Kornimate/medical-research-clean huggingface dataset:
an evaluation of axs-05 for the treatment of trd in treatment-adherent patients

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Summary: the target study is an active-controlled evaluation of axs-05 compared to bupropion in patients with treatment-resistant major depressive disorder (mdd) who are adherent to study drug. subjects are considered to have treatment-resistant mdd if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (adts) and a prospective inadequate response to treatment with bupropion sr, during the current major depressive episode. the target study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the axs-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of axs-05 in patients determined to be treatment-adherent. efficacy data for evaluation of treatment effect will be obtained from assessments made during study axs-05-301.


Eligibility criteria:
key inclusion criteria: * provided written informed consent to participate in study axs-05-301 * has treatment-resistant depression, defined as an inadequate response to 2 or 3 prior adts * body mass index (bmi) between 18 and 40 kg/m2, inclusive key exclusion criteria: * suicide risk * treatment with any investigational drug within 6 months * history of electroconvulsive therapy (ect), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months * pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Keywords: axs-05 axsome nmda receptor
rtms treatment in vascular parkinsonism

Conditions: Vascular Parkinsonism

Summary: vascular parkinsonism (vp), parkinsonism resulting from ischemic cerebrovascular disease, was suggested in 1929. the main features are wide-based gait, postural instability, and falls, which make patients with vp frustrated. currently, the treatment is challenging. transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain, and repetitive transcranial magnetic stiumation (rtms) can selectively change brain activity to enhance desired effects. the aim of this study is to explore the therapeutic effect of rtms for the vp.


Eligibility criteria:
inclusion criteria: * vascular parkinsonism * age 18 and older exclusion criteria: * pregnant or any, other medical, surgical, neurological or psychiatric conditions * other restrictions which prevent you from undergoing tms recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines * any past or current history of seizure disorder or epilepsy * unable to give informed consent

Keywords: parkinsonism vascular parkinsonism repetitive transcranial magnetic stimulation brain stimulation
transnasal endoscopic surgery combined with adjuvant immunotherapy for recurrent npc

Conditions: Recurrent Nasopharyngeal Carcinoma

Summary: a prospective, single-arm, multicenter clinical study of transnasal endoscopic surgery combined with adjuvant immunotherapy for recurrent nasopharyngeal carcinoma


Eligibility criteria:
inclusion criteria: * pathology or radiography confirmed recurrent nasopharyngeal carcinoma. * ajcc rt1-t4 which can be surgically removed. * age ≥18 years old. * informed consent signed. * with or without lymph node metastasis, which can be surgically removed. * no distant metastasis. * ≥6 months from the end of initial radiotherapy to recurrence. * sufficient organ function a)hematology: white blood cells ≥3.0 x 109/l, absolute neutrophil count ≥1.5x 109/l, hemoglobin ≥80 g/l, platelets ≥100 x 109/l. b) liver function: bilirubin ≤ 1.5 times the upper limit of normal (uln), ast and alt ≤ 3 times the uln c) international normalized ratio (inr) or prothrombin time (pt) or activated partial thromboplastin time (aptt) ≤ 1.5 times uln. d) renal function: serum creatinine ≤ 1.5 times uln. * ecog score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy. exclusion criteria: * evidence of distant metastasis or leptomeningel disease (lmd). * have received radioactive seed implantation in the treatment area. * suffer from uncontrolled disease which could interfere with treatment. * suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.). * the patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on. * the patients have autoimmune diseases. * the patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration. * severe allergic reaction to other monoclonal antibodies. * previously received pd-1 monoclonal antibody, ctla-4 monoclonal antibody (or any other antibody that acts on t cell co-stimulation or checkpoint pathway) treatment. * live vaccines have been inoculated within 4 weeks before the first administration or during the study period. * the patient has any situation that may hinder study compliance or the safety during the study period. * existence of serious neurological or psychiatric diseases, such as dementia and seizures. * uncontrolled active infection. * pregnant or breastfeeding women. * those who have no personal freedom and independent capacity for civil conduct. * there are other situations that are not suitable for entry into the study.
the effect of citric flavonoid on endothelial function

Conditions: Obesity; Overweight

Summary: this randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects. futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.


Eligibility criteria:
inclusion criteria: * overweight men/women (bmi 25-35 kg/m2) * healthy individuals * age between 18 and 70 years * fasting glucose \< 7.0 mmol/l * normal hba1c (4.4 to 6.2%) exclusion criteria: * type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/l) * gastroenterological diseases or abdominal surgery * cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years * self-admitted hiv-positive status * abuse of products; alcohol (\> 20 alcoholic consumptions per week) and drugs * smoking * plans to lose weight or following a hypocaloric diet during the study period * weight gain or loss \> 3 kg in previous 3 months * use of medication interfering with endpoints * intake of antihypertensive medication, statins, corticosteroids, nsaids, ciclosporin a, rifampicin are strictly forbidden * use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine * hormone replacement therapy (women) * use of antibiotics in the 90 days prior to the start of study * administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study * known pregnancy (assessed by a pregnancy test before start of study), lactation * blood donation within 3 months before study period * failure to comply prohibited intake of hesperidin containing food products during study period and prohibited intake of food products that are able to influence the fmd measurements one day prior to test days. * history of any side effects towards the intake of flavonoids or citrus fruits

Keywords: polyphenols endothelial function gut barrier function
faith-based initiative to promote health in appalachia

Conditions: Cancer; Obesity

Summary: the project will target two behavioral causes of obesity: a sedentary lifestyle and an unhealthy diet. the goal is to test a faith-based intervention among men and women who are members of participating appalachian churches. the primary hypothesis being tested in this project is: the change in body mass index from baseline to one year follow-up in intervention churches will be greater than among comparison churches, such that the differential change will be negative on average.


Eligibility criteria:
inclusion criteria: * age 18 or older * member of the participating church who has attended services at least 4 times in the past 2 months * resident of an appalachia county * able bodied (no contraindications to physical activity and no dietary restrictions that are part of a medically prescribed diet for weight loss or formal weight loss program) * able to read and write in english * have a bmi indicating that they are overweight (bmi \> or = 25.0, assessed during biometric measurement) * under 400 pounds (per self-report and confirmed during biometric measurement) * not planning to move out of the area within the next year * does not reside in nursing facility or residential home * if female, is not pregnant, breastfeeding or less than 9 months post-partum and does not intend to become pregnant during the study * able to provide informed consent. exclusion criteria: * does not meet inclusion criteria

Keywords: cancer obesity body mass index
home-based kidney care in native americans of new mexico (hbkc) - enhancement: covid-19 study

Conditions: CKD

Summary: novel severe acute respiratory syndrome coronavirus 2 (sars-cov-2) or covid-19 related addition: the aim of this addition activity is to track the impact of the covid-19 epidemic on participants with diabetes and chronic kidney disease (ckd). investigators have modified the original hbkc study protocol to expand data currently collected from study participants to include data in the following domains linked to the covid-19 epidemic: symptoms of covid-19 disease, access to healthcare, and impact on health related behaviors (such as medication adherence, physical activity, dietary behaviors, smoking, and alcohol use).

investigators will administer a survey by phone or mail to all participants screened for diabetes and chronic kidney disease in the original hbkc study protocol. the survey will address to the following aims: aim 1. develop a phone-based and or mail based survey to understand the impact of covid19 on patient-reported outcomes for adults with diabetes and ckd. aim 2. test the feasibility and acceptability of this phone-based and or mail based survey in the hbkc cohort.

Eligibility criteria:
inclusion criteria: * willingness to participate in the phone-based and or mail based survey. exclusion criteria: * none

Keywords: ckd, diabetes, ameircan indians, covid-19,
investigation of urinary biomarkers for the detection of breast cancer

Conditions: Breast Cancer; Urine; Liquid Biopsy

Summary: the aim of this study is to investigate and possibly validate urinary biomarkers for breast cancer. during this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, ctc or blood derived cfdna. proteins will be explored in urine as well. this is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with breast cancer. the participants will be asked to provide a urine sample collected with the collipee® device and fill out an online questionnaire to collect usability data. thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.


Eligibility criteria:
inclusion criteria: * being at least 18 years old * being able to understand and read dutch * for cancer patients: diagnosed with breast cancer exclusion criteria: * for cancer patients: suffering from a blood cancer * for healthy volunteers: diagnosed with cancer

Keywords: first-void urine liquid biopsy oncology colli-pee biomarker
effectiveness of traditional and computerized versions of super skills for life in children

Conditions: Depressive Disorder; Depressive Symptoms; Anxiety Disorders; Anxiety Disorders and Symptoms; Mood Disorders; Emotional Disorder

Summary: super skills for life (ssl) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills). ssl consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies. the aim of the study is to investigate the comparative effectiveness of ssl in its traditional and computerized versions on internalizing symptoms in spanish children between 8 and 12 years of age.

children will be selected to receive the ssl program based on results on psychometrically robust measurements and inclusion/exclusion criteria. selected children will be randomly assigned to the conditions of the two intervention groups (traditional and computerized versions of ssl). parents and children from the two groups will complete the same measures at baseline and post-treatment. they will also complete these measures at 6 months follow-up, and 12 months follow-up. researchers will compare the results of pre-test to post-test assessments in children participating in the traditional and multimedia versions of ssl on depressive symptoms, anxiety symptoms, interference of anxiety on child's life, self-esteem, social skills, social worries, and cognitive emotional regulation. the investigators will also assess these variables in the intervention group at 6 months and 12 months follow-up.

Eligibility criteria:
inclusion criteria: * children aged 8 - 12 years old. * presence of emotional symptoms, which will be assessed using the scas and the mfq, parent versions. the cut-off point for inclusion in the study is a score equal to or above 25 on the scas and/or equal to or above 20 on the mfq. * speaking, reading, writing and understanding spanish. exclusion criteria: * intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment. * being receiving current psychological or pharmacological treatment for anxiety and/or depression. * not accepting or revoking informed consent to participate in the study.
refining paracervical block techniques for pain control in first trimester surgical abortion

Conditions: Pain

Summary: the purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that varying paracervical block techniques might have on that pain. these different techniques involve wait time following the injection as well as the number of sites injected.

the investigators plan to conduct a single-blinded randomized trial of 350 women undergoing elective first-trimester surgical abortion. subjects will be randomized to two different paracervical block techniques, but both the medications and the amount of medications will remain the same. subjects will not know to which group they have been randomized as this knowledge may affect how much pain is felt. primary outcome: patient reported pain with cervical dilation during first trimester surgical abortion. pain is measured as mm distance from the left of the 100-mm visual analogue (vas) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. the 100-mm vas scale is a well established and validated study instrument. secondary outcomes: 1. socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms 2. pain (vas scale): * anticipated * baseline * with speculum insertion * with placement of the pcb * with aspiration * 30 min postoperatively * intrapersonal pain changes (calculated in analysis) * anxiety \[baseline\] (vas scale; anchors 0 = none, 100mm = worst imaginable): * of pain * of surgery * satisfaction (vas scale; anchors 0 = not, 100mm = very satisfied): * with pain control * overall abortion experience * adverse events * need for additional intraoperative and/or postoperative pain medication * participants' belief if they were in the intervention or control group

Eligibility criteria:
inclusion criteria: * age 18 years or older * voluntarily requesting pregnancy termination * ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age * generally healthy * english or spanish speaking * able or willing to sign an informed consent and agree to terms of the study exclusion criteria: * gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this gestational age at the study sites) * incomplete abortion * failed medical abortion * required or requested iv sedation (prior to randomization) * patient who declines ibuprofen, lorazepam or pcb * medical contraindication or allergy to any of the study medications * chronic use of narcotic pain medication or heroin * significant physical or mental health condition * adnexal mass or tenderness on pelvic exam consistent with inflammatory disease * known hepatic disease * women who, in the opinion of the investigator, are not suitable for the study protocol

Keywords: pain during first-trimester surgical abortion
corevitas generalized pustular psoriasis (gpp) drug safety and effectiveness registry

Conditions: Generalized Pustular Psoriasis

Summary: prospective, observational registry for subjects with gpp under the care of a dermatology investigator.approximately 200 subjects and 75 clinical sites in north america will be recruited to participate with no defined upper limit for either target

the objective of the registry is to obtain information on the treatment patterns, disease activity progression, and the development of comorbidities and adverse events in a cohort of patients with gpp. data collected will be used to better characterize the natural history and longitudinal trajectory of the disease. this will be done through the standardized data collection including validated patient-reported outcomes (pro) and clinician-reported outcomes (clinro), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of gpp for the purposes of clinical, market, or outcomes research. this provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Eligibility criteria:
inclusion criteria: * a subject must meet all the following criteria to participate in the registry: 1. has been diagnosed with gpp by a dermatologist or a qualified dermatology practitioner. 2. is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted. 3. is willing to provide consent for participation in the registry. 4. is willing to provide personal information exclusion criteria: * any of the following would exclude the subject from participating in the registry: 1. is participating or planning to participate in a blinded clinical trial evaluating a systemic agent for the treatment or prevention of flares related to gpp. 2. is enrolled in another corevitas registry for a dermatological condition. subjects enrolled in another corevitas registry must be exited to be eligible for enrollment into the gpp registry
a pilot study of mitoxantrone for the treatment of recurrent neuromyelitis optica (devic's disease)

Conditions: Neuromyelitis Optica; Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System

Summary: neuromyelitis optica (nmo) is a severe demyelinating disease that selectively involves the optic nerves and the spinal cord but usually spares the brain. nmo is considered to have a b cell induced pathogenesis. mitoxantrone (mito, novantrone®), a synthetic anthracenedione approved for worsening relapsing-remitting multiple sclerosis (ms) and secondary progressive ms, has been shown to primarily suppress the humoral response. we conducted a prospective 2-year study to evaluate the benefit of mito in five relapsing nmo patients.

the treatment protocol consisted of monthly 12 mg/m2 mito intravenous infusions for 6 months followed by 3 additional treatments every 3 months. neurological assessment including the determination of the expanded disability status scale (edss) score was performed every 3 months and during relapses. orbital, brain and spinal cord mri was performed at baseline, 3, 6, 12, 18, and 24 months. visual evoked potentials and ophthalmologic evaluations were performed at baseline and annually.

Eligibility criteria:
inclusion criteria: * recurrent longitudinal myelitis (\>3 segments of spinal cord involvement by mri) with or without recurrent on (unilateral or bilateral) but with normal brain mri. * patients with recurrent longitudinally extensive myelitis without optic neuritis have an underlying pathology and serology similar to nmo and it is appropriate to consider this a form of nmo10. * cerebrospinal fluid required no intrathecal igg synthesis or oligoclonal bands. * age was required to be 18-55 years * extended disability status score ≤ 7. exclusion criteria: * cardiac risk factors (e.g history of congestive heart failure and left ventricular ejection fraction (lvef) \< 50% * systemic diseases such as lupus, sjogren's syndrome, anti-phospholipid antibody syndrome, sarcoidosis, rheumatoid arthritis, or vitamin b12 deficiency * previous treatment with mitoxantrone or anthracyclines

Keywords: novantrone
optical tomographic scanner for skin lesions

Conditions: Skin Cancer, Benign Skin Tumor, Inflammatory Skin Disease

Summary: optical coherence tomography is technology widely used in medicine. in this study, the investigators will use an optical tomographic scanner to scan skin tissue image.

the investigators will use optical tomographic scanner to scan skin specimen and obtain tissue images. part of skin specimen obtained from skin biopsy or surgery will be scanned.

Eligibility criteria:
patient who receive skin biopsy or surgery due to skin cancers, benign skin diseases, or inflammatory skin diseases.

Keywords: optical coherence tomography