotherapeutics (ctx) * clinically indicated routine pet/ct (baseline t0) demonstrating at least one measurable lesion * pet/ct for baseline-staging and therapy monitoring (clinical indication required) * informed consent exclusion criteria: * contraindications for mr-imaging (metal implants, claustrophobia, etc.) * contraindications for gadolinium-based contrast agent * acute infections or other acute diseases * pregnant or breast-feeding women * disability for informed consent
cognitive training in stroke patients

Conditions: Vascular Diseases

Summary: the study aims to investigate the behavioral effects, neural correlates and functional connectivity of cognitive training in patients with stroke

the study will investigate the effects of two cognitive training strategies on behavior, neural correlates and functional connectivity of patients with vascular lesions. the first strategy is associated to the ability to apply efficient organizational semantic category strategy to a list of words. this strategy will be trained in activities similar to everyday life activities. there will be in total 5 sessions, two for measuring the generalization effects before and after training and three sessions to apply the semantic strategy in order to improve encoding and episodic memory performance. the second strategy is related to the ability to remember face-names and the strategy will involve the identification of a salient face feature, creation of a nickname and association of the nickname to the real name. there will be 5 sessions in total, two for measuring the generalization effects before and after training and three sessions to apply the face-name association strategy in order to improve encoding and episodic memory performance. these two cognitive training procedures will be carried out in two separate moments. before and after each procedure all participants will be examined by functional mri during resting state and during a active task using a memory encoding paradigm. the same procedure will be carried out with normal control participants.

Eligibility criteria:
inclusion criteria: * people with chronic vascular ischemic lesions (more than 6 months) exclusion criteria: * vascular hemorrhages, stenosis, psychiatric problems

Keywords: vascular ischemic lesion
disco: a patient intervention to reduce the financial burden of cancer

Conditions: Financial Toxicity; Cancer; Question Prompt List; Breast Cancer; Prostate Cancer

Summary: the disco app is designed to improve, during the interaction, patient active participation and patient-initiated oncologist treatment cost discussions, and, in the short term, patient's treatment cost knowledge, self-efficacy for managing both cost and physician interactions, referrals, perceived financial toxicity (i.e., distress and material hardship); in turn, these will affect longer-term outcomes of financial toxicity and adherence.

this work is based on the core scientific premise - that increasing patient active participation and the frequency and quality of treatment cost discussions will decrease the short- and longer-term burdens of financial toxicity through their influence on self-efficacy for managing treatment cost. the focus is on patient self-efficacy for managing treatment cost because it is expected that improved treatment cost education and patient-oncologist treatment cost discussions prompted by the disco app will directly improve the self-efficacy needed for patients to proactively manage treatment costs, thus reducing the material and psychological burden of financial toxicity. the disco app is not designed to increase patients' ability to pay or reduce the cost of treatment, but it may benefit patients by increasing: their knowledge of treatment costs, their self-efficacy for managing cost, and the likelihood they receive financial and psychological assistance and support. this research is significant because, if successful, reducing the material and psychological burden of financial toxicity will improve the quality of care and work toward achieving health equity. the disco app has already been tested for its feasibility and acceptability. the disco app will now be tested for its effectiveness in a diverse population of people with solid tumors treated with iv and oral chemotherapies.

Eligibility criteria:
inclusion criteria: * oncologists are eligible if they treat patients with breast, prostate, lung, or colorectal cancers at karmanos cancer institute. data from oncologists will include their self-report data and video-recorded treatment discussions with participating patients. * patients: must be able to read and write in english; have an email account; and are newly diagnosed with breast, prostate, lung or colorectal cancer (stage i-iv) for which systemic therapy is a likely recommended treatment. data from patients will include their self-report data, video-recorded treatment discussions with participating oncologists, and medical record data exclusion criteria: -

Keywords: financial toxicity cancer treatment cost patient-provider communication
neuropsychological and psychosocial follow up of children and adolescents with neuromuscular disease

Conditions: Neuromuscular Diseases

Summary: this project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease.

this project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease. children and adolescents in uz leuven will be evaluated according to a psychosocial and neuropsychological protocol including different psychological tests and patient questionaires.

Eligibility criteria:
inclusion criteria * children and adolescents (0-18 years) * diagnosis of neuromuscular disease
brain glioma registry combining clinical and imaging information

Conditions: Adult Glioma

Summary: this registry aims to collect clinical and radiologic information including detailed clinical, conventional mr and advanced mr imaging data of patients with brain gliomas. advanced mr imaging may include diffusion-weighted imaging, perfusion-weighted imaging (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and chemical exchange saturation transfer (cest) imaging. this registry will describe course of disease and long-term outcomes of brain gliomas.

though the cure for brain glioma- from low grade to glioblastoma- is yet to be found, seeking for curable treatment option is actively developing. multimodal advanced mr imaging (contrast-enhanced t1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging) on 3 tesla have shown potential in patients with glioma to monitor treatment response with quantitative assessment. to find suitable imaging biomarker for treatment response, assessing clinical and radiologic outcome for long-term is essential. the creation of a registry for brain glioma in long-term follow up provides an overview of the clinical, relevant treatment standards, advanced mr imaging information, and survival data of patients and thus create opportunities for imaging biomarker research.

Eligibility criteria:
inclusion criteria: * patients must have radiologically and histologically confirmed diagnosis of brain glioma * life expectancy of greater than 3 months * must receive a first- or second-line therapy * signed informed consent exclusion criteria: * no brain gliomas * patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction * patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential

Keywords: adult glioma mri
a safety and efficacy study of the combination of oral pf-00299804 and intravenous cp-751,871 given every 3 weeks

Conditions: Carcinoma, Non-Small Cell; Neoplasm Metastasis

Summary: this study will explore the combination of the oral drug pf-00299804 and intravenous cp-751,871 in patients with advanced solid tumor. each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.


Eligibility criteria:
inclusion criteria: * histologically documented advanced cancer, eastern cooperative oncology group (ecog) 0-1; * platelets \> 100,000, anc \> 1500; * ccr \> 60 or serum creat. \<1.5 * non-small cell cancer cohort: * eastern cooperative oncology group (ecog) 0-2, prior platin, \< 4 prior chemotherapy regimen * hga1c \<5.7% exclusion criteria: * active central nervous system (cns) metastases; * prior igf1-r targeted therapy * any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

Keywords: advanced cancer refractory advanced non-small cell lung cancer
metabolic effects of acute cortisol withdrawal in adrenal failure

Conditions: Addison Syndrome

Summary: effects of adrenal steroids is generelly drawn from studies of hypercortisolism. the effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.


Eligibility criteria:
inclusion criteria: * female adrenal failure * age 18-50 * written informed content exclusion criteria: * diabetes mellitus * cancer * thromboembolic events * pregnancy and lactation * heart disease

Keywords: cortisol adrenal insufficiency glucose metabolism protein metabolism lipid metabolism insulin sensitivity.
post market surveillance & post market clinical follow up, international, medical registry to confirm the safety and the performance of the anecova intra uterine culture device

Conditions: Infertility; Reproductive Sterility

Summary: this study is designed to generate a comprehensive survey of the use on the market of the anecova device within its intended indications according to the instructions for use. the anecova registry is part of the anecova quality system, to enable the post marketing surveillance and the post market clinical follow-up.

as soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place. these biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female dna and the chromosome segregation on the newly formed mitotic spindle. if any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. in other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy. in vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions. the registry will capture information from the anecova procedure, from the outcomes, from the procedure performance, from the safety and from the utilization of the anecova medical device in clinical routine.

Eligibility criteria:
inclusion criteria: * age between 18 and 43, * hormonal serum levels within normal ranges for the routinely or specifically tested hormones (fsh, lh, amh, e2, prl, p4, tsh), * bmi between 18 and 29, if assessed normal antral follicular count and regular menses exclusion criteria: * endometrial, autoimmune or hormonal specificities, as well as presence of pathology that could be potentially deleterious to the healthy development of embryos in the uterine cavity (i.e. severe endometriosis), * acute or chronic gynecological infection

Keywords: in vivo culture