Kornimate/medical-research-clean huggingface dataset:
xanamem® in adults with major depressive disorder and impaired cognition (xanacidd)

Conditions: Major Depressive Disorder; MDD; Cognitive Impairment

Summary: xanamem is being developed as a potential treatment for symptomatic, early stages of alzheimer's disease (ad) and major depressive disorder (mdd). this xanacidd phase ii study in mdd is to investigate the safety and efficacy of xanamem™ in treating patients with cognitive and depressive symptoms. trial participants will be randomized to either receive 10mg of xanamem™ once daily or a placebo at a 1:1 ratio in a double-blinded fashion.


Eligibility criteria:
key inclusion criteria: * male or female aged 18 to 75, inclusive. * positive mdd primary diagnosis confirmed by the mini-international neuropsychiatric interview (mini). * persistent depressive symptoms as determined by a hamilton depression rating scale (ham-d) ≥ 17 at screening. * cognitive abilities on a coding test \> 0.5 standard deviations below expected. * self-reported subjective cognitive dysfunction. * currently or previously treated with a stable dose of a first- or second-line antidepressant that is approved for the treatment of depression (but not a tricyclic antidepressant, monoamine oxidase inhibitor, or vortioxetine). if on current treatment, dose must be stable for at least 6 weeks. * smokers are eligible if they are able to comfortably abstain from nicotine for 2 hours prior to scheduled cognitive assessments. * able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments. * must provide written informed consent to participate in the trial and be willing and able to comply with the requirements of the protocol and complete all trial visits. key exclusion criteria: * active suicidal ideation within the previous 3 months * on a tricyclic antidepressant, monoamine oxidase inhibitor, esketamine, or vortioxetine. * a history of clinically diagnosed dementia of any type * previous clinically significant systemic illness or infection, including test positive covid-19, within the past 4 weeks prior to screening * has a bmi or body weight that will interfere with participation in the trial * type i or type ii diabetes requiring insulin * clinically significant ecg abnormalities * participation in another clinical trial of a drug or device * trial participants who in the opinion of the investigator exhibit physical, cognitive, or language impairments of such severity as to adversely affect the validity of the data derived from the neuropsychological tests. * positive testing for hiv, hepatitis b surface antigen, or hepatitis c antibodies at screening. * participants with a history of drug abuse or addiction in the past 2 years * current use of cannabis/marijuana, or tetrahydrocannabinol-containing medications.

Keywords: xanamem ue2343 actinogen cortisol 11β-hsd1 11-beta-hydroxysteroid dehydrogenase type 1 emestedastat
a study of brontictuzumab with chemotherapy for subjects with previously treated metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic colorectal cancer.

this is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic colorectal cancer. this study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for up to 24 months. patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. approximately 34 patients will be enrolled in this study at approximately 5 study centers in the united states.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic colorectal cancer (mcrc) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf biological therapy, and if kras wild-type, an anti-egfr therapy * ecog performance status 0 or 1 exclusion criteria: * prior treatment with gamma secretase inhibitors or other notch 1 inhibitors * subjects with known active hiv infection. subjects with hiv that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal cd4 counts), undetectable viral load, and no hiv-related infections are eligible * subjects with uncontrolled diarrhea \<30 days prior to first administration of study drug * subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to: * inflammatory bowel disease (including ulcerative colitis and crohn's disease) * active peptic ulcer disease * known intraluminal metastatic lesion(s) with risk of bleeding
vasopressor infusion in cesarean delivery

Conditions: Cesarean Section Complications; Spinal Anesthesia

Summary: comparison will be conducted between continuous variable infusions of both drugs (phenylephrine and norepinephrine) with starting doses of 0.75 mcg/kg/min and 0.1 mcg/kg/min respectively for prophylaxis against post-spinal hypotension during cesarean delivery.

maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (cd). many vasopressors have been used for prevention of post-spinal hypotension (psh) during cd; however, the optimum protocol for prophylaxis is not established yet. phenylephrine (pe) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. norepinephrine (ne) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, ne is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make ne an attractive alternative to pe. in this study, we will compare continuous variable infusion of both drugs (pe and ne) with doses of 0.75 mcg/kg/min and 0.1 mcg/kg/min respectively for prophylaxis against psh during cd.

Eligibility criteria:
inclusion criteria: * full term * pregnant women * scheduled for cesarean section exclusion criteria: * pre-ecpamsia * eclampsia * bleeding * cardiac dysfuction
phenotypes, biomarkers and pathophysiology in spastic ataxias

Conditions: Spastic Ataxia

Summary: the aim of this study is to determine the clinical spectrum and natural progression of spastic ataxias (spax) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

the investigators will perform a registry-based standardized prospective natural history study (nhs) in spax and related disorders. participants will be seen annually. at study visits a standardized clinical examination will be performed including application of clinical rating scales (selection of rating scales may vary depending on the individual phenotype and specific genotype); data will be entered into a clinical database (hsp registry; https://www.hsp-registry.net and arca registry; www.arca-registry.org). at all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, csf, and/or a skin biopsy. optionally, additional examinations may be performed including imaging, quantitative movement analysis, neuropsychological examinations, analysis of patient or observer reported outcomes and omics analysis to characterize molecular biomarkers. in participants without a genetic diagnosis, next generation sequencing may be performed. thus this study will establish a model of disease progression and mechanistic evolution in spax, which will allow to track and understand selective as well as overlapping dysfunction of the cerebellum and corticospinal tract. in a transatlantic natural history study we will longitudinally validate clinician- and patient-reported, digital and molecular outcomes. in addition, we will improve on existing and develop new outcome parameters that show superior sensitivity to change. these include a novel clinical spax composite score, a smartphone mhealth toolbox combining remote assessment of daily living by wearable sensors with app-based patient-entered outcomes (spax.app), and multimodal mri radiomics with an innovative machine learning approach for multisite mri analysis, including in particular the infratentorial space. longitudinal validation of targeted fluid biomarker candidates will aslo be an important part.

Eligibility criteria:
inclusion criteria: * arsacs cohort: genetic diagnosis of arsacs and clinically manifest disease * spg7 cohort: genetic diagnosis of spg7 and clinically manifest disease * unrelated healthy controls: no signs or history of neurological or psychiatric disease and * written informed consent provided and * participants are willing and able to comply with study procedures exclusion criteria: * missing informed consent * for controls: evidence of a neurodegenerative disease or movement disorders; inability to give informed consent

Keywords: spastic ataxia biomarker genetic etiology molecular mechanisms natural history study
study of cipterbin®, used alone or with vinorelbine in patients with her2/neu-overexpressed metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the her2 gene (also known as her2/neu and erbb2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. trastuzumab,a humanized anti-her2/neu receptor monoclonal antibody, has been proved a valuable treatment for her2-positive breast cancer patients.the combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. cmab302, a biosimilar of trastuzumab, was developed by shanghai cp guojian pharmaceutical co.ltd. efficacy and safety of cmab302 as a single agent or in combination with vinorelbine were evaluated in patients with her2-overexpressing metastatic breast cancer.

the her2 gene (also known as her2/neu and erbb2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. trastuzumab,a humanized anti-her2/neu receptor monoclonal antibody, has been proved valuable treatment for her2-positive breast cancer patients.the combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. cmab302, a biosimilar of trastuzumab, was developed by shanghai cp guojian pharmaceutical co.ltd. previous phase i study showed that cmab302 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 100 to 500 mg, similar to that of trastuzumab. in this study, efficacy and safety of cmab302 as a single agent or in combination with vinorelbine were evaluated in patients with her2-overexpressing metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis breast cancer * her2+ status defined as ihc3+ staining or in situ hybridization positive at least 1 measurable lesion as per recist criteria * adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3) * adequate liver (bilirubin \<1.0 times upper limit of normal and sgot/sgpt \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl) * adequate cardiac function (lvef\>50%). normal electrocardiogram and absence of significant heart disease * age from 18 to 70y * karnofsky performance score ≥ 60 * life expectancy of greater than 3 months * negative hcg pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. * signed icf exclusion criteria: * prior exposure vinorelbine for breast cancer * prior exposure trastuzumab for breast cancer * prior chemotherapy and radiation therapy within the last 4 weeks before enrollment * use of any other investigational agents within the last 4 weeks before enrollment * symptomatic, central nervous system metastases * hypersensitivity to trial medications * breastfeeding or pregnant

Keywords: her2-overexpressed
the effect of electrical stimulation on tear production

Conditions: Dry Eye

Summary: the purpose of this study is to investigate whether electrical stimulation of the nerve innervating the tear gland results in tear production in subjects with severe dry eye.

a non-randomized, open-label study designed to investigate the feasibility of a novel treatment for severe dry eye disease, which involves safe delivery of small electrical currents to the lacrimal nerve to induce tear production.

Eligibility criteria:
inclusion criteria: * schirmer test with topical anesthesia of ≤ 5 mm/5 min in at least one eye * sum of corneal and interpalpebral conjunctival staining of \> +5 in the same eye where corneal staining is \> +2 using the clek criteria. exclusion criteria: * individuals with the presence or history of any ocular disorder or condition (including ocular surgery, trauma, and disease) that could possibly interfere with the interpretation of the study results. individuals who have had lasik or other refractive surgeries are eligible. excluded conditions include: * history of orbital trauma * history of orbital surgery * orbital cancer * history of orbital cancer * within the 3 months before the screening visit, known history of ocular infection (viral, bacterial, fungal), inflammation not associated with dry eye, or active ocular herpes
pharmacogenetic treatments for alcoholism

Conditions: Alcoholism

Summary: heavy drinking can cause serious health, family, and economic problems. finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. a novel and important strategy to enhance alcoholism treatment efforts uses a personalized medicine approach to optimize treatment effects by selecting the "right" patient therapeutically and potentially with a minimum of adverse events, for a specific medication. this study will extend findings from a randomized double-blind clinical trial of ondansetron, in which the medication was found to reduce drinking among individuals with certain genotypes (i.e., forms of dna, the material that controls the inheritance of characteristics). the proposed study will address a number of limitations in the prior work, including testing the medication in both european-american and african-american samples.

this study is a 24 week clinical trial. during the 24 weeks participants will receive either ondansetron or placebo. participants will also receive brief behavioral compliance enhancement treatment (bbcet) as their psychosocial adjuct weekly in weeks 1 to 12, and then every 2 weeks in weeks 12 to 24. we will enroll two separate population groups (i.e., african-americans and european-americans), each with 128 treatment-seeking, alcohol-dependent individuals in a 24-week clinical trial. subjects in each of these two population groups (n=128/group) will be randomized into 4 cells (n=32/cell) in a 2 (tt vs. tg or gg) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. group assignment will be achieved using a block randomization procedure that balances the treatment groups on phdd, age, and gender.

Eligibility criteria:
inclusion criteria: * males and females who have given written informed consent * between the ages of 18 and 65 years and weighing within 30% of ideal body weight. also, patients must weigh at least 40 kg and no more than 155 kg. * good physical health as determined by a complete physical examination, an electrocardiogram (ekg) within normal limits, and laboratory screening tests within acceptable parameters. * current dsm-iv diagnosis of alcohol dependence * audit score of ≥8 * currently drinking ≥14 alcohol units/week for women and ≥21 alcohol units/week for men in the last 30 days, and have met this criteria prior to randomization * provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next 9 months. * literate in english and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments * expressed a wish to reduce or stop drinking * willingness to participate in behavioral treatments for alcoholism exclusion criteria: * please contact site for additional information

Keywords: alcohol dependence alcohol addiction
individually tailored web-based multimodal pain rehabilitation in primary health care

Conditions: Musculoskeletal Pain

Summary: the aim is to evaluate effects of early individually tailored web-based multimodal rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary health care. the aim is also to study if this early web-based pain rehabilitation program is more cost-effective than only multimodal rehabilitation. randomization will be done at each primary health care centre after screening to 1) multimodal pain rehabilitation with web-based education and coaching support or 2) multimodal pain rehabilitation. the investigators suggest a clear rehabilitation chain where a web-based program is developed,evaluated and ready to implement if it shows positive effects on work-ability and/or is cost-effective. the research and implementation will be performed in a close cooperation with luleå university of technology.


Eligibility criteria:
inclusion criteria: * with persistent neuromusculoskeletal pain from the neck/shoulder/back-area and/or fibromyalgia and a screening * \> 90 on lintons´ questionnaire, the örebro musculoskeletal pain questionnaire (linton \& halldén., 1998; hockings et.al., 2008) * fluent in swedish language * working, or in disposition to at least 25% exclusion criteria are persons with: * dementia * restricted cognitive functioning * comorbidity which might prevent treatment participation * identified abuse, retirement pension * ongoing causal treatment * pregnancy * patients lacking internet attached computers in their home

Keywords: persistent neuromusculoskeletal pain neck shoulder back-area risk longlasting pain syndrome
interventions for english language learners at-risk for adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the goal of this clinical trial is to compare the effect of language and behavioral interventions for students who are english language learners and who have symptoms of attention-deficit/hyperactivity disorder (adhd). the main question it aims to answer is: - which intervention is better for the students: the behavioral intervention, the language intervention, or a combination of the behavioral and language interventions? participants will be asked to do the following: * participants' parents and teachers will be asked to complete questionnaires about their behavior. * participants will be asked to complete tests assessing language, cognitive, and academic abilities. * members of the research team will complete classroom observations for the participating students. * participants will be randomly assigned to one of four groups: a school as usual group, a language group, a daily report card group, and a combined daily report card and language group. * if assigned to the language group, participants will receive an 18-week language intervention. * if assigned to the daily report card group, a behavioral consultant will work with participants' parents and teachers to set up a home-school behavior plan called a daily report card. * if assigned to the combined daily report card and language group, participants will receive both the language intervention and the daily report card. * if assigned to the school as usual group, participants will no study interventions. researchers will compare the language group, the daily report card group, the combined language and daily report card group, and the school as usual group to see which group has the best language learning and classroom behavior at the end of the program.


Eligibility criteria:
inclusion criteria: * identified as an english language learner level 1 through 4 by their school district * enrolled in kindergarten or 1st grade during the year of participation * 6 or more symptoms of attention-deficit/hyperactivity disorder endorsed by parent or teacher * has a teacher who is willing to participate * has a parent or primary caregiver who is willing to participate exclusion criteria: * participant has an active individualized education plan for language or behavior * participant iq is less than 70 * participant is diagnosed with psychosis * participant is diagnosed with autism spectrum disorder with severity level 2 or greater or another pervasive developmental disorder * participant is enrolled in home-school

Keywords: english language learners classroom behavioral intervention language intervention
the clinical study for evaluation of efficacy and safety of egf on oral mucositis in radiation therapy patients

Conditions: Stomatitis

Summary: the purpose of this study is to evaluate the efficacy and safety of rhegf on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy

radiation therapy causes many side effects especially oral mucositis. the purpose of this study is to evaluate the efficacy and safety of rhegf on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. head and neck cancer patients who have a plan to receive a minimum of 50 gy radiation therapy will be enrolled.

Eligibility criteria:
inclusion criteria: * male or female, aged at least 18 years exclusion criteria: * females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential * have oral mucositis or other oral conditions at study entry
glucocorticoid therapy for covid-19 critically ill patients with severe acute respiratory failure

Conditions: COVID-19 Infections

Summary: in this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for covid-19 patents with severe acute respiratory failure.

covid-19 is a novel coronavirus that was initially outbreak in wuhan, china. severe acute respiratory infection with covid-19 causes severe acute respiratory failure with substantial mortality. currently, the standard care is supportive care, and no treatment is proven to be effective for this condition. glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as sars (severe acute respiratory syndrome) and mers (middle east respiratory syndrome). however, whether glucocorticoid improved the outcome of covid-19 remains unknown. we hypothesized that glucocorticoid would improve the prognosis of patietns with covid-19. in this study, critically ill patients with covid-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. the primary outcome is the difference of murray lung injury score between two groups.

Eligibility criteria:
inclusion criteria: * adult * pcr confirmed covid-19 infection * symptoms developed more than 7 days * pao2/fio2 \< 200 mmhg * positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (hfnc) higher than 45 l/min for less than 48 hours * requiring icu admission exclusion criteria: * pregnancy; * patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent); * severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease; * severe adverse events before icu admission, i.e. cardiac arrest; * underlying disease requiring corticosteroids; * contraindication for corticosteroids; * recruited in other clinical intervention trial